In July of this year, The Supreme Court of the United States (SCOTUS) issued an Orwellian 5-4 opinion that shields generic drug manufacturers from liability for harm caused by generic ‘equivalent’ drugs. Karen Bartlett, a New Hampshire resident, sued a generic drug manufacturer after the drug caused permanent disability and disfigurement. After Ms. Bartlett emerged from a coma, she endured thirteen surgeries, and remains legally blind. Justice Alito, who authored the majority opinion, called her situation “tragic,” but then essentially told her and all others in her life-altering situation to go pound sand.
To put it mildly, this SCOTUS decision is horrendous, because it leaves people like Karen Bartlett and others, who are harmed by generic drugs no recourse whatsoever. As Justice Sotomayor states in her dissent:
If manufacturers of products that require preapproval are given de facto immunity from design-defect liability, then the public will have to rely exclusively on imperfect federal agencies with limited resources and sometimes limited legal authority to recall approved products. And consumers injured by those products will have no recourse.
What Justice Sotomayor is saying in her dissent is that when Congress passed the Food and Drug Act, it meant to protect people; it did not pass a law that says one has no remedy when harmed, by removing any basis for a lawsuit in the state courts.
In this case, the label in question did not mention the side effect that caused the injury (which took the form of third-degree burns on much of the plaintiff’s body). The answer is that the plaintiff cannot sue the manufacturer. Because the FDA has approved the product and the label, the state court cannot impose damages for harm from using the product.
Ironically, had Ms. Bartlett taken the brand version of the same drug (Clinoril, marketed by Merck), she could have sued Big Pharma, when she suffered from Stevens-Johnson Syndrome, the life-threatening skin condition that she contracted after taking sulindac, the generic version of Clinoril. In an article titled Supreme court rules it’s o.k. for drugs to hurt you, Eric L. Zielinski explains:
In March 2009, the Supreme Court ruled that consumers could sue Big Pharma companies for damages if they were harmed by brand-name drugs.
Directly going against this historical landmark decision, the Court’s decision against Bartlett surprisingly gives generic drug companies a new-found immunity. However, this is not the first time the Court has ruled against common sense and integrity.
According to L.A. Times, “The court has now handed down two rulings that have closed the door to lawsuits from people injured by a generic drug.” With 80 percent of FDA-approved drugs on the market being made by generic sources, this puts most Americans at an unreasonable risk of being harmed and having no retribution.