U.S. Supreme Court Receives Unsolicited Drug Safety Advice From Top Doctors Questioning the FDA’s Ability to Protect Patients

The United States Supreme Court is expected to hear the case of Wyeth v. Levine this November which could have far reaching implications as to pharmaceutical litigation cases against drug companies, including those in Illinois and the Chicago area. The legal advice comes from top doctors and editors of the New England Journal of Medicine who have submitted a friend-of-the-court brief. The doctors state that the Food and Drug Administration (FDA) “is in no position” to guarantee drug safety. The doctors went on to to say that lawsuits can serve as “a vital deterrent” and protect consumers if drug companies don’t disclose risks.

The underlying case is about Diana Levine, a Vermont guitarist, who lost her right arm below the elbow after being injected with the drug Phenergen, a medicine used mostly for nausea. She sued the drug manufacturer, Wyeth, contending that the drug company had a duty to warn consumers that injections, like the one she experienced, could have devastating consequences. The state courts in Vermont agreed with Ms. Levine in awarding her nearly $7 million.

But Wyeth appealed stating that it was protected from such lawsuits. It argued that the FDA’s judgment could not in effect be overruled by a state court. FDA scientists had weighed the risk and benefits of Phenergan in approving the drug’s safety literature as a guide for doctors. The FDA was aware of the risks associated with injecting some forms of Phenergan, but the label did not specifically warn about the technique used for this patient.

It has been commented before that the FDA has been the “gold standard” in drug evaluation. The New England Journal of Medicine editors warned the justices to be skeptical in taking such a view now.

“The FDA alone simply lacks the ability to serve as the sole guarantor of drug safety,” the doctors said in a brief filed last week. Without cases like the Levine matter, “the FDA would be stripped of an essential source of information that the agency has consistently relied on when making its regulatory decisions and the American public would be deprived of a vital deterrent against pharmaceutical company misconduct.”
The medical editors joined 47 state attorneys general and two former FDA commissioners in supporting Levine’s position.

This case is being closely watched because earlier this year the U.S. Supreme Court ruled that manufacturers of FDA-approved medical devices were shielded from litigation in state courts.

“The law in the [device] case had a preemption provision,” said David Vladeck, a lawyer representing two former FDA commissioners, David Kessler and Donald Kennedy. Vladeck went on to say, “Congress has never put a preemption provision in the Food and Drug Act.”
Nonetheless, the Bush administration is supporting the drug company’s position in this case. “FDA considers and approves specific labeling for a drug, and the drug manufacturer is generally barred from making unilateral changes to the FDA-approved labeling,” Solicitor General Paul Clement wrote in the administration’s brief.

According to journal editor Dr. Jeffrey Drazen, the FDA is overwhelmed trying to keep up with the rigors of drug safety problems, ranging from rare but serious side effects to shortcomings in manufacturing drugs in far away plants such as China.

“Even if the FDA is doing the best it can it simply can’t see the future clearly enough to preempt manufacturers from litigation,” he said. “The [court] system represents one of the key defense mechanisms that individuals have if a manufacturer has not made the risks of a product clear to the public.”
If the Supreme Court decides in Wyeth v. Levine that drug manufacturers are shielded from litigation if their drug is FDA-approved then it will effectively eliminate legal recourse for injured parties. In order to ensure that this doesn’t happen our nation’s top doctors are taking a stand against this by arguing that the FDA is by no means a gold standard. In order to minimize consumer risk we need more than one watchdog- the FDA alone is not enough. We need the court system, too.

Kreisman Law Offices has been practicing medical malpractice law in Chicago and Cook County for over 30 years, serving such areas as Berwyn, Forest Park, Lincolnwood, and Spaulding.