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The Food and Drug Administration's ('FDA') pre-emption analysis in the preamble to its Jan. 24, 2006 drug-labeling rule has resulted in a significant shift in judicial recognition of pre-emption in prescription drug litigation. While only a handful of courts had upheld prescription drug pre-emption arguments prior to the FDA preamble, a solid majority of courts informed by the FDA's preamble analysis have found state law claims pre-empted. Part One of this series discussed key battlegrounds upon which future FDA pre-emption arguments will be fought. This second installment reviews recent case law and also discusses two new FDA <i>amicus</i> briefs in which the FDA provides further guidance on the proper scope of pre-emption in prescription drug litigation.
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Why we are publishing this important Special Issue.
The Internet has revolutionized how companies conduct business. Utilizing Internet technologies, people now instantly share ideas with individuals around the globe, and companies can now reach previously inaccessible markets through their Web sites. Along with these advantages, however, the Internet and related technologies have added unique risks to today's businesses. As discussed in Part One of this article, these dangers include threats to a company's electronic information through viruses and worms as well as new legal liabilities stemming from a business' Internet usage. In addition, the Internet provides numerous threats to a business's intellectual property and makes unwary companies susceptible to suit for treading on the intellectual property rights of others. This part of the article reviews some of these hazards and summarizes steps that companies can take to minimize their exposure to these risks.
The past few weeks have witnessed the evolution of the world of user-upload sites.<br>MySpace.com and YouTube. com were once youthful rebels ' their founders were young, their audience was predominantly under 30. These sites allowed youngsters to post their own video material. This, in turn, enraged copyright holders, since some of the postings utilized (and sometimes were in their entirety) copyrighted material, taken without permission.
Prescription drug manufacturers have unsuccessfully asserted pre-emption as a defense to product liability claims for decades. A new FDA final rule and the first federal case interpreting that rule indicate that the tide may be turning. On May 25, 2006, Judge Baylson of the U.S. District Court for the Eastern District of Pennsylvania issued his opinion in <i>Colacicco v. Apotex, Inc.</i>, 432 F. Supp. 2d 514 (E.D. Pa. 2006). The decision is the first federal court opinion discussing the pre-emptive effect of the preamble to the FDA's final rule on prescription drug labeling (the 'preamble'). <i>See</i> 71 Fed. Reg. 3922, 3934 (Jan. 24, 2006).
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The House and Senate worked late into the night on Friday, Sept. 29, 2006 to finalize 'H.R. 4954: Security and Accountability For Every Port Act' or the SAFE Port Act and get it to the House floor. By early in the morning on Saturday, Sept. 30, 2006, just before adjourning for the election break, the House had passed the bill by a count of 409-2, and the Senate had agreed to the conference report by unanimous consent. Senate Majority Leader, and Presidential hopeful Bill Frist (R-TN) was the point-person for certain groups lobbying to ban Internet gambling with the addition of Title VIII to the legislation.
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On Dec. 1, 2006, new amendments to the Federal Rules of Civil Procedure addressing discovery of electronically stored information will take effect unless Congress enacts legislation to reject, modify, or defer the amendments. The amendments to Rules 16, 26, 33, 34, 37, and 45, which were approved by the U.S. Supreme Court on April 12, 2006, attempt to bring the discovery rules up-to-date in an Information Age where the majority of new communication and information is now created, disseminated, and stored in electronic media.
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One question that has been raised in pre-emption decisions is the degree of deference to be shown an agency's explicit statement that it intends certain failure-to-warn claims to be pre-empted. For example, in the pharmaceutical arena, the Food and Drug Administration ('FDA') through the Department of Justice ('DOJ') filed amicus briefs in several lawsuits to reiterate its position on pre-emption of state law tort claims. In these briefs, the United States stressed that in the context of warnings, 'more is not always better.' <i>Amicus</i> Brief for the United States, <i>Kallas v. Pfizer</i>, No. 04-00998 (D. Utah Sept. 29, 2005) at 28. The FDA's regulation of prescription drugs ensures each drug's optimal use by requiring inclusion of only scientifically substantiated warnings. <i>Id.</i> Plaintiffs' failure-to-warn claims therefore 'stand as an obstacle' to the FDA's accomplishment of its congressionally mandated purpose of ensuring the public health and are therefore pre-empted. <i>See Id.</i> The FDA has also stated its position on pre-emption in the preamble to its Rulemaking for Labeling requirement, which became effective on June 30, 2006. <i>See</i> 21 C.F.R. '10.85(d)(1) (2006).
Highlights of the latest commercial leasing cases from around the country.
