The Week In Mass Torts By Mass Tort Nexus for December 18, 2017









By Mark York, Mass Tort Nexus Media

(December 21, 2017)

New Jersey Supreme Court Review Reinstatement Of Accutane Experts

The New Jersey Supreme Court recently granted petitions and cross-petitions to appeal a state appellate court’s reversal of expert exclusions in the state’s Accutane multicounty litigation and the reinstatement of 2,076 dismissed cases (In Re:  Accutane Litigation, C-388 September Term 2017, C-329 September Term 2017 and C-390 September Term 2017, N.J. Sup.) See Mass Tort Nexus Accutane Briefcase Accutane New Jersey State Court Litigation.

New Trial Denied in 3rd Xarelto MDL Bellwether Case After Defense Verdict

Judge Eldon Fallon, overseeing the Xarelto multidistrict litigation, recently denied a motion for a new trial by the plaintiff in the third bellwether trial, where Bayer was found not liable in the Dora Mingo trial that took place in a Mississippi federal court in front of Judge Fallon. He ruled that plaintiff was unsuccessful in presenting new findings, among other things, that the plaintiff’s “newly discovered evidence” is actually cumulative of previously known and admitted evidence (In Re:  Xarelto [Rivaroxaban] Products Liability Litigation, MDL Docket No. 2592, E.D. La., 2017 U.S. Dist. LEXIS 205422). See Mass Tort Xarelto Briefcase for the entire Mingo trial transcripts as well as full transcripts of the Orr and Boudreaux trials, XARELTO MDL 2592 US District Court ED Louisiana Including Trial Transcripts.

 With Last 2 Cases Gone, Pradaxa MDL Judge Again Recommends Termination

With the final two pending cases now closed, the Illinois federal judge overseeing the Pradaxa multidistrict litigation on Dec. 11 again recommended that the Judicial Panel on Multidistrict Litigation (JPMDL) terminate the MDL (In Re:  Pradaxa [Dabigatran Etexilate]Products Liability Litigation, MDL No. 2385, No. 12-md-2385, S.D. Ill.).  After a global settlement was reached in 2014 with defendant Boehringer Ingelheim Pharmaceuticals Inc., the JPMDL suspended the transfer of tag-along actions into the MDL, and now the judge has moved for termination of the Pradaxa MDL. However, there remains over 700 Pradaxa cases pending in the State Court of Connecticut, Complex Litigation Docket, known as “Connecticut Pradaxa Actions”, see Mass Tort Nexus Pradaxa Case Briefcase,  Connecticut Consolidated Pradaxa Litigation.

Boehringer To Pay $13.5M To End Off-Label Marketing Claims

Drugmaker Boehringer Ingelheim Pharmaceuticals Inc. has agreed to distribute $13.5 million among all 50 states and the District of Columbia to end allegations that it marketed four of its prescription drugs for off-label uses, attorneys general announced Wednesday.
The settlement would resolve allegations that Boehringer marketed its prescription drugs Micardis, Aggrenox, Atrovent and Combivent for uses that weren’t approved by their labels or backed by scientific evidence. (Getty) The settlement, of which New York will receive about $490,000, would resolve allegations that the drugmaker marketed it products for off-label use, which often leads to unknown or studied adverse events and medical complications for patients taking these drugs for unapproved purposes.

 J&J Fined $30 Million Over French Opioid Drug Smear Campaign In Efforts To Sell Fentanyl Patch

France’s antitrust enforcer fined Johnson & Johnson and its Janssen-Cilag unit €25 million ($29.7 million) on Wednesday for hindering the marketing and sale of a generic version of the company’s Durogesic pain patch.The French Competition Authority found that Janssen and J&J had not only successfully delayed a generic competitor for the powerful opioid for several months, but had also done lasting damage by discrediting rival versions of the drug with doctors and pharmacists in a country where medical professionals still remain reluctant to opt for prescribing opioids.  The J&J conduct reflects the same claims being asserted against opioid drug makers in the US, where lawsuits have been consolidate into Opiate Prescription Litigation MDL No. 2804, in the US District Court of Ohio, see Mass Tort Nexus Opioid Crisis Briefcase, OPIOID CRISIS MATERIALS INCLUDING: MDL 2804 OPIATE PRESCRIPTION LITIGATION.

