Products Liability and Safety Update March 2011

March 2011

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

Preemption of Pain Pump Claims Affirmed by 11th Circuit
State law claims by a patient and her husband concerning a pain pump system that was implanted in the patient's back and then later removed in rescission surgery were preempted by the Medical Device Amendments of 1976 (MDA), the U.S. Court of Appeals for the Eleventh Circuit held, affirming a federal district court in Florida. The patient's action alleged that the pain pump manufacturer, its successor, and the pump distributor were strictly liable and negligent on manufacturing and design theories, as well as strictly liable on a failure to warn theory, for infection injuries sustained by the patient. The court found that the patient's claims imposed requirements that were "different from, or in addition to" the federal requirements established for the pump. Because the patient and her husband failed to allege facts demonstrating the presence of the elements of a parallel claim—their allegations did not set forth any specific problem or failure to comply with any FDA regulation that could be linked to the patient's injury—the court ruled that the lower court did not err when it concluded that the state common law claims were preempted. In addition, the court rejected the patient and her husband's contention that they were entitled to an inference that a defect existed within the pain pump, even though the pump's catheter connector, which the patient alleged had malfunctioned, was destroyed by the manufacturer following the patient's rescission surgery. The court of appeals found that the patient failed to show that her injuries were "most probably" caused by a defect in the pump rather than some other malfunction or obstruction. The patient's experts testified that although the catheter connector could have malfunctioned, they were unable to exclude alternate possible causes for a connector to fail, such as an idiosyncratic complication with the patient, clogging, or natural bodily rejection. Therefore, the court concluded, a finding that the patient was not entitled to a presumption that the pump was defectively made was not error. (Wolicki-Gables v. Arrow International, Inc. (11thCir) CCH Products Liability Reports ¶18,589 (ip access user)(IntelliConnect))

Reconsideration of Two Preemption Decisions Ordered
The South Carolina Supreme Court and the Georgia Supreme Court must reconsider their preemption opinions, Priester v. Cromer [CCH Products Liability Reports ¶18,458 (ip access user)(IntelliConnect)] and American Home Products Corp. v. Ferrari [CCH Products Liability Reports ¶18,116 (ip access user)(IntelliConnect)], respectively, in light of two recent U.S. Supreme Court decisions—Williamson v. Mazda Motor of America, Inc. [CCH Products Liability Reports ¶18,581 (ip access user)(IntelliConnect)] and Bruesewitz v. Wyeth LLC [CCH Products Liability Reports ¶18,580 (ip access user)(IntelliConnect)]. The U.S. Supreme Court granted two petitions for certiorari (Priester v. Ford Motor Co., Dkt. No. 10-668, February 28, 2011 and American Home Products Corp. v. Ferrari, Dkt. No. 08-1120, February 28, 2011) stemming from the state court rulings and ordered both judgments vacated and remanded for further consideration.

Homeowners Fail to Show Propane Grill Defect Caused Fire
Expert testimony by a mechanical engineer, including the tests he performed, in support of an action by homeowners against the manufacturer of a propane-fired gas grill for fire damage to their house was inadmissible, and, therefore, the homeowners failed to establish that the fire was caused by a design defect in the cabinet of the grill, the U.S. Court of Appeals for the Eighth Circuit held, affirming a federal district court in Missouri [CCH Products Liability Reports ¶18,304 (ip access user)(IntelliConnect)]. The homeowners alleged that the defect in the grill allowed a rubber regulator hose to come in contact with a heated grease tray, and then to melt and become breached, thereby permitting propane vapors to escape and become ignited by the grill's burners. The court of appeals determined that the expert did not have to position the propane hose against the grease tray with a tie-down in order to test his theory that a heated grease tray could compromise the hose. Positioning the hose as he did was a "strong indicator," the court said, that the expert was, in fact, trying to recreate how and why the fire occurred. Alternatively, the expert's experiments were not substantially similar to the conditions existing at the time of the fire in the homeowners' residence for the expert's testimony to be admitted, the court found. The appellate court concluded that it was not an abuse of the lower court's discretion to determine that the lack of substantial similarity would tend to confuse rather than enlighten the jury, and, therefore, that the exclusion of the testimony was proper. With the exclusion of the expert's testimony, the homeowners could offer no expert testimony to support their claim that the grill was in a "defective condition, unreasonably dangerous" when they put the grill "to a reasonably anticipated use," as required under Missouri products liability law. The court held that without the testimony by the homeowners' excluded expert, their other experts' testimony was limited to the origin and source of the fire and did not establish how the fire actually started, and the homeowners could not establish any genuine issue of material fact as to whether there was a defect in the grill and whether the alleged defect caused the fire. (Dunn v. Nexgrill Industries, Inc. (8thCir) CCH Products Liability Reports ¶18,582 (ip access user)(IntelliConnect))

