The New England Journal of Medicine (NEJM) has come down on the side of consumers in a vital Supreme Court case that could have far reaching effects on the rights of patients to sue over injuries cased by defective drugs. According to the editors of the NEJM, if the Court sides with drug makers in Wyeth vs. Levine this fall, efforts to insure drug safety would be jeopardized.
In an Amicus Brief to the U.S. Supreme Court, 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. During an interview with the Associated Press, NEJM editor Dr. Jeffrey M. Drazen said the FDA is overwhelmed trying to keep up with drug safety problems, 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.”
The NEJM Amicus Brief relates to Wyeth vs. Levine, a defective drug personal injury case expected to be taken up by the High Court this fall. 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. Levine, a guitar player, developed gangrene in her arm, which resulted in it being amputated.
Inadvertent arterial injection of Phenergan is known to be dangerous, and some hospitals have banned Phenergan. 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 has argued that FDA approval of a drug bars consumers from bringing product liability lawsuits in state courts if they suffer injury. 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.
That prospect that the Supreme Court could hand the drug industry a lawsuit shield has alarmed a lot of patient advocates, and it seems to have hit a nerve at the NEJM. In their Amicus Brief, the doctors 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 of the NEJM Amicus brief also 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 that product liability lawsuits result in “over-warnings” that obscure a drug’s true risks and benefits. According to the industry, 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.”
Finally, the brief points out that the pharmaceutical industry’s arguments supporting a lawsuit shield are the same arguments routinely made by manufacturers of all products against product liability lawsuits. The authors argue that drug makers have not presented any “evidence to explain why the pharmaceutical industry uniquely deserves such blanket protection.”
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.
But 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, the High Court nearly ruled in favor of drug makers in another preemption case it heard earlier this year. But in Warner-Lambert Co. vs. Kent, Supreme Court Chief Justice John Roberts removed himself because he is a stock-holder in one of the drug makers involved in the case. In the end, the Court voted 4-4, denying drug makers their lawsuit shield for the time being.
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. That law clearly says that states can’t maintain requirements that are different from federal standards. But Congress didn’t specify that those federal standards preempted state common law claims. But Medtronic believes that the amendments do just that.
Unfortunately for consumers, the Court agreed with the device maker. Because of the Medtronic case, many legal experts predict that the Court will grant drug makers the same type of lawsuit preemption shield when it takes up Wyeth Vs. Levine in the fall.