Who should decide when a medication is safe?

Health and medicine explained.
March 11 2009 1:25 PM

Drug Dealing

Who should decide when a medication is safe?

Diana Levine. Click image to expand.
Diana Levine

The medical events that culminated in last week's dramatic U.S. Supreme Court decision Wyeth v. Levine began in 2000, when Vermont musician Diana Levine came down with a migraine and visited a small medical clinic. Her treatment led to a horrifying complication, and her right forearm—which she used to strum her guitar—had to be amputated. After she sued and received a settlement from her treating medical providers, Levine successfully hunted bigger game: the drug giant Wyeth, which makes the anti-nausea drug responsible for her injury. The story of Levine's victory has narrative gusto: A one-armed children's musician takes down a heartless multinational corporation. But that's the wrong drama to highlight.

Wyeth's failed case hinged on a legal doctrine called "implied pre-emption," which would have allowed companies that comply with FDA regulations—as Wyeth did—to avoid later state lawsuits about the content of their drugs' labels. A win for Wyeth would not (as is popularly believed) have immunized big drug companies from all litigation. A company that intentionally omits important safety data from FDA review (as some allege, for example, about Merck's nondisclosure of the cardiovascular risks associated with Vioxx) would still not be protected. The company could still be sued under product-liability and fraud laws. Furthermore, Wyeth's loss in court may not help avoid future catastrophes, and the ruling has the potential to undermine the centralized authority of the Food and Drug Administration—which, though far from perfect, is arguably the most effective public-health agency in the nation's history.

So, what was the case really about? Let's review what happened to Diana Levine: To treat her migraine, a health provider first injected a combination of Demerol (a narcotic pain reliever) and Phenergan (an antihistamine to reduce nausea) into her muscle. When Levine's pain persisted, the provider concluded the medicine was being absorbed too slowly from the muscle to offer speedy relief, placed an intravenous line in Levine's right arm, and quickly injected another dose directly into Levine's bloodstream. The provider made a serious error by accidentally and unknowingly putting the IV into an artery (a high-pressure, pulsatile vessel going out to the arm) instead of a vein (a low-pressure vessel returning blood to the heart). Dispersed at high pressure throughout the distal forearm, Phenergan caused irreversible blood vessel damage resulting in gangrene and, ultimately, amputation.

There's no question the provider fouled up and was deservedly sued. But how is that Wyeth's fault? The package insert for Phenergan—which is worth reading—clearly warned about the risk of gangrene, explained the danger of accidentally putting the IV in an artery, recommending stopping injections if patients felt any pain, and prescribed a specific infusion rate and dose. According to court documents, the risk of gangrene is only 1 per 10 million doses. Even fool medical students graduating at the bottom of their classes know you're never supposed to inject drugs into arteries.

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Aaron Kesselheim, a Harvard researcher and intellectual-property lawyer, admitted to me that any reasonable physician knows not to inject drugs into arteries. But in his opinion, Wyeth still should have put a "black box" warning about push injections on the package insert decades ago, when the first reports of gangrene surfaced.

By that loose standard, however, every drug given intravenously probably needs one. (Stronger warnings might also be needed for over-the-counter drugs like infant Tylenol, which each year causes thousands of emergency-room visits and a handful of deaths in young children because parents regularly mess up the dosing despite the label's instructions.) The Phenergan insert already has a "black box" warning not to give the drug to young children, an admonition not to give anti-nausea drugs of any kind to kids with "uncomplicated vomiting," and, as a bonus, numerous dire warnings about glaucoma, peptic ulcers, prolonged exposure to the sun, permanent nerve damage, and dozens of other precautions.

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