FDA supreme, for now

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The U.S. Supreme Court ruled in February that manufacturers of FDA-approved medical devices cannot be held liable for defects in design or malfunction, unless the company lied in their application for approval.

This is good news for consumers and for public health, and it may be a harbinger of other FDA regulatory developments to come: An even more important case looms about what liability risks pharmaceutical companies face when sued over alleged adverse effects of FDA-approved drugs.

In the device case, Riegel v. Medtronic, the court agreed (8-1) with the manufacturer that the Food, Drug, and Cosmetic Act expressly pre-empts state-level suits arising from injuries alleged to have resulted from faulty devices approved for marketing by the FDA.

But the more important case, which the Justices have agreed to hear this fall, is Wyeth v. Levine. Miss Levine, a Vermont musician, received an anti-migraine drug (phenergan) in an emergency room — but it was injected into an artery instead of a vein, causing gangrene, which led to amputation of her arm. (The doctors settled, wisely.) She sued the drug-maker, Wyeth, because (she claimed) its FDA-approved label did not contain adequate warnings about the danger of injecting near an artery. In lower courts, she was awarded several millions in damages, but Wyeth appealed, stating its belief the FDA-mandated label required no such warning.

Indeed, since the 2006 rule by which the FDA asserted sole authority over both maximum and minimum label contents — the listing of various warnings and precautions specific for each drug — Wyeth claims it were not even "permitted" to add more complexity to their phenergan label.

The FDA's deputy commissioner for policy, Randall Lutter, said, somewhat ineloquently: "If you put too much junk on the label, people don't understand it. ... There is a risk of overreaction and ignoring it."

The issue of who's in charge of the drug label is not as clear as the expressed pre-emption for medical devices (the law states clearly the FDA approval on medical devices takes precedence over state laws, including tort litigation). There is no such statute regarding drugs, so the drug companies rely on "implied pre-emption" to win the day.

Recent Supreme Court decisions point toward the court's support for this concept, so the outlook for a pro-industry decision is positive — and that would ultimately be pro-consumer, since the danger of suits in state after state can create a disincentive to put drugs through the centralized FDA approval in the first place. If FDA pre-emption is endorsed by the Supreme Court, drugmakers will get substantial protection from frivolous lawsuits that have sent some companies reeling.

Even so, tort actions for unpredictable drug effects will not be completely stymied by even a Supreme Court win. What would a verdict finally establishing nationwide FDA pre-emption on pharmaceutical tort liability mean — and how big a boon might it be for consumers?

If the court reins in predatory lawsuits and unjustified jury awards, perhaps drug innovation will return to the healthy pace of the "fast-track" approval years of 1997-2003. Further, fewer tort lawyers will be able to go on fishing expeditions, abusing the discovery process in hopes of finding some document, e-mail or letter that will make a drug company look guilty in the eyes of jurors. It is usually easy to find such a purported smoking gun, since the drug development process typically takes more than 10 years (and a billion dollars) to navigate, producing plenty of documents and data to sift — while plenty of "whistle-blowers" circle overhead, enticed by a potential windfall.

If the court sides with the injured patients, the current 50-state patchwork of tort laws will go on as is. Each venue will decide for itself how to apply corporate liability for each adverse drug effect and each unpredictable allergic reaction. Tort lawyers will continue to entrance lay juries, who tend to focus on injured patient-plaintiffs (or their survivors) instead of parsing complex medical issues. The lawyers will continue to extract lucrative awards from deep-pocket drug developers. Never mind that this process is choking off the production of new, lifesaving drugs as never before — leaving those with cancer, heart disease, AIDS and neurodegenerative diseases to hope against hope that drug companies will ignore the threat of frivolous litigation and keep on producing safe, effective drugs.

All drugs may have side effects. But the net benefits of FDA-approved drugs outweigh their risks, when used appropriately. The decision to allow a new drug on the market should rest with the FDA. The decision to prescribe it should belong to doctors and patients. These decisions should not involve tort lawyers and juries. Let's hope the Supreme Court agrees.

Gilbert Ross, M.D., is executive and medical director of the American Council on Science and Health (ACSH.org, HealthFactsAndFears.com).