BB&T Executive Editor
and KARL THIEL
BB&T Contributing Writer

The Supreme Court's recent decision in Riegel v. Medtronic comes at a difficult time for the FDA. And it was certainly the best news the agency has had in some months because the Court backed up its authority as trumping state liability laws.

Consumers, consumers advocates and the general media generally billed the ruling as a win for the medical device industry and essentially a slap in the face for consumers wanting to seek redress when healthcare devices go wrong.

But do we really want a weaker — or much weaker — FDA? Though the ruling blocks compensation by state courts to those harmed, a ruling for Riegel would have had much broader implications for consumers of healthcare. Backing Riegel would have opened up a veritable Pandora's cornucopia of lawsuits that the agency would have had to participate in at the state level, whether as "expert witness" defending its regulatory process, or, even worse, a defendant. often, probably, as defendant.

Having to defend itself against state court second-uessing concerning devices gone bad would would serve to undermine its already shaky regulatory foresight and its claim to being the global "gold standard" of medical regulation. And the costs of litigation would onlly add additional hefty dollars to the already high costs of medical technologies.

The agency is under enough pressure these days, constantly being pelted with the slings and arrows of accusations that it isn't doing its job (by its own science board), those criticisms ranging from weak leadership to lousy IT systems; calls for removal of its chief executive, Andrew von Aschenbach (by Representative Bart Stupak [D-Mich.]); and charges of shoddy oversight concerning the safety of various products (mostly of drugs, but many still questioning its role in the quick approval of drug-eluting stents).

But the justices were really only doing what they are supposed to do: stick to the essence of the law. Rather than rehashing each minute detail of the initial case, the Court is concerned with the correctness of decisions by the lower courts, in this case whether or not those courts had ruled correctly on federal preemption, based on the preponderance and strength of federal laws and guidelines.

Fingers pointing various directions

The original circumstances was this: Charles Riegel in 1996 suffered a serious injury after a balloon catheter made by Medtronic burst while he was undergoing an angioplasty procedure. Riegel's physician reportedly had inflated the balloon to too high a pressure, but Riegel nonetheless took the manufacturer to a state court, saying in part that the product was unsafe and that FDA had erred in approving it.

The physician's argument was that he had been guided by a visual on the labeling that suggested that the pressure could be increased, pointing a finger of blame at Medtronic.

Medtronic's argument was that the device was FDA approved, in effect, a prima facie demonstration of its safety (thus putting the blame back on the physician) and saying that, in any case, it was protected from state lawsuits by federal preemption written into the Food, Drug and Cosmetic Act.

Even Riegel's lawyer acknowledged that it would have been more comfortable to take a stronger case to the Court, but the device's safety, or lack therof, wasn't the issue for the Justices, only on the quality of the decisions of the lower courts.

And Riegel was rebuffed at each level of the federal court system, albeit with some dissents along the way. That might have made this case seem like a shoe-in for affirmation without comment by the high court.

But there may have been a compelling reason for the Supreme Court to take the case • probably simply to make these types of cases, finally, go away and not bother the legal system any more with the issue (though other inevitaly are likely to arise, given the litigous nature of U.S. society).

Some key differences

Importantly, Riegel v. Medtronic isn't the first case in which "the Supremes" had dealt with the ability of federal product law to pre-empt state laws.

In 1996, the Court heard a somewhat similar case, also concerning Medtronic (those deep-pocketed chaps, once again). And in that case the Court found that federal action did not preempt state action.

But there is a key difference between Medtronic v. Lohr and Medtronic v. Riegel. In Medtronic vs. Lohr, the product in question was 510(k)-cleared, while the catheter allegedly gone bad in the Riegal case had received the more rigorous PMA approval.

The court backed federal preemption in the PMA-approved device case 8 to 1. Justice Antonin Scalia, arguing for the majority, wrote that any state tort law requiring a device to be safer than the FDA requirement constituted a "new requirement" that was disruptive to the federal regulations.

Law change rather than wrong decision?

So if you are among those that didn't like the decision, you are on firmer ground to ask for a change in the law than in charging that the Supreme Court decided incorrectly.

And already, some members of Congress are making noises about doing some law-changing and seeking a legislative correction. Rep. Henry Waxman (D-Calif.) told the Washington Post that "this isn't what Congress intended, and we'll pass legislation as quickly as possible to fix this nonsensical situation."

But because the Court is less concerned with a law's intent than what a law says, some sort of new legislation will indeed be necessary to strengthen state liability laws and the right for consumers to sue — not very probable, given all the other things that Congress will probably be busy putting off doing as it waits for November's presidential balloting (and then what?)

Additionally, given the general concerns about how robustly the FDA goes about its job, any move to undermine federal preemption would further weaken the agency when everybody is asking that this agency be strengthened.

The agency keeps getting told to do more jobs without a commensurate increase in resources and, in real terms, its resources constnatly declining. But even with improved funding, adverse events will happen with the use of devices and drugs and consumers will want to sue the companies that made them.

On to drugs and preemption

So will Riegel foreshadow the high court's decision concerning drugs, also set for review? We have to wait a few months for that answer.

In January, the Supreme Court agreed to hear Wyeth v. Levine, a case that involves the nausea drug Phenergan (though the Court early this month made a narrow, and rather confusing decision on the device side [see sidebar]).

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 (the loss made significantly worse by the fact that she was a guitarist).

Similar to Riegel, Wyeth v. Levine is a question of whether a state claim is preempted by 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 on Feb. 25, and the judges clearly struggled to find the line where preemption should begin.

Drug makers are perhaps less likely to get the broad protection that was won by Medtronic. (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 have produced some critical questions about where the preemption line should be drawn. For instance, the approval of Ketek was allegedly based in part on fraudulent clinical data. Would a theoretical FDA decision that was clearly errant be preempted from state suit?

One would think not, but it's something the high court may have to address.

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 these 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 ends, that's all to the good.

And that's how we think the legal system is supposed to work: Lawmakers make laws; courts interpret them • and we can only hope they do it correctly.

'Supremes' tie 4-4 on narrow drug preemption case

The U.S. Supreme Court in early February voted 4-4 in the case of Warner-Lambert Co. v. Kent, offering a distinctly narrow decision on the broad pre-emption issue that the court will take up in its next term.

The tie vote affirms the ruling by the lower New York appeals court that rejected Warner Lambert's argument that the reasoning of a previous high court precedent barred individual damage suits based on the claim that a drug manufacturer obtained FDA approval through fraud.

A ninth vote on the issue was not made because Chief Justice John Roberts recused himself because of holding stock in Pfizer. And the tie vote resolves only this particular dispute, without setting a precedent for other cases.

In the next, broader case of Wyeth v. Levine, the question is whether the FDA's approval of a drug's label precludes individual damage suits based on the claim that the label failed to include sufficient information or adequate warnings.