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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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.
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False Narratives Opioids and Xarelto

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

 

 

 

 

 

 

 

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

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

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

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

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

 

 

 

 

 

 

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

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

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

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

 

 

 

 

 

 

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

Start at 29 Seconds (claims worked into general conversation)

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

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

 

 

 

 

 

 

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

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

 

 

 

 

 

 

 

 

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

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

 

 

 

 

 

 

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

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

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

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

______________________________________________________________________________________________________

 

 

Food and Drug Administration

Silver Spring, MD 20993

Roxanne McGregor-Beck, Director

Johnson & Johnson International, Inc.

1000 Route 202 South

P.O. Box 300

Raritan, New Jersey 08869-0602

 

RE: NDA #202439

XARELTO (rivaroxaban) tablets

MA #215

Dear Ms. McGregor-Beck:

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

Background:

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

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

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

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

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

Minimization of Risk Information

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

• “If you have atrial fibrillation (AFib)”

• “Ready to break your AFib routine?”

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

the risk of stroke—without routine blood monitoring.”

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

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

Misleading Claim

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

• “And there are no dosage adjustments…”

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

Conclusion and Requested Action

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

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

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

Sincerely,

{See appended electronic signature page}

Zarna Patel, Pharm.D.

Regulatory Review Officer

Office of Prescription Drug Promotion

{See appended electronic signature page}

Amy Toscano, Pharm.D., RAC, CPA

Team Leader

Office of Prescription Drug Promotion

____________________________________________________________________________________

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

 

 

 

 

 

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

 

 

 

 

 

 

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

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

Do these two statements seem the same to you?

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

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

11/07/2018 (SUPPL-29)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Risk of Bleeding

Reversal of Anticoagulant Effect

Additions and/or revisions underlined:

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

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

“Now We Turn to “No Dietary Restrictions Necessary”

 06/28/2017 (SUPPL-23)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Risk of Bleeding

(additions underlined)

(excerpts)

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

(additions underlined)

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

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

7 Drug Interactions

7.1 General Inhibition and Induction Properties

(additions underlined)

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

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

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

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

End excerpt

What is the significance of the above?

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

The inhibitors make the user more likely to bleed.

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

 

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

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

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

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

Xarelto Potential Food Restrictions

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

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

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

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

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

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

We think not!

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FDA Fails to Cite Big Pharma for False Marketing and Advertisements

“PROFITS BEFORE PATIENTS REIGNS SUPREME AT FDA”

By Mark A. York (April 22, 2019)

Purdue Pharma and OxyContin Never Warned By FDA

(MASS TORT NEXUS MEDIA)  In the midst of a national opioid crisis, the federal agency that monitors drug ads has issued a record low number of warning letters to pharmaceutical companies caught lying about their products.

The Food and Drug Administration has sent just three notice letters to drug makers busted for false marketing their medications to unknowing consumers, the lowest ever since the FDA historic decision to ease strict rules for drug ads in 1997. “It certainly raises questions,” said Dr. David Kessler, head of the FDA from late 1990 through 1996, who’s industry credentials would add weight to the issue of why the FDA is not doing more to monitor false marketing campaigns by Big Pharma and Opioid Drug makers in particular.

The FDA’s Office of Prescription Drug Promotion monitors all ads drug companies issue to make sure patients aren’t being scammed by false assertions or misleading marketing campaigns. Which now seems to be the norm, based on the hundreds of lawsuits filed against Opioid Drug Makers in the last 3 months, and recently consolidated into Opiate Prescription MDL 2804 see Opioid Crisis Briefcase-Mass Tort Nexus, where Big Pharma is being sued by states, cities and counties across the country. The primary claim in almost every suit is long term boardroom coordinated false marketing campaigns designed to push opioid drug prescriptions at any cost.

 BILLIONS IN PROFITS

The pharmaceutical industry spent a vast $6.4 billion in “direct-to-consumer” advertisements to hype new drugs in 2016, according tracking firm Kantar Media. That figure has gone up by 62% since 2012, Kantar Media says. This number may seem large at first but compared to the multi-billions in yearly profits just by opioid manufacturers over the last 15 years, the numbers is small.  Corporate earnings have risen every years since the push to increase opioid prescriptions in every way possible became an accepted business model Big Pharma boardrooms across the country.

In 2017 and continuing into 2018, Big Pharma has been fighting major legal battles related to off-label marketing of drugs for unintended uses. They also engaged in a parallel strategy, where they were influencing the FDA and other policy making agencies behind the scenes in Washington DC. Big Pharma was paying millions to lobbyists, making campaign donations and generally buying influence as they always have. It was a foregone conclusion that with the Trump administration view of , “no regulatory oversight required” that there would be some loosening of the FDA regulatory shackles.

Big Pharma was getting ready for freedom to sell, sell, sell their drugs in any way they could, including off-label marketing of the drugs for unintended use purposes. A corporate policy, that’s technically illegal, yet results in billions of dollars in profits every years for Big Pharma. Then the FDA rolled out an unexpected new proposed rule, in March 2017 cracking down on “off-label’ marketing of drugs. This new rule change wasn’t in Big Pharma’s bests interests, sending the drug industry into a furious lobbying scramble. Bring in the Trump camp and on January 12, 2018 Big Pharma and the army of lobbyists and elected officials that were recruited, seem to have succeeded in stopping the FDA rules change that would have tightened up “off label” marketing of drugs.

Trump stops FDA enforcement rule change: January 12, 2018 Food and Drug Administration Press Release: FDA Delays Change to “Off-Label” Drug Use Enforcement Rules

WHAT IS “OFF-LABEL” MARKETING?

Global health care giant Johnson & Johnson (J&J) and its subsidiaries will pay more than $2.2 billion to resolve criminal and civil liability arising from allegations relating to the prescription drugs Risperdal, Invega and Natrecor, including promotion for uses not approved as safe and effective by the Food and Drug Administration (FDA) and payment of kickbacks to physicians and to the nation’s largest long-term care pharmacy provider.  The global resolution is one of the largest health care fraud settlements in U.S. history, including criminal fines and forfeiture totaling $485 million and civil settlements with the federal government and states totaling $1.72 billion.

“The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust,” stated Eric Holder, then US Attorney General, “This multibillion-dollar resolution demonstrates the Justice Department’s firm commitment to preventing and combating all forms of health care fraud.  And it proves our determination to hold accountable any corporation that breaks the law and enriches its bottom line at the expense of the American people” he added.

The resolution includes criminal fines and forfeiture for violations of the law and civil settlements based on the False Claims Act arising out of multiple investigations of the company and its subsidiaries.

“When companies put profit over patients’ health and misuse taxpayer dollars, we demand accountability,” said Associate Attorney General Tony West.  “In addition to significant monetary sanctions, we will ensure that non-monetary measures are in place to facilitate change in corporate behavior and help ensure the playing field is level for all market participants.”

The Federal Food, Drug, and Cosmetic Act (FDCA) protects the health and safety of the public by ensuring, among other things, that drugs intended for use in humans are safe and effective for their intended uses and that the labeling of such drugs bear true, complete and accurate information.  Under the FDCA, a pharmaceutical company must specify the intended uses of a drug in its new drug application to the FDA.  Before approval, the FDA must determine that the drug is safe and effective for those specified uses.  Once the drug is approved, if the company intends a different use and then introduces the drug into interstate commerce for that new, unapproved use, the drug becomes misbranded.  The unapproved use is also known as an “off-label” use because it is not included in the drug’s FDA-approved labeling.

“When pharmaceutical companies interfere with the FDA’s mission of ensuring that drugs are safe and effective for the American public, they undermine the doctor-patient relationship and put the health and safety of patients at risk,” said Director of the FDA’s Office of Criminal Investigations John Roth.  “Today’s settlement demonstrates the government’s continued focus on pharmaceutical companies that put profits ahead of the public’s health.  The FDA will continue to devote resources to criminal investigations targeting pharmaceutical companies that disregard the drug approval process and recklessly promote drugs for uses that have not been proven to be safe and effective.”

FDA PLEADS NO STAFF

But the agency has long struggled to keep track of the thousands of ads published each year, largely due to lack of staff.

There are approximately 60 FDA staffers responsible for keeping track of at least 75,000 ads and other promotional material published each year. Although in the age of electronic monitoring and hi-tech tracking of data it would seem that monitoring drugs such as Schedule 2 – 4 narcotics or other drugs that are considered high risk for abuse, the FDA could create a quarterly e-review or a flagging system when new campaigns are started by Big Pharma.

“It’s a very, very small unit,” a former high-ranking FDA official said. “It’s historically been underfunded.” Which seems to support the contention that Washington D.C lawmakers are in the pockets of Big Pharma and the hundreds of lobbyists they utilize to ensure a true lack of oversight in the pharmaceutical industry as a whole.

Additionally, many of the ads are submitted to the FDA for review at the same time they begin to run. So by the time the assessment is complete the ad has “already had a significant impact,” the FDA insider said. This policy flies in the face of the creation regulatory oversight based on the fact that when a problem or an issue with a product is discovered, the FDA, EPA or other agency should enforce the law and correct the problem. In the case of the FDA, that is not happening and Big Pharma is and has been aware of the lack of oversight for years.

Critics say the FDA needs to do more to stay on top of an industry with a history of trying to maximize profits by at times misleading consumers, which has recently been described as a policy of “patients before patients” which has resulted in the current Opioid Crisis that’s firmly in place across the United States.

