May 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

Subclinical Injuries Excluded From Beryllium Exposure Action
The existence of a subclinical injury from beryllium exposure was insufficient to support a claim for physical injury or emotional distress, the U.S. Court of Appeals for the Eleventh Circuit held. A group of 120 current and former employees of an aerospace company alleged that they were injured through their exposure to a respirable form of beryllium. The employees alleged various injuries, including subclinical injuries, beryllium sensitization, emotional distress, and increased fear and risk of future disease. Although the workers presented evidence of elevated levels of toxins in themselves and their children, the court held that they failed to allege that their subclinical damage had resulted in an identified physical disease, illness, or other impairing symptoms. The court also found, however, that the workers' claims of beryllium sensitization were sufficient to preclude summary judgment because there were material issues of fact surrounding whether sensitization constituted a physical injury (Parker v. Brush Wellman, 11th Cir., CCH Products Liability Reporter ¶17,729).

Physician's Heeding of Warning Fatal to Diet Drug Claim
In applying the learned intermediary doctrine to a consumer's action against a diet drug manufacturer, there was insufficient evidence that the physician would have acted differently had he received a stricter warning earlier, according to the U.S. District Court for the Eastern District of Missouri. The consumer alleged that she suffered heart complications as a result of her use of the diet drugs phentermine, fenfluramine (Pondimin™) and dexfenfluramine (Redux™). Although the Food and Drug Administration (FDA) issued an advisory in July 1997 and the drug manufacturer withdrew the drugs from the market in September 1997, the consumer alleged that the manufacturer knew about a link between the drug and heart disease as early as 1993 and failed to warn physicians or consumers. After determining that Iowa was likely to adopt the learned intermediary doctrine, the court found that the doctrine did not bar the consumer's warning claim, as a matter of law. As a challenge to the adequacy of the drug's warnings, the consumer's claim was viable because it asserted that an adequate warning not only failed to reach her but also failed to reach her physician. The court, however, found that there was insufficient support for a causal link between a stricter warning to the intermediary and her heart condition. The court noted that a more serious warning would not have altered the intermediary's decision because her physician continued to prescribe the diet drugs to his other patients even after he became aware of the risk of heart disease from the 1997 advisory (Madsen v. American Home Prods. Corp., E.D. Mo., CCH Products Liability Reporter ¶17,715).

Consumer Product Safety

CPSC Stops Sale of Banned Fireworks Components
The Consumer Product Safety Commission had authority to stop a retailer's sale of chemicals and components used in the manufacture of banned fireworks, according to a federal court in Idaho. On December 6, 2006, the court granted summary judgment in favor of the government’s claim that Firefox Enterprises, Inc., sold to consumers everything needed to manufacture illegal fireworks. On April 30, 2007, the court entered a permanent injunction against Firefox and its owners. Convinced that too many injuries and deaths have resulted from the manufacture and use of illegal fireworks, the CPSC conducted an investigation and discovered that from November 1999 to May 2005, the retailer was selling and shipping chemicals, tubes, end caps and fuses in hundreds of separate transactions. When assembled, the chemicals and components comprise dangerous and illegal fireworks.

According to the court, the retailer's conduct violated the Federal Hazardous Substances Act and the Hazardous Materials regulations by illegal packaging and shipping of the chemicals. The CPSC had jurisdiction under the Federal Hazardous Substances Act to regulate the fireworks components as banned hazardous substances, regardless of whether they were consumer products. The court noted that although the agency was originally created to protect against injuries related to consumer products, Congress broadened the authority of the Commission by transferring to it the functions of the Secretary of Health, Education and Welfare under the Federal Hazardous Substances Act. The court determined that the CPSC's jurisdiction over the chemicals and components intended for use in the construction of the fireworks was not preempted by the Bureau of Alcohol, Tobacco, Firearms, and Explosives, notwithstanding the fact that regulations promulgated by the ATFE refer to fireworks devices that also are covered by regulations administered by the CPSC. Because neither permits conduct that the other prohibits, the court construed the ATFE and FHSA as consistent and co-existent. According to the court, therefore, the ATFE regulations do not overrule or preempt the FHSA regulations. Although the court granted summary judgment for the government in an earlier decision, it refrained from granting the requested injunctive relief, which could have severely impacted the seller's business, and instead ordered the parties to negotiate an agreeable remedy [see CCH Consumer Product Safety Guide ¶75,745].

After the parties failed to negotiate an agreeable remedy, the court fashioned an injunction to prevent most of the retailer's sales associated with the manufacture of banned fireworks without shutting down the retailer's business. The court balanced the equities, duly considered the public interest, and determined that a permanent injunction was proper to stop the sale of certain fuel sources, oxidizers, fuses and other components used in large-scale manufacturing of illegal fireworks. The court also imposed shipping and record keeping requirements on the retailer, and granted the Commission authority to make surprise inspections of the retailer's facilities. (United States v. Purrington, DC Idaho, CCH Consumer Product Safety Guide ¶75,746.)

