Why Proper Service At Start Of State Court Filing Counts: “Bayer Essure Litigation Update”

Federal judge rules Essure personal injury cases not headed back to state court due to no initial service on Bayer 

By Mark A. York (June 24, 2019)

(MASS TORT NEXUS MEDIA) A federal judge in Pennsylvania has limited tort and breach of warranty claims in the Bayer Essure litigation in recent rulings, as well as ruling that no service at start of certain state court cases, keeps them in the federal docket.

U.S. District Court ED Pennsylvania Judge John R. Padova excerpt: 

“Plaintiffs have filed a motion to remand all 24 cases to the Court of Common Pleas of Philadelphia County. They argue that defendant Bayer HealthCare LLC, which is a named defendant in each complaint but is not one of the removing defendants, is a citizen of Pennsylvania and that the Forum Defendant Rule therefore bars removal. The removing defendants counter that the Forum Defendant Rule does not bar removal in these cases because the sole Pennsylvania defendant – Bayer HealthCare, LLC – was not ‘properly joined and served’ as it was not served with the complaint prior to removal,” Padova later adding “that the plaintiffs could have prevented the consequence of his ruling by sending the complaint to all of its named defendants, simultaneously with its filing.”

Bayer Essure USDC ED Pennsylvania Order Denying Motion to Remand May 24, 2019 (Judge Padova)

Additional recent rulings by the same judge, which are favorable to Bayer, state that express pre-emption applied to many of the plaintiffs’ claims as well as those that failed to be filed within the statute of limitations.

The judge ruled on:

  • Statute of limitations — whether time had run out on cases
  • Discovery rule — an exception to the statute of limitations for tort claims that applies in certain cases
  • Breach of warranty — refers to a company’s failure to live up to a claim made about a product
  • Fraudulent concealment — when a company hides a fact that it had a duty to disclose

In a recent 60-page opinion, U.S. District Judge John Padova of the Eastern District of Pennsylvania weighed the claims of a dozen women suing Bayer over the device and determined that many should be dismissed at the summary judgment phase because they were not brought within the allowable time frame.

Padova commented that the ruling is meant to give guidance to the parties litigating over 1,000 defective device lawsuits in state and federal courts.

NO REMAND TO PHILLY COURT

Twenty-four personal injury cases filed against Bayer Pharmaceuticals from women who used its Essure birth control device will not be returning to the Philadelphia County Court of Common Pleas, per a recent federal court ruling.

In an order dated May 24, U.S. District Court for the Eastern District of Pennsylvania Judge John R. Padova disagreed with the plaintiffs’ assertion that a state court had subject matter jurisdiction over the disputes.

Essure are metal coils placed in a woman’s fallopian tubes, which serve as a blockage device for the tubes to prevent pregnancy.

“Essure is a Class III medical device that received Conditional Premarket Approval from the Food and Drug Administration (FDA) before it was marketed to the public. The complainants allege that, instead of working as intended, the Essure device ‘migrates from the fallopian tubes, perforates organs, breaks into pieces and/or corrodes. Each plaintiff had Essure implanted and, as a result, suffered severe and permanent injuries,” Padova previously said.

The plaintiffs brought a number of claims sounding in negligence against Bayer – specifically, negligent training, negligent risk management, breach of express warranty, negligent misrepresentation and negligent failure to warn, alleging the company failed to warn doctors, patients or the FDA about the supposed dangers of the Essure device.

Defendants Bayer Corporation, Bayer U.S. LLC, Bayer Essure Inc., and Bayer HealthCare Pharmaceuticals Inc. removed the cases to federal court, asserting jurisdiction based on diversity of citizenship. On Jan. 4, defendants filed their notices of removal with the state court.

Bayer asserted the cases were properly heard in federal court due to state law claims turning on construction of federal law, but the plaintiffs countered that the Forum Defendant Rule prohibits Bayer from removing based on diversity of citizenship.

“Plaintiffs have filed a motion to remand all 24 cases to the Court of Common Pleas of Philadelphia County. They argue that defendant Bayer HealthCare LLC, which is a named defendant in each complaint but is not one of the removing defendants, is a citizen of Pennsylvania and that the Forum Defendant Rule therefore bars removal. The removing defendants counter that the Forum Defendant Rule does not bar removal in these cases because the sole Pennsylvania defendant – Bayer HealthCare, LLC – was not ‘properly joined and served’ as it was not served with the complaint prior to removal,” Padova stated.

See https://www.masstortnexus.com/Briefcases/46/ESSURE-(Bayer)-Philadelphia-Court-of-Common-Pleas for related docket information.

“Plaintiffs maintain, however, that Bayer HealthCare, LLC was ‘properly joined and served’ because plaintiffs served it with the writs of summons. Thus, the primary question raised by plaintiffs’ motion is whether service with a writ of summons suffices to satisfy the ‘properly joined and served’ condition of the Forum Defendant Rule.”

Padova said that the plaintiffs could have prevented the consequence of his ruling by sending the complaint to all of its named defendants, simultaneously with its filing.

“While the rule we apply today encourages some level of gamesmanship because it arguably encourages defendants who have been served with writs of summons to strategically remove before a forum defendant is properly served with the complaint, we are confident that the rule’s effect in this regard will be slight,” Padova said.

In citing precedent from the U.S. Court of Appeals for the Third Circuit which concluded that the practical outcome of that interpretation of the Forum Defendant Rule is not “so outlandish as to constitute an absurd or bizarre result” – and thus, concluded that “a writ of summons does not suffice to satisfy the ‘properly joined and served’ condition of the Forum Defendant Rule, and thus the Forum Defendant Rule does not prohibit removal of this action to this court where Bayer HealthCare, LLC was not properly served with the complaint prior to removal.”

“For the foregoing reasons, we deny plaintiffs’ motion to remand,” Padova said.

U.S. District Court for the Eastern District of Pennsylvania cases 2:14-cv-07315 et al

Philadelphia County Court of Common Pleas cases 180202502 et al

Essure USDC ED Pennsylvania Ruling Barring Tort and Warranty Claims March 27, 2019 (Padova, J)

______________________________________________________

Opinion in Essure USDC ED Pennsylvania Ruling Barring Tort and Warranty Claims March 27, 2019 (Padova, J)

IN THE UNITED STATES DISTRICT COURT

FOR THE EASTERN DISTRICT OF PENNSYLVANIA

HELEN McLAUGHLIN                            CIVIL ACTION NO. 14-7315

BAYER ESSURE, INC., et al.

And Related Actions

  1. 14-7316 (Ruble) NO. 16-3732 (Gross)
  2. 14-7318 (Stelzer) NO. 16-3733 (Johnson)
  3. 14-7317 (Strimel) NO. 16-3766 (Summerlin)
  4. 15-0384 (Walsh) NO. 16-3767 (Rodvill)
  5. 16-1458 (Dunstan) NO. 16-3769 (Quinton)
  6. 16-1645 (Clarke) NO. 16-4081 (Bradford)

: NO. 16-1921 (Souto)                 NO. 17-2915 (Wistrom)

: NO. 16-2166 (Bailey)                 NO. 17-3968 (Bobo)

: NO. 16-2154 (Campos)             NO. 17-4417 (Guess)

: NO. 16-2717 (Bolds)                  NO. 17-4936 (Gonzalez)

: NO. 16-3049 (Tulgetske)            NO. 18-37 (Jenson)

: NO. 16-3409 (Abeyta)                NO. 18-836 (Morua)

: NO. 16-3589 (Burgis)                 NO. 18-837 (Galan)

: NO. 16-3710 (Dong)                  NO. 18-838 (Alfaro)

: NO. 16-3730 (Mantor)               NO. 18-908 (Archer)

: NO. 16-3731 (Olague)

MEMORANDUM

Opinion in Essure USDC ED Pennsylvania Ruling Barring Tort and Warranty Claims March 27, 2019 (Padova, J) (link is above)

Padova, J. March 27, 2019

Essure Statute of Limitations

Defendants in Essure personal injury cases have argues that the statute of limitations period in all Essure cases should begin on November 18, 2016, the date the FDA approved a black box warning (its strongest warning level) for Essure. In reality, the dates triggering Essure limitation periods will vary, with the beginning of each plaintiff’s limitation period will depend on the plaintiff’s individual claims and state law applicable to the particular case.

Bayer Stops USA Sales

Bayer announced in June 2018 that it would voluntarily discontinue U.S. sales of Essure by the end of this year “for business reasons” but earlier this month affirmed the safety profile of the device. Last week, Bayer took Netflix to task over the accuracy of its medical device documentary “The Bleeding Edge.” The tide was turning for Bayer at that point, sales were already down 70% after the 2016 FDA warning and the public became aware of the risks of using Essure.

Bayer received FDA approval to sell Essure in 2002 and promoted it as a quick and easy permanent solution to unplanned pregnancies. Essure consists of two thin-as-spaghetti nickel-titanium coils inserted into the fallopian tubes, where they spur the growth of scar tissue that blocks sperm from fertilizing a woman’s eggs.

Because of the reported complaints, the FDA added its most serious warning to the device in 2016 and ordered the company to conduct a 2,000-patient study. FDA Commissioner Scott Gottlieb said Friday, the agency would work with Bayer to continue the study, but noted “Bayer will not be able to meet its expected enrollment numbers” for new patients. The study was designed to follow patients for three years to better assess complications.

Gottlieb said the FDA will continue to monitor adverse events reported to its database after Essure is removed from the market.  He stated “I also want to reassure women who’ve been using Essure successfully to prevent pregnancy that they can continue to do so,” and added “Those who think it’s causing problems, such as persistent pain, should consult with their doctors,” with Gottlieb further noting that device removal “has its own risks.”

Essure’s original label warned that the device’s nickel can result in allergic reactions. Its current labeling lists hives, rash, swelling and itching as possible reactions.

But many women have attributed other problems to the implant, including mood disorders, weight gain, hair loss and headaches. Those problems are listed in the current FDA labeling for the device, with the qualifier: “It is unknown if these symptoms are related to Essure or other causes.”

Informational material Bayer supplied to doctors and patients lists potential problems and states the devices are meant to be permanent. It also says removal may require complicated surgery, including a hysterectomy, that might not be covered by insurance.

Bayer is currently facing more than 30,000 additional lawsuits over various products across the United States, as referenced in the Bayer 2018 Annual Report, see link: https://www.bayer.com/en/bayer-annual-report-2018.pdfx.

 

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Note: (Excerpts within this article include Penn Record materials and other online media sources)

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ROUNDUP MDL 2741 REMAND ORDER ENTERED: Is Settlement Coming Soon?

Does Bayer Now Have $10 Billion Or More Reasons To Settle?

Order Re: Roundup MDL 2741 PTO No. 147 Re: Remand of Cases (May 21, 2019)

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) Bayer AG and its recently acquired asset Monsanto Co., lost a recent California state court trial over the Roundup weedkiller in Oakland County, California when a jury awarded the plaintiffs $2.055 billion. They were ordered to pay the blockbuster verdict to a couple who successfully showed that Roundup use caused their non-Hodgkin’s lymphoma. The plaintiffs, Alva and Alberta Pilliod of Livermore, California, claimed they used Roundup once a week for nine months of the year over three decades, when they were both diagnosed with cancer in 2011 and 2015 respectively.

Now attention has moved from the state court Roundup docket to the US District Court in San Francisco, where Judge Vince Chhabria is handling the Monsanto Roundup Glyphosate MDL 2741. Judge Chhabria has entered an order setting a tentative plan in place to remand the federal cases back to their original courts of jurisdiction for trial. (see May 21, 2019 order excerpt below)

Among the financial and legal parties who are monitoring MDL 2741 the number attached to a full  settlement looks to be somewhere around $10 billion — an average of $1 million for each of the 11,200 people who are suing over Roundup, which may be a conservative estimate.

https://www.masstortnexus.com/Briefcases/Other-Mass-Litigations/116/ROUNDUP-MONSANTO-(GLYPHOSATE)-MDL-2741-(USDC-ND-California)

The tentative bench ruling by U.S. District Judge Vince Chhabria could help Bayer AG-owned Monsanto win future cases by trying them in agricultural states where farmers heavily depend on the company’s glyphosate-based herbicides Roundup and Ranger Pro, and where medical-causation laws favor the defendants.

Chhabria is now proposing  to send them back to their home districts for trial in phases, starting with 16 cases filed in California. Cases filed in other states would be transferred in subsequent phases.

Glyphosate is the most widely used agrichemical in history. Monsanto introduced it in 1974, and its use exploded in 1996 after Monsanto introduced “Roundup-ready” seeds engineered to resist the chemical. More than 2.6 billion pounds of glyphosate were spread on U.S. farmlands and yards between 1992 and 2012, according to the U.S. Geological Survey.

Roundup’s product label instructs users to wear protective clothing and equipment like goggles and long-sleeved shirts while spraying Roundup, and to not breathe it in. But because the first phase of the trial was limited to causation, the jury didn’t learn about the safety instructions included on the Roundup label.

The proposal comes after a federal jury awarded plaintiff Ed Hardeman $80 million in the first bellwether trial before Chhabria in San Francisco in March. Hardeman claimed decades of Roundup use had caused his non-Hodgkin lymphoma.

RELEVANT EXCERPTS FROM MAY 21, 20-19 REMAND ORDER

 

ROUNDUP PRODUCTS LIABILITY LITGATION
 

MDL No. 2741

Case No. 16-md-02741-VC

 

 PRETRIAL ORDER NO. 147:

TENTATIVE REMAND PLAN

  • The Court will decide all case-specific summary judgment motions. In addition, because Daubert motions relating to causation are so intertwined with summary judgment, the Court will decide those as well. Ninth Circuit law will govern the Daubert motions regardless of where the case originated.1 The courts that will eventually try the cases will be left with any other pretrial motions, including motions in limine, motions to bifurcate, and Daubert motions unrelated to summary judgment.
  • The Court will then group the cases by their governing state law. The first group will likely be cases governed by California law. For this group, the Court’s prior summary judgment rulings will govern, at least absent intervening authority. Therefore, to obtain summary judgment in a particular case, Monsanto will need to identify a material difference between that case and the cases for which summary judgment has already been denied. Assuming summary judgment and Daubert motions are denied for a particular case, that case will be remanded to the multi-district litigation panel for transfer back to its original district in California.
  • A similar process will take place for subsequent groups of cases, but with the parties also setting forth their positions on whether the law of the state relating to causation is materially different from California law.
  •  Individual states may be grouped together if it is determined that the relevant law is the same.
  • Absent extraordinary circumstances, all multi-plaintiff cases must be severed into separate, individual cases, both because it is not proper for those plaintiffs to be joined under Federal Rule of Civil Procedure 20 and because severance will facilitate implementation of the above-described plan.

IT IS SO ORDERED.

Date: May 21, 2019

VINCE CHHABRIA

United States District Judge

The World Health Organization’s International Agency for Research on Cancer (IARC) did deem Roundup a probable carcinogen in 2015—and though the evidence was mixed and partially based on animal studies, some scientific research has backed that classification. The Environmental Protection Agency’s official position is that “there are no risks to public health when glyphosate is used in accordance with its current label and that glyphosate is not a carcinogen,” with the EPA reiterating this stance at the end of April.

However, Monsanto has also faced accusations that it benefited from a cozy relationship with EPA officials and that it interferedwith supposedly independent scientific reviews that concluded Roundup is safe.

DEFENSE OPPOSES REMAND

Monsanto’s attorney Brian Stekloff, of Washington-based firm Wilkinson Walsh Eskovitz, opposed the plan in court Wednesday. Remanding California cases first likely means getting verdicts in those cases first, which Stekloff said would provide no new data about the litigation given Monsanto’s three trial losses in the state. Additional losses would further weaken the company’s bargaining position in court-ordered settlement discussions.

In addition to the $80 million Hardeman verdict, Monsanto has been ordered to pay $2 billion to a married couple and $289 million – later reduced to $78.5 million – to a school groundskeeper in state court trials in Oakland and San Francisco, respectively. All three plaintiffs alleged they developed non-Hodgkin lymphoma after using Roundup. The World Health Organization’s cancer agency declared Roundup’s main ingredient glyphosate a probable human carcinogen in 2015.

Chhabria rejected Stekloff’s argument by noting the California cases will be sent to federal courts spanning the entire state.

“California is a pretty diverse state,” the judge said. “It’s not like the Bay Area.”

Some observers contend Bay Area residents are too liberal to find for Monsanto.

In a follow-up question, Chhabria clarified Stekloff’s position. “You’d want to pick a state where you think the law on causation is different?” he asked. “More favorable to the defendants?”

“Correct,” Stekloff replied.

Earlier in Wednesday’s hearing, Stekloff said Monsanto wants to try cases in states where glyphosate is “used heavily in agriculture” and has a positive reputation.

Chhabria agreed to remand cases from one additional state during the first phase, but said he will revert to just California cases if the process becomes unwieldy.

Both parties can choose states for subsequent remands. Chhabria suggested they take turns for each remand phase and group states together based on similar laws on medical causation.

Chhabria split up the San Francisco bellwether trials into causation and liability phases to avoid biasing the jury against Monsanto, and Stekloff on Wednesday asked him to formally recommend that judges who get remanded cases also bifurcate their trials.

Chhabria demurred. But “[i]f somebody called me and asked me, I’d say aside from the misconduct in the opening statement, bifurcation worked well,” he said. “It’s a little more challenging for the judge, but I think it worked well.”

The judge recently sanctioned Hardeman’s two lead trial attorneys $500 each for presenting prohibited evidence in their opening statement to the jury.

Also Wednesday, Chhabria set a Feb. 10, 2020, trial date for the next bellwether case. Originally set for this month, Chhabria postponed it to prepare the remaining cases for summary judgment by late 2019.

He also appointed Kenneth Feinberg to mediate settlement discussions between Monsanto and the plaintiff’s MDL Executive Committee. Feinberg has served as Special Master of the September 11 Victim Compensation Fund and the Asbestos Personal Injury Litigation, and as administrator of the BP Deepwater Horizon Disaster Victim Compensation Fund.

Monsanto Bad Conduct Is Revealed At Trial

* Monsanto never conducted epidemiology studies for Roundup and its other formulations made with the active ingredient glyphosate to evaluate the cancer risks for users.

* Monsanto was aware that the surfactants in Roundup were much more toxic than glyphosate alone.

* Monsanto spent millions of dollars on covert public relations campaigns to finance ghostwritten studies and articles aimed at discrediting independent scientists whose work found dangers with Monsanto’s herbicides.

* When the US Agency for Toxic Substances and Disease Registry sought to evaluate glyphosate toxicity in 2015, Monsanto engaged the assistance of EPA officials to delay that review.

* Monsanto enjoyed a close relationship with certain officials within the Environmental Protection Agency (EPA), who have repeatedly backed Monsanto’s assertions about the safety of its glyphosate products.

* The company internally had worker safety recommendations that called for wearing a full range of protective gear when applying glyphosate herbicides, but did not warn the public to do the same.

 

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Fosamax Ruling: “A Small Win for Defense, A Big Win for Plaintiffs”

SCOTUS Fosamax Ruling (May 20, 2019)

Issue: Whether a state-law failure-to-warn claim is pre-empted when the Food and Drug Administration rejected the drug manufacturer’s proposal to warn about the risk after being provided with the relevant scientific data, or whether such a case must go to a jury for conjecture as to why the FDA rejected the proposed warning

Small Win for Defendants

Defendants Won the argument that a Judge not a jury is the proper authority to decide impossibility preemption arguments arising under the FDCA (Food and Drug Cosmetics Act, Title 21). However, the win on this one issue is a hollow victory for defendants considering the entirety of SCOTUS order and opinion.

SCOTUS ruled that judges not juries are the proper authority to decide the issue however, SCOTUS also placed significant limits on what those lower court judges could and could not consider when ruling on impossibility pre-preemption arguments like those raise by Merck in the Fosamax Case.

JUSTICE THOMAS SUMMARY OF RULING

JUSTICE THOMAS, concurring:

I join the Court’s opinion and write separately to explain my understanding of the relevant pre-emption principles and how they apply to this case.

“Because Merck points to no statute, regulation, or other agency action with the force of law that would have prohibited it from complying with its alleged state-law duties, its pre-emption defense should fail as a matter of law”

Big Win for Plaintiffs

SCOTUS ruled that Judges decide however, SCOTUS went much further and defined limits on what facts and information could be considered by lower court judges when making decisions related to impossibly preemption arguments like those raised by Merck in Fosamax.

SCOTUS opinion limits the clear and convincing evidence standards to OFFICAL Acts taken by the FDA which would in general rise1. If the defendant did not go through the CBE process and make the change (the exact warning plaintiffs allege was needed) and the FDA later told them to remove the warning, then FDA OFFICALLY told them to remove the warning, then no pre-emption exists.

1. If the defendant did not go through the CBE process and make the change (the exact warning plaintiffs allege was needed) and the FDA later told them to remove the warning, then FDA OFFICALLY told them to remove the warning, then no pre-emption exists.

2. If the defendant did not ask to make the specific label change (which plaintiffs allege was needed) having provided the FDA all relevant information, and the FDA OFFICIALLY denied the label change, then no pre-emption exists.

Arguments that postulate “hypotheticals” (absent either of the above official actions (facts)) are not to be considered. Communications between the defendant and the FDA, Statements by the FDA that do not constitute an official act under the law, are not to be considered.

The pre-emption question dates back to the original Fosamax case, which was filed by patients who suffered femoral fractures while taking the osteoporosis drug. Merck added language to the product’s label about the risk in 2011, but more than 500 patients claimed that their injuries occurred before then, and Merck should have warned them sooner.

In January 2019, the full Supreme Court heard arguments in Merck Sharp & Dohme Corp. v. Albrecht, a case arising out of the In Re: Fosamax (Alendronate Sodium) Products Liability Litigation. Fosamax is a drug used to treat osteoporosis, with a cited adverse event being that it may inhibit bone repair, which could result in an atypical femoral fracture.

