The Preemption Threat

It can't come naturally for the Journal of the American Medical Association to be consistently more liberal than its rival New England Journal of Medicine. JAMA, based in Chicago, is housed within the reliably conservative physicians' guild, while NEJM is firmly nestled within Brahmin Boston's ivy-covered institutions.

A commentary in this week's JAMA (registration required) by Georgetown law professor Lawrence O. Gostin is a case in point. This non-physician properly warns physicians and the public that the Supreme Court's recent decision in Riegel v Medtronic Inc. removes the final safety net that protects consumers from unsafe medical devices: the right to sue when federal regulation has failed.

The case involved a New York man who sued after his arterial balloon catheter ruptured and almost killed him. Medtronic, the device manufacturer, claimed that since the Food and Drug Administration had approved the device, the company was no longer liable under state product liability laws. In legal parlance, federal regulation preempted state legislation. Last February, Chief Justice John Roberts' Supreme Court agreed.

According to Gostin, this misrepresented Congress' intent in passing the Medical Device Amendments in 1976, which gave the FDA the responsibility for the first time of approving medical devices for their safety and efficacy. Even its sponsors said "the legislation was to provide additional protection to consumers, not to withhold existing safeguards against defectively designed or labeled devices," he wrote. (It's interesting to note that a comparable NEJM commentary earlier this month drew similar conclusions about the negative consequences of the court's decision, but didn't buy the Congressional intent argument. "The fact that this question was answered in the affirmative by a vote of eight to one indicates that the issue was not a difficult one for the justices," its authors wrote.)

For 25 years, even the FDA held to the view that its regs didn't preempt state laws. But in 2004, after President Bush had appointed drug industry lawyer Dan Troy as FDA general counsel, the agency reversed its position and argued the preemption case.

In an era where the FDA has been systematically underfunded and its postmarket surveillance systems are clearly inadequate to identifying serious risks that emerge once the product is on the market, the courts provide a final line of defense for consumers where they can get compensation for injuries, Gostin argues. But just as importantly, it deters industry negligence and encourages a constant search for safer products. Litigation can also improve product labeling by bringing risks to light, which serves both patients and physicians.

Litigation also can uncover fraud committed against the FDA. Studies showing that companies knew about the risks of certain drugs and devices have frequently been revealed only because someone sued and their lawyers uncovered the documents during discovery. Alas, far too often that kind of information remains under seal when the cases are settled out of court. But that's a separate problem. Under this decision, that avenue of uncovering corporate wrongdoing will be shut down entirely.

Next year, the Supreme Court will hear a companion case involving drugs: Wyeth v. Levine. Dan Troy may have returned to Sidley & Austin to represent his drug industry clients. But his influence lives on at the FDA. The agency's legal office is still backing the idea that the obviously inadequate federal regulation of drugs preempts state product liability laws.

Concludes Gostin: "If the FDA's view were to prevail, patients would have no safety net in the likely event that the agency fails to detect and correct safety hazards."

Posted by gooznews at May 21, 2008 08:35 AM