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 8–1 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. In a brief press release in response to the decision, Bill Hawkins, Medtronic's president and CEO, stated, “This is a very important decision, which ensures that patients continue to have appropriate access to innovative, life-saving medical devices. The decision recognizes the rights and interests of the vast majority of patients who benefit from a medical device.”

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. Justice Ruth Bader Ginsburg, the lone dissenter among the justices, contended that “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.”

However, legal experts familiar with the case argue that the ruling—although momentous—may not have as great of an impact on patients as many opponents contend.

Distinguishing PMA from 510(k)

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 claims—a 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.”

Isbester points out that the PMA process will remain expensive, uncertain, and time-consuming. “But maybe with Riegel, it becomes just a little more attractive to manufacturers of medical devices wanting to chart their own path to marketing approval,” he says.

Preserving FDA Authority

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. “FDA—and not a patchwork of state regulations or multiple jury verdicts—should determine the safety and effectiveness of medical technology,” Ubl said. “We are pleased today's ruling will allow FDA to continue its science-based approach to approvals and prevents the inconsistencies in standards and delayed patient access to products that would occur if juries or others were to impose additional regulatory hurdles.”

Similarly, in issuing the majority opinion of the court, Justice Antonin Scalia noted that permitting state-law claims that companies ought to have done more to ensure device safety would be disruptive to the federal system for approving devices. “A jury . . . sees only the cost of a more dangerous design, and is not concerned with its benefits,” Scalia wrote. “The patients who reaped those benefits are not represented in court.”

Scalia's contentions echoed the long-standing position of the medical device industry. Prior to the justices' ruling, AdvaMed—in conjunction with Medmarc Insurance Group, the Medical Device Manufacturers Association, and international attorney organization DRI—filed an amicus brief with the Supreme Court. The brief argued that FDA should continue to be the sole regulator of medical devices and that allowing a state-law liability approach to assessing safety and effectiveness would lead to reduced patient access to essential medical technologies.

“FDA is the party best suited to balance the risks and rewards of medical technology innovations,” says 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 tradeoffs.”

Not Out of the Woods

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 immediately file summary judgment motions seeking dismissal of those lawsuits. “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 (D–MA) 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 medtech 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.”

Business as Usual

Indeed, despite the significant amount of attention the Riegel decision has garnered, the ruling will likely do little to affect public health or the day-to-day practices of medical device firms. “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 redress for injured patients.”

Lockard agrees. “The decision does not preclude lawsuits against manufacturers who failed to comply with FDA's specifications and labeling rules during the process,” she says. “Thus, the next battleground in medical device product liability litigation will be a fight over whether the company complied with FDA requirements imposed on the product.”

Quinley adds, “It's important to remember that Riegel will only affect a small slice of the universe of medical device product liability claims. Most medical device claims flow from non-PMA devices, and injured patients can still file suit against manufacturers of those products on any basis they like. And even for a PMA product, injured patients can still sue for manufacturing defects. Further, they can still pursue claims against a doctor who used a device inappropriately.”

Quinley notes that physician device misuse played a huge role in Riegel. Charles Riegel, now deceased, sued Medtronic for injuries he suffered when a balloon catheter manufactured by the company burst during angioplasty. Contrary to the catheter's warning label, Riegel's physician inflated the device beyond its specified rate burst pressure. Moreover, the catheter was contraindicated for use in patients who, like Riegel, had diffusely diseased and heavily calcified coronary arteries.

“It seems like a pretty clear-cut case of medical malpractice,” Quinley says. “But the doctor was never sued because the deep pockets were perceived to be at the device manufacturer level.”

Just as Riegel does not signal an end to claims against manufacturers, it's also unlikely to have a drastic effect on the path by which most medical devices are cleared to market. Although PMA devices will come to market under an added level of legal protection not available to 510(k) devices, the 510(k) will continue to be an attractive regulatory path.

“In the occasional case where a manufacturer could elect one path or the other, it will have to balance the potential long-term protections of preemption under the PMA process against the immediate and substantial costs and delays of the PMA process,” says Brooks Magratten, a partner in the law firm of Vetter & White (Providence, RI). “For a new manufacturer, short-term considerations may prevail.”

“The 510(k) route is much less expensive to pursue and much quicker—so it leaves more of a product's patent life available after the device is approved,” adds Mark Herrmann, a product liability defense partner in the Chicago office of law firm Jones Day. “Manufacturers will probably continue to use the 510(k) route even though that route does not offer the benefit of preemption.”

Quinley agrees that the business imperative of getting to market faster via 510(k) clearance is likely to override the enhanced legal protection afforded to PMA devices. “To choose the PMA path for that reason would be the risk-management tail wagging the business dog,” he says.

© 2008 Canon Communications LLC

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