Recent Second Circuit Implied-Preemption Decision Confirms That A 'Major Change' Is A Big Deal In Pharmaceutical Litigation

• Published date: 25 August 2021
• Subject Matter: Consumer Protection, Food, Drugs, Healthcare, Life Sciences, Compliance, Product Liability & Safety, Food and Drugs Law
• Law Firm: Winston & Strawn LLP
• Author: Andrew Tauber

We'll get to the recent Second Circuit decision, Ignacuinos v. Boehringer Ingelheim Pharms., Inc., ' F.4th '-, 2021 WL 3438355 (2d Cir. 2021), in due course, but first some background.

One of our top ten decisions in 2018 was Gustavsen v. Alcon Labs., Inc., 903 F.3d 1 (1st Cir. 2018), an important implied-preemption decision. In a one-two punch, Gustavsen held (1) that federal law preempts any state-law tort claim that would require what 21 C.F.R. ' 314.70(b) defines as a "major change" in a pharmaceutical product; and (2) that any change identified in ' 314.70(b)(2) is necessarily a "major change" within the meaning of ' 314.70(b).

In holding that federal law preempts any state-law tort claim that would require a "major change" within the meaning of ' 314.70(b), Gustavsen'which involved prescription eye drops'confirmed that the logic of PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), applied not only to generic drugs but to all FDA-approved pharmaceutical products.

As readers of this blog know, Mensing held that failure-to-warn claims targeting generic drugs are impliedly preempted because federal law requires that generic drug labels be identical to their branded counterparts. That federal requirement'the so-called "duty of sameness" embodied in 21 C.F.R. ' 314.94(a)(8)(iii), 314.150(b)(10)'makes it impossible for a generic manufacturer to unilaterally change its label to comply with a purported state-law duty to provide different or additional warnings. Given that simultaneous compliance with state and federal law is impossible, any state-law duty to provide such warnings is preempted under the Supremacy Clause.

Bartlett built on Mensing. In addition to requiring that generic labels have the same labeling as their branded counterparts, federal law also requires that generic drugs have the same active ingredients, route of administration, dosage form, and strength as their branded counterparts. See 21 U.S.C. ' 355(j)(2)(A)(ii)-(v) and (8)(B); 21 C.F.R. ' 320.1(c). Moreover, federal law prohibits a drug manufacturer from making any "major changes" to the "qualitative or quantitative formulation of the drug product." 21 C.F.R. ' 314.70(b)(2)(i). Taken together, this means that, as a matter of federal law, a generic drug manufacturer may neither reformulate its drug nor warn of its supposed risks (unless the branded label also warns of those supposed risks). Consequently, a state-law claim...