Supreme Court to Review Generic Drug Defective Design Decision in Bartlett
Despite the Supreme Court's decision in Pliva v. Mensing whereby the Court held that federal regulations preventing generic drug manufacturers from independently changing their drug's labeling pre-empted state law failure-to-warn claims for injuries caused by the generic drugs, the First Circuit in Bartlett held that the generic drug manufacturer could still be liable under state law design defect claims because they could have refused to manufacture the drug in the first place:
But although Mutual cannot legally make sulindac in another composition (nor is it apparent how it could alter a one-molecule drug anyway), it certainly can choose not to make the drug at all; and the FDCA might permit states to tell Mutual it ought not be doing so if risk-benefit analysis weights against the drug, despite what the Supreme Court made of similar arguments in the labeling context….
And, not only has the Supreme Court not yet said it would extend [Mensing's] exception to design defect claims, but—while the generic maker has no choice as to label—the decision to make the drug and market it in New Hampshire is wholly its own. Thus, Bartlett having lost her warning claim by the mere chance of her drug store's selection of a generic, the Supreme Court might be less ready to deprive Bartlett of her remaining avenue of relief.
True, such arguments can be turned on their head. To refuse preemption here is…in tension not with the holding but with part of [Mensing’s] rationale; [however,] a generic maker can avoid defective warning lawsuits as well as design defect lawsuits by not making the drug...
As the First Circuit partially admitted in its opinion--its decision was at least opposed to the rationale of Mensing--but not the holding. Our previous posts covered the seemingly logical inconsistencies in the First Circuit's reasoning. Moreover, other courts have since disagreed with that very same reasoning employed by the First Circuit. However, despite the First Circuit's characterization, there wasn't much of a split in the circuits on this issue anyway. For this reason, Mutual appealed, specifically presenting the following question to the Supreme Court on appeal:
Whether the First Circuit erred when it created a circuit split and held—in clear conflict with this Court’s decisions in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011); Riegel v. Medtronic, Inc., 552 U.S. 312 (2008); and Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992)—that federal law does not preempt state law design-defect claims targeting generic pharmaceutical products because the conceded conflict between such claims and the federal laws governing generic pharmaceutical design allegedly can be avoided if the makers of generic pharmaceuticals simply stop making their products.
The apposite statement in the petition question is that the First Circuit created the circuit split with its very own decision--despite the First Circuit's views to the contrary. However, as the First Circuit stated: “[g]iven the widespread use of generic drugs and the developing split in the lower courts, …this issue needs a decisive answer from the only court that can supply it.” The First Circuit's wish has been now been granted.
The Boulder Business Lawyers at Laszlo & Associates, LLC provide legal counsel for businesses on a variety of business needs, including products liability, risk management, corporate protection, and legal compliance.