In 2011, the U.S. Supreme Court held that people harmed by generic prescription drugs cannot sue generic manufacturers under the claim of inadequate warning labels. In PLIVA, Inc. v. Mensing, the High Court dismissed the legal claims of two women who suffered physical injury because of the inadequate warning labels on their generic medication.
While the Court ruled in 2009 that injured plaintiffs could bring state law claims against pharmaceutical companies for poor labeling on name-brand drugs, the PLIVA ruling bars similar suits against manufacturers of the generic versions of those same medications.
Why the Discrepancy?
The U.S. Food and Drug Administration (FDA) approves and regulates pharmaceutical drugs, including the labels warning of potential health risks from their use. Federal law requires the labels on generic medications to mirror the FDA-approved versions on their name-brand counterparts.
The claims against PLIVA were brought under state laws requiring adequate consumer warnings on prescription labels. However, federal law governs the content of those labels. The Court held that it is impossible for PLIVA and other generic manufacturers to comply with both the state and federal laws. As federal law trumps any conflicting state law, the Court ruled that by federal law preempts the state law claims.
Impact on Plaintiffs
The PLIVA case eliminates 100 percent of potential failure to warn claims against generic pharmaceutical manufacturers as they are now essentially immune from inadequate warning liability. The ruling also eliminates about 70 percent of all potential failure to warn cases as approximately 70 percent of prescriptions are in generic form. This leaves a significant number of consumers without redress for their injuries, pain and suffering.
What Remedies are Available?
Plaintiffs' attorneys may now need to rely on a negligence theory or claims that the generic manufacturer failed to suggest label changes knowing of specific safety risks. However, the validity and strength of such theories is largely untested and unknown. The unfortunate reality is that consumers of generic prescription drugs may have no true remedy for injuries from defective drugs.
Faulty prescription drugs can cause life long and life altering disabilities. If prescription drugs have harmed you or a loved one, contact an experienced attorney to discuss your situation and your options.