Products Liability and Safety Update March 2009

April 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.

Products Liability

ATV Design and Warning Defects Claims Allowed To Proceed
A jury issue existed as to whether the clutch of an all-terrain vehicle (ATV) included an adequate cover to keep it from overheating to the point that an ATV rider received a serious burn to his inner left ankle, the U.S. Court for the District of Colorado held. The ATV rider alleged he received the burn while riding the ATV because the clutch cover became overheated, and, therefore, the ATV was in a defective and unreasonably dangerous condition. The court found there were jury questions as to whether there was a design defect in not including adequate housing over the clutch, and whether the ATV was in a defective condition because the ATV's manufacturer did not warn riders of a possible overheating of the ATV's clutch cover housing that could cause a serious burn. While the ATV manufacturer’s safety manual warned that persons riding the ATV should wear protective cover, including boots, it did not warn of the particular risk of the clutch cover overheating and causing a burn, the court said. Moreover, the ATV manufacturer had prior notice of at least one incident of a temperature at the clutch cover high enough to melt the cover and potentially cause a burn injury. The court also ruled that issues existed as to whether the ATV rider misused the ATV by riding without the recommended protective covering over his feet and whether the manufacturer could have foreseen the misuse. (Shaw v. Play Dirty Colorado ATV Tours, L.L..C., D. Colo., CCH Products Liability Reporter ¶18,187 (ip access users))

Parallel State Law Claims Preempted by MDA Rules
A patient's claims against a manufacturer of an artificial hip alleging that the sound made by the hip caused her discomfort and that the defect caused bone loss were preempted by the Medical Device Amendments Act (MDA) to the federal Food, Drug, and Cosmetic Act, the U.S. District Court for the Eastern District of New York held. The patient argued that because her claims were premised on federal violations by the manufacturer, the parallel regulation exception applied to save her action from dismissal. The court determined, however, that the prosthesis was a device approved through the Food and Drug Administration's (FDA) premarket approval process, a form of federal safety review involving federal requirements, and the patient's claims, including strict liability and negligence, concerned violations of state requirements relating to the safety of the device making them subject to preemption. The state law claims were parallel to the federal requirements already imposed on the device and the patient's generalized allegations failed to establish the necessary link between the manufacturer's federal violations and her alleged causes of action. Two FDA warning letters did not provide the necessary connection to her particular product. Therefore, her claims could not withstand preemption. (Horowitz v. Stryker Corp., E.D. NY, CCH Products Liability Reporter ¶18,192 (ip access users))

FDA PMA "Requirement" Preempted State Claims
State law tort claims in negligence and strict liability against the manufacturer of an implantable cardioverter defibrillator by a patient who had the device surgically implanted were preempted by the express preemption provision of the 1976 Medical Device Amendments to the Federal Food, Drug and Cosmetic Act (21 U.S.C. §360k(a)), even though supplemental premarket approval was given to a later version of the defibrillator, the Wisconsin Supreme Court held. The defibrillator, which originally had received premarket approval (PMA) by the Food and Drug Administration (FDA) in 2002, was implanted in the patient in 2004. Approximately nine months after the patient's surgery, the manufacturer advised physicians of a possible battery shorting problem with the device. Less than ten days after his physician received notice of the problem, the patient underwent another surgery to remove the device and replace it with the improved version. The Wisconsin court found that the patient's state law claims of negligence and strict liability related to the safety of the original defibrillator (which was a Class III medical device) and also imposed requirements that were different from or in addition to the federal requirement of premarket approval; therefore, the claims were preempted. (Blunt v. Medtronic, Inc., Wis. S.Ct., CCH Products Liability Reporter ¶18,177 (ip access users))

Design Questions Existed for Offshore Oil Platform Bunk Beds
A factual issue existed as to whether a successor-in-interest to an oil and gas company was a "manufacturer" under the Louisiana Products Liability Act (LPLA) to determine whether and to what extent the successor exercised control over the design of the living quarters and the bunk bed out of which a worker fell, the U.S. District Court for the Western District of Louisiana ruled. The worker allegedly was attempting to climb down out of the top bunk bed in the living quarters of an oil rig platform when he missed a step and fell backwards sustaining severe injuries. The court found there was sufficient evidence—including approving the design of the platform and carefully reviewing quality control requirements—to create a question of how much control over the design of the bunk bed and the living quarters of the platform was exercised by the predecessor oil and gas company, and, by extension, the successor, so that it was a "manufacturer" under state law. Another factual issue existed as to whether the bunk bed was a "product" under the LPLA. Under the statute, a "product" meant a "corporeal moveable" that was manufactured for placement into trade or commerce, "including a product that forms a component part of or that is subsequently incorporated into another product or an immovable." (Hughes v. Pogo Producing Co., W.D. La., CCH Products Liability Reporter ¶18,188 (ip access users))

