In In re Fosamax Products Liability Litigation, 2013 WL 4306434 (S.D.N.Y. Aug. 15, 2013), the Southern District of New York decided an issue of first impression in the Second Circuit, holding that failure to update claims against generic drug manufacturers are not preempted by federal law.
Plaintiffs brought suit against the branded and generic manufacturers of Fosamax, alleging the drug caused them to suffer from a condition known as osteonecrosis of the jaw. Plaintiffs asserted claims for failure to warn, negligence, design defect, breach of warranty, and fraud. The generic defendants moved for judgment on the pleadings, arguing that the state law claims were preempted under PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013). Plaintiffs conceded that some of their failure to warn claims were preempted, but argued that generic manufacturers may still be held liable under state law for failure to timely update drug warning labels. In re Fosamax, 2013 WL 4306434 at *3. The court agreed, holding the failure to update claims were not preempted because “it was possible for the [g]eneric [d]efendants to comply with their federal duty to match their labels to the Fosamax label, while also satisfying their state tort law duty to adequately warn the consumers of [the generic drug].” Id. at *4. The court also rejected defendants’ argument that failure to update claims are impliedly preempted, finding they “are not premised on federal law, but rather on an independent state duty.” Id.
This holding contrasts with certain other jurisdictions that have found that failure to update claims against generic manufacturers preempted because they “sound exclusively in federal (not state) law” and essentially amount to failure to warn claims preempted by Mensing. See Morris v. PLIVA, Inc., 713 F.3d 774, 777 (5th Cir. 2013); Gross v. Pfizer, 825 F. Supp. 2d 654, 660 (D. Md. 2011).
The Fosamax court also held that, pursuant to Mensing, any claims stemming from the generic defendants’ alleged failure to communicate additional warnings through some method other than their package inserts — such as “dear doctor letters” — are preempted. 2013 WL 4306434, at * 5. The court also rejected plaintiffs’ argument that their design defect claims are not preempted because Bartlett applies only to design defect claims predicted on label inadequacies. Id. at *6.
The Fosamax decision demonstrates that although many claims against generic drug manufacturers may be preempted in light of Mensing and Bartlett, the contours of preemption continue to be hotly litigated.