Manufacturer Not Liable for Seatbelt, Airbag Failure
The manufacturer of a Chevy Suburban was not liable for injuries to a driver who was injured when the vehicle's seatbelt failed to lock and the airbag failed to inflate when the vehicle was involved in an accident, because the driver failed to identify a specific defect and erroneously relied on circumstantial evidence to create an inference of liability on the part of the manufacturer, according to the Eight Circuit. The driver lost control of the vehicle on the highway, traveled more than 260 feet across the shoulder, through a drainage ditch, through a barbed wire fence, up an embankment, and collided with a tree. The driver was wearing a seatbelt at the time of the accident and the airbag failed to deploy on impact. The driver brought an action against the manufacturer of the vehicle, alleging a design or manufacturing defect caused the failure of the vehicle's occupant protection system. A biomechanics expert testifying for the driver stated that a design or manufacturing defect caused the failure of the occupant protection system, and identified twelve possible defects that could have caused the failure, but could not specify which of the twelve caused the failure. The driver's failure to provide proof concerning a specific defect in the occupant protection system was fatal to the claim. The driver also was unable to demonstrate the manufacturer's liability on the basis of circumstantial evidence. The driver failed to meet its burden of negating other possible causes of the failure of the occupant crash protection system to raise the inference that the dangerous condition was present when the vehicle was still under the manufacturer's control. The court noted that because the complexity of occupant protection systems, and of potential defects therein, is beyond a juror's experience, common experience does not create the inference that injuries resulting from an accident are likely the result of a defect in the occupant protection system. The court, accordingly, affirmed summary judgment in favor of the manufacturer. (Ruminer v. General Motors, 8th Cir., CCH Consumer Product Safety Guide ¶75,744.

House Panel Says CPSC Regulatory Regime Needs Improvement
The regulatory regime of the Consumer Product Safety Commission (CPSC) must be improved so that the number of preventable child deaths in the future can be minimized, House Commerce, Trade and Consumer Protection subcommittee chairman Rep. Bobby Rush (D-Ill.) said May 15. At a hearing convened to assess child safety issues, concerns about the CPSC’s ability to operate on a limited budget and without a full quorum were voiced by several members. “This is an agency we need to strengthen,” said ranking member Rep. Cliff Stearns (R-Fla.) who added that the number of imported products that don’t always abide by industry safety standards has risen dramatically. Rep. John Barrow (D-Ga.) noted that in 1981 the CPSC operated with a staff of approximately 1,000, whereas today that number has dropped to around 400. Acting CPSC Chairman Nancy Nord told members that the CPSC’s quorum, which is necessary for the agency to vote on certain regulatory and enforcement actions, expired on January 15. Nord explained that due to the CPSC’s staffing levels, the agency is forced to prioritize. “We simply do not have the resources to fully investigate and examine every one of the hundreds of thousands of annual product incidents of which we become aware,” Nord said. Turning to the issue of imported toys, Nord emphasized this is a “huge problem” for the CPSC. According to Nord, the growing number of imported toys that do not meet voluntary industry standards “has strained our resources and challenged us to find new ways to work to ensure the safety of products in the stream of commerce.” Nord said that three years ago the CPSC negotiated a memorandum of understanding and established an action plan with its counterpart agency in China. Working groups have been set up between the two agencies, leading up to a U.S.-China safety summit in the fall, Nord said. (Sarah Borchersen-Keto, CCH Washington News Bureau, CCH Consumer Product Safety Guide, Report No. 891, May 30, 2007)

Recall of Bicycle Helmet Did Not Prove Causation
A bicyclist's products liability claim against the seller of the helmet she was wearing at the time of an cycling accident that resulted in severe head injuries was dismissed because the cyclist's failure to identify a specific defect in the helmet precluded any finding that a defect could have been the cause of her head injuries, according to a federal court in Michigan. The helmet was a replacement obtained by the cyclist from the manufacturer after a voluntarily recall of the original helmets [see CCH Consumer Product Safety Guide Transfer Binder “Developments 2003 to 2004” ¶54,620]. The manufacturer, in cooperation with the Consumer Product Safety Commission, recalled the helmets for failure to meet impact testing requirements under the Commission's safety standards for bicycle helmets, 16 CFR Part 1203. The cyclist was wearing the replacement helmet when she was involved in a crash that resulted in serious injuries, including subdural hematoma, fractured vertebrae and collarbone, bulging spinal discs, crushed rib cage, and a collapsed lung. The court ruled that expert testimony that the severity of the cyclist's head injuries resulted from the inability of the helmet to meet CPSC standards was inadmissible speculation. The cyclist failed to identify a manufacturing or design defect that led to the recall or that was causally connected to her injuries. The court concluded, therefore, that there was insufficient evidence to raise a question of material fact with respect to causation, and the cyclist's claim against the seller was dismissed. (Jenish v. Monarch Velo LLC, et al., ED Mich., CCH Consumer Product Safety Guide ¶75,747.)

Senate Panel Passes Child Car Safety Legislation
The Senate Committee on Commerce, Science, and Transportation has passed the bipartisan Cameron Gulbransen Kids Transportation Safety Act, S. 694, which aims to protect children in and around new motor vehicles by utilizing backover avoidance technologies, power window auto-reverse mechanisms, and brake transmission shift interlocks. The bill would require the Department of Transportation (DOT) Secretary to initiate a rulemaking to consider amending or prescribing federal motor vehicle safety standards to require that power windows and panels reverse direction when they detect an obstruction in order to prevent children from being trapped, injured or killed. The DOT secretary would also be required to initiate a rulemaking to expand the required field of view to enable the driver to detect the presence of a person or object behind the vehicle. Meanwhile, the bill calls for the issuance of regulations to require automatic transmission vehicles to have a system that requires the brake to be depressed before the transmission is shifted out of park position. This system would apply to cars and trucks manufactured on or after September 1, 2010. The DOT secretary would also need to establish and maintain a database of injuries and deaths in non-traffic, non-crash events involving cars and light trucks. (Sarah Borchersen-Keto, CCH Washington News Bureau, CCH Consumer Product Safety Guide, Report No. 891, May 30, 2007)