JAMA stands up to drug companies over patients’ right to sue

by Kristi Park, October 22nd, 2008, 7:00 am

First the Bush administration gave us the doctrine of preemptive war. Now they want to give us the legal precedent of preemption. But they’re going to have to shout down the Journal of the American Medical Association before they can get their way.

Preemption refers to a legal argument stating that, in cases where people are harmed by defective drugs, federal law (that is, FDA approval of the products) preempts state laws governing drug safety. If preemption were the law of the land, consumers who suffer injury from harmful drugs would have no legal right to sue the pharmaceutical companies who made and sold them.

Next month, the Supreme Court will decide on the issue in the case of Wyeth vs. Levine, in which a woman is suing the drug company, claiming that improper labeling of a drug cost her part of her arm. In a parallel case involving medical devices made by Medtronic, the Court agreed with the preemption doctrine. Now, drugmakers everywhere are on pins and needles to see if they, too, can escape liability.

JAMA just published an editorial arguing against preemption, following the New England Journal of Medicine’s denunciation of the principle earlier this year. The Bush administration and the pharmaceutical lobbying group PhRMA both support preemption.

I will admit, there’s a certain obvious logic to the thinking behind preemption: If the FDA has already deemed a drug or medical device to be safe, why should a company be punished for selling it sometime down the road?

There are a couple of major problems with that theory, however. One is that the clinical trials the FDA bases its decisions on are largely short-term studies that provide no information on what a drug’s long-term side effects might be. Who is to be held responsible if a drug proves harmful over time? Second, those studies are conducted by the drugmakers themselves, and they’ve been known to withhold a piece or two of critical information from the public about a drug’s dangers.

One such recent case, involves Johnson & Johnson, who just this month settled a slew of cases involving its birth control patch Ortho Evra. The patch releases significantly more estrogen into the body than the birth control pill, something the company knew but at first failed to tell patients (its label has been revised several times since it was approved in 2002). The higher levels of estrogen increase a woman’s risk of blood clots and stroke; in the hundreds of lawsuits recently settled, some 4,000 women complained of injury from using the drug, mostly in the form of blood clots in the legs and lungs. Some of the lawsuits involved women who died.

If the drug companies have their way — and they look pretty likely to — those women and their families wouldn’t be allowed to have their day in court, and drug companies would have little reason not to withhold crucial safety data from the public or the FDA. The only thing that’s preempting is justice.