In Jankowski v. Zydus Pharmaceuticals USA Inc, No. 22-2212 (3d Cir. July 24, 2023), the 3rd Circuit U.S. Court of Appeals upheld dismissal of a multi-plaintiff lawsuit against a manufacturer of generic amiodarone, ruling that their claims are preempted because they would require the defendant to issue communications to doctors that go above and beyond those implemented by the name-brand manufacturer.
On July 24, the appellate panel explained that federal law prevents generic manufacturers like Zydus Pharmaceuticals USA Inc. from engaging in communications that surpass the labeling provided by the name-brand manufacturer because they would run the risk of “inaccurately imply[ing]a therapeutic difference between the brand and generic drugs. . . and be[ing] impermissibly ‘misleading.”
Plaintiffs did not assert that Zydus?s label lacks the FDA-approved warnings concerning Amiodarone. Rather, Plaintiffs alleged that New Jersey law required Zydus to take affirmative steps to further alert doctors as to those side effects by, for example, sending the FDA-approved warning information via Dear Doctor letters or placing this same information in other physician reference sources
The Court determined that the apparent mismatch would have violated the duty of sameness, which prohibits generic manufacturers from acting to unilaterally provide additional warnings. Because this is well established law, the opinion was issued under a local rule under which it does not constitute binding precedent.