The U.S. Supreme Court will hear arguments next year on whether lawsuits against defective generic drugs can proceed in state court if they are not in violation of federal law.
In Mutual Pharmaceutical Co v. Bartlett, the court will decide if federal law protecting generic drugs trumps state consumer protection laws, or if both can exist in harmony. If the court finds the laws to be in conflict, consumers will not be able to bring lawsuits over injuries they suffered from flawed generic drugs.
Karen Bartlett was awarded $21 million by a New Hampshire jury in 2010 after she was left blind and covered in lesions from an allergic reaction to the anti-inflammatory drug, sulindac. She sued the manufacturer, Mutual Pharmaceutical, for selling a defective product.
However, Mutual argued that its drug, an FDA-approved generic, was merely mimicking the design of its brand-name predecessor, Merck’s Clinoril, as mandated by federal law. It’s up to the high court to decide if the award will stand, and similar lawsuits can proceed — or if the generic manufacturers will be shielded from suits regardless of what state laws they violate.
Free Pass on Labels
Prescription drugs have been the subject of near-constant lawsuits for improper labeling and failure to accurately warn of side effects. And serious or fatal side effects of prescription drugs rose nearly 10 percent from 2010 to 2011.
Meanwhile, use of generics to treat illness is wide-spread. For prescriptions where doctors and patients have a choice to use generics, they opt for the cheaper version about 90 percent of the time over name-brand options.
However, generics are much less vulnerable to civil suits than name-brand drugs, due to the way they are regulated by the FDA. In fact, generic drugs may not by law update their label to include new information about risks — they must match their label to the name-brand pill that they are mimicking.
In 2011 the Supreme Court ruled in PLIVA v. Mensing that consumers harmed by side effects of generic drugs that they were not properly warned about could not sue over their injuries, precisely because the generics are not allowed to change their labels.
Austin P. Kirk
“Generic drug makers are allowed to continue to profit from the sale of dangerous medications that they know contain inaccurate or misleading warnings,” writes Austin P. Kirk, an attorney with the firm Saiontz & Kirk, in response to the ruling. “In the interim, dozens of lawsuits against generic manufacturers are being dismissed . . . not because the cases do not have merit, not because the injuries are not real and not because generic drug manufacturers provided sufficient warning for dangerous drug side effects; but because until the law is changed they have no legal responsibility to tell consumers about any risk information that is not provided on the name-brand drug label, even if they are aware that current label is inaccurate or inadequate.”
Free Pass on Design?
The big conflict in PLIVA is that the generics were actually in violation of state law for improper labeling, although they complied with federal rules. By the standard of preemption, the federal law trumps state, the court reasoned, and plaintiffs couldn’t sue. A similar issue is at hand for Mutual v. Bartlett. Should consumers be able to bring a lawsuit over generic drug design, not labeling, even if the design is what is mandated by the FDA?
The plaintiff’s lawyers have argued that the generic manufacturer still has a choice if they want to comply with FDA rules yet still not kill or injure their customers: If a drug is dangerous or defective, don’t sell it.
A key issue for consumers is the expansion of the notion of preemption, which could give Congress vast powers to render impotent state consumer protection laws. “Corporate interest groups, the Chamber of Commerce and the Litigation Center have been pushing this fairly aggressively,” says Ian Millhiser, an attorney and senior constitutional policy analyst for the Center for American Progress Action Fund, “The law isn’t just preempted because Congress says it’s preempted, but because Congress said something similar about a similar topic.”