On February 20, the U.S. Supreme Court handed Medtronic Inc. (Minneapolis) a resounding victory in a much-watched and long-fought product liability dispute. In issuing their landmark decision, the justices established a new level of legal protection for medical devices cleared to market via the premarket approval (PMA) path.
In an 81 decision in the case of Riegel v. Medtronic Inc., the justices ruled that the preemption provision of the Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act overrides most state-law claims seeking damages for injuries caused by medical devices approved by FDA under the PMA process.
While the decision was widely lauded by the medical device community, many consumer advocate groups have expressed outrage over the decision, which they view as significantly limiting the legal recourse of patients injured by medical devices.
However, legal experts familiar with the case argue that the rulingalthough momentousmay not have as great of impact on patients as many opponents contend.
Victoria Davis Lockard, a partner in the law firm of Alston & Bird LLP (Atlanta), says the Riegel decision represents a watershed event for the medical device industry. "Not only will it limit the number of lawsuits, but it will allow for more certainty and consistency in the standards by which these devices are judged to be safe," she says.
At its core, the Court's opinion confirms that the federal PMA process preempts state-law tort claimsa protection not afforded to devices that undergo the less-rigorous 510(k) path to market. James Isbester, founder of Isbester & Thackray LLP (Berkeley, CA), notes that this distinction is key. "As the Supreme Court notes, the PMA process is comparatively rare," he says. "In 2005, FDA granted more than 3000 510(k) approvals, but only 32 PMAs. Riegel will apply to only a tiny percentage of the products on the market. So at first blush, one might regard Riegel as a 'so what' decision. That is probably a mistake.
"Although PMA devices may be only a small portion of the market, they are the bedrock products," Isbester adds. "Without one product undergoing the PMA process, hundreds of subsequent products could not take advantage of 510(k). Riegel clearly reduces one of the big risks associated with the introduction of a new medical technology and, therefore, increases the incentive to innovate in this area."
Stephen J. Ubl, president and CEO of industry association AdvaMed (Washington, DC), noted that the ruling reaffirmed what two previous lower court rulings in this case had already made clear: that the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act expressly provide for FDA's ultimate regulatory authority over medical devices. "FDAand not a patchwork of state regulations or multiple jury verdictsshould determine the safety and effectiveness of medical technology," Ubl said.
"FDA is the party best suited to balance the risks and rewards of medical technology innovations," agrees Kevin M. Quinley, senior vice president for Medmarc Insurance Group (Chantilly, VA). "For all its imperfections, the agency is in the best position to assess those trade-offs."
Based on the Riegel ruling, Caryn M. Silverman, a partner in the New York office of the law firm of Sedgwick, Detert, Moran & Arnold LLP, expects to see device manufacturers sued in pending cases involving PMA devices to file summary judgment motions seeking dismissal. "The Riegel decision should support the dismissal of many pending claims in those suits," she says.
Despite the favorable ruling in Riegel, Lockard notes that the medical device industry is not yet in the clear when it comes to preemption for PMAs. "The reaction by some members of Congress has been immediate, and we will certainly see legislative efforts to respond to the decision," she says.
Indeed, immediately following the ruling, Senator Edward M. Kennedy (DMA) issued a statement that read, "In enacting legislation on medical devices, Congress never intended that FDA approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices," he says. "Congress obviously needs to correct the court's decision. Otherwise, FDA approval will become a green light for shoddy practices by manufacturers."
However, many industry observers have been quick to dispute the generalizations being made by politicians and public health advocate organizations in protesting the Riegel decision.
"To say that this decision conveys blanket immunity to device manufacturers is a gross overstatement," Lockard says. "The decision applies only to those Class III devices that went through FDA's premarket approval process. The decision also allows for exceptions where state requirements mirror the federal requirements or where a company failed to comply with FDA specifications and labeling rules."
"It's easy to get caught up in hyperbole," Quinley says. "But the Riegel decision does not represent a sea change in issues such as insurance pricing, market dynamics, or access to re-dress for injured patients."