Ruling against Wyeth could undermine FDA

A ruling in favor of the plaintiff could threaten the authority of the FDA by giving more power to state courts, says Maureen Martin, JD, senior fellow for legal affairs with The Heartland Institute in Chicago. She says the case could lead to a wholesale expansion of state regulation in other areas of law for any industry subject to intensive federal regulation. If that happens, the FDA will become ineffective, she predicts.

If the FDA's drug labeling authority has no value, the agency should be abolished, she says.

Martin notes that, while the Phenergan label did not explicitly prohibit push IV, it did make clear that the method carried serious risks. The FDA required the label to include four warnings telling providers to exercise "extreme care" in injections with IVs. Gangrene would "likely" result if done improperly, the label says.

The label also warned health care providers to stop the injection immediately if the patient complained of pain, which the plaintiff did, Martin notes. And it warned dosages shouldn't exceed 25 mg.

"The plaintiff got twice that much. It sounds like the assistant didn't read the label at all," Martin says. "That's understandable. The label is two pages long."

Martin says in closing arguments at the Vermont trial, the plaintiff's lawyer told the jury, "The FDA doesn't make the decision, you do."

"So what use is the FDA, if states can impose additional warning requirements?" she asks. "The Vermont Supreme Court found federal law imposed only minimum requirements and states are free to mandate stricter ones. If the plaintiff wins and each of the 50 states becomes free to impose drug safety laws in addition to federal laws, drug makers will have to monitor state law carefully and modify labels state-by-state. This is an unworkable system that would destroy any semblance of a national product market. It endangers drug marketing and new drug development, and therefore the public's health."

Martin says a Supreme Court ruling in favor of the plaintiff would lead to a surge in similar suits.

"State attorneys general are clearly salivating at the prospect of preserving and expanding their authority. Forty-seven of them filed a joint amici brief supporting the plaintiff," she says. "If the plaintiff wins, there are going to be 50 separate requirements for drug approvals, with the FDA as just the 51st. In that case, it should be abolished."