January 2009

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.

Hot Topics

Regulation of lead content levels, especially in children’s products, and the establishment of testing procedures as required by the Consumer Product Safety Improvement Act of 2008 continues to be the focus of regulatory activity by the Consumer Product Safety Commission. January saw the release of several proposals addressing these issues.

Changes Made to Lead-Containing Paint Rules
As required by the Consumer Product Safety Improvement Act of 2008 (CPSIA), the Consumer Product Safety Commission has amended regulations concerning the ban of lead-containing paint and certain consumer products bearing lead-containing paint to reduce the permissible lead limit. The changes are effective August 14, 2009. The regulations currently define as “banned hazardous products” certain consumer products, including paint and similar surface-coating materials, toys and other articles intended for use by children, and certain furniture articles that bear lead-containing paint. Lead-containing paint is defined as paint in which the lead content is in excess of 0.06 percent of the weight of the total nonvolatile content of the paint or the weight of the dried paint film. The CPSIA mandated that the 0.06 percent lead limit be reduced to 0.009 percent, effective August 14, 2009. In addition, the CPSIA provided that any ban or rule promulgated under the regulations shall be considered a regulation promulgated under or for the enforcement of the Federal Hazardous Substances Act and the Commission made this amendment in the final rule. (CCH Consumer Product Safety Guide ¶41,998 (ip access users))

Testing Requirements for Children's Metal Jewelry Established
Requirements for accreditation of third-party conformity assessment bodies to test to the 600 ppm and 300 ppm lead limits in metal and metal alloy parts of children's metal jewelry established by the Consumer Product Safety Improvement Act of 2008 (CPSIA) have been issued by the Consumer Product Safety Commission. The Commission stated that it was not currently addressing third-party testing to the 100 ppm lead limit. That limit may become effective three years after the date of enactment of the CPSIA, depending on technological feasibility. The requirements for accreditation of laboratories to test to the 600 ppm and 300 ppm lead limits in children's metal jewelry were effective December 22, 2008. (CCH Consumer Product Safety Guide ¶56,944 (ip access users))

Comments Sought on Products Excluded from Lead Limits
The Commission is seeking comments concerning its preliminary determination, based on findings by its staff, that certain natural, untreated and unadulteralted metals, do not exceed the lead content limits set by the Consumer Product Safety Improvement Act of 2008 (CPSIA). Pursuant to that act, the CPSC has the authority to issue regulations on its own initiative or at the request of any interested party, to make a determination that a material or product does not exceed the lead limits set by the CPSIA. (CCH Consumer Products Safety Guide ¶40,222 (ip access users))

Procedures for Determining Lead Content Limits Proposed
Procedures and requirements to determine whether a commodity or class of materials or a specific material or product exceeds the lead content limits specified under the CPSIA have been proposed by the CPSC. The procedures would also determine exclusions for a commodity or class of materials or a specific material or product that exceeds the lead content limits, but which would not result in the absorption of any lead into the human body nor have any other adverse impact on public health or safety. Such a determination would relieve the material or products from the testing requirements of the CPSIA for purposes of required certification. The notice solicits comments on proposed procedures and requirements and information to be supplied with such requests. (CCH Consumer Products Safety Guide ¶40,223 (ip access users))

Lead Exposure Requirements Proposed for Electronic Devices
The CPSC has proposed requirements to eliminate or minimize the potential for exposure to and accessibility of lead for certain electronic devices for which it is not technologically feasible to meet the lead limits imposed by the Consumer Product Safety Improvement Act of 2008 (CPSIA). The Commission proposes to adopt, as exemptions to the CPSIA lead limits for electronic devices, exemptions published in the Annex to EU Directive 2002/95/EC, provided that the exemption is based on a functional requirement both for the use of a lead-containing component and for the use of lead in such component. The exemptions are based, in part, on scientific technological feasibility. (CCH Consumer Product Safety Guide ¶40,220 (ip access users)

