February 2008

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.

Supreme Court Rules PMA Approval Preempts Medical Device Actions
The Court ruled that federal device-specific requirements established under the Food and Drug Administration's (FDA) premarket approval (PMA) process for medical devices preempt state products liability claims. The Court's 8–1 decision was issued in a case involving a patient who was injured when a catheter burst during his coronary angioplasty procedure. In a majority decision written by Justice Scalia, the Court explained that the patient's claims would be preempted if it were determined that the federal requirements imposed by the FDA were device-specific and the state claims constituted “requirements” that differed from or added to the federal requirements. In finding that the FDA's approval of the catheter constituted a device-specific requirement, the Court distinguished the PMA process from the less-rigorous § 510(k) process, which only requires a showing that the device is equivalent to one that was on the market prior to the creation of the PMA process in 1976. The Court reiterated its view that § 510(k) approval did not result in device-specific requirements because it did not focus directly on safety but was more accurately described as an exemption from a direct review of safety. In contrast, the Court found that the PMA approval process, under which the patient's catheter had been approved, constituted device-specific requirements because PMA approval was based on a more rigorous process involving a review of a device's safety and effectiveness. In analyzing whether state common-law tort claims constituted state requirements, the Court looked to the underlying focus of the claims. The Court found that the tort duties underlying negligence and strict liability claims constituted requirements similar to PMA approval because they both focused on product safety and effectiveness. Although the Court recognized the differences between direct state regulation and common-law tort duties, it found that common-law claims were a “potent method of governing conduct and controlling policy” and had the same effect as direct state regulation of medical devices. The Court concluded that the common-law duty under state tort law was preempted by the federal review and approval of the catheter. (Riegel v. Medtronic, Inc., U.S. S. Ct.; CCH Products Liability Reporter, February 27, 2008, ¶17,924 (ip access user)).

Texas High Court Dismisses Gen-3 Seat Belt Class Action
A proposed nationwide class of approximately 10 million owners and lessees of vehicles equipped with allegedly defective seatbelt buckles failed to demonstrate the concrete injury necessary to establish standing, the Texas Supreme Court ruled. The class representatives alleged that the Gen-3 model seatbelt buckle violated Federal Motor Vehicle Safety Standard (FMVSS) No. 209's requirement that a “[b]uckle release mechanism shall be designed to minimize the possibility of accidental release.” In seeking to establish that the Gen-3 violated FMVSS No. 209, the class representatives presented evidence of the seatbelt's rate of accidental release, including its poor performance on industry minimum force release tests, customer complaints documenting 100 instances of unintentional release, and the buckle's accidental release during crash tests performed by NHTSA and the Canadian government. The Texas high court, however, dismissed the proposed class on jurisdictional grounds because the court found that class representatives failed to demonstrate a concrete injury. The court reasoned that the threat posed by the seat belt's accidental release was not a sufficient injury because the rate of consumer complaints (i.e., one complaint for every 200,000 owners or lessees) demonstrated that the threat was too remote. Further, the court noted that the risk posed by the allegedly defective buckle design was minimal when balanced against the risk of non-use. (DaimlerChrysler Corp. v. Inman, Tex. S.Ct.; CCH Products Liability Reporter, February 27, 2008; ¶17,919 (ip access user); CCH Consumer Products Safety Guide, February 29, 2008, ¶75,757 (ip access user)).

Congressional Subpoenas Issued in Dangerous Antibiotic Inquiry
Congressional subpoenas related to the approval of the antibiotic Ketek were issued on January 29 by the Energy and Commerce Oversight and Investigations Subcommittee. The antibiotic, which was used to treat pneumonia and is manufactured by Sanofi-Aventis (formerly Aventis), has been linked to liver failure and the possible death of some patients. By a vote of 12–0, the subcommittee authorized subpoenas for the testimony of two current and one former criminal investigator of the Food and Drug Administration (FDA) for a public hearing on February 12, 2008. The hearing will focus on the FDA's 2004 approval of the antibiotic and the clinical trial data relied on in the approval process. The antibiotic had two of its three indications removed by the FDA for safety concerns just before the subcommittee’s first hearing in February of 2007. Rep. Bart Stupak (D-Mich.), Chairman of the subcommittee expressed regret that the subpoenas were necessary, but was pleased that the vote to authorize the subpoenas was bipartisan. “It is important for the Subcommittee to ascertain what the FDA and Aventis knew and when they knew it regarding fraud in the pivotal safety trial for Ketek. The integrity of the drug approval process is at stake,” Stupak said. The subcommittee also approved a subpoena for documents related to FDA Commissioner Andrew von Eschenbach's testimony before the subcommittee in March of 2007 and a fourth subpoena to a private sector witness who the subcommittee believes has information relevant to its inquiry. (CCH Products Liability Reporter, February 13, 2008).

Presumption Undermined by Drain Cleaner’s Congressional Subpoenas
The warning label on a chemical drain cleaner was not presumed to be nondefective because the manufacturer failed to demonstrate that it complied fully with federal regulations on the labeling of hazardous substances, according to an Indiana appeals court. A consumer lost his left eye and suffered corrosive burns on his face and chest when his drain's drum trap cap exploded as he attempted to remove it, spraying him with drain cleaner. The consumer argued that the drain cleaner's warning label was defective because it inadequately warned him of the risk. In analyzing the specific requirements, the court determined that the manufacturer's warning label failed to include (1) the signal word "DANGER" as required on corrosive products and (2) either the signal word "WARNING" or "CAUTION" as required on any hazardous substances. The court ruled that the manufacturer's failure to comply fully with the federal regulations prevented it from using those regulations as a basis for Indiana's presumption and, therefore, the presumption that the warning label was not defective did not apply. The court further held that the manufacturer's failure to comply fully with the federal labeling requirements was sufficient to create a disputed issue of material fact concerning the adequacy of the cleaner's warnings and instructions. (Lind v. Menard, Inc., Ind. Ct. App., CCH Consumer Products Safety Guide, February 29, 2008, ¶76,756 (ip access user); CCH Products Liability Reporter, February 27, 2008, ¶17,914 (ip access user))

NHTSA Announces 5-Star Rating System for Child
A new five star rating system was designed to grade child safety seats according to how easy they are to properly install, and to assist parents in selecting a car seat to keep their children safe. The new rating system was announced on January 30 by Transportation Secretary Mary E. Peters. NHTSA established a yearly ease of use assessment program pursuant to the Transport Recall Enhancement, Accountability, and Documentation Act. The program has resulted in many improvements to child restraint harness designs, labels, and accompanying manuals. The new rating system was adopted as an enhancement to the ease of use assessment program, and incorporates the agency's responses to public comments. Further details will appear in a future report. (CCH Consumer Products Safety Guide, Report No. 908, February 12, 2008)