The number of public admonishment letters has been at or close to single digits from 2014 until 2016 during the Obama administration, records show. The FDA sent out 11 of those caution missives in 2016, nine in 2015 and 2014, and 24 in 2013.

A SINGLE FDA WARNING IN 2016

This year, one of the warning letters was sent to Canadian drugmaker Cipher Pharmaceuticals, ordering it stop using deceptive promotional material to hawk its extended-release opioid ConZip.

The ad failed to note “any risk information” highlighting the potentially addictive nature of the powerful painkiller, the FDA letter issued Aug. 24 said. The promotional material was also misleading because it asserted other treatment options “are inadequate,” the oversight agency concluded.

“By omitting…serious and potentially fatal risks, the detail aid…creates a misleading impression about the drug’s safety, a concern heightened by the serious public health impacts of opioid addiction, abuse and misuse,” the FDA said.

The agency demanded that Cipher “immediately cease misbranding” the medication. The drug company responded by yanking the promotional material, the firm’s execs said in a statement issued after the warning letter was made public.

But that was the single caution letter issued to an overhyped painkiller by the FDA this year so far, records show. The other caution letters were sent to Amherst Pharmaceuticals for the insomnia drug Zolpimist, and to Orexigen Therapeutics Inc. for its weight loss drug Contrave.

There are many long term FDA and other senior DC officials who have for whatever reasons, chosen to defer reigning in Big Pharma sales and marketing abuses and now it appears the corrective action has been undertaken in federal courts across the country by mass tort lawyers in litigation which will apparently make the “Tobacco Litigation” of the 1980’s pale in financial comparison.

With the primary lawsuits recently consolidated by in the Multidistrict Litigation titled “National Prescription Opiate Litigation” Case No. MDL 2804, recently assigned to the US District Court, Northern District of Ohio.  With the key case heading including “prescription and opiate” which reflects the federal court recognizing that opiate prescriptions have become such a major issue the federal courts will now determine the penalties assessed against Big Pharma. The focus will be on the long term “sales and marketing campaigns” designed in corporate boardrooms of Fortune 100 companies, to increase corporate profits, while ignoring the known catastrophic increases in addictions and other inter-connected healthcare, economic and social upheavels caused by the flood of opioid drugs in the US market.

The FDA maintains that letters to drug companies are merely one tool the agency uses to keep the pharmaceutical industry in line.

“We have many efforts to encourage compliance by industry, including our work on guidance, by providing advice to companies on draft promotional materials, and outreach to our stakeholders,” FDA spokeswoman Stephanie Caccomo said. “The FDA’s priorities regarding prescription drug promotion are policy and guidance development, labeling reviews, core launch and TV ad reviews, training and communications and enforcement.” The key terms referred to by Ms. Caccamo are “guidance and by providing advice” from the FDA, when direct enforcement actions are required, as Big Pharma see the terms “guidance and advice” as harmless and not applicable to their efforts to increase sales and profits. In-house lawyers at Big Pharma have reviewed FDA enforcement failures and offered opinions to the boardrooms for years about the FDA not willing to enforce anything close to restrictions on opioid drug marketing and sale practices, all the while reaping the profits of the opioid crisis.

U.S. DEPT OF JUSTICE INDICTMENTS

While the FDA has failed, the US Department of Justice has launched a massive crackdown on opiate drug makers including indictments of company executives, sales & marketing personnel as well as the doctors and pharmacies that have enabled the flood of easy access narcotics into the US market for over 15 years. The question is “how and why” did the FDA drop the ball or was this an intentional lack of enforcement and oversight by the FDA and other agencies due to Big Pharma influence over Congressional members who would blunt any true oversight of drug companies.

US CONGRESS IS NOT HELPING

Perhaps a look at former US Representative Tom Price, will provide insight into how our lawmakers work within the healthcare industry. Rep. Price was appointed by President Trump to head the Department of Health and Human Services, which the FDA reports to, was forced to resign as HHS head due to various transgression within 6 months of being appointed, as well as leaks that while a sitting congressman he enacted a bill favoring a medical device makers extension of a multi-year government contract. Not only did Price enact the bill, he purchased stock in the company prior to the bill introduction and secured a massive profit on the stock price increase after the contract extension was announced. In normal business circles this is considered “insider trading” and is illegal, but when you’re one of those people in charge of creating the rules and regulations, there’s an apparent “get out of jail card” that comes with your congressional seat.

As long as the US Congress fails to correct the lack of oversight by the FDA and other regulatory agencies into what and how dangerous drugs and products are placed into the US marketplace, there will always be bad drugs entering the healthcare pipeline in the United States, with the now enduring default misnomer of “Profits Before Patients” firmly in place in boardrooms and within our government.

WHITE HOUSE IGNORES BIG PHARMA ABUSE

With the Trump Administration still claiming that no regulatory oversight is needed to monitor the US drug industry, that they can self-regulate, it appears that there will be no letup in the rampant “off-label: and unintended use marketing of pharmaceutical drugs in the United States.  The one way that Big Pharma is held accountable is in the courtroom, although financial damages and penalties against the drug companies amounting to billions of dollars each year being awarded by juries, won’t change FDA policy, it does provide a small amount of official recognition that there are ongoing abuses by the pharmaceutical industry in the USA.

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Xarelto Settlement: Dead on Arrival?

April 15, 2019

(Mass Tort Nexus Media) Bayer and Johnson & Johnson both issued press releases on March 25th indicating to the public, as well as stockholders and analysts, that the companies had reached a settlement to resolve approximately 25,000 claims related to Xarelto. This announcement was arguably highly misleading, in that the agreement reached has not actually resulted in the settlement of a single Xarelto lawsuit (to the best of our knowledge) and certainly not 25,000 cases.

This was the headline in Reuters:  Bayer, J&J settle U.S. Xarelto litigation for $775 million,see Reuters.com/article/us-bayer-xarelto/bayer-jj-settle-us-xarelto-litigation-for-$775-million

At the time of press release, in which Bayer and Johnson & Johnson led the public and the market to believe they had resolved (settled) 25,000 pending Xarelto lawsuits, the overwhelming majority of firms representing those 25,000 clients had yet to receive significant details related to the proposed settlement, and of course had yet to present any offer to their individual clients, who would have to accept any offer made before a case could actually be settled.

Law Firms attending the Mass Torts Made Perfect conference in Las Vegas last week received more details related to the defendants proposed settlement and the reaction was not positive.

Large Scale Rejection of Proposed Settlement?

Mass Tort Nexus has spoken with a great a number of firms who were in attendance at MTMP, as well as numerous others since that time, and the clear indication that we have received would lead us to the conclusion that it is highly unlikely that the defendants proposed settlement will be accepted by enough firms (or rather their clients), to make going forward with the current proposed settlement anything other than a waste of time.

Law Firms that have been in contact with Mass Tort Nexus have indicated that they will fulfill their duty to present any offer made by defendants for their cases to the individual clients; however, they will not likely recommend that clients accept the offers made under the proposed settlement scheme. Many of the firms made colorful comments that we will not publish; however, there was a common theme among the comments:

“I would feel like I was selling out my clients if I recommend they accept the current offer the defendants have made.”

Others went as far as to say:

“I think it would be malpractice to recommend that clients accept the final amounts likely to be offered in this settlement scheme”

Dilemma for Bayer and Johnson & Johnson

The premature and arguably misleading public announcement, which would likely be considered official stock holder guidance, may create additional problems for the corporations already plagued by legal woes, which pose risks to their respective stock prices and stock holder value. If the proposed Xarelto settlement does fall through, as it appears will likely be the case, the companies will be faced with having to walk back previous positive news  “We have resolved the risk associated with the Xarelto litigation” to “not only have we not resolved the risk associated with the Xarelto litigation, but that risk may now be more significant than it was before we proposed a settlement, and many plaintiffs firms see it as more of an insult than an offer.”

If the proposed settlement was even close to something plaintiffs might except in significant numbers, Bayer and J&J might have been in a position to “tweak the settlement” and avoid having to deliver bad news to their stockholders and the public. Unfortunately for Bayer and J&J, the proposed settlement seems to be so far from “acceptable” that their only option may be to scrap the current proposed settlement and come back with another proposal, that will not be received with such strong resistance. If the two corporate giants have any hope of salvaging their messaging to the market, they will need to act quickly.

Proposed Settlement Appears to be a “Non-Starter” 

      

For now, it appears that there is no amount of lipstick that would make the proposed Xarelto settlement scheme attractive.  Most of the firms Mass Tort Nexus has spoken to have indicated that the defendants offer is not even a starting point.

 

 

 

 

MTN will provide more information in future articles about the proposed settlement, as well as the reasons a large number of firms do not feel the settlement is fair and just to their clients. At this point in time; however, it seems likely that the proposed Xarelto settlement is:

The Industry Comment

       XARELTO SETTLEMENT

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Insys Therapeutics “Fentanyl Spray Criminal Trial” In Jury Deliberations

“Fentanyl Spray Federal Criminal Trial” Now In US District Court of Massachusetts Jury Deliberations

By Mark A. York (April 8, 2019)

Subsys: a highly addictive fentanyl spray.

December 2016 saw Insys Therpaeutics Founder John Kapoor, CEO Michael Babich and five other senior executives indicted on criminal charges for paying kickbacks and bribes to medical professionals and committing fraud against insurance companies across the country for offering a highly addictive Fentanyl prescription product “Subsys” to the masses. The Insys boardroom was indicted in the US District Court of Massachusetts, where the entire team has engaged a stable of top national law firms to defend the indictments. The “Subsys” sales teams were charged in federal indictments across the country, including Arkansas, Connecticut, Alaska and New York and the indictments will only increase as these cases proceed and “cooperating witnesses” decide that prison isn’t an option.