The central claim at issue concerns the Fosamax warning label, which initially did not warn of the risk of an atypical femoral fracture. Plaintiffs contend that the label should have included such a warning, while Merck counters that it tried to add language addressing the risk of a “Low-Energy Femoral Shaft Fracture,” but was prevented from doing so by the FDA, who affirmatively told Merck to “hold off” on adding any such language until the FDA could decide on “atypical fracture language, if it is warranted.”  Ultimately, the FDA rejected Merck’s proposed warning label, stating that the justification for such language was “inadequate.” The FDA reversed course the following year, and Merck then added a risk of atypical femoral fracture to Fosamax’s label.

Based on these facts, Merck moved for summary judgment on the plaintiff’s failure-to-warn claims, arguing that such claims were preempted under Wyeth v. Levine because “clear evidence” demonstrated that the FDA would not—and did not—approve of the proposed label change.  The District Court agreed, but the Third Circuit did not, holding instead that: (1) Levine’s reference to “‘clear evidence’ referred solely to the applicable standard of proof,” which Merck failed to satisfy; and (2) the issue of whether the FDA would have rejected the label change was a fact question for the jury, (see Fosamax [Merck] Appeal U.S. Court of Appeals 3rd Circuit).

SCOTUS RULED 9-0

Additional Concurring Opinion on the judgment only (Jury vs Judge only) from Justices Cavanaugh, Alito’s  and Chief Justice Roberts could be interpreted as allowing lower court Judges to consider other Official acts by the FDA other than those delineated above however, the additional opinion did not define what official acts other than the two discussed could be considered and inasmuch as these two official actions are constitute the limit of the powers relevant to such matters, delegated to the FDA by Congress, it is doubtful that a defendant could show a lower court Judge any other document (without posing hypotheticals) that would constitute an official action taken by the FDA that would have prevented the defendant from meeting its State Law duties (impossibility preemption).

In that the only powers delegated to the FDA by Congress (powers under the law) are those defined in the two types of actions listed above, relevant to the type of impossibility preemption arguments that were raised in Fosamax, based on unofficial actions, communications and statements from the FDA (and that defendants hoped to raise in numerous other cases) the Fosamax ruling taken in its entity, is a major blow to defendants hoping to open major cracks in Wyeth v Levine.

The central issue in this case concerns federal preemption, which as relevant here, takes place when it is “‘impossible for a private party to comply with both state and federal requirements.’” Mutual Pharmaceutical Co. v. Bartlett, 570 U. S. 472, 480 (2013). See also U. S. Const., Art. VI, cl. 2. The state law that we consider is state common law or state statutes that require drug manufacturers to warn drug consumers of the risks associated with drugs. The federal law that we consider is the statutory and regulatory scheme through which the FDA regulates the information that appears on brand-name prescription drug labels. The alleged conflict between state and federal law in this case has to do with a drug that was manufactured by petitioner Merck Sharp & Dohme and was administered to respondents without a warning of certain associated risks.

FOSAMAX HISTORY

Merck developed Fosamax to strengthen bones and reduce the risk of fractures from osteoporosis. However, numerous studies have linked the medication to an elevated risk of abnormal femur fractures. Furthermore, plaintiffs in the litigation argue that Merck had an intrinsic obligation to its consumers to provide stronger warnings that users could experience femur fractures from little or no trauma while taking the medication. This includes falling from standing height or less.

Merck introduced Fosamax in 1995, and the company didn’t add a thigh bone fracture risk warning label to the drug until 2011. Plaintiffs claim Merck knew about the risk for years but concealed it to maximize sales and profits.

Fosamax was a blockbuster drug with annual sales of over $3 billion, until the company  lost its exclusive patent rights in 2008, even then the brand name drug still brought in $284 million in sales in 2016.

MERCK SHARP & DOHME CORP. v. ALBRECHT Opinion of the Court(excerpt)

III

We turn now to what is the determinative question before us:

Is the question of agency disapproval primarily one of fact, normally for juries to decide, or is it a question of law, normally for a judge to decide without a jury?

The complexity of the preceding discussion of the law helps to illustrate why we answer this question by concluding that the question is a legal one for the judge, not a jury. The question often involves the use of legal skills to determine whether agency disapproval fits facts that are not in dispute. Moreover, judges, rather than lay juries, are better equipped to evaluate the nature and scope of an agency’s determination. Judges are experienced in “[t]he construction of written instruments,” such as those normally produced by a federal agency to memorialize its considered judgments. Markman v. Westview Instruments, Inc., 517 U. S. 370, 388 (1996). And judges are better suited than are juries to understand and to interpret agency decisions in light of the governing statutory and regulatory context. Cf. 5 U. S. C. §706 (specifying that a “reviewing court,” not a jury, “shall . . . determine the meaning or applicability of the terms of an agency action”); see also H. R. Rep. No. 1980, 79th Cong., 2d Sess., 44 (1946) (noting longstanding view that “questions respecting the . . . terms of any agency action” and its “application” are “questions of law”). To understand the question as a legal question for judges makes sense given the fact that judges are normally familiar with principles of administrative law. Doing so should produce greater uniformity among courts; and greater uniformity is normally a virtue when a question requires a determination concerning the scope and effect of federal agency action. Cf. Markman, 517 U. S., at 390–391.

We understand that sometimes contested brute facts will prove relevant to a court’s legal determination about the meaning and effect of an agency decision. For example, if the FDA rejected a drug manufacturer’s supplemental application to change a drug label on the ground that the information supporting the application was insufficient to warrant a labeling change, the meaning and scope of that decision might depend on what information the FDA had before it. Yet in litigation between a drug consumer and a drug manufacturer (which will ordinarily lack an official administrative record for an FDA decision), the litigants may dispute whether the drug manufacturer submitted all material information to the FDA.

But we consider these factual questions to be subsumed within an already tightly circumscribed legal analysis. And we do not believe that they warrant submission alone or together with the larger pre-emption question to a jury. Rather, in those contexts where we have determined that the question is “for the judge and not the jury,” we have also held that “courts may have to resolve subsidiary factual disputes” that are part and parcel of the broader legal question.  Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., 574 U. S. ___, ___–___ (2015) (slip op., at 6– 7). And, as in contexts as diverse as the proper construction of patent claims and the voluntariness of criminal confessions, they create a question that “‘falls somewhere between a pristine legal standard and a simple historical fact.’” Markman, 517 U. S., at 388 (quoting Miller v. Fenton, 474 U. S. 104, 114 (1985)). In those circumstances, “‘the fact/law distinction at times has turned on a determination that, as a matter of the sound administration of justice, one judicial actor is better positioned than another to decide the issue in question.’” Markman, 517 U. S., at 388 (quoting Miller, 474 U. S., at 114). In this context, that “better positioned” decisionmaker is the judge.

 IV

Because the Court of Appeals treated the pre-emption question as one of fact, not law, and because it did not have an opportunity to consider fully the standards we have described in Part II of our opinion, we vacate its judgment and remand the case to that court for further proceedings consistent with this opinion.

It is so ordered.

____________________________________________________________

How Big Pharma’s cadre of lobbyists and congressional insiders attempt to reap major dividends, as we address the Fosamax ruling remains to be seen, but considering the wide-open lack of federal oversight for pharmaceutical and medical device manufacturers by the current administration, it would appear that Big Pharma investments in the FDA and related oversight agencies is paying off very well.

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SUPREME COURT OF THE UNITED STATES in “MERCK SHARP & DOHME CORP. v. ALBRECHT” May 20, 2019

SUPREME COURT OF THE UNITED STATES

MERCK SHARP & DOHME CORP. v. ALBRECHT ET AL.
CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE THIRD CIRCUIT

No. 17–290. Argued January 7, 2019—Decided May 20, 2019
Petitioner Merck Sharp & Dohme Corp. manufactures Fosamax, a drug that treats and prevents osteoporosis in postmenopausal women. However, the mechanism through which Fosamax treats and prevents osteoporosis may increase the risk that patients will suffer “atypical femoral fractures,” that is, a rare type of complete, low-energy fracture that affects the thigh bone. When the Food and Drug Administration first approved of the manufacture and sale of Fosamax in 1995, the Fosamax label did not warn of the then-speculativerisk of atypical femoral fractures associated with the drug. But stronger evidence connecting Fosamax to atypical femoral fractures developed after 1995. And the FDA ultimately ordered Merck to add a warning about atypical femoral fractures to the Fosamax label in 2011. Respondents are more than 500 individuals who took Fosamax andsuffered atypical femoral fractures between 1999 and 2010. Respondents sued Merck seeking tort damages on the ground that statelaw imposed upon Merck a legal duty to warn respondents and their doctors about the risk of atypical femoral fractures associated withusing Fosamax. Merck, in defense, argued that respondents’ state-law failure-to-warn claims should be dismissed as pre-empted by federal law. Merck conceded that the FDA regulations would have permitted Merck to try to change the label to add a warning before 2010, but Merck asserted that the FDA would have rejected that attempt.In particular, Merck claimed that the FDA’s rejection of Merck’s 2008 attempt to warn of a risk of “stress fractures” showed that the FDA would also have rejected any attempt by Merck to warn of the risk ofatypical femoral fractures associated with the drug. The District Court agreed with Merck’s pre-emption argument and
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granted summary judgment to Merck, but the Third Circuit vacatedand remanded. The Court of Appeals recognized that its pre-emption analysis was controlled by this Court’s decision in Wyeth v. Levine, 555 U. S. 555, which held that a state-law failure-to-warn claim is pre-empted where there is “clear evidence” that the FDA would not have approved a change to the label. The Court of Appeals, however,suggested that the “clear evidence” standard had led to varying lower court applications and that it would be helpful for this Court to “clarif[y] or buil[d] out the doctrine.” 852 F. 3d 268, 284.
Held:
1. “Clear evidence” is evidence that shows the court that the drugmanufacturer fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve a change tothe drug’s label to include that warning. Pp. 9–15.
(a)
The Wyeth Court undertook a careful review of the history of federal regulation of drugs and drug labeling and found both a reluctance by Congress to displace state laws that would penalize drug manufacturers for failing to warn consumers of the risks associatedwith their drugs and an insistence by Congress that drug manufacturers bear the responsibility for the content of their drug labels. Accordingly, this Court held in Wyeth that “absent clear evidence that the FDA would not have approved a change” to the label, the Court“will not conclude that it was impossible . . . to comply with both federal and state requirements.” 555 U. S., at 571. Applying that ruleto the facts of that case, the Court said that Wyeth’s evidence of preemption fell short for two reasons. First, the record did not show that Wyeth “supplied the FDA with an evaluation or analysis concerning the specific dangers” that would have merited the warning. Id., at 572–573. And second, the record did not show that Wyeth “attempted to give the kind of warning required by [state law] but was prohibited from doing so by the FDA.” Ibid., and n. 5. Pp. 10–13.
(b)
Thus, in a case like Wyeth, showing that federal law prohibited the drug manufacturer from adding a warning that would satisfystate law requires the drug manufacturer to show that it fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve changing the drug’s label to include that warning. These conclusions flow from this Court’s precedents on impossibility pre-emption and the statutory and regulatory scheme thatthe Court reviewed in Wyeth. See 555 U. S., at 578. In particular,this Court has refused to find clear evidence of impossibility wherethe laws of one sovereign permit an activity that the laws of the othersovereign restrict or even prohibit. And as explained in Wyeth, FDA
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regulations permit drug manufacturers to change a label to “reflect newly acquired information” if the changes “add or strengthen a . . . warning” for which there is “evidence of a causal association.” 21 CFR §314.70(c)(6)(iii)(A). Pp. 13–14.
(c) The only agency actions that can determine the answer to thepre-emption question are agency actions taken pursuant to the FDA’s congressionally delegated authority. The Supremacy Clause grants “supreme” status only to the “the Laws of the United States.” U. S. Const., Art. VI, cl. 2. And pre-emption takes place “ ‘only when and if [the agency] is acting within the scope of its congressionally delegated authority.’ ” New York v. FERC, 535 U. S. 1, 18 (some alterations omitted). P 15.
2. The question of agency disapproval is primarily one of law for a judge to decide. The question often involves the use of legal skills todetermine whether agency disapproval fits facts that are not in dispute. Moreover, judges, rather than lay juries, are better equipped toevaluate the nature and scope of an agency’s determination, and are better suited to understand and to interpret agency decisions in light of the governing statutory and regulatory context. While contested brute facts will sometimes prove relevant to a court’s legal determination about the meaning and effect of an agency decision, such factual questions are subsumed within an already tightly circumscribed legal analysis and do not warrant submission alone or together with the larger pre-emption question to a jury. Pp. 15–17.
852 F. 3d 268, vacated and remanded.
BREYER, J., delivered the opinion of the Court, in which THOMAS, GINSBURG, SOTOMAYOR, KAGAN, and GORSUCH, JJ., joined. THOMAS, J., filed a concurring opinion. ALITO, J., filed an opinion concurring in thejudgment, in which ROBERTS, C. J., and KAVANAUGH, J., joined.
_________________

