January 2010

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

Generic Drug Makers Can Be Liable for Inadequate Labeling
A patient's failure to warn claims against the manufacturers of a generic form of a name brand prescription drug which had been prescribed to treat her diabetic gastroparesis were not preempted by federal law, the U.S. Court of Appeals for the Eighth Circuit held, reversing a federal district court in Minnesota. The appellate court also upheld the lower court's ruling that name brand drug manufacturers of the prescription drug did not owe the patient a duty of care under Minnesota law because she never ingested the name brand drug. The patient alleged that her long-term ingestion of the drug caused her to develop tardive dyskinesia, a neurological movement disorder. She argued that despite evidence that long-term use of the drug carried a risk of the disorder, none of the manufacturers of the generic drug took steps to change their label warnings. The court said that the federal regulatory framework made clear that a generic manufacturer must take steps to warn its customers when it learns it may be marketing an unsafe drug. Moreover, the court said, federal law empowered the Food and Drug Administration (FDA) to withdraw approval for a drug that was "misbranded" due to an insufficient label. Finally, the Eighth Circuit affirmed that the name brand manufacturers of the drug taken by the patient in generic form were not liable for the development of the patient’s disease. The court said that Minnesota law required that the patient demonstrate a strong relationship and direct communication to show the name brand manufacturers owed her a duty of care. However, the patient never ingested the name brand drug and failed to show that the name brand manufacturers owed her a duty of care necessary to trigger liability. (Mensing v. Wyeth, Inc. (8thCir) CCH Products Liability Reporter ¶18,332 (ip access user) (Intelliconnect))

$1.5 Million Verdict for HRT Drug Patient Reinstated
A jury verdict finding in favor of a patient who alleged that the hormone replacement therapy (HRT) drugs she was prescribed caused her breast cancer was reinstated by the Superior Court of Pennsylvania along with a damage award for $1.5 million against the drug manufacturer, Pharmacia & Upjohn Co., LLC. The Pennsylvania appellate court ruled that the trial court erred in granting judgment notwithstanding the verdict in favor of the drug maker based on the lower court's conclusion that the action was barred by Pennsylvania's two-year statute of limitations for personal injury claims. In addition, the appellate court ruled that the evidence at trial was sufficient to support the jury's determination that the drug manufacturer negligently failed to provide adequate warnings of the risks of breast cancer to the patient's prescribing physicians during the time she took the drug. (Simon v. Wyeth Pharmaceuticals, Inc. (PaSuperCt) CCH Products Liability Reporter ¶18,341 (ip access user) (Intelliconnect))

Res Ipsa Loquitur Provided Theory for Broken Catheter Claims
Although a patient, who alleged injury when an epidural catheter broke off in her back after her doctor tried to remove it following administration of a sedative via the catheter, failed to present sufficient evidence to establish her product defect and breach of warranty claims against the catheter manufacturer, she was able to pursue her claims under a theory of res ipsa loquitur, the U.S. District Court for the District of Massachusetts held. In addition, the court ruled that even though the patient could not pursue damages for pain that occurred following the surgery to remove the broken catheter piece, she could pursue damages for a three-week period from the birth of her child, when the sedative was given, to her recovery from the second surgery to remove the catheter. The patient claimed she experienced considerable pain after the removal of the catheter. Expert testimony was necessary for a jury to assess whether the catheter incident had a causal connection with the patient's subsequent pain. While the patient presented no expert testimony regarding injury causation, the manufacturer's expert provided a detailed discussion of the patient's medical history to establish that her later pain could not have been caused by the catheter incident. As such, the court held, the patient did not meet her burden of demonstrating a genuine triable issue with regard to her later pain, so she could not pursue claims for damages based on the later pain. However, the court concluded that as long as the patient prevailed on the theory of res ipsa loquitur, it was possible to show that the catheter caused a portion of her injuries. (Laspesa v. Arrow Int'l, Inc. (DMass) CCH Products Liability Reporter ¶18,340 (ip access user) (Intelliconnect))

