Practice Tip
April 28, 2006
The Bush administration has adopted a new tactic in its ongoing efforts to create liability shields on behalf of various industries, including the pharmaceutical industry. Despite a number of failed legislative attempts at tort reform, on Jan. 18, the administration quietly enacted its own liability-shield agenda under the guise of federal pre-emption. A new U.S. Food and Drug Administration ('FDA') rule titled <i>'Final Rule: Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products'</i> (21 C.F.R. 201, 314 and 601), which goes into effect on June 30, 2006, extensively modifies the format of prescription drug information, commonly referred to as the 'package insert' and published in the Physician's Desk Reference', and will come with an attempt at broad federal pre-emption.
Verdicts
April 27, 2006
Recent rulings of interest to you and your practice.
Med Mal News
April 27, 2006
Developments in the medical malpractice arena.
Accidents Don't Just Happen
April 27, 2006
In medical negligence litigation, one must understand exactly what went wrong, and when, before one may litigate a case. It is this microscopic attention that requires lawyers to dissect a case in minute detail that would inspire envy in a forensic pathologist. Unfortunately, the fact is that few physicians want to engage in such analysis. Once we understand the who, what, where, and when, however, 'why' becomes much more clear, thus leading to answers as to how future accidents and miscalculations can be prevented.
Doctor/Patient Confidentiality and Abuse Allegations
April 27, 2006
The Health Insurance Portability and Accountability Act, 42 U.S.C.A. ' 1320(d) <i>et seq.</i> (HIPAA), was meant to offer a baseline for the disclosure of individual medical information. The law, calling for standards to be promulgated by the Secretary of Health and Human Services, became effective in April 2001 and full compliance was required by April 2003. <i>Crenshaw v. Mony et al.</i>, 318 F. Supp. 2d 1015, 1027 (D.S.D. Cal. 2004). The regulations are hardly a model of clarity, even for federal regulations, and frequent reference to state law and state reporting agencies can heighten the confusion.
Jury Hits Merck With $9M in Punitives
April 27, 2006
On April 11, a jury in Atlantic City, NJ, ordered Merck & Co. to pay $9 million in punitive damages to a user of Vioxx, finding the drug maker knowingly withheld data from federal regulators about the painkiller's cardiovascular risks. Merck withdrew Vioxx from the market in 2004 when a study showed it doubled heart attack risk after 18 months of use. The Atlantic City trial was the first involving plaintiffs who had used Vioxx longer than that period of time.
Medical Implants in the New Biomedical Frontier
April 27, 2006
More than a million tissue transplants and medical device implants were performed in 2005, according to available estimates. It is reported that the organ and tissue transplantation market in the U.S. was valued at more than $11 billion in 2005. Today, the multi-billion-dollar biomedical industry continues to expand well beyond its more humble origins of blood, organ and tissue banking. These developing biotechnologies have forced courts to address novel issues and concerns regarding a new generation of biosurgical implants outside the parameters of settled judicial and statutory frameworks dealing with medical implants. The widespread usage of such new implants has also called into question the settled case law that hospitals and physicians may not be held strictly liable for the implantation of defective medical device products.
Verdicts
March 29, 2006
Recent rulings for your review.
