<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.
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.
Retiring a Defined Benefit Pension Plan
August 01, 2006
According to a 2005 report of the Pension Benefit Guaranty Corporation (PBGC, the agency that administers the federal insurance program for DB plans), more than 2700 DB plans ' nearly 10% of all PBGC-insured plans ' were frozen as of 2003, and more than 165,000 DB plans were terminated between 1975 and 2004. This same period has seen a rise in popularity of defined contribution (DC) and other individual account plans (IAPs), such as 401(k) plans. This article explores the thinking that has led many employers to freeze and/or terminate their DB plans as a means of managing the risk/reward attributes of their tax-qualified deferred compensation programs, as well as some special considerations for law firm financial managers.
Executive Compensation: It's Hot and About to Get Hotter
August 01, 2006
With the business community eagerly anticipating more reports recommending SOX ' 404 relief for smaller companies, executive compensation issues seem far removed, except for the occasional (or not so occasional) headline. Don't be lulled, however, into a false sense of security. Executive compensation is about to take center stage as THE latest 'corporate governance' topic.
Increasing Competition in China Causes Friction for Law Firms
July 31, 2006
To U.S. lawyers, Becky Xia's career move may not make much sense. <br>Earlier this year, the 27-year-old Chinese immigration lawyer leapt at the chance to join Littler Global, even though ' technically speaking ' doing so meant she could no longer practice law.
Doing Business in China via the Cayman Islands (2006 Update)
July 31, 2006
Many companies doing business in China are using a structure that includes a company formed under the laws of the Cayman Islands (CI). Chinese technology and Internet companies listed on NASDAQ ' such as Actions Semiconductor, Baidu, CTrip, China Medical Technologies, Focus Media, Shanda, Suntech Power and Tom Online ' are actually CI companies. The primary business reasons for an offshore structure are flexibility in an exit strategy, whether in connection with an initial public offering (IPO) or an acquisition; the possibility of reducing U.S. taxes; and reducing the impact of China's currency exchange restrictions.
Compliance Programs for Private Companies
July 31, 2006
We all know that a proactive Securities Exchange Commission (SEC), combined with implementation of the Sarbanes-Oxley Act of 2002 (SOX), and activation of the Public Company Auditor Oversight Board (PCAOB), has triggered intense scrutiny on corporate ethics and accountability. One by-product of this is that the public company has come to serve as a mentor of sorts to the private company in the arena of corporate compliance programs, offering certain 'best practices' that may also be useful to the privately held company, its management, and its shareholders or owners.