Products Liability

Smoker Failed To Prove "Utility" of Light Cigarettes
The reversal of a jury's award of compensatory and punitive damages to a smoker for her negligent design claim against a cigarette manufacturer was upheld by the New York Court of Appeals. Because the smoker did not show that regular and "light" cigarettes had the same "utility" to smokers, her tort claim failed. The smoker, who was diagnosed with lung cancer and another condition caused by smoking and died during the pendency of her appeal, brought a negligent design complaint against a successor tobacco company. Although the smoker showed that light cigarettes with significantly lower levels of tar and nicotine were "safer," she failed to show that light cigarettes remained "functional," that is, that they provided the same satisfaction to smokers as regular cigarettes. The court noted that not every products liability claim must show that a safer alternative was as acceptable as the product provided. However, the court continued, where the only "utility" of cigarettes was a smoker's pleasure or satisfaction, the plaintiff was required to show that the safer, light cigarettes had the same "utility" or function as regular cigarettes, which inarguably they did not. While it is still lawful to make and sell cigarettes, and for people to buy and smoke them despite their questionable "utility," the court concluded that to expose a tobacco company to tort liability for every sale of regular cigarettes would result in a judicial ban on cigarettes and that was the responsibility of the legislature not the court. (Adamo v. Williamson Tobacco Co., N.Y. Ct. App., CCH Products Liability Reporter ¶18,142 (ip access users))

No Bar to Wrongful Death Claim Against Tobacco Company
A wrongful death action brought by survivors of a long-time cigarette smoker under Missouri’s wrongful death statute against a tobacco company for personal injury claims based in negligence and product defect was not barred despite the deceased's having brought, during her lifetime, a personal injury action in federal court for the injuries eventually resulting in her death, the Missouri Court of Appeals held. The tobacco company argued that the decedent's survivors were statutorily prohibited from asserting the same claims against it under the state's wrongful death statute as the decedent did in federal court, which dismissed her complaint with prejudice. However, the state's supreme court recently had determined that providing compensation to bereaved plaintiffs was the "manifest purpose" of the wrongful death statute, and the appellate court said that finding the survivors' wrongful death cause of action was not barred by the decedent’s suit in federal court was consistent with that "manifest purpose." Further, the court said, the state high court's decision found that the wrongful death statute created a new cause of action and did not revive an action belonging to the decedent, and that the statute did not condition recovery on the existence of a right to sue at either the time of the injury or the time of the death. In addition, the damages recoverable in the wrongful death action differed from damages recoverable in a personal injury cause of action. Pecuniary losses incurred by the decedent's death, including, funeral expenses, and "the reasonable value of the services, consortium, companionship, comfort, instruction, guidance, counsel, training, and support" the decedent would have provided were among the recoverable damages under the wrongful death statute. Another difference was that the statute provided a statute of limitations for wrongful death action, separate from the statute of limitations applicable to the underlying personal injury action. The court of appeals also ruled that sufficient evidence was presented to make a submissible case to a jury on the claim that the tobacco company's particular brand of cigarettes was unreasonably dangerous. The evidence presented went beyond a categorical attack on the danger of cigarettes in general, but instead demonstrated specific design choices by the tobacco company had the potential to affect the decedent's health during the time period that she smoked. The survivors’ strict liability product defect and negligent design claims were not preempted by federal law. (Smith v. Brown & Williamson Tobacco Corp., Mo. Ct. App., CCH Products Liability Reporter ¶18,143 (ip access users))

Contract Limitations Period Barred $2.5 Recovery for Defective Truck
Claims by a company that purchased a 240-ton rock truck against the truck's seller and manufacturer to recover $2.5 million, the purchase price of the truck, were barred by the sales contract's one-year limitations period for filing a lawsuit, the U.S. District Court for the Western District of Pennsylvania held. Although the Pennsylvania Uniform Commercial Code provided a four-year statute of limitations, the parties' sales contract for the truck provided a one-year limitations period. The truck was purchased by a coal mining operating company in a commercial contract with the equipment seller. The purchaser alleged that a design defect in the truck caused a fire that completely destroyed the truck, and it sought to recover the full sales price of the truck. Arguing that the sales agreement terms, including the one-year limitations period for filing a lawsuit, were unconscionable, the purchasing company contended the terms were unenforceable because they were not part of the negotiation process, they were never read, and the limitations period rendered the two-year warranty illusory. The seller and truck manufacturer argued that the contract terms, which were negotiated in a commercial contract, were not unconscionable and the lawsuit was untimely. Under the Pennsylvania UCC, the four-year period of limitations for a breach of contract action could be reduced, but not to less than one year, upon agreement between the parties. Pennsylvania law provided that contractual modification of a statute of limitations was valid and enforceable. Not reading the contract did not justify avoiding the contract terms, the court reasoned, and did not render a commercial contract unconscionable. With regard to the two-year warranty, the loss of the truck occurred within the two-year period. The lawsuit was not timely filed and no evidence supported extending the one-year contract period of limitations. (Amvest Corp. v. Anderson Equip. Co., W.D. Pa., CCH Products Liability Reporter ¶18,135 (ip access users))

