FDA approval preempts medical-device injury claims, Third Circuit says.

A divided Third Circuit panel has ruled 2-1 that the survivor of a patient injured by an FDA-approved medical device cannot sue the manufacturer under Pennsylvania law. (Horn v. Thoratec Corp., 376 F.3d 163 (3d Cir. 2004).)

The 1976 Medical Device Amendments (MDA) to the Food, Drug, and Cosmetic Act included an express preemption clause that nullities any slate or local safety or efficacy requirements "different from, or in addition to" the act's requirement, the court held.

The device, a heart pump, was subject to extensive scrutiny by the FDA during its premarket approval (PMA) process, wrote Judge Leonard Garth, who, along with Judge Thomas Ambro, found that a lower court correctly dismissed the suit because its common law claims would conflict with the federal requirements of that process.

Other circuits--including the Sixth, Seventh, Ninth, Tenth, and Eleventh--have addressed when and how preemption applies to cases involving approved medical devices. The ingredient added to the stew in the Third Circuit's pot was an FDA amicus curiae brief in which the agency reversed its previous stances favoring detachment or supporting consumers' rights to sue in state court: The brief argued that preemption should apply.

The agency claimed that lay judges and juries in state suits "second guess" the FDA's assessment of the benefits and risks of a device. The threat of damages, it argued, pressures manufacturers to either add warnings that the FDA has not found to be scientifically required, or to withdraw products that it has determined to be safe and effective.

"This situation can harm the public health by retarding research and development and by encouraging 'defensive labeling' by manufacturers to avoid state liability,, resulting in scientifically unsubstantiated warnings and underutilizations of beneficial treatments," according to the agency's brief.

But its position "is one of improper involvement in private litigation," said plaintiff attorney Dan Sigelman of Washington, D.C., adding that FDA General Counsel Dan Troy is at the helm of this movement "to basically throw private plaintiffs out of court."

The device at issue, the HeartMate pump by Thoratec Corp., was designed to assist blood flow in cardiac patients. The PMA process stretched over 10 years of studies plus seven years of clinical trials before the device gained approval in 1994.

When Daniel Horn had a heart attack in January 1998, doctors determined that he needed a heart transplant, and he was put on the list for a donor. His condition worsened, and a HeartMate pump was implanted to aid circulation. Three months later, he began bleeding from an area where the pump's tubing exited his body. Exploratory surgery determined that a suture had worn off and a crucial component had disconnected, permitting an air embolus to form. Horn suffered a brain hemorrhage and died.

His wife, Barbara, sued in U.S. district court in Pennsylvania, claiming defective design and manufacture and failure to warn of the alleged defects. The district court granted Thoratec's motion for summary judgment on the grounds that the MDA expressly preempted state law claims.

The court used a two-prong test: State claims about the safety of medical devices are preempted if the FDA has established specific federal requirements that are applicable to that particular device and if the state claim is different from, or in addition to, the specific federal requirements.

The district court held that Horn met the test: The PMA process imposes a specific federal requirement on the HeartMate, and "any judgment that the HeartMate was unsafe or otherwise substandard would be in direct conflict [with]--i.e., different from--the FDA's determination that the product was suitable for use."

Before the Third Circuit, the plaintiff argued that her state common-law claims would impose generally applicable duties for manufacturing and labeling--not specific requirements for the HeartMate--relying on another suit involving an FDA-approved device in which the U.S. Supreme Court found that preemption did not apply. (Medtronic v. Lohr, 116 S. Ct. 2240 (1996) .)

But in that case, the Third Circuit said, the FDA used a different approval process and determined that the device was "substantially similar" to an existing, approved device. The premarket notification submitted under that process is "entirely different from a PMA, which must include data sufficient to demonstrate to [the] FDA that the device is safe mad effective," said the agency's amicus brief.

The PMA process for the HeartMate was more rigorous, the court said, and it did impose federal requirements. "Other courts of appeal have held that PMA approval by the FDA constitutes approval of the product's design, testing, intended use, manufacturing methods, performance standards, and labeling that is specific to the product," the court wrote.

"The FDA, when PMA approval is granted, imposes federal requirements based on the highly detailed and prescriptive nature of the PMA process and the approval order that results from it."

Because of the "extensive consideration by the FDA leading up to its PMA approval, any finding in Horn's favor based on her general claims of negligence or defective design and manufacture--be it by a jury or a court--would necessarily amount to a state substantive requirement 'different from, or in addition to, the federal requirements imposed by the FDA,'" the court wrote.

Judge Julio Fuentes disagreed that Horn's claims imposed specific state law requirements on the HeartMate and said the case should have been allowed to proceed. "I believe that allowing common-law liability would simply have the effect of encouraging [Thoratec] and other device manufacturers to go above and beyond FDA standards, and this effect would clearly not contradict the MDA's purpose of enhancing medical device safety," he wrote.

Given the circuit courts' trend toward preemption of these cases, said Sigelman, when there is a chance that the defendant didn't comply with the FDA requirements, there may be fact questions to be tried.

"In the Third Circuit case, there was no evidence that the defendant didn't comply, but had there been such evidence, it might have conic out differently," he said.

Meanwhile, lawyers who take a case like Horn "who don't think they can come up with evidence at least creating general issues of material fact regarding compliance with the PMA are taking the case at their peril," Sigelman said. Horn has requested a rehearing by the full Third Circuit.