Worker's Use of Uniform Not "Reasonably Anticipated"
Because a worker's use of his work uniform was not a reasonably anticipated use, the worker failed in his claim under the Louisiana Products Liability Act (LPLA) that the uniform was an unreasonably dangerous product, the U.S. Court of Appeals for the Fifth Circuit held in an unpublished opinion. The worker, a shop foreman for a construction firm and the head mechanic in charge of servicing and repairing the firm's equipment, was severely burned while wearing the uniform, which was a 65-35 percent poly-cotton blend and was provided to him by the firm pursuant to a rental agreement with the uniform manufacturer. The worker argued that whether his injuries arose from a reasonably anticipated use pursuant to the LPLA was a fact question. However, the court of appeals found that because the danger of exposing the uniform to flammability risks was obvious to the worker—the record demonstrated that the worker knew that his uniform was not flame retardant and knew that his poly-cotton uniform would melt—the worker's use of the uniform was not a "reasonably anticipated use" under the LPLA as a matter of law. Moreover, the danger involved in starting the engine with a gasoline-soaked rag was not relevant to whether the worker's use of the uniform was a reasonably anticipated use. Rather, the correct obvious-danger analysis related to the possibility of the uniform's melting when exposed to flame, according to the court. Finally, the worker argued that his was a reasonably anticipated use because the manufacturer should have known that, despite a warning in the rental agreement, the firm's employees were exposed to flammability risks while wearing the uniform. However, the court determined that the worker failed to show that the manufacturer should have known that its warning was being ignored by the uniform's users. The fact that the manufacturer laundered uniforms with stains on them and that there was welding equipment on the firm's premises was insufficient to establish that the manufacturer should have known that the firm's employees were using the uniforms in areas of flammability risk, contrary to the rental agreement. (Spears v. Cintas Sales Corp. (5thCir) CCH Products Liability Reports ¶18,588 (ip access user)(IntelliConnect))

RV Owner Barred from Arguing RV Defect to Jury
A recreational vehicle (RV) owner who fell and seriously injured her shoulder when the stair-step controller on her RV unexpectedly retracted could not argue to the jury that the RV was the product at issue in her action alleging strict liability and negligence against the RV manufacturer and the manufacturer of the stair-step controller, the U.S. Court of Appeals for the Seventh Circuit ruled, affirming an opinion of a federal district court in Illinois. The owner had maintained throughout the litigation that it was the step controller that was the proximate cause of her injuries and, therefore, she could not change the product at issue in the case to the RV as a whole for reasons of consistency and the prevention of surprise to the manufacturers. Thus, the court held that the owner was barred from arguing that anything other than the step controller was the defective product at issue and that it was not an abuse of discretion to disallow the owner from applying an inference of a defect in the recreational product as a whole. In addition, the court of appeals found it was not an abuse of the lower court's discretion to disallow the owner's amendment of her complaint and of her proposed jury instructions regarding the ultimate issue of liability. Finally, the appellate court agreed with the federal district court that there was no basis for ordering a new trial following the jury verdict in favor of the manufacturers. (Aldridge v. Forest River, Inc. (7thCir) CCH Products Liability Reports ¶18,590 (ip access user)(IntelliConnect))

