Every day, millions of Americans have prescriptions filled with generic drugs. Because we have become so accustomed to generic drugs – over 80% of prescriptions are filled using generics – we don’t give much thought to it. In most circumstances, a doctor or pharmacist will tell you that there is no difference between the name brand drug or its generic equivalent. However, your ability to recover for injuries caused by prescription drugs depends on whether you took the branded or generic version.
In 2011, the U.S. Supreme Court issued a ruling, Pliva v. Mensing, that effectively made generic drug makers not responsible for injuries to consumers. The most common theory for a products liability claim against a drug manufacturer is a failure to adequately warn of the drug’s side effects and risks. These claims are brought under state laws that are stricter than FDA regulations and impose a duty on a manufacturer to change the label on a drug when they know of potential injuries. A branded drug manufacturer has the ability under federal law (the FDA) to change their warning label whenever necessary. But under federal law, the labeling and warnings on a generic drug must be identical to the named brand counterpart. Meaning, the warnings on a generic drug can only be changed if the warnings on the brand name drug are changed. Since federal law usually preempts or overrules state laws, the Supreme Court said it would be “impossible for the [generic drug] manufacturer to comply with both their state law duty to change the label and their federal law duty to keep the label the same.” Accordingly, plaintiffs cannot sue a generic drug manufacturer for failure to adequately warn of a drug’s side effects.
The FDA has been considering a rule that would allow generic drug manufacturers to independently update their warning labels. Efforts to convince Congress to change the rules with legislation failed. Until there is a change, many consumers will have no legal recourse against the manufacturers of the drugs that injure them.
Written by Jean Sutton Martin of the Law Office of Jean Sutton Martin PLLC. Attorney Jean Sutton Martin provides focused, personalized legal solutions for people who have been harmed by pharmaceutical drugs and medical devices.