What follows is a guest post from Kelly Savage Day of Sedgwick Detert. Kelly gets all the credit, and all the blame, for this post.
As many of you know, earlier this week, the United States Supreme Court invited the Solicitor General (or for now Acting Solicitor General) to “express the view of the United States” in the Mensing case (Supreme Court Nos. 09-993, 09-1039, 588 F.3d 603 (8th Cir. Nov. 27, 2009). Mensing was the first federal appellate case to address generic preemption in the wake of Wyeth v. Levine. (For an overview of the current generic drug preemption landscape, see the Washington Legal Foundation’s recent Legal Backgrounder on the topic.) In Mensing, the Eighth Circuit concluded that the federal regulatory regime governing generic pharmaceuticals does not preempt state-law failure-to-warn claims against generic drug manufacturers. The Court also rejected the reasoning set forth by the California Court of Appeal in Conte v. Wyeth and held that brand-name drug manufacturers were not liable for harm caused by a plaintiffs’ use of a generic version of the pioneer’s brand-name drug. Id. at 613-14.
The United State Supreme Court’s invitation to the Acting Solicitor General suggests that it has at least some interest in the preemption issues presented by generic drug manufacturers. While this may ultimately bode well for generic manufacturers, we believe any consideration of Mensing may also ultimately impact pioneers (and not necessarily for the better). Here’s how and why.
In 2008, California’s First District Court of Appeals ruled in Conte v. Wyeth that a brand-name drug manufacturer could be held liable for harm to individuals who take the generic version of their name-brand product for alleged deficiencies in the generic drug’s labeling. At the time, many defense attorneys [editors’ note – especially us] viewed the decision as a misguided attempt by a California court to provide a remedy to plaintiffs injured by generic products, because plaintiff’s failure-to-warn claim against the generic drug manufacturer (of the drug plaintiff actually ingested) was dismissed on conflict preemption grounds. Implicit in the decision was the ideal that if the federal Food, Drug and Cosmetic Act (“FDCA”) required generic drug labeling be the “same as” brand-name labeling, then injured plaintiffs should not be left remediless. Instead, harmed plaintiffs should be permitted to recover against brand-name drug manufacturers who could change their labeling to provide stronger warnings without violating the Act; these warnings would ultimately make their way on to generic labeling and protect generic drug users. Brand-name manufacturers (and their attorneys) viewed Conte as an improper end-run around generic preemption and feared the decision would dramatically shift liability on to pioneers for their generic competitor’s defective products.
This fear appeared to be unjustified. No reported decision anywhere has followed Conte. This is partially because Levine drastically changed the preemption landscape. Since Levine, only two courts have concluded that failure-to-warn claims against generic drug manufacturers are preempted, and both are currently on appeal. Morris v. Wyeth, Inc., 582 F. Supp.2d 861 (W.D. Ky 2008), reaff’d, 2009 WL 4245905 (W.D. Ky Feb. 20, 2009), motion for reconsideration denied, 642 F. Supp.2d 677 (W.D. Ky 2009); Wilson v. Pliva, Inc., 640 F.Supp.2d 879 (W.D. Ky. 2009) (same history); Gaeta v. Perrigo Pharms., Inc., 672 F. Supp.2d 1017 (N.D. Cal. 2009).
The legal landscape, however, may soon change. If the Supreme Court accepts Mensing and concludes that failure-to-warn claims against generic drug manufacturers are preempted (or worse that brand-name manufacturers may be liable for harm caused by their generic counterparts’ drug labeling), then other courts may feel compelled (or even required) to follow Conte to avoid leaving injured plaintiffs remediless. For now, both generics and pioneers must simply wait and see what happens next.