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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Court Tosses 2d Verdict in Accutane Case Because of Expert Testimony Mistakes

For the second time, an Alabama man had a jury award in his favor thrown out by New Jersey appellate courts in a case involving Accutane, which caused him to be surgically disemboweled.

The Appellate Division of New Jersey Superior Court reversed and remanded a 2010 jury award of $25.2 million, saying that it was error for the trial judge to prohibit duplicative defense expert testimony. Andrew McCarrell v. Hoffmann-La Roche, Inc. and Roche Laboratories, Case No. A-4481-12T1 (NJ Appellate Division, May 2, 2017).

The plaintiff, an Alabama resident, was prescribed by his dermatologist the acne medication Accutane, a drug manufactured by defendants. After his course of treatment with the drug, plaintiff developed inflammatory bowel disease (“IBD”) and other gastrointestinal disorders.

Eventually, his colon and rectum were surgically removed, and he underwent years of treatment.

Defective product

McCarrell filed suit in New Jersey state court against the defendants, alleging that Accutane is a defective product and that the defect proximately caused his injuries. In particular, the plaintiff claimed that defendants’ labeling and marketing of the drug was inadequate and failed to warn sufficiently of the risks of a patient contracting IBD.

The case was tried in 2007 and McCarrel recovered $2.6 million for in damages, but that verdict was overturned on an evidentiary issue,

Regarding the 2010 retrial, the appellate court said it was error for the trial judge, now deceased, to disallow duplicative expert testimony, limiting the parties to a general causation expert and a specific causation expert. This meant that two defense experts could not testify.

“[t]he trial court’s decision to disallow overlapping expert testimony about the scientific studies relating to causation was an error. The significance of those studies was a “central issue” in this hard-fought case,” the appeals court said.

Second error

The court reversed based on a second issue concerning the plaintiff’s prescribing dermatologist, Dr. Ann Gerald. Her deposition was taped in 2007 but no attorney asked her whether the doctor’s decision to prescribe Accutane would have been different if the drug had come with a stronger warning.

“Given this important factual gap in the record made significant by ensuing Alabama precedent, this matter should be remanded to enable the record to be appropriately developed on this critical issue,” the appeals court said.

“Assuming Dr. Gerald is still available, the parties should have the opportunity to re-depose her and obtain her sworn responses on the central prescribing question.”

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NJ Judge Dismisses 160 Cases in Accutane Litigation — 4,000 Remain

accutaneNew Jersey Superior Court Judge Nelson Johnson issued two orders dismissing a total of 160 cases from 20 states against Hoffman-LaRoche Ltd. in Accutane product liability litigation that alleges the acne drug caused inflammatory bowel disease. At least 4,000 cases remain in the consolidated litigation, Case No. 271. The court:

  • Granted summary judgment for the defendants in 86 cases from 35 jurisdictions because the plaintiff’s prescribing physicians are deceased on unable to be located.
  • Similarly dismissed 74 cases from 16 jurisdictions for failure to show proximate cause.

The rulings turned on a doctrine in product liability law known as the “heeding presumption.” This is a rebuttable presumption that the recipient of an adequate warning in a failure-to-warn case would have heeded the warning. It holds that a physician would not have prescribed a drug if its warning had been adequate, and places the burden on the drug maker to prove that the doctor would have heeded a different warning.

Proximate cause

The plaintiffs argued that the testimony of the missing physicians was not required to establish proximate cause because of the heeding presumption. They asserted that this presumption has been upheld in pharmaceutical failure to warn cases in 20 states. The plaintiffs argued that because the defendants did not present evidence to rebut the presumption, that the prescribing physicians would have heeded a stronger warning.

The defendants argued successfully that in a pharmaceutical products liability action alleging failure to warn, a plaintiff must show that a different warning would have altered their physician’s decision to prescribe the medication to satisfy proximate cause. However, there is no physician testimony.

“First, the heeding presumption does not eliminate Plaintiffs’ burden of proving a prima facie case,” the court stated.

The heeding presumption was rebutted because The American Academy of Dermatology (“AAD”) and The American Academy of Pediatrics (“AAP”) both issued statements approving the continued use of Accutane or isotrentinoin for the treatment of acne. The AAD’s statement confirmed the lack of association between isotrentinoin and inflammatory bowel disease and states that physicians should continue to prescribe the medicine while being aware of the risk, the court  said.

“Accordingly, the Court finds that under New Jersey law, a heeding presumption does not apply in cases such as these, and even if it did, Defendants’ FDA approved warning carries a presumption of adequacy until rebutted by Plaintiffs.”

See also Learned Intermediary Doctrine Causes Dismissal of New Jersey Accutane Suits

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