Parallel Misbranding Exception To PLIVA/Bartlett Is No Substitute For A New Rule From FDA

In PLIVA v. Mensing and Mutual Pharmaceutical Co. v. Bartlett, the Supreme Court ruled that state law based failure-to-warn and design defect claims against generic drug manufacturers were barred on federal preemption grounds.  Earlier this Summer, in In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, Nos. 12-5368, et al. (6th Cir. June 27, 2014), the Sixth Circuit rejected the plaintiff’s bar’s latest attempt to circumvent PLIVA/Bartlett while sidestepping the question of whether the Supreme Court left room for a design defect “parallel misbranding” exception.      [Read more...]

FDA Proposed Rule Would “Preempt” Supreme Court Rulings in Pliva and Bartlett

Last week the FDA announced a proposed Rule that would put generic manufacturers on the same “products liability” footing as branded manufacturers.  By requiring generic manufacturers to update their labels to take into account new safety information, the FDA rule would effectively overrule the Supreme Court’s holdings in PLIVA v. Mensing and Mutual Pharmaceutical Co., Inc., v. Bartlett, which effectively barred most state law products liability suits against generic drug manufacturers on federal preemption grounds. [Read more...]

Novartis’ PLIVA-Bartlett Argument Rejected on the Eve of ZometaTrial

In a clever move, Novartis sought to use the Supreme Court’s decisions in PLIVA, Inc. v Mensing and Mutual Pharmaceutical Co., Inc. v Bartlett, to exclude evidence that it could have strengthened the labeling of its bone-cancer drug, Zometa, in a products liability suit slated to start on Monday in a Florida federal court.  The court rejected Novartis’ motion in limine, ruling that those Supreme Court decisions provided a preemption defense to generic manufacturers only. [Read more...]

Fallout From Mensing/Bartlett: FDA Proposes Leveling The Labeling Playing Field Between Brandeds and Generics

In response to growing pressure from lawmakers and consumer groups, the FDA recently announced plans in a July 3, 2013 notice posted by the OMB to issue a rule in September that would allow generic drug makers to change their labeling based on new information.  If approved and implemented, the new rule would effectively overrule the Supreme Court’s decisions in PLIVA, Inc. v Mensing and Mutual Pharmaceutical Co., Inc., v. Bartlett, enabling the plaintiffs’ mass tort bar to go after generic drug manufacturers for personal injuries caused by their products. [Read more...]

Supreme Court Rejects Design Defect End-Around Of Pliva v Mensing Ruling

In the last week of the its 2012-13 term, the Supreme Court spurned the First Circuit’s attempt to circumvent the Court’s 2011 decision in PLIVA, Inc. v. Mensing, which immunized generic manufacturers from liability based on state “failure to warn” claims on federal preemption grounds.  In Mutual Pharmaceutical Co., Inc., v. Bartlett, the Court re-affirmed Mensing and ruled that design defect claims were also preempted, leaving consumers injured by generic drug products with no legal recourse . . . except for a possible “misbranding” claim against generic manufacturers or even a possible direct claim against the original pioneer manufacturer in some state courts. [Read more...]

Pay for Delay and Drug Design Defect Cases Take Center Stage at Supreme Court

While the NCAA “March Madness” Tournament is always the lead sports story this time of year – did anybody out there watch Florida Gulf Coast College over the weekend?! –March can also provide a madness of sorts for high-profile Supreme Court arguments.  Last March, the Supreme Court set aside an unprecedented number of days for lengthy arguments over the constitutionality of President Obama’s Affordable Care Act.  Although this year the mainstream media will be focusing on the arguments regarding the constitutionality of California’s Proposition 8 and the Defense of Marriage Act (regarding gay marriage), two significant cases with far-reaching consequences for the branded and generic drug industries were also argued this month.  How the Supreme Court rules on so-called “pay for delay” settlements in patent infringement litigations and a First Circuit decision holding that generic drug makers can be held liable for personal injuries on a “design defect” theory, even if federal preemption would bar an identical suit on a “failure to warn” theory, should decide the course for much drug industry litigation for years to come. [Read more...]

More Trouble Ahead for Diabetes Drug Makers

The pressure on Merck, Bristol-Myers Squibb (BMS) and other manufacturers of incretin mimetic drugs used to treat type 2 diabetes appears to be increasing both from the FDA and plaintiff’s lawyers specializing in products liability and mass tort litigation.  Unpublished research results are behind a recent FDA Drug Safety Communication relating to incretin mimetic drugs and the FDA is collecting information on how this class of drugs might contribute to inflammation of the pancreas as well as pre-cancerous conditions (known as pancreatic duct metaplasia) in patients with type 2 diabetes.  After several years of tighter label warnings and published reports of pancreatitis and pancreatic cancer in patients taking Januvia (Merck), Byetta (Amylin/BMS) and Victoza (Novo Nordisc), the number of lawsuits and lawyers trolling for clients on the web are proliferating. [Read more...]