As a pharmaceutical liability attorney, I’ve written here a few times before about the potential for a rare but very serious reaction to nonsteroidal anti-inflammatory drugs, a class of painkillers that includes over-the-counter ibuprofen as well as prescription drugs. So I was saddened to see a case out of New England involving devastating injuries to a woman who took an NSAID as prescribed. Karen Bartlett of New Hampshire was given the drug Clinoril (sulindac) for shoulder pain, but developed a hypersensitivity reaction called toxic epidermal necrolysis, which is related to Stevens-Johnson syndrome. She suffered chemical burns and near-blindness, among other injuries. In Bartlett v. Mutual Pharmaceutical Co. et al, she alleged the drug was defectively designed because its risks outweighed its benefits, and the First U.S. Circuit Court of Appeals upheld a jury verdict in her favor.
Bartlett filled the prescription for generic sulindac in late 2004 and developed TEN in early 2005. She suffered chemical burns to 60 to 65 percent of her body and spent 70 days in the hospital, more than 50 in a specialized burn unit. Among her permanent injuries are near-blindness, disfigurement and loss of the ability to eat normally, have sex, exercise and work. She originally sued drug manufacturer Mutual Pharmaceutical Company in New Hampshire state court, and after removal to federal court and pretrial motions, her core claim became one for defective design. She alleged that sundliac’s risks outweighed its benefits, noting that it had more reports of TEN and SJS than other NSAIDs and that a similar NSAID, valdecoxib, had been withdrawn from the market in 2005. The jury ultimately awarded Bartlett $21.06 million in damages. Mutual appealed on a variety of theories, including mistakes of New Hampshire design defect law, federal preemption, inadmissible expert testimony and excessive damages.
The First Circuit examined each claim in turn, but upheld the verdict. On design defect claims, Mutual argued that New Hampshire law requires a showing that a safer alternative design exists, but the appeals court said no such requirement exists — indeed, the state Supreme Court has rejected such a rule. On federal preemption, a recent issue at the U.S. Supreme Court, the appeals court took more time. The Supreme Court declined to find implied preemption in 2009’s Wyeth v. Levine, and while 2011’s PLIVA v. Mensing did find preemption of failure to warn claims for generic drugs, the court drew a distinction between that case’s logic on generic drug labels and claims for design defects. The First next rejected arguments that the two experts for Bartlett were underqualified or unreliable, noting that their use of FDA adverse event reports could actually strengthen Bartlett’s case. It also found that no misconduct by Bartlett’s counsel was serious enough to create a new trial, and that the jury award, while large, was not unreasonable given the “truly horrific” injuries Bartlett suffered.
As a dangerous drug lawyer, I’m pleased to see the First Circuit deciding for a patient whose injuries were clearly quite severe. TEN and SJS are not common, but when they strike, they can sometimes leave the victim with severe, permanent injuries. In fact, death from infection or respiratory distress is estimated in 30 to 40 percent of cases. I am particularly pleased by the appeals court’s thoughtful analysis of the federal preemption issue, which is a popular defense by drug companies and others that wish to escape the consequences of their actions by hiding behind compliance with inadequate federal laws. While it decided for Bartlett, the First acknowledged that PLIVA may apply before leaving it to the Supreme Court to make that call. As a defective drug attorney, I will be watching for that decision very closely.
If you or someone you love suffered a serious injury, illness or death after taking a drug you expected to help, don’t wait to call Carey, Danis & Lowe. Based in St. Louis, we represent clients across the United States who suffered serious injuries from taking dangerous or defective drugs. You can set up a free, confidential consultation by sending us an email or calling 1-877-678-3400 today.
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