Inadequate labeling can rob medical patients of their right to make informed decisions about the benefits and risks of taking certain medications. When known side effects aren’t listed, there is a good chance doctors and pharmacists don’t know about them, and patients are exposed to unexpected risks.
Generic drugs account for about 90 percent of the prescription pharmaceuticals market. In 2011, the U.S. Supreme Court ruled that patients cannot sue generic drug makers for inadequate labeling. Why? Generic drugs are required by law to carry the same warning labels as the brand-name versions.
Does that mean a patient who was harmed by an unexpected side effect could sue the brand-name company for inadequate labeling — even if they took the generic version of the drug?
Yes, said the Massachusetts Supreme Judicial Court recently. The decision follows a December ruling by the California Supreme Court that generic drug users can sue brand-name drug makers for inadequate labeling.
The Massachusetts decision is slightly more restrictive than the California one. It requires a finding that the brand-name manufacturer recklessly or intentionally failed to update their warning labels when new information becomes available.
The case involved a patient who suffered adverse side effects, including sexual dysfunction, after he took the generic version of Proscar, a Merck & Co., Inc., prostate medication. Since this occurred after the 2011 Supreme Court ruling, the patient sued Merck. He alleged the Proscar label, which generic drug makers must copy, failed to warn the side effect could persist even after the patient stopped taking the drug.
The trial court dismissed the case, but the Massachusetts Supreme Judicial Court reversed. Although a negligence suit would not be allowed, the patient can move forward with a claim based on alleged recklessness by Merck.
“Where a brand-name drug manufacturer provides an inadequate warning for its own product, it knows or should know that it puts at risk not only the users of its own product, but also the users of the generic product,” wrote the court’s chief justice in the 4-0 ruling.
If this type of lawsuit were not allowed, it would leave suffering people without any recourse in about 90 percent of cases.