The Bush administration told the Supremes that FDA-approved medical devices are shielded from product-liability lawsuits in state courts. That position backs Medtronic in a case that has broad implications for devices makers - at issue is whether patients can sue device makers through state law when their products have already been approved by the FDA. Medtronic argues that the Food, Drug, and Cosmetic Act expressly preempts state law claims brought by patients who were hurt by devices that received premarket FDA approval.

“Even serious problems are exempt from state tort liabilities,” Deputy US Solicitor General Edwin Kneedler told the court when asked about lawsuits over medical-device labeling, Dow Jones reports. [UPDATE: Want to know what everyone said? Here is the transcript, courtesy of Drug & Device Law blog].

[Unlike medical devices, there is no statute providing for preemption for drugs. The battle today centers on whether decisions by state courts and juries should have the right to trump an FDA rule, which the agency and industry say is the final word on safety and effectiveness. In legal parlance, this is the difference between expressed preemption and implied preemption. However, there is no implied preemption covering drugs. Rather, it is an argument offered by drugmakers. The Supreme Court, though, will review a preemption case involving the Rezulin diabetes drug in February.]

The Medtronics case was brought by a New York man, Charles Riegel, who was injured when a Medtronic balloon catheter burst during a 1996 angioplasty procedure. Riegel has since passed away, but his wife charges that the catheter had design flaws and labeling instructions for the device were misleading. The case went to the Supremes after Riegel lost in US District Court in New York and then on appeal.

Allison Zieve, an attorney for Public Citizen who represents Riegel, tried to convince the justices that federal law allows Riegel to sue Medtronic over the device, which had received so-called premarket approval from the FDA. But Justice Antonin Scalia may not have been convinced. “It is clear Congress didn’t want any additional requirements,” he said, indicating he thinks Congress wanted the FDA to regulate medical devices without interference from state regulators or courts, according to Dow Jones.

A majority of the Supreme Court, in fact, appeared to support this view, Dow Jones reports, but the justices probed for the extent to which the FDA’s national regulation of medical devices bars patients from suing in state courts over an approved device. Justice Anthony Kennedy posed several questions aimed at testing the limits of FDA authority over medical devices. For example, he and others wondered if a company can be sued if it sells a device while simultaneously seeking changes to it at the FDA.

Kneedler and Theodore Olson, a Washington attorney representing Medtronic, said federal law only allows product-liability lawsuits when a company fails to report problems with a device and someone is injured or killed because of the flaw. In that instance, a medical-device company would face possible federal charges by the FDA that could be paralleled by a civil product-liability case.

Otherwise, the government said Congress meant to shield companies from lawsuits because approved medical devices meet reasonable safety and effectiveness standards that, on balance, have benefits to some patients even though the device may also have risks, Dow Jones writes.

Zieve said that this view of the law “is incorrect,” because the law doesn’t explicitly single out product-liability lawsuits as barred in provisions that addressed limits on state regulation of medical devices. Several federal appeals court circuits have held federal law doesn’t allow liability lawsuits. In this case, the 2nd US Circuit Court of Appeals affirmed a trial court holding that Riegel could not sue Medtronic over the failure of the catheter.

Hat tip to the WSJ Health Blog