To compound further harsh scrutiny for Insys, it’s new CEO Saeed Motahari, moved over from Purdue Pharmaceuticals, the Oxycontin maker, who’s also a major target of criminal and civil investigations across the country by various agencies. Purdue is being investigated for false marketing, off-label use and ignoring Oxycontin’s highly addictive dangers for years, while bringing in literally billions of dollars in profits.

PRIOR DOCTOR INDICTMENTS

Doctors who’ve written massive numbers of Subsys prescription, under the “fee to speak” program have been indicted and they include pain clinics, medical centers and other healthcare facilities who now face federal criminal charges for fraudulent prescription writing, submitting false claims to insurance companies and numerous other federal charges and all face a minimum of 20 to 50 years in federal prison. Two of the busiest “Subsys” prescription writers in the country were Alabama doctors, John Couch and Xiulu Ruan, who earned over $40 million from Insys, and were charged with running a pill mill between 2013 and 2015, have been convicted and sentenced to 20 years each in federal prison.

The top “Subsys” prescriber of all, Dr. Gavin Awerbach, of Saginaw, MI pled guilty to defrauding Medicare and Blue Cross out of $3.1 million in improper Subsys prescriptions, his criminal sentence is pending. To show the far reach of Insys and its corporate plans to saturate the US market with opioids, in Anchorage, Alaska Dr. Mahmood Ahmad, was charged with a massive Subsys prescribing operation, which he denies, but immediately surrendered his Alaska medical license which caused the revocation of his license Arkansas.

THE OFF LABEL CAMPAIGN

The only people who are supposed to be taking Subsys are adult cancer patients, according to the FDA “Subsys” approval files, anything other than that is an “off label” indication. Now you can take a drug to treat something off label if you want to, but you have to get your doctor to get pass a prior authorization.

Anthem alleges that Insys has an entire unit to get around this requirement — it’s titled the “reimbursement unit.” Investigative journalists exposed this fraud initially as far back as 2015 on behalf of the Southern Investigative Reporting Foundation, see Insys Therapeutics “Subsys” Off Label Rx Fraud.

The Reimbursement Unit claim was basically the company’s fraudulent prescription approval factory, which helped participating doctors process claims (the doctors had so many they couldn’t handle them all). The unit falsified records to show patients had cancer and called insurers, pretending to be patients or other medical professionals, to facilitate approval of payment for off-label treatment.

This is the Unit’s script for obtaining off-label approval (taken from the Anthem suit):

The script read: “The physician is aware that the medication is intended for the management of breakthrough pain in cancer patients. The physician is treating the patient for their pain (or breakthrough pain, whichever is applicable).” The script deliberately omitted the word “cancer as applied to the patient treatment under discussion.”

Prosecutors also said that two former Insys employees who were first charged in 2016 in connection with the scheme, Jonathan Roper and Fernando Serrano, had secretly pleaded guilty and become cooperating witnesses. The five doctors were arrested last Friday morning and face charges including that they violated the federal anti-kickback law and conspired to commit fraud.

INSYS RX ABUSES WERE BLATANT

The case is the latest in a series of medical practitioners and former Insys executives and employees facing criminal charges related to Subsys, the company’s potentially addictive fentanyl-based spray.

Federal prosecutors in Boston are moving forward aggressively against the seven former Insys executives and managers as well billionaire founder John Kapoor, all accused of actively designing and participating in the scheme to bribe doctors to prescribe Subsys and to defraud insurers into paying for it. Insys has said it may need to pay at least $150 million towards part of a settlement with the U.S. Justice Department as well as numerous other state investigations around the country, not to mention the civil complaints filed against the company in the Opiate Prescription MDL 2804, see OPIOID-CRISIS-BRIEFCASE-INCLUDING-MDL-2804-OPIATE-PRESCRIPTION-LITIGATION, where the Insys sales and marketing tactics are listed as prime examples of boardroom designed “profits over patients” policies are cited.

Insys is joined in the massive Federal Opioid MDL 2804, by other Big Pharma defendants including Purdue Pharmaceuticals, Endo Health, J&J’s Janssen Pharmaceutical and other opioid manufacturers who were allowed to place profits over patients for more than 15 years, while earning billions in profits.

UNETHICAL SALES TACTICS

According to the most recent and prior doctor indictments, the physicians have participated in Insys’ speaker programs, which were in reality social gatherings at high-end restaurants. They earned kickbacks ranging from $68,000 and $308,000 and were among the top 20 prescribers of Subsys nationwide at some point during the marketing campaign. A few doctors indicted as far back as late 2016 have already been sentenced to federal prison terms up to 20 years and forfeit of millions of dollars in assets. The Insys marketing tactics included trips with doctors to strip clubs with Insys sales managers; and often with Insys executives, where they covered lap dances and drinks which on one trip ran up a tab of over $4,100 which was apparently enough to convince physicians to write massive numbers of off-label fentanyl prescriptions.

The Criminal Trial Status

A cooperating witness testified by calling the payments bribes, a former vice president of Insys Therapeutics stood by a giant spreadsheet in court Tuesday and described how the drug company funneled phony “speaking fees” to doctors in exchange for prescribing its highly addictive opioid painkiller.

Alec Burlakoff, who has pleaded guilty to racketeering charges and is testifying in US District Court in Boston against Insys founder John N. Kapoor and four former colleagues, said Kapoor encouraged the program in late 2012 to spur doctors to prescribe Subsys, an under-the-tongue fentanyl spray.

But Kapoor insisted that each practitioner generate at least twice as much revenue for Insys by writing Subsys prescriptions than he or she received from the company.

Burlakoff stood next to an enlarged spreadsheet that executives prepared in December 2012. One column showed what each “speaker” received every time he or she supposedly met with other doctors to promote Subsys. The amounts ranged from $1,000 to $1,600 to $2,400 depending on whether Insys designated them local, regional, or national experts.

In truth, he said, the designation “national expert” was ludicrous and some doctors had only sordid reputations for running “pill mills.”

Another column showed how many prescriptions the practitioners wrote for Subsys, while another displayed how many they wrote for competing fentanyl products.

Assistant US Attorney Fred Wyshak Jr. asked Burlakoff what another column listing sums of money represented.

“That’s the amount of money we paid in bribes to date,” said Burlakoff, the former vice president of sales, prompting one of the defense lawyers for the five defendants to object.

Kapoor and four other former executives of the Chandler, Ariz.-based company are on trial for allegedly conspiring to violate the federal criminal Racketeer Influenced and Corrupt Organizations Act, or RICO, by paying bribes and kickbacks to practitioners. Prosecutors typically use RICO to go after alleged mobsters.

It is the first criminal trial of pharmaceutical executives who marketed an opioid painkiller since the nation’s deadly opioid epidemic began.

Burlakoff, whom jurors first saw last month dressed as a bottle of Subsys spray in a jaw-dropping in-house rap video, said that at least one executive strenuously objected to the company tracking how many Subsys prescriptions participants in the speakers program wrote.

Matthew Napoletano, Insys’s former head of marketing, who has already testified under immunity for the government, rose from his chair at a meeting with Kapoor, Burlakoff, and other executives, Burlakoff said. Napoletano said such a spreadsheet could be viewed as evidence of a crime.

But the company went forward with the payment program.

The payments were hardly the only way Insys prodded doctors to write Subsys prescriptions, Burlakoff said. Leaders of the sales team, including Joseph Rowan, a former regional sales director who is among the defendants, would buy coolers full of steaks for doctors, according to Burlakoff.

In other cases, he said, Insys executives would put staffers in the offices of big Subsys prescribers on the payroll of the drug company; those staffers were often spending considerable time on the phone with insurers trying to get them to approve Subsys prescriptions, and “now doctors would no longer be complaining” about the expense of paying those employees to do that.

Burlakoff, who became vice president of sales in 2012 after spending years at Cephalon, Eli Lilly and Company, and other drug makers, said Insys didn’t only provide incentives to physicians; the company also gave incentives to members of the sales team.

Sales representatives at Insys, he said, had a starting salary of $40,000 a year, less than half of what such employees typically made at other drug companies. But they received an extraordinary commission of 10 percent on the sales they made each quarter, and it wasn’t capped.

Several sales representatives, he said, made $110,000 in a quarter based just on the commission.

As part of the boardroom strategy to get doctors to prescribe Subsys, Insys spent millions paying them off through a fraudulent “speakers program” meant to educate medical professionals about the drug. The speaking engagements were a veiled attempt to cover-up the direct payment to doctors for writing prescriptions, the more prescriptions you wrote, the higher your “speaking fees” increased. There are e-mails, texts and other Insys communications from all levels of company personnel stating “if they not writing prescription, they’re off the speaking program”, this policy resulted in one Alabama sales rep being paid over $700 thousand in Subsys based Rx commissions for one year, while her base salary was $40 thousand.

SALES REP NATALIE REED PERHAC

In the plea, Perhacs admitted that she was hired to be the personal sales representative for one of Insys’s most important prescribers, Dr. Xiulu Ruan. Ruan is one of two Alabama doctors who picked up over $115,000 in speaker fees from 2012 to 2015, and earned in excess of $40 million in related medical earnings during the same period. Earlier this year they were sentenced to 20 years in jail each for running a “pill mill” and helping Insys sales rep Natalie Reed Perhacs sell Subsys, for which she was paid in excess of $700 thousand in commissions, see Perhac Guilty Plea in Alabama Federal Court.

