Generic pre-emption raises its ugly head again

Home/Policies & Legislation | Posted 07/12/2012 post-comment0 Post your comment

The US Supreme Court is to review a case, which could determine whether generics companies can be held responsible for design flaws in the drugs they copy.

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The news comes despite the fact that the same court ruled in June 2011 that generics companies could not be sued under state law over allegations that they failed to provide adequate label warnings about potential side effects [1]. This was pre-empted by federal law which states that generics manufacturers have to have the same labelling as their brand-name counterparts.

The current case concerns a patient who suffered side effects after taking Mutual Pharmaceutical’s (Mutual) generic non-steroidal anti-inflammatory drug sulindac for shoulder pain.

The patient, Ms Bartlett, suffered a rare hypersensitivity reaction, which caused burn-like lesions on two-thirds of her body and left her with permanent near-blindness. She sued Mutual for alleged design defects under New Hampshire law and was awarded a US$21 million jury award. The ruling was upheld by the 1st US Circuit Court of Appeals in Boston, who refused to extend the Supreme Court ruling of generic pre-emption to design defect claims.

Mutual, which is a subsidiary of Japan’s Takeda Pharmaceutical, in its appeal to the Supreme Court, is claiming that federal law barred such claims because its drug had already been approved by FDA, and federal law requires generic drugs to have the same design as their brand-name equivalents.

In its brief filed with the Supreme Court, Mutual claims that ‘scores’ of lower courts had rejected the 1st Circuit’s rationale that Mutual could be held liable because it refused to stop selling FDA-approved sulindac.

The Supreme Court will hear arguments in 2013, and a ruling is expected in June 2013.

Related articles

The ethics of generic drug liability

Generic pre-emption: what are the implications


1.  GaBI Online - Generics and Biosimilars Initiative. Generics manufacturers do not have to change drug safety labels in the US []. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Dec 7]. Available from:

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Source: Reuters

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