No Lift or Expert Witnesses Precluded Defect Claims; Spoliation Issue Raised
In the absence of an allegedly defective scissors lift with its attached level sensor and/or any expert witness testimony, strict liability and negligence claims by two ranchers against the manufacturer of the lift with an attached level sensor was precluded, the U.S. District Court for the North Dakota District held. However, the ranchers were granted further discovery to determine if the hardware store that rented them the lift engaged in spoliation by disposing of the lift before it was examined, despite the ranchers' request that the lift be preserved for their lawsuit. (Krosch v. JLG Industries et al., D. N.D., CCH Products Liability Reporter ¶18,141 (ip access users))

MDA Preempts Claims Against Knee Replacement Manufacturer
A patient's claims against a manufacturer of her knee replacement, which was allegedly removed to prevent further osteolysis caused by the implant, were preempted by the Medical Device Amendments (MDA) to the Food, Drug and Cosmetic Act, the U.S. District Court for the Northern District of Illinois held. The patient's state law claims of negligence, strict liability, and breach of warranty claims were preempted to the extent they differed from the federal requirements. The patient unsuccessfully argued that the implant's defect became apparent only after the rigorous premarket approval process (PMA) for the Class III medical device conducted by the Federal Drug Administration (FDA). The FDA approval of the implant represented a determination that it was safe and effective, and at the time of the patient's knee replacement, the manufacturer had maintained continuing compliance with MDA regulations and was under FDA supervision. All the components of the knee replacement were manufactured in compliance with FDA-approved specifications. In granting summary judgment to the manufacturer, the court concluded that the patient's state common-law claims and fraud allegations against the manufacturer were preempted. Other assertions were not supported by the record. (Link v. Zimmer Holdings, Inc., N.D. Ill., CCH Products Liability Reporter ¶18,139 (ip access users))

Claim Against Generic Drug Maker Not Preempted by FDA Labeling Rules
Food and Drug Administration labeling requirements for generic drugs did not preempt a state products liability warning claim against the maker of a generic drug used to treat acid reflux disease because those requirements did not prevent the manufacturer from including additional warnings. A patient claimed that the generic drug manufacturer failed to warn her of the side effects of extended use of a drug to combat acid reflux disease and further breached a duty to provide updated information on side effects to the FDA after she was diagnosed with tardive dyskenseisa, a neurological disorder affecting facial muscles. The generic drug manufacturer argued FDA labeling requirements limited its ability to modify warning label language and preempted the claim. However, the argument was rejected because the language of the requirements and later amendments set forward a minimum labeling requirement, but implicitly indicated that the manufacturer could include a stronger warning or add information about known side effects that did not affect the brand name drugs. Moreover, the court found that the case law cited by the generic drug manufacturer did apply to the facts of the case. (Demahy v. Wyeth Inc., E.D. La., CCH Products Liability Reporter ¶18,134 (ip access users))

Product Safety

CPSC Proposes Guidance on Component Parts Accessibility
As directed by the CPSIA, the Commission has proposed a rule to provide guidance with respect to what product components or classes of components would be considered to remain inaccessible to a child through normal and reasonably foreseeable use and abuse. The CPSIA specifies that a component part is not accessible if it is not physically exposed by reason of a sealed covering or casing and does not become physically exposed through reasonably foreseeable use and abuse of the product including swallowing, mouthing, breaking, or other children’s activities, and the aging of the product as determined by the Commission. (CCH Consumer Products Safety Guide ¶40,221 (ip access users))