Perhac Plea Excerpts:

Admision No. 78: . Perhacs admitted that her primary responsibility at Insys was to increase the volume of Subsys® prescribed by Dr. Ruan, and his partner Dr. John Patrick Couch. This… was accomplished by (1) handling prior authorizations for their patients who had been prescribed Subsys®; (2) identifying patients who had been at the same strength of Subsys® for several months and recommending that Dr. Ruan or Dr. Couch increase the patients’ prescription strength; and (3) setting up and attending paid speaker programs.

Admission No. 79:. Ms. Perhac admitted that because of her involvement in the prior authorization process, she knew that the vast majority of Dr. Ruan and Dr. Couch’s patients did not have breakthrough cancer pain.

As you can see by the Perhac admissions, numbers 78 and 79, which reflect the vast number of charges lodged against her, the federal government is cracking down on everyone involved with the “Subsys” fraud. According to confidential sources, the recent June 2017 FDA “Opioid Crisis” Conference and related strategic review of the opioid crisis, will result in many more indictments and charges against drug makers and the medical providers who’ve helped facilitate the opioid epidemic that is currently in place across the United States.

How the results of the trail against the Insys Therapeutics boardroom plays out in the overall “Opioid Crisis” battle remains to be seen. There is always the question of why the Sackler family (Purdue Pharma) and the billions they’ve earned off improper marketing of Oxycontin and their scorched earth sales tactics, have not resulted in criminal indictments yet? Perhaps the Sackler family habit of donating billions to charities and having hospital wings named in their honor was a very strategic and forward looking business model that is now paying great dividends.

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THE DEALFLOW LITIGATION FUNDING FORUM

LITIGATION FUNDING FORUM

Why You Should Attend

April 4, 2019 in New York City

MASS TORT NEXUS: A Media Sponsor Of This Event

By Mark A. York

(MASS TORT NEXUS MEDIA) Whether you’re active in litigation funding or a firm exploring outside capital sources to fund your practice, the Litigation Funding Forum April 4th in New York City is where you should be.

Mass Tort Nexus has been invited by DealFlow to meet and discuss the most current issues as well as the forecast for litigation funding in law firm business models. We will be meeting with key members of the industry and asking how the funding world may impact mass torts and other practice areas at law firms.

This includes looking at parties who demand oversight and disclosures to the court when outside capital is used to fund a docket, [not needed from a personal perspective] but there are also those that are demanding more open disclosure. Certain courts including Federal Judge Dan Polster in the Opiate Prescription Litigation MDL 2804, now require firms in that litigation to file disclosures when they are using outside capital to fund their litigation, and this view is being pushed by more defense firms who claim this is needed to show outside interests are involved in ongoing litigation.

This may be a unique trend that goes away once all involved see that securing capital investment in any type of ongoing business is often required for any number of reasons from infrastructure development to business expansion – and why a law firm securing funding from a third party should be viewed any differently seems to be not only intrusive but as interfering with a private business matter. This is an evolving area that may or may not become more open to discussion or it may simply become a non-issue as the parties realize that litigation funding is a regular part of the legal world these days.

The Event

Litigation funding is an increasingly popular way to finance the high cost of a legal action, whether as plaintiff or defendant. Lawyers at the highest ranks of the legal profession are updating their toolkits to perform work in litigation funding, while financiers raise hundreds of millions of dollars to fuel demand.

In an uncertain and complex regulatory environment, The Litigation Funding Forum 2019 is your single greatest resource for getting up-to-the-moment information from the brightest minds in the business.

Groups attending this event include:

  • Specialty Litigation Investment Funds
  • Law Firms
  • Accounting and Financial Advisory Firms
  • Corporate Counsels
  • Brokerage Firms
  • Hedge Funds
  • Private Equity Firms
  • Pension Funds and Endowments

Why Funding May be Needed

Litigation funding offers significant benefits in terms of financial reporting and operations. Funding solutions can create immediate improvements in cash flow, bring greater certainty over forecasts of legal expenditure and divert valuable resources into revenue-generating areas of the business. Critically, third-party funding can enable a law firm to pursue cases that it would not otherwise pursue due to budget constraints, at zero risk and at zero cost.

Generally, these are the financial concerns when expanding a practice, the last three often require outside capital.

  • Executive Summary
  • Company Description
  • Market Research
  • Service/Product Description
  • Management & Operational Infrastructure
  • Marketing & Sales Strategy
  • Financials (Bottom Line)

Seeking a reliable source for capital investment makes sense if there’s a viable model and a plan to enter into a mass tort program or other specialty practice area.  Law firms that use outside funding lee experience increases in their chance of success based on the ability to move faster and develop a timely docket, once capital funding is in place. Often banks and certain investors will keep their wallets closed unless they can see a well-planned and structured method of attack and a stellar credit rating as they are not in the business of working with law firms entering or expanding in to a new practice area. That’s why a fund or capital group that focuses on the legal is now an accepted source of expansion capital or to support and existing firm’s practice.

How Firms Use New Capital:

  • Marketing Campaigns
  • Website launch
  • Social media activity
  • Lead list building
  • Customer retention efforts
  • Potential consumer loyalty programs
  • Intake and verification
  • Securing your docket
  • Managing case docket once filed

What the Defense is Saying:

  • Outside funding views from the defense bar and the U.S. Chamber of Commerce, have called for a nationwide disclosure rule that would lift the veil on the details of litigation finance agreements and reveal the identities of the funders. But the effort has been unsuccessful so far.
  • Lisa Rickard, president of the U.S. Chamber Institute for Legal Reform, wrote in a June 2017 letter that not having a disclosure rule lets funders “continue to operate in the shadows, concealing from the court and other parties in each case the identity of what is effectively a real party in interest that may be steering a plaintiff’s litigation strategy and settlement decisions.”

For more information on the Litigation Funding Forum in New York City this week contact:

Charlie— Charlie@dealflow.com     516 876 8006 ex 20

 TKP CONFERENCE CENTER

APRIL 4, 2019

For this event, DealFlow has contracted to rent the entire 2nd floor to accommodate attendees. The TKP Conference Center is conveniently located within walking distance of Grand Central Terminal, the Port Authority Bus Terminal, and Penn Station.

Web LINK TO LITIGATION FUNDING FORUM EVENT

Location

109 West 39th Street,
New York, NY 10018

 

 

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Purdue Pharma’s Historical Bad Conduct Started 50 Years Ago: “Crafted By The Sackler Brothers”

 DOCUMENTS SHOW LONG-TERM DRUG INDUSTRY MANIPULATION BY THE SACKLERS

By Mark A. York (January 16, 2019

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) In 2007, Purdue Frederick Co. (not Purdue Pharma) and three company executives pled guilty to misbranding OxyContin and agreed to pay $634.5 million to resolve a U.S. Department of Justice investigation, in the US District Court of Virginia, see Purdue Criminal Plea Agreement US Department of Justice May 10, 2007. This plea deal “a get-out-of-jail free card” was engineered by none other than former New York City Mayor and political/corporate fixer, Rudy Guiliani, by directly leveraging high level US DOJ contacts and other DC insiders to derail the prosecution of Purdue Pharma, and instead offer up Purdue Fredrick Co. as the guilty party and thereby permitting the multi-billion dollar per year Oxycontin assembly line to continue operations.

The Sackler family has always been protected by the company shield, even though their most profitable selling opioid drug Oxycontin, and its boardroom coordinated marketing campaign was the brainchild and a direct result of the Purdue Pharma company founders, the Sackler brothers and their tried and true business model.

That is now changing, as the State of Massachusetts has filed a lawsuit against Purdue Pharma and the Sackler family as well as various Purdue executives over the prescription painkiller OxyContin. Oxycontin is now recognized as the opioid fuse that ignited America’s opioid crisis, and in a positive move forward, the leading executives and members of the multibillionaire Sackler family, now known to be feuding over the opioid crisis have been named in civil litigation.

The Sacklers named in the lawsuits include Theresa and Beverly, widows of Purdue founders, brothers Mortimer and Raymond Sackler and Ilene, Kathe and Mortimer David Alfons Sackler, three of Mortimer’s children; Jonathan and Richard Sackler, Raymond’s two sons; and David Sackler, Raymond’s grandson. The Sackler family is worth conservatively, an estimated$13 billion according to Forbes, which has been generated from sales of OxyContin.  As is normal procedure by the Sackler family and the company itself, the Sackler family feuding members always decline requests for comment on the catastrophic opioid crisis and avoid discussing any Purdue Pharma links to how the crisis came about.

As Purdue Pharma comes to grips with the fact that they are being designated as the primary litigation targets of states, counties and cities across the country for being the Opiate Big Pharma leader in creating the current opioid crisis in the United States, they may need to determine how they will pay the billions of dollars in jury verdicts and affiliated legal settlements resulting from the lawsuits that now number over 1,200 cases in state and federal courts.

The entire Sackler brothers’ Oxycontin marketing plan followed their previously proven drug marketing test drive of “Valium” – when Hoffman-LaRoche hired the Sacklers to market their new drug “diazepam” commonly known as Valium and its sister drug Librium.

