Last month, the United States Supreme Court ruled on Monday that generic drug manufacturers could not be sued by patients who claim that drugs they took were defectively designed, leaving the manufacturers immune from lawsuits accusing them of fraud, mislabeling, side effects or accidental death.
In a 5-4 ruling, the justices overturned the verdict of a jury who awarded a N.H. woman $21 million in her suit against the Mutual Pharmaceutical Company. Karen Bartlett sued the company after she experienced "toxic epidermal necrolysis," a severe skin condition that causes peeling akin to a third degree burn. Ms. Bartlett suffered permanent disfiguring injuries from the generic anti-inflammatory drug Sulindac, which was manufactured by Mutual.
At the time Ms. Bartlett was prescribed the drug, there was no warning information provided of this potential side effect. The court found that because Mutual Pharmaceutical Company was required by federal law to make a copy of the brand-name drug, Clinoril, it could not be held responsible for claims that the drug was unsafe.
The court did acknowledge the terrible injuries suffered by the victim, who lost nearly two-thirds of her skin, was placed in a medically induced coma and is legally blind after suffering a reaction to the medication she took for a sore shoulder, but said that sympathy for the victim could not influence their duty to follow the law.
Critics say federal law should make generic drug companies more accountable by permitting them to change their warning labels when they become aware of a safety risk. Brand-name companies can already do so. Generic drug makers now have a responsibility to only mirror the safety label of the brand-name company and to alert the FDA whenever they learn of an adverse event related to their products. It is then up to the agency to decide whether to change the label.
If you or a loved one has suffered harmful side effects from taking a prescription drug, you should consult with a prescription drug injury attorney. Our Virginia personal injury law firm has compiled an in-depth guide that explains what to do if you’ve been injured by a prescription drug.
Supreme Court rules in favor of generic drug companies.