11th Circuit Affirms Pelvic Mesh Group Trial, Exclusion Of 510(k) Status

(October 24, 2017, 1:25 PM EDT) -The 11th Circuit U.S. Court of Appeals on Oct. 19 said multidistrict litigation court judge did not err in consolidating four pelvic mesh cases for a bellwether trial and in excluding the so-called 510(k) defense raised by defendant Boston Scientific Corp. (BSC) (Amal Eghnayem, et al. v. Boston Scientific Corporation, No. 16-11818, 11th Cir., 2017)   See Mass Tort Nexus Mesh Case Briefcase, All Pelvic Mesh Litigation Case Files.

Preemption Summary Judgment Reversed By 9th Circuit In Incretin Mimetic MDL Appeal

The Ninth Circuit U.S. Court of Appeals on Dec. 6 unsealed its Nov. 28 opinion reversing summary judgment in the incretin mimetic multidistrict litigation, saying the MDL judge misapplied a U.S. Supreme Court precedent, improperly blocked discovery, misinterpreted what constituted new evidence and improperly disqualified a plaintiff expert (In Re:  Incretin-Based Therapies Products Liability Litigation, Jean Adams, et al. v. Merck Sharp & Dohme Corp., et al., No. 15-56997, 9th Cir., 2017 )

Pennsylvania Appeals Court Affirms $29.6M Remitted Zimmer Knee Judgment

A Pennsylvania appeals court panel on Dec. 15 said a trial judge did not err when remitting a Zimmer Inc. knee verdict to $29.6 million and said it declined to substitute its judgment in place of the jury’s (Margo Polett, et al. v. Public Communications, Inc., et al., No. 80 EDA 2017, Pa. Super., 2017 Pa. Superior Court)

Risperdal Gynecomastia Cases Barred By Michigan Shield Law, Pennsylvania Panel Says

A Pennsylvania state appeals panel on Nov. 28 affirmed the dismissal of 13 Risperdal gynecomastia cases, agreeing with a trial judge that the plaintiffs’ claims are preempted by Michigan’s drug shield law and that the plaintiffs could not prove that the fraud exception

applied to their claims (In Re:  Risperdal Litigation versus Janssen Pharmaceuticals Inc., et al., No. 55 EDA 2015, et al., Pennsylvania Court of Appeals, 2017.

U.S. Supreme Court Asks Solicitor General To Weigh In On Fosamax Preemption

The U.S. Supreme Court on has invited the U.S. solicitor general to express the views of the United States on whether there is “clear and convincing evidence” that the Food and Drug Administration would have rejected a stronger warning about femur fractures from the osteoporosis drug Fosamax (Merck Sharpe & Dohme Corp. v. Doris Albrecht, et al., No. 17-290, U.S. Supreme Court)  This is a unique turn when the Supreme Court is seeking input from an outside agency in what is now a common legal issue placed in front of the court, where dug makers are using the FDA regulatory process as a shield in defending thousands of claims where warnings of drug dangers are not clear or not provided. See Mass Tort Nexus Fosamax Case Briefcase, FOSAMAX MDL 2243 (FEMUR FRACTURE CLAIMS).

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3d Circuit: Preemption Issue is Question of Fact for Jury, Not Legal Issue for Judge

Plaintiff attorney Ryan L. Thompson of Watts Guerra in San Antonio, TX
The Fosamax decision is good news for Plaintiff attorney Ryan L. Thompson of Watts Guerra in San Antonio, TX.

In a far-reaching opinion, the Third Circuit US Court of Appeals revived 5,000 product liability cases involving the osteoporosis drug Fosamax, ruling that federal preemption of state-law claims is a question of fact for a jury to decide, not a question of law for a judge.

The ruling in In re Fosamax Products Liability Litigation, Case No. 14-1900 et al, decided March 22, 2017, is a major setback for Merck and other Big Pharma companies that seek to torpedo patient claims in summary judgment motions, by arguing that:

  1. State-law failure-to-warn lawsuits are pre-empted by federal law
  2. When there is “clear evidence” that the FDA would not have approved a warning label that the plaintiffs claim is necessary.

