October 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.

U.S. High Court Agrees to Michigan Drug Preemption Case
The U.S. Supreme Court granted certiorari to the manufacturers of the diabetes drug Rezulin concerning a decision by the U.S. Court of Appeals for the Second Circuit, 467 F.3d 85, that found no preemption of a Michigan statute that barred lawsuits involving FDA-approved drugs unless a plaintiff could demonstrate fraud in the drug approval process. Although a direct claim of fraud on a federal agency brought in a state court would not be entitled to the normal presumption against preemption because of the inherently federal nature of the claim, the Second Circuit held that state products liability claims that are subject to the Michigan statute are entitled to the presumption because they are based primarily on state tort law. The appeals court distinguished those claims that are based solely on fraud-on-the-FDA from those that are required to demonstrate fraud on a federal agency as a requirement of a state law, such as the Michigan statute. In their petition, the manufacturers asked the Supreme Court to address whether the claim brought under the exception in the Michigan statute would be conflict preempted, arguing that the appeals court's decision conflicted with the Supreme Court's previous ruling in Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001). The underlying Second Circuit decision was Desiano v. Warner-Lambert Co, Inc. and was reported at CCH Products Liability Reports ¶17,584 (ip access user) (Warner-Lambert Co. LLC v. Kent, U.S. S.Ct., Dkt. No. 06-1493).

U.S. House Passes Bill Requiring Regulation of Diacetyl Flavoring
House bill H.R. 2693, which passed the House September 26, 2007, would require the Occupational Safety and Health Administration (OSHA) to institute a national interim standard limiting worker exposure to the artificial butter flavoring diacetyl within 90 days. The flavoring chemical has been blamed for causing an irreversible lung disease known as bronchiolitis obliterans in food industry workers. Concern over the risk posed by the flavoring focused initially on workers at microwave popcorn manufacturing plants and is often referred to as “popcorn lung.” Although some of the largest manufacturers of microwave popcorn have announced recently that they are substituting the artificial flavoring in their products, it continues to be used in a large number of other food products and there is some concern that the flavoring could pose a risk to consumers. The bill, which passed the House by a vote of 260 to 154, was sponsored by

Rep. Lynn Woolsey (D-Cal.) who blamed OSHA for failing to limit worker exposure for the past several years in which it had knowledge of the risk to workers. “It’s a travesty that OSHA has done nothing to regulate this chemical, while workers have fallen seriously ill and some have actually died,” said Rep. Woolsey. The bill requires that the interim standard include specified exposure levels, medical surveillance of workers, worker training, and requirements for protective equipment. The bill also requires that the interim standard remain in effect until a final standard is released under the Occupational Safety and Health Act, giving OSHA two years to develop a final standard. The bill was opposed by a group of 14 business interest groups, labeled the OSHA Fairness Coalition, that argued there is insufficient data available to set a permissible exposure limit. The group also criticized the bill for its attempt to mandate a standard outside of the established OSHA rulemaking process. (CCH Products Liability Reports, No. 1144, Oct. 3, 2007)

Utah's High Court Clarifies Presumption for Standards Compliance
When a presumption of nondefectiveness arises because a product complied with government standards, the jury should be informed of the presumption with instructions that proof by a preponderance of the evidence is sufficient to overcome it, according to the Utah Supreme Court. A pregnant passenger was ejected through the windshield of a motor vehicle, allegedly causing brain damage to her fetus. The U.S. District Court for the District of Utah sent a certified question to the Utah Supreme Court, inquiring whether the jury should be informed about the presumption under Utah Code Ann. §78-15-6(3) which was triggered by the manufacturer's compliance with Federal Motor Vehicle Safety Standards for vehicle windshields in force at the time the vehicle was manufactured. The state court explained that presumptions generally must be incorporated into the fact-finding process for juries to appropriately discharge their obligations. The court also ruled that although the standard of proof needed to overcome the presumption was not specified in the Utah statute, there were no factors weighing in favor of increasing the standard of proof beyond a preponderance of the evidence to require clear and convincing evidence. The court reasoned that the higher standard of clear and convincing evidence was reserved for “particularly important” civil cases which involve possible damages beyond the mere loss of money. Lastly, the court rejected the manufacturer's argument that without an increased burden of proof, the presumption was meaningless (Egbert v. Nissan N. Am., Inc., Utah S. Ct., CCH Products Liability Reporter ¶17,825 (ip access user)).

Consumer Product Safety

Entrapment Protection Improved for Garage Door Openers
The "Safety Standard for Automatic Residential Garage Door Operators," 16 CFR Part 1211, was amended by the CPSC to incorporate changes made to Underwriter Laboratories, Inc. ("UL") standard UL 325, "Door, Drapery, Louver and Window Operators and Systems." According to the Commission, the UL revisions addressing the entrapment hazard of a child becoming stuck under a partially open door which could then move down if a bystander pressed the wall control button, should be adopted because they carry out the purposes of the Consumer Product Safety Improvement Act. Changes to the entrapment protection requirements in the UL standard become effective February 21, 2008, and the CPSC adopted the same effective date for the CPSC standard. (CCH Consumer Product Safety Guide ¶41,967 (ip access user))

