Drugs

Courts Strengthen ‘Implied Preemption’ of Drug Changes

Attorney Andrew Tauber (Winston & Strawn) says decisions by both the 1^st and 2^nd Circuit Courts of Appeal have broadened the definition of what constitutes a major change in a drug that must be approved by FDA before a labeling change, expanding implied preemption of cases brought in state courts. Writing in an online post, Tauber reviews the history of implied preemption cases, including a 2018 1^st Circuit case that held (1) that federal law preempts any state law tort claim that would require what regulations define as a “major change” in a drug product; and (2) provided a broader definition of a “major change.” That case also confirmed that preemption applies not only to generic drugs but to all FDA-approved drug products, Tauber says.

In 2021, he continues, the 2^nd Circuit heard a case involving state law claims targeting a branded metered-dose inhaler to treat chronic obstructive pulmonary disease. Boehringer Ingelheim argued that the plaintiff’s claims were impliedly preempted because the company was prevented from changing the inhaler’s design or manufacturing methods without prior FDA approval. The 2^nd Circuit agreed, affirming the dismissal of the claims.

Tauber says the 2^nd Circuit followed the reasoning in the 1^st Circuit case in determining that any change listed in the specific regulatory section constitutes a “major change” that requires prior FDA approval, and that any state law claim that would require such a change is impliedly preempted, whether the drug product at issue is a generic drug or a branded drug.

“That’s a big deal,” he concludes.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome