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Teva not liable in US due to FDCA implied preemption Posted 16/04/2021

In early 2021, implied preemption related to the Federal Food, Drug and Cosmetic Act of 1938 (FDCA or the Act) has prevented generics manufacturer Teva Pharmaceuticals (Teva) from being held liable for three different failure-to-warn theories.

In US law, an implied preemption can be applied which will invalidate US state law, if it conflicts with federal law. In the recent case of Bennett against generics manufacturer, Teva, Bennett claimed that the defendant generic drug manufacturer was liable on three different failure-to-warn theories. These were all rejected by the court as impliedly preempted.

This is not the first time that implied preemptions have been utilized to dismiss claims against generic drugs manufacturers. These have been highlighted in a recent Drug and Device Law post, by US attorney Andrew Tauber.

Here, Tauber notes that implied preemption was first applied in the 2001 Buckman Company v. Plaintiffs’ Legal Committee case. Here, the Supreme Court held that 21 United States Code (U.S.C) impliedly preempts any private suit seeking to enforce the FDCA.

Tauber also shares the example of PLIVA, Inc against generics manufacturer Mensing where he states, ‘The Supreme Court held that federal law impliedly preempts state-law failure-to-warn claims based on a generic drug manufacturer’s failure to give warnings different from those given by the drug’s brand-name manufacturer on its FDA-approved labeling’. In this case, the claims are impliedly preempted because it is impossible for a generic drug manufacturer to simultaneously comply with a purported state-law duty to provide additional warnings and the federal requirement that generic drug labels be identical to their brand-name equivalents.

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