§402A Remains PA Law; Causation, Defenses for Fact Finder
Absent a specific finding by the Pennsylvania Supreme Court that the Restatement (Third) of Torts applies to products liability action, a federal court sitting in diversity must apply Section 402A of the Restatement (Second) of Torts in an action against a manufacturer of a paste mixer even though the resulting decision might be at odds with case law in the Third Circuit Court of Appeals. A worker's finger was amputated allegedly by a mixer paddle as the worker was scraping residue inside the mixer. In considering what evidence was admissible, the injured worker argued for the application of the Second Restatement while the manufacturer argued that the Restatement Third would apply to the issues of admissibility. Although the federal appellate court predicted, after extensive analysis of Pennsylvania case law, that the state supreme court would adopt the Third Restatement's definition of a cause of action for strict products liability, it had not done so. Thus, the state's adoption of the Second Restatement remained the governing law of the state. The court went on to find that evidence of the worker's conduct while cleaning the mixer and his statement that the accident was his fault could have been relevant on the issue of causation, and, therefore, the worker's request that this evidence be found inadmissible was denied. Similarly, the court found that the manufacturer could plead assumption of the risk on the part of the worker who, according to the manufacturer, had been trained on the mixer, but had failed to follow the cleaning procedures he had been taught. The question of whether the worker used the mixer as directed and whether he knew of the specific defect in the mixer were questions for the jury. However, the court refused to allow evidence that a paste mixer was manufactured in compliance with industry standards and OSHA regulations to show the reasonableness of the manufacturer's design choice or the absence of a product defect. The admission of evidence of compliance with industry standards or regulations improperly introduced negligence concepts to strict liability law and diverted the jury's attention from the product to the reasonableness of the manufacturer's conduct in choosing its design, the court explained. (Sweitzer v. Oxmaster (EDPa) CCH Products Liability Reports ¶18,577 (ip access user)(IntelliConnect))

Indemnity/Warning Duties Resolved in Generator Action
Portable generator manufacturers that did not make an allegedly defective generator, which leaked carbon monoxide, causing the deaths of three people, did not have a duty to indemnify a retailer who had been wrongly named as the seller of the product, a Texas federal district court ruled. The allegedly defective portable generator was operating inside a closed garage attached to the decedent's house. Before the retailer was dismissed from the action, it notified the named manufacturers of their duty to defend and indemnify it with respect to the products liability claims brought by representatives of the deceased estates. The court noted that under Texas law, a manufacturer's duty to indemnify a seller applied not to the manner in which the action is concluded (in this case, dismissal of the claims against the seller) but by the pleadings. Thus, a manufacturer would have a duty to indemnify a party wrongly accused of having sold an allegedly defective product. However, the court found that the named manufacturers did not make the generator in question and, thus, they did not meet the definition of manufacturer under state law. According to the court, the duty to indemnity did not extend so far as to require a party wrongly accused of having manufactured an allegedly defective product to indemnify a party wrongly accused of having sold it. The court also found that, under the component parts doctrine, neither the company that made the engine nor the distributor that supplied an engine to the maker of the generator had a duty to warn of any risks associated with the generator. (Smith v. Robin America, Inc. (SDTex) CCH Products Liability Reports ¶18,583 (ip access user)(IntelliConnect))

MDA Allows Claims Against Disc Implant Maker
Claims sounding in products liability, breach of express warranty, and fraud and misrepresentation by a patient who suffered from degenerative disc disease against a manufacturer of an artificial intervertebral disc were expressly preempted by the Medical Device Amendments of 1976 (MDA) to the Food, Drug, and Cosmetic Act, a federal district court in Texas held. However, the patient's claims that the disc implanted in his spine was not manufactured and labeled as represented to and approved by the Food and Drug Administration (FDA) were not expressly preempted. The patient's products liability claims were based on allegations that the disc was defective and unreasonably dangerous, while the express warranty claim was based on false representations made about the product's safety and effectiveness. Because these claims related to the safety and effectiveness of the device, the court concluded that they were preempted. However, the claims that the particular device was not manufactured or labeled as represented were parallel claims that were not preempted. Reviewing the expert testimony offered in support of these claims, the court found that there was no evidence in the record showing that, with respect to the disc implanted in the patient, the manufacturer failed to meet the manufacturing and labeling specifications imposed by the Food and Drug Administration (FDA) as part of the pre-market approval process. In fact, according to the court, the manufacturer's evidence showed that the disc was made properly and in accordance with all design, manufacturing and labeling specifications approved by the FDA. (Timberlake v. Synthes Spine, Inc. (SDTex) CCH Products Liability Reports ¶18,586 (ip access user)(IntelliConnect))

