The Supreme Court in a 5-4 majority this week ruled that generic drugs cannot be sued under state law for adverse reactions to their products. The ruling comes as a crushing blow to Karen Bartlett who suffered horrific injury after taking the generic anti-inflammatory drug Sulindac. The plaintiff had to spend weeks in the burn unit after suffering burn-like injuries to 60% of her body and suffering from near-blindness.
The brand name drug Clinoril had been given a “safe and effective” designation by the FDA, this approval permitting generic drug makers such as Mutual to manufacturer an equivalent drug, “Sulindac.” These generic drugs are required by federal law to be the equivalent to the brand version in chemical composition right down to their warning label.
It was held that the suggested solution to avoid liability in state “failure to warn” claims by altering the generic drug ”Sulindac” composition/ label was prohibited by federal law. The Supreme Court also held that the suggestion to halt manufacturing of the drug completely in order to avoid liability was incompatible with the preemptive jurisprudence.
The impact of such a ruling means that the federal law regulating generic drugs prevents people from suing under state law for defective generic drugs. Given that up to 80% of all prescriptions are for generic versions this ruling is to the detriment of thousands of consumers using the cheaper option of generic drugs leaving them vulnerable to defectively designed drugs with no hope of holding the manufacturing companies culpable.