Warning: Generic Drug Makers Not Liable for Inaccurate Labels

The Supreme Court ruled in 2011 that consumers cannot sue generic drug makers for damages caused by inadequate warning labels. So when Debbie Schork’s hand was amputated as a result of an anti-nausea drug that caused gangrene (a known risk when injecting the drug), her case was tossed out of court. The same injury and treatment was endured by Diana Levine, though she was able to sue drug maker Wyeth – and she won a $6.8 million verdict.

The cases are practically identical but for one thing: Schork was given a generic version of Phenergan, the brand-name drug that Levine received.

By law, a generic drug is required to carry the same warning as its branded counterpart – even if the label isn’t accurate. As in the instance above, Wyeth failed to warn of the known risk of gangrene if the drug was injected and was held liable for that oversight; the maker of the generic drug, in accordance with the Supreme Court ruling, isn’t accountable for the lack of warning because it had no control over the label contents.

To complicate matters, consumers don’t choose medicine they receive during emergency care, and most states permit pharmacists to dispense a generic in place of a brand name. Most people are completely unaware that they give up legal protection when they use generic drug substitutions.