WASHINGTON, D.C. - (Mealey's) The U.S. solicitor general will be allowed to argue March 19 that design defect claims involving generic drugs are preempted by federal law, the U.S. Supreme Court decided March 4 in granting the federal government's motion to participate in oral arguments (Mutual Pharmaceutical Company, Inc. v. Karen L. Bartlett, No. 12-142, U.S. Sup.).
The Supreme Court will consider whether last year's ruling by the First Circuit U.S. Court of Appeals that federal law does not preempt state law design defect claims conflicts with the high court's preemption rulings in PLIVA, Inc. v. Mensing (131 S. Ct. 2567 ), Riegel v. Medtronic, Inc. (552 U.S. 312 ) and Cipollone v. Liggett Group, Inc. (505 U.S. 504 ). The First Circuit held that there is no preemption because the conflict between state tort claims and federal regulations governing the design of generic drugs can be avoided if the generic drug makers simply stop making their products.
At issue is a 2010 $21 million verdict for plaintiff Karen L. Bartlett in the U.S. District Court for the District of New Hampshire. Bartlett was prescribed Clinoril, a prescription nonsteroidal anti-inflammatory drug (NSAID), to treat shoulder pain.
The pharmacy dispensed sulindac, the generic version of Clinoril. Bartlett subsequently developed Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), reactions that resulted in burnlike damage to 60 to 65 percent of her body.
Bartlett spent 70 days in a hospital, including a burn unit, and suffered permanent tissue damage and near blindness.
Sole Surviving Claim
The trial court dismissed Bartlett's failure-to-warn claim, and the sole claim at trial was design defect against the sole remaining defendant, Mutual Pharmaceutical Co. Inc.
The trial court and the First Circuit both ruled that design defect claims are not preempted. Mutual Pharmaceutical petitioned the Supreme Court for a grant of certiorari.
In its Jan. 14 brief, Mutual Pharmaceutical says the First Circuit's opinion was an "outlier." "Regardless of whether a state court claim is captioned 'failure to warn,' 'design defect,' or something else entirely, these courts have recognized that the Constitution requires state law to yield if that would obligate a generic drug manufacturer to violate the federal sameness mandate as a precondition to engaging in interstate commerce," the company says.
The "sameness mandate" was found by the Supreme Court in the Hatch-Waxman Act, which requires that generic drugs carry the same warning information as their brand-name predecessor drugs. In Mensing, the court ruled that only brand-name drug makers could add warnings to their drug labels.
Drug Withdrawal Effect
Mutual Pharmaceutical says Mensing reversed an Eighth Circuit ruling that also found that generic drug makers could stop selling their drugs if they could not change drug labels by adding new warnings. "State-law verdicts that effectively order generic drugs withdrawn from interstate commerce because they complied with the federal sameness mandate eviscerate that core statutory objective," it says, referencing Hatch-Waxman's intention of getting cheaper generic drugs on the market once brand-name patents expire.
In her Feb. 13 brief, Bartlett says her case differs from the preempted failure-to-warn claims in PLIVA v. Mensing. "In PLIVA, state law undisputedly required the manufacturers affirmatively to improve the drug's label," she says.
"Here, however, the only state-law obligation is to compensate consumers for injuries caused by an unreasonably dangerous product," she continues. "Nothing in federal law prohibits petitioner from paying compensatory damages to Ms. Bartlett."
Compensation Doesn't Interfere
Bartlett says her judgment "presents no obstacle to the fulfillment of Congress's purposes." "Requiring manufacturers to pay compensation for injuries that their drugs cause does not interfere with [the Food and Drug Administration's] ability to perform [its] gatekeeping function."
"In addition, nothing in the statute gives manufacturers a federal right to market FDA-approved drugs in interstate commerce, let alone a right to do so free from damages liability under state law," she continues.
"[T]his case exemplifies why FDA has long regarded state tort actions as 'a complimentary form of drug regulation,'" Bartlett says. "The litigation below unearthed important evidence about a dangerous drug, and the judgment provided compensation to a woman injured horribly by that drug."
United States: Mensing Controls
In its Jan. 22 amicus curiae brief, the United States says the First Circuit's "reasoning cannot be squared with Mensing, which reflects and implicit judgment that the option of withdrawing from the market is not sufficient to defeat impossibility preemption in this context."
"The Court need not decide whether the FDCA [Food, Drug and Cosmetic Act] would preempt a 'pure' design-defect claim that does not consider the adequacy of labeling," the government says. "That issue is difficult and close, with several factors weighing in favor of finding no preemption."
"The government nevertheless concludes that the FDCA would preempt a pure design-defect claim where, as here, the claim does not require the plaintiff to prove that the manufacturer knew or should have known of new and scientifically significant evidence that rendered the drug 'misbranded' under federal law," the government says.
"A State that permitted a pure design-defect claim, however, would require a jury independently to balance the health risks and benefits for an FDA-approved drug to determine if the drug is 'unreasonably dangerous,'" the government continues. It says Congress' intent to have expert judgments made by the FDA "would be undermined by ad-hoc reconsiderations on a State-by-State and lawsuit-by-lawsuit basis."
Data Came From FDA
"Tort judgments second-guessing FDA's expert drug-safety determination would undermine the federal regime to the extent that they forbade or significantly restricted the marketing of an FDA-approved drug," the government continues. "In this case, respondent's counsel relied on the absence of evidence that FDA was aware of data concerning sulindac's relative safety risk, but, in reality, the underlying data came from the FDA; FDA was aware of an considered the publication addressing reporting rates of SJS/TEN on which petitioner relied; FDA conducted a comprehensive review of the risks and benefits of all NSAIDs; and FDA did not conclude that sulindac should be removed from the market."
Fifteen other amicus curiae briefs from 22 companies, trade organizations, congressmen, former FDA commissioners and advocacy groups were filed.
Mutual Pharmaceutical is represented by Jay P. Lefkowitz of Kirkland & Ellis in New York and Michael W. McConnell, Michael D. Shumsky and John K. Crisham of Kirkland & Ellis in Washington. Bartlett is represented by David C. Frederick, Brendan J. Crimmins and Joshua D. Branson of Kellogg, Huber, Hansen, Todd, Evans & Figel in Washington, Steven M. Gordon and Christine M. Craig of Shaheen & Gordon in Concord, N.H., and Keith M. Jensen of Jensen & Associates in Fort Worth, Texas.
The United States is represented by Solicitor General Donald B. Verrilli Jr., Stuart F. Delery, Edwin S. Kneedler, Anthony A. Yang, Scott R. McIntosh and Jonathan H. Levy of the U.S. Justice Department and William B. Schultz, David Horowitz, Elizabeth H. Dickinson and Julie Dohm of the U.S. Department of Health and Human Services, all in Washington.
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