FDA's New Labeling Rule
On Jan. 18, 2006, the U.S. Food and Drug Administration (FDA) issued a final rule to revise the required format of prescription drug labels so as to enable physicians to find the information they need more readily. New features include a section called 'Highlights' and a Table of Contents. According to the FDA's press release, this is the first time in 25 years that the labeling requirements have undergone a major revision.
What Types of Ex Parte Communications Are Permissible?
The Health Insurance Portability and Accountability Act (HIPAA) (42 U.S.C.A ' 1320d) was enacted by Congress in 1996 and took effect on April 14, 2003. Although it was originally intended to increase access to health care by expanding insurance portability and renewability, privacy issues evolved due to developing technology that provided easy access to health information. As a result, Congress added additional safeguards to the seemingly innocuous Act. Such procedural safeguards have spawned a debate on whether HIPAA preempts state privacy laws, and if so, whether it prohibits ex parte communications between a plaintiff's treating physicians and defense counsel. Therefore, it's important for counsel to be aware of the various state and federal court decisions on the subject and the issues raised by both plaintiffs and defendants in this amorphous area of law.
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Practice Tip
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
Recent rulings of interest to you and your practice.
Accidents Don't Just Happen
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
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
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.
