January 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

Warning Claim Not Preempted By FDA-Approved Label
A patient's inadequate warning claim against the maker of a nausea medication was not preempted because federal regulations allowed manufacturers to strengthen a drug's label without prior agency approval, according to the Vermont Supreme Court. The patient's arm required amputation as a result of being injected with a nausea reducing medication that was administered to treat her migraine headache. The patient brought warning defect claims against the drug manufacturer, arguing that the drug's label should not have allowed the drug to be directly injected into veins. The court found that, according to Food and Drug Administration regulations, the drug's manufacturer could have warned against IV injection without prior agency approval. The court concluded that the patients claims were not preempted and that federal labeling requirements create a floor, not a ceiling, for state regulation. (Levine v. Wyeth, Vt. S.Ct., CCH Products Liability Reporter ¶17,627).

Access to Manufacturer's Trade Secret Formulae Denied

A plaintiff who sought the chemical formulae used in the manufacture of cross-linked polyethylene (PEX) tubing was denied access to the information because the formulae constituted trade secrets, according to an Ohio appeals court. The plaintiff alleged that millions of feet of the PEX tubing used in hydronic heating and plumbing systems were defective and likely to fail because the stabilizers used in the tubing material were insufficient, however, the plaintiff's expert opined that he was unable to determine the nature of the defect without the formulae of the tubing material. The manufacturer resisted a subpoena for the formulae, claiming that they were trade secrets and that confidentiality was impossible because one of the defendants was its competitor. The appeals court found that the plaintiff had not demonstrated a need for the formulae sufficient to overcome the damage that would be caused by dissemination of manufacturer's trade secrets. The court noted that the plaintiff's expert had stated that the formulae would be “helpful” in determining the cause of the tubing's failure and that other possible causes had not been sufficiently eliminated. (Splater v. Thermal Ease Hydronic Sys. Ohio Ct.App., CCH Products Liability Reporter ¶17,629).

Farmer Assumed the Risk of Eye Injury in Removing Goggles

A farmer's decision to remove his safety goggles due to poor visibility constituted an assumption of the risk of eye injury, the U.S. Court of Appeals for the Eighth Circuit held. The farmer's eye was injured when the pry bar he struck with a hammer splintered, sending fragments into his eye. Although the product's packaging contained a warning that cautioned he should “always wear safety goggles,” the farmer argued that the warning was inadequate because it did not describe the specific risk. In affirming the trial court's ruling, the appeals court held that the farmer assumed the risk of his injury because his testimony indicated that he understood the specific risk he faced, even if the warning may have been inadequate. The court reasoned that the farmer's understanding of the risk was more specific than the warning and that his decision to take off his tinted safety goggles for better visibility indicated an affirmative decision to assume the risk of an eye injury. The court also noted that the farmer had not claimed that the pry bar posed any greater risk of chipping or splintering than other similar tools and, therefore, posed the typical type of risk as understood by the farmer. (Krajewski v. Enderes Tool Co., Inc., 8th Cir., CCH Products Liability Reporter ¶17,602).

Product Safety

CPSC Signs Cooperation Agreement with Japan
The Guidelines for Information Exchange and Administrative Cooperation was signed by the CPSC's Acting Chairman Nancy Nord and President Makoto Misono of the National Institute of Technology and Evaluation (NITE) at the International Consumer Product Health and Safety Organization (ICPHSO) conference in Brussels, Belgium. The agreement was designed to improve the safety of consumer products in the U.S. and Japan, and was previously signed by Director-General Midori Tani, Consumer Affairs, of the Ministry of Economy, Trade and Industry (METI). The agreement calls for an exchange of information between Japan and the U.S. on consumer product safety issues, the development of training programs dealing with consumer product safety, and an exchange of safety professionals to carry out consumer safety programs. The CPSC has signed similar agreements with other countries, including Canada, Chile, China, Costa Rica, the European Commission, India, Israel, Mexico and the Republic of Korea. (CCH Consumer Product Safety Guide, Report No. 1551, Dec. 2006)

Crash Test Dummies to Stay in Front Seat, for Now
A petition was submitted to NHTSA to request a two-part amendment to Federal Motor Vehicle Safety Standard No. 208, Occupant Crash Protection. The petition sought, first, to include belted test dummies in the rear seats of dynamic crash tests, and second, to include an unrestrained cargo test in the safety standard. NHTSA already has undertaken a research program to examine rear seat occupant protection. The purposes of this program are to examine the performance of existing rear seat restraints, to assess the effectiveness of advanced rear seat restraint systems, and to determine the biofidelity of anthropomorphic crash test dummies in the rear seat. (CCH Consumer Product Safety Guide ¶55,920)