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Opinion of the Court
NOTICE: This opinion is subject to formal revision before publication in thepreliminary print of the United States Reports. Readers are requested to notify the Reporter of Decisions, Supreme Court of the United States, Washington, D. C. 20543, of any typographical or other formal errors, in orderthat corrections may be made before the preliminary print goes to press.
SUPREME COURT OF THE UNITED STATES
No. 17–290
MERCK SHARP & DOHME CORP., PETITIONER v. DORIS ALBRECHT, ET AL.
ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE THIRD CIRCUIT
[May 20, 2019]
JUSTICE BREYER delivered the opinion of the Court. When Congress enacted the Federal Food, Drug, and
Cosmetic Act, ch. 675, 52 Stat. 1040, as amended, 21
U. S. C. §301 et seq., it charged the Food and Drug Administration with ensuring that prescription drugs are “safefor use under the conditions prescribed, recommended, orsuggested” in the drug’s “labeling.” §355(d). When the FDA exercises this authority, it makes careful judgmentsabout what warnings should appear on a drug’s label for the safety of consumers.
For that reason, we have previously held that “clear evidence” that the FDA would not have approved a changeto the drug’s label pre-empts a claim, grounded in statelaw, that a drug manufacturer failed to warn consumers of the change-related risks associated with using the drug.See Wyeth v. Levine, 555 U. S. 555, 571 (2009). We here determine that this question of pre-emption is one for a judge to decide, not a jury. We also hold that “clear evidence” is evidence that shows the court that the drugmanufacturer fully informed the FDA of the justificationsfor the warning required by state law and that the FDA, in
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turn, informed the drug manufacturer that the FDA would not approve a change to the drug’s label to include that warning.
I The central issue in this case concerns federal preemption, which as relevant here, takes place when it is“‘impossible for a private party to comply with both stateand federal requirements.’” Mutual Pharmaceutical Co. v. Bartlett, 570 U. S. 472, 480 (2013). See also U. S. Const., Art. VI, cl. 2. The state law that we consider is state common law or state statutes that require drug manufacturers to warn drug consumers of the risks associated withdrugs. The federal law that we consider is the statutory and regulatory scheme through which the FDA regulatesthe information that appears on brand-name prescriptiondrug labels. The alleged conflict between state and federallaw in this case has to do with a drug that was manufactured by petitioner Merck Sharp & Dohme and was administered to respondents without a warning of certainassociated risks.
A The FDA regulates the safety information that appearson the labels of prescription drugs that are marketed in the United States. 21 U. S. C. §355(b)(1)(F); 21 CFR§201.57(a) (2018). Although we commonly understand a drug’s “label” to refer to the sticker affixed to a prescription bottle, in this context the term refers more broadly to the written material that is sent to the physician whoprescribes the drug and the written material that comeswith the prescription bottle when the drug is handed to the patient at the pharmacy. 21 U. S. C. §321(m). These (often lengthy) package inserts contain detailed information about the drug’s medical uses and health risks. §355(b)(1)(F); 21 CFR §201.57(a).
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FDA regulations set out requirements for the content, the format, and the order of the safety information on the drug label. §201.57(c). Those regulations require druglabels to include, among other things: (1) prominent “boxed” warnings about risks that may lead to death or serious injury; (2) contraindications describing any situation in which the drug should not be used because the riskof use outweighs any therapeutic benefit; (3) warnings and precautions about other potential safety hazards; and
(4) any adverse reactions for which there is some basis to believe a causal relationship exists between the drug and the occurrence of the adverse event. Ibid.
As those requirements make clear, the category inwhich a particular risk appears on a drug label is anindicator of the likelihood and severity of the risk. The hierarchy of label information is designed to “preventoverwarning” so that less important information does not “overshadow” more important information. 73 Fed. Reg. 49605–49606 (2008). It is also designed to exclude “[e]xaggeration of risk, or inclusion of speculative or hypothetical risks,” that “could discourage appropriate use of a beneficial drug.” Id., at 2851.
Prospective drug manufacturers work with the FDA to develop an appropriate label when they apply for FDA approval of a new drug. 21 U. S. C. §§355(a), 355(b),355(d)(7); 21 CFR §314.125(b)(6). But FDA regulationsalso acknowledge that information about drug safety may change over time, and that new information may requirechanges to the drug label. §§314.80(c), 314.81(b)(2)(i). Drug manufacturers generally seek advance permissionfrom the FDA to make substantive changes to their druglabels. However, an FDA regulation called the “changesbeing effected” or “CBE” regulation permits drug manufacturers to change a label without prior FDA approval if the change is designed to “add or strengthen a . . . warning”where there is “newly acquired information” about the
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“evidence of a causal association” between the drug and a risk of harm. 21 CFR §314.70(c)(6)(iii)(A).
B Petitioner Merck Sharp & Dohme manufactures Fosamax, a drug that treats and prevents osteoporosis in postmenopausal women. App. 192; In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F. 3d 268, 271, 274–275 (CA3 2017). Fosamax belongs to a classof drugs called “bisphosphonates.” Fosamax and other bisphosphonates work by affecting the “bone remodeling process,” that is, the process through which bones are continuously broken down and built back up again. App.102, 111. For some postmenopausal women, the two parts of the bone remodeling process fall out of sync; the body removes old bone cells faster than it can replace them.That imbalance can lead to osteoporosis, a disease that is characterized by low bone mass and an increased risk ofbone fractures. Fosamax (like other bisphosphonates)slows the breakdown of old bone cells and thereby helps postmenopausal women avoid osteoporotic fractures. Id., at 102. However, the mechanism through which Fosamax decreases the risk of osteoporotic fractures may increase therisk of a different type of fracture. Id., at 400–444, 661–
663. That is because all bones—healthy and osteoporoticalike—sometimes develop microscopic cracks that are not due to any trauma, but are instead caused by the mechanical stress of everyday activity. Id., at 102. Those so-called “stress fractures” ordinarily heal on their own through the bone remodeling process. But, by slowing the breakdown of old bone cells, Fosamax and other bisphosphonates may cause stress fractures to progress to complete breaks that cause great pain and require surgical intervention to repair. Id., at 106–109, 139, 144–145. When that rare type of complete, low-energy fracture
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Opinion of the Court
affects the thigh bone, it is called an “atypical femoral fracture.” Id., at 101.
The Fosamax label that the FDA approved in 1995 did not warn of the risk of atypical femoral fractures. 852
F. 3d, at 274–275. At that time, Merck’s scientists were aware of at least a theoretical risk of those fractures. Indeed, as far back as 1990 and 1991, when Fosamax was undergoing preapproval clinical trials, Merck scientists expressed concern in internal discussions that Fosamaxcould inhibit bone remodeling to such a “‘profound’” degree that “inadequate repair may take place” and “‘microfractures would not heal.’” App. 111–113. When Merck applied to the FDA for approval of Fosamax, Merck brought those theoretical considerations to the FDA’s attention. 852 F. 3d, at 274–275. But, perhaps because the concerns were only theoretical, the FDA approved Fosamax’s label without requiring any mention of this risk. Ibid.
Evidence connecting Fosamax to atypical femoral fractures developed after 1995. Merck began receiving adverse event reports from the medical community indicating that long-term Fosamax users were suffering atypical femoral fractures. App. 122–125. For example, Merckreceived a report from a doctor who said that hospital staffhad begun calling atypical femoral fractures the “‘Fosamax Fracture’” because “‘100% of patients in his practice who have experienced femoral fractures (without being hit by a taxicab), were taking Fosamax . . . for over 5 years. ’” Id., at 126. Merck performed a statistical analysis of Fosamax adverse event reports, concluding that these reports revealed a statistically significant incidence offemur fractures. 3 App. in No. 14–1900 (CA3), pp. A1272– A1273, A1443. And about the same time, Merck began to see numerous scholarly articles and case studies documenting possible connections between long-term Fosamax use and atypical femoral fractures. App. 106–110, 116–
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122.
In 2008, Merck applied to the FDA for preapproval tochange Fosamax’s label to add language to both the “Adverse Reaction[s]” and the “Precaution[s]” sections of thelabel. Id., at 670. In particular, Merck proposed adding a reference to “‘low-energy femoral shaft fracture’” in theAdverse Reactions section, and cross-referencing a longerdiscussion in the Precautions section that focused on the risk of stress fractures associated with Fosamax. Id., at
728. The FDA approved the addition to the Adverse Reactions section, but rejected Merck’s proposal to warn of a risk of “stress fractures.” Id., at 511–512. The FDA explained that Merck’s “justification” for the proposedchange to the Precautions section was “inadequate,” because “[i]dentification of ‘stress fractures’ may not be clearly related to the atypical subtrochanteric fracturesthat have been reported in the literature.” Id., at 511. The FDA invited Merck to “resubmit” its application and to “fully address all the deficiencies listed.” Id., at 512; see 21 CFR §314.110(b). But Merck instead withdrew its application and decided to make the changes to the Adverse Reactions section through the CBE process. App.654–660. Merck made no changes to the Precautionssection at issue here. Id., at 274.
A warning about “atypical femoral fractures” did notappear on the Fosamax label until 2011, when the FDA ordered that change based on its own analyses. Id., at 246–252, 526–534. Merck was initially resistant to the change, proposing revised language that, once again,referred to the risk of “stress fractures.” Id., at 629–634. But the FDA, once again, rejected that language. And this time, the FDA explained that “the term ‘stress fracture’ was considered and was not accepted” because, “for most practitioners, the term ‘stress fracture’ represents a minorfracture and this would contradict the seriousness of the atypical femoral fractures associated with bisphosphonate
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Opinion of the Court
use.” Id., at 566. In January 2011, Merck and the FDA ultimately agreed upon adding a three-paragraph discussion of atypical femoral fractures to the Warnings and Precautions section of the Fosamax label. Id., at 223–224. The label now refers to the fractures five times as “atypical” without using the term “stress fracture.” Ibid.
C The respondents here are more than 500 individuals who took Fosamax and who suffered atypical femoralfractures between 1999 and 2010. Brief for Respondents
7. Respondents, invoking federal diversity jurisdiction, filed separate actions seeking tort damages on the groundthat, during the relevant period, state law imposed uponMerck a legal duty to warn them and their doctors aboutthe risk of atypical femoral fractures associated with usingFosamax. Id., at 1. One respondent, for example, filed a complaint alleging that she took Fosamax for roughly 10years and suffered an atypical femoral fracture. One dayin 2009, when the respondent was 70 years old, she turned to unlock the front door of her house, heard a poppingsound, and suddenly felt her left leg give out beneath her.She needed surgery, in which doctors repaired her leg witha rod and screws. She explained she would not have usedFosamax for so many years if she had known that she might suffer an atypical femoral fracture as a result. See id., at 18–19.
Merck, in defense, argued that respondents’ state-law failure-to-warn claims should be dismissed as pre-emptedby federal law. Both Merck and the FDA have long been aware that Fosamax could theoretically increase the riskof atypical femoral fractures. But for some period of timebetween 1995 (when the FDA first approved a drug label for Fosamax) and 2010 (when the FDA decided to requireMerck to add a warning about atypical femoral fracturesto Fosamax’s label), both Merck and the FDA were unsure
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Opinion of the Court
whether the developing evidence of a causal link between Fosamax and atypical femoral fractures was strongenough to require adding a warning to the Fosamax druglabel. Merck conceded that the FDA’s CBE regulationwould have permitted Merck to try to change the label toadd a warning before 2010, but Merck asserted that the FDA would have rejected that attempt. In particular,Merck pointed to the FDA’s rejection of Merck’s 2008 attempt to amend the Fosamax label to warn of the risk of “stress fractures” associated with Fosamax. On that basis, Merck claimed that federal law prevented Merck from complying with any state-law duty to warn the respondents of the risk of atypical femoral fractures associatedwith Fosamax.
The District Court agreed with Merck’s pre-emption argument and granted summary judgment to Merck, In re Fosamax (Alendronate Sodium): Products Liability Litigation, 2014 WL 1266994, *17 (D NJ, Mar. 22, 2017), but theCourt of Appeals vacated and remanded, 852 F. 3d, at 302.The Court of Appeals concluded that its pre-emption analysis was controlled by this Court’s decision in Wyeth. Ibid. The Court of Appeals understood that case as making clear that a failure-to-warn claim grounded in state law is pre-empted where there is “‘clear evidence that the FDA would not have approved a change to the . . . label.’” Id., at 280 (quoting Wyeth, 555 U. S., at 571). The Court of Appeals, however, suggested that this statement had ledto varying lower court applications and that it would be helpful for this Court to “clarif[y] or buil[d] out the doctrine.” 852 F. 3d, at 284.
In attempting to do so itself, the Court of Appeals held that “the Supreme Court intended to announce a standard of proof when it used the term ‘clear evidence’ in Wyeth.” Ibid. That is, the Court of Appeals believed that “[t]heterm ‘clear evidence’ . . . does not refer directly to the typeof facts that a manufacturer must show, or to the circumCite
as: 587 U. S. ____ (2019) 9
Opinion of the Court
stances in which preemption will be appropriate.” Id., at
285. “Rather, it specifies how difficult it will be for the manufacturer to convince the factfinder that the FDA would have rejected a proposed label change.” Ibid. And in the Court of Appeals’ view, “for a defendant to establisha preemption defense under Wyeth, the factfinder must conclude that it is highly probable that the FDA would not have approved a change to the drug’s label.” Id., at 286. Moreover and importantly, the Court of Appeals also held that “whether the FDA would have rejected a proposed label change is a question of fact that must be answered by a jury.” Ibid.
Merck filed a petition for a writ of certiorari. Merck’s petition asked the Court to decide whether Merck’s case and others like it “must . . . go to a jury” to determine whether the FDA, in effect, has disapproved a state-lawrequired labeling change. In light of differences and uncertainties among the courts of appeals and state supreme courts in respect to the application of Wyeth, we granted certiorari. See, e.g., Mason v. SmithKline Beecham Corp., 596 F. 3d 387, 391 (CA7 2010) (“The Supreme Court . . . did not clarify what constitutes ‘clear evidence’”); Reckis v. Johnson & Johnson, 471 Mass. 272, 286, 28 N. E. 3d 445, 457 (2015) (“Wyeth did not define ‘clear evidence’ . . . ” (some internal quotation marks omitted)).
II We stated in Wyeth v. Levine that state law failure-towarn claims are pre-empted by the Federal Food, Drug, and Cosmetic Act and related labeling regulations when there is “clear evidence” that the FDA would not have approved the warning that state law requires. 555 U. S., at 571. We here decide that a judge, not the jury, must decide the pre-emption question. And we elaborate Wyeth’s requirements along the way.
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A We begin by describing Wyeth. In that case, the plaintiffdeveloped gangrene after a physician’s assistant injected her with Phenergan, an antinausea drug. The plaintiffbrought a state-law failure-to-warn claim against Wyeth,the drug’s manufacturer, for failing to provide an adequatewarning about the risks that accompany various methods of administering the drug. In particular, the plaintiff claimed that directly injecting Phenergan into a patient’s vein (the “IV-push” method of administration) creates a significant risk of catastrophic consequences. And those consequences could be avoided by introducing the druginto a saline solution that slowly descends into a patient’s vein (the “IV-drip” method of administration). A juryconcluded that Wyeth’s warning label was inadequate, and that the label’s inadequacy caused the plaintiff ’s injury.On appeal, Wyeth argued that the plaintiff ’s state-law failure-to-warn claims were pre-empted because it wasimpossible for Wyeth to comply with both state law dutiesand federal labeling obligations. The Vermont Supreme Court rejected Wyeth’s pre-emption claim. Id., at 563. We too considered Wyeth’s pre-emption argument, and we too rejected it. In rejecting Wyeth’s argument, we undertook a careful review of the history of federal regulation of drugs and drug labeling. Id., at 566–568. In doingso, we “assum[ed] that the historic police powers of theStates were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.” Id., at 565 (internal quotation marks omitted). And we found nothing within that history to indicate that the FDA’s power to approve or to disapprove labeling changes, by itself, pre-empts state law.Rather, we concluded that Congress enacted the FDCA“to bolster consumer protection against harmful products;”that Congress provided no “federal remedy for consumersharmed by unsafe or ineffective drugs”; that Congress was
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“awar[e] of the prevalence of state tort litigation;” andthat, whether Congress’ general purpose was to protectconsumers, to provide safety-related incentives to manufacturers, or both, language, history, and purpose allindicate that “Congress did not intend FDA oversight to bethe exclusive means of ensuring drug safety and effectiveness.” Id., at 574–575 (emphasis added). See also id., at 574 (“If Congress thought state-law suits posed an obstacle to its objectives, it surely would have enacted an express pre-emption provision at some point during theFDCA’s 70-year history”).
We also observed that “through many amendments tothe FDCA and to FDA regulations, it has remained a central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label at all times.” Id., at 570–571. A drug manufacturer “is charged both with crafting an adequate label and withensuring that its warnings remain adequate as long as the drug is on the market.” Id., at 571. Thus, when the risks of a particular drug become apparent, the manufacturerhas “a duty to provide a warning that adequately describe[s] that risk.” Ibid. “Indeed,” we noted, “prior to2007, the FDA lacked the authority to order manufacturers to revise their labels.” Ibid. And even when “Congressgranted the FDA this authority,” in the 2007 Amendments to the FDCA, Congress simultaneously “reaffirmed the manufacturer’s obligations and referred specifically to theCBE regulation, which both reflects the manufacturer’s ultimate responsibility for its label and provides a mechanism for adding safety information to the label prior toFDA approval.” Ibid.
In light of Congress’ reluctance to displace state laws that would penalize drug manufacturers for failing to warn consumers of the risks associated with their drugs,and Congress’ insistence on requiring drug manufacturers to bear the responsibility for the content of their drug
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labels, we were unpersuaded by Wyeth’s pre-emption argument. In Wyeth’s case, we concluded, “when the riskof gangrene from IV-push injection of Phenergan becameapparent, Wyeth had a duty” under state law “to provide a warning that adequately described that risk, and the CBEregulation permitted it to provide such a warning beforereceiving the FDA’s approval.” Ibid.
At the same time, and more directly relevant here, we pointed out that “the FDA retains authority to rejectlabeling changes made pursuant to the CBE regulation in its review of the manufacturer’s supplemental application, just as it retains such authority in reviewing all supplemental applications.” Ibid. We then said that, nonetheless, “absent clear evidence that the FDA would not have approved a change to Phenergan’s label, we will not conclude that it was impossible for Wyeth to comply with bothfederal and state requirements.” Ibid. (emphasis added).
We reviewed the record and concluded that “Wyeth has offered no such evidence.” Id., at 572. We said that Wyeth’s evidence of pre-emption fell short for two reasons. First, the record did not show that Wyeth “supplied the FDA with an evaluation or analysis concerning the specific dangers” that would have merited the warning. Id., at 572–573. We could find “no evidence in this record that either the FDA or the manufacturer gave more than passing attention to the issue of IV-push versus IV-drip administration”—the matter at issue in the case. Id., at 572 (internal quotation marks omitted). Second, the record did not show that Wyeth “attempted to give the kind of warning required by [state law] but was prohibited from doing so by the FDA.” Ibid., and n. 5. The “FDA had not made an affirmative decision to preserve” the warning asit was or “to prohibit Wyeth from strengthening its warning.” Id., at 572. For those reasons, we could not “credit Wyeth’s contention that the FDA would have prevented it from adding a stronger warning about the IV-push method
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of intravenous administration.” And we could not conclude that “it was impossible for Wyeth to comply withboth federal and state requirements.” Id., at 573. We acknowledged that meeting the standard we set forth would be difficult, but, we said, “[i]mpossibility preemption is a demanding defense.” Ibid.
B The underlying question for this type of impossibility pre-emption defense is whether federal law (includingappropriate FDA actions) prohibited the drug manufacturer from adding any and all warnings to the drug label that would satisfy state law. And, of course, in order to succeed with that defense the manufacturer must show that the answer to this question is yes. But in Wyeth, we confronted that question in the context of a particular setof circumstances. Accordingly, for purposes of this case,we assume—but do not decide—that, as was true of the warning at issue in Wyeth, there is sufficient evidence to find that Merck violated state law by failing to add a warning about atypical femoral fractures to the Fosamaxlabel. In a case like Wyeth, showing that federal law prohibited the drug manufacturer from adding a warning that would satisfy state law requires the drug manufacturer to show that it fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that theFDA would not approve changing the drug’s label to include that warning.These conclusions flow from our precedents on impossibility pre-emption and the statutory and regulatory scheme that we reviewed in Wyeth. See 555 U. S., at 578. In particular, “it has long been settled that state laws thatconflict with federal law are without effect.” Mutual Pharmaceutical Co., 570 U. S., at 480. But as we have cautioned many times before, the “possibility of impossibil14
MERCK SHARP & DOHME CORP. v. ALBRECHT
Opinion of the Court
ity [is] not enough.” PLIVA, Inc. v. Mensing, 564 U. S. 604, 625, n. 8 (2011) (internal quotation marks omitted). Consequently, we have refused to find clear evidence of such impossibility where the laws of one sovereign permit an activity that the laws of the other sovereign restrict oreven prohibit. See, e.g., Barnett Bank of Marion Cty.,
N. A. v. Nelson, 517 U. S. 25, 31 (1996); Michigan Canners & Freezers Assn., Inc. v. Agricultural Marketing and Bargaining Bd., 467 U. S. 461, 478, and n. 21 (1984).
And, as we explained in Wyeth, 555 U. S., at 571–573, federal law—the FDA’s CBE regulation—permits drugmanufacturers to change a label to “reflect newly acquired information” if the changes “add or strengthen a . . . warning” for which there is “evidence of a causal association,” without prior approval from the FDA. 21 CFR §314.70(c)(6)(iii)(A). Of course, the FDA reviews CBE submissions and can reject label changes even after themanufacturer has made them. See §§314.70(c)(6), (7). And manufacturers cannot propose a change that is not based on reasonable evidence. §314.70(c)(6)(iii)(A). But in the interim, the CBE regulation permits changes, so adrug manufacturer will not ordinarily be able to show thatthere is an actual conflict between state and federal law such that it was impossible to comply with both.
We do not further define Wyeth’s use of the words “clear evidence” in terms of evidentiary standards, such as “preponderance of the evidence” or “clear and convincing evidence” and so forth, because, as we shall discuss, infra, at 15–17, courts should treat the critical question not as a matter of fact for a jury but as a matter of law for thejudge to decide. And where that is so, the judge must simply ask himself or herself whether the relevant federal and state laws “irreconcilably conflic[t].” Rice v. Norman Williams Co., 458 U. S. 654, 659 (1982); see ibid. (“Theexistence of a hypothetical or potential conflict is insufficient to warrant the pre-emption of the state statute”).
15 Cite as: 587 U. S. ____ (2019)
Opinion of the Court
We do note, however, that the only agency actions thatcan determine the answer to the pre-emption question, of course, are agency actions taken pursuant to the FDA’scongressionally delegated authority. The SupremacyClause grants “supreme” status only to the “the Laws of the United States.” U. S. Const., Art. VI, cl. 2. And preemption takes place “‘only when and if [the agency] isacting within the scope of its congressionally delegatedauthority, . . . for an agency literally has no power to act,let alone pre-empt the validly enacted legislation of a sovereign State, unless and until Congress confers power upon it.’” New York v. FERC, 535 U. S. 1, 18 (2002) (some alterations omitted). Federal law permits the FDA to communicate its disapproval of a warning by means of notice-and-comment rulemaking setting forth labelingstandards, see, e.g., 21 U. S. C. §355(d); 21 CFR §§201.57,314.105; by formally rejecting a warning label that would have been adequate under state law, see, e.g., 21 CFR §§314.110(a), 314.125(b)(6); or with other agency actioncarrying the force of law, cf., e.g., 21 U. S. C. §355(o)(4)(A). The question of disapproval “method” is not now before us.And we make only the obvious point that, whatever the means the FDA uses to exercise its authority, those meansmust lie within the scope of the authority Congress has lawfully delegated.
III We turn now to what is the determinative questionbefore us: Is the question of agency disapproval primarily one of fact, normally for juries to decide, or is it a questionof law, normally for a judge to decide without a jury?The complexity of the preceding discussion of the law helps to illustrate why we answer this question by concluding that the question is a legal one for the judge, not ajury. The question often involves the use of legal skills todetermine whether agency disapproval fits facts that are
16 MERCK SHARP & DOHME CORP. v. ALBRECHT
Opinion of the Court
not in dispute. Moreover, judges, rather than lay juries,are better equipped to evaluate the nature and scope of anagency’s determination. Judges are experienced in “[t]he construction of written instruments,” such as those normally produced by a federal agency to memorialize itsconsidered judgments. Markman v. Westview Instruments, Inc., 517 U. S. 370, 388 (1996). And judges arebetter suited than are juries to understand and to interpret agency decisions in light of the governing statutoryand regulatory context. Cf. 5 U. S. C. §706 (specifying that a “reviewing court,” not a jury, “shall . . . determine the meaning or applicability of the terms of an agencyaction”); see also H. R. Rep. No. 1980, 79th Cong., 2d Sess., 44 (1946) (noting longstanding view that “questionsrespecting the . . . terms of any agency action” and its“application” are “questions of law”). To understand the question as a legal question for judges makes sense giventhe fact that judges are normally familiar with principles of administrative law. Doing so should produce greateruniformity among courts; and greater uniformity is normally a virtue when a question requires a determination concerning the scope and effect of federal agency action. Cf. Markman, 517 U. S., at 390–391.
We understand that sometimes contested brute facts will prove relevant to a court’s legal determination about the meaning and effect of an agency decision. For example, if the FDA rejected a drug manufacturer’s supplemental application to change a drug label on the ground that the information supporting the application was insufficient to warrant a labeling change, the meaning and scope of that decision might depend on what information the FDA had before it. Yet in litigation between a drugconsumer and a drug manufacturer (which will ordinarily lack an official administrative record for an FDA decision),the litigants may dispute whether the drug manufacturersubmitted all material information to the FDA.
17 Cite as: 587 U. S. ____ (2019)
Opinion of the Court
But we consider these factual questions to be subsumed within an already tightly circumscribed legal analysis. And we do not believe that they warrant submission alone or together with the larger pre-emption question to a jury.Rather, in those contexts where we have determined that the question is “for the judge and not the jury,” we have also held that “courts may have to resolve subsidiaryfactual disputes” that are part and parcel of the broader legal question. Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., 574 U. S. ___, ___–___ (2015) (slip op., at 6– 7). And, as in contexts as diverse as the proper construction of patent claims and the voluntariness of criminal confessions, they create a question that “‘falls somewherebetween a pristine legal standard and a simple historicalfact.’” Markman, 517 U. S., at 388 (quoting Miller v. Fenton, 474 U. S. 104, 114 (1985)). In those circum-stances, “‘the fact/law distinction at times has turned on adetermination that, as a matter of the sound administration of justice, one judicial actor is better positioned thananother to decide the issue in question.’” Markman, 517
U. S., at 388 (quoting Miller, 474 U. S., at 114). In this context, that “better positioned” decisionmaker is the judge.
IV Because the Court of Appeals treated the pre-emption question as one of fact, not law, and because it did not have an opportunity to consider fully the standards wehave described in Part II of our opinion, we vacate its judgment and remand the case to that court for furtherproceedings consistent with this opinion.
It is so ordered.
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THOMAS, J., concurring
SUPREME COURT OF THE UNITED STATES
No. 17–290
MERCK SHARP & DOHME CORP., PETITIONER v. DORIS ALBRECHT, ET AL.
ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE THIRD CIRCUIT
[May 20, 2019]
JUSTICE THOMAS, concurring. I join the Court’s opinion and write separately to explainmy understanding of the relevant pre-emption principles and how they apply to this case. The Supremacy Clause of the Constitution provides: “This Constitution, and the Laws of the United States which shall be made in Pursuance thereof; and all Treaties made, or which shall be made, under the Authority of the United States, shall be the supreme Law of the Land; and the Judges in every State shall bebound thereby, any Thing in the Constitution or Laws of any State to the Contrary notwithstanding.” Art. VI, cl. 2.
Under this Clause, “[w]here state and federal law ‘directlyconflict,’ state law must give way.” PLIVA, Inc. v. Mensing, 564 U. S. 604, 617 (2011). Although the Court has articulated several theories of pre-emption, Merck’s sole argument here is that state law is pre-empted because it is impossible for Merck to comply with federal and state law.I remain skeptical that “physical impossibility” is a proper test for deciding whether a direct conflict exists between federal and state law. But even under our impossibility precedents, Merck’s pre-emption defense fails.
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I As I have explained before, it is not obvious that the “‘physical impossibility’ standard is the best proxy for determining when state and federal laws ‘directly conflict’ for purposes of the Supremacy Clause.” Wyeth v. Levine, 555 U. S. 555, 590 (2009) (opinion concurring in judgment). Evidence from the founding suggests that, underthe original meaning of the Supremacy Clause, federal law pre-empts state law only if the two are in logical contradiction. See ibid.; Nelson, Preemption, 86 Va. L. Rev. 225, 260–261 (2000). Sometimes, federal law will logically contradict state law even if it is possible for a person to comply with both. For instance, “if federal law gives an individual the right to engage in certain behavior that state law prohibits, the laws would give contradictorycommands notwithstanding the fact that an individual could comply with both by electing to refrain from the covered behavior.” Wyeth, 555 U. S., at 590 (opinion of THOMAS, J.). Merck does not advance this logical-contradictionstandard, and it is doubtful that a pre-emption defense along these lines would succeed here. “To say, as thestatute does, that [Merck] may not market a drug withoutfederal approval (i.e., without [a Food and Drug Administration (FDA)] approved label) is not to say that federal approval gives [Merck] the unfettered right, for all time, to market its drug with the specific label that was federallyapproved.” Id., at 592. Nothing in the federal brand-name-drug “statutory or regulatory scheme necessarilyinsulates [Merck] from liability under state law simplybecause the FDA has approved a particular label.” Id., at
593. The relevant question would be whether federal law gives Merck “an unconditional right to market [a] federally approved drug at all times with the precise label initially approved by the FDA,” id., at 592, or whether it instead provides a federal floor that can be supplemented by difCite
as: 587 U. S. ____ (2019) 3
THOMAS, J., concurring
ferent state standards, see Brief for Cato Institute as Amicus Curiae 14, n. 4. Absent a federal statutory right tosell a brand-name drug with an FDA-approved label, FDA approval “does not represent a finding that the drug, aslabeled, can never be deemed unsafe by later federalaction, or as in this case, the application of state law.” Wyeth, supra, at 592 (opinion of THOMAS, J.).
II Applying the Court’s impossibility precedents leads tothe same conclusion. The question for impossibility iswhether it was “lawful under federal law for [Merck] to dowhat state law required of ” it. Mensing, 564 U. S., at 618. Because “[p]re-emption analysis requires us to compare federal and state law,” I “begin by identifying the [relevant] state tort duties and federal labeling requirements.” Id., at 611. Respondents’ claim here is “that state lawobligated Merck to add a warning about atypical femur fractures” to the Warnings and Precautions section of Fosamax’s label. In re Fosamax (Alendronate Sodium) Prods. Liability Litig., 852 F. 3d 268, 282 (CA3 2017).Under the Federal Food, Drug, and Cosmetic Act, a manufacturer of a brand-name drug “bears responsibility for thecontent of its label at all times.” Wyeth, 555 U. S., at 570– 571 (majority opinion). The manufacturer “is charged both with crafting an adequate label and with ensuringthat its warnings remain adequate as long as the drug is on the market.” Id., at 571. Generally, to propose labeling changes, the manufacturer can submit a Prior ApprovalSupplement (PAS) application, which requires FDA approval before the changes are made. 21 CFR §314.70(b)(2018). Alternatively, under the FDA’s Changes Being Effected (CBE) regulation, if the manufacturer would liketo change a label to “add or strengthen a contraindication,warning, precaution, or adverse reaction” “to reflect newlyacquired information,” it can change the label immediately
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THOMAS, J., concurring
upon filing its supplemental application with the FDA,without waiting for FDA approval. §314.70(c)(6)(iii); see Wyeth, supra, at 568. If the FDA later disapproves theCBE application, “it may order the manufacturer to cease distribution of the drug product(s)” with the new labeling.§314.70(c)(7).
Here, Merck’s impossibility pre-emption defense failsbecause it does not identify any federal law that “prohibited [it] from adding any and all warnings . . . that would satisfy state law.” Ante, at 13. By its reference to “the Laws of the United States,” the Supremacy Clause “requires that pre-emptive effect be given only to those federal standards and policies that are set forth in, or necessarily follow from, the statutory text that was produced through the constitutionally required bicameral and presentmentprocedures.” Wyeth, supra, at 586 (opinion of THOMAS, J.).Merck’s primary argument, based on various agency communications, is that the FDA would have rejected a hypothetical labeling change submitted via the CBE process.But neither agency musings nor hypothetical future rejections constitute pre-emptive “Laws” under the SupremacyClause.
As the Court describes, in 2008 Merck submitted PAS applications to add certain language regarding fractures tothe Adverse Reactions and the Warnings and Precautions sections of Fosamax’s label. Ante, at 6. In 2009, the FDA sent Merck a “complete response” letter “agree[ing] thatatypical and subtrochanteric fractures should be added” tothe Adverse Reactions section. App. 510–511. But the letter said that Merck’s proposed Warnings and Precautions language, which focused on “the risk factors for stressfractures,” was “inadequate” because “[i]dentification of‘stress fractures’ may not be clearly related to the atypicalsubtrochanteric fractures that have been reported in theliterature.” Id., at 511. In accord with FDA regulations, the letter required Merck to take one of three actions: (1)
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THOMAS, J., concurring
“[r]esubmit the application . . . , addressing all deficienciesidentified in the complete response letter”; (2) “[w]ithdraw the application . . . without prejudice to a subsequent submission”; or (3) “[a]sk the agency to provide . . . an opportunity for a hearing,” after which “the agency will either approve” or “refuse to approve the application.” 21 CFR §314.110(b); see App. 512. As this regulation suggests and the FDA has explained, complete response letters merely “infor[m] sponsors of changes that must be made before an application can be approved, with no implication as to the ultimate approvability of the application.” 73 Fed. Reg. 39588 (2008) (emphasis added). In other words, the 2009 letter neither marked “the consummation of the agency’s decisionmaking process” nor determined Merck’s “rights or obligations.” Bennett v. Spear, 520 U. S. 154, 178 (1997) (internal quotation marks omitted). Instead, it was “of a merely tentative or interlocutorynature.” Ibid. Therefore, the letter was not a final agencyaction with the force of law, so it cannot be “Law” with pre-emptive effect.
Merck’s argument that the 2009 letter and other agency communications suggest that the FDA would have denied a future labeling change fares no better: hypotheticalagency action is not “Law.” As Merck acknowledges, itcould have resubmitted its PAS applications, sought a hearing, or changed its label at any time through the CBE process. See Reply Brief 13. Indeed, when Merck instead decided to withdraw its PAS applications, it added atypical femoral fractures to the Adverse Reactions section through the CBE process. That process also enabledMerck to add language to the Warnings and Precautionssection, but Merck did not do so. If it had, it could have satisfied its federal and alleged state-law duties—meaning that it was possible for Merck to independently satisfyboth sets of duties. Merck’s belief that the FDA would have eventually rejected a CBE application does not make
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THOMAS, J., concurring
an earlier CBE change impossible. As the Court correctly explains, “‘the possibility of impossibility [is] not enough.’” Ante, at 13–14. The very point of the CBE process is that a manufacturer can “unilaterally” make a labeling changethat does not violate other federal law, Wyeth, 555 U. S., at 573; see id., at 570; e.g., 21 U. S. C. §352, at least until the FDA rules on its application.*
Because Merck points to no statute, regulation, or other agency action with the force of law that would have prohibited it from complying with its alleged state-law duties, its pre-emption defense should fail as a matter of law.
—————— *In 2007, Congress “granted the FDA statutory authority to require a manufacturer to change its drug label based on safety information that becomes available after a drug’s initial approval,” but even after this amendment, brand-name-drug “manufacturers remain responsible for updating their labels.” Wyeth, 555 U. S., at 567–568; see 21 U. S. C. §355(o)(4). As I understand the Court’s opinion, if proper agencyactions pursuant to this amendment, or other federal law, “prohibited the drug manufacturer from . . . satisfy[ing] state law,” state law would be pre-empted under our impossibility precedents regardless of whetherthe manufacturer “show[ed] that it fully informed the FDA of the justifications for the warning required by state law.” Ante, at 13; see, e.g., Wyeth, 555 U. S., at 576; id., at 582 (BREYER, J., concurring). Of course, the only proper agency actions are those “that are set forth in, or necessarily follow from, the statutory text,” and they must have the force of law to be pre-emptive. Id., at 586 (opinion of THOMAS, J.). I am aware of no such agency action here that prevented Merck from complying with state law.
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ALITO, J., concurring in judgment
SUPREME COURT OF THE UNITED STATES
No. 17–290
MERCK SHARP & DOHME CORP., PETITIONER v. DORIS ALBRECHT, ET AL.
ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE THIRD CIRCUIT
[May 20, 2019]
JUSTICE ALITO, with whom THE CHIEF JUSTICE and JUSTICE KAVANAUGH join, concurring in the judgment.
I concur in the judgment because I agree with the Court’s decision on the only question that it actually decides, namely, that whether federal law allowed Merck toinclude in the Fosamax label the warning alleged to be required by state law is a question of law to be decided by the courts, not a question of fact. I do not, however, jointhe opinion of the Court because I am concerned that itsdiscussion of the law and the facts may be misleading on remand.
I I begin with the law. The Court correctly notes that a drug manufacturer may prove impossibility pre-emption by showing that “federal law (including appropriate [Food and Drug Administration (FDA)] actions) prohibited the drug manufacturer from adding any and all warnings to the drug label that would satisfy state law.” Ante, at 13. But in expounding further on the pre-emption analysis,the Court provides a skewed summary. While dwelling on our decision in Wyeth v. Levine, 555 U. S. 555 (2009), see ante, at 9–14, the Court barely notes a statutory provisionenacted after the underlying events in that case that may have an important bearing on the ultimate pre-emption
2 MERCK SHARP & DOHME CORP. v. ALBRECHT
ALITO, J., concurring in judgment
analysis in this case.
Under 21 U. S. C. §355(o)(4)(A), which was enacted in 2007, Congress has imposed on the FDA a duty to initiatea label change “[i]f the Secretary becomes aware of new information, including any new safety information . . . that the Secretary determines should be included in the labeling of the drug.”* This provision does not relieve drugmanufacturers of their own responsibility to maintain their drug labels, see §355(o)(4)(I), but the FDA’s “actions,” ante, at 13, taken pursuant to this duty arguably affect the pre-emption analysis. This is so because, if the FDA declines to require a label change despite having received and considered information regarding a new risk, the logical conclusion is that the FDA determined that a label change was unjustified. See United States v. Chemical Foundation, Inc., 272 U. S. 1, 14–15 (1926) (“The presumption of regularity supports the official acts of public officers and, in the absence of clear evidence to the contrary, courts presume that they have properly discharged their official duties”). The FDA’s duty does not depend on whether the relevant drug manufacturer, as opposed to some other entity or individual, brought the new information to the FDA’s attention. Cf. ante, at 13 (“the drugmanufacturer [must] show that it fully informed the FDAof the justifications for the warning required by statelaw”). Nor does §355(o)(4)(A) require the FDA to communicate to the relevant drug manufacturer that a label change is unwarranted; instead, the FDA could simplyconsider the new information and decide not to act. Cf. ante, at 13 (“[T]he FDA, in turn, [must have] informed the drug manufacturer that the FDA would not approve ——————
*Prior to October 2018, §355(o)(4)(A)’s language contained slight differences not relevant here. See Substance Use–Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act, Pub. L. 115–271, §3041(b), 132 Stat. 3942–3943, effective Oct. 24, 2018.
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ALITO, J., concurring in judgment
changing the drug’s label to include that warning”).
Section 355(o)(4)(A) is thus highly relevant to the preemption analysis, which turns on whether “federal law (including appropriate FDA actions) prohibited the drugmanufacturer from adding any and all warnings to thedrug label that would satisfy state law.” Ante, at 13 (emphasis added). On remand, I assume that the Court of Appeals will consider the effect of §355(o)(4)(A) on the preemption issue in this case.
Two other aspects of the Court’s discussion of the legal background must also

