A frequent question that we receive from our clients is why we are unable to accept their generic pharmaceutical lawsuit. Unfortunately, a United States Supreme Court ruling that came out in 2011 has affected our ability to handle these cases.
Pharmaceutical injury cases are premised on the drug manufacturer’s failure to warn of serious side effects associated with its product which results in an injury to the consumer of that product. On June 23, 2011, the United States Supreme Court in Pliva, Inc. v. Mensing ruled that the makers of generic drugs cannot be sued for failing to warn of risks associated with their products. While federal law requires the brand name manufacturers to update their drug labels as new side effects or warnings are necessary, the Supreme Court ruled that this duty does not extend to the makers of generic drugs because federal regulations require those drugs to carry the same warnings as their brand-name counterparts. The court concluded that state laws requiring generic drug manufacturers to change their product labels would result in product warnings that differ from those of their brand-name counterparts, are “pre-empted” by federal law prohibiting such differences. The court also suggested it is the responsibility of Congress and the FDA to revise federal regulations in a way that would allow lawsuits against the makers of generic drugs.
This decision has caused hundreds of lawsuits against generic pharmaceutical companies to be dismissed. What once seemed like such a small decision, whether to opt for the pricey brand name drug or cheaper generic version now affects whether you can maintain a lawsuit against the manufacturer of the drug. What is worse, in many instances, patients are not even told whether they are receiving a generic or brand name drug. The pharmacist will often unilaterally make the decision to fill a prescription with a generic drug unless the patient specifically asks for the brand.
This ruling has very significant consequences because nearly 80 percent of the prescriptions in the United States are generic with many states allowing pharmacists to fill a generic in place of a brand name drug. However, there is some light under the tunnel, a consumer advocacy organization, Public Citizen has petitioned the FDA to change their requirements and force generic companies to change their labels. A copy of the petition can be found here. We remain hopeful that Congress and the FDA will take note of this grave injustice and make changes to allow consumers to sue for injuries resulting from the ingestion of a generic drug. The FDA recently created a proposed rule to hold generic drug manufacturers responsible for the labeling of their drugs.