Supreme Court Ruling Changes the Landscape in Medical Device Lawsuits
From the desk of Hector Lombana
The recent U.S. Supreme Court ruling in the case of Riegel v. Medtronic has taken a significant toll on the rights of injured patients in cases involving defective medical devices. The Court ruled in favor of Medtronic, one of the largest makers of cardiovascular devices, and found that manufacturers of federally approved medical devices cannot be sued under state law if the device causes an injury.
Those who represent the victims of faulty medical devices are now preparing for a flurry of court filings from manufacturers such as Medtronic asking that lawsuits involving their products be dismissed.
In the Riegel case, the Supreme Court concluded that Congress intended that the FDA's pre-market approval (PMA) process would bar patients from filing lawsuits that second-guess regulators' judgments about the safety and effectiveness of approved devices. The Court also ruled that the labels that companies develop to warn of side effects and limitations are adequate because they, too, receive FDA review.
The lawyers of Gamba & Lombana as well as others who represent injured patients believe that there is a serious flaw with the Supreme Court's reasoning. The majority of the new medical devices that are covered under the ruling are actually variants of standard pacemakers and other products that were already on the market in 1976 when Congress enacted the law. The FDA does not require extensive safety and effectiveness testing for these products before approving them for use, yet they are now protected under the new ruling. For example, Medtronic's own Sprint Fidelis heart defibrillator lead, which the manufacturer recalled after reports that the wires were more prone to deadly fractures than the company's older model, was classified as a supplement to earlier leads and approved in less than 30 days despite a major change in how the wires were welded.
Two crucial figures in the passage of the original 1976 device law, Representative Henry Waxman of California and Senator Edward Kennedy of Massachusetts said in the days following the ruling that it was contrary to Congress's intent and they would introduce legislation to overturn it.
For the present, medical device injury lawsuits involving design flaws will be restricted. The focus will shift to whether a manufacturer failed to follow the safety processes set forth in the documents approved by the FDA.
The full implications of this ruling by the Supreme Court will become apparent in the months to come. These lawsuits may be barred even in cases where manufacturers deceived regulators by providing false or incomplete information regarding the safety and effectiveness of the product in order to secure FDA approval. Lawyers will be precluded from gaining access to this information through discovery to prove such violations of the product approval process took place.
Unfortunately for the victims of faulty medical devices, the Supreme Court decision will act to shield medical device companies from most product injury lawsuits. Prior to this decision, medical device manufacturers, even with the threat of lawsuits, were not able to effectively ensure product safety. Without the threat of lawsuits, medical product safety problems will become more prevalent.
This further elaborates on the ruling:
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.”
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.”
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.