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.
Thimerosal and Autism: A Paradigm for Judges to Act As Gatekeepers
One of the principal problems in our civil justice system is holding a defendant responsible for some very bad harm that it did not cause. Acting as 'gatekeepers,' judges are the key persons who can prevent this injustice, and many keep out both so-called 'junk science' and preserve the integrity of our legal system. Some very well meaning judges, however, do not do so. Sometimes, they can be persuaded to allow a jury to have a look at a case that should have been dismissed.
The Changing Face of FDA Consent Decrees
Historically, when a health care company had a compliance failure, counsel could help it remain in business by negotiating with the relevant agency. If the problem involved sales, marketing or pricing, the company could seek a Corporate Integrity Agreement (CIA) with the Office of Inspector General (OIG) at Health and Human Services (HHS). If the problems related to manufacturing, counsel could obtain a consent decree of permanent injunction ('consent decree') with the Food and Drug Administration (FDA) under the Food Drug and Cosmetic Act (FDCA). Consent decrees and CIAs each had their particular burdens and benefits, which health care practitioners had learned to navigate. Now this tidy distinction has become blurred as the FDA has borrowed features from HHS's CIAs.
IP News
Highlights of the latest intellectual property news from around the country.
Trademark Investigations Revisited
The use of investigations to uncover and evaluate potential infringement and unfair competition claims can be an extremely effective weapon for any trademark owner. Usually, a key to successful trademark investigations rests in having the mark owner's investigator pose as an ordinary consumer ' essentially misrepresenting his or her true identity or purpose to the potential infringer. This practice of attempting to gain information through the arguable use of deception or invented scenario is now commonly referred to as 'pretexting' and has led to controversy in the general corporate context. This article concludes that properly conducted and supervised pretext investigations remain in harmony with both the relevant case law and the policy goals of trademark and unfair competition law.
Trends in Financial Services Patents
Armed with a well-stocked patent portfolio, a company can effectively corner valuable markets for a limited amount of time. While this concept is second nature for most makers of tangible products, pharmaceuticals, or even software, it is only now becoming widely accepted in the financial services sector. As a result, another battlefield is emerging in which patents are becoming the weapon of choice, and trading floors and back-office processing centers have become the new settings for patent disputes.
Drug Companies and Failure to Warn
For more than one year, product liability cases have been pending against Merck's osteoporosis drug, Fosamax'. Despite having one of the highest side effect profiles of any drug in the U.S. prescription database, Fosamax remains on the market, and available by prescription. When a drug remains on the market during litigation but the manufacturer refuses to warn about a known risk, places the information about the risk in an obscure location or provides inadequate information about the severity of the risk, there is a public problem ' for both patients and prescribers alike ' in the form of a health hazard about which most prescribers have insufficient information.