While running the drug advertising company, Arthur Sackler became a publisher, starting a biweekly newspaper, the Medical Tribune, which eventually reached 600,000 physicians. He scoffed at suggestions that there was a conflict of interest between his roles as the head of a pharmaceutical-advertising company and the publisher of a periodical for doctors. Later it emerged that a company he owned, MD Publications, had paid the chief of the antibiotics division of the FDA, Henry Welch, nearly $300,000 in exchange for Welch’s help in promoting certain drugs. Sometimes, when Welch was giving a speech, he inserted a drug’s advertising slogan into his remarks. After the payments were discovered, Welch was forced to resign from the FDA.

When Purdue Pharma started selling its prescription opioid painkiller OxyContin in 1996, Dr. Richard Sackler asked people gathered for the launch party to envision natural disasters like an earthquake, a hurricane, or a blizzard. The debut of OxyContin, said Sackler — a member of the family that started and controls the company and then a company executive — “will be followed by a blizzard of prescriptions that will bury the competition.”

Five years later, as questions were raised about the risk of addiction and overdoses that came with taking OxyContin and opioid medications, Sackler outlined a strategy that critics have long accused the company of unleashing: divert the blame onto others, particularly the people who became addicted to opioids themselves.

“We have to hammer on the abusers in every way possible,” Sackler wrote in an email in February 2001. “They are the culprits and the problem. They are reckless criminals.”

Sackler’s comments at the party and his email are contained in newly public portions of a lawsuit filed by the state of Massachusetts against Purdue that alleges that the company, the Sackler family, and company executives misled prescribers and patients as they aimed to blanket the country with prescriptions for their addictive medications.

“By their misconduct, the Sacklers have hammered Massachusetts families in every way possible,” the state’s complaint says, noting that since 2007, Purdue has sold more than 70 million doses of opioids in Massachusetts for more than $500 million. “And the stigma they used as a weapon made the crisis worse.”

The new filing also reveals how Purdue aggressively pursued tight relationships with Tufts University’s Health Sciences Campus and Massachusetts General Hospital — two of the state’s premier academic medical centers — to expand prescribing by physicians, generate goodwill toward opioid painkillers among medical students and doctors in training, and combat negative reports about opioid addiction.

Since the beginning of May, the attorneys general of Florida, Nevada, Massachusetts, North Carolina, North Dakota, Tennessee, Texas, Utah and Virginia have also filed lawsuits against the company.

New York City previously filed a $500 million suit, against pharmaceutical companies that make or distribute prescription opioids, the complaint was filed in New York state court, the Superior Court of Manhattan, which is a break from other Opioid lawsuits filed by cities, who filed into federal court, see Mass Tort Nexus Briefcase,  OPIOID-CRISIS: MDL-2804-OPIATE-PRESCRIPTION-LITIGATION. The primary claims state that the opiate drug companies fueled the deadly epidemic now afflicting the most populous U.S. city, joining Chicago, Seattle, Milwaukee and other major cities across the country in holding Big Pharma drug makers accountable for the opioid crisis. The case docket information is: City of New York v Purdue Pharma LP et al, New York State Supreme Court, New York County, No. 450133/2018.

Major US Cities Filing Suit Against Opioid Big Pharma-New York, Seattle, Chicago Join MDL 2804

Gov. Andrew Cuomo said in a statement “The opioid epidemic was manufactured by unscrupulous manufacturers and distributors who developed a $400 billion industry pumping human misery into our communities”.

The suit comes three months after Underwood first announced her intention to sue the pharma giant, joining several other states that have already targeted Purdue for its alleged role in the epidemic that saw more than 3,000 New Yorkers die of opioid overdoses in 2016. Daniel Raymond, deputy director of the Harm Reduction Coalition, said that the cities and states are forced to file suits now, after realizing initially that the opioid overdose rates “were primarily driven by prescription painkillers — they weren’t concentrated in urban areas.”

“But the recent rises in prescription overdoses, which in turn has accelerated a major increase in heroin overdoses, and particularly fentanyl, and the latter seems particularly prevalent in urban drug markets,” said Raymond, whose organization is based in New York City. “That’s certainly true in places like Ohio and Philadelphia, which are seeing a lot of fentanyl-involved overdose deaths. That doesn’t mean the problems have waned in smaller cities and rural areas, which are also seeing fentanyl, but we are seeing increasing vulnerability in major urban centers.”

The only bright spot — and it’s a dim one at that — was that the CDC found decreases in opioid overdoses in states like West Virginia, New Hampshire and Kentucky that have been leading the nation in the category.

“We hope this is a positive sign,” said Schuchat, who credited leadership, particularly in West Virginia, with taking bold steps to combat the crisis. “But we have to be cautious in the areas that have reported decreases.”

Dr. Rahul Gupta, then Director of Public Health for West Virginia has been at the forefront of addressing the opioid crisis in not only West Virginia but across the country, he stated “Sometimes places that have had such high rates have no place to go” but down, he added, with West Virginia being one of the states to address the issues pro-actively in all areas.

The same drug abuse related issues that are in New York and other major metropolitan areas are now at healthcare crisis levels, with the causation now being seen as based on the ongoing marketing abuses by Purdue Pharma and other opiate industry drug makers and distributors.

The new CDC “Vital Signs” report was released a week after Attorney General Jeff Sessions issued a “statement of interest” in support of local governments that are suing the big pharmaceutical makers and distributors, accusing them of swamping many states with prescription painkillers and turning millions of Americans into junkies.

The new CDC numbers come from analysis of emergency room data from 16 states, including some hardest hit by the plague — Delaware, Illinois, Indiana, Kentucky, Massachusetts, Maine, Missouri, Nevada, New Hampshire, New Mexico, North Carolina, Ohio, Pennsylvania, Rhode Island, West Virginia and Wisconsin.

Dozens of states, counties and local governments have independently sued opioid drugmakers in both state and federal courts across the country, (see OPIOID-CRISIS-BRIEFCASE-MDL-2804-OPIATE-PRESCRIPTION-LITIGATION by Mass Tort Nexus) with claims alleging all opiate drug makers, distributors and now the pharmacies engaged in fraudulent marketing to sell the powerful painkillers. They also failed to monitor and report the massive increases in opioid prescriptions flooding the US marketplace. Which has now resulted in fueling the nationwide epidemic, that’s reported to have killed over a quarter million people. The now organized approach steps up those efforts as officials sift evidence and are holding not only the companies, but the executives and owners culpable in the designing the opioid crisis.

Purdue Pharma is facing a legal assault on many fronts, as cities, counties and states have either filed suit or are probing the company for an alleged role in the United States’ opioid and addiction epidemic. The lawsuit filed by Massachusetts’ Attorney General Maura Healey, is the first to bring the company’s current and former execs into the mix, including the billionaire family with sole ownership of Purdue.

The Sackler family name graces some of the nation’s most prestigious bastions of culture and learning — the Sackler Center for Arts Education at the Guggenheim Museum, the Sackler Lefcourt Center for Child Development in Manhattan and the Sackler Institute for Developmental Psychobiology at Columbia University, to name a few.

Now for the first time since the opioid crisis came to the attention of America, the Sackler name is front and center in a lawsuit accusing the family and the company they own and run, Purdue Pharma, of helping to fuel the deadly opioid crisis that has killed thousands of Americans.

Lawsuit filed by the state of Massachusetts against Purdue Pharma

Under an agreement with Mass. General, Purdue has paid the hospital $3 million since 2009 and was allowed to propose “areas where education in the field of pain is needed” and “curriculum which might meet such needs,” the court document shows. Tufts made a Purdue employee an adjunct associate professor in 2011, Purdue-written materials were approved for teaching to Tufts students in 2014, and the company sent staff to Tufts as recently as 2017, the complaint says. Purdue’s New England staff was congratulated for “penetrating this account.”

A Tufts spokesman declined to comment, citing the ongoing legal process. Mass. General did not immediately comment.

In a statement Purdue criticized the Massachusetts Attorney General Maura Healey’s office, which is spearheading the lawsuit, and said the complaint was “a rush to vilify” Purdue. It noted that its medications were approved by the Food and Drug Administration and regulated by the government, and that the company promoted the medications “to licensed physicians who have the training and responsibility to ensure that medications are properly prescribed.”

“Massachusetts’ amended complaint irresponsibly and counterproductively casts every prescription of OxyContin as dangerous and illegitimate, substituting its lawyers’ sensational allegations for the expert scientific determinations of the [FDA] and completely ignoring the millions of patients who are prescribed Purdue Pharma’s medicines for the management of their severe chronic pain,” the company said.

It also said the state attorney general’s office omitted information about the steps Purdue has taken in the past decade to promote safe and appropriate use of opioid medicines.

“To distract from these omissions of fact and the other numerous deficiencies of its claims, the Attorney General has cherry-picked from among tens of millions of emails and other business documents produced by Purdue,” the company said. “The complaint is littered with biased and inaccurate characterizations of these documents and individual defendants, often highlighting potential courses of action that were ultimately rejected by the company.”

Healey’s office sued Purdue, current and former executives, and members of the Sackler family in June. In December, it filed an amended complaint that was nearly 200 pages longer than the June filing, with more allegations spelled out against the individual defendants. Many of the details were redacted; a portion of them were made public in an updated document filed Tuesday in state court, though much of the complaint is still blacked out.

The state’s suit focuses on Purdue’s actions since 2007, when the company and three current and former executives pled guilty in federal court to fraudulently marketing OxyContin and the company agreed to pay $600 million in fines. The case is separate from litigation being waged by STAT to obtain sealed Purdue documents in Kentucky, including the only known deposition of Richard Sackler, about the company’s marketing practices in earlier years, which have been blamed for igniting the current opioid addiction crisis.

