In what will be seen as a victory for the medical device industry, the U.S. Supreme Court has affirmed the limits on lawsuits against device makers, voting 8-1 to bar a lawsuit filed against powerhouse Medtronic (Minneapolis).
The ruling in the case of Riegel v. Medtronic from the high court gives protection against thousands of lawsuits filed against device companies who received premarket application (PMA) approvals from the FDA, saying patients generally can’t sue in state courts for defects in products that have received that agency approval.
The ruling came rather quickly by Supreme Court standards. The case was heard by the court in early December (Medical Device Daily, Dec. 5, 2007), and many thought a decision would not come down until May.
In 1996, Charles Riegel underwent a balloon angioplasty with a stent placement, with Medtronic’s Evergreen serving as the balloon catheter. The Evergreen’s label indicated a maximum inflation rate of eight atmospheres and the device was contraindicated for patients with calcification in the affected arteries. However, the surgeon inflated the Evergreen used on Riegel to 10 atmospheres causing the device to rupture, and Riegel’s arteries were demonstrably “heavily calcified,” according to lower court documents.
The plaintiff lost the initial trial and subsequent appeal. Riegel died three years ago, and the case was being pressed by his widow.
The lawsuit accused Medtronic of breaching a warranty on the device and negligently designing, manufacturing and labeling the catheter.
Medtronic said the surgeon didn’t follow guidance on the device’s FDA-approved label which warned against using the catheter to treat patients with calcified arteries.
Lawyers for Riegel’s estate argued that a manufacturer can use FDA approval as a legal defense, but cannot use the law to block state lawsuits altogether.
Writing for the majority, Justice Antonin Scalia said the FDA review was “rigorous” and precluded imposition of any additional state liability rules.
Justice Ruth Bader Ginsburg, the lone dissenter, said that Congress never intended “a radical curtailment of state common-law lawsuits seeking compensation for injuries caused by defectively designed or labeled medical devices.” Scalia, in response, said it is not the court’s role “to speculate upon congressional motives.”
With the ruling, states are barred from imposing product requirements different from federal requirements
The ruling will affect the medical devices most frequently targeted in lawsuits: cutting-edge products such as bone screws and defibrillator wires that undergo the FDA’S more rigorous PMA process. Because the PMA process typically takes up to a year or more, companies use it sparingly; only 43 new PMAs were filed in 2005.
Medtronic spokesperson Rob Clark told Medical Device Daily that the ruling was particularly important for medium and smaller medical device companies with fewer than 100 employees, the lifeblood of industry innovation, that could be hurt the worst.
After one of these companies invests major dollars to win PMA process and commercialization, “and then, once that happens, being subjected to 50 [state] standards and laws placing more requirements on that product, for a small- to mid-size company would be particularly devastating. The wherewithal and the means to try to compete and try and bring technologies to market with such a lack of clarity and a lack of standards around what they have to comply with across the country would have been staggering for innovation.”
Steve Ubl, president/CEO of the Advanced Medical Technology Association (AdvaMed; Washington), in a statement termed the ruling “a win for patients and public health and safety. It reaffirms what two previous lower court rulings in this case have already made clear — the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act expressly provide for the U.S. Food and Drug Administration’s ultimate regulatory authority over medical devices.”
Ubl said the “FDA — and not a patchwork of state regulations or multiple jury verdicts — should determine the safety and effectiveness of medical technology” and that the ruling “prevents the inconsistencies in standards and delayed patient access to products that would occur if juries or others were to impose additional regulatory hurdles.”
PMA-approved devices must comply with other rigorous post-market requirements including quality systems regulations, adverse event reporting and post-market surveillance, he said. “This is why many consider the FDA approval the gold standard for safe and effective medical devices.”
Allison Zieve, the Public Citizen Litigation Group (Washington) attorney who represented Riegel’s widow, judged the verdict “Pretty bad for patients, pretty good for industry profits.”
In another case involving Medtronic (Medtronic v. Lohr), in 1996 a splintered Supreme Court allowed some product liability suits over devices cleared under the 510(k) process.
Medical device makers and the Bush administration had argued that the more rigorous federal pre-market system preclude state-law claims that companies ought to have done more to ensure safety. Unfavorable state jury verdicts would compel companies to alter product designs or labels that had received FDA approval, they said.
In his opinion, Scalia largely agreed with those contentions, saying product liability suits would be as disruptive to state regulations as to the federal system for approving devices.
A jury “sees only the cost of a more dangerous design, and it is not concerned with its benefits,’’ Scalia wrote. “The patients who reaped those benefits are not represented in court.’’
Patient advocates will see the ruling in favor of Medtronic as leaving patients unable to win adequate compensation for injuries caused by the riskiest medical devices.
Scalia said that, while states can impose requirements that are “parallel” to federal rules, they can’t have rules that are “different from or in addition to the requirements imposed by federal law.”
In her dissent, Ginsburg wrote: “It is difficult to believe that Congress would, without comment, remove all means of judicial recourse for large numbers of consumers injured by defective medical devices.”
A key question in the case was when the “pre-emption” provision in the 1976 Medical Device Amendments kicks in to bar state lawsuits that claim a product is defective or that a manufacturer failed to warn of risks.
The federal law says pre-emption applies when the U.S. government imposes a “requirement,’’ but not specifying if this term applies to FDA approval.