A Supreme Court ruling on June 23 reversed separate U.S. appeals court rulings that would have held generic drug manufacturers responsible for warning patients of safety label changes. By a 5-4 vote, the justices said generic drug companies cannot be sued under state law over allegations that they failed to warn patients about new dangerous side effects from the drugs . Generic drugs make up 70 to 75 percent of all prescriptions filled in the United States, meaning the majority of the American public is now at the mercy of the drug companies.
Manufacturers of brand-name medications are required by the U.S. Food & Drug Administration (FDA) to report any adverse events associated with their medications to the FDA. These possible side effects are then included in an FDA-approved safety label that tells doctors and patients about these possible risks.
When the patent expires on a particular drug, it can then be manufactured in a generic form, which is often much cheaper than the brand-name drug. As a result many insurance companies encourage patients to use the cheaper version, and some even require it or automatically switch patients from brand-name to generic drugs when the less expensive version becomes available.
Generic drug makers are required to include the drug information and any safety warnings that were originally placed on a brand-name drug by the FDA. However, they are now under no obligation to update any of the labeling or issue warnings to their consumers if new safety information about a particular drug is uncovered.
The ruling has directly affected pending lawsuits from two women who suffer from a severe involuntary movement disorder known as tardive dyskinesia. The condition is linked to metoclopramide, which was sold under the brand name Reglan. The product initially included in its safety information a note that the effects of long-term use had not been determined. It was only years later that research discovered that long-term use of the drug for 12 weeks or longer is linked to the development of tardive dyskinesia.
Generic drug manufacturers did not update safety labels or provide any additional information to consumers about this new risk, and as a result of the Supreme Court ruling, they don’t have to.
The ruling also means that generic drug manufacturers will not be required in the future to warn patients about any new risks for any of their drugs, and will not be held responsible for the damage these drugs may cause patients.
Justice Sonia Sotomayor, who dissented with the ruling, noted that the decision creates a potentially deadly roll of the dice for the consumer, who can now only obtain justice in court “based on whether her pharmacist filled her prescription with a brand-name or generic drug.”