On the other hand, the ruling is a boon to plaintiff lawyers who are striving to preserve their lawsuits against preemption attacks that have nothing to do with the merits of the case.

For example, the Fosamax opinion is already being cited in an appeal to the 9th Circuit in Incretin-Based Therapies Products Liability Litigation, MDL 2452 in US District Court for the Southern District of California. In that case, the trial court made a summary judgment ruling in favor of the defendant — including Merck — knocking out the plaintiffs’ state law failure-to-warn claims.

In the Incretin case, Plaintiff attorney Ryan L. Thompson of Watts Guerra in San Antonio, TX, notified the 9th US Circuit Court of Appeals about the Third Circuit’s Fosamax ruling in a March 23 letter, seeking to vacate the trial court’s adverse summary judgment, discovery and disqualification orders.

What is “clear evidence”?

The source of the confusion stems from a fuzzy US Supreme Court Opinion, Wyeth v. Levine, 555 U.S. 555 (2009), that says that state-law failure-to-warn claims are preempted by federal law when there is “clear evidence” that the FDA would not have approved a label change. “This standard is cryptic and open-ended, and lower courts have struggled to make it readily administrable,” the Third Circuit commented.

Resolving the issue, the Third Circuit held that “The meaning of “clear evidence,” as Supreme Court usage confirms that the term is synonymous with “clear and convincing evidence.” The latter is a well-recognized intermediate standard of proof—more demanding than a preponderance of the evidence, but less demanding than proof beyond a reasonable doubt.”

Edward Braniff of Simmons Hanly Conroy LLC in New York
Edward Braniff of Simmons Hanly Conroy LLC in New York successfully argued the Fosamax case.

Furthermore, the appeals court ruled:

  • Whether the FDA would have rejected a label change is a question of fact for the jury.
  •  At the summary judgment stage, the court cannot decide for itself whether the FDA would have rejected a change, but must instead ask whether a reasonable jury could find that the FDA would have approved the change.
  • A mass tort MDL is not a class action. Merck’s actual burden at the summary judgment stage was to prove that there is no genuine dispute in every single MDL case that plaintiffs’ doctors would have continued to prescribe Fosamax even if a fracture warning had been added to the Adverse Reactions section before May 2009.

The successful argument to the Third Circuit was made by plaintiff attorneys Edward Braniff of Simmons Hanly Conroy LLC in New York, Michael E. Pederson of Weitz & Luxenberg in New York, and Donald A. Ecklund of Carella Byrne Cecchi Olstein Brody & Agnello in Roseland, NJ.

Beginning in 2010, hundreds of plaintiffs filed personal-injury suits against the drug manufacturer Merck Sharp & Dohme, alleging that the osteoporosis drug Fosamax caused them to suffer serious thigh bone fractures.

Each Plaintiff brought a state-law tort claim alleging that Merck failed to add an adequate warning of the risk of thigh fractures to Fosamax’s FDA-approved drug label. Many Plaintiffs also filed additional claims including defective design, negligence, and breach of warranty. Plaintiffs’ suits were consolidated for pretrial administration in a multi-district litigation in the District of New Jersey. Following discovery and a bellwether trial, the District Court granted Merck’s motion for summary judgment and dismissed all of Plaintiffs’ claims on the ground that they were preempted by federal law.

Plaintiffs’ suits were consolidated for pretrial administration in a multi-district litigation in the District of New Jersey. Following discovery and a bellwether trial, the District Court granted Merck’s motion for summary judgment and dismissed all of Plaintiffs’ claims on the ground that they were preempted by federal law.

Fosamax is a treatment for osteoporosis, but plaintiffs claim that the drug actually increases the risk of thigh bone fractures. Plaintiffs claim that while stress fractures typically heal on their own, “some Fosamax users who develop insufficiency fractures have reduced bone toughness, and Fosamax prevents the normal repair of the fracture.” According to Plaintiffs, these patients may then go on to develop what are known as “atypical femoral fractures”: severe, non-traumatic, low energy complete fractures of the femur.

In 2013, Merck reached a separate settlement of $27 million with 1,200 Fosamax users who suffered necrosis of the jawbone.

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