In January, the Alabama Supreme Court ruled that drug manufacturer Pfizer can be sued by a man who alleges he was injured by a generic formulation of its heartburn medication Reglan. Pfizer allegedly failed to warn the man’s physician about the drug’s risks.
The decision has caused much alarm among drugmakers, and Pfizer has requested a re-hearing. The ruling is one of only a few in which a court has ruled that a drug manufacturer may be sued for injuries allegedly caused by a generic version of its product.
The pharmaceutical industry worries that the decision will encourage more such lawsuits, particularly in light of a 2011 case in which the U.S. Supreme Court ruled that generic drugmakers are not required to update safety warnings on their product labels when they become newly aware of possible side effects. This effectively protects manufacturers of generics from being sued for not advising patients of such risks.
Now, patients appear to have another avenue to pursue legal redress.
Pfizer argues that in order for the injured man’s suit to proceed, Pfizer must first have been obliged to notify the man of the drug’s risks. Pfizer maintains that because the patient took a generic version of their drug, they had no means by which to convey that information.
Pfizer faces many lawsuits over Reglan, and this is not the first time a court has allowed a suit brought by a patient taking a generic version of the drug to proceed. Courts in California and Vermont have issued similar rulings. However, in 23 states, 61 decisions have been handed down in favor of Pfizer, allowing the drugmaker to argue that Alabama goes against an established consensus.
It is unclear whether the Alabama Supreme Court will agree to rehear the case, but the impact may be minimized by updated FDA regulations. The agency plans to allow generic drugmakers to update their product labels to warn patients of risks. This would open them up to lawsuits if they failed to warn consumers of any risks of which they become aware.
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