Alabama’s Supreme Court has ruled that the manufacturers of brand name medications can be held responsible for failing to warn about the risk of side effects, even if the plaintiff only used a generic equivalent, allowing a lawsuit to proceed over claims that Pfizer’s Wyeth subsidiary failed to warn about the risk of users developing tardive dyskinesia from Reglan.
The opinion (PDF) was handed down by the Alabama Supreme Court on January 11, potentially allowing plaintiffs in the state to side step a recent U.S. Supreme Court ruling in Pliva v. Mensing, which determined that generic drug makers could not be held liable for failure to warn about risks associated with medications they sell, since generic equivalents are required by federal law to duplicate the drug’s original label.
Although hundreds of generic drug lawsuits have been dismissed throughout the United States, the decision will allow a Reglan lawsuit brought in Alabama to move forward against Wyeth, alleging that the manufacturer of the brand name version of the drug had a duty to warn physicians about the risks associated with long-term use of a generic version of the acid reflux medication.
The lawsuit was brought by Danny Weeks and his wife Vicki, alleging that side effects of metoclopramide, the active pharmaceutical ingredient in Reglan and generic equivalents, caused him to develop a rare and debilitating disorder known as tardive dyskinsesia, which involves involuntary muscle movements.
Reglan is approved for the short-term treatment of gastrointestinal disorders, such as diabetic gastroparesis, gastroesphageal reflux (GERD) and delayed gastric emptying. However, it is often prescribed for longer periods of time due to the often chronic persistence of those ailments, which has left many users with the movement disorder tardive dyskinesia.
In February 2009, the FDA required the manufacturers of all medications containing metoclopramide to update the warning label to indicate that users may face an increased risk of tardive dyskinesia when the medications are used at high doses or for a long period of time.
Symptoms of tardive dyskinesia can include grimacing, chewing, smacking of lips, rapid eye movements and impaired finger movements. There is no known effective treatment of the socially debilitating disorder, and the involuntary movements can be permanent, persisting even after use of the drug has stopped.
While Wyeth did not make the generic version of the medication taken by Weeks, the generic manufacturer was required by law to duplicate Wyeth’s warning label for Reglan, which Weeks claims failed to adequately warn doctors about the risks of tardive dyskinesia.
“In the context of inadequate warnings by the brand-name manufacturer placed on a prescription drug manufacted by a generic-drug manufacturer, it is not fundamentally unfair to hold the brand-name manufacturer liable for warnings on a product it did not produce because the manufacturing process is irrelevant to misrepresentation theories based, not on manufacturing defects in the product itself, but on information and warning deficiencies,w hen those alleged misrepresentations were drafted by the brand-name manufacturer and merely repeated by the generic manufacturer,” wrote Justice Michael F. Bolin in the 8 to 1 decision of the Supreme Court of Alabama.