SCOTUS: Generic Drug Makers Off the Hook

It was 2005 and Karen Bartlett, 53, took a generic drug, a version of the nonsteroidal anti-inflammatory drug Clinoril.

Instead of relieving the pain in her shoulder, Bartlett’s skin began eroding from two-thirds of her body. Her reaction was identified as Stevens-Johnson syndrome, which is an allergic reaction triggered by drugs including Clinoril and other NSAIDS such as sulindac. Today she is legally blind, has lung damage, difficulty swallowing, is disfigured and unable to work.

In a recent five-four decision, the U.S. Supreme Court (SCOTUS) overturned a New Hampshire court jury ruling that awarded Bartlett $21 million. The justices decided that since the drug is a generic version of a brand-name drug, that the drugmaker is immune from lawsuits. In essence they decided that the generic drug make is required by federal law to copy the brand-name drug without variation, therefore federal preemption should apply.

Bartlett’s lawyer won a failure to warn case against drugmaker Mutual Pharmaceutical before the lower court arguing that Stevens-Johnson syndrome was a known side effect, though very rare. The $21 million was intended to compensate her for her loss of life and physical and mental pain and suffering.

Through its decision, the Supreme Court pointed out the label did mention “severe skin reactions” and “fatalities.” Essentially the generic drugmaker has no option under law to vary from that standard when it comes to either the formulation of the product or its label, according to the majority opinion written by Supreme Court Justice Samuel Alito.

One year after Bartlett suffered her reaction, the FDA recommended changing the label of all NSAIDS to explicitly warn about Stevens-Johnson syndrome. He opined that even though Bartlett’s case evokes sympathy, the justices have the responsibility to follow the law.

That did not satisfy Justice Elena Kagan who wrote one dissenting opinion along with Justice Breyer. She argued that the FDA had no regulation regarding pre-emption of state laws and it would not be impossible for the drugmaker to comply with both state and federal law. The other dissenting opinion by Justice Ruth Bader Ginsburg and Sonia Sotomayor said the decision allows Mutual Pharmaceutical to sell a dangerous drug just because it was federally approved free of any liability. If New Hampshire law “were correctly construed” then Karen Bartlett would have a remedy through the courts, she wrote.

Karen Bartlett is left with nothing but disability checks and a feeling that the highest court in the land just doesn’t seem to care.

In a new report, Public Citizen warns that unless generic drugmakers are allowed to update their label we will continue to find citizens who fall between the cracks. Their reasoning is that the more people who use a drug, the more we find out about it. At least 53 drugs have had additional black-box warnings added over the last decade as dangers emerge, says the consumer group, and of those, 11 were generic drugs.

Considering that 80 percent of prescriptions are filled with generic drugs, the consumer is facing a dangerous frontier unless the generic drugmaker can individually update its label. To not allow Karen Bartlett to successfully hold a drugmaker liable for her injuries injures the rights of the individual permanently.

The Supreme Court decision along party lines reflects the tilt of the court with the majority of justices leaning away from citizen rights and toward corporate empowerment.