Design Defect Claim Failed Without Expert Testimony
Testimony by a patient's causation expert that the sterilization methods used by a manufacturer of a prosthetic knee led to severe oxidation and failure of the prosthesis which was surgically implanted in the patient was inadmissible because the expert failed to bridge the analytical gap between accepted principles and his conclusions, a federal district court in Illinois held. Additionally, the court held that the testimony of the patient's orthopedic surgeon who performed the surgery implanting the prosthetic knee in the patient was admissible if limited to the care, treatment, prognosis, and/or conditions present during the patient's surgery. The court said that the surgeon's testimony beyond that of a treating physician did not satisfy reliability standards and so he would be unable to offer an expert opinion as to causation and defect. The court concluded by ruling that the patient could not prevail on his claims of strict liability and negligence against the manufacturer of the prosthetic knee. The patient had to show the existence of a defective condition in the prosthesis when it left the manufacturer's control, and a causal link between the design defect and the injury. Without the testimony of the patient's causation expert or the expert testimony of the patient's orthopedic surgeon, however, the patient could not make the requisite showing to prevail on his claims. (Fuesting v. Zimmer, Inc., C.D. Ill., CCH Products Liability Reporter ¶18,189 (ip access users))

$677,000 Jury Verdict Upheld as Expert's Ladder Testimony Affirmed
A ladder manufacturer's objections to expert testimony on whether a defect in a ladder from which a worker fell caused the fall were rejected by the U.S. Court of Appeals for the Seventh Circuit, thereby upholding a damages award of $677,000. The worker, who weighed 350 pounds, erected one of the manufacturer's eight-foot fiberglass ladders to check a ceiling panel. While standing halfway up the ladder and reaching into a space in the ceiling with his hands, the worker fell off the ladder, landing on his back. The ladder collapsed with him, and one of the rivets which fastened the rear legs of the ladder to the platform at the top of the ladder was found on the floor, and the leg had separated from the ladder. The worker's expert, an experienced designer of mechanical products, testified that in the manufacturing process the rivet had been misaligned with the hole through which it was supposed to pass and, as a result, had not securely fastened the leg to the platform. The manufacturer complained that the worker's expert did not perform a test to determine whether the misalignment of the rivet with the hole could cause the ladder to collapse, but did not explain what kind of test could be performed to make that determination, the court observed. Also, the court said that the expert's demonstration to the jury of how the accident may have occurred by jerking the rear leg assembly of the ladder that had collapsed (as one would do in opening a ladder), and showing that the leg with the missing rivet became detached from the platform, was not conducting a test that had to be mentioned in the expert's report. The expert was merely demonstrating to the jury what could happen when a rivet was missing. The demonstration could have been performed by a layperson: there was no suggestion that the expert used expert knowledge in jerking the ladder's rear leg, the court said. (Schmude v. Tricam Industries, Inc., 7th Cir., CCH Products Liability Reporter ¶18,183 (ip access users))

Engineering Expert's Test Failed Daubert Requirements
The testimony of an engineering expert was not admissible, under Daubert reliability factors, in support of a ladder user's products liability claim against the manufacturer of the ladder, from which the user had fallen, a federal court in Tennessee held. The engineer, who had more than 20 years experience in the testing and development of ladders, had applied his own test for ladders that he called the "Induced Walking" test. The engineer said that he developed the test based on the American National Standards Institute's (ANSI) Racking test, which measures a ladder's resistance to twisting under an uneven loading. The engineer said his test more closely simulated actual ladder use conditions than the ANSI test, and that the difference between tests was that in his test, all of the ladder's feet are placed on the ground and are not clamped. The court concluded, however, that the methodology used by the engineer, along with his Induced Walking test, did not satisfy any reliability factors set forth by the U.S. Supreme Court in Daubert v. Merrell Dow Pharmaceuticals, Inc. [CCH PRODUCTS LIABILITY REPORTER ¶13,494]. (Walker v. Louisville Ladder, Inc., W.D. Tenn., CCH Products Liability Reporter ¶18,180 (ip access users))

