On June 23, the US Supreme Court issued its long-awaited decision in the case of PLIVA, Inc. et al. v. Mensing 2011 WL 2472790 on whether users of generic drugs could use state laws to sue the manufacturer for a failure to warn about dangerous drugs. In its decision, the Court stated that this type of lawsuit was preempted because it would create a situation where it was impossible for generic drug manufacturers to comply with both state and federal regulations.
The case centered on the drug metoclopramide, originally sold under the brand name Reglan. The drug is used to control chronic heartburn, medicalized as GERD (gastroesophageal reflux disorder), but when used for long periods it can result in a number of neurological dysfunctions, including tardive dyskinesia. Tardive dyskinesia is a disorder characterized by involuntary movements of the face and limbs. There is no cure. many people who suffered this condition did so after taking generic metoclopramide and have sought compensation from the generic drug manufacturers due to a failure to warn about the drug’s dangers.
However, the Supreme Court decided that generic drug manufacturers were not liable under failure-to-warn laws because such failure to warn laws were in direct conflict with FDA rules governing the manufacture and labeling of generic drugs. According to FDA rules, generic drugs must be chemically equivalent to their name brand predecessor and their labeling must be identical. This means that a generic drug manufacturer actually could not legally add any warnings to the labeling of their drugs, unlike name-brand manufacturers, who, as the Supreme Court noted in Wyeth v. Levine could spontaneously add warning utilizing the FDA’s changes being effects (CBE) system.
So where does that leave people who suffer injuries from generic versions of dangerous drugs? They may be able to seek compensation from the name-brand manufacturer. After all, the sum of these two rulings seems to imply that name brand manufacturers are responsible for all injuries suffered by people who never took the name brand version of the drug. On the other hand, people who are injured taking generic drugs may simply have no legal recourse whatsoever, a truly scary prospect.
Perhaps the Supreme Court will revisit this decision in the future, and at Robert W. Kerpsack, CO, LPA, we believe anyone who has been injured by a dangerous drug deserves compensation for their injuries. To learn whether we can help you with your pharmaceutical liability case, please contact us today for a free case evaluation.