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Supreme Court Agrees to Decide Whether Design Defect Claims Are Barred for Generic Drugs

By December 19, 2012July 18th, 2019Dangerous Drugs

As a pharmaceutical liability attorney, I was very interested to see that the U.S. Supreme Court will decide a case with huge implications for victims of injuries caused by generic prescription drugs. As Reuters reported, the Supreme Court will review a First U.S. Circuit Court of Appeals decision making Takeda Pharmaceuticals legally liable for catastrophic injuries to a New Hampshire woman injured by the generic drug sulindac. Karen Bartlett took sulindac, a nonsteroidal anti-inflammatory pain medication, for shoulder pain, and had a rare reaction that left her severely burned, blind, and unable to eat or have sex. Takeda argued that Bartlett’s lawsuit should have been barred by 2011’s PLIVA v. Mensing, which said generic drug manufacturers cannot be sued for failure to warn. But the district court and First Circuit said Bartlett’s claim is for design defects, making it different.
PLIVA made waves because it removed all legal liability for manufacturers of generic drugs who fail to warn about safety risks. In that case, the high court found that because generic manufacturers are required to include accurate safety information for the name-brand version of the drug, and cannot update safety information on their own, it is unfair to also make them responsible for lawsuits based on state-law claims. (Name-brand manufacturers can still face these suits.) Because failure-to-warn claims are a type of product liability claim, most lower courts have applied PLIVA to any product liability claim, including claims for defective design and defective manufacture. But in Bartlett’s case, the First Circuit said the logic applied in PLIVA doesn’t apply to design defect claims. Because the claim is not about packaging information Takeda doesn’t control, the court said, there’s no conflict; Takeda is free to stop making a drug if it’s too defective to be sold at all.
The case is also making waves because of what the First Circuit called “truly horrific” injuries suffered by Bartlett. Because of a rare allergic reaction to sulindac, Bartlett lost skin over 60 percent of her body, needed 12 eye surgeries, and spent nearly a year in a medically induced coma. She is nearly blind, cannot eat normally, cannot have sex and cannot exercise vigorously because of organ damage. Her lawsuit alleged that sulindac is so dangerous that it shouldn’t be sold at all. The U.S. Supreme Court’s acceptance of the case means it will decide whether design defect claims are different from failure-to-warn claims, or whether the First Circuit’s ruling blasts a hole in the PLIVA decision. A ruling is expected by June.
As a dangerous prescription drug lawyer, I think this is a fantastic development. The PLIVA decision was a narrow one at 5-4, so if even one justice accepts the First Circuit’s logic, Bartlett could win her case. This is important because the decision could set a precedent for lots of plaintiffs, not just for Bartlett. As things currently stand, generic drug manufacturers are able to escape responsibility for selling defective drugs—even if they know the drugs are defective—simply because of the way Congress wrote generic drug laws. That gives them less responsibility for their actions than the manufacturers of name-brand drugs, even when the drug itself is supposed to be identical. A ruling establishing a right to sue over design defects would correct at least some of that imbalance, and that’s good news for defective drug attorneys and our clients.

If you or someone you love suffered serious injuries or illnesses because of a prescription drug you thought you could trust, don’t wait to call Carey, Danis & Lowe. For a free, confidential consultation, send us a message online or call 1-877-678-3400.
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