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Supreme court ruling sets important precedent for litigation against the medical device industry.

On Feb. 20, the US Supreme Court rendered a ruling making it more difficult for consumers to sue manufacturers of federally approved medical devices. The decision sets a significant precedent for the medical technology industry.

In an 8-to-1 decision, the court ruled against the estate of a patient who suffered serious injuries when a Medtronic catheter burst during an angioplasty procedure in 1996.

At issue was whether the estate of Charles Riegel could sue the company under state law over a device previously cleared for sale by the FDA. The legal question was when the "preemption provision" in the 1976 Medical Device Amendments (MDA) is used to prevent state lawsuits that claim a product is defective or that a manufacturer failed to issue a warning of possible risks. The law bars states from imposing any requirement on top of those mandated by the federal government.

Riegel survived the procedure to unclog an artery, though he suffered permanent disabilities, his family charged. He died in 2004. In Riegel v. Medtronic Inc., the patient's family alleged that the catheter had a design defect and an inadequate warning label. In addition, the suit accused Medtronic of breaching its warranty. Medtronic maintained that the surgeon performing the procedure didn't follow guidance on the device's FDA-approved label not to use the catheter on patients with calcified arteries. Lawyers representing the plaintiffs argued that a manufacturer can use FDA approval as a legal defense but cannot use the law to block state lawsuits altogether.

This most recent ruling means that state lawsuits are barred to the extent they would impose requirements that are different from federal requirements, according to the ruling by Justice Antonin Scalia.

The case dealt only with medical devices that had gone through the premarket approval (PMA) process specified by the MDA. Most devices reach the market through the 510(k) clearance process, by which the FDA finds them "substantially equivalent" to predicate devices. The Supreme Court ruled in 1996 that the 510(k) process does not preempt state damage suits against the manufacturers of such devices.

Medical devices subject to the PMA process, and thus affected by the court's opinion, usually are novel devices, more technologically advanced, expensive and, in some cases, more risky. Devices that have been the subjects of recent lawsuits include implantable defibrillators, spinal cord stimulators, drug-coated stents, artificial heart valves and reconstructive hips and knees.

The Ruling's Implications

It remains too early to tell how many of the pending lawsuits against medical device manufacturers could be affected by the ruling. The court's decision, for example, will not impact lawsuits claiming that a device was made in violation of FDA specifications. Cases also may be brought under state laws that mirror federal rules, as opposed to supplementing them.

As the only voice of dissent, Justice Ruth Bader Ginsburg 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."

She added: "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." Until now, most federal appeals courts that considered this issue had restricted patient lawsuits.

In response, Scalia said it was not the Supreme Court's place to "speculate on congressional motives."

According to an attorney for the Riegel estate, the decision leaves patients without options. "Pretty bad for patients, pretty good for industry profits," Allison Zieve, the lawyer who represented Riegel's widow, told the Associated Press." Clearly a lot of people will lose their ability to have even the possibility of getting any compensation for injuries caused by medical devices."

Following the ruling, Medtronic issued a statement saying the decision reaffirms the FDA's PMA process, which "expertly balances the patient benefits and risks," and" appropriately preempts state tort lawsuits involving devices approved through that process."

Bill Hawkins, president and CEO of Minneapolis, MN-based Medtronic, said the ruling" recognizes the rights and interests of the vast majority of patients who benefit from a medical device."

Industry had argued that a decision against Medtronic would have a chilling effect on device innovation and the number of new products companies brought to market. Scalia agreed, noting that product liability suits would be disruptive to approval process for devices. A jury "sees only the cost of a more dangerous design and it is not concerned with its benefits," he wrote in his decision. "The patients who reaped those benefits are not represented in court."

Within the past few years, the Bush administration has tried to preempt tougher state regulation, reversing longstanding federal policy and arguing that premarket approval of a new medical device by the FDA overrides most claims for damages under state law. Federal law makes no provision for damage suits against device makers, so injured patients have turned to state law--often winning significant sums.

Democratic lawmakers, however, have voiced their support of Justice Ginsberg's dissenting vote. Rep. Henry Waxman (D-CA), chairman of the House Committee on Oversight and Government Reform (he also sat on the House panel that approved the 1976 MDA bill), said the court's decision "strips consumers of the rights they've had for decades," Waxman added: "This isn't what Congress intended, and we'll pass legislation as quickly as possible to fix this nonsensical situation."

Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association in Washington, DC, said the decision reinforces that the Medical Device Amendments provided for the FDA's "ultimate regulatory authority" over medical devices.

"The FDA and not a patchwork of state regulations or multiple jury verdicts should determine the safety and effectiveness of medical technology. We are pleased today's ruling will allow the 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," Ubl said in a statement. "Today's ruling also expressly recognizes the rigorous premarket approval process which entails extensive pre-clinical and clinical testing and thorough expert FDA review and risk analysis to ensure their safety and effectiveness."
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Title Annotation:Top of the News
Publication:Medical Product Outsourcing
Date:Mar 1, 2008
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