Anti-SLAPP Statutes and Peer Review
October 30, 2006
Hospitals trying to assemble a peer review committee to review another practitioner's record and perhaps impose sanctions for substandard performance have their jobs cut out for them because physicians are often reluctant to pass judgment on a colleague. In addition to this natural reticence, those who sit on or testify at a peer review proceeding have another reason to want to avoid it: the threat of lawsuits brought by the medical practitioner facing discipline. The scope of the problem is obvious: without willing and honest participants, the peer-review system that helps keep patients safe is compromised.
Case Notes
October 30, 2006
Highlights of the latest product liability cases from around the country.
Excluding Unreliable Expert Testimony in Fire Cases
October 30, 2006
Fire cases, especially those involving appliances, present unique challenges because the lack of compelling physical evidence often permits ex-perts to give unreliable opinions concerning causation. Fire usually destroys evidence showing its cause, and many fire scenes contain multiple possible causes in the area of origin. Moreover, the area of origin can only be defined in the most general sense in most significant cases because there are no fire patterns indicating a specific point of origin. Many times, the likely area of origin is no smaller than a large portion of a particular room. Moreover, property owners are reluctant to reveal that they negligently started a fire, so they provide misleading information in some cases. In many fires, certain or even likely identification of any particular cause is simply not possible.
Prescription Drug Litigation Pre-emption: A Status Report from the Defense Perspective
October 30, 2006
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.
Minimizing Internet Risk
October 30, 2006
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.
Colacicco v. Apotex: A New Era in Prescription Drug Pre-emption
October 30, 2006
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).
Practice Tip: Proposed Changes to the FRCP Regarding Discovery of Electronically Stored Information
October 30, 2006
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.
Deference to Agency Decisions: Lessons from Recent Pharmaceutical Pre-emption Decisions
October 30, 2006
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).
Avoiding the Sand Trap: Silica Liability and the Premises Owner
October 30, 2006
Many landlords have commissioned refurbishing or cleaning that involved sand blasting, concrete cutting, or masonry drilling on or at a building that remained in use. Some have leased premises to tenants that engage in these activities or that engage in production steps that include sanding, blasting, or scouring. There are special concerns about these activities that landlords should address, and this article explains why.