Non-Prescription Cold Drug Warning Claims Not Preempted
State failure-to-warn claims brought against a manufacturer of an over-the-counter cold medication were not preempted by federal law, the Florida Court of Appeal ruled, reversing a lower court’s judgment in favor of the manufacturer. A roller hockey player took the cold medicine with a soda and collapsed during a hockey game. He was diagnosed with having suffered a heat stroke and cardio-respiratory arrest, resulting in a brain injury and hypoxic ischemic encephalopathy, which left him completely disabled. The hockey player and his parents filed claims against the cold medicine manufacturer for strict liability and negligent failure to warn, contending that the medication, which contained pseudoephedrine, increased the risk of heat-related illness and heart-related risks when ingested with caffeinated products and coupled with strenuous or athletic events in a hot environment. They asserted that the manufacturer's failure to warn of these risks on the labels of the cold medicine's packaging breached Florida state law requirements. The lower court determined that the hockey player's state law claims against the drug maker were preempted by federal law governing over-the-counter and non-prescription drugs and by the FDA's labeling requirements, which did not require the manufacturer to include the risk of heat-related illness on the label. The court of appeal held, however, that the U.S. Supreme Court's ruling in Wyeth v. Levine [CCH Products Liability Reporter ¶18,176 (ip access user) (Intelliconnect)], which determined that the Food, Drug, and Cosmetic Act (FDCA) did not expressly preempt state law failure-to-warn claims and found that state law claims were not an obstacle to the purposes of the FDCA, was controlling. Therefore, the appellate court concluded that federal law regulating the labels of the over-the-counter medication expressly saved the state law failure-to-warn cause of action, and there was no implied federal preemption that prevented the hockey player and his parents from going forward with their action against the manufacturer. (Valdes v. Optimist Club of Suniland, Inc. (FlaCtApp) CCH Products Liability Reporter ¶18,339 (ip access user) (Intelliconnect))

Brand Name Drug Maker Not Liable for Generic's Warnings
A patient who ingested the generic form of a gastrointestinal/gastroesophogeal drug could not hold the manufacturers of the brand name formulation of the drug, which the patient did not ingest, liable for the warnings and information distributed by the generic drug manufacturers, a federal district court in Louisiana held. The patient alleged that as a result of her taking the generic drug for over two years, she developed tardive dyskinesia, a neurological condition, and asserted claims against the brand name drug manufacturers, including negligent misrepresentation, fraudulent misrepresentation, and breach of implied warranty, claiming that they were liable for the warnings and information distributed by the generic drug makers whose product the patient did ingest. However, because the Louisiana Products Liability Act (LPLA) provided the patient her exclusive remedy, and because the patient admitted that she did not ingest the products manufactured and/or sold by the named drug makers, the court concluded that the patient had no cause of action against them. Moreover, the court said, the U.S. Supreme Court's decision in Wyeth v. Levine [CCH Products Liability Reporter ¶18,176 (ip access user) (Intetlliconnect)] held only that the FDA's approval of a branded drug's labeling did not preempt a plaintiff's state law failure-to-warn claim against the manufacturer of the branded drug; it did not stand for the proposition that the brand-name manufacturer of a drug could be held liable under Louisiana law for the warnings provided by a generic manufacturer. (Morris v. Wyeth, Inc. (WDLa) CCH Products Liability Reporter ¶18,338 (ip access user) (Intelliconnect))

Federal Court Proper Forum for BPA-Based Claims
The doctrine of primary jurisdiction did not apply to class action claims brought against manufacturers who used bisphenol-A (BPA) in making baby products such as baby bottles, sippy cups, reusable drink containers and containers used to package baby formula, a federal district court in Missouri ruled. The court also determined that the misrepresentation and breach of implied warranty of merchantability claims brought against product manufacturers were not preempted, but misbranding claims against formula manufacturers—those who actually produced food—were expressly preempted. The manufacturers' arguments that the FDA's approval of BPA as safe without labeling requirements preempted the class's claims were rejected in part. The court found that the U.S. Supreme Court's decision in Wyeth v. Levine [CCH Products Liability Reporter ¶18,176 (ip access user) (Intelliconnect)], was controlling because the FDA labeling requirements set minimum regulatory standards and, therefore, the class's claims would not affect the FDA's procedure for reviewing the use of BPA in food additives. The court also found nothing in federal law or FDA regulations that prevented the product manufacturers from strengthening their labels as necessary to comply with state law. However, the court did find that the misbranding claims against formula manufacturers were expressly preempted. The FDA had determined that epoxy resins made with BPA were exempt from labeling disclosures as an incidental additive when used in conformity with FDA regulations. The FDA had determined that BPA was safe as long as the manufacturer abided by the FDA's prescribed conditions for the additive and allowing states to set additional labeling requirements would directly conflict with that determination, the court concluded. (In re: Bisphenol-A (BPA) Polycarbonate Plastic Products Liability Litigation (WDMo) CCH Products Liability Reporter ¶18,331 (ip access user) (Intelliconnect))

