An appellate court has upheld a decision protecting pharmaceutical companies from a product liability lawsuit over warning labels.
The ruling immunized Pfizer and GlaxoSmithKline from claims that pre-existing drug warning labels had not sufficiently articulated safety risks on Pfizer's Zoloft and a generic version of Paxil, made by Apotex. Families representing two patients who committed suicide after taking selective serotonin reuptake inhibitors (SSRIs) were told that FDA personnel are responsible for the accuracy and approval of drug labels, not state courts.
The 2-1 ruling demonstrates the concept of “pre-emption,” or federal regulatory law superseding state-law tort actions. The decision stopped short of deciding “whether pre-emption would be appropriate under different facts” or “whether the FDA's mere approval of drug labeling is sufficient to pre-empt state-law claims,” according to a majority opinion written by circuit judge Dolores Sloviter. “Our holding is limited to circumstances in which the FDA has publicly rejected the need for a warning that plaintiffs argue state law requires.”
In a dissenting opinion, circuit judge Thomas Ambro noted that “state tort law complements FDA provisions on drug warnings, in part by eliciting more information than the FDA would glean otherwise from pharmaceutical manufacturers.”
The “pre-emption” ruling follows a similar decision in the Supreme Court last February that found in favor of Medtronic, a manufacturer of medical devices. In that case, Medtronic was exempted from a liability suit over a malfunctioning catheter, since the device had received premarket approval from the FDA.
“The Medtronic decision is, across the board, much stronger for the medical device industry than the appellate decision is for pharma, because it's so narrow. The only claim [successfully pre-empted] is the failure to warn patients – the ruling doesn't address design defects or manufacturing negligence,” said Richard Samp, chief council, Washington Legal Foundation.
In October, the Supreme Court is scheduled to hear Wyeth v. Levine, a pre-emption case related to drug safety that could further solidify current precedent. Several lawyers told the Philadelphia Inquirer that the case “could determine the scope of future pharmaceutical litigation unless Congress intervened.”
Brian Wolfman, director of Public Citizen Litigation Group and currently a legal representative of Diana Levine, said the appellate court decision will certainly have a short-term effect, but is confident that plaintiffs will ultimately succeed. “State drug-liability laws have peacefully co-existed alongside FDA regulation for 70 years,” says Wolfman.
On the upcoming Supreme Court case, Wolfman says a major precedent is possible but unlikely, given the judges' tendency to avoid broad pronouncements. “The [Supreme] Court typically eschews that approach, and focuses on the particular details of the specific case.” However, “the devil is--in some degree--in the details,” he said.