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WASHINGTON-The U.S. Supreme Court will decide how far the federal government can go in shielding manufacturers of certain medical devices from product liability.
Beyond that, the eventual ruling in Medtronic Inc. vs. Lohr could focus attention on how far Congress has intended to go in pre-empting state tort suits and at least indirectly affect other industries.
The case, which the justices accepted for review earlier this month, began in 1990, when Lora Lohr's pacemaker failed and she had to undergo emergency surgery. Her doctors attributed the failure to a defect in the lead wire that delivers an electrical impulse from the pacemaker to the heart. Mrs. Lohr and her husband sued Minneapolis-based Medtronic, which manufactured both the pacemaker and the Model 4011 lead, under state product liability law.
Soon the case was removed to a federal district court, where a judge ruled that state product liability law was pre-empted by the 1976 Medical Device Amendments to the Food, Drug and Cosmetics Act.
Now at the center of the Supreme Court appeal, those amendments were intended by Congress to balance public health concerns with the concerns that medical device innovations not be stifled by unneeded regulations.
Under the amendments, no state or jurisdiction "may establish or continue in effect with respect to a device intended for human use any requirement which is different from or in addition to any requirement applicable under this chapter to the device, and which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter."
Some courts have interpreted this to pre-empt product liability suits against manufacturers of medical devices that the Food and Drug Administration has authorized for market.
Getting to market can be a long road for makers of so-called Class III devices-those that sustain life, are of substantial importance to preventing impairment of health or present a potentially unreasonable risk to patients, such as pacemakers, artificial hip joints, kidney dialysis systems and some breast implants.
The FDA can review these devices under several clearance processes. It can clear a product for experimental use only, or it can allow the product on the market through "pre-market approval" if test data reasonably assure the safety of a product.
Third, and the most common way for devices to get to the market, is through the so-called "510(k) process," named for a section of the Food, Drug & Cosmetic Act. Under this process, the FDA evaluates whether the device is substantially equivalent to devices on the market before the 1976 amendments took effect.
The pacemaker leads manufactured by Medtronic fell into the third category.
On appeal, the 11th U.S. Circuit Court of Appeals in Atlanta took a middle road. It said that claims based on allegations of failure to warn of the device's potential for harm and for manufacturing defects were pre-empted. But, the 11th Circuit said, allegations of design defects were not pre-empted by the amendments.
Both sides sought Supreme Court review, which was granted last week. This is the first case in which the high court will decide whether or to what extent the 1976 amendments pre-empt state product liability suits based on design criteria for Class III medical devices, which were cleared for market through the 510(k) process.
This could prove to be a very important case, explained Brian Wolfman, a staff attorney with Public Citizen in Washington who helped prepare the Lohrs' petition for Supreme Court review.
"What's at stake is the ability of those injured by the use of medical devices to be compensated under the laws of various states. It's an affront to their rights and to the concept of federalism that they would be denied the right to compensation," he said.
"They're saying that the mere permission of the federal agency that the product may be marketed pre-empts the ability of injured consumers to any compensation at all. The fact that it was permitted on the market, not necessarily proved as safe and effective, by the FDA means that they get zero. That's probably the most pernicious example of extension of the pre-emption doctrine that I've seen," Mr. Wolfman said.
Medtronic agrees that the case could be very important.
"(It) would have widespread and profound effects upon the medical device industry and the consuming public, because it would define the scope of potential liability for the vast majority of the most critical medical devices. The court certainly would resolve the scope of pre-emption concerning Class 510(k) devices such as the Model 4011 lead, a question that is being litigated repetitively throughout the country with hopelessly inconsistent results," the company said in seeking Supreme Court review.
"Essentially, the Supreme Court is going to decide the scope of product liability for the entire medical device industry. Although this case involves Medtronic, ultimately the entire industry will be effected," said Jeff Kimbell, executive director of the Medical Device Manufacturers Assn. in Washington.
"It presents the question of whether 510(k) clearance-which is a notification to go to market, it's not an approval-for a Class III product insulates the device manufacturer from product liability claims. If the Supreme Court affirms the pre-emption, it could go a long way toward achieving tort reform without a single vote from this Congress or the next Congress," he said.
Others were less sure about the breadth of the case's potential impact.
Class III devices are unique, pointed out Victor Schwartz, counsel to the Arlington, Va.-based Product Liability Coordinating Committee.
Whatever decision the Supreme Court makes, its impact "will be on the medical device field-which is not small-but it will be difficult to jump from there" to other areas, said Mr. Schwartz, a partner with the Washington law firm of Crowell & Moring.
"This is a classic case where the court has to resolve what a federal law means. There is no one who can predict what will occur," he said.
"The impact potentially on tort law and product liability law by a Supreme Court decision can be profound or otherwise," said Bob Charrow, a former law professor, federal official and expert on medical device law. The case could have "profound implications for everyone who is concerned with pre-emption issues," and its reasoning might be extended to other areas of law, said Mr. Charrow, who also is of counsel with Crowell & Moring.
But like Mr. Schwartz, Mr. Charrow pointed out the uniqueness of Class III devices and the pertinent amendments, noting that the amendments are the only section of the FDC Act that contain any pre-emption language.
An attorney for a consumer advocacy group predicted that the court's opinion on the Medtronic case is only the beginning of a larger legal battle.
"You're going to see a lot more attorneys ask the Supreme Court to grant cert to determine whether state court claims are pre-empted-specifically pesticide claims and claims relating to medical devices," said Rich Vuernick, legal policy director at Citizen Action in Washington.