Makers of brand-name medications can be held liable for warnings on generic drugs even if the generic was produced by another drug company, the Alabama Supreme Court ruled. A majority of the nine-member court upheld a 2013 decision, which was viewed as a defeat by business leaders in this mostly Republican state.
The ruling is based on a federal lawsuit filed by Danny and Vick Weeks against five current and former drug makers alleging that long-term use of the heartburn drug metoclopramide, which was also sold under the brand name Reglan, caused a debilitating movement disorder known as tardive dyskinesia. The couple claimed that the safety labels on the generic drugs failed to warn of potential side effects, including the risk of tardive dyskinesia.
A federal judge assigned to hear the case asked the Alabama Supreme Court to clarify state law on whether brand-name drug makers could be held responsible for generic companies’ failure to warn. The Supreme Court last year said the couple could sue the brand-name makers, but the decision was met with a motion from the drug companies asking the court to reconsider.
However, the court said it was not unfair for the maker of a brand-name drug to be liable for warnings on generic drug counterparts. Generic drug companies bylaw must use the same safety labels as their brand-name counterparts.
The Supreme Court has been criticized for the 2013 ruling by business groups. However, the justices said that the ruling applied to only a specific set of facts involving a medication that is subject to a lot of heavy federal regulation. The same legal principles, they said, would not apply to products that were not so heavily regulated by the federal government.