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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.
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Like most rights, the right to a jury trial can be waived. In general, commercial landlords disfavor jury trials, especially when the opposing party is an individual, finding the outcomes of such trials to be either too uncertain, or if consistent, consistently against the landlord's interest. The general perception is that juries tend to favor individuals in disputes against institutional parties as a way to rectify a perceived injustice that corporations and other institutions allegedly inflict on the public. Jury trials are also more costly than non-jury trials, and parties may waive their right to a jury trial to avoid the added expense.
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Your company (the 'Company') has decided it needs to find additional space for lease and/or to dispose of excess space and, after extensive due diligence, the Company has identified the ideal real estate broker (the 'Broker') to work with in the transaction(s). You and your new Broker have shaken hands on the basic terms of engagement (such as term and commission rates), and you have received and are now asked to review your Broker's standard form of retention agreement (the 'Agreement'). The Agreement, as is customary with most broker's standard forms of retention agreements, is only a couple of pages long. Should the Company sign it? After you have considered the issues described in this article and negotiated to protect the Company's interests to fit your particular circumstances, the answer is 'yes.' This article discusses some of the common issues that you may want to explore before the Company signs and delivers the Broker's form of retention agreement.
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Leases keep getting longer and tougher. Unfortunately, sometimes the people drafting them outsmart themselves and include unenforceable provisions.
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Rulings of importance to you and your practice.
