FROM THE EDITORS
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“That result would be devastating for medical device manufacturers, which could then be placed in the position of having different state courts imposing different standards of safety and warnings—many of which would conflict with FDA’s process,” says Patrick Lewis, an attorney with Porter, Wright, Morris & Arthur LLP in Cleveland.
The device industry has argued that FDA approval shields device companies from liability lawsuits for premarket approval (PMA) products. Many lower courts have agreed. The case, Riegel v. Medtronic (06-179), involves a patient, Charles Riegel, whose Medtronic catheter burst inside of him during an angioplasty. As a result, Riegel then required bypass surgery. Medtronic maintains that the doctor was using the catheter off-label.
A decision in Riegel’s favor could shift the tide against the industry. An increasing number of cases in the federal appeals courts have found that the FDA regulation of the devices and the PMA process does protect the companies from lawsuits.
“This case fits into the larger question of whether federal agency regulation of a product preempts state law product-liability claims such as failure to warn,” says Lewis. “There has been litigation recently as to whether a pharmaceutical manufacturer is under a duty to warn physicians about possible side effects to a drug, even if FDA determines that no warning is necessary or prudent.”
The concern, he says, is that manufacturers could be put into a catch-22. “State courts could impose failure-to-warn liabilities on them because FDA decided that the manufacturer ought not to warn about a particular danger,” he says.
The 2nd U.S. Circuit Court of Appeals in New York last year upheld a lower court ruling that dismissed Riegel’s suit. The appeals court noted that device manufacturers cannot alter their products, once on the market, without FDA approval.
In its 1996 decision in Medtronic v. Lohr, the Supreme Court held that all three claims—based on defective design, defective manufacture, and failure to warn—were not preempted by the Medical Device Amendments.
“In a highly fractured opinion, the Supreme Court decided in the Lohr case that Section 360(k) of the Federal Food, Drug, and Cosmetic Act did not provide preemption to medical devices identified under Section 510(k) as being substantially equivalent to devices marketed prior to the 1976 Medical Device Amendments,” says Lewis. “The holding in Lohr was that the substantial equivalence finding by FDA does not constitute significant enough regulation of the device to justify preemption.”
Lewis notes that in the Lohr case there was disagreement among the justices as to whether medical devices regulated under the PMA process would qualify. “Justices Stevens, Kennedy, Souter, and Ginsburg felt that state law products liability claims would be rarely preempted, whereas Justices O’Connor, Rehnquist, Scalia, and Thomas felt that preemption did apply. It now appears that the Court has decided to revisit that issue in Riegel.”
According to published reports, the justices ignored the advice of the Bush administration in the Riegel case. The administration had agreed with a federal appeals court and recommended last month that the court turn down the case. The Court will hear the case in October 2007.
Lewis says that he certainly will be watching the PMA process with great interest. I suspect that the rest of the device industry will be as well. A decision against Medtronic—and the device industry—would be a disaster for device manufacturers.
Sherrie Conroy for the Editors