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Bayer/Monsanto and Roundup Verdict of $2 Billion = Settlement

  • Pilliod v. Monsanto Co. RG17862702, California Superior Court, County of Alameda (Oakland)

 

(MASS TORT NEXUS MEDIA) Combine the $2 billion verdict of May 13, 2019 and the two previous jury awards of $159 million in damages and you get major legal and financial issues for Bayer and the board of directors.

The Monsanto Roundup MDL 2741 May trial, initially set for next week was stopped by Judge Chhabria, who vacated the May 20, 2019 bellwether trial date, in the case of, Stevick v. Monsanto  where plaintiff Elaine Stevick, asserts that Roundup caused non-Hodgkin lymphoma. Federal Judge Vince Chhabria is overseeing thousands of Roundup lawsuits and has deemed Hardeman’s case and two others “bellwether trials” in ROUNDUP-MONSANTO-(GLYPHOSATE)-MDL-2741-(USDC-ND-California).

The numbers being discussed between Bayer corporate and their now very concerned board of directors for a global settlement are between $3 billion and $5 billion, which may be a low number after the $2 billion Pilliod jury award.

Here is the breakdown of the Pilliod vs. Monsanto trial verdict in the Alameda County Superior Court, Oakland, CA

$2.055 billion total verdict

 $55,206,172.80 compensatory damages and $2 billion punitive damages

Alva Pilliod

Compensatory:

Past economic – $47,296.01

Past non-economic loss – $8M

Future non-economic loss – $10M

——————————————-

$18,047,296.10

Punitive damages – $1 billion

Alberta Pilliod

Compensatory:

Past economic – $201,166.76

Past non-economic – $8M

Future economic  – $2,957,710

Future non-economic – $26M

——————————————-

$37,158,876.70

Punitive damages – $1 billion

 Monsanto Hit with Historic $2.055 Billion Verdict Losing Third Roundup Trial

Baum Hedlund Firm Press Conference on Verdict:  https://www.facebook.com/BaumHedlund/

 May 13, 2019  An Alameda jury in the case of Pilliod et al. v. Monsanto Company (Case No. RG17862702, JCCP No. 4953) returned a verdict today of $2.055 billion in favor of a husband and wife with non-Hodgkin lymphoma, ordering Monsanto to pay $55 million in compensatory damages and $2 billion in punitive damages ($1 billion each for Mr. and Mrs. Pilliod) for failing to warn consumers that exposure to Roundup weed killer causes non-Hodgkin lymphoma (NHL).

The verdict is the third in a row against Monsanto (now Bayer). Combined with the first two legal defeats (the Johnson v. Monsanto verdict of $289.2M and the Hardeman v. Monsanto verdict of $80M), verdicts against Monsanto in the Roundup cancer litigation now stand at $2.424 billion with 13,400 cases still pending in state and federal courts. (Johnson’s verdict was later reduced to $78.5M but his verdict is on appeal.)

A press conference on today’s landmark verdict will be held at the offices of Audet & Partners in San Francisco at 4:30 p.m. Plaintiffs Alva and Alberta Pilliod and their legal team will give statements on the verdict. A Q&A with the attorneys will follow. Details can be found below. We will also live stream this from our Facebook page.

Monsanto Loses Third Straight Roundup Cancer Trial

Alva and Alberta Pilliod, a Livermore, California couple in their 70s, used Monsanto’s Roundup weed killer together for more than 30 years to landscape their home and other properties. They were both diagnosed with the same type of NHL, diffuse large B-cell lymphoma (DLBCL), associated with Roundup exposure. In 2011, Alva was diagnosed with systemic NHL in many of his bones, which spread to his pelvis and spine. Alberta was diagnosed with NHL brain cancer in 2015.

In their Roundup cancer lawsuit, the couple attributed their cancer diagnoses on exposure to Roundup and its active ingredient, glyphosate, and accused Monsanto of fraudulently representing that Roundup is safe despite scientific evidence linking exposure to NHL.

At trial, attorneys for the Pilliods, Michael Miller of the Miller Firm and R. Brent Wisner of Baum, Hedlund, Aristei & Goldman, showed jurors a trove of internal Monsanto documents they say demonstrate the agrochemical giant’s manipulation of scientific literature, including ghostwriting several review papers on glyphosate published in scientific journals and cited in Environmental Protection Agency (EPA) regulatory reviews.

The jury also saw documents showing Monsanto’s efforts to influence EPA and other regulatory agencies, as well as evidence that Monsanto ran a public relations campaign to plant favorable stories in Reuters and other media outlets to defend its products and discredit scientists who determined glyphosate was linked to cancer.

During closing arguments, Wisner told the jury that Roundup was “born in fraud” because the agrochemical received EPA approval in 1974 based on studies conducted at Industrial Bio-Test Laboratories (IBT). A subsequent EPA review of the data found that IBT routinely falsified data. Three IBT executives were later convicted of fraud. According to Wisner, from that point on, Monsanto repeatedly refused to conduct studies on glyphosate and Roundup, even after the EPA and its own toxicologist told Monsanto that it needed to conduct more studies to address safety concerns.

After approximately 7 weeks of trial proceedings, the jury found that exposure to Roundup caused the Pilliods to develop NHL and that Monsanto failed to warn of this severe health hazard. Importantly, the jury also found that Monsanto acted with malice, oppression or fraud and should be punished for its conduct.

Since the Monsanto acquisition last summer and two negative jury verdicts, Bayer has lost more than $30 billion in shareholder value.

Monsanto Co. continues to refuse to warn consumers of the dangers of its multi-billion-dollar product Roundup despite the world’s foremost authority on cancer—the International Agency for Research on Cancer (IARC)—listing glyphosate as a probable carcinogen in 2015.

Monsanto Bad Conduct Is Revealed

* Monsanto never conducted epidemiology studies for Roundup and its other formulations made with the active ingredient glyphosate to evaluate the cancer risks for users.

* Monsanto was aware that the surfactants in Roundup were much more toxic than glyphosate alone.

* Monsanto spent millions of dollars on covert public relations campaigns to finance ghostwritten studies and articles aimed at discrediting independent scientists whose work found dangers with Monsanto’s herbicides.

* When the US Agency for Toxic Substances and Disease Registry sought to evaluate glyphosate toxicity in 2015, Monsanto engaged the assistance of EPA officials to delay that review.

* Monsanto enjoyed a close relationship with certain officials within the Environmental Protection Agency (EPA), who have repeatedly backed Monsanto’s assertions about the safety of its glyphosate products.

* The company internally had worker safety recommendations that called for wearing a full range of protective gear when applying glyphosate herbicides, but did not warn the public to do the same.

Pilliod v. Monsanto Trial Transcripts

Pilliod v. Monsanto Trial Exhibits

Pilliod v. Monsanto Jury Instructions

Attorneys React to Verdict Against Monsanto

After the verdict, co-lead trial counsel R. Brent Wisner thanked the jury for dutifully listening to scientific evidence and testimony over the course of several weeks. “They were given an incredibly difficult task having to analyze the highly-complex scientific issues in this case,” said Wisner. “They took detailed notes, asked incredibly thoughtful questions and in the end, came to understand that the science shows there are serious health hazards associated with Roundup and that Monsanto did nothing to warn people about the risk.”

“The jury saw for themselves internal company documents demonstrating that, from day one, Monsanto has never had any interest in finding out whether Roundup is safe,” Wisner said. “Instead of investing in sound science, they invested millions in attacking science that threatened their business agenda.”

Wisner also thanked everyone on the trial team, calling the victory a “true team effort that would not have been possible without the tenacity and resolve of everyone who worked on the case.”

Michael Miller, who served with Wisner as co-lead trial counsel added: “Unlike the first two Monsanto trials, where the judges severely limited the amount of plaintiffs’ evidence, we were finally allowed to show a jury the mountain of evidence showing Monsanto’s manipulation of science, the media and regulatory agencies to forward their own agenda despite Roundup’s severe harm to the animal kingdom and humankind.”

Roundup Cancer Attorneys in Pilliod v. Monsanto

A team of attorneys from three law firms represented the Pilliods in this trial: Michael Miller, Curtis G. Hoke, David J. Dickens and Jeffrey Travers of The Miller Firm of Orange, Virginia; R. Brent Wisner, Michael L. Baum and Pedram Esfandiary of Baum, Hedlund, Aristei & Goldman of Los Angeles, California; and Mark Burton of Audet & Partners of San Francisco, California.

The Miller Firm and Baum, Hedlund, Aristei & Goldman co-tried the case of Dewayne “Lee” Johnson v. Monsanto Co., the first Monsanto Roundup lawsuit to proceed to trial. The case resulted in a $289.2 million jury verdict last August. The judge later upheld the jury’s verdict but reduced the punitive damages award, bringing the total award to $78.5 million.

Baum Hedlund partner, R. Brent Wisner, was also part of the Hardeman trial team (the second Roundup trial) conducted by Aimee Wagstaff of Andrus Wagstaff and Jennifer Moore of Moore Law in U.S. District Court for the Northern District of California (federal court). Mr. Wisner presented one of the key fact witnesses (Dr. Christopher Portier) and he cross-examined most of the corporate witnesses in Hardeman v. Monsanto Co. Wisner is also administrator and co-lead counsel for the Roundup Products Cases JCCP 4953 (known as the Roundup Judicial Council Coordination Proceedings or simply Roundup JCCP) before the California Superior Court for the County of Alameda (where he Pilliod trial occurred).

Baum Hedlund managing partner, Michael Baum, and a team working under him assisted the Hardeman trial team as members of the MDL Executive Committee by presenting and preparing experts, corporate testimony and documents for Hardeman v. Monsanto Co. Mr. Baum is also a member of the Executive Committee for the Monsanto Roundup MDL (federal multi-district litigation). Mr. Miller is a co-leader of the Roundup MDL Executive Committee.

Pilliod v. Monsanto Docket History and Links

Alva and Alberta Pilliod v. Monsanto Co. (Case No. RG17862702, JCCP No. 4953) is the first Roundup non-Hodgkin lymphoma lawsuit from the California Roundup Judicial Council Coordination Proceedings (JCCP) to go to trial. Hundreds of lawsuits filed in California state courts are consolidated in the Roundup JCCP before Judge Winifred Smith for the Superior Court of Alameda County.

Pilliod v. Monsanto Co. is the third Roundup cancer case to go before a jury. The first Monsanto Roundup trial, Dewayne “Lee” Johnson v. Monsanto Co., resulted in a $289.2 million jury verdict last August. The judge later upheld the jury’s verdict but reduced the punitive damages award, bringing the total award to $78.5 million. The second case, Edwin Hardeman v. Monsanto Co., resulted in an $80 million jury verdict against the agrochemical company.

Plaintiffs in the litigation against Monsanto (now Bayer) allege that exposure to Roundup weed killer caused them to develop non-Hodgkin lymphoma.

Quick link to Pilliod trial transcripts

Quick link to Pilliod trial exhibits

Quick link to Pilliod trial press release

Jury Instructions

Alberta Pilliod verdict form

Alva Pilliod verdict form

Looking for unsealed Monsanto emails, communications, studies and other memoranda? Visit the Monsanto Papers page.

Alva Pilliod and his wife, Alberta, are in their 70s and have been married for nearly 50 years. They started using Roundup in the 1970s and continued using the weed killer until only a few years ago. The Livermore couple has two children and four grandchildren.

Alva suffers from non-Hodgkin lymphoma in his bones that spread to his pelvis and spine. He was diagnosed in 2011. Alberta was diagnosed with non-Hodgkin lymphoma brain cancer in 2015.

Attorneys for the Pilliods asked Judge Ioana Petrou (the previous presiding judge who has since been appointed to the First District Court of Appeal) to expedite the trial due to their advanced ages and cancer diagnoses. Judge Petrou granted their trial preference. The presiding judge for this trial is now Judge Winifred Smith.

The Miller Firm senior partner Michael J. Miller and Baum, Hedlund, Aristei & Goldman attorney R. Brent Wisner are co-lead trial counsel for the Pilliods. The Miller Firm and Baum, Hedlund, Aristei & Goldman co-tried the Johnson case last year.

Pilliod v. Monsanto Company Trial Transcripts

Day 1: 3/28/2019 – Plaintiff opening statement by R. Brent Wisner. Defense opening statement by Tarek Ismail.

Day 2: 4/2/2019 – Dr. Christopher Portier 402 Hearing (short hearing out of the presence of the jury to determine the admissibility of evidence). Direct examination by R. Brent Wisner. Cross-examination by Tarek Ismail. Redirect examination by R. Brent Wisner.

Dr. Christopher Portier testimony (jury present). Direct examination by R. Brent Wisner.

Dr. Portier holds a Ph.D. in Biostatistics (with a minor in Epidemiology). For over three decades, Dr. Portier held prominent leadership positions in the U.S. government that combined the disciplines of toxicology, statistics and epidemiology, including:

  • Associate Director of the National Institute of Environmental Health Sciences (NIEHS) National Toxicology Program and thus the nation’s chief toxicologist, among other roles at NIEHS.
  • Director of the National Center for Environmental Health, Center for Disease and Prevention.
  • Director of the Agency for Toxic Substances and Disease Registry (ATSDR).

