Products Liability and Safety Update March 2009

March 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

Product Liability Desk Reference, 2009 Edition, Now Available
Product Liability Desk Reference, 2009 Edition is a comprehensive resource that provides the most recent statutory and case law developments on product liability laws for each of the fifty states and the District of Columbia. Practitioner-oriented, and written by leading state experts, each chapter summarizes the variants and developments particular to a specific state jurisdiction, resulting in a text that will assist you in making critical choices in product liability disputes wherever they arise.

You'll find detailed coverage of each state's standards regarding:

Causes of action
Statutes of limitation and repose
Strict liability
Negligence
Breach of Warranty
Punitive damages
Wrongful death
Pre- and post-judgment interest
Employer immunity from suit
Joint and severable liability
Relevant statutes to product liability actions.

Product Liability Desk Reference, 2009 Edition includes important developments in all fifty states. For example, a New York court has recently held plaintiffs failed to make a prima facie case that light cigarettes were a feasible alternative design without presenting evidence that consumers would accept light cigarettes in place of regular cigarettes. A Maryland court has held that a drug manufacturer did not owe a duty of care to a plaintiff whose car was hit by a driver that blacked out while taking the manufacturer’s medicine. The Ohio Supreme Court recently held that 2004 amendments to asbestos claims could be applied retroactively.

FDA Label Laws Did Not Preempt State Warning Claim
Food and Drug Administration (FDA) regulations governing drug labels did not preempt a patient's state-law warning defect claim against the manufacturer of an antinausea drug, the U.S. Supreme Court held in a 6-3 decision that affirmed a Vermont Supreme Court ruling (sub nom Levine v. Wyeth, CCH PRODUCTS LIABILITY REPORTER ¶17,627 (ip access user)). The patient, a professional musician, suffered from migraines and, as part of her treatment, was given an antinausea drug by the "IV-push" method, as opposed to the "IV-drip" method. The drug, however, entered the patient's artery where it came in contact with arterial blood, and, as a result, the patient developed gangrene, requiring doctors to amputate her forearm. In support of her warning defect claim against the drug manufacturer, the patient argued that the drug's label should not have allowed the IV-push method of administration. The Vermont Supreme Court affirmed the trial court's rejection of the manufacturer's preemption arguments, finding that the jury's verdict in favor of the patient did not conflict with FDA labeling requirements for the drug because the manufacturer could have warned against IV-push administration without prior FDA approval, and "because federal labeling requirements create a floor, not a ceiling, for state regulation." The U.S. Supreme Court agreed, rejecting the manufacturer's argument that it was impossible for it to comply with both the state-law duties underlying the state-law claims and its federal labeling duties. FDA regulations permitted certain pre-approval labeling changes that would add or strengthen a warning to improve drug safety, the Court said. Similarly, the manufacturer's argument that requiring it to comply with a state-law duty to provide a stronger warning would interfere with Congress' purpose of entrusting an expert agency with drug labeling decisions was ruled meritless by the Court because it relied on an unsupportable interpretation of congressional intent and an overbroad view of an agency's power to preempt state law. (Wyeth v. Levine, S.Ct., CCH Products Liability Reporter ¶18,176 (ip access user))

Colacicco v. Apotex, Inc.In light of the U.S. Supreme Court's decision in Wyeth v. Levine, the Court also vacated and remanded the Third Circuit Court of Appeals decision in Colacicco v. Apotex, Inc. (Dkt. No. 08-437) (reported at [CCH PRODUCTS LIABILITY REPORTER ¶17,977 (ip access user)] ). In that case, the families of two adults who committed suicide while using an antidepressant from a class of drugs known as selective serotonin reuptake inhibitors had asked the U.S. Supreme Court to review a decision by the court of appeals that preempted the claims on the basis of the FDA's public rejection of the families' suicide warning for these drugs.

U.S. High Court Declines to Review D.C. Gun Case . . .
A shooting victim's request for review of a decision by the U.S. Court of Appeals for the District of Columbia Circuit in Lawson v. Beretta U.S.A. Corp. (Dkt. No. 08-437 [CCH PRODUCTS LIABILITY REPORTER ¶17,899 (ip access user)]) dismissing strict liability claims brought under a District of Columbia statute (which permitted tort claims against manufacturers of assault weapons) against various manufacturers of those weapons was denied by the U.S. Supreme Court. The claims were properly dismissed under the federal Protection of Lawful Commerce in Arms Act (PLCAA) which mandated a ban on causes of action against manufacturers for harm caused by the unlawful misuse of a firearm despite the plaintiff's argument that the claims were exempted under the statute's exception for instances in which the manufacturer violates a state or federal statute. The federal court of appeals found that the reliance on the District of Columbia's statute was misplaced because the general duty of care imposed under tort law was not of the type of statutory violation the authors of the PLCAA reasonably intended. In addition, the D.C. Circuit ruled that application of the PLCAA to dismiss a lawsuit authorized under a District of Columbia statute did not violate the separation of powers principles or due process principles embodied in the Fifth Amendment of the U.S. Constitution. The D.C. Circuit decision is left standing.