Adequacy of Warnings on Drug Labels Raised Jury Question
Whether two drug companies' actions surrounding their purported failure to provide adequate warnings on their over-the-counter ibuprofen product constituted malice sufficient to support a claim for punitive damages was a question for the jury, according to a California appellate court, which denied the companies' motion for summary adjudication. When a child developed two rare and serious skin diseases (SJS and TEN) after taking an over-the-counter pain reliever, he sued the companies for strict liability, alleging that the product was defectively designed and that the companies failed to provide adequate warnings about SJS and TEN (even though they had long known about them). In addition to seeking damages for medical expenses and lost income, punitive damages were sought for the companies' alleged despicable conduct, which allegedly amounted to a willful and conscious disregard or the rights or the safety of others. Although the companies complied with FDA regulations and labeling requirements, federal regulations allow companies to strengthen a warning label even before receiving FDA approval and require a manufacturer to revise its label to include a warning as soon as there is reasonable evidence of an association between a serious hazard and a drug. Before February 2005, the FDA had not required specific mention of the two diseases (on the assumption that very few consumers knew what they were). At that time, however, the agency required a change, to be implemented by December 2005, so that the label would describe the early symptoms of SJS, including skin reddening and blisters. The medication ingested by the child, however, was purchased in October of 2005 and did not contain the new warnings. The evidence, therefore, raised a triable issue as to whether the manufacturer failed to warn of SJS/TEN in its labeling, with conscious disregard of the risk to the safety of those with those conditions. (Johnson & Johnson v. Superior Court of LA County (CalCtApp) CCH Products Liability Reports ¶18,574 (ip access user)(IntelliConnect))

Expert Testimony OK'd; Defect/Warnings Issues for Jury
Both mechanical engineer and a human factors expert were qualified to testify and their opinions were relevant in a products liability action brought by a worker who, while working as a member of a ground crew that was paving a road, seriously injured his leg when it got caught in the tracks of a road milling machine as he attempted to grab a shovel mounted to the side of the truck directly above the crawler tracks in order to clear debris scattered debris out of the path of the machine, a federal district court in Maryland held. The court also concluded that the worker's evidence was sufficient to raise jury issues on the questions of whether the machine was defectively designed, whether the manufacturer's warnings were adequate and whether the worker's own negligence contributed to the accident. (Cantrell v. Wirtgen America, Inc. (DMd) CCH Products Liability Reports ¶18,584 (ip access user)(IntelliConnect))

Expert Qualified to Testify on Mop Wringer Alternative Design
The testimony of a qualified expert met the reliability standard established in Daubert v. Merrell Dow Pharmaceuticals, Inc. [CCH Products Liability Reports ¶13,494 (ip access user)(IntelliConnect)] and, therefore, was admissible on the issue of whether a mop wringer was defectively designed, the Minnesota federal district court held, finding that the expert's alternative design theory was sufficient to raise a question for the jury. A retail store employee was using a mop wringer supplied by his employer when, while he was wringing the mop, the tension spring in the wringer snapped and a fragment of the spring flew up and struck him in his right eye. The expert, a metallurgical engineer, concluded that the spring failed because of fatigue and that the failure was a result of a design defect. According to the expert, two alternative designs would have prevented the design: (1) the use of a looped end spring on the wringer or (2) the placement of a cover on the wringer would have prevented the injury in question. The manufacturer of the wringer mop challenged the expert's testimony as unreliable because the alternative designs were not tested, had not been published in peer-reviewed literature, and were not accepted generally in the industry. However, the court found that both of the design alternatives were available readily and used in the marketplace for other applications. In addition, several treatises and publications discussed looped end springs, and the expert's methodology for arriving at his proposed alternative stemmed from a learned treatise. The court concluded that the fact that the expert did not test his alternative design or the use of the looped end spring in a mop wringer did not render his testimony unreliable. The court further determined that whether the manufacturer failed to warn of risks associated with use of the product remained for a jury to determine because there were no warnings supplied with the wringer, and therefore, only a jury could determine if warnings were necessary. However, there was no evidence showing that the retailer relied on the judgment of the manufacturer in determining which wringer was appropriate for its requirements and, therefore, the worker's claim for breach of implied warranty of fitness for a particular purpose was dismissed by the court. (Rouso v. Rubbermaid Commercial Products, LLC (DMinn) CCH Products Liability Reports ¶18,585 (ip access user)(IntelliConnect))