Children’s Product Resellers' Requirements Clarified
The CPSC has provided guidance for resellers of children’s products, thrift and consignment stores, and has addressed the requirements of the Consumer Product Safety Improvement Act (CPSIA) that take effect in February 2009. Under the CPSIA, children’s products with more than 600 ppm total lead cannot be sold in the United States on or after February 10, 2009, even if they were manufactured before that date. On August 14, 2009, the total lead limit drops to 300 ppm. The CPSIA requires that domestic manufacturers and importers certify that children’s products made after February 10, 2009, meet all new safety standards and the lead ban. The Commission stated that sellers of used children’s products, such as thrift stores and consignment stores, were not required to certify that those products met the new lead limits, phthalates standard, or the new toy standards. (CPSC News Release, #09-086, January 8, 2009, CCH Consumer Product Safety Guide, Report No. 931, January 26, 2009)

Nursing Pillows Exempted from Hazardous Substances Ban
An exemption from regulations banning infant cushions/pillows has been issued for the Boston Billow Nursing Pillow and substantially similar nursing pillows effective December 19, 2008. Based on staff assessment, incident data, and comments received in response to a notice of proposed rulemaking, the Commission concluded that an exemption from the ban on infant cushions/pillows should be granted. A “substantially similar nursing pillow” is a pillow designed to be used only as a nursing aide for breastfeeding mothers. (CCH Consumer Product Safety Guide ¶41,999 (ip access users))

Target Announces New Recall Notification System
The Consumer Product Safety Commission and Target, of Minneapolis, Minnesota, announced a new system for communicating product recalls in Target stores. Target will post signs throughout its stores directing customers to gift registry kiosks where they will be able to learn about recalled products. The system will provide notices of new and past recalls for all product categories and customers will be able to print copies of the safety and recall notices. CPSC has also recommended that consumers sign up to receive automatic email updates on recalls at https://www.cpsc.gov/cpsclist.aspx (CPSC News Release, #09-070, December 18, 2008, CCH Consumer Product Safety Guide, Report No. 930, January 12, 2009).

Changes to Early Reporting Rule Proposed
NHTSA has proposed amendments to certain provisions of the early warning reporting (EWR) rule published in accordance with the Transportation Recall Enhancement, Accountability, and Documentation (TREAD) Act. The proposed amendments also are in response to a petition for rulemaking, and to information identifying products involved in a recall under regulations dealing with defect and noncompliance responsibility and reports. Written comments regarding these proposed rule changes may be submitted to NHTSA and must be received on or before February 3, 2009. (CCH Consumer Product Safety Guide ¶40,719 (ip access users))

Child Restraint System Language Amendment Denied
A petition for rulemaking requesting that NHTSA amend the language and definitions in Federal Motor Vehicle Safety Standard (FMVSS) No. 213, “Child restraint systems,” to apply the standard to products that are not yet defined by the standard, such as belt positioning devices, was denied. As an alternative, the petitioner asked the agency to adopt a new definition, which would allow his product, the Hip-Hugger, to be recognized and defined as a child restraint device under FMVSS No. 213. In denying the petition, the agency stated that it disagreed with the petitioner’s argument that the definitions in FMVSS No. 213 were too restrictive and, therefore, saw no reason to alter the definitional requirements at the current time. Furthermore, because the agency did not believe that belt positioners offer the same level of occupant protection as age-appropriate child restraint systems, the agency also denied the request to incorporate a new definition for belt positioning devices into FMVSS No. 213. The agency also was concerned that applying FMVSS No. 213 to seat belt positioners might actually degrade child occupant protection by promoting premature graduation to lap/shoulder belts. (CCH Consumer Product Safety Guide ¶56,942 (ip access rules))

NHTSA Recommends Best Practices for Importers
NHTSA has provided guidance concerning best practices to be followed by importers of motor vehicles and motor vehicle equipment to reduce the likelihood of importing products that contain defects related to motor vehicle safety or that do not comply with applicable federal motor vehicle safety standards. NHTSA issues and enforces federal motor vehicle safety standards that apply to motor vehicles and to certain items of motor vehicle equipment. NHTSA also monitors motor vehicles and items of motor vehicle equipment that are imported into the United States for compliance with applicable FMVSS. Imports of motor vehicles and motor vehicle equipment items sold in the United States have increased in recent years. (CCH Consumer Product Safety Guide ¶56,945 (ip access users))