<b>Online Exclusive:</b> Medical Information, Privacy Bill Passes U.S. House
August 08, 2006
Recently, the U.S. House passed its version of S 1418, which would standardize record keeping of medical records and support expanded dissemination of electronic medical records. Among the key modifications to the Senate bill was the House's creation of a task force to make recommendations on national standards for medical data storage, which would focus on ensuring privacy while supporting interoperability of communications systems and record keeping.
<b>Online Exclusive:</b> GAO Report Finds Gaps, Loopholes in Federal Data Collection Laws
August 03, 2006
A new report by the Government Accountability Office ('GAO') finds that Congress can significantly strengthen federal privacy laws by requiring data collection and reseller firms to improve their privacy safeguards and by enhancing the authority of the Federal Trade Commission ('FTC') to issue civil penalties for violations of current federal privacy laws.
<b>Online Exclusive:</b> New Hampshire Medical Privacy Law Challenged
August 03, 2006
IMS Health Inc. and Verispan LLC filed a lawsuit in U.S. District Court, seeking a stay of New Hampshire's new privacy law. The law, which went into effect on June 30, bans the collection, distribution, and sale of individual doctors' prescription information by pharmaceutical companies or their agents. It affects only prescriptions written by physicians, not by other medical professionals such as nurse practitioners.
<b>Online Exclusive:</b> Around the States
August 01, 2006
<b>Kansas.</b> Kansas recently became the sixth state in the nation to collect DNA samples of people who are arrested, but not yet charged with a crime.<p><b>Massachusetts.</b> Four bills are under consideration in the Senate ' S. 183, S. 184, S. 236, S. 237 ' related to privacy and ID theft.
What Jurors Think Of American Corporations ' And What You Can Do About It
August 01, 2006
These are challenging times for those of us who represent and defend corporations in litigation. The recent criminal convictions of Enron's Ken Lay and Jeffrey Skilling only confirm what we have known for quite some time ' jurors are skeptical of, and even hostile toward, corporations and corporate executives. '
Case Notes
August 01, 2006
Highlights of the latest product liability cases from around the country.
Increased Scrutiny of Pharmaceutical Company Clinical Trials: The Plaintiff Responds
August 01, 2006
<i>'Men occasionally stumble over the truth, but most of them pick themselves up and hurry off as if nothing ever happened.'</i> In this author's opinion, Winston Churchill's keen observation of human nature is an apt description for how the pharmaceutical industry deals with dangers revealed or at least signaled in clinical trials. For years, plaintiffs' lawyers have honed in on clinical trials conducted by pharmaceutical companies when preparing for and trying cases. These studies, often the banner touted by defendants as evidence of their innocence, are a natural place to begin the search for what went wrong when a drug is subsequently pulled from the market despite the supposed 'rigors' of clinical testing. While there is nothing new about plaintiffs' lawyers reviewing clinical trials with a fine-toothed comb, there has been a radical and bold step taken in the world of medical/science academia. Specifically, major publications such as the New England Journal of Medicine ('NEJM') and the Journal of the American Medical Association ('JAMA') are ensuring that industry-sponsored studies do not merely contain partial truths.
Increased Scrutiny of Pharmaceutical Company Clinical Trials: The Defense Perspective
August 01, 2006
In recent large-scale pharmaceutical litigation, plaintiffs' counsel have concentrated significant resources seeking the details of how individual patients in pre- and post-marketing company clinical trials were assessed, characterized, and reported to the Food and Drug Administration ('FDA'). The reason is clear: They are seeking to develop (in the author's opinion unfairly) a story that the pharmaceutical company hid risks and overstated benefits. The efficacy and safety data generated by industry-sponsored studies, and the manner in which the data are analyzed and reported, have therefore become the focus of large-scale pharmaceutical litigation.