The Massachusetts complaint sketches an image of the Sacklers, as board members, exercising tight control over the company, overseeing the deployment of a phalanx of sales representatives who were pushed to get Purdue medications into more hands, at higher doses, and for longer periods of time. The Sacklers, the complaint states, reaped “billion of dollars,” even as the company blurred the risks of addiction and overdose that came with the drugs.

Richard Sackler, who was named president of the company in 1999 before becoming co-chairman in 2003, is singled out in the complaint as particularly domineering as he demanded greater sales. In 2011, he decided to shadow sales reps for a week “to make sure his orders were followed,” the complaint states.

Russell Gasdia, then the company’s vice president of sales and marketing, who is also a defendant in the Massachusetts lawsuit, went to Purdue’s chief compliance officer to warn that if Sackler directly promoted opioids, it was “a potential compliance risk.”

“LOL,” the compliance officer replied, according to the complaint. Other staff raised concerns, but they ultimately said that “Richard needs to be mum and anonymous” when he went into the field.

After the visits to doctors, Richard Sackler claimed that Purdue’s drugs shouldn’t need a legally mandated warning. He wrote in an email cited in the complaint that the warning “implies a danger of untoward reactions and hazards that simply aren’t there.”

Secret trove reveals bold ‘crusade’ to make OxyContin a blockbuster

The following year, Sackler’s pressure on the staff grew so intense that Gasdia asked the CEO to intervene: “Anything you can do to reduce the direct contacts of Richard into the organization is appreciated,” Gasdia wrote in an email cited by the complaint.

It apparently didn’t work. The next week, Richard Sackler emailed sales managers to say that U.S. sales were “among the worst” in the world.

Sales managers were badgered on nights, weekends, and holidays, according to the filing. The marketing campaigns focused on high-volume doctors, who were visited repeatedly by salespeople, and pushed doctors to prescribe high doses. The demands on sales managers created such a stressful environment that in 2012, they threatened to fire all sales representatives in the Boston area because of lackluster numbers.

The complaint also accuses Purdue of rarely reporting alleged illegal activity, such as improper prescribing and massive Oxycontin order increases to government officials when it learned about it. In one 2009 case, a Purdue sales manager wrote to a company official that Purdue was promoting opioids to an illegal pill mill.

“I feel very certain this is an organized drug ring,” the employee wrote, adding “Shouldn’t the DEA be contacted about this?” Purdue did nothing for two years, according to the complaint.

In addition to relying on its sales force, Purdue cultivated ties with academic hospitals, which both treat patients and train the next generation of prescribers.

In 2002, the company started the Massachusetts General Hospital Purdue Pharma Pain Program after a Purdue employee reported that access to the hospital’s doctors “is great … they come to us with any questions, and allow us to see them when we need to.” The hospital, the staffer added, “has significant influence through most of New England, simply because they are MGH.”

As part of the program, Purdue gained influence over training programs and organized a symposium in the hospital’s famed “Ether Dome” — the site of the first public surgery with anesthetic.

The Sacklers renewed the deal with Mass. General in 2009 and agreed to contribute $3 million to fund the program, the lawsuit says.

Purdue’s funding, however, didn’t stop researchers at Mass. General from raising concerns about its products. The complaint cites a July 2011 email from Purdue’s then-chief medical officer Craig Landau — who is now the CEO and is a defendant in the lawsuit — flagging a study questioning the use of opioid painkillers for chronic pain that was conducted by Mass. General researchers with Purdue funding. Landau wanted to make sure that any Purdue-funded study supported the use of its medicines.

Purdue’s ties to Tufts date back even further, according to the lawsuit. In 1980, three Sacklers donated funding to launch the Sackler School of Graduate Biomedical Sciences. In 1999, the Sacklers gave money to help start the Tufts Masters of Science in Pain Research, Education, and Policy. Through the program, “Purdue got to control research on the treatment of pain coming out of a prominent and respected institution of learning,” the filing states. Purdue employees even taught a Tufts seminar about opioids, and Tufts and its teaching hospital collaborated with Purdue on a publication for patients called, “Taking Control of Your Pain.”

Purdue also allegedly used Tufts’s ties in Maine as reports about addiction emerged in the state. Tufts ran a residency program in the state, the complaint says, and in 2000 “agreed to help Purdue find doctors to attend an event where Purdue could defend its reputation.”

The bulk of the documents cited in the Massachusetts complaint were filed by Purdue in federal court in Ohio as part of a consolidated case involving hundreds of lawsuits filed by states, cities, counties, and tribes against Purdue, other opioid manufacturers, and others in the pharmaceutical industry.

Purdue says it produced 45 million pages of documents for the federal court case — known as a multidistrict litigation. In a motion filed last month and in an emergency hearing before the federal judge in Ohio overseeing the MDL, Purdue argued that the details in Massachusetts’ amended complaint were largely drawn from about 500 Purdue documents it had filed on a confidential basis in the federal court. The company’s lawyers argued the rules of confidentiality established in the federal court should apply to Massachusetts’ filing in state court, while state officials say the issue of what should be made public should be decided in state court.

Among the records Purdue said last month should remain confidential are those involving the company’s board of directors. Making them public, the company argued, would have a “chilling effect” on corporate governance.

The effort to protect the disclosure of board-related documents serves another purpose not cited by the company: It protects the Sackler family, whose members have long constituted the majority of board members.

In its filing last month, Purdue also said one company official, whom it did not name, was concerned for his safety because his home address was listed in the complaint along with “numerous irrelevant, incendiary, and misleading comments about his career at Purdue.”

Purdue’s attorneys contend the Massachusetts amended complaint is a “concerted effort by the Commonwealth to use confidential documents in an attempt to publicly embarrass Purdue and its officers, directors and employees.” They claim the information selected was “cherry-picked” to “bolster a series of inflammatory and misleading allegations against Purdue.”

In September 2017, Landau, by that time Purdue’s CEO, jotted down a note summarizing some of the roots of the opioid crisis. It reads:

“There are:
Too many Rxs being written
Too high a dose
For too long
For conditions that often don’t require them
By doctors who lack the requisite training in how
to use them appropriately.”

The state’s lawsuit concludes: “The opioid epidemic is not a mystery to the people who started it. The defendants knew what they were doing.”

The Sackler family is the 19th richest in the nation, with an estimated fortune of $13 billion, according to Forbes.

The Sacklers involved with Purdue Pharma are the descendants of brothers Mortimer and Raymond Sackler. Their eldest brother, Arthur, died in 1987, well before Purdue began making and selling OxyContin. Arthur also worked in pharmaceuticals and developed a reputation for cleverly marketing new drugs directly to doctors, convincing them to prescribe medications including tranquilizers to their patients.

Arthur was inducted into the Medical Advertising Hall of Fame after his death, but he has also been criticized for originating “most of the questionable practices that propelled the pharmaceutical industry into the scourge it is today,” as Allen Frances, the former chair of psychiatry at Duke University School of Medicine, told the New Yorker last year.

Arthur’s family has made a point of noting that he was not involved in the sale of OxyContin and would prefer him to be remembered for his philanthropy, including funding the Arthur M. Sackler Gallery of Chinese Stone Sculpture at The Metropolitan Museum in Manhattan and the Arthur M. Sackler Museum at Harvard University.

“None of the charitable donations made by Arthur prior to his death, nor that I made on his behalf after his death, were funded by the production, distribution or sale of OxyContin or other revenue from Purdue Pharma,” his widow, Jillian Sackler, said in a February statement. “Period.”

Seven of the Sacklers named in the suit have been on the Purdue board since the 1990s, according to the suit, while David Sackler, the grandson, has served since 2012.

The board met on a weekly — sometimes daily — basis while the company was being investigated by 26 states and the Justice Department from 2001 to 2007, according to the lawsuit. In 2007, the board settled and agreed to pay a $700 million fine after the company’s CEO at the time, Michael Friedman, and two other high-ranking company officials pleaded guilty to misleading doctors and patients about opioids.

KENTUCKY LEGAL FIGHT TO KEEP SACKLER TESTIMONY SEALED

In an example of the past coming back to haunt the present, in 2015 Purdue Pharma agreed to pay $24 million to settle a lawsuit filed by Kentucky, December 22, 2015 Purdue Pharma Settlement With State of Kentucky,  which Purdue thought would end that problem by paying a fine and moving on, which isn’t the case it seems. See Purdue Pharma settles with Kentucky over Oxycontin claim(statnews.com/pharmalot) for information on the claims in Kentucky.

That state court litigation is now subject to an ongoing legal battle in the Kentucky courts where Purdue is fighting to keep the original court records from that settlement sealed, due to the only deposition testimony of one of the Sackler brothers is known to be located. The Purdue court records were unsealed by Pike County Judge Stephen Combs in May 2016, and Purdue immediately appealed with oral arguments taking place June 26, 2017 in front of a three judge panel of the Kentucky Court of Appeals, which as of June 20, 2018 has not issued a ruling on releasing the records. The original Kentucky vs. Purdue docket information is case no. 07-CI-01303, Judge Stephen Combs, Pike County Circuit Court of Kentucky.

OxyContin was hailed as a medical marvel when it debuted in 1995. Pitched as balm for people suffering from moderate to severe pain, it reportedly generated more than $35 billion in revenue for Purdue Pharma.

Oxycontin’s chief ingredient is oxycodone, a cousin of heroin, and prosecutors say Purdue played down the dangers of addiction while getting hundreds of thousands of Americans hooked on opioids.

