Once federal regulators deem a drug safe, can a lawsuit challenge it as not safe enough?
That was the question that faced the 1st U.S. Circuit Court of Appeals in a design-defect case in which a New Hampshire woman, Karen L. Bartlett, suffered severe and permanent injuries after taking sulindac, a generic non-steroidal anti-inflammatory drug (NSAID) manufactured by Mutual Pharmaceutical Company.
The U.S. Food and Drug Administration had originally designated the non-generic version of the drug as “safe and effective,” a designation that carried over to generic versions. In rare instances, the drug is known to cause a syndrome known as toxic epidermal necrolysis, referred to as “SJS/TEN,” that results in skin burns and open wounds.
At trial, the plaintiff’s case hinged on the testimony of two expert witnesses. Both said that the drug’s risks outweighed its benefits, making it unreasonably dangerous to consumers, despite the FDA’s designation. After a 14-day trial, a jury awarded Bartlett $21.06 million – reportedly the largest award in New Hampshire history.
The case raises an issue of federal preemption law that is likely to eventually land in the lap of the Supreme Court: Whether the Federal Food, Drug and Cosmetic Act (FDCA) preempts design defect claims against generic drug manufacturers.
No Implied Preemption
The FDCA statute contains no express preemption language and, in 2009, the Supreme Court rejected implied preemption. In Wyeth v. Levine, 555 U.S. 555, the court held that the FDCA did not preempt a failure-to-warn claim against a brand-name drug manufacturer.
Last year, however, the Supreme Court carved out an exception to Wyeth, ruling in PLIVA, Inc. v. Mensin, 131 S. Ct. 2567, that the FDCA does preempt failure-to-warn claims against generic drug manufacturers. The reason for the exception was that generic manufacturers, unlike brand-name companies, cannot unilaterally change their labels to add or revise warnings.
Relying on PLIVA, Mutual Pharmaceutical argued to the 1st Circuit that, just as it could not change the label, it also could not alter the composition of the drug. Thus, it asserted, federal law should preempt Bartlett’s design defect claim.
But the 1st Circuit drew a distinction between this design-defect case and the PLIVA failure-to-warn case. “Although Mutual cannot legally make sulindac in another composition …, it certainly can choose not to make the drug at all,” the court said.
It would be “second-guessing the FDA” for a manufacturer to question the safety of a drug, the court conceded. “But – while the generic maker has no choice as to label – the decision to make the drug and market it in New Hampshire is wholly its own.”
Reiterating that, in Wyeth, the Supreme Court adopted a general no-preemption rule for product-liability suits involving pharmaceuticals, the 1st Circuit concluded it would adhere to that rule in this case. “It is up to the Supreme Court to decide whether PLIVA’s exception is to be enlarged to include design defect claims,” the court said.
Sufficiency of Expert Testimony
With that, the circuit turned to a lengthy analysis of whether the testimony of the plaintiff’s experts was sufficient to support the verdict in her favor. She presented two experts, a pharmacologist/toxicologist and a burn surgeon. Mutual argued that neither expert was qualified to provide an opinion on the safety of the drug and that their opinions were unreliable.
Each of the experts testified about the overall risk/benefit profile of sulindac and about safer alternatives. They cited “adverse event reports” (AERs) voluntary filed with the FDA by prescribing doctors and gave their opinions that sulindac was more likely than other NSAIDs to cause SJS/TEN.
Because neither expert had ever prescribed an NSAID, Mutual argued that they were not qualified to testify as they did. Mutual also argued their testimony lacked scientific basis because both experts focused on the voluntarily submitted AERs, which have no quality controls or methodological standards.
The 1st Circuit rejected these challenges to the experts. Both were amply qualified, it concluded, each having more than three decades of experience in their respective fields. As for the use of the AERs, the court said that these constituted “relevant input for a witness who is prepared to opine on the risk-benefit ration based on a range of considerations.”
As its final challenge to the experts, Mutual argued that their pre-trial reports did not adequately disclose the opinions they gave and supporting materials they used at trial. After considering Mutual’s contentions and the experts’ reports in some detail, the 1st Circuit concluded that Mutual “was hardly ambushed” by the experts’ testimony.
The 1st Circuit ended its opinion with a discussion of whether the jury award of $21.06 million was excessive. After describing the severe and permanent damages Bartlett suffered, the court concluded that the award was not “disproportionate to the harm suffered.” In fact, said the court, the outcome of the case was “not surprising or, with respect to sulindac, patently alarming.”
The case is Bartlett v. Mutual Pharmaceutical Company Inc., No. 10-2277 (1st Circuit, May 2, 2012).
Your turn: Do you think the $21.06 million award was excessive?