Expert Report of Dr. Portier

Day 3: 4/3/2019 – Dr. Christopher Portier testimony (continued). Direct examination by R. Brent Wisner. Cross-examination by Tarek Ismail. Redirect examination by R. Brent Wisner.

Day 4: 4/4/2019 – Dr. Charles Jameson testimony. Direct examination by R. Brent Wisner. Cross-examination by Tarek Ismail. Redirect examination by R. Brent Wisner. Recross-examination by Tarek Ismail.

Dr. Jameson worked for the National Institutes of Health’s National Cancer Institute (NCI) as a senior chemist for the NCI’s Rodent Bioassay Program where he served as chief chemist, directing all chemistry activities and participating in the development of all two-year rodent bioassays while also serving as secretary for the NCI’s Chemical Selection Working Group. He also served as program leader for the National Toxicology Program at the NIH’s National Institute of Environmental Health Sciences (NIEHS) for 12 years.

Expert Report of Dr. Jameson

Day 5: 4/8/2019 – Dr. Beate Ritz, Chair of the Epidemiology Department at UCLA, direct examination by Michael Miller. Cross-examination by Kelly Evans. Redirect examination by Michael Miller. Recross-examination by Kelly Evans. Further redirect examination by Michael Miller.

Mark Martens video testimony (taken on April 7, 2017 in Washington, D.C.).  Mr. Martens is a former Monsanto executive, Toxicology Agriculture Research & Development Director for Monsanto Europe.

Dr. Ritz is a professor of Epidemiology at the University of California, Los Angeles. She holds doctoral degrees in Medicine and Epidemiology and is the author of numerous toxicology publications, lectures and presentations. Dr. Ritz engaged in a systematic review of the literature in this case, utilized the Bradford Hill Criteria and concluded that “to a reasonable degree of scientific certainty, glyphosate causes NHL. Furthermore, to a reasonable degree of scientific certainty, glyphosate-based formulations, including Roundup, cause NHL.”

Dr. Ritz Expert Report

Day 6: 4/9/2019 – Dr. Dennis Weisenburger direct examination by Michael Miller. Cross-examination by Tarek Ismail.

Dr. Weisenburger specializes in the studies of the hematopoietic and immune systems, with a special interest in non-Hodgkin lymphoma. His study of the pathological mechanisms by which NHL develops began in the 1980s when he was directing large epidemiologic studies related to NHL.

Over the last four decades, Dr. Weisenburger has published over 300 papers on NHL in peer-reviewed journals, and over 50 papers on the epidemiology of NHL, including studies on glyphosate and NHL. In his expert report, Dr. Weisenburger concluded that to “a reasonable degree of medical certainty that glyphosate and GBFs [glyphosate-based formulations] (including Roundup) can cause NHL in humans exposed to these chemicals in the workplace or environment.”

Dr. Weisenburger Expert Report

Day 7: 4/10/2019 – Dr. Dennis Weisenburger cross-examination by Tarek Ismail (resumed). Redirect examination by Michael Miller. Recross-examination by Tarek Ismail. Further re-direct examination by Michael Miller. Further recross-examination by Tarek Ismail.

Mark Martens video testimony (resumed).

William Reeves video testimony. Mr. Reeves is Global Health and Safety Issues Management Lead at Bayer Crop Science.

Day 8: 4/11/2019 – Dr. William Robert Sawyer, toxicologist, direct examination by Brent Wisner. Cross-examination by Kelly Evans. Redirect examination by Brent Wisner.

William Reeves video testimony (resumed)

Day 9: 4/15/19 – William Reeves video testimony (resumed)

William Heydens video testimony (Monsanto Regulatory Product Safety Assessment Lead)

Michael Koch video testimony (Product Safety Team Lead, Bayer Crop Science)

Day 10: 4/16/19 – Michael Koch video testimony (resumed)

William Pease, direct examination by Brent Wisner. Cross-examination by Eugene Brown, Jr. Redirect examination by Brent Wisner.

Dr. Pease, toxicologist and assistant adjunct professor at the School of Public Health, University of California at Berkeley. In the early 90s he was a Research Toxicologist at UC Berkeley, where he coordinated the school’s Environmental Health Policy Program and conducted research on the impacts of pesticide use in California. Dr. Pease served as the co-chair of the Human Health Committee of CalEPA’s Comparative Risk Project, organizing its risk assessment and risk ranking process.

Michael Koch video testimony (resumed)

Aaron Blair video testimony. Dr. Blair currently serves as an advisor on the Chlordecone Scientific Committee (Institute National du Cancer, France), Pesticide Advisory Committee (Carex Canada), and Independent Advisory Board for Exposure Assessment (Institute of Occupational Medicine, Scotland). He has authored/coauthored more than 500 papers on occupational and environmental causes of cancer, other diseases, and epidemiologic methodology.

Daniel Goldstein video testimony. Dr. Goldstein works for Monsanto as Monsanto Lead Medical Sciences and Outreach.

Day 11: 4/17/2019 – Charles Benbrook, scientist and agricultural economist, direct examination by Brent Wisner. Cross-examination by Eugene Brown, Jr. Redirect by Brent Wisner.

Kavitha Raj video testimony. Dr. Kavitha Raj is the treating physician for Mr. and Mrs. Pilliod.

Day 12: 4/18/2019 – Kavitha Raj video testimony (resumed)

Alberta Pilliod direct examination by Brent Wisner. Cross-examination by Eugene Brown, Jr.

Alva Pilliod direct examination by Brent Wisner

Michael Pilliod direct examination by Michael Miller

Alberta and Alva Pilliod are the plaintiffs in this case. Michael Pilliod is their son.

James Rubenstein video testimony

Dr. Rubenstein, attending physician in hematology and oncology from the University of California San Francisco, was Alberta Pilliod’s treating physician.

Day 13: 4/22/2019 – Neel Gupta video testimony. Dr. Gupta is Alberta Pilliod’s physician.

Chadi Nabhan direct examination by Michael Miller. Voir dire examination by Tarek Ismail. Direct examination by Michael Miller.

Dr. Chadi Nabhan is a board-certified clinical medical oncologist and past Assistant Professor of Medicine at the University of Chicago. Currently, Dr. Nabhan serves as Medical Director of Cardinal Health. His clinical practice and academic research for the past 17 years has focused on lymphomas.

Expert Report of Dr. Nabhan

Day 14: 4/23/2019 – Alberta Pilliod 402 hearing (out of the presence of the jury). Direct examination by Brent Wisner. Cross-examination by Tarek Ismail. Redirect examination by Brent Wisner.

Chadi Nabhan testimony (continued). Direct examination by Michael Miller. Cross-examination by Tarek Ismail. Redirect examination by Michael Miller. Recross-examination by Tarek Ismail.

Direct examination of James Mills by Michael Miller. Cross-examination by Tarek Ismail.

Mr. Mills is a forensic economist.

Video testimony of Samuel Murphey. Mr. Murphey is Head of Global Issues Management, Bayer Crop Science.

Video testimony of James Guard. Mr. Guard is Global Roundup Lawn & Garden Lead, Bayer Crops Science.

Plaintiffs rest.

Day 15: 4/25/2019 – Proceedings without jury present.

Day 16: 4/27/2019 – Testimony of defense expert witness, Celeste Bello.

Direct examination by Tarek Ismail. Voir dire examination by Brent Wisner. Direct examination resumed by Tarek Ismail. Cross-examination by Brent Wisner. Redirect examination by Tarek Ismail. Recross-examination by Brent Wisner.

Dr. Bello is a hematologist and oncologist at the Moffitt Cancer Center.

Day 17: 4/30/2019 – Testimony of defense expert witness, Robert Phalen.

Direct examination by Kelly Evans. Voir dire examination by Brent Wisner. Direct examination resumed by Kelly Evans. Cross-examination by Brent Wisner. Redirect examination Kelly Evans. Recross-examination by Brent Wisner.

Dr. Phalen is an associate professor in industrial hygiene and safety at the University of Houston, Clear Lake.

Day 18: 5/1/2019 – Testimony of defense expert witness, Lorelei Mucci.

Direct examination by Kelly Evans. Voir dire examination by Michael Miller. Direct examination resumed by Kelly Evans. Cross-examination by Michael Miller. Redirect examination by Kelly Evans. Recross-examination by Michael Miller.

Dr. Mucci is an Associate Professor of Epidemiology at Harvard T.H. Chan School of Public Health and Assistant Professor of Medicine at Harvard Medical School.

Day 19: 5/6/2019 – Testimony of defense expert witness, Alexandra Levine.

Direct examination by Tarek Ismail. Voir dire examination by Michael Miller. Direct examination resumed by Tarek Ismail. Cross-examination by Michael Miller. Redirect examination by Tarek Ismail. Recross-examination by Michael Miller.

Dr. Levine is a professor in City of Hope’s Hematologic Malignancies and Stem Cell Transplantation Institute.

Defendant rests.

Day 20: 5/7/2019 – Proceedings without jury present.

Pilliod v. Monsanto Company Trial Exhibits

Plaintiffs’ Trial Exhibits

The jury in Bayer AG’s third Roundup weedkiller trial was urged by a plaintiffs’ lawyer to consider socking the company with $1 billion in damages as punishment for covering up the health risks of the herbicide for decades.

The aggressive demand on behalf an elderly couple who claim they got cancer from exposure to Roundup shows that plaintiffs are becoming bolder after winning the first two trials against Bayer, which together yielded $159 million in damages.

The couple’s attorney said the billion-dollar request is roughly based on the gross profit of $892 million recorded in 2017 by the agricultural-chemicals division of Monsanto, which was making Roundup long before Bayer acquired the company last year.

“That is a number that changes things,” lawyer Brent Wisner said Wednesday at the close of a trial in state court in Oakland, California. He also asked the jury to award about $55 million to compensate Alva and Alberta Pilliod for economic damages like hospital bills and noneconomic losses such as pain and suffering.

Investors have been closely watching developments in the costly Roundup litigation, and Bayer fell as much as 2.6% Thursday in Frankfurt. The shares have fallen about 40 percent since the $63 billion Monsanto purchase was completed in June.

Wisner argued that Monsanto’s internal data and documents reveal its “manipulation and fabrication of science,” just like other defective products that got to market based on fraudulent representations that they were safe.

An attorney for the company sought Wednesday to poke holes in the Pilliods’ efforts to show that they wouldn’t have developed non-Hodgkin lymphoma if they hadn’t used Roundup for landscaping their properties over a period of 30 years.

Tarek Ismail told the jury that’s an impossible, illogical conclusion given that Alva Pilliod’s weakened immune system greatly increased his risk of developing cancer. Digging into Pilliod’s medical history, Ismail cited 22 different types of skin cancers starting in his 20s, five brain infections starting in the late 1970s caused by herpes, other viral infections and colitis.

“You put this picture together and what do you see?” Ismail asked. “How anyone can stand here and deny this evidence of a weakened immune system is incredible.”

Alberta Pilliod, who Ismail said started smoking before she was 20 years old, similarly suffered from conditions that increased her risk of developing non-Hodgkins lymphoma, the lawyer said. He highlighted testimony from a doctor for the couple to argue her cancerous tumor wasn’t a type associated with exposure to herbicides, “full stop.”

Bayer Chief Executive Officer Werner Baumann faces increased shareholder pressure over the litigation it inherited from Monsanto. The agrochemical giant that operates out of St. Louis is the named defendant in U.S. lawsuits over Roundup filed by 13,400 people, a number that jumps by thousands with each passing quarter.

Why Bayer Shares Are Facing Such Trials Over Roundup: QuickTake

Bayer denies that Roundup causes cancer and the company has been holding out hope for a court win that would give Baumann some breathing space as the company hones its legal response to the swelling wave of litigation. A third loss, however, could force the company to accelerate talks on a global settlement, which analysts have said could top $5 billion. The judge in San Francisco handling the federal suits canceled a trial scheduled for May 20 to allow for confidential negotiations.

Plaintiffs’ lawyers, meanwhile, are honing their own arguments. In Oakland, Wisner presented evidence previous juries hadn’t seen, and portrayed internal emails and company advertising as evidence of glib disregard for consumer safety.

He played a video of an advertisement for Roundup showing a suburban man in shorts and a short-sleeved shirt killing weeds using the company’s “one-touch wand” to a soundtrack invoking the Old West. He pointed to Monsanto’s own exposure studies recommending that the herbicide be applied with chemical boots and overalls.

“That’s deliberate and knowing disregard for human safety, and it directly links to the Pilliods,” Wisner said.

An award of $1 billion would be vulnerable to a legal challenge by Bayer because courts have generally held that punitive damages shouldn’t be more than 10 times higher than compensatory damages.

The Alameda County Court case is Pilliod v. Monsanto Co. RG17862702, California Superior Court, County of Alameda (Oakland).

Mass Tort Nexus wants to thank Robin McCall and the Baum Hedlund firm for sharing their comments immediately after the trial verdict was announced.

Contact: Robin McCall, Media Relations

Baum, Hedlund, Aristei & Goldman, PC

Los Angeles – Sacramento – San Francisco

10940 Wilshire Blvd., 17th Floor

Los Angeles, CA 90024

Phone: (310) 207-3233

Email: rmccall@baumhedlundlaw.com

Web:  https://www.baumhedlundlaw.com/pilliod-v-monsanto-trial/

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MENTOR WORLDWIDE (J&J) ON FDA RADAR OVER TEXTURED IMPLANTS: What’s Next?

MENTOR WORLDWIDE (J&J) ON FDA RADAR OVER TEXTURED IMPLANTS AND CANCER: IS THIS AN EMERGING MASS TORT? 

Link to: FDA criminal-investigations/warning-letters/mentor-worldwide to Alex Gorsky CEO Mentor (J&J) March 18, 2019 -llc-acclarent-573520-03182019

Melissa Shirley vs. Mentor Worldwide (J&J) Complaint USDC ND Georgia (May 15, 2017)

By Mark A. York (May 8, 2019)

 

 

 

 

 

 

 

The primary makers of breast implants approved for use in the United States include:

Allergan, Inc.

Ideal Implant, Inc.

Mentor World Wide, LLC (Johnson & Johnson)

Sientra, Inc.

Breast augmentation remains the most common cosmetic surgical procedure in the U.S. with more than 300,000 performed each year, according to the American Society of Plastic Surgeons.

In addition to the warning notice to Mentor Worldwide in March 2018 (above), the FDA has taken additional steps to ensure the agency is monitoring the safety and risks of breast implants. The FDA shas  coordinated with the American Society of Plastic Surgeons and the Plastic Surgeons Foundation to develop the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (BIA-ALCL) Etiology and Epidemiology (PROFILE), which collects real world data regarding patients who have a confirmed diagnosis of BIA-ALCL. The data collected from this registry, have contributed to a better understanding of BIA-ALCL and FDA communication updates to the public regarding BIA-ALCL.

According to a complex analysis of FDA adverse event data, the number of suspected breast implant injuries jumped from an average of fewer than 200 a year through 2016, before the FDA’s more rigorous reporting rules, to 4,567 events in 2017 and at least 8,242 in the first half of 2018. More than 10 million women worldwide have received breast implants over the last decade, a remarkable comeback for a medical product that had suffered a crippling safety scandal and a lengthy ban in the United States.

The agency was aware of the true number of reported injuries but did not disclose them until recently. In Europe, some manufacturers have avoided reporting ruptures altogether, Dutch regulators were told. This was discovered during the  International Consortium of Investigative Journalists long term investigation titled, Implant Files investigation , which revealed the ongoing health problems plaguing many thousands of women with breast implants as part of its global research project that was released in November 2018.

In the U.S. and Canada, regulators did not impose any consequences after manufacturers lost track of most of the participants in a large-population health study within three years, although a 10-year study was ordered as a condition of allowing silicone implants back on the market.

Experts worldwide agree that more long-term studies are desperately needed, but neither Allergan nor Johnson & Johnson’s Mentor completed the studies of 40,000 women ordered by the FDA.  After two years, about 40 percent of the participants in the breast augmentation section of the Allergan study had dropped out; after three years, Mentor had lost about 80 percent of its breast augmentation study subjects.

The FDA now says that although it does not have evidence to support a link between breast implants and systemic illness, safety studies “would need to be much larger and longer than those conducted so far” to clearly rule out an association. Allergan and Mentor faced no consequences for failing to complete the mandatory studies.

In September 2018, researchers at the MD Anderson Cancer Center in Houston reported the results of the largest-ever long-term safety study of breast implants. The study found associations between silicone implants and three autoimmune diseases. In the same month, an Israeli study of tens of thousands of women also discovered a link between breast implants and autoimmune diseases. Several smaller studies conducted in recent years in the Netherlands and the U.S., reached similar conclusions.

In March 2017, the FDA issued a breast implant cancer warning, indicating that it was aware of at least 359 medical device reports involving women diagnosed with a rare form of non-Hodgkins lymphoma, known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The illness has been linked to at least nine deaths.

The agency indicated at the time that the lymphoma cases appeared to be more common among breast implants with textured surfaces, as opposed to smooth breast implants, but a definitive connection was not able to be made.

Australia’s Therapeutic Goods Administration (TGA) launched an effort monitor the association between breast implants and anaplastic large cell lymphoma, more than doubling the recognized number of cases identified among Australian patients between September 2016 and April 2017.

Researchers from the TGA published a study in May indicating that side effects of textured breast implants may be linked to a 14 times higher risk of ALCL in some cases.

The TGA has estimated that the breast implant lymphoma risk may be between 1-in-1,000 and 1-in-10,000, with most cases occurring between 3 and 14 years after implant, but the median being 8 years and some cases diagnosed as much as 37 years after breast surgery,

Due to the potential lymphoma risk with breast implants, regulators have made efforts to increase awareness among health care providers about cases of the rare cancer linked to textured breast implants, indicating that they should discuss the benefits and side effects of the implants with their patients.

The FDA has also recommended that doctors consider the possibility that a breast implant recipient is suffering from anaplastic large cell lymphoma (ALCL) when they present with late, onset, persistent peri-implant seroma.

Each year in the United States more than 300,000 women and undergo breast augmentation, with the total number of breast implants procedures each year being  anywhere between 5 to 10 million around the world.

Before the operations women are often told by their surgeons that it is a safe procedure with “very little” risk, with the . FDA generally supporting that incorrect statement, by offering that “breast implants are relatively safe” which is now being shown to be very inaccurate.

There is a growing body of evidence, now supported by  thousands of examples of adverse events from women all over the world who have had implants. Facts are emerging that breast implants have been and continue to cause  debilitating autoimmune disorders  as well as emerging evidence of links to certain types of cancer.

No implant on the market today can last a lifetime. Every type is prone to leaking and rupturing, and instance, the saline valve implants, can even become black with mold, causing a systemic fungal problem in a person’s body.

Typical Breast Implants Placement

Silicone Breast Implant History

History that breast implants have caused serious health problems, but for most of the public, that problem is assumed to be a historical reference, because those implants were removed from the market, so the current implants on the market must be very safe.

While the FDA now openly mentions problems that often occur in many women with breast implants, such as leaking and rupturing, they fail to warn the public about the more dangerous connection to auto-immune disorders.

The FDA actually allowed implants to be put onto the market for over 40 years without formally approving them, so it’s not a best practice to trust what the FDA says.

The lawsuits in the 1990’s involved 450,000 US women who sued  Dow Corning, one of the world’s largest manufacturers of silicone implants.

While Dow Corning never admitted that their implants were dangerous, they paid out enormous amounts to the victims. Their implants of the 1970’s had a very thin outer shell, and had a high leakage rate. Many women even lost their lives from illness caused by these implants, while waiting for a legal resolution of their lawsuits against Dow.

It was disclosed that Dow Corning knew for a very long time that their implants were toxic, yet covered it up for as long as they could.

In their own animal studies, researchers found that silicone could easily leak into the body, and caused tumours in up to 80% of the rats that were being tested on, see Fig. 7. The numbers were so alarming that the FDA, instead of being concerned, called these studies “erroneous,” which basically means they ‘must’ have been incorrect. The FDA then approved the Dow Corning implants, despite protests from some staff members that there were troubling warning signs.

We’ve also heard about the now infamous French PIP implant scandal which hit worldwide news recently. These implants (which were found to contain toxic chemicals used in mattresses and not approved for human use) are now banned, and women in the UK were offered free treatment to have them removed.

Shocking Ingredients Found In Dow Silicone Implants

When women are told that their implants contain silicone or saline, they often don’t tend to ask if anything else is being used alongside it. They certainly aren’t told this by the surgeons, who more than likely don’t even know themselves.

Check out the long list of alarming ingredients used in Dow’s silicone implants which came out during their court case when they were forced to disclose what was in their dangerous implants:

  • Methyl ethyl ketone (neurotoxin)
  • Cyclohexanone (neurotoxin)
  • Isopropyl Alcohol
  • Denatured Alcohol
  • Acetone (used in nail polish remover and is a neurotoxin)
  • Urethane
  • Polyvinyl chloride (neurotoxin)
  • Amine
  • Toulene
  • Dicholormethane (carcinogen)
  • Chloromethane
  • Ethyl acetate (neurotoxin)
  • Silicone
  • Sodium fluoride
  • Lead Based Solder
  • Formaldehyde
  • Talcum powder
  • Oakite (cleaning solvent)
  • Methyl 2- Cynanoacrylates
  • Ethylene Oxide (Carcinogen)
  • Xylene (neurotoxin)
  • Hexon
  • 2-Hedanone
  • Thixon-OSN-2
  • Stearic Acid
  • Zinc Oxide
  • Naptha (rubber solvent)
  • Phenol (neurotoxin)
  • Benzene (carcinogen/neurotoxin)
  • Lacquer thinner
  • Epoxy resin
  • Epoxy hardener
  • Printing Ink
  • Metal cleaning acid
  • colour pigments as release agents
  • heavy metals such as aluminium (neurotoxin linked to Alzheimer’s and auto immune disorders)
  • Platinium
  • Silica * (2)

What’s In Implants Today?

