Federal Government Will Argue Against Lawsuits Against Generic Drug Manufacturers

By March 12, 2013 July 23rd, 2019 Dangerous Drugs

In December, I noted that the U.S. Supreme Court will soon hear a case that could open up the field to more lawsuits against the makers of generic drugs that hurt or kill their patients. As a pharmaceutical liability attorney, I eagerly await the decision from the U.S. Supreme Court in Mutual Pharmaceutical Co. v. Bartlett, which will have its oral arguments March 19. Karen Bartlett developed Stevens-Johnson Syndrome from taking a generic drug called sunlindac, a nonsteroidal anti-inflammatory drug she used for shoulder pain. SJS is a rare but extremely serious reaction to NSAIDs; it left Bartlett severely burned, blind and unable to lead a normal life. Her lawsuit alleges design defects by the maker of the generic sulindac, Takeda Pharmaceuticals. The U.S. Supreme Court will decide whether her lawsuit is preempted by FDA regulations.
Bartlett suffered injuries that the First U.S. Circuit Court of Appeals called horrific. She spent nearly a year in a coma and lost skin over 60 percent of her body. The SJS burned many of her internal organs, leaving her blind despite 12 eye surgeries; she cannot eat normally, have sex or engage in vigorous exercise. Her lawsuit says sulindac’s design is so defective that it should not be sold at all. This is a different claim from the “failure to warn” claims common in defective drug lawsuits. In PLIVA v. Menseng, the U.S. Supreme Court ruled that failure to warn claims against generic manufacturers are preempted by FDA regulations. In Bartlett’s case, Takeda is arguing that the same logic should apply: like generic drug labels, generic drug formulas are required to be the same as the underlying name-brand drug’s.
Forbes magazine reported March 11 that the U.S. Solicitor General will make the same argument before the Supreme Court. As the article points out, this is a turnaround from the PLIVA case, in which the Obama administration had argued against federal preemption. Here, the Solicitor General is expected to argue in favor of preemption. According to the Forbes piece, the administration’s top lawyer will also argue that the First Circuit was wrong to suggest that drug makers can handle unreasonably dangerous drugs by simply taking them off the market. The Solicitor General’s brief argues that this would undermine the assurance that FDA approval provides for both manufacturers and patients, by replacing the FDA’s judgment with a patchwork of case-by-case decisions. It’s not clear yet when the Supreme Court might reach a decision.
This case will be important for defective drug lawyers like me. The PLIVA case was a blow against patients who were hurt by generic drugs, because it said their cases would be blocked no matter how strong they were. Worse, the ruling took away the economic incentive for makers of generic drugs to stop selling drugs found to be dangerous. By stopping all lawsuits, regardless of merit, the Supreme Court gave drugmakers permission to protect their profits at the expense of public health, by continuing to sell drugs they know are dangerous. PLIVA was decided by a 5-4 majority, so a change of heart by just one justice could be enough to change the outcome. As a dangerous drug attorney, I very much hope that one justice will have that change of heart, because I know from experience how insufficient FDA compliance is to protect patients.


Carey, Danis & Lowe represents clients across the United States who suffered serious injuries or lost a loved one because of an unsafe prescription drug. To learn more or tell us your story, call us today at 1-877-678-3400 or send us a message online.
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