BPA-Based Claims Against Baby Product Makers Dismissed
A class of consumers who brought non-injury products liability claims against manufacturers who used Bisphenol-A (BPA) in baby products failed to allege specific statements made by the manufacturers as a basis for their misrepresentation and breach of express warranty claims and, therefore, a federal district court in Missouri dismissed those claims. The court also dismissed breach of implied warranty claims, but found that the class's unjust enrichment claims raised questions of fact that required resolution by a jury. The complaint alleged that the manufacturers failed to disclose information concerning the safety of their products that used BPA. Instead of alleging specific false statements, the court explained that the class sought to base their misrepresentation claims on the theory that mere placement of a product in the stream of commerce conveyed a representation about the product's safety that could serve as a basis for misrepresentation or fraud. However, according to the court, to state a claim for intentional or negligent misrepresentation, the class had to demonstrate reliance and causation, which required that a statement made by the manufacturer must have been heard by a purchaser. The court similarly concluded that the class's failure to identify specific affirmations of fact or promises made by the manufacturers relative to the safety of their products was not sufficient to establish that an express warranty was made or became part of the basis of the bargain. The court also dismissed the implied warranty claims because the class failed to show that the products were used for a particular purpose other than the intended ordinary purpose for which each product was made. However, with respect to those claims based on breach of an implied warranty of merchantability, the court found that they were premised on the unique characteristics of various state laws and individual class members' claims and, thus, deferred them for future consideration. (In re: Bisphenol-A (BPA) Polycarbonate Plastic Products Liability Litigation (WDMo) CCH Products Liability Reporter ¶18,330 (ip access user) (Intelliconnect))

Alleged Warnings Defect Not the Cause of Riding Mower Injury
An injured user of a riding lawnmower failed to submit sufficient evidence to establish a reasonable inference that defective warnings proximately caused his injury, a federal district court in Pennsylvania ruled. The user was driving his lawnmower on a level surface and was attempting to turn when the mower lurched forward onto a slope, causing the user to jump off. The mower continued to function as it rolled back, striking the user in the leg, and, with the mower blades still spinning, made contact with the user's hand, causing serious injury. The user had his third, fourth, and fifth fingers of his left hand amputated, suffered the laceration of his forearm, and lost the use his left hand. In addition to the user's allegations of design and manufacturing defects against the lawnmower seller, the user complained that the seller failed to adequately warn users of the dangers associated with the lawnmower. However, the court found that there was insufficient evidence relating to how the inadequacy of warnings caused the user's injuries. The user made no statement indicating that he would have changed his behavior had there been further warnings either in the manual, in other printed or point-of-sale materials accompanying the product, or on the product itself. (Hartsock v. Wal-Mart Stores East, Inc. (EDPa) CCH Products Liability Reporter ¶18,334 (ip access user) (Intelliconnect))

Manufacturers' Offsetting Indemnification Obligations Affirmed
Offsetting indemnification was appropriate between the manufacturer of a liquefied petroleum (LP) gas cylinder and the manufacturer of a valve assembly, which was a component part of the cylinder, as a result of a products liability action filed after the LP gas cylinder exploded, killing two people and severely burning four others, the Texas Court of Appeals ruled. Nothing under Texas law precluded a final-product manufacturer from having a duty to its component product manufacturers for indemnity. The duty to indemnify was triggered by the injured claimants' pleadings which averred that both the cylinder and the valve were defective and asserted separate claims alleging defectiveness against both manufacturers as to their products, thus triggering the duty to indemnify as to both manufacturers, the court said. The only exception under the Texas statute stated that a manufacturer must indemnify a seller "except for any loss caused by the seller's negligence, intentional misconduct, or other act or omission, such as negligently modifying or altering the product for which the seller is independently liable." The court found that the exception was inapplicable in this case where neither product manufacturer offered such proof of negligence or intentional misconduct against the other. (Manchester Tank & Equipment Co. v. Engineered Controls Int'l, Inc. (TexCtApp) CCH Products Liability Reporter ¶18,343 (ip access user) (Intelliconnect))

Product Safety

CPSC Requests Comments Regarding Drywall Labeling
Comments and information about a proposed rulemaking regarding labels that would identify the date and place of manufacture of drywall, the product, cohort information (batch, run number, or other identifying characteristic), and the manufacturer of the product have been requested by the CPSC. As part of its investigation of various problems related to drywall primarily imported from the People’s Republic of China, CPSC has received over 2,000 incident reports from 32 states, the District of Columbia, and Puerto Rico. The investigation indicated that it was often difficult to determine the manufacturer and origin of drywall in homes. The Commission believes that being able to identify the manufacturer and origin of drywall could aid in investigating complaints related to drywall and narrow the scope of any investigation or necessary remedial action in the future. (CCH Consumer Product Safety Guide ¶57,416 (ip access user) (IntelliConnect))

