Court: Can generic makers be sued for drug flaws?

November 30, 2012

(AP)—The Supreme Court will decide whether generic drug manufacturers can be held responsible in state courts for possible design defects that are in the brand-name medicine they are copying.

The high court on Friday agreed to hear an appeal from Philadelphia-based Mutual Pharmaceutical, manufacturer of the generic, anti- sulindac.

Karen Bartlett was awarded $21.6 million after claiming a design defect in sulindac caused blindness and severe burning of her skin and . But Mutual says they shouldn't have to pay because they made sulindac exactly the same way as its brand-name equivalent, Clinoril, as required by federal law.

The court last year said are not responsible for failing to warn consumers of possible side effects if they copy the exact warnings from their brand-name equivalents.

Explore further: Variation in make-up of generic epilepsy drugs can lead to dosing problems


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