BioWorld Today Columnist

The Supreme Court's recent decision in Riegel v. Medtronic comes at a difficult time for the FDA. The agency has been accused of shoddy oversight of a number of products. The kind of problems that once seemed rare have become much more common of late.

Consider the controversies involving the agency that have been in the headlines over just the past few weeks: There's Merck and Schering-Plough's cholesterol drug, Vytorin; the Sanofi-Aventis antibiotic, Ketek; Bayer's heart drug, Trasylol; Pfizer's smoking cessation drug, Chantix; Allergan's Botox; and Baxter's heparin. That's quite a list, and it's only February. A November 2007 report from the FDA's own science board called into question the agency's ability to meet its own mandate.

Yet, just as Rep. Bart Stupak (D-Mich.) has called on FDA Commissioner Andrew von Eschenbach to resign, the Supreme Court has declared that the buck stops with the agency as far as determinations of medical device safety go. Its decision said, in essence, that liability suits cannot be brought in state courts concerning a product that has been declared safe by the FDA.

Consumers might be forgiven for thinking that they're stuck between a rock and a hard place. They've just lost some power to redress injuries associated with the decisions of an overburdened and, according to some, incompetent agency.

Yet despite some handwringing in the New England Journal of Medicine, The New York Times, and elsewhere, I believe the court's decision was legally straightforward - almost inevitable. It narrowly applies to medical device regulations, which have specific language about state preemption that would have been hard for the justices to ignore.

That still doesn't leave consumers feeling better protected now, however. Already, some members of Congress are making noises about a legislative fix to what the court has decided. Rep. Henry Waxman (D-Calif.) was quoted in the Washington Post as saying, "this isn't what Congress intended, and we'll pass legislation as quickly as possible to fix this nonsensical situation."

Waxman may be right about congressional intent - but anyone who follows this Supreme Court knows that the justices pay scant intention to intent and stick to a narrow reading of the law. And a legislative solution would be a welcome thing. But instead of concentrating on reinforcing the right of the U.S. consumer to sue anything and anyone, legislators ought to concentrate on strengthening the FDA, which has been burdened with major new responsibilities over the past several years even as its budget has declined in real terms.

Of course, even with a better-funded, better-run FDA, mistakes still will happen. And consumers should have some recourse. But before legislators look to make a broad change to tort law, we'll need to know if drug manufacturers, too, will get the kind of broad shield granted device makers under the Riegel decision.

That case involved Charles Riegel, who in 1996 suffered a serious injury after a balloon catheter burst while he was undergoing an angioplasty procedure. Riegel's physician reportedly was using the catheter in a manner not approved - inflating it to too high a pressure - but Riegel nonetheless sued the manufacturer, saying in part that the product was unsafe and that the FDA had erred in approving it. Medtronic moved to dismiss the case, arguing that because the FDA had approved the device, state damage proceedings were preempted by the Food, Drug and Cosmetic Act.

The Supremes found in favor of Medtronic by an 8-1 majority - only Justice Ginsburg dissented - and there was a partial concurrence from Justice Stevens. Indeed, Riegel was rebuffed at each level of the federal court system, albeit with some dissents along the way, which might have made the case seem like a shoe-in for affirmation without comment by the high court. But there was a compelling reason for the Supreme Court to take the case.

Back in 1996, the Supreme Court heard a seemingly similar case, also concerning Medtronic, and in that case, found that state action was not preempted by FDA action. The chief difference in Medtronic v. Lohr, however, was that the product in question was approved by 510(k), not by a more rigorous product marketing application (PMA). The 510(k) requires companies to file paperwork but doesn't involve a comprehensive review on the part of the agency, while a PMA is more akin to the arduous new drug application process.

Justice Scalia, arguing for the majority, stated that any state tort law requiring a device to be safer than the FDA required constituted a new "requirement" that was disruptive to the federal regulations, and therefore was preempted.

So will Riegel also apply to drugs? We won't have to wait long for an answer. In January, the Supreme Court agreed to hear Wyeth v. Levine, a case that involves the nausea drug Phenergan. A woman from Vermont was awarded $6.8 million by a jury after she lost an arm to gangrene following incorrect administration of the drug. Similar to Riegel, the case involves a question of whether a state claim is preempted by the FDA's approval of the drug. In this case, Levine claims the FDA-approved labeling was unsafe. The case will be argued in October.

Another case that bears on a similar situation, Warner-Lambert v. Kent, concerns the drug troglitazone, withdrawn in 2000 due to liver toxicity. It was argued Feb. 25, and the judges clearly struggled to find the line where preemption should begin.

Drugmakers are unlikely to get broad protection. Even Riegel didn't prevent a suit concerning faulty manufacture of an approved product - that was a separate issue that Medtronic settled with Riegel years ago. In the case of drugs, today's headlines draw some real questions about where the preemption line should be drawn. For instance, the approval of Ketek allegedly was based in part on fraudulent clinical data. Would a theoretical FDA decision that was clearly errant be preempted from a state suit? One would think not, but it's something the High Court may have to address. And if it doesn't, then Congress will - hopefully by making a stronger FDA and a clearer set of laws on how liability should be pursued.

If those decisions draw attention to the need to improve FDA, that's all to the good. And if narrowly drawn rulings help Congress to clarify where liability starts and stops, that's good, too. That's how it is supposed to work. Lawmakers make laws, and the courts interpret them.