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A classic medical malpractice trial generally conjures up images of strategic trial lawyers, sympathetic plaintiffs, and zealous expert witnesses all culminating in one statement from the jury regarding both liability and damages. This vision -- one of a unitary trial -- contrasts starkly with a device of civil procedure called a bifurcated trial. One of the primary methods of bifurcating a trial is to separate the liability phase from the damages phase. Though widely utilized in other civil cases, bifurcation is seldom requested -- or granted -- in medical malpractice cases. What is the current state of the law and its application to medical malpractice cases, and what are some practical considerations that may factor into the decision whether to seek bifurcation?

A patient implanted with a medical device is vulnerable to injury if that device is defective, even long after the operation and recovery phases have passed. Some courts have recognized a right to certain types of recovery when there is a prospect of future injury, but others have not. In the recent case of <i>Sutton v. St. Jude Medical S.C. Inc.</i>, 2005 U.S. App. LEXIS 18013 (6th Cir. 9/23/05), the U.S. Court of Appeals for the Sixth Circuit was asked to answer a related threshold question of first impression in a medical monitoring case: Does an increased risk of harm requiring current medical monitoring serve as a sufficient injury in fact to confer standing to sue?

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Recent developments in the drug and device arena.

Introduction to this Special Issue: This past June, the American Medical Association (AMA) joined myriad other consumer and medical interest groups to ask the question whether direct-to-consumer (DTC) advertising by pharmaceutical companies had gotten out of hand. Sensing the way the winds were blowing, the pharmaceutical industry's trade group PhRMA (Pharmaceutical and Research Manufacturers of America) announced on Aug. 2 that it would self-police DTC drug advertising practices by signing up pharmaceutical manufacturers to a voluntary agreement to follow PhRMA's new DTC policies. In this issue, we will look at those policies and at the reactions they caused in the medical, legislative and consumer communities.

When the Pharmaceutical and Research Manufacturers of America (PhRMA) announced it was instituting a new policy on direct-to-consumer advertising, PhRMA President and CEO Billy Tauzin stated, "With these principles, we commit ourselves to improving the inherent educational value of advertisements. Patients need accurate and timely information and should be encouraged to discuss diseases and treatment options with their physicians. These principles will help us reach that goal."

Six years ago, in <i>Perez v. Wyeth Laboratories Inc.</i>, 161 N.J. 1 (1999), the New Jersey Supreme Court enunciated a novel exception to the learned intermediary doctrine intended to address the rise of direct-to-consumer (DTC) marketing of prescription pharmaceuticals. The learned intermediary doctrine is a common law principle, codified in many states, that shields prescription pharmaceutical manufacturers from liability for failing to warn consumers of the potential side-effects associated with their products as long as they have adequately warned prescribing physicians. The <i>Perez</i> court, however, held that when pharmaceutical companies employ DTC advertising, there is an additional duty to warn consumers of potential risks.

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In response to continued scrutiny from the public and from legislators concerned over the effects of direct-to-consumer (DTC) advertising, the Board of Directors of the Pharmaceutical Research and Manufacturers Association (PhRMA) voted this past July 29 to institute what it calls a set of "Guiding Principles" that will extend and augment the current FDA rules for DTC advertisement. These principles will go into effect in January 2006.