No Defective Drug Lawsuit Preemption, NEJM Editors Say

The New England Journal of Medicine (NEJM) has urged the Supreme Court to reject a lawsuit shield that the pharmaceutical industry is seeking. In an Amicus Brief filed in the Supreme Court case Wyeth vs. Levin, the editors of the NEJM said that the Food and Drug Administration (FDA) ”is in no position” to guarantee <"">drug safety, and that product liability lawsuits can serve as ”a vital deterrent” and protect consumers if drug companies don’t disclose risks.

Wyeth vs. Levine involves a Vermont woman who alleged she lost her arm from adverse events tied to Wyeth’s nausea and motion sickness drug Phenergan. Levine, who was awarded more than $6 million in her state court claim against Wyeth, said she was administered Phenergan at her local hospital emergency room. The product normally is administered intramuscularly, but hospital staff used a method called I.V. push of injecting the drug into her vein, which resulted in an inadvertent arterial injection. Inadvertent arterial injection of Phenergan is known to be dangerous. Levine, a guitar player, developed gangrene in her arm, which resulted in it being amputated.

Levine has contended that Phenergan’s labeling failed to adequately warn about the dangers of using the I.V. push method. In 2000, the same year Levine sustained her injury, Wyeth changed the label of Phenergan to warn that the drug should not be given by intra-arterial injection because of the risk of gangrene.

Wyeth claims that the FDA had weighed the risks and benefits of Phenergan in approving the drug’s prescribing literature, or label, as a guide for doctors. The FDA was aware of risks associated with injecting some forms of Phenergan, but did not require the label to specifically warn about the technique used with Levine. Wyeth claims that the FDA’s judgment in such matters cannot be overruled by a state court.

During an interview with the Associated Press, NEJM editor Dr. Jeffrey M. Drazen said that if the High Court finds in favor of Wyeth, it could be a disaster of consumers. The FDA is overwhelmed trying to keep up with drug safety problem, Dr. Drazen said, and that defective drug lawsuits often find safety issues the FDA has missed.

‘Even if the FDA is doing the best it can, it simply can’t see the future clearly enough to pre-empt 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.”

In their Amicus Brief, the Dr. Drazen and others wrote that the “FDA alone simply lacks the ability to serve as the sole guarantor of drug safety.” Without the discoveries found by plaintiff’s lawyers during the course of defective drug lawsuits, “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 authors point to several instances were FDA oversight was not able to keep dangerous drugs – such as Vioxx, Trasylol, fen-phen and Redux – off the market. In many cases, evidence that drug makers withheld or manipulated vital safety information about these drugs was only discovered once lawsuits were underway.

The NEJM Amicus Brief also takes issue with the pharmaceutical industry’s arguments too many drug warnings hurt consumers. According to the industry’s line of thinking, such “over-warnings” confuse patients and doctors, and cause people to stop taking drugs that could benefit them. They also make the claim that the FDA could punish drug companies for adding unnecessary warnings to medications.

But as the NEJM editors point out, the agency has never once in its history punished a drug maker for furnishing consumers with too many warnings. Also, the NEJM Amicus Brief argues that pharmaceutical companies have not provided any empirical evidence to support their assertions that consumers will top using beneficial medications because of too many warnings.

The NEJM editors also contradict claims that lawsuits are causing the drug industry serious economic harm. In the brief they write that “The prescription drug industry earns global revenues of more than $700 billion per year, an increase of $178 billion over the last five years.” While, “As of 2004, Americans were responsible for $248 billion in pharmaceutical sales, accounting for nearly 45 percent of all revenue worldwide. Despite representations of a so-called explosion of stifling litigation, the pharmaceutical market has grown, not shrunk.”

Forty-seven state attorneys general have joined the NEJM in supporting Levine’s lawsuit. So have two former FDA commissioners – David Kessler, who served in the Clinton Administration, and Donald Kennedy who served in the Administration of George H.W. Bush.

Sadly, the current Bush Administration is backing Wyeth, and the U.S. Solicitor General filed his own Amicus Brief favoring the drug maker back in June. What’s more, in February, the Supreme Court ruled in favor of medical device makers in a similar case, Riegel vs. Medtronic, Inc. That case stemmed from a lawsuit filed by the family of a New York man who suffered severe medical complications when a Medtronic-made balloon catheter burst during a procedure to clear his arteries. The man’s family sued Medtronic, claiming his injuries were caused by the catheter’s negligent design, manufacture and labeling, despite the fact the device had won FDA approval.

Before the Supreme Court, Medtronic argued that the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act that require FDA approval of medical devices preempt product liability lawsuits in state courts. Unfortunately for consumers, the Court agreed with the device maker. Now, many Court watchers say they have no reason to believe that the Justices will rule differently in Wyeth Vs. Levine.

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