Final Rule Introduces New Adult Male Test Dummy
An advanced crash test dummy, called the "ES-2re," was adopted for use in side impact testing in a final rule issued by NHTSA. The ES-2re is a 50th percentile adult male dummy for use in testing under Federal Motor Vehicle Safety Standard No. 214, "Side Impact Protection." According to the agency, the new dummy is technically superior to other devices currently used in side impact testing. The new dummy is a modified version of a European side impact dummy (ES-2 dummy), having a weight of 72 kilograms (158.8 pounds) and seated height of 90.9 centimeters (35.8 inches). The new dummy includes modifications to thoracic rib extensions that have been added to address structural deficiencies identified by NHTSA that could affect injury measurement made by instruments within the chest of the dummy. The ES-2re can be instrumented with a vast array of sensors to better predict a wider range of injury potential than any other currently available mid-size male side impact test dummy. It can assess the potential for head, neck, thoracic, abdominal, pelvic, and other injuries. The ES-2re can also assess load transfer between the upper and the lower torso, torso interaction with the vehicle seat back, and the impact severity of the vehicle structure on the legs by way of a femur sensor. In addition, a clavicle sensor is available to assess shoulder loading. The final rule becomes effective June 12, 2007. (CCH Consumer Product Safety Guide ¶41,953)

Specifications Adopted for Adult Female Test Dummy
A final rule amending the regulation for female anthropomorphic test devices was issued by NHTSA. The final rule added specifications and qualification requirements for a 5th percentile adult female crash test device, the SID-IIs Build Level D ("SID-IIs"), for use in vehicle side impact tests under Federal Motor Vehicle Safety Standard No. 214, "Side Impact Protection." The SID-IIs allows regulators and researchers to assess the actual performance of vehicles in protecting small-stature vehicle occupants in side impact crashes. NHTSA found the need for the SID-IIs based on data from the National Automotive Sampling System (NASS) and Crashworthiness Data System (CDC). According to the NASS/CDC data, small stature occupants have a higher proportion of head, abdominal and pelvic injuries than medium stature occupants, and a lower proportion of chest injuries. NHTSA believes the addition of SID-IIs, a small-statured dummy, in side impact testing will better represent the population at risk and substantially enhance protection for small adult occupants. (CCH Consumer Product Safety Guide ¶41,954)

Performance Standards Proposed for Portable Generators
A rule addressing safety hazards, particularly those hazards involving carbon monoxide (CO) exhaust, associated with the use of portable generators has been proposed by the CPSC. The Commission has proposed specific strategies to reduce consumers' exposure to CO including generator engines with reduced CO emissions and a CO-sensing interlock mechanism or automatic shut-off device triggered by a concentration of CO gas. The agency also proposed measures to enable and encourage consumers to use the generators outdoors, a safe distance from their homes. Other proposed performance standards include weatherization requirements, theft deterrence, and noise reduction. Comments on the proposal must be received by February 12, 2007. (CCH Consumer Product Safety Guide ¶40,212)

CPSC Proposal Addresses Hazardous Children’s Jewelry
The CPSC gave advance notice of a proposed rule to address the risks of injury associated with children's jewelry containing lead. The agency cited a consensus among the scientific community that a level of 10 micrograms of lead per deciliter (mg/dL) is a concern for lead poisoning among children. Although efforts to remove lead hazards from children's environments have reduced average blood lead levels, according to the Commission, approximately 310,000 U.S. children still exceed the 10 mg/dL level of concern. The agency has identified toy jewelry as among the remaining sources of lead exposure to children. CPSC investigations have indicated that when metal jewelry is ingested by children, excess lead exposure is likely from items containing more than 0.06% lead, and that there is a corresponding increase in the extent of exposure with increasing levels of lead in the items. The agency's recent announcement proposed a number of regulatory alternatives to address the concern, including a mandatory rule to declare children's metal jewelry containing lead to be a banned hazardous substance, a labeling rule to require warnings and instructions for children's jewelry containing lead, adoption of an existing standard as a proposed regulation, deference to a voluntary standard if substantially conformed to by the industry, or corrective actions on a case-by-case basis under the Federal Hazardous Substances Act. Public comments on these various options must be must be received by the CPSC before March 12, 2007. (CCH Consumer Product Safety Guide ¶40,213)