Generic drugs should carry the same warnings as the brand name drug and, if not, then users of the generic drug can sue the name-brand drug maker for fraudulent misrepresentation, the Alabama Supreme Court ruled.
The ruling comes as a response to a certified question from a U.S. District Court, which arose during a case where a plaintiff alleged that a generic version of the prescription heartburn drug Reglan caused him to develop a movement disorder called Tardive Dyskinesia. The plaintiff sued the brand name maker, Wyeth, alleging that the company failed to warn both doctors and patients of the long-term risks associated with Reglan.
Wyeth fought back, saying that under state law it was not required to warn people who used a generic version of its drug of the potential side effects. However, the court referenced the Food and Drug Administration (FDA) regulatory process, which requires generic drug makers to include the same warnings as on the brand-name drug’s label.
Thus, generic drug makers have no control over whether warnings and risk data are included on the safety label. If a brand-name drug maker places an inadequate warning on its drug, it is fair for the brand-name drug maker to be held liable for a product it did not produce, the court said.
The emphasis does not fall on the actual manufacturing defects of the medications, “but on information and warning deficiencies, when those alleged misrepresentations were drafted by the brand-name manufacturer and merely repeated by the generic manufacturer,” the court said.
Hundreds of patients have sued Wyeth alleging that the drug company did not do enough to warn about the risk of Tardive Dyskinesia with long-term use of Reglan. The FDA required warnings about the risks to be added to the drug’s label as well as generics in 2009.
Source: Lawyers USA