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
2 MERCK SHARP & DOHME CORP. v. ALBRECHT
Syllabus
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
Cite as: 587 U. S. ____ (2019) 3
Syllabus
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.
_________________

Cite as: 587 U. S. ____ (2019) 1
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
2 MERCK SHARP & DOHME CORP. v. ALBRECHT
Opinion of the Court
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).
Cite as: 587 U. S. ____ (2019) 3
Opinion of the Court
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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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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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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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
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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
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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”).
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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
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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.
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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
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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
4 MERCK SHARP & DOHME CORP. v. ALBRECHT
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)
Cite as: 587 U. S. ____ (2019) 5
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
6 MERCK SHARP & DOHME CORP. v. ALBRECHT
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.
_________________
_________________
Cite as: 587 U. S. ____ (2019) 1
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.
Cite as: 587 U. S. ____ (2019) 3
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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