Purdue has argued that OxyContin is approved by the Food and Drug Administration and accounts for just 2 percent of the opioid prescriptions nationwide.

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

Mass Tort Nexus “CLE Immersion Course”

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(Disclaimer: Excerpts in this document and media content may have originated in other media publications)

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How Johnson & Johnson Hid Asbestos In J&J Baby Powder Products For Over 40 Years

“Why Did Johnson & Johnson Hide Asbestos In Baby Powder Products?” 

By Mark A. York  (January 2, 2019)

 

 

 

 

 

 

  (Mass Tort Nexus Media) Johnson & Johnson has hidden the fact that they’ve known its raw talc and finished powders tested positive for quantities of asbestos, with the company’s doctors and lawyers being fully aware of the findings but failed to alert regulators or consumers.  This may currently be due to the Talc based litigation docket that’s quickly becoming a major mass tort, but in looking back over 40 years, it seems that J&J simply chose to ignore the science and hide the data from the public.

Among the recent documents unsealed in court indicates that in May 1974, an official at Johnson & Johnson’s Windsor mine in Vermont recommended “the use of citric acid in the depression of chrysotile asbestos” from talc extracted from the site.

“The use of these systems is strongly urged by this writer to provide protection against what are currently considered to be materials presenting a severe health hazard and are potentially present in all talc ores in use at this time,” the mine’s director of research and development wrote then.

See also “New Evidence of Johnson & Johnson Bad Conduct Moved LA Jury to Award $417 Million Talc Verdict”.

Johnson & Johnson stock — up 6 percent for the year — plunged 11 percent on news of the report, based on memos, internal documents and confidential memos that the maker of Johnson’s Baby Powder had been compelled to share with attorneys for some 11,700 plaintiffs who claim the company’s powder products caused their cancers. The cases include thousands of women with ovarian cancer.

Johnson & Johnson is facing thousands of lawsuits across the country including in a federal multi-district litigation in New Jersey, see Johnson & Johnson Talcum Powder MDL 2738 (USDC New Jersey). This litigation is related primarily to the ovarian cancer claims brought by women, who claim that J&J talcum powder products cause ovarian cancer, which combined with the emerging talc mesothelioma lawsuits, would open an entire new area of mass tort litigation for J&J and its affiliates to defend.

Any exposure to asbestos is a health risk, according to the World Health Organization and other medical groups.  ompany documents, along with deposition and trial testimony, show that from at least 1971 to the early 2000s, tests showed small amounts of asbestos could sometimes be found in the company’s raw talc and finished powders, Reuters reported.

At the same time, company executives, mine managers, scientists, doctors and lawyers worried about the problem and how to address it but did not disclose the issue to regulators or the public.

https://www.cbsnews.com/video/johnson-johnson-vows-to-appeal-4-7-billion-talcum-products-verdict/

An examination of the documents also revealed how J&J succeeded in curbing regulators’ plans to curtail asbestos in cosmetic talc products as well as scientist research on talc’s health effects, Reuters stated.

Johnson & Johnson denied reports in a statement to the Associated Press. J&J said “thousands of independent tests by regulators and the world’s leading labs prove our baby powder has never contained asbestos.”

The New Brunswick, New Jersey, company  also has publicly maintained in recent years there is no science to back alleged links between its powder and cancer. J&J has won several recent court cases alleging liability and damages, and is appealing other judgments, including $4.6 billion awarded in July to 22 women who claimed its product caused their ovarian cancer.

J&J dominated the talc powder market for more than a century, with its talc products adding $420 million to the company’s $76.5 billion in sales in 2017. While contributing a relatively small portion to overall revenue, Johnson’s Baby Powder is seen as a major component of J&J’s image as a caring company — a “sacred cow,” as one 2003 internal email cited by Reuters put it.

SCIENCE SAYS TALC IS DANGEROUS

The debate over talc began decades ago. In the early 1970s, scientists discovered talc particles in ovarian tumors. In 1982, Harvard researcher Daniel Cramer reported a link between talcum powder and ovarian cancer. His study was followed by several more finding an increased risk of ovarian cancer among regular users of talcum powder. Cramer, who at one point advised J&J to put a warning on its products, has become a frequent expert witness for women suing the company. J&J ignored and suppressed Mr. Cramer’s attempts to show them the study data then publicly declared this research as flawed, which J&J still continues to this day.

DOES J&J TALCUM POWDER CAUSE CANCER?

Johnson & Johnson has been ordered to pay nearly $1 billion in total damages after just 5 trials, alleging its baby powder is causing ovarian cancer, all jury verdicts have been in state courts in Missouri and California, see J&J Talc Trials St. Louis Missouri.

Talc, a mineral composed of magnesium, silicon, oxygen and hydrogen, is used extensively in cosmetics and personal care products. Women sometimes use talcum powder on their genital areas, sanitary napkins or diaphragms to absorb moisture and odor – contrary to the guidance of most physicians. (Asbestos, linked to lung cancer, was once an impurity in talc, but it has been banned for several decades.)  J&J is notorious for using any means possible to influence scientific data and opinion as well as manipulating research reports and public media commentary by industry experts. The recent California trial showed payments made to previously perceived impartial Science Council members, who were declaring publicly that J&J talcum powder does not pose a cancer risk, the Los Angeles jury did not agree with J&J and other pro-talc defense team members, as over $300 million of the total $417 million judgment was for punitive damages, usually awarded for intentional misconduct, see “New Evidence of Johnson & Johnson Bad Conduct Moved LA Jury to Award $417 Million Talc Verdict”.

His studies and the many others that have found a relationship used a case-control approach. A group of women diagnosed with ovarian cancer and a group without it were asked to recall their past diet and activities, and the results were then compared.

Critics say these kinds of studies have serious drawbacks, particularly “recall bias.” Women may forget what they did or, if diagnosed with cancer, might inadvertently overestimate their use of a suspect substance. People without a serious disease may be less motivated to remember details.

Three other studies – considered cohort studies – did not find any overall link. Unlike the case-control studies, these efforts began with a large group of women who did not have cancer and followed the progress of their health, with participants recording what they were doing in real time. The results of this approach, most scientists say, are stronger because they aren’t subject to the vagaries of memory.

One such study included more than 61,000 women followed for 12 years as part of the National Institutes of Health’s well-respected Women’s Health Initiative.

WILL “MESOTHELIOMA TALC” BE THE NEW MASS TORT?

Two recent verdicts for asbestos contamination demonstrate the risk to cosmetic talc defendants, when a Los Angeles County jury awarded $18M to Philip Depolian against Whittaker, Clark & Daniels finding it 30% responsible for his mesothelioma due to his alleged exposure to various cosmetic talc products used at his father’s barbershops that contained asbestos. The jury apportioned liability against various cosmetic talc defendants that had settled and several other cosmetic talc product defendants that sold products including Old Spice, Clubman, Kings Men and Mennen Shave Talc.

In 2015, another Los Angeles jury awarded Judith Winkel $13M against Colgate-Palmolive for mesothelioma allegedly caused by exposure to talc in its baby powder. The jury rejected Colgate and its experts’ claims that the cosmetic talc at issue was not contaminated by asbestos and that the talc in question were non-fibrous “cleavage fragments” unlikely to be inhaled or embedded in the lungs. Although details of the trial are not readily verified, at least one report indicated that evidence presented at trial showed that the talc contained 20% asbestos fibers.

These cases are particularly important because the defendants were held responsible for cosmetic talc containing asbestos and for having caused mesothelioma and not ovarian cancer as in the earlier J&J talc cases. Further, both juries found that the defendants acted with malice. However, the cases were confidentially settled before the respective punitive damage phases.

Will “Talc Mesothelioma” be the next mass tort against Johnson & Johnson and its affiliates? Mass Tort Nexus will continue to report on this as additional information becomes available.

 

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The Opioid Epidemic and State Courts – Why some aren’t filing into Opiate MDL 2804

Florida, Texas, Nevada, North Carolina, North Dakota, Oklahoma, Tennessee, Massachusetts and others have started  their own Opioid Litigation in state courts across the country

By Mark A. York (December 10, 2018)

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) Opioid abuse has been steadily increasing in the United States, and now state courts are becoming the legal venue of choice for filing lawsuits against the “opioid industry” and there may be a need for partnerships with other organizations to confront this epidemic. Lawsuits have already been filed in federal courts and by 22 U.S. states and Puerto Rico against Opiate Big Pharma. 

For a look at the Federal Opiate Litigation MDL 2804 see “OPIOID-CRISIS-BRIEFCASE -MDL-2804-OPIATE-PRESCRIPTION-LITIGATION” where states, counties, cities, indian tribes as well as unions, hospitals and individuals have filed more than 1000 lawsuits against the opioid industry as a whole.

BILLIONS IN PROFITS

The pharmaceutical industry spent a vast $6.4 billion in “direct-to-consumer” advertisements to hype new drugs in 2016, according tracking firm Kantar Media. That figure has gone up by 62% since 2012, Kantar Media says. This number may seem large at first but compared to the multi-billions in yearly profits just by opioid manufacturers over the last 15 years, the numbers is small.  Corporate earnings have risen every year since the push to increase opioid prescriptions in every way possible, to became an accepted business model in Big Pharma boardrooms across the country.

Opioids were involved in more than 42,000 overdose deaths in 2016, the last year for which data was available, according to the U.S. Centers for Disease Control and Prevention. Kentucky, one of the nation’s hardest-hit states, lost more than 1,400 people to drug overdoses that year.

