Can generics makers be held accountable for design flaws in the drugs they copy? That's the essential question in a case the U.S. Supreme Court has decided to review. If a Takeda Pharmaceutical generics unit wins this appeal, it would further curtail patients' ability to sue over injuries linked to generic drugs.
In this case, a New Hampshire woman sued Takeda's Mutual Pharmaceutical over severe vision loss and burns she suffered after using its anti-inflammatory drug sulindac. The patient, Karen L. Bartlett, won a $21 million judgment that survived all the way through the 1st Circuit Court of Appeals. That court said Mutual wasn't shielded by the drug's FDA stamp of approval.
But as The Wall Street Journal reports, Mutual and other generics makers argue that their products can't be different from the brand-name drugs they copy. Nor can they be labeled differently, as the Supreme Court confirmed itself last year in shielding generics makers from lawsuits over inadequate warnings on drug labels.
The question now is whether the justices will extend the same protections to generics makers when it comes to actual product design. In its brief filed with the Supreme Court, Mutual claims that "scores' of lower courts rejected the 1st Circuit's rationale in the design defect case--that Mutual could be held liable because it could have stopped selling sulindac, Reuters reports. The Supreme Court will hear arguments next year, a ruling is expected in June.