Product Safety

NHTSA Issues New, Age-Focused Child-Restraint Guidelines
NHTSA has revised its child restraint guidelines to focus on age category rather than to type of child seat, which is more consistent with the latest scientific and medical research and the development of new child restraint technologies. Under the new guidelines, parents and caregivers are advised to keep children in each restraint type, including rear-facing, forward-facing and booster seats, for as long as possible before moving them up to the next type of seat. For instance, NHTSA recommends using the restraints in the rear-facing position as long as children fit within the height and weight limits of the car seat as established by the manufacturer, because the rear-facing position reduces stresses to the neck and spinal cord and is particularly important for growing babies. This is in line with the advice from the American Academy of Pediatrics to keep kids in rear-facing restraints until two years of age or until they reach the highest weight or height allowed by their car safety seat's manufacturer. Thus, there is no need to hurry to transition a child to the next restraint type.

NHTSA's revised guidelines will help consumers pick the appropriate seat for their child, but parents are advised to consider other factors when selecting a car seat, including their child's weight, height, physical development and behavioral needs, as well the family's economics and type of vehicle. Additional recommendations for child seat use from NHTSA are as follows: always read child seat manufacturers' instructions and the vehicle owner's manual for important information on height and weight limits and how to install the car seat using the seat belt or the LATCH system; all children under 13 years old should ride in the back seat; and children in rear-facing car seats should never ride in front of an active passenger air bag. CCH Consumer Product Safety Guide Report No. 984, April 4, 2011)

Proposed ARS Rulemaking Withdrawn by NHTSA
NHTSA has withdrawn a proposed rulemaking that would amend the federal motor vehicle safety standard to require automatic reversal systems (ARS) for power-operated windows on "express-up" or "one-touch closing" windows, i.e., those windows which close without continuous actuation of the window switch by the window operator. Before withdrawing the proposal, NHTSA considered comments received, injury data, cost estimates, and the benefits to be derived from the proposed requirements. The agency concluded that there was no reason to believe that auto manufacturers would discontinue their current voluntary practice of providing ARS for all express-up windows or that the benefits of specifying a particular ARS would be substantial. In addition, injury data gathered from a survey conducted by a safety organization showed that there were very few fatalities or serious injuries associated with power windows and the proposed ARS requirements would do little to mitigate or prevent the types of minor injuries reported. Finally, NHTSA stated that it would continue to monitor power window designs on new vehicles along with data relevant to power window injures to determine if future rulemaking might be warranted. (CCH Consumer Product Safety Guide Report No. 983, March 21, 2011)

Ms. Bubbles to Pay $40,000 to Settle Alleged Violations of Drawstrings in Hooded Sweatshirts Ms. Bubbles, Inc., a California corporation, with its principal offices located in Los Angeles, California, has entered into a provisional settlement with CPSC to settle allegations that Ms. Bubbles knowingly failed to report to CPSC immediately, as required by federal law, that the girl's denim passport jackets with terrycloth and drawstrings (collectively, "jackets") that it imported and sold had drawstrings through the hood. The settlement agreement contains a civil penalty of $40,000.00, to be paid within 20 days of service of the Commission's final order accepting the agreement. On January 6, 2009, the Commission announced Ms. Bubbles' recall of approximately 55,000 jackets [CCH Consumer Product Safety Guide ¶56,966 (ip access users) (Intelliconnect)]. CCH Consumer Product Safety Guide ¶58,036 (ip access users) (IntelliConnect)

CPSC Launches New Product Safety Database
CPSC has launched its new consumer product safety information database, SaferProducts.gov, as mandated by the Consumer Product Safety Improvement Act (CPSIA) and the agency's implementing regulations [CCH Consumer Product Safety Guide ¶42,044]. The CPSA and its implementing regulations created a new disclosure requirement with respect to product safety-related incident reports, referred to as "reports of harm." With the launch of the database, CPSC is encouraging consumers to visit the website to submit reports of harm or risks of harm, as well as to search for safety information on products. Following procedures set up by CPSIA, CPSC will review all reports filed online and will have five business days to transmit qualifying reports to the manufacturer, if practicable. Manufacturers will then have ten business days during which they may respond and provide comments and/or claims. At the end of the 10-day period, if all requirements are met, the report— along with the manufacturer's comments—will be posted on the website. (CCH Consumer Product Safety Guide Report No. 983, March 21, 2011)