The current problem is we just don’t know. Its very difficult to find out exactly what is in current implants today. There nothing that shows a full ingredient list. Plastic surgeons state they have ‘never seen a full list’ and implant websites, do not disclose what is in their products.

Some scientists have been taking an in-depth look at the platinum, a toxic salt, found in silicone implants and its connection to ill health. However, after looking at this list above, it seems ludicrous to suggest that one individual ingredient would be the sole cause of these health problems. It’s clear that breast implants are completely toxic.

Its important to know that saline implants ALL have silicone outer shells, so these too can leak silicone and other ingredients into the body, either through rupturing or when the textured surface flakes off.

Types of Breast Implants Used Today

Silicone Implants

Many women opt out of having silicone implants due to the Dow Corning Lawsuit. But a growing number of women are now choosing to have them again due to the implant’s ability to look more natural than other types. These implants have an elastic type envelope which is pre-filled with a sticky, clear, jelly-like form of silicone. There are a few varieties of shapes to choose from, with smooth or textured surfaces.

With the FDA allowing silicone implants to come back on the market, it is very concerning to know that statistics show (according to Nancy Bruning, author of Breast Implants — Everything You Need To Know) that almost half of all women who have this type of implant will experience a rupture within 6-10 years, and one in five women were found to have silicone migrate to other parts of their bodies.

 

 

 

 

 

 

According to Dr Susan Kolb, world expert on breast implants, silicone implants should be completely avoided.

 

 

 

 

 

Saline implants – silicone outer shell, saline liquid inserted during surgery by surgeon

Saline Implants

Saline implants are commonly thought to be safer, yet they have their own problems. Saline implants have a silicone shell filled with a saline water, which is salt based and ‘sterile.’ Some types are inserted empty which the surgeon will inflate during surgery with this saline liquid. There is another type of saline implant, which also has a silicone shell, but the inside contains a gel like texture. There are smooth surface saline implants and textured surface saline implants.

According to research experts, 60% of women with these types of implants have complications within four years, and one out of five require additional surgery within three years.  This seems to be a cause for concern, since patients are commonly told that implants either never need to be removed or should be removed every ten years.

Possible Side Effects

This is what your surgeon does not tell you:

  • tenderness, lumpiness, or discomfort around the implants
  • change in the shape of your breast(s)
  • change in the consistency of your breast, such as increased softness
  • change in the way your breast moves – all of these symptoms may be a sign your implant has ruptured.
  • hardening of breast tissue
  • muscle pain
  • pain and swelling of the joints
  • pain in the soft tissues
  • a burning sensation of pain
  • tightness, redness, or swelling of the skin
  • swollen glands or lymph nodes
  • unusual, extreme, or unexplained fatigue
  • swelling of the hands and feet
  • unusualhair loss
  • rashes
  • skin thickening or hardening
  • dry eyes, mouth, or vagina
  • loss of memory, mental confusion, or ‘fogginess’
  • autoimmune disorders such as fibromyalgia, rheumatoid arthritis, scleroderma, multiple chemical sensitivity disorder, cancer, and biotoxicity problems.

Above is an excerpt from Breast Implants – All You Need To Know by Nancy Bruning.

 

 

 

 

 

 

 

 

 

 

A ruptured silicone implant. The red is tissue that had to be removed from the patient. The sticky consistency on the right is what comes out when ruptures and leakage occur.

Breast Implants Can Cause Cancer

It might not surprise some of you reading this to learn that there is a link between cancer and implants. Just recently in France, their National Cancer Institute released a study that found a “clearly established link” between Anaplastic large cell lymphoma (ALCL) and breast implants.

French officials have now recommended that breast implants in their country must carry a “cancer warning.”

There is also more evidence to back this connection now that a study conducted by Cambridge University in the UK found that nearly all cases of ALCL were discovered in women who had breast implants.

When you think about how breast implants are inserted — indeed it is quite gory and gruesome surgery — and about the horrific chemicals they are comprised of, it makes sense that they would, of course, pose a cancer risk. And now we have the data to support this.

Suicide Risk

Another little known factor about breast implants is that there is a connection between suicide. While this connection might be more about the woman’s mental status prior to having the surgery (perhaps she suffered from low self esteem and thought implants would make her much happier), it could also be because of the stressful impact the implants have on the body and its many important systems. As we have seen above, implants are linked to neurological disorders, amongst other concerns.

Women who have implants are at least 3 (some sources say 4) times more likely to commit suicide than those who do not have them.

The American Society of Plastic Surgeons (ASPS) reported that 329,396 women have undergone breast augmentation in the United States, an increase of 55% between 2000 and 2006, making it the most frequent US surgical cosmetic procedure for 2006 (ASPS, 2007). Although many studies have explored psychological aspects of this type of surgery, the consistently dramatic increase in numbers of breast augmentations, some that result in adverse psychological outcomes, remains a serious concern for health care providers. Surprisingly, very little is known about either the psychological characteristics of cosmetic surgery patients or the psychological impact of the surgical procedures. This literature review focuses on psychological issues in relation to breast augmentation procedures, including recent suicide findings related to this procedure. Conclusion of this review supports the necessity by health care providers to consistently screen patients for psychological disorders, such as Body Dysmorphic Disorder (BDD), prior to conducting cosmetic surgical procedures, specifically breast augmentation. See https://www.ncbi.nlm.nih.gov/pubmed/19499438, Psychological Issues Associated With Breast Augmentation  2009 Jun;30(6):377-82

Mammograms Can Rupture Breast Implants

 

 

 

 

 

 

 

Mammogram on a patient without implants 

If you have implants, you need to be aware that having mammograms can actually do serious damage to them. Because the procedure involves intense squashing down of the breast tissue, this has been known to cause ruptures, and if the implants do begin to leak, what is inside them will likely leak into your body.

It must be said that there is also alarming information that mammograms are not safe to have, even if you don’t have implants.

Is There A Safe Implant?

If you choose to get implants, then according to breast implant expert Dr. Susan Kolb, the safest type is the saline implant that has a smooth surface and does not have a valve. This is because the textured implants have been found to have particles flake off into the person’s body which can then attack the immune system. If there is a valve, as mentioned previously, a systemic fungal infection can ensue.  But even with this type, problems can happen in the future and lead to drastic complications, and it now seems to be leading toward Breast Implant Litigation Round II.

As discussed in the article What You Need To Know About Breast Implants, the authors wrote about the concerns with breastfeeding and toxicity:

According to the Institute of Medicine (IOM), women with any kind of breast surgery, including breast implant surgery, are at least three times as likely to have an inadequate milk supply for breastfeeding. Concerns about the safety of breast milk have also been raised, but there has not been enough research to resolve this issue. A study of a small number of women with silicone gel breast implants found that the offspring born and breastfed after the mother had breast implants had higher levels of a toxic form of platinum in their blood than offspring born before the same women had breast implants.

THE FAILS AGAIN

The FDA has also posted an unusually blunt warning on its website. It advises patients that the risk of complications is high and says flatly:  “You should assume that you will need to have additional surgeries.”

Since the FDA’s decision, the breast implant business has boomed, now exceeding $1 billion in revenue a year and projected to reach $2 billion by 2025. More than 1.6 million women worldwide received cosmetic breast implants in 2017, including an estimated 345,236 in the U.S., 235,950 in Brazil, 67,478 in Mexico and 54,045 in Italy. As of 2017, breast enlargement was the most common cosmetic surgery in the world.

A Clear Example of What Can Go Wrong

Please check out Susan’s experience that really turned into an utter nightmare for her, which is still affecting her health today. Below is a picture of her implants that she had recently removed.

 

 

 

 

 

 

 

 

 

 

 

 

 

Susan’s implants which were moved back in April this year. The one on the left was so ‘jelly like’ it had to be scraped off her ribs. The right one, although looks quite normal, actually had a small rupture too. The red tissue is what the surgeon also had to remove to ensure all the silicone was gone.

To access information on Breast Implants II and the most relevant and real time information on Mass Torts  sign up for:

Mass Tort Nexus “CLE Immersion Course”

May 31 – June 3, 2019 at The Riverside Hotel in Fort Lauderdale , FL

For class attendance information please contact Barbara Capasso at 954.530.9892 or Barbara@masstortnexus.com.

  1. For the most up-to-date information on all MDL dockets and related mass torts visit www.masstortnexus.com and review our mass tort briefcases and professional site MDL briefcases.
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FDA BANS THE USE OF PELVIC MESH PRODUCTS – How Will This Affect The TVM Litigation?

Will this move by the FDA re-ignite the mass tort engine in TVM litigation or possibly force settlement in Ethicon TVM MDL 2327?

By Mark A. York (April 17, 2019)

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) Manufacturers of pelvic synthetic surgical mesh products must stop selling and distributing their products in the United States immediately, the US Food and Drug Administration ordered Tuesday. The surgical mesh is typically used to repair pelvic organ prolapse (POP) and incontinence, but reported side effects have included permanent incontinence, severe discomfort and an inability to have sex.  The key issue with the product for many years is the fact that its made from polypropylene, basically the same material as fishing line.

The FDA said it “has determined that the manufacturers, Boston Scientific and Coloplast, have not demonstrated a reasonable assurance of safety and effectiveness for these devices.”

The FDA said its April 16, 2019 action to remove surgical mesh products from the market is part of its commitment to ensuring the safety of medical devices. In a November statement, the agency said that it “regulates more than 190,000 different devices, which are manufactured by more than 18,000 firms in more than 21,000 medical device facilities worldwide.”

FDA Release January 4, 2019

FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks

Summary: The U.S. Food and Drug Administration issued two final orders to manufacturers and the public to strengthen the data requirements for surgical mesh to repair pelvic organ prolapse (POP) transvaginally, or through the vagina. The FDA issued one order to reclassify these medical devices from class II, which generally includes moderate-risk devices, to class III, which generally includes high-risk devices, and a second order that requires manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.

FDA Finally Takes Action

Each year, thousands of women undergo transvaginal surgery to repair pelvic organ prolapse, a condition where weakened muscles and ligaments cause the pelvic organs to drop lower in the pelvis, creating a bulge or prolapse in the vagina. In the 1990s, gynecologists began implanting surgical mesh for the transvaginal repair of the condition and in 2002, the first mesh device specifically for this purpose was cleared for use by the FDA, according to the agency’s statement.

“We couldn’t assure women that these devices were safe and effective long term,” said Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health.

For years, medical device companies have stated that the products they are developing and placing into the marketplace are safe and helping patients in the USA and worldwide. That is often not the case and people around the world are suffering.

Medical device makers and compensated doctors have touted FDA approved implants and other devices as the surgical cure for millions of patients suffering from a wide range of pain disorders, making them one of the fastest-growing products in the $400 billion medical device industry. Companies and doctors aggressively push them as a safe antidote to the deadly opioid crisis in the U.S. and as a treatment for an aging population in need of chronic pain relief and many other afflictions.

2017 Pelvic Mesh Study in England Showed High Number of Adverse Events:

Scientific Reports Volume 7, Article number: 12015 (2017) |

Complications following vaginal mesh procedures for stress urinary incontinence: an 8 year study of 92,246 women

Conclusions

Summary: This is the largest study to date of surgical mesh insertions for SUI. It includes all NHS patients in England over an 8-year period. We estimate that 9.8% of patients undergoing surgical mesh insertion for SUI experienced a complication peri-procedurally, within 30-days or within 5 years of the initial mesh insertion procedure. This is likely a lower estimate of the true incidence. Given concerns about the safety of these procedures, this study provides robust data to inform both individual decision-making and national guidance.

Why Device Makers Tout FDA Approvals

  1. “Medtronic receives FDA clearance for two heart devices”
  2. “FDA approves device to help curb cluster headaches”
  3. MRI approved for young infants in intensive care

Manufacturer headlines like these instill consumer confidence that medical devices are safe and effective. After all, they have the FDA’s stamp of approval, right? NO!

The reality is, the FDA seldom requires rigorous evidence that a device works well–and safely–before allowing it onto the market. Medical devices are the diverse array of non-drug products used to diagnosis and treat medical conditions, from bandages to MRI scanners to smartphone apps to artificial hips.

This low standard of evidence applies to even the highest risk devices such as those that are implanted in a person’s body. Surgical mesh, pacemakers and gastric weight loss balloons are just a few examples of devices that have had serious safety problems.

Devices are subject to weaker standards than drugs because they’re regulated under a different law. The Medical Device Amendments of 1976 was intended to encourage innovation while allowing for a range of review standards based on risk, according to legal expert Richard A. Merrill. An array of corporate lobbying has since prompted Congress to ease regulations and make it easier for devices to get the FDA’s approval.

In 2011, an Institute of Medicine panel recommended that the “flawed” system be replaced, because it does not actually establish safety and effectiveness. At the time the FDA said it disagreed with the group’s recommendations.

Defective devices cleared through this system have included hip replacements that failed prematurely, surgical mesh linked to pain and bleeding and a surgical instrument that inadvertently spread uterine cancer.

Bard took the Avaulta implants off the market in 2012 and did the same with the Align inserts in 2016. The company chose to remove the products the day after the U.S. Food and Drug Administration in 2010 ordered Bard and other mesh-manufacturers, including Johnson & Johnson (Ethicon), Boston Scientific and Endo (American Medical S), to review their mesh products, which also resulted in J&J removing four lines of synthetic surgical mesh products from the market. .J&J’s Ethicon subsidiary is facing more than 50 thousand lawsuits regarding its synthetic mesh device in Ethicon (J&J) Pelvic Mesh TVM Litigation MDL-2327.

The Ethicon MDL is in the same West Virginia federal court as the Bard and other mesh manufacturer multidistrict litigation, which are all being heard by Judge Goodwin.  Judge Goodwin has previously expressed his frustration with the parties not engaging in substantive settlements discussions to resolve the thousands of cases, the one option he has is to begin remanding cases back for trial in court venues around the country, possibly forcing both sides to begin earnest settlement talks. Goodwin has held hearings with leadership attorneys from both sides appearing before the court to possibly kickstart settlements. He has gone so far as to warn mesh manufacturers that if they do not settle, U.S. juries appear poised to inflict hundreds of millions, or even billions, of dollars in compensatory and punitive damages on them in thousands of cases that would overload the federal judicial system for years to come.

The FDA forcing mesh manufacturers to stop the use of synthetic mesh is long overdue, and how this action results in renewed interest by mass tort firms across the country, remains to be seen. Regardless, it would seem that Ethicon and the other defendants in the pending TVM litigation that have been unwilling to discuss settlement, may now be forced to deal with the catastrophic consequences of manufacturing and marketing medical devices that have injured untold thousands of patients around the world.

To access the most current TVM case status and other real time information on Mass Torts  sign up for:

Mass Tort Nexus “CLE Immersion Course”

May 31 to June 3, 2019 at The Riverside Hotel in Fort Lauderdale , FL

For class attendance information please contact  Barbara Capasso 954.383.3932 or Barbara@masstortnexus.com

  1. For the most up-to-date information on all MDL dockets and related mass torts visit www.masstortnexus.com and review our mass tort briefcases and professional site MDL briefcases.
  2. To obtain our free newsletters that contains real time mass tort updates, visit www.masstortnexus.com/news and sign up for free access.

 

 

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The FDA Revamped Their Website

 

 

https://www.fda.gov/ as of April 26, 2019

 

 FDA has announced the launch of a newly redesigned FDA public access website. They have made changes to provide a more modern and customer friendly access for the public. The new FDA website launch was completed April 26, 2019.

PRODUCTS THE FDA REGULATES

FoodDrugsMedical DevicesRadiation-Emitting ProductsVaccines, Blood, and BiologicsAnimal and VeterinaryCosmetics and Tobacco Products

____________________________________________________________

The FDA public website receives nearly 5 million visitors—consumers, health professionals, scientists/researchers, and industry stakeholders each month. It serves as the face of the agency and a critical vehicle for meeting FDA’s mission, as it’s home to agency policy and perspectives and information about recalls, safety alerts and important regulatory actions. Ensuring that this content is easy to find is a top priority.

The FDA has attempted to make the FDA.gov website more user friendly, by redesigning not only the functionality, but the way it looks as well. The new FDA site is cleaner and the overall layout is less distracting and the content is much more contemporary.

The goals for the new FDA.gov website include:

https://www.fda.gov/

  • Remodeled webpages that can be viewed on any internet-ready device
  • Easier access to popular content
  • Updated navigation based on data and audience behavior
  • Easier to find FDA content in search results
  • Better consistency of FDA content across web and social channels

The FDA.gov website refresh centers around the migration to a new web content management system (WCMS). The current WCMS is end-of-life and we are replacing it with a new modern publishing platform.

Here are some of the things we are doing to improve FDA.gov:

  • Using data to archive and expire webpages that aren’t being used, consolidating similar content/renaming page titles to reduce redundancy so it’s easier for online audiences to find what they are looking for.
  • Adding stronger and more relevant metadata to the webpages to optimize them for search and social media.
  • Updating FDA.gov’s design to provide more visuals and interactive content. Overall the site will have a more modern look-and-feel. FDA content will appear consistently regardless of web and social channels.
  • Upgrading to a modern publishing platform ensures that our content is accessible anywhere, anytime and on any device.

WHAT THE FDA DOES AND LINKS TO RESOURCES.GOV

FDA Mission

The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.

FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.

FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.

FDA also plays a significant role in the Nation’s counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.

FDA’s Regulatory Responsibilities: Laws and Regulations

Product Approval

Recalls, News, and Events

Guidance Documents, Rulemaking, and Freedom of Information

Navigating The New FDA Site

Being a large and diverse agency with aesthetics apart, just keeping track of pathways and names is overwhelming in such a complex website, and it is easy to lose track of what needs to be updated.  The FDA stated that one of the goals was to make the site more friendly to consumers and it has improved. The former site ran banner photos of some topical interest, the new site landing pages feature a topic with a photo array focused on a feature topic. To get to the information, you need to click on the box announcing the feature, not the photos. Key to success for this approach will be topics that change out frequently as well as the topics themselves. This month’s is about children and allergy relief, timely given the time of year and the number of children, but perhaps not as serious as the recall of blood pressure medications.

Each FDA division – DrugsFoodMedical Devices has “featured information” that generally mirrors the FDA landing page (though stylistically there is not consistency across all divisions in terms of layout). For FDA to achieve its consumer friendly goal here they will have to work at providing information that is of interest to consumers and not necessarily just focus on that information FDA wants most to talk about.

Longer, Less Crowded Landing Page – It used to be when you went to FDA’s landing page, you had a LOT of information crammed into the screen offering you pathways in a bunch of different directions at once – from links to speeches to advisory committee information to meetings information to the latest press releases, etc. All of that is still on the landing page, but it is more coherently laid out. That means that there is less splashed in your face on the screen, but the content has been elongated – and you now have to scroll down to find all the bits and pieces. That may not be entirely apparent to some. As you scroll down, you come to additional featured topics beyond the main one mentioned above. Right now one of them includes a link to information about the revamp of the site; a link to information about combatting opioids and one on FDA fostering drug competition. As noted above, these topics fall a little more into the category of things FDA may want to say versus the things we want to hear more about from a consumer perspective. As you scroll down, you come to press announcements (where curiously the title of the section is in smaller type than the titles of the most recent press releases). Scrolling down further takes you past many of the links that were formerly crammed into the landing square of the old site. It is almost all still there, just there more for your leisurely scrolling rather than in your face. But not everything is on the landing page. For that you need the next section.

Menu Function is Key – In the upper right hand corner is the Menu Function. You are going to need this as it is the key to providing you a one-size fits all access to various divisions of the agency. It takes you to a site-map-lite that is actually very helpful if there are some specific things you want to look up. Most notably on the left side are a list of “featured links”. These are vital. They take you not only to guidance documents, but also one is the link that gets you to Advisory Committee information — to the page that is set up for each committee containing such information as the committee roster and meeting notices as well as documents related to specific meetings. To the right of this menu you will also find access to the FDA’s divisions, though it is not called that – instead it is called “Products”. Under that heading you will not see links to “CDER”, “CBER” or the others and where is the Office of Prescription Drug Promotion? Actually CDER, CBER and the others are there, but they are not called that. They are under their generic names (haha) – Drugs, Food, Medical Devices, Radiation-Emitting Products, etc. FDA may want to consider adding the acronyms here. These pages are generally laid out in similar fashion to the initial agency landing page, with a heading that is meant to cover topical information, prompting the user to scroll down to find the bits desired. Here you will find a link as you travel down the page to the Warning and Untitled Letters issued (still only one issued this year so far). The link to the Office of Prescription Drug Promotion exists but not on this page – it is under the About FDA Tab, and then drilling down through organizational structure through CDER there before you find it – here.

Finding Specifics Related to Function in the About FDA Link – One thing you don’t see when you go to the Drug page or the Food page or any of the other division pages is a map for getting to where you want to go within that division (hence the lack of an OPDP link from the Drugs Page). To find that level of detail – to find a specific office that does a specific function, you may have to either conduct a Search (which can offer up a messy slew of links) or go to the About FDA link mentioned above. Here’s the thing – that is in very small letters at the very bottom of the landing page. It is a small, obscure link to an important function. Overall, navigation of the site is less confusing now that everything is removed from a single frame shot. The order of things as you scroll down is pretty logical, though the demarcation of sections is subtle. Of note, if you have links to FDA materials at any site, some of the material may have shifted.

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Bayer’s Board Gets Vote of No Confidence Due To Monsanto Merger And Roundup Litigation MDL 2741 Docket

Product liability math works differently than regular math. In the case of Bayer and the Monsanto Roundup herbicide litigation, jury verdicts of $78 million and $80 million somehow adds up to $40 billion.

By Mark A. York (April 30, 2019)

(MASS TORT NEXUS MEDIA) The Monsanto glyphosate legal drama may be about to hit the agriculture firm’s new owners Bayer where it hurts the most-“The Boardroom.” This is where the executive suite is being forced to address the claims that they neither recognized nor took into account the enormous legal risks associated with the Monsanto takeover and the Roundup Litigation.

Bayer’s board received a vote of no confidence at the German company’s annual  meeting, last Friday April 26, 2019, coming from major financial inverstor widespread concerns over the Bayer purchase of  Monsanto last year, the major stakeholders in Bayer made it clear how unhappy they are.

