NEW ENGLAND JOURNAL OF MEDICINE ARGUES THAT LAWSUITS CAN HELP GUARANTEE DOCTOR SAFETY

In a case pending before the Supreme Court of the United States, the editors of the New England Journal of Medicine (NEJM) filed an amicus, or “friend-of-the-court,” brief to assist the members of the Court in reaching their decision. In their brief, the editors argue that the United States Food and Drug Administration (FDA) is in “no position” to guarantee drug safety, and that lawsuits can serve as “a vital deterrent” and to “protect consumers” if drug companies fail to disclose risks associated with their products.

The case currently pending before the Supreme Court is Wyeth v. Diana Levine. In this case, Diana Levine, a guitarist, lost her right arm below the elbow after she was injected with Phenergan, a medicine for nausea. The injection caused gangrene in her arm. Ms. Levine sued the manufacturer of Phenergan, Wythe, arguing that Wythe owed a duty to warn consumers that such injections could have horrible effects. After a trial court in Vermont rendered a verdict of $7 million dollars in her favor, Wythe appealed. The basis of Wythe’s appeal is that the company is protected from lawsuits because of the role of the FDA. According to Wythe, the FDA was aware of the risks associated with Phenergan, yet chose not to require a warning on the drug’s prescribing label as a guide for doctors.

The NEJM editors filed their amicus brief on August 14, 2008, with the assistance of Public Justice, an organization of trial attorneys serving to protect the rights of individuals. The brief focuses on two basic reasons why Wythe’s position is flawed. First, they argue that the FDA lacks sufficient information and resources to serve as the sole monitor of pharmaceutical risks. The authors stress that for the FDA to properly strike the balance between safety and efficacy, they must be privy to all pertinent information regarding the benefits and risks of all prescription drugs. Given that 11,000 FDA-regulated drugs are currently on the market, and roughly 100 are approved each year, it is physically impossible for the FDA to complete this task. Further, the FDA conducts no independent testing, and the information it relies upon is provided by the party most interested in bringing a prospective drug to market – the manufacturer. Second, the authors outline that the FDA’s limitations are illustrated by the numerous drugs that were withdrawn from the market for safety concerns, after their initial warnings proved inadequate. Such drugs include Vioxx, Trasylol and Redux.

Next, the editors argue that Wythe’s position that federal law “pre-empts” state law, is flawed in two respects. First, Wythe argues that there is a risk of “over-warning” if the FDA is not considered the sole body responsible for determining risks associated with pharmaceuticals, and that drug manufacturers will be “punished” by the DFA adding unnecessary warnings in response to failure-to-warn lawsuits. Wythe takes this position despite a single example of such an occurrence in the seventy years of drug regulation by the FDA. Further, the warnings are designed and directed to a sophisticated physician, who is then required to wade through the labels and comprehend the risks. Therefore, any “over-warning” simply provides the medical professional with additional necessary information prior to prescribing the medication. Second, the NEJM editors argue that Wythe’s position is simply a general indictment of the general product liability system.

The NEJM editors conclude that under the current regulatory structure, a “robust tort system” is required to effectively monitor the risks associated with pharmaceuticals. According to the brief, “[p]roduct liability lawsuits and the FDA have peacefully coexisted for seventy years for one simple reason: they have complementary, rather than conflicting, goals. The tort system complements the federal regulatory structure by providing a mechanism for compensating victims of hazardous drugs. Product liability litigation provides the FDA with key information unearth in litigation that the agency can use to better protect the public from unsafe and inadequately labeled drugs.” The editors argue that the various tools provided through the court system and litigation, such as subpoena power, the discovery process and tort liability, work to provide the FDA with additional information while protecting the American public.

What is clear is that if the pharmaceutical industry had its way, the American public would be its guinea pigs for dangerous drugs and products and they would never be held accountable – all the while raking in billions of dollars of profits. This current Supreme Court cases is just one of many examples of how trial attorneys fight every day for individuals – and how the NEJM, a medical publication, is working with the trial lawyers on this issue. The work of trial attorneys on a daily basis is designed to protect all individuals, both in the present and in the future, from harm caused by dangerous products, drugs, and other dangerous situations. Trial lawyers fight not only so their current clients are reasonably compensated for their injuries, but also to ensure that other individuals are not harmed by the same situation in the future. If you or a loved one has been injured as a result of a harmful product or drug, call the attorneys at Goldberg, Finnegan & Mester, LLC at 301-589-2999 extension 102 today for your free consultation.

Mark A. Schofield, Esquire