February 2007

From the editors of Wolters Kluwer Law & Business, this update describes important developments from CCH products liability and safety publications.

If you have any comments or suggestions concerning the information provided or the format used, we'd like to hear from you. Please send your comments to pamela.maloney@wolterskluwer.

Products Liability

Certification for National Paxil Class Action Denied
Certification for a national class action to represent all persons whose children committed or attempted to commit suicide while using the antidepressant drug Paxil was denied based on the unavoidable need for individualized fact-finding, the U.S. District Court for the Eastern District of Pennsylvania held. The claims alleged that the manufacturer had specific knowledge of the drug's association with an increased risk of suicidality in pediatric patients and that it failed to warn doctors, the medical community, or the public of the danger. In denying the class certification, the court found that the proposed class failed to meet the typicality and adequacy prongs of Rule 23(a) because the manufacturer was able to raise defenses that were unique to most class members, splintering the interests of each class member. In addition, the court found problems with predominance and superiority because the common issues were overwhelmed by the individualized factual and legal issues. Lastly, the court found that the proposed class would have been unmanageable in light of the choice-of-law conflicts among the class members (Blain v. SmithKline Beecham Corp., E.D. Pa., CCH Products Liability Reporter ¶17,674).

Nation-Wide Vioxx Class Action Denied Certification
A proposed nation-wide class of Vioxx plaintiffs was denied certification because individual legal issues undermined the ability of the claimants to sufficiently demonstrate the requirements for typicality and predominance, according to the U.S. District Court for the Eastern District of Louisiana. Although thousands of Vioxx claims and over 160 class actions had been transferred to the Vioxx MDL court, the MDL Plaintiffs' Steering Committee sought to combine all Vioxx claimants into a single nation-wide class action of all persons who were allegedly injured from taking the drug. The court first determined that New Jersey's choice-of-law rules dictated that the substantive law of each plaintiff's home jurisdiction should be applied to each individual claim. In addressing the certification of the proposed class, the court held that with approximately 20 million Vioxx consumers in the U.S. as potential class members, the numerosity requirement was clearly satisfied. The court also found that the commonality requirement was clearly meet because of the numerous common questions regarding the development, manufacturing, and testing of the drug. On the typicality requirement, the court found that while the claims asserted by the various class members were very similar, numerous individual legal issues such as injury, causation, possible learned intermediaries, and comparative fault issues created too much variation to satisfy typicality. In addition, the court determined that non-typical claims would not receive adequate representation in such a large class and predominance could not be satisfied because of the numerous individualized issues, including the multiple changes the manufacturer had made to its warning while the drug was on the market (In re Vioxx Prods. Liab. Litig., E.D. La., CCH Products Liability Reporter ¶17,657).

Products Safety

Hoover to Pay $750,000 Civil Penalty for Not Reporting Vacuum Hazard
Hoover Co., Inc., of North Canton, Ohio, agreed to pay a $750,000 civil penalty to settle allegations that it failed to report defects in its vacuum cleaners. The CPSC alleged that Hoover failed to report to the government in a timely manner that vacuum cleaners the firm sold could overheat and catch on fire. The company manufactured about 636,000 of the vacuum cleaners between May 1998 and November 1999. Between April 1999 and March 2003, it received at least 171 reports of malfunctions with the vacuum cleaners, including overheating and fire. After receiving notice of several incidents, the CPSC contacted Hoover requesting a report pursuant to Section 15(b) of the Consumer Product Safety Act. A month later, Hoover submitted a report in response to the Committee's request. By that time, Hoover had received notice of at least 260 consumer incidents, of which 141 involved fire and minor burns to hands. The company subsequently recalled 636,000 of the affected vacuum cleaners (see CCH Consumer Product Safety Guide Transfer Binder “Developments 2005 to 2006,” ¶55,327). Although the CPSC asserted that Hoover had acquired sufficient information that could reasonably support the conclusion that the vacuum cleaners contain a defect which could create a substantial product hazard or unreasonable risk of serious injury or death, the company did not report the problem to the CPSC until after the Commission requested that it do so. In agreeing to settle the allegations, Hoover denied it violated the Consumer Product Safety Act by failing to report defects with its vacuum cleaners in a timely manner. (CCH Consumer Product Safety Guide ¶55,974.)

Warning Labels Required for Portable Generators
A final rule requiring manufacturers to provide consumers with specified notification of the carbon monoxide (CO) poisoning hazard associated with the use of portable generators was issued by the CPSC. The final rule requires manufacturers to label portable generators with performance and technical data indicating the presence of CO in the portable generator exhaust, and to include statements connecting that technical data with safety concerns, such as “Using generators indoors CAN KILL YOU IN MINUTES”; “Generator exhaust contains carbon monoxide. This is a poison you cannot see or smell”; “NEVER use inside a home or garage, EVEN IF doors and windows are open” and “Only use OUTSIDE and far away from windows, doors, and vents.” The warning label also includes pictograms that depict prohibited actions. According to the CPSC, sales of portable generators may exceed a million units annually, and the death toll from CO associated with generators has been steadily rising in recent years. At least 64 people died in 2005 from generator-related CO poisoning, with many of the deaths occurring after hurricanes and major storms. CPSC staff is aware of at least 32 CO deaths related to portable generators from October 1 through December 31, 2006. The CO produced by one generator is equal to the CO produced by hundreds of running cars and can incapacitate and kill consumers within minutes. In a separate action taken last month (see ¶40,212), the CPSC approved an advance notice of proposed rulemaking to begin a separate rule to address safety hazards with generators. The agency directed staff to investigate various strategies, including generator engines with substantially reduced CO emissions, interlocking or automatic shutoff devices, weatherization requirements, theft deterrence and noise reduction, to reduce consumers’ exposure to CO and to enable and encourage them to use generators outdoors only. The agency believes that the final rule requiring manufacturers to place the “Danger” label on all new generators and the generators’ packaging will reduce unreasonable risks of injury associated with these products. The final rule becomes effective May 14, 2007. (CCH Consumer Product Safety Guide ¶41,955.)

Multistage Bus Certification Proposal Terminated
A 2005 proposed rule that would have amended motor vehicle certification regulations (49 CFR Part 567) to require that, in addition to the vehicle identification number (VIN), a 10-digit suffix be recorded on the certification label of each bus manufactured in two or more stages, was terminated by NHTSA. The additional information appended to the VIN would have identified the bus body manufacturer and certain attributes about the type of bus, such as model number, seat configuration, and bus body length. The proposal also would have added new regulations (49 CFR Part 584) requiring that manufacturers of multistage buses obtain a manufacturer's identifier and provide NHTSA descriptive information regarding the bus bodies produced. NHTSA initially determined the additional information was significant because of the difficulty in determining detailed descriptive characteristics of buses manufactured in two or more stages from the Fatality Analysis Reporting System (FARS) database. Although bus body manufacturers are required to certify that their vehicles meet the FMVSS, they are not required to encode in the certification label affixed to the completed vehicle any descriptive information about the body they install. When buses are involved in crashes, the VIN is recorded in FARS. However the VIN only identifies the incomplete vehicle manufacturer. The final stage manufacturer's name and the bus model are not encoded in the VIN and are not recorded in the Police Accident Report. The agency has identified an alternative approach to obtain accurate bus accident data for analysis and safety improvement that it believes is more efficient and less burdensome. The agency believes that the best way to improve information collected about bus crashes is through simplification of data collection at the crash scene. NHTSA claims to have made significant efforts to simplify the data collection techniques at the crash scene and enable the states to collect more accurate data. (CCH Consumer Product Safety Guide ¶55,975.)