. . . and Receives Petition on Vaccine Act Preemption Defense
Several vaccine manufacturers have asked the U.S. Supreme Court (Docket No. 08-1120) to review a decision by the Georgia Supreme Court in American Home Products Corp. v. Ferrari [CCH PRODUCTS LIABILITY REPORTER ¶18,116 (ip access user)] holding that individual and representative design defect claims against the manufacturers by the parents of a child who allegedly suffered neurological damage caused by a vaccine made with the preservative thimerosal were not preempted by the National Childhood Vaccine Injury Compensation Act of 1986 (Vaccine Act). The petition asked whether the Vaccine Act expressly preempted a state-law claim against a vaccine manufacturer based on an allegation that the vaccine-related injury could have been avoided by a vaccine with a safer design than the one approved by the U.S. Food and Drug Administration for use nationwide. The petition for certiorari was filed March 5, 2009.

Ohio Products Rule for Suppliers Not Retroactive; High Court Review Sought
The U.S. Supreme Court has been asked to review a decision by the Ohio Supreme Court (Dkt. No. 08-932) holding that a prior ruling by the Ohio court, which imposed strict liability on nonmanufacturing sellers of defective products, did not apply retroactively to products sold before that Ohio decision was announced in 1977 [CCH PRODUCTS LIABILITY REPORTER ¶8280]. The Ohio Supreme Court ruled that its prior holding’s application was prospectively only so that a supplier of insulation products to a steel mill was not liable under a theory of strict products liability for the death of a steel mill employee who was exposed to the products, which contained asbestos, during his employment at the mill. The employee was diagnosed with mesothelioma and died three months later. His estate brought products claims against the supplier and others, including strict liability, defective design and failure to warn; negligent failure to warn; and breach of warranty. A retroactive application of the judicial precedent would have neither promoted nor hindered the purpose behind the state's products liability law of making products safer. In addition, nonmanufacturing sellers of asbestos, such as the supplier, could not have foreseen that the products, which were distributed from the 1950s to the 1970s, could have resulted decades later in the supplier being liable for injuries caused by those products. It would be inequitable, the court said, to impose a potential financial burden on a nonmanufacturing supplier many years after the fact for an obligation that was not foreseeable at the time of the products' distribution. The petition for certiorari asks whether the selectively prospective application of a new state common law rule violates the Equal Protection clause of the United States Constitution. (DiCenzo v. A-Best Products Co., Inc., Ohio S.Ct., CCH PRODUCTS LIABILITY REPORTER ¶18,162 (ip access user))

Adequate Warning Prevented Taser Maker's Liability
A manufacturer of a taser device was not liable for products liability claims based on a failure-to-warn theory in the case of a 21-year old man who died after receiving multiple applications of the device by police outside a nightclub, a federal district court in Tennessee ruled. The manufacturer adequately warned the municipal government via a training bulletin that repeated applications of the taser device could cause health problems, including breathing difficulties, over-exertion, or potential impairment of full ability to breathe over a protracted time period. The court determined that the warning clearly identified the risk stemming from one particular use of the product and clearly and appropriately instructed its audience how to avoid that risk. Raising the concern that repeated applications of the device could cause specific health problems, such as metabolic acidosis, would not have added anything useful to the warning, the court said, given that the intended audience was law enforcement officials, not physicians. Further, the court noted, the man's parents made no attempt to argue that any failure to warn made the product unreasonably dangerous and that the inadequate warning proximately caused the claimed injury. To effectively advance their theory, the parents had to show that the supposed "recission" of the bulletin was somehow tied to the injuries the man sustained. The man’s parents also failed to show that the product was unreasonably dangerous. It was a matter of common sense and Tennessee law that simply because a product caused death in certain circumstances did not make the product unreasonably dangerous, according to the court. The issue was whether the dangerousness was beyond what the reasonable consumer would expect or a reasonably prudent manufacturer would invite. The court determined that the facts showed that the municipal government was well-apprised of the risks of the taser device, and that it, and not the manufacturer, had the responsibility to explain those risks to its officers. Finally, the court ruled that the manufacturer of the taser device was not liable for design or manufacturing defect claims asserted by the man's parents. The manufacturer effectively argued that the parents could not point to any design or manufacturing defect in the taser device. (Lee v. Metropolitan Gov't of Nashville and Davidson Cty , M.D. Tenn., CCH PRODUCTS LIABILITY REPORTER ¶18,163 (ip access user))

