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Features
Amid a cacophony of wailing and gnashing of teeth decrying the Food and Drug Administration's ("FDA's") failure to protect the public from unsafe drugs, the FDA held an emergency advisory committee meeting, which included consultants, to address the safety issues associated with the use of COX-2 selective and non-selective non-steroidal anti-inflammatory drugs ("NAIDs"). The meeting was scheduled and held at warp speed. It provided a transparent dispassionate opportunity to address the safety issues for scientists, affected parties and the public. The decisions of the advisory committee were to some extent, unexpected. This accelerated review process differs from the current advisory committee process of reviewing limited data in a product pre-approval setting. However, this use is a natural extension of the FDA's historic use of advisory committees, <i>ie</i>, analysis of voluminous data on any active ingredient over a period of years and application of the analysis to specific drug products containing the active ingredient.
It seems that the same question is asked every time two pharmaceutical plaintiffs' lawyers get together these days: "Don't you think Merck can just pull a Baycol?" Referring to Bayer's strategy for resolving the recent litigation over Bayer's dangerous — and withdrawn — statin drug, these lawyers are concerned that Merck, like Bayer, can somehow escape compensating thousands of victims. No doubt due to the widely read article in The Wall Street Journal (May 3, 2004) that essentially gave Bayer an "academy award" for its handling of Baycol, reporters across the country, trying to analyze the emerging Merck debacle last fall, were asking the same question of their trial lawyer interviewees. What these inquiring minds are inquiring about is whether Merck, clearly faced with thousands of actions, can "lump and split" them. On the one side, Merck would place a very large pile of cases it deems non-compensable, and on the other, a much smaller pile comprised of those cases that Merck will agree to discuss and value. The answer to this question seems to be, at this relatively early date, that even if Merck wishes it could approach the problem this way, it cannot. Moreover, it cannot use the strategy it used in the phenylpropanolamine ("PPA"), Propulsid, or Rezulin litigation, either. In fact, any attempt to apply the strategies employed in those litigations may end in sheer disaster.
On April 20, 2005, President Bush signed The Bankruptcy Abuse Prevention and Consumer Protection Act of 2005 into law (the "Act"). Although the Act has received much media attention in recent months for its potential impact upon consumers seeking protection under Chapter 7 of the Bankruptcy Code (the "Code"), it does contain a number of amendments to the Code that will affect, either directly or indirectly, the ways in which equipment lessors will relate to their liquidating or reorganizing lessees. This article provides a brief overview of some of the new amendments to the Code and explains how they will change the dynamics between lessors and lessees.
Legal standards regarding electronic discovery and document retention have recently undergone a rapid transformation. Increased regulatory oversight of corporations ' and resulting recordkeeping obligations ' coupled with the increasing volume of electronic communication have created new challenges with regard to document retention and production. More than 99% of information is now being created and stored electronically. Anything that can store, transmit, replay or access electronic data may potentially hold useful corporate records and electronic evidence. Recently, courts and regulators have issued a multitude of new obligations requiring document retention that attempt to define and reconcile the duties of parties and counsel with regard to electronic documents as the judiciary struggles to keep pace with technology. In determining whether a document should, or is required to, be kept, the focus should not and cannot be on the media ' <i>ie</i>, whether it is an e-mail, paper copy, facsimile, instant message, text file, or a Web site. Rather, the relevant question is what information is contained in that document.
Features
Federal courts most likely will see an increase in age discrimination cases with so-called disparate impact claims, but employers will be able defend themselves successfully in many of them as a result of a recent U.S. Supreme Court decision. The High Court on March 30 held that disparate impact claims ' those that allege that a facially neutral policy adversely affects a protected class ' can be brought under the federal Age Discrimination in Employment Act (ADEA).
In the not too distant past, the only way business people could communicate in a real time, convenient and spontaneous way was through face-to-face meetings and telephone conversations. When the all-too-common dispute arose as to who said what to whom, the traditional "my word against your word" battle would play itself out. <br>Fast-forward to the 21st century, where e-mail ' easy, instant, and universally accepted ' has become virtually the default mode of communication. What was once an unverifiable conversation is now a transaction set forth in print. As a result, the "my word against your word" conundrum becomes more of a contest between e-mails, as opposed to a competition between the memories of testifying witnesses.
Forget what you know about the Hart-Scott-Rodino Antitrust Improvements Act (HSR) and partnerships. Forget what you know about HSR and LLCs. The rules have changed ' again. The good news is that the rules make more sense, and certain exemptions to the filing requirements have been codified or expanded. The bad news is that a small number of deals that used to slide under the HSR radar may now be caught. More strategically speaking, the rules now provide more opportunities to "choose" whether your next joint venture will be subjected to substantive agency review under the HSR scheme, heightening the value of HSR counselors' advice on structure issues at early planning stages.