The Supreme Court agreed to consider whether federal law preempts state products liability claims that allege design defects against generic drug manufacturers in a case that could further impede plaintiffs’ ability to bring similar lawsuits and hold these companies accountable. The First Circuit’s ruling in Mutual Pharmaceutical Co., Inc. v. Bartlett is the only appellate decision to tackle the design defect issue since the Court preempted failure-to-warn claims in Pliva, Inc. v. Mensing, so plaintiff attorneys will be closely watching the outcome. (Mutual Pharm. Co., Inc. v. Bartlett, No. 12-142 (U.S. cert. granted Nov. 30, 2012).)
Mutual Pharmaceutical Co., Inc. (Mutual), a wholly owned subsidiary of Japan-based Takeda Pharmaceutical Co., Ltd., seeks to overturn a $21 million jury award to Karen Bartlett, a New Hampshire woman who was seriously injured when she used the generic anti-inflammatory drug sulindac for shoulder pain. Mutual argues that the Court should apply its 2011 ruling in Mensing to state law design defect claims. In Mensing, the Court held that FDA regulations bar failure-to-warn suits against generic drug manufacturers because it is impossible for them to comply with both federal law—which requires generic drugs to have the same labeling as their brand-name equivalents—and state laws, which may require stronger warnings.
In 2004, Bartlett’s doctor prescribed Clinoril for shoulder pain, and her pharmacist dispensed sulindac, the generic equivalent manufactured by Mutual. Bartlett developed Stevens-Johnson syndrome (SJS)—a life-threatening skin condition that is a rare reaction to sulindac.
She also developed a more severe form of SJS, known as toxic epidermal necrolysis, which resulted in burn-like lesions on almost two-thirds of her body and permanent near-blindness.
Bartlett sued Mutual in New Hampshire state court in 2008, alleging products liability claims including design defect. She alleged that Mutual knew SJS was a possible reaction to the drug. Mutual had the case removed to district court in New Hampshire, which dismissed all claims except the design defect claim that sulindac was unreasonably dangerous and therefore defective. Under New Hampshire law, sellers are strictly liable for any injuries caused by selling products in an unreasonably dangerous and defective condition.
The district court jury returned a verdict for Bartlett in 2009, awarding $21 million in compensatory damages. Mutual appealed on various grounds, including preemption.
As reported in Trial News, the First Circuit upheld the verdict in May 2012. Judge Michael Boudin, writing for the unanimous three-judge panel, concluded that federal law does not render compliance with state law impossible so the plaintiff’s design defect claim is not preempted. Boudin noted that the Supreme Court adopted a general no-preemption rule in Wyeth v. Levine in 2009, and Mensing was an exception. The First Circuit held that Mutual could “choose not to make the drug at all,” and the Supreme Court would need to ultimately decide whether Mensing should be expanded to include design defects.
Louis Bograd, senior litigation counsel with the Center for Constitutional Litigation in Washington, D.C., said the First Circuit essentially invited the Supreme Court to review the case. “Bartlett is really the only post-Mensing design defect ruling by an appellate court, and that’s because it was litigated in the trial court long before Mensing came down,” noted Bograd, who wrote an amicus brief for AAJ in Bartlett and also represented the plaintiff before the Court in Mensing. “In virtually all of the pre-Mensing rulings on design defects, the courts have consistently held that design defect claims are not preempted.”
But Bograd said it’s hard to tell how the Court will rule in Bartlett. “Mensing is a rarity. It is the only case in which the Supreme Court has ever found impossibility preemption in over 200 years of jurisprudence,” said Bograd. “The biggest hurdle is going to be convincing the Court that a design defect claim is meaningfully different from a failure-to-warn claim.”
Plaintiff attorneys will be watching Bartlett closely, according to William Curtis of Dallas. “The Supreme Court’s evaluation of Bartlett should not be impacted by the preemption holding in Mensing. Defective design cases are inherently the province of state courts and their respective tort laws,” said Curtis, who represents plaintiffs in Reglan and metoclopramide litigation. “The Court should not be using preemption as a judicial fiat to prevent the state courts from enforcing their tort laws, whether they are drug cases, automotive design cases, dangerous consumer product cases, or any other type of tort that involves a defectively designed product.”
The Court is scheduled to hear Bartlett in March.