Exclusion of Drug's Post-Suicide Warnings Upheld
The widow of a patient who committed suicide shortly after taking a prescribed antidepressant drug could not introduce warnings that accompanied the drug in the years following the patient's death in her claim that the drug's manufacturer was strictly liable for failing to provide adequate warnings for the drug, the U.S. Court of Appeals for the Seventh Circuit ruled. The court found that because the later warnings focused on the risk of suicide in younger persons, not adults of the patient's age, and because there was no evidence that the manufacturer knew, or should have known, the information contained in the later warnings at the time of the patient's death, it was not an abuse of discretion by the district court to exclude the later warnings on the basis that their probative value was substantially outweighed by the danger of confusing the jury. (Giles v. Wyeth, 7th Cir., CCH Products Liability Reporter ¶18,173 (ip access user))

Expert, Design Claims Allowed Despite Misuse of Drain Snake
An expert's testimony on behalf of an injured user of an electronic drain snake, a plumbing tool used to clear a clogged drainage pipe, to establish the drain snake's defective design was admissible, the U.S. District Court for the Middle District of Florida held. It was the expert's opinion that the thumb set screw protruding from the drain snake's rotating drum was a snag hazard. Despite warnings in the drain snake's operating manual against operating the machine in reverse, the user was injured when he operated the machine in reverse while feeding the snake back into the machine's drum. It was during this action that the user alleged that his glove snagged in the thumb set screw, pulling his hand down and around the machine's rotating cage. The court also ruled that there was sufficient conflicting evidence regarding whether the misuse of the drain snake was the sole cause of the user's injuries to create a genuine issue of fact for the jury in his negligent design claim against the manufacturer, as well as whether that misuse contributed to his injuries. The user was barred, however, from pursuing damages under a failure to warn theory because he could not establish proximate cause. Finally, the user's misuse of the drain snake did not prevent his recovery action against the machine's manufacturer under a theory of strict liability. Although it was undisputed that the user did not follow the directions in operating the machine, the court said that a question of fact nonetheless remained for a jury to decide as to whether he was using the drain snake for its intended purpose. (Alvarez v. General Wire Spring Co., M.D. Fla., CCH Products Liability Reporter ¶18,169 (ip access user))

Asbestos Complaint Timely Filed Due to Supplier's Actions
A complaint by a decedent's estate against a supplier of talc for the decedent's death allegedly caused by her exposure to asbestos was timely filed, the Kentucky Court of Appeals ruled. The estate alleged that the decedent's development of mesothelioma was caused by asbestos fibers in the talc. The talc supplier was not included in the initial complaint, but during discovery there was evidence that the supplier misrepresented that its product contained asbestos. The court concluded that it was reasonable for the jury to find that the estate exercised due diligence to discover that the decedent's disease was caused by the supplier's talc, and, because of the misrepresentation, the discovery rule did not toll Kentucky’s one-year statute of limitations. (R.T. Vanderbilt Co., Inc., Ky. Ct. App., CCH Products Liability Reporter ¶18,175 (ip access user))

Claims for Off-Premises Asbestos Exposure Barred in Ohio
Claims by the estate of a worker and his spouse relating to the spouse's exposure to the asbestos the worker allegedly brought home from work on his clothing were barred by Ohio's asbestos-related liability statute, the Ohio Court of Appeals held. The worker was exposed to asbestos-containing products at work and brought asbestos home on his clothing that his wife washed. Allegedly, the spouse shook the worker's clothing before washing them and breathed in the dust from the clothing. She was diagnosed with mesothelioma and died four months later. Under Ohio law, a premises owner was not liable for injury to an individual resulting from asbestos exposure unless the individual's alleged exposure occurred while the individual was on the premises owner's property. Moreover, unless the individual's exposure occurred on the premises, all tort claims against the premises owner were barred. It was clear that the spouse's asbestos exposure did not occur on the worker's employer's premises, the court said. Because the statute barred recovery for injury where an individual was not exposed to asbestos on a defendant's property, the spouse's claims failed as a matter of law. In addition, the worker's employer did not owe the worker's spouse a duty of care under Ohio law for her exposure to the asbestos that he allegedly brought home from work on his clothing. Therefore, the negligence claim brought by the estate also failed as a matter of law, the court ruled. (Adams v. Goodyear Tire and Rubber Co., Ohio Ct. App., CCH Products Liability Reporter ¶18,172 (ip access user))