What Would Settlement Cost?

Analysts at Liberum, an investment bank with offices in New York and London, figure a settlement cost of $11 billion — an average of $1 million for each of the 11,200 people who are suing over Roundup — sounds conservative.

While $1 million is far less than the recent jury awards, it’s high by the standards of other notorious product liability cases. Merck settled suits over its Vioxx painkiller for an average of $184,000 per plaintiff, and American Home Products paid $422,000 per person to settle claims over the diet drug fen-phen.

See Federal Jury Verdict Forms of March 19, 2019 Trial Findings Re: “Monsanto Roundup Caused Plaintiff’s Cancer”

Roundup MDL 2741 Federal Trial Jury Instructions of March 19, 2019

Roundup MDL 2741 Federal Trial Jury Verdict Form of March 19, 2019

Bayer bought Monsanto as part of its reinvention as a life-science firm with a focus on health and agriculture. At the time the deal was proposed in 2016, the competitive landscape of the agricultural-science space was shifting dramatically—Dow and DuPont were merging, and so were ChemChina and Syngenta. Bayer wanted to become a bigger player in seeds and genetically modified crops, and Monsanto offered just that.

Bayer’s share price has fallen by around two-fifths thanks to two jury verdicts in the U.S. that Monsanto’s glyphosate-based weedkiller, Roundup, was responsible for causing plaintiffs’ cancer. There are still 13,400 cases to go, and the liability costs could end up being astronomical. Some disgruntled Bayer investors say the management and supervisory boards should go—they’ve recommended that shareholders vote against ratifying the board’s actions, which would effectively be a vote of no confidence.

Bayer Chief Executive Werner Baumann has nine months to prove he shouldn’t be kicked out as a result of last year’s Monsanto acquisition, a corporate law expert warned Tuesday.

Professor Christoph Schalast, a mergers and acquisition specialist at the Frankfurt School of Finance and Management, said Friday’s unprecedented rebuke of Bayer’s management was in part caused by Baumann’s overconfidence in the company’s handling of glyphosate lawsuits that have already lopped two-fifths off Bayer’s value. The nine-month timescale he laid out refers to the timing of when Bayer sets the agenda for its next annual general meeting, after which dissident shareholders can file counter motions against management.

Baumann, for his part, has insisted that “management acted conscientiously” in assessing the liability risk around Monsanto.

There have so far been two multi-million-dollar verdicts in the U.S. that held Monsanto liable for plaintiffs’ cancers, on the basis that those cancers were caused by years of using the glyphosate-based weedkiller Roundup. There are another 13,400 such claims waiting in the wings. Bayer’s shareholders do not believe the company adequately assessed this financial risk when buying Monsanto for $63 billion last year in an effort to become a leading player in agriculture.

Extraordinary pressure

At Bayer’s annual general meeting last week, 55.5% of investors voted against “discharging”—or ratifying—the board of management’s actions over the past year. This does not have direct legal implications, but it certainly sent a message.

Ordinarily, German shareholders discharge management by 90% or more, and anything less is seen as a stain on management’s reputation. Deutsche Bank’s co-CEOs were forced out several years ago after 39% of investors refused to back them in such a vote. Baumann now has the distinction of being the first CEO of a DAX-listed company to have a majority of investors vote against him.

Just as unusually, many of those voting against Baumann and his team said they did not want Bayer’s management to go just yet, due to the added chaos that would introduce into the situation. As Janne Werning of shareholder Union Investment put it to the Financial Times, management now gets a “second chance to get to grips with the risks and take the company back on to a path of stable growth.”

Schalast said Baumann’s situation was not directly comparable with that of ousted Deutsche Bank chiefs Anshu Jain and Jürgen Fitschen, because their defenestration was the result of generally poor performance at the bank.

“It is the one deal. That’s why [Baumann] is under such strong pressure,” said Schalast. “[The AGM vote] is a wake-up call for both the supervisory board and board of management, but [Baumann] is in the spotlight.”

Germany has a two-tier system for boards of directors in corporations, with the supervisory board being responsible for monitoring the board of management. Immediately following Friday’s vote, Bayer’s supervisory board—which itself only won 66% approval from shareholders—expressed its support for Baumann. However, supervisory board chair Werner Wenning is known to see Baumann as his protégé, so this support is less than surprising.

Bayer’s route to change

If the board of management does not prove in the next nine months that it is capable of getting a handle on the legal situation in the U.S., Schalast said, shareholders will need to apply pressure to the supervisory board. This may involve calling for a new supervisory board member who has expertise in U.S. litigation of the sort Monsanto faces.

“If they want a change and the supervisory board is not open to such a change, then they have to vote in a new supervisory board,” Schalast said, explaining that in Germany supervisory boards are generally responsive to pressure from shareholders, to whom they are ultimately responsible. “You usually talk to them and they resign and then you have the possibility to vote for a new member,” he said. “If that doesn’t happen, then you need an extraordinary general assembly.”

Investor pressure could be accelerated if there are more major verdicts that go against Bayer/Monsanto, Schalast said.

A Bayer spokesperson said shareholders’ decision not to discharge management was “a new situation for us,” but highlighted the fact that investors had also said “there is no real alternative to the current management.”

“There was nobody who asked the board or the CEO to step down,” said the spokesperson. “There is no real basis for speculation about Mr. Baumann’s future as CEO.”

BAYER FINANCIAL DISCLOSURE OCTOBER 2018

Why is there no mention of Monsanto Roundup MDL 2741?

Bayer Interim Financial Report Third Quarter 2018

(Excerpt from Official Bayer Report)

 Explanatory Notes

Legal Risks

Product-related litigation

Mirena™: As of January 30, 2018, lawsuits from approximately 2,900 users of Mirena™, a levonorgestrel-releasing intrauterine system providing long-term contraception, had been served upon Bayer in the United States (excluding lawsuits no longer pending). Plaintiffs allege personal injuries resulting from the use of Mirena™, including perforation of the uterus, ectopic pregnancy or idiopathic intracranial hypertension, and seek compensatory and punitive damages. Plaintiffs claim, inter alia, that Mirena™ is defective and that Bayer knew or should have known of the risks associated with it and failed to adequately warn its users. Additional lawsuits are anticipated. In April 2017, most of the cases pending in U.S. federal courts in which plaintiffs allege idiopathic intracranial hypertension were consolidated in a multidistrict litigation (“MDL”) proceeding for common pre-trial management. As of January 30, 2018, lawsuits from approximately 400 users of Mirena™ alleging idiopathic intracranial hypertension had been served upon Bayer in the United States. Another MDL proceeding concerning perforation cases has, in the meantime, been dismissed. The Second Circuit Court of Appeals affirmed the perforation MDL district court’s summary judgment order of 2016 dismissing approximately 1,230 cases pending before that court. In August 2017, Bayer reached an agreement in principle with plaintiffs’ counsel leadership for global settlement of the perforation litigation, for a total amount of US$12.2 million. As of January 30, 2018, a total of approximately 4,000 cases would be included in the settlement. The idiopathic intracranial hypertension MDL proceeding is not included in the settlement.

As of January 30, 2018, five Canadian lawsuits relating to Mirena™ seeking class action certification had been served upon Bayer. Bayer believes it has meritorious defenses and intends to defend itself vigorously.

        XARELTO LITIGATION

Xarelto™: As of January 30, 2018, U.S. lawsuits from approximately 22,000 recipients of Xarelto™, an oral anticoagulant for the treatment and prevention of blood clots, had been served upon Bayer. Plaintiffs allege personal injuries from the use of Xarelto™, including cerebral, gastrointestinal or other bleeding and death, and seek compensatory and punitive damages. They claim, amongst other things, that Xarelto™ is defective and that Bayer knew or should have known of these risks associated with the use of Xarelto™ and failed to adequately warn its users. Additional lawsuits are anticipated. Cases pending in U.S. federal courts have been consolidated in an MDL for common pre-trial management. In May, June and August 2017, the first three MDL trials resulted in complete defense verdicts; plaintiffs have appealed all three verdicts. In January 2018, after the first trial to proceed in Pennsylvania state court had initially resulted in a judgment in favor of the plaintiff, the trial judge vacated the jury’s verdict and granted judgment in favor of Bayer. Further Pennsylvania state court trials are currently scheduled for the first and second quarters of 2018. Bayer anticipates that additional trials will be scheduled.

As of January 30, 2018, ten Canadian lawsuits relating to Xarelto™ seeking class action certification had been served upon Bayer. Bayer believes it has meritorious defenses and intends to defend itself vigorously.

Essure™: As of January 30, 2018, U.S. lawsuits from approximately16,100 users of Essure™, a medical device offering permanent birth control with a nonsurgical procedure, had been served upon Bayer. Plaintiffs allege personal injuries from the use of Essure™, including hysterectomy, perforation, pain, bleeding, weight gain, nickel sensitivity, depression and unwanted pregnancy, and seek compensatory and punitive damages. Additional lawsuits are anticipated.

As of January 30, 2018, two Canadian lawsuits relating to Essure™ seeking class action certification had been served upon Bayer. Bayer believes it has meritorious defenses and intends to defend itself vigorously.

Class actions over neonicotinoids in Canada: Proposed class actions against Bayer were filed in Quebec and Ontario (Canada) concerning crop protection products containing the active substances imidacloprid and clothianidin (neonicotinoids). Plaintiffs are honey producers, who have filed a proposed nationwide class action in Ontario and a Quebec-only class action in Quebec. Plaintiffs claim for damages and punitive damages and allege Bayer and another crop protection company were negligent in the design, development, marketing and sale of neonicotinoid pesticides. The proposed Ontario class action is in a very early procedural phase. In Quebec, the plaintiff sought authorization (certification) of a class for which a motion was heard in November 2017. Bayer believes it has meritorious defenses and intends to defend itself vigorously.

INSURANCE COMPANY PAYS THE BILLS

In connection with the above-mentioned proceedings, Bayer is insured against statutory product liability claims against Bayer to the extent customary in the respective industries and has, based on the information currently available, taken appropriate accounting measures for anticipated defense costs. However, the accounting measures relating to Essure™ claims exceed the available insurance coverage.

_____________________________________________________________________________

SHOULD BAYER HAVE INSERTED ROUNDUP MDL LITIGATION HERE?

https://www.masstortnexus.com/News/4362/Monsanto-Bayer-Facing-Over-11-000-Lawsuits-Over-Roundup-Cancer-Risk-As-New-Federal-Trial-Starts

Link to US District ND California Monsanto MDL 2741 litigation case outline and case related orders: https://www.cand.uscourts.gov/VC/roundupmdl

  1. Pretrial order no. 70: Final Juror Questionnaire (.pdf, 224 KB)264502/05/2019
  2. Pretrial order no. 71: Re Motion to Amend PTO 50 (.pdf, 72 KB)265102/06/2019
  3. Pretrial order no. 72: Procedure for Certain Motions to Remand (.pdf, 31 KB)266302/07/2019
  4. Pretrial order no. 73: Re Caselaw on Statute of Limitations (.pdf, 53 KB)267102/07/2019
  5. Pretrial order no. 74: Tentative View on Monsanto’s Specific Causation Experts(.pdf, 104 KB)268202/11/2019
  6. Pretrial order no. 75: Discussion of Expert Witnesses at Feb. 13, 2019, Hearing (.pdf, 69 KB)269102/12/2019
  7. Pretrial order no. 76: Re Missing Submissions (.pdf, 71 KB)269902/12/2019
  8. Pretrial order no. 77: Court’s Proposed Phase 1 Jury Instructions (.pdf, 154 KB)270602/12/2019
  9. Pretrial order no. 78: Guidance for the Parties re Motions in Limine (.pdf, 113 KB)270702/12/2019
  10. Pretrial order no. 79: Confidentiality of Juror Questionnaires (.pdf, 62 KB)275802/13/2019
  11. Pretrial order no. 80: Tentative Juror Excusals (.pdf, 70 KB)276902/15/2019
  12. Pretrial order no. 81: Ruling on Motions in Limine (.pdf, 119 KB)277502/18/2019
  13. Pretrial order no. 82: Parties’ Proposed Voir Dire Questions (.pdf, 104 KB)277602/18/2019
  14. Pretrial order no. 83: Time Limits for Trial (.pdf, 68 KB)279002/21/2019
  15. Pretrial order no. 84: Ruling on Deposition Objections for Drs. Turk, Turley, and Ye(.pdf, 81 KB)279702/23/2019
  16. Pretrial order no. 85: Denying Monsanto’s Motion for Summary Judgment on Specific Causation (.pdf, 195 KB)279902/24/2019
  17. Pretrial order no. 86: Remaining Summary Judgment Arguments (.pdf, 73 KB)280002/24/2019
  18. Pretrial order no. 87: Order to Show Cause Re Sanctions (.pdf, 78 KB)280202/25/2019
  19. Pretrial order no. 88: Deposition Designations for Dr. Matthew Ross (.pdf, 85 KB)281002/25/2019
  20. Pretrial order no. 89: Initial Ruling on Deposition Designations for Dr. William Reeves(.pdf, 50 KB)281202/25/2019
  21. Pretrial order no. 90: Ruling on Deposition Objections for Dr. Goldstein (.pdf, 72 KB)281702/26/2019
  22. Pretrial order no. 91: Order Sanctioning Mr. Hardeman’s Counsel (.pdf, 117 KB)282802/26/2019
  23. Pretrial order no. 92: Evidentiary Rulings on Dr. Portier’s Direct Testimony (.pdf, 112 KB)282902/26/2019
  24. Pretrial order no. 93: Further Order re Reeves Deposition Designations (.pdf, 90 KB)283002/27/2019
  25. Pretrial Order no. 94: Order Regarding Opening Statement Slides (.pdf, 47 KB)283102/26/2019
  26. Pretrial order no. 95: Ruling on Deposition Objections for Dr. Blair (.pdf, 72 KB)283702/27/2019
  27. Pretrial order no. 96: Evidentiary Rulings on Dr. Portier’s Testimony on Cross-Examination (.pdf, 128 KB)283802/27/2019
  28. Pretrial order no. 97: Evidentiary Rulings on Dr. Portier’s Re-Direct and Re-Cross Testimony (.pdf, 118 KB)286102/28/2019
  29. Pretrial order no. 98: Initial Rulings on Deposition Designations for Dr. Reeves(.pdf, 101 KB)286703/01/2019
  30. Pretrial order no. 99: Order re Dr. Weisenburger’s Testimony (.pdf, 56 KB)287703/02/2019
  31. Pretrial order no. 100: Ruling on Monsanto’s Deposition Designations for Dr. Reeves(.pdf, 98 KB)289403/04/2019
  32. Pretrial order no. 101: Order re Monsanto’s Motion for Summary Judgment on Non-Causation Grounds (.pdf, 146 KB)293703/07/2019
  33. Pretrial order no. 102: Court’s Draft Phase 1 Instructions (.pdf, 173 KB)294003/07/2019
  34. Pretrial order no. 103: Order re Monsanto’s Proposed Questions for Drs. Arber and Levine(.pdf, 107 KB)294103/07/2019
  35. Pretrial order no. 104: Scope of Dr. Arber’s Testimony (.pdf, 97 KB)294203/08/2019
  36. Pretrial order no. 105: Order re Authentication of Mr. Hardeman’s Medical Records(.pdf, 106 KB)295803/11/2019
  37. Pretrial order no. 106: Court’s Revised Phase 1 Instructions (.pdf, 178 KB)295903/11/2019
  38. Pretrial order no. 107: Order re Final Jury Instructions (.pdf, 97 KB)296103/12/2019Pretrial order no. 108: Final Phase 1 Instructions (.pdf, 177 KB)296303/12/2019
  39. Pretrial order no. 109: Final Verdict Form (.pdf, 80 KB)296403/12/2019
  40. Pretrial order no. 110: Order re Plaintiff’s Expert James Mills (.pdf, 104 KB)297903/13/2019
  41. Pretrial order no. 111: Order Requesting Further Information on Drs. Benbrook and Mills(.pdf, 86 KB)298203/13/2019
  42. Pretrial order no. 112: Order re Design Defect Jury Instruction (.pdf, 88 KB)298303/13/2019
  43. Pretrial order no. 113: Order Denying Monsanto’s Motion for a Directed Verdict(.pdf, 102 KB)298403/13/2019
  44. Pretrial order no. 114: Outstanding Evidentiary Issues from PTO 81 (.pdf, 90 KB)298703/13/2019
  45. Pretrial order no. 115: Order re Phase 2 Opening Statements (.pdf, 97 KB)299903/14/2019
  46. Pretrial order no. 116: Order re Design Defect Claim (.pdf, 92 KB)305103/18/2019
  47. Pretrial order no. 117: Ruling on Deposition Designations for Mark Martens (.pdf, 91 KB)308203/18/2019
  48. Pretrial order no. 118: Ruling on Phase 2 Deposition Designations for Dr. Reeves(.pdf, 103 KB)309303/19/2019
  49. Pretrial order no. 119: Ruling on Initial Phase 2 Deposition Designations for Dr. Farmer(.pdf, 100 KB)309403/20/2019
  50. Pretrial order no. 120: Ruling on Phase 2 Designations for Dr. Heydens (.pdf, 74 KB)310803/20/2019
  51. Pretrial order no. 121: Order re Rowland and Housenger Evidence (.pdf, 84 KB)312103/21/2019
  52. Pretrial order no. 122: Ruling on Phase 2 Designations for Dr. Portier (.pdf, 85 KB)314003/22/2019

[End of Bayer-Mosanto Docket in MDL 2741]

March 6, 2019 https://www.masstortnexus.com/mass-torts-news/bayer-ag-completes-monsanto-purchase-whats-next-on-litigation-dockets/

___________________________________________________________________________

Patent Disputes

Adempas™: In January 2018, Bayer filed patent infringement lawsuits in a U.S. federal court against Alembic Pharmaceuticals Limited, Alembic Global Holding SA, Alembic Pharmaceuticals, Inc. and INC Research, LLC (together “Alembic”), against MSN Laboratories Private Limited and MSN Pharmaceuticals Inc. (together “MSN”) and against Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd. (together “Teva”). In December 2017, Bayer had received notices of an Abbreviated New Drug Application with a paragraph IV certification (“ANDA IV”) pursuant to which Alembic, MSN and Teva each seek approval of a generic version of Bayer’s pulmonary hypertension drug Adempas™ in the United States.

Betaferon™ / Betaseron™: In 2010, Bayer filed a complaint against Biogen Idec MA Inc. in a U.S. federal court seeking a declaration by the court that a patent issued to Biogen in 2009 is invalid and not infringed by Bayer’s production and distribution of Betaseron™, Bayer’s drug product for the treatment of multiple sclerosis. Biogen is alleging patent infringement by Bayer through Bayer’s production and distribution of Betaseron™ and Extavia™ and has sued Bayer accordingly. Bayer manufactures Betaseron™ and distributes the product in the United States. Extavia™ is also a drug product for the treatment of multiple sclerosis; it is manufactured by Bayer, but distributed in the United States by Novartis Pharmaceuticals Corporation, another defendant in the lawsuit. In 2016, the U.S. federal court decided a disputed issue regarding the scope of the patent in Biogen’s favor. Bayer disagrees with the decision, which may be appealed at the conclusion of the proceedings in the U.S. federal court.

Damoctocog alfa pegol (BAY 94‑9027, long-acting recombinant factor VIII): In August 2017, Bayer filed a lawsuit in a U.S. federal court against Nektar Therapeutics (“Nektar”), Baxalta Incorporated and Baxalta U.S., Inc. (together “Baxalta”) seeking a declaration by the court that a patent by Nektar is invalid and not infringed by Bayer’s drug candidate BAY 94‑9027 for the treatment of hemophilia A. In September 2017, Baxalta and Nektar filed a complaint in a different U.S. federal court against Bayer alleging that BAY 94‑9027 infringes seven other patents by Nektar. Regarding the complaint by Bayer, Nektar and Baxalta gave Bayer a covenant not to make any claims against Bayer for infringement of that patent. Bayer amended the complaint to now seek a declaration by the court that the seven other patents by Nektar are not infringed by BAY 94‑9027. The patents are part of a patent family registered in the name of Nektar and further comprising European patent applications with the title “Polymer-factor VIII moiety conjugates” which are at issue in a lawsuit Bayer filed against Nektar in 2013 in the district court of Munich, Germany. In this proceeding, Bayer claims rights to the European patent applications based on a past collaboration between Bayer and Nektar in the field of hemophilia. However, Bayer believes that the patent family does not include any valid patent claim relevant for Bayer’s drug candidate BAY 94‑9027 for the treatment of hemophilia A.

Nexavar™: In 2015, Bayer filed patent infringement lawsuits in a U.S. federal court against Mylan Pharmaceuticals Inc. and Mylan Inc. (together “Mylan”). In 2014 and 2015, Bayer had received notices of an ANDA IV application pursuant to which Mylan seeks approval of a generic version of Bayer’s cancer drug Nexavar™ in the United States. In October 2017, Bayer reached agreement with Mylan to settle this patent dispute. Under the settlement terms, Mylan will obtain a license to sell its generic version of Nexavar™ in the United States at a date after the expiration of the patent for the active ingredient expiring in January 2020. In 2016, Bayer had received another notice of such an ANDA IV application by Teva Pharmaceuticals USA, Inc. Bayer filed a patent infringement lawsuit against Teva in the same U.S. federal court. In January 2018, Bayer reached agreement with Teva to settle this patent dispute. Under the settlement terms, Teva will obtain a license to sell its generic version of Nexavar™ in the United States at a date after the expiration of the patent for the active ingredient expiring in January 2020.

Stivarga™: In 2016, Bayer filed patent infringement lawsuits in a U.S. federal court against Apotex, Inc. and Apotex Corp. (together “Apotex”) and against Teva. Bayer had received notices of an ANDA IV application pursuant to which Apotex and Teva each seek approval of a generic version of Bayer’s cancer drug Stivarga™ in the United States.