A NEW INFANT NAS MDL 2872

Kevin Thompson of the Opioid Justice Team, has filed a motion for a new prescription opiate related multidistrict litigation, which was heard in front of the JPML panel on November 28, 2018 in New York City, where the panel was requested to designate MDL No. 2872 (INFANTS BORN OPIOID-DEPENDENT PRODUCTS LIABILITY LITIGATION) as a new and separate litigation focused on infants born addicted to opiates and suffering from what’s commonly knows as Neonatal Abstinence Syndrome (NAS) and numerous other long-term medical issues.

The current Opiate MDL 2804 is not moving litigation related to individuals forward in any way. Thompson’s team is requesting that the infant cases be carved out from the sprawling lawsuit in Cleveland and transferred to a federal judge in West Virginia, one of the hardest hit states where roughly 5 percent of all babies are born dependent on opioids. The overall Infant NAS MDL 2872 docket can be viewed here MDL 2872 Infant NAS Re-infants-born-opioid-dependent-products-liability-litigation docket.

The misuse of opioids starting with the flood of prescription pain medicines, which has cast a wide net to now include heroin, fentanyl, morphine, and other drugs both legal and illegal is a serious national problem. In 2015 one in ten Americans reported using an illicit drug in the past 30 days.[1] Marijuana use and the misuse of prescription pain relievers account for the majority of illicit drug use. Of the 21.5 million Americans 12 or older who had a substance-use disorder in 2014, 1.9 million had a substance-use disorder involving prescription pain relievers, and 586,000 had a substance-use disorder involving heroin.[2]

 

Widespread use of opioids has had a devastating impact on many communities. In 2014, more people died from drug overdoses than in any year on record, with 78 Americans dying every day from an opioid overdose. Drug overdose now surpasses motor-vehicle crashes as the leading cause of injury death in the United States. Most opioid-related overdoses involve prescription painkillers, but a growing number are the result of a powerful combination of heroin and fentanyl, a synthetic opioid often packaged and sold as heroin. Some of the largest concentrations of overdose deaths were in Appalachia and the Southwest, according to county-level estimates by the Centers for Disease Control and Prevention.[3]

One contributing factor behind the opioid epidemic is the increase in the use of prescription painkillers nationally. From 1991 to 2011, the number of opioid prescriptions dispensed by U.S. pharmacies tripled from 76 million to 219 million.[4] This increase in the use of opioids is unique to America. The United States represents less than 5 percent of the world’s population but consumes roughly 80 percent of the world’s supply of opioid drugs.[5] There is also wide variation from one state to another in opioid-prescribing rates. In 2012 twelve states had more opioid prescriptions than people: Alabama (142.9 per 100 people), Tennessee (142.8), West Virginia (137.6), Kentucky (128.4), Oklahoma (127.8), Mississippi (120.3), Louisiana (118), Arkansas (115.8), Indiana (109.1), Michigan (107), South Carolina (101.8), and Ohio (100.1).[6]

The impact of the opioid epidemic touches every aspect of our public safety and judicial system. Drug-related arrests involving opioids are skyrocketing. In many communities, court dockets and probation caseloads are filled with individuals with opioid-use disorders. Access to treatment, particularly medication-assisted treatment combined with cognitive behavioral interventions, is limited—particularly in rural communities. This epidemic also comes at a price. In 2015 the Ohio Department of Mental Health and Addiction Services began providing substance-abuse treatment in Ohio’s prisons, spending an estimated $30 million per year on drug treatment in prisons, $4 million on housing for individuals in recovery, and $1 million over two years for naloxone to reverse drug overdoses. The Ohio State Highway Patrol spent over $2 million to expand and improve their crime lab to keep up with substance testing.

In addition to the impact of opioid abuse on the criminal courts, the nation’s family courts and child welfare system are being deeply impacted. A recent report by the Administration for Children and Families shows that after years of decline, the number of children in foster care is rising. Nearly three-quarters of all states reported an increase in the number of children entering foster care from 2014 to 2015. The largest increases occurred in Florida, Indiana, Georgia, Arizona, and Minnesota. From 2012 to 2016, the percentage of removals nationally due to parental substance abuse increased 13 percent to 32.2 percent.

In addition to hundreds of cases consolidated in federal court in Opiate MDL 2804, the defendants face a wave of litigation in state courts as well as civil and criminal investigations by numerous state attorneys general and the federal government. Any settlement would have to protect the defendant companies from future lawsuits over the same issue and that may be difficult to negotiate given all the concurrent litigation in different courts.

The primary federal litigation involving many cities and counties was consolidated by the JPML in December 2017 in a federal court in Cleveland, Ohio, in front of Judge Daniel Polster. The defendants include Purdue, J&J, Teva, Endo, AmerisourceBergen, Cardinal Health and McKesson. The federal litigation is growing daily see, Opiate Prescription MDL 2804, US District Court of Ohio link.

The time has now arrived for Opioid Big Pharma, in all forms to face the facts that for close to 20 years they have flooded the mainstream commerce of America with massive amounts of opiates with little to no oversight, which whether caused by a catastrophic systemic failure on many levels, or simple greed, the time has now come for the opiate industry to face the music of complex litigation in state and federal court venues across the country.

The judiciary can play a critical role in addressing the opioid epidemic. In August 2016, representatives from the Kentucky, Illinois, Indiana, Michigan, Ohio, Pennsylvania, Tennessee, Virginia, and West Virginia courts convened for the first-ever Regional Judicial Opioid (RJOI) Summit. The judicial summit brought together multidisciplinary delegates from each state to develop a regional action plan and consider regional strategies to combat the opioid epidemic. RJOI member states continue to work both within their home states and regionally to share promising practices, as well as to implement the objectives of the regional action plan. Courts are encouraged to work with partners in similar ways to:

  • Invest in local, state, and regional multidisciplinary, system-level strategic planning to identify policies or practice changes that can improve treatment engagement and reduce the risk of overdose death. Judges are particularly effective at using their convening power to bring together a variety of agencies and community stakeholders. The sequential intercept model is an effective approach to identifying gaps and opportunities for diverting criminal-justice-involved people to treatment. Communities are encouraged to not focus singularly on heroin use but to focus on substance-use disorders in general. A recent CDC study found that nearly all people who used heroin also used at least one other drug; most used at least three other drugs.[7]
  • Implement law-enforcement diversion programs, prosecutor diversion programs, or both to deflect or divert individuals with substance-use disorders from the criminal justice system into treatment at the earliest possible point.
  • Expand court diversion and sentencing options that provide substance-abuse treatment as an alternative to incarceration. Problem-solving courts, such as adult drug courts or veterans treatment courts, are the most notable examples of effective approaches.  
  • Incorporate strategic screening questions designed to identify criminal-justice-involved individuals at high-risk for overdose death into all criminal-justice-agency intake forms. Specifically, research suggests that individuals with a history of non-fatal overdoses, individuals with a history of opioids in combination with benzodiazepines like Xanax (alprazolam) and Soma (Carisoprodol), and individuals with an opioid-use disorder recently released from a confined environment (e.g., residential treatment or incarceration) are at particular risk for overdose death. This population should be prioritized for treatment and overdose-prevention services, such as naloxone access.

On January 24, 2017, the Bureau of Justice Assistance released funding for a “Comprehensive Opioid Abuse Program.” Through this solicitation, courts and their partners may implement overdose outreach projects, technology-assisted treatment programs, and diversion and alternatives to incarceration.

What remains to be seen is where and how the directly affected “individuals” who were prescribed millions of addictive opiates and subsequently became addicted and where thousands more overdosed and died, remains to be seen.

Who will be the advocate to make sure that these individuals as well as their children, families and communities as a whole are placed on the road to recovery. Historically, Big Pharma is not an industry to put the best interests of the paying consumer at the forefront of their agendas.

__________________________________________________________________________________________

[1] Center for Behavioral Health Statistics and Quality, “Key Substance Use and Mental Health Indicators in the United States: Results from the 2015 National Survey on Drug Use and Health” (HHS Publication No. SMA 16-4984, NSDUH Series H-51), report prepared for the Substance Abuse and Mental Health Services Administration, Rockville, Maryland, 2016. Retrieved from http://www.samhsa.gov/data/.

[2] Substance Abuse and Mental Health Services Administration, Center for Behavioral Health Statistics and Quality, Behavioral Health Trends in the United States: Results from the 2014 National Survey on Drug Use and Health (Rockville, MD: Substance Abuse and Mental Health Services Administration, 2015).

[3] L. M. Rossen, B. Bastian, M. Warner, D. Khan, and Y. Chong, “Drug Poisoning Mortality: United States, 1999–2014,” National Center for Health Statistics, 2016.

[4] National Institute on Drug Abuse, “Prescription Opioids and Heroin,” Research Report Series, Department of Health and Human Services, National Institutes of Health, Washington, D.C., 2015. Retrieved from https://d14rmgtrwzf5a.cloudfront.net/sites/default/files/rx_and_heroin_rrs_layout_final.pdf.

[5] L. Manchikanti and A. Singh, “Therapeutic Opioids: A Ten-Year Perspective on the Complexities and Complications of Escalating Use, Abuse, and Nonmedical Use of Opioids,” Pain Physician 11, 2nd supp. (2008): S63-S88.

[6] L. J. Paulozzi, K. A. Mack, and J. M. Hockenberry, “Vital Signs: Variation Among States in Prescribing Pain Relievers and Benzodiazepines—United States,” Center for Disease Control and Prevention, Atlanta, 2014.

[7] National Survey on Drug Use and Health, 2011-2013.

 

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