Product Safety

Draft Guidance for Meeting Phthalates Requirements Issued
The Consumer Product Safety Commission (CPSC) is seeking public comments on its staff's draft approach for determining which products are subject to the requirements of section 108 of the Consumer Product Safety Improvement Act of 2008 (CPSIA) [CCH Consumer Product Safety Guide ¶10,888], and to seek additional information on how the approach could be applied to particular product classes. Section 108 permanently prohibits the sale of any “children's toy or child care article” containing more than 0.1 percent of three specified phthalates. The CPSIA also prohibits, on an interim basis, “toys that can be placed in a child's mouth” or “child care articles” containing more than 0.1 percent of three additional phthalates. The prohibitions became effective on February 10, 2009. Comments and submissions must be received by March 25, 2009. The Commission stated that it would consider issuing a notice of proposed rulemaking to address the issues based upon the comments received. (CCH Consumer Product Safety Guide ¶57,013 (ip access user))

Comments Sought on Tracking Label Requirements
Comments are being sought by the CPSC on implementation of the requirements of the Consumer Product Safety Improvement Act of 2008 (CPSIA) for tracking labels for children’s products. As of August 14, 2009, the manufacturer of a children’s product must place permanent distinguishing marks on the product and its packaging in order to provide certain identifying information. Comments must be received by April 27, 2009. CCH Consumer Product Safety Guide ¶57,015 (ip access user))

Indicator Lamp Function Requirement Extended for Six Months
A requirement that trailers with antilock brake systems be equipped with an external antilock malfunction indicator lamp has been extended for six months by NHTSA, effective February 28, 2009. This requirement, which is included in the federal motor vehicle safety standard that governs vehicles equipped with air brakes, was scheduled to sunset on March 1, 2009. As a result of NHTSA's action , the sunset date is September 1, 2009. NHTSA took this action in connection with consideration of a petition for rulemaking from the Commercial Vehicle Safety Alliance (CVSA) requesting that the requirement be made permanent. In a separate document, NHTSA proposed a further extension of the requirement to March 1, 2011 (see following story for complete details). The interim final rule prevents the occurrence of a potential time gap for vehicles that are subject to the requirement, should the agency ultimately decide to further extend the time period. (CCH Consumer Product Safety Guide ¶42,001 (ip access user))

NHTSA Proposes Extension of Indicator Lamp Requirement
NHTSA has proposed to extend by 18 months a requirement that trailers with antilock brake systems be equipped with an external antilock malfunction indicator lamp. The agency is also considering making the requirement permanent. The indicator lamp requirement, which is included in the federal motor vehicle safety standard that governs vehicles equipped with air brakes, was originally scheduled to sunset on March 1, 2009, but has been extended to September 1, 2009 in an interim final rule (see preceding story for more details). NHTSA’s proposal would extend the sunset date until March 1, 2011. The rulemaking is in response to a petition from the Commercial Vehicle Safety Alliance (CVSA), which has asked that this requirement be made permanent. Extending the sunset date for an additional 18 months would enable NHTSA to fully analyze CVSA’s request and avoid a potential confusing time gap in the vehicles subject to the requirement. (CCH Consumer Product Safety Guide ¶40,720 (ip access user))

Comments Sought on Improvements to Vehicle Blind Zones
NHTSA has initiated a rulemaking to amend Federal Motor Vehicle Safety Standard (FMVSS) No. 111, “Rearview Mirrors,” to improve a driver’s ability to see areas to the rear of a motor vehicle in order to mitigate fatalities and injuries associated with backover incidents. The agency and Congress are concerned that vehicles have “blind zones,” areas behind the vehicle in which drivers may have difficulty seeing and avoiding a person or other obstacle. NHTSA noted that this was different than what many people informally call a “blind spot,” a term used to describe an area to the side of the car where people may not be able to see a vehicle when changing lanes. The agency is presenting its initial research and soliciting additional information that will enable the agency to develop an effective proposal to mitigate backover incidents related to vehicle rear blind zones. Comments must be received by May 4, 2009. (CCH Consumer Product Safety Guide ¶40,721 (ip access users))