Xarelto™: In 2015, Bayer and Janssen Pharmaceuticals filed a patent infringement lawsuit in a U.S. federal court against Aurobindo Pharma Limited, Aurobindo Pharma USA, Inc. (together “Aurobindo”), Breckenridge Pharmaceutical Inc. (“Breckenridge”), Micro Labs Ltd., Micro Labs USA Inc. (together “Micro Labs”), Mylan, Prinston Pharmaceutical Inc. (“Prinston”), Sigmapharm Laboratories, LLC (“Sigmapharm”), Torrent Pharmaceuticals, Limited and Torrent Pharma Inc. (together “Torrent”). Bayer had received notices of an ANDA IV application by Aurobindo, Breckenridge, Micro Labs, Mylan, Prinston, Sigmapharm and Torrent, each seeking approval to market a generic version of Xarelto™, an oral anticoagulant for the treatment and prevention of blood clots, in the United States. In 2016, Bayer received another notice of such an ANDA IV application by InvaGen Pharmaceuticals, Inc. (“InvaGen”). Bayer and Janssen Pharmaceuticals filed a patent infringement lawsuit against InvaGen in the same U.S. federal court.

Bayer believes it has meritorious defenses in the above ongoing patent disputes and intends to defend itself vigorously.

Further Legal Proceedings

Trasylol™ / Avelox™: A qui tam complaint relating to marketing practices for Trasylol™ (aprotinin) and Avelox™ (moxifloxacin) filed by a former Bayer employee is pending in the United States District Court in New Jersey. The U.S. government has declined to intervene at the present time.

Newark Bay Environmental Matters: In the United States, Bayer is one of numerous parties involved in a series of claims brought by federal and state environmental protection agencies. The claims arise from operations by entities which historically were conducted near Newark Bay or surrounding bodies of water, or which allegedly discharged hazardous waste into these waterways or onto nearby land. Bayer and the other potentially responsible parties are being asked to remediate and contribute to the payment of past and future remediation or restoration costs and damages. In 2016, Bayer learned that two major potentially responsible parties had filed for protection under Chapter 11 of the U.S. Bankruptcy Code. While Bayer remains unable to determine the extent of its liability for these matters, this development is likely to adversely affect the share of costs potentially allocated to Bayer.

In the Lower Passaic River matter, a group of more than sixty companies including Bayer is investigating contaminated sediments in the riverbed under the supervision of the United States Environmental Protection Agency (EPA) and other governmental authorities. Future remediation will involve some form of dredging, the nature and scope of which are not yet defined, and potentially other tasks. The cost of the investigation and the remediation work may be substantial if the final remedy involves extensive dredging and disposal of impacted sediments. In the Newark Bay matter, an unaffiliated party is currently conducting an investigation of sediments in Newark Bay under EPA supervision. The investigation is in a preliminary stage. Bayer has contributed to certain investigation costs in the past and may incur costs for future investigation and remediation activities in Newark Bay.

Bayer has also been notified by governmental authorities acting as natural resource trustees that it may have liability for natural resource damages arising from the contamination of the Lower Passaic River, Newark Bay and surrounding water bodies. Bayer is currently unable to determine the extent of its liability.

Asbestos: A further risk may arise from asbestos litigation in the United States. In many cases, the plaintiffs allege that Bayer and co-defendants employed third parties on their sites in past decades without providing them with sufficient warnings or protection against the known dangers of asbestos. Additionally, a Bayer affiliate in the United States is the legal successor to companies that sold asbestos products until 1976. Union Carbide has agreed to indemnify Bayer for this liability. Bayer believes it has meritorious defenses and intends to defend itself vigorously.

There is no official reference to Monsanto Roundup MDL 2741, even though an August 2018 verdict award for the plaintiff in California State Court was for more than $280 million, and showed that non-hodgkins lymphoma was caused by use of Monsanto Roundup herbicide containing Glyphosate. f

https://www.reuters.com/article/us-bayer-glyphosate-lawsuit/bayer-shares-slide-after-latest-roundup-cancer-ruling-idUSKCN1R02O3

Bayer Legal Disclaimer October 2018: Cautionary Statements Regarding Forward-Looking Information

Certain statements contained in this communication may constitute “forward-looking statements.” Actual results could differ materially from those projected or forecast in the forward-looking statements. The factors that could cause actual results to differ materially include the following: the risk that the parties may be unable to achieve expected synergies and operating efficiencies in the merger within the expected timeframes (or at all) and to successfully integrate the operations of Monsanto Company (“Monsanto”) into those of Bayer Aktiengesellschaft (“Bayer”); such integration may be more difficult, time-consuming or costly than expected; revenues following the transaction may be lower than expected; operating costs, customer loss and business disruption (including difficulties in maintaining relationships with employees, customers, clients or suppliers) may be greater or more significant than expected following the transaction; the retention of certain key employees at Monsanto; the parties’ ability to meet expectations regarding the accounting and tax treatments of the merger; the impact of refinancing the loans taken out for the transaction; the impact of indebtedness incurred by Bayer in connection with the transaction and the potential impact on Bayer’s rating of indebtedness; the effects of the business combination of Bayer and Monsanto, including the combined company’s future financial condition, operating results, strategy and plans; other factors detailed in Monsanto’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (the “SEC”) for the fiscal year ended August 31, 2017, and Monsanto’s other filings with the SEC, which are available at http://www.sec.gov and on Monsanto’s website at www.monsanto.com; and other factors discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. Bayer assumes no obligation to update the information in this communication, except as otherwise required by law. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof.

BAYER LITIGATION DOCKETS IN MDL’s ARE STILL GROWING

ROUNDUP-MONSANTO-(GLYPHOSATE)-MDL-2741-(USDC-ND-California) Mass Tort Nexus Briefcase

XARELTO-(rivaroxaban)-MDL-2592-(USDC-ED-Louisiana) Mass Tort Nexus Briefcase

XARELTO-Case-No-2349–Philadephia-Court-of-Common-Pleas-Complex-Litigation-(PA-State-Court) Mass Tort Nexus Briefcase)

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For class attendance information please contact Barbara Capasso at 954.383.3932 

  1. For the most up-to-date information on all MDL dockets and related mass torts visit www.masstortnexus.com and review our mass tort briefcases and professional site MDL briefcases.
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Read More

False Narratives Opioids and Xarelto

Mass Tort Nexus is compiling an evidentiary package for law firms who intend to reject the current Xarelto settlement offer and prepare for trial. This article represents an extremely small segment of what any firm who prepares for trial will have at their disposal; however, we believe most everyone involved in Mass Torts might find the following topic interesting.

It is well known how Big Pharma allegedly promoted a false narrative regarding Opioids and the risk posed by these highly addictive drugs. Despite the fact that thousands of people were dying every year from opioid overdose, doctors seemed unaware that the narrative they had bought into was false.

What might the death toll ultimately be for the new anticoagulants?

We are aware that both the Xarelto primary defendants are also accused of being party to the opioid false narrative conspiracy in opioid litigation complaints.  If Big Pharma can keep doctors prescribing opioids like skittles for decades, despite the rising death toll, how hard could it be to keep doctors prescribing an anticoagulant with a few tweaks to the truth?

Why Did Doctors Prescribe Xarelto and Why do they Continue to Prescribe Xarelto?

The clinical trials for Xarelto did not prove the drug to be superior in efficacy to Warfarin, only “non inferior.” It was not a better drug from an efficacy stand point. Doctors had no reason to switch patients to Xarelto because it “worked better” than Warfarin.

Xarelto is exponentially more expensive that Warfarin, so doctors had to reason to switch patients to Xarelto based on cost.

What were the makers of Xarelto able to claim about their new (unproven in the general patient population) to convince them to switch patients to Xarelto?

  1. No Routine Blood Testing (monitoring.)
  2. No Dietary Restrictions.

What if these claims were false, patients do need routine blood monitoring while on Xarelto?

What if patients taking Xarelto do need to restrict their diet (not consume certain food products?)

Would doctors keep prescribing Xarelto? Probably not, if the arguably false narrative first presented to them was corrected (warned) as having been false. That said, once a claim is made, people, including doctors, are not likely to realize that the claim is no longer being made once they have bought into the claim, unless they are specifically informed that the claim might have been false.

The following will explain why the makers of Xarelto may have stopped claiming (in their television and print ads,) that patients taking Xarelto did not need routine blood testing nor adhere to any dietary restrictions.

We will first review Xarelto television spots beginning in 2013 and more recent ads. Then we will explain why the makers of Xarelto quit claiming that users of their product stopped claiming that:

  1. No Routine Blood Testing (monitoring) was needed.
  2. No dietary restrictions.

You may view a larger selection of ads than those provided below at: https://www.ispot.tv/brands/ISA/xarelto

2013: Xarelto Bob Ad  (both “no routine monitoring” and “no dietary restrictions claims made”.)

 

 

 

 

 

 

 

https://www.ispot.tv/ad/7dJt/xarelto-bob

Start at 16 Seconds, “Bob took Wafarin and made a monthly trip to the clintic to get his blood tested but not anymore.”

Start at  36 Seconds,   “Xarelto is the first and only once per day prescription blood thinner… That does not require rountine Blood Monitoring.”

Start at 57 Seconds, “and there’s no dietary restrictions…Bob can eat the health foods he likes. ”

2014 Mary Ad (both “no routine monitoring” and “no dietary restrictions claims made.”)

 

 

 

 

 

 

https://www.ispot.tv/ad/7pGC/xarelto-mary-song-by-arturo-cardelus

Start at 12 Seconds  “Which required monthly testing, but that’s history.”

Start at 56 Seconds “Plus with no Known Dietary Restrictions.”

2015  Arnold Palmer (they did not specifically say no routine testing and dietary restrictions, but they  implied the claims. )

 

 

 

 

 

 

https://www.ispot.tv/ad/AYGi/xarelto-game-plan-feat-chris-bosh-arnold-palmer-brian-vickers

Start at 29 Seconds (claims worked into general conversation)

article link: https://www.masstortnexus.com/News/366/Did-Xarelto-the-Drug-Arnold-Palmer-Promoted-Lead-to-His-Death?

2016: Jerry West (neither of the claims were made in this ad.)

 

 

 

 

 

 

https://www.ispot.tv/ad/ARh_/xarelto-high-risk-of-stroke-featuring-jerry-west

2017  Xarelto “Protect Themselves” ad feature authority figures  (neither of the claims were made in this ad.)

 

 

 

 

 

 

 

 

https://www.ispot.tv/ad/wtdp/xarelto-protect-themselves

2018  “Learn all you can ad” (we do not think irony was intended), (neither of the claims were made in this ad)

 

 

 

 

 

 

https://www.ispot.tv/ad/wPmP/xarelto-learn-all-you-can

So Why Did the Makers of Xarelto Quit Making Their “Claims to Fame?”

We will first address why the makers of Xarelto most likely stopped making the “no rountine blood testing (monitoring claim.) This answer to this one is easy; Because the FDA warned them about making this claim.

It is difficult to understand why the makers of Xarelto did not unilaterally determine (and warn that their original messaging no routine blood monitoring needed) might have been misleading based solely on the number of adverse events reported to the FDA since the product’s introduction.

______________________________________________________________________________________________________

 

 

Food and Drug Administration

Silver Spring, MD 20993

Roxanne McGregor-Beck, Director

Johnson & Johnson International, Inc.

1000 Route 202 South

P.O. Box 300

Raritan, New Jersey 08869-0602

 

RE: NDA #202439

XARELTO (rivaroxaban) tablets

MA #215

Dear Ms. McGregor-Beck:

The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) has reviewed a direct-to-consumer (DTC) print advertisement (K02XS121040 AF) (Print Ad) for XARELTO (rivaroxaban) tablets (Xarelto) submitted by Johnson & Johnson International, Inc. (Johnson & Johnson) on behalf of Janssen Pharmaceuticals, Inc. under cover of Form FDA 2253 and observed during routine surveillance in the January/February 2013 issue of WebMD magazine. The Print Ad is false or misleading because it minimizes the risks associated with Xarelto and makes a misleading claim. Thus, the Print Ad misbrands Xarelto in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 352(n) and FDA implementing regulations. 21 CFR 202.1(e)(5)(i); (e)(7)(viii), (ix).

Background:

Below is the indication and summary of the most serious and most common risks associated with the use of Xarelto.1 According to its FDA-approved product labeling (PI), in pertinent part:

Xarelto is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

There are limited data on the relative effectiveness of XARELTO and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well controlled.

 The PI for Xarelto contains Boxed Warnings regarding increased risk of stroke after discontinuation in patients with nonvalvular atrial fibrillation and the risk of spinal/epidural

hematoma. The PI also contains Contraindications regarding active pathological bleeding and severe hypersensitivity reaction to Xarelto, as well as Warnings and Precautions regarding the risk of bleeding, use in patients with renal impairment and hepatic impairment, use with P-gp and strong CYP3A4 inhibitors or inducers, and risk of pregnancy related hemorrhage. The most common adverse reactions with Xarelto were bleeding complications.

Minimization of Risk Information

 Promotional materials are false or misleading if they fail to present risks associated with a drug with a prominence and readability reasonably comparable with the presentation of information relating to the benefits of the drug. Factors impacting prominence and readability include typography, layout, contrast, headlines, paragraphing, white space, and other techniques apt to achieve emphasis. The Print ad prominently presents various efficacy claims for Xarelto, such as, but not limited to, the following, that are presented in large, bolded and/or colorful text and graphics (emphasis original):

• “If you have atrial fibrillation (AFib)”

• “Ready to break your AFib routine?”

• “XARELTO® is the first and only once-a-day prescription blood thinner for patients with AFib not caused by a heart valve problem, that is proven to reduce

the risk of stroke—without routine blood monitoring.”

• “…With XARELTO®, there’s no routine blood monitoring—so you have more time for yourself. There are no dietary restrictions, so you’re free to enjoy the healthy foods you love. And there are no dosage adjustments, which means you can manage your risk with just one pill a day, taken with your evening meal. Learn how XARELTO® can help simplify your AFib-related stroke risk treatment….”

In contrast, the risk information is presented on the preceding adjacent page without any of the emphasis (i.e. color scheme, borders, layout, and graphics) used with the efficacy claims. The result is a presentation which appears unconnected to the efficacy claims and is therefore not likely to draw readers’ attention. This overall presentation misleadingly  minimizes the risks associated with Xarelto because it fails to convey this important risk information with a prominence and readability reasonably comparable to the efficacy claims. We note that the Print Ad contains the statement, “Please see accompanying Medication Guide on the following pages” (emphasis original) at the bottom of the page, and that risk information is presented on an adjacent page, but this is not sufficient to mitigate the overall misleading presentation.

Misleading Claim

 The Print Ad includes the following claim (emphasis original):

• “And there are no dosage adjustments…”

The above claim misleadingly suggests that dosage adjustments are not necessary with Xarelto. However, according to the DOSAGE AND ADMINISTRATION section of the PI, the dose should be lowered to 15 mg once daily for patients with renal impairment who may have a CrCL of 15 to 50 mL/min. In addition, the WARNINGS AND PRECAUTIONS section of the PI states, “…Periodically assess renal function as clinically indicated…and adjust therapy accordingly….” Thus, patients with renal impairment may need to have their dosage adjusted while on Xarelto therapy.

Conclusion and Requested Action

For the reasons discussed above, the Print Ad misbrands Xarelto in violation of the FD&C Act, 21 U.S.C. 352(n) and FDA implementing regulations. 21 CFR 202.1(e)(5)(i); (e)(7)(viii), (ix). OPDP requests that Johnson & Johnson immediately cease the dissemination of violative promotional materials for Xarelto such as those described above. Please submit a written response to this letter on or before June 20, 2013, stating whether you intend to comply with this request, listing all promotional materials (with the 2253 submission date) for Xarelto that contain violations such as those described above, and explaining your plan for discontinuing use of such violative materials.

Please direct your response to the undersigned at the Food and Drug Administration,

Center for Drug Evaluation and Research, Office of Prescription Drug Promotion, 5901-B Ammendale Road, Beltsville, Maryland 20705-1266 or by facsimile at (301) 847-8444. To ensure timely delivery of your submissions, please use the full address above and include a prominent directional notation (e.g. a sticker) to indicate that the submission is intended for OPDP. Please refer to MA# 215 in addition to the NDA number in all future correspondence relating to this particular matter. OPDP reminds you that only written communications are considered official. The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for Xarelto comply with each applicable requirement of the FD&C Act and FDA implementing regulations.

Sincerely,

{See appended electronic signature page}

Zarna Patel, Pharm.D.

Regulatory Review Officer

Office of Prescription Drug Promotion

{See appended electronic signature page}

Amy Toscano, Pharm.D., RAC, CPA

Team Leader

Office of Prescription Drug Promotion

____________________________________________________________________________________

It is difficult to understand why the makers of Xarelto did not unilaterally determine (and warn that their original messaging (no routine blood monitoring needed) might have been misleading bases solely on the number of adverse events reported to the FDA since the products introduction.

 

 

 

 

 

https://fis.fda.gov/sense/app/d10be6bb-494e-4cd2-82e4-0135608ddc13/sheet/59a37af8-d2bb-4dee-90bf-6620b1d5542f/state/analysis

 

 

 

 

 

 

https://fis.fda.gov/sense/app/d10be6bb-494e-4cd2-82e4-0135608ddc13/sheet/59a37af8-d2bb-4dee-90bf-6620b1d5542f/state/analysis

Having not corrected their prior claims (warned) related to the need for routine blood testing (monitoring) the makers of Xarelto did add the words underlined (below) to the label for Xarelto NDA -022406 in November of 2018. This statement in no way corrects the arguably false prior statements related to “No Routine Blood Testing” needed.  This statement simply warns that many of the common “blood monitoring tests used” are not recommended for individuals using Xarelto. A more accurate statement might have been: “These tests have no diagnostic value for individuals on Xarelto,” as the drug skews the test, and not in a predictable fashion, which would allow for adjustment of the test results.

Do these two statements seem the same to you?

  1. No Routine Blood Monitoring Needed with Xarelto.
  2. The test routinely used for anticoagulation monitoring has no diagnostic value for individuals taking Xarelto.

Which of the above two statements would likely increase revenues from the drug and which one would likely have the opposite effect?

11/07/2018 (SUPPL-29)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Risk of Bleeding

Reversal of Anticoagulant Effect

Additions and/or revisions underlined:

… anticoagulant activity of rivaroxaban. Use of procoagulant reversal agents, such as prothrombin complex concentrate (PCC), activated prothrombin complex concentrate or recombinant factor VIIa, may be considered but has not been evaluated in clinical efficacy and safety studies. Monitoring for the anticoagulation effect of rivaroxaban using a clotting test (PT, INR or aPTT) or anti-factor Xa (FXa) activity is not recommended.

https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=287

“Now We Turn to “No Dietary Restrictions Necessary”

 06/28/2017 (SUPPL-23)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Risk of Bleeding

(additions underlined)

(excerpts)

5.6 Use with P-gp and Strong CYP3A4 Inhibitors or Inducers

(additions underlined)

Avoid concomitant use of XARELTO with known combined P-gp and strong CYP3A4 inhibitors.

Avoid concomitant use of XARELTO with drugs that are known combined P-gp and strong CYP3A4 inducers.

7 Drug Interactions

7.1 General Inhibition and Induction Properties

(additions underlined)

Rivaroxaban is a substrate of CYP3A4/5, CYP2J2, and the P-gp and ATP-binding cassette G2 (ABCG2) transporters. Combined P-gp and strong CYP3A4 inhibitors increase exposure to rivaroxaban and may increase the risk of bleeding. Combined P-gp and strong CYP3A4 inducers decrease exposure to rivaroxaban and may increase the risk of thromboembolic events.

7.2 Drugs that Inhibit Cytochrome P450 3A4 Enzymes and Drug Transport Systems

Interaction with Combined P-gp and Moderate CYP3A4 Inhibitors in Patients with Renal Impairment

XARELTO should not be used in patients with CrCl 15 to <80 mL/min who are receiving concomitant combined P-gp and moderate CYP3A4 inhibitors (e.g., erythromycin) unless the potential benefit justifies the potential risk.

End excerpt

What is the significance of the above?

The inducers make the user more susceptible to clots (ischemic stroke, DVT, PE, etc.)

The inhibitors make the user more likely to bleed.

On a side note, the GI tract is significant to the actions of CYPE4A as well as P-gp. And if you remember from above, what was the most reported AE with Xarelto:

 

So what does the use of Strong and Moderate CYP34A and P-gp Inhibitors and Inducers have to do with dietary restrictions?

Most everyone is familiar with the fact that some drugs carry a warning about restricting grapefruit juice from your diet while on the given drug (i.e. statins).

The relation to the above and the “no dietary restrictions” claim, that the makers of Xarelto use to promote their drug (and then stopped making but did not correct the narrative) is simple. There are numerous foods which are CYP34A, and P-gp inhibitors and/or inducers. We provide a small sampling of foods and dietary supplements below.

The dietary restrictions associated with Warfarin restricted foods high in Vitamin K, like Kale (yummy Kale).

Xarelto Potential Food Restrictions

It is worth nothing that due to genetic differences, the strength of a given CYP34A and P-gp Inhibitor or Inducer necessary to interfere with a drug is not the same for everyone. Women as a general rule are more susceptible to the effects of CYP34A and P-gp Inhibitors or Inducers than men.

Grape Fruit Juice: Inhibits CYP34A and P-gp Seville Orange Juice CYP34A and P-gp
Lime Juice Inhibits CYP34A Lemon Juice Inhibits CYP34A
Pomegranate Juice Inhibits CYP34A Star Fruit Juice Inhibits CYP34A
Kiwi Juice Inhibits CYP34A Passion Fruit Juice Inhibits CYP34A
 St. John’s wort Induction of P-gp Ginkgo Biloba Induces P-gp

 In addition to food interactions Approximately 50% of prescription drugs either induce or inhibit CYP34A or P-gp.

While many drugs are deactivated by CYP3A4, there are also some drugs which are activated by the enzyme. Some substances, such as grapefruit juice and some drugs, interfere with the action of CYP3A4. These substances will therefore either amplify or weaken the action of those drugs that are modified by CYP3A4.

https://en.wikipedia.org/wiki/CYP3A4

So, what the Xarelto label (warnings) universally adequate in 2015, 2016 or today?

We think not!

Read More