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 Second, the authors outline that the FDA’s limitations are illustrated by the numerous drugs that were withdrawn from the market for safety concerns, after their initial warnings proved inadequate.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

Tort-Liability for Patient Caused Accidents

A recent article in the New England Journal of Medicine highlights the growing controversy over a doctor’s liability in tort for a motor vehicle accident caused by one of the doctor’s patients. The article, written by George J. Annas, J.D., M.P.H., tries to address the question of whether a doctor owes a duty of care to individuals who may be harmed when a patient under the doctor’s care ingests a prescribed medication and attempts to operate a motor vehicle.

The article opens with disturbing numbers from a study conducted by the Centers for Disease Control and Prevention. According to a study conducted by this organization in West Virginia, there is a higher prevalence of prescription medication than illegal drugs in the blood of fatally injured drivers. Further, in over seven percent of all fatalities, and in nine percent of fatalities in drivers involved in motor vehicle accidents, blood samples contained two or more of five commonly prescribed drugs.

With this study as a backdrop, Annas analyzes a case decided in Massachusetts, in the matter of Coombes v. Florio. In this case, a doctor was treating a 72 year old man for a variety of conditions, including asbestosis, chronic bronchitis, emphysema, high blookd pressure, and metastatic lung cancer. During the first year of the treatment, the doctor advised his patient that it would not be safe to drive during cancer treatment, advice the patient heeded.

Once the treatment was concluded, the patient returned to the road. Months later, the patient was driving his car when he lost consciousness and struck a ten year old boy, killing the child. At the time of the incident, the patient was in possession of prescriptions for oxycodone, metolazone, prednisone, tamsulosin, potassium, Paxil, oxazepam and furosemide from his treating doctor. Possible side effects for these medications include drowsiness, dizziness, lightheadedness, fainting, altered consciousness, and sedation. These side effects, including any impairment they may cause behind the wheel, were not discussed between doctor and patient.

The mother of the young child brought suit against both the driver and his doctor. A trial court dismissed the suit, and it came up to the Massachusetts Supreme Court for review. The Supreme Court of Massachusetts, through a plurality decision, reversed the trial court. The judge issuing the plurality opinion noted that this was not a medical malpractice decision, but rather an ordinary negligence issue. Therefore, the issues to be decided were: Did the doctor owe a duty to the injured boy? Was that duty breached, and if so, did the breach cause the boy harm?

The plurality opinion cited numerous examples of similar situation to demonstrate that negligence could be found on the part of the doctor. Consider the liquor store held liable for a bicyclist’s injuries, when a bicyclist is injured by an intoxicated minor operating a vehicle after purchasing liquor from the store. Consider also the homeowner held liable for failing to store a gun properly, later used by the homeowner’s son in the killing of a police officer. As the Court stated: “Relying on these same principles, I conclude that a physician owes a duty of reasonable care to everyone foreseeably put at risk by his failure to warn of the side effects of his treatment of a patient.”

As to the issue of whether the accident was “foreseeable,” the court held that since the medications had known potential side effects which “were likely to impair a motorist,” that fact coupled with the prior advice that the patient could resume driving made it all the more foreseeable that such an accident could occur.

This case does not settle the issue, and courts in this area have not addressed this issue. The Massachusetts case should inform attorneys and individuals that the potential for such liability, and the dangers that arise when consuming prescription medication, do exist. If you are currently under the care of a doctor and taking prescription medication, make sure you speak with your doctor about all potential side effects and risks. Further, if you or a loved one has been injured in a motor vehicle accident, contact one of the attorneys at Goldberg, Finnegan & Mester, LLC at 301-589-2999 extension 102 for your free consultation today.

Mark A. Schofield, Esquire
Goldberg, Finnegan & Mester, LLC

Taking a Road Trip? Recent Studies Suggest Safety First

August in the Washington Capital Region is often the hottest time of the year weather-wise. There’s a little known fact that decades ago, foreign countries paid their diplomats who were stationed here in Washington hazard pay because of the oppressive heat. Perhaps that is the reason that the area seems to empty during the month, as families head to area beaches or tourist destinations for a few weeks of rest and relaxation before school begins in the fall. However, three recent studies from the National Highway Traffic Safety Administration suggest that road travelers take caution as they head out of town.

One study focuses on 15-passenger vans. Statistics show that June through August are the deadliest time of the year for those vehicles and their occupants. More than 30 percent of fatal rollovers involving these vehicles occur during the busy summer travel months. Further, the risks increase when the van is fully loaded with drivers and passengers. In 2006, 50 percent of occupant fatalities that occurred in these vans took place when the van was fully loaded.

Other factors that contribute to rollover incidents include improperly inflated tires, poor tire conditions, and inexperienced drivers.

Another study from the NHTSA indicates that unfortunately, traffic accidents are the leading cause of death for every age 3 through 6 and 8 through 34. According to the study, motor vehicle traffic crashes ranked third overall in terms of the years of life lost (i.e., the number of remaining years that the person is expected to live had they not died) behind only cancer and diseases of the heart.

The final study, released by the NHTSA on August 5, 2008, analyzed the ratio of motor vehicle crash fatalities by sex and age from 1996 to 2006. The study indicated that motor vehicle crash fatalities where higher for males than females in all age groups, even though the male population is equal to or less than the female population in all age groups. The study also found that while fatality rates for most age and sex groups decreased, the fatality rates increased only among males in the age groups 41-45, 46-50 and 51-55.

These studies indicate the continued hazards and risks associated with traveling our nation’s highways. Please take due care and caution when taking your summer road trips and we wish you a happy and safe time. However, if you or a loved one has been injured in an automobile accident, please contact one of the attorneys at Goldberg, Finnegan & Mester, LLC today at (301)589-2999 x102 for a free consultation.

Mark A. Schofield, Esquire
Goldberg, Finnegan & Mester, LLC