Failure to Warn
The author, Tim O'Brien, was appointed Lead Counsel by the U.S. District Court for the Southern District of New York in MDL No. 1789, <i>In re Fosomax Products Liability Litigation</i>. The opinions expressed herein are Mr. O'Brien's and represent some of the arguments the plaintiffs are or will be making in the litigation.
Do You Know What Companies Really Want?
In the 20 years I have worked with and for in-house counsel and CEOs, this recent statement to me by a Fortune 100 senior in-house counsel is the strongest yet. Over the years I've compiled a number of such statements, which, if more moderate in tone, are equally serious in intent. Many of them zero in with a great deal of specificity on buyers' discontent and, as such, are particularly helpful, if disconcerting.
Case Notes
Highlights of the latest product liability cases from around the country.
State Consumer Protection Law: A New Path to Medical Monitoring Class Actions?
Medical monitoring is often pursued as a claim in class actions against corporate defendants based on exposures to environmental pollutants or products that allegedly have the potential to cause future health problems. Because medical monitoring is an exception to the general requirement that the plaintiff must have a present injury in order to pursue a claim, many jurisdictions have adopted strict elements that a plaintiff must satisfy in order to succeed on a medical monitoring claim. These elements often require the court to consider issues specific to individual plaintiffs, particularly aspects of each plaintiff's medical history that have an impact on the need for or the extent of the proposed medical monitoring. As a result of these individual medical issues, many courts in recent years have refused to certify medical monitoring class actions. <i>See, e.g., Ball v. Union Carbide Corp.</i>, 385 F.3d 713, 727-28 (6th Cir. 2004); <i>Zinser v. Accufix Research Inst., Inc.</i>, 253 F. 3d 1180, 1195-96, <i>amended,</i> 273 F.3d 1266 (9th Cir. 2001); <i>Barnes v. Am. Tobacco Co.</i>, 161 F.3d 127, 143 (3d Cir. 1998); <i>Boughton v. Cotter Corp.</i>, 65 F.3d 823, 827 (10th Cir. 1995).
The Consumer Expectation Test: Fostering Unreasonable Expectations of Safety
Automakers have implemented an incredible amount of safety features into vehicles over the past century. For as long as automakers have been implementing those features into vehicles, however, they have had to defend themselves against critics and purported safety advocates wanting to know why a particular safety innovation was not implemented sooner and why it was not more effective, as consumers 'expected.' On their face, many safety-related criticisms appear valid, given that in 2005 alone, more than 2.7 million people were killed or injured in more than six million police-reported traffic accidents. <i>See</i> NHTSA's National Center for Statistics & Analysis, <i>Motor Vehicle Traffic Crash Fatalities and Injuries — 2005 Projections</i>, DOT HS-810-583 (2006), available at <i>www-nrd.nhtsa.dot.gov/ pdf/nrd30/NCSA/PPT/2006/810583.pdf.</i>
FDA's New Quality System Guidance: Minimizing a Pharmaceutical Company's Risk
On Sept. 29, 2006, the Food and Drug Administration ('FDA') issued a final guidance on quality systems for pharmaceutical companies: formalized business practices that define management responsibilities for organizational structure, processes, procedures, and resources needed to fulfill product and service requirements, improve customer satisfaction, and ensure continual improvement. The 'Quality Systems Approaches to Pharmaceutical Current Good Manu-facturing Practice Regulations' (the 'Guidance Document') is intended to help companies comply with the FDA's current Good Manufacturing Practices ('cGMP') regulations. The Guidance Document is part of the FDA's Pharmaceutical cGMPs for the 21st Century Initiative, a program that seeks to integrate quality systems and risk management approaches into existing manufacturing programs with the goal of encouraging industry to adopt modern and innovative manufacturing technologies.