Expert Testimony on Asbestos Not Sufficiently Reliable
The testimony of two experts for an auto mechanic, who developed mesothelioma after a 38-year career of installing and repairing "friction products," including brake shoes and clutch pads, was not sufficiently reliable based on the record evidence in the mechanic's claims against two automotive companies, the Delaware Supreme Court ruled. The mechanic worked with products manufactured and supplied by the two companies, and alleged that the dust from brake shoes and other friction products the companies manufactured caused his illness. The friction products contained chrysotile, one of three forms of commercially used asbestos, and while some products containing chrysotile cause mesothelioma, the friction product manufacturers contended that the chrysotile fibers in friction products were significantly different and that there was insufficient reliable evidence linking exposure to friction products and lung disease. The high court said that the motion judge mischaracterized and misconstrued the epidemiologist's testimony such that the judge's conclusions in favor of the admissibility of the epidemiologist's testimony were not supported by the record. Therefore, the reliability of both experts’ opinions was remanded by the court. (General Motors Corp. v. Grenier, Del. S.Ct., CCH Products Liability Reporter ¶18,178 (ip access users))

Product Safety

Procedures Established for Lead-Containing Products
In a final rule effective March 11, 2009, the Consumer Product Safety Commission issued procedures and requirements on requests for a Commission determination that a commodity or class of materials or a specific material or product does not exceed the lead content limits specified under section 101(a) of the Consumer Product Safety Improvement Act of 2008 (CPSIA). The procedures and requirements also addressed requests for an exclusion of a commodity or class of materials or a specific material or product under section 101(b)(1) of the CPSIA, that exceeds the lead content limits under section 101(a) of the CPSIA, 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. (CCH Consumer Product Safety Guide ¶42,002) (ip access user)

Guidelines for Mandatory Recall Notices Proposed
As required by the Consumer Product Safety Improvement Act of 2008 (CPSIA), the CPSC has proposed guidelines and requirements for recall notices ordered by the Commission or by a U. S. District Court under the Consumer Product Safety Act. The CPSIA requires that recall notices include certain specific information, unless the Commission determines otherwise. This information includes, but is not limited to, descriptions of the product, hazard, injuries, deaths, action being taken, and remedy; identification of the manufacturer and retailers; identification of relevant dates; and any other information the Commission deems appropriate. Written comments must be received by April 20, 2009. (CCH Consumer Product Safety Guide ¶40,224) (ip access user)

Temporary Exemption from Crash Protection Standard Granted
Spyker Automobielen B.V. (Spyker) was granted a limited extension of a previously received temporary exemption from certain requirements of Federal Motor Vehicle Safety Standard (FMVSS) No. 208, “Occupant Crash Protection,” for the Spyker C vehicle line. NHTSA determined that compliance would cause substantial economic hardship to a low-volume manufacturer that had tried in good faith to comply with the standard, and that the exemption would have a negligible impact on motor vehicle safety. The exemption is effective through December 15, 2010. (CCH Consumer Product Safety Guide ¶57,058) (ip access user)

CPSC Warns of Child Poisoning Dangers in the Home
In conjunction with the 48th observance of National Poison Prevention Week, which was March 15-21, the CPSC warned that nine out of ten unintentional child poisonings occur in the home and recommended that parents and caregivers take the following steps:

Keep medicines and household chemicals in their original, child-resistant containers;
Store the potentially hazardous substances up and out of a child's sight and reach; and
Keep the national toll-free poison control center telephone number, 800-222-1222, handy in case of a poison emergency. (CPSC News Release, #09-159, March 18, 2009, CCH Consumer Product Safety Guide, Report No. 936, April 6, 2009)

Guidelines Issued for State Highway Safety Programs
The National Highway Traffic Safety Administration has revised five of the existing uniform guidelines for state highway safety programs and has added a new guideline effective April 1, 2009. NHTSA stated that these guidelines reflect program methodologies and approaches which have proven to be successful and are based on sound science and program administration. The revised guidelines are Guideline No. 4 Driver Education; Guideline No. 5 Non-Commercial Driver Licensing; Guideline No. 7 Judicial and Court Services; Guideline No. 10 Traffic Records; and Guideline No. 17 Pupil Transportation. The new guideline is Guideline No. 12 Prosecutor Training. (CCH Consumer Product Safety Guide ¶57,073) (ip access user)

Free Repairs Offered by Yamaha for Rhino Vehicles
Yamaha Motor Corp. U.S.A., of Cypress, California, in cooperation with the CPSC, has announced a free repair program to address safety issues with all Rhino 450, 660, and 700 model off-highway recreational vehicles. Yamaha has also agreed to voluntarily suspend sale of these models until repaired and has advised consumers to stop using the recreational vehicles until the repair is installed by a dealer. (CPSC News Release, #09-172, March 31, 2009, CCH Consumer Product Safety Guide, Report No. 937, April 20, 2009)