Changes Proposed to “Make Inoperative” Exemptions
In response to a petition from Bruno Independent Living Aids (Bruno) to expand and update existing exemptions to the “make inoperative” prohibition with respect to the federal motor vehicle safety standard on head restraints FMVSS No. 201, Occupant Protection in Interior Impact, NHTSA proposed changes to the exemptions. The exemptions are included in a regulation that provides exemptions for the “make inoperative” provision for, among other things, vehicle modifications to accommodate people with disabilities. (CCH Consumer Product Safety Guide ¶40,729 (ip access user) (IntelliConnect))

CPSC Warns of Dangers of Alternative Heating Sources
Noting the increased risk of carbon monoxide (CO) poisonings and fire deaths associated with the use of alternative heating and power sources, the CPSC has urged consumers to check all home heating systems from fireplaces to furnaces, including any back-up power systems. The Commission provided several safety tips to prevent fires. (CPSC News Release, #10-090, December 22, 2009, CCH Consumer Product Safety Guide, Report No. 954, January 11, 2010)

Comment Date for ROVs Proposal Extended
In response to letters received from manufacturers and distributors of multi-purpose off-highway utility vehicles and a trade association, the CPSC has extended the comment period to receive information regarding the advance notice of proposed rulemaking concerning recreational off-highway vehicles (ROVs). The Commission extended the comment period 75 days after the original comment period of December 28, 2009. Comments should be submitted by March 15, 2010. (CCH Consumer Product Safety Guide ¶40,230 (ip access user) (IntelliConnect))

Excelligence To Pay $25,000 for Violation of Lead Paint Ban
Excelligence Learning Corporation, d/b/a Discount School Supply was fined $25,000 in civil penalties for allegedly violating the federal lead paint ban. Between August 2000 and September 2007, Excelligence sold, manufactured for sale, offered for sale, distributed in commerce, or imported into the United States products in violation of the federal lead paint ban. Although Excelligence reported no incidents or injuries associated with brushes, charts, and mats, the Commission said that it failed to take adequate action to ensure that no products would contain lead containing paint, thereby creating a risk of lead poisoning and adverse health effects to children. (CCH Consumer Product Safety Guide ¶57,417 (ip access user) (IntelliConnect))

Compliance with “Designated Seating” Definition Extended
In response to petitions for reconsideration of an October 2008 final rule [CCH Consumer Product Safety Guide ¶41,989] that amended the definition of the term, “designated seating position,” as used in the federal motor vehicle safety standards, to clarify which areas within the interior of a vehicle meet that definition, NHTSA has provided one additional year of lead time until the new definition is applicable. The final rule made the new definition applicable to vehicles manufactured on and after September 1, 2010. The agency received petitions for reconsideration asking for additional time to comply with the new requirements. (CCH Consumer Product Safety Guide ¶42,018 (ip access user) (IntelliConnect))

Changes Proposed to Bus Emergency Exits Standard
Two changes have been proposed by NHTSA to Federal Motor Vehicle Safety Standard (FMVSS) No. 217, “Bus emergency exits and window retention and release.” The purpose of FMVSS No. 217 is to minimize the likelihood of occupants being thrown from the bus and to provide a means of readily accessible emergency egress. FMVSS No. 217 applies to all buses, including school buses, except buses manufactured for the purpose of transporting persons under physical restraint. FMVSS No. 217 establishes requirements for the retention of windows other than windshields in buses, and establishes operating forces, opening dimensions, and markings for bus emergency exits. (CCH Consumer Product Safety Guide ¶40,730 (ip access user) (IntelliConnect))

Testing/Certification Enforcement Stay Revised
The terms of a stay of enforcement of certain testing and certification provisions of the Consumer Product Safety Act, as amended by the Consumer Product Safety Improvement Act of 2008, have been revised by the CPSC. On February 9, 2009, the Commission announced a stay of enforcement that would remain in effect until February 10, 2010 [CCH Consumer Product Safety Guide ¶56,998], at which time the Commission would vote to terminate the stay. Through the current notice, the Commission has announced changes to the stay, including when the stay will lift as to certain testing and certification requirements and how the testing and certification requirements would be implemented or otherwise become effective with regard to specific products subject to the testing and certification requirements of the CPSIA. (CCH Consumer Product Safety Guide ¶57,438 (ip access user) (IntelliConnect))

Interim Enforcement Policy for Lead Limits Announced
An interim enforcement policy effective December 16, 2009, regarding component testing and certification of children's products and other consumer products to the 90 parts per million (ppm) lead in paint limit and to the 300 ppm lead limit for children's products established by the Consumer Product Safety Improvement Act of 2008 has been announced by the Commission. (CCH Consumer Product Safety Guide ¶57,439 (ip access user) (IntelliConnect))