Updates Proposed for List of Child Restraints Used in Crash Protection Testing
The list of child restraint systems (CRSs) in Federal Motor Vehicle Safety Standard No. 208, "Occupant crash protection," would be updated by an amendment proposed by NHTSA. The proposed amendment would replace certain CRSs listed in Appendix A to the child restraint standard with other models that are more representative of the CRSs currently on the market. The agency uses the CRSs listed in Appendix A to test advanced air bag suppression or low risk deployment systems (LRSs), in order to minimize the risk of injuries to infants and small children from deploying air bags. Although air bags have proven to be an effective means of occupant protection in frontal crashes, under certain circumstances air bag deployment has caused serious, even fatal, injuries to occupants close to the air bag when it deployed. Manufacturers, therefore, are required to employ either a system to suppress an air bag in the presence of a CRS, or an LRD system, and to ensure that the vehicle complies with the suppression or LRD requirements when tested with the CRSs specified in Appendix A of the standard. The appendix, however, has not been revised since 2003. The proposed amendments would remove six CRSs from the list, and add five new CRSs. (CCH Consumer Product Safety Guide ¶40,703 (ip access user))

Lead Paint Safety Bills Introduced in House, Senate
By Sarah Borchersen-Keto, CCH News Bureau Staff Writer
Bills that set a statutory limit on the amount of lead paint in children’s products, rather than directing the CPSC to impose such a ban, were introduced in both the House of Representatives and the Senate October 4. The Lead Free Toys Act will ban lead from toys, toy jewelry, and other products used by children under age six. “This is the kind of simple, commonsense action that the CPSC should have taken years ago,” said Rep. Henry A. Waxman (D-Cal.), a co-sponsor of the act. The bill is a re-introduction of legislation first put forward in 2005. Under the bill, any product marketed for use by children under the age of six may contain no more than: 600 parts per million (ppm) of lead, effective within 30 days of enactment; 250 ppm, effective one year after enactment; 100 ppm, effective two years after enactment. Sen. Barack Obama (D-Ill.), who introduced the bill in the Senate, said “the extraordinary scale of this challenge demands meaningful and innovative solutions to prevent lead-contaminated toys from harming our children.” (CCH Consumer Product Safety Guide, No. 900, Oct. 12, 2007)

House Responds to Recalls by Approving Product Safety Bills
The House passed four measures on October 9, intended to increase protection for children from hazardous products. The “Product Safety Civil Penalties Improvement Act” (H.R. 2474), introduced by Rep. Rush (D-Ill.), would increase the maximum civil penalty for violations of the Consumer Product Safety Act, the Federal Hazardous Substances Act, and the Flammable Fabrics Act, from $1.5 million to $10 million. The Danny Keysar Child Product Safety Notification Act (H.R. 1699), which was introduced by Rep. Schakosky (D-Ill.), was named after the 17-month-old boy who was fatally injured when his crib collapsed in 1998. The bill was based on CPSC findings that every year an average of 50 children under the age of 5 are fatally injured by incidents involving nursery products, and that approximately 32% of the fatalities involve cribs. The bill would direct the CPSC to require certain manufacturers to provide consumer product registration forms to facilitate recalls of durable infant and toddler products intended for use, or that may be reasonably expected to be used, by children younger than 5 years, including full-size and nonfull-size cribs, toddler beds, high chairs, booster chairs, bath seats, gates and other enclosures used to confine a child, play yards, stationary activity centers, infant carriers, strollers, walkers, swings, bassinets and cradles. The safety of swimming pools and spas would be increased under the “Virginia Graeme Baker Pool and Spa Safety Act” (H.R. 1721), introduced by Rep. Wasserman Schultz (D-Fla.). Virginia Graeme Baker, the child after whom the legislation was named, drowned at age 7 by entrapment in a residential spa. The legislation would require the use of proper anti-entrapment drain covers and pool and spa drainage systems, and would establish a grant program, to be administered by the CPSC, encouraging states to improve pool and spa safety laws and public awareness. The bill arose from congressional findings that drowning is the second leading cause of injury-related death in children between ages 1 and 14, and that approximately 260 children younger than age 5 drown each year in swimming pools, with almost 2,725 children treated every year in hospital emergency rooms for residential pool submersion injuries. Finally, the Children's Gasoline Burn Prevention Act (H.R. 814), introduced by Rep. Moore (D-Kan.) would require the CPSC to issue regulations mandating child-resistant closures on all portable gasoline containers. (CCH Consumer Product Safety Guide, No. 900, Oct. 12, 2007)

CPSC Study Reveals Home Lead Test Kits Unreliable
The CPSC conducted an evaluation of consumer lead test kits, using commonly available test kits on a variety of paints and other products containing different levels of lead. Many of the tests registered false negatives, failing to detect lead when it was present. Other test kits registered false positives, indicating lead was present when it was not. Of 104 total test results, more than half were false negatives, and two were false positives. None of the kits consistently detected lead in products if the lead was covered with a non-leaded coating. Based on the study, the Commission has advised that consumers should not use lead test kits to evaluate consumer products for potential lead hazards. Laboratory testing by qualified personnel remains the only way to accurately assess the risk posed by a product that may contain lead, the agency concluded. (CPSC News Release, #08-038, October 22, 2007, CCH Consumer Product Safety Guide, No. 901, Oct. 26, 2007)