Justia Products Liability Opinion Summaries

The case involves hundreds of plaintiffs who allege that they were injured by the drug Fosamax, manufactured by Merck Sharp & Dohme Corp. (Merck), due to inadequate warnings about the risk of atypical femoral fractures. The plaintiffs claim that they would not have taken the drug if they had been properly warned. Merck contends that it proposed a label change to the Food and Drug Administration (FDA) to address this risk, but the FDA rejected the proposed change due to insufficient scientific support.The United States District Court for the District of New Jersey granted summary judgment in favor of Merck, concluding that the plaintiffs' state law claims were preempted by federal law. The court found that Merck had fully informed the FDA of the justifications for the proposed warning and that the FDA had rejected the proposed label change, thus preempting the state law claims. The court relied on the FDA's Complete Response Letter and other communications to determine that the FDA's rejection was based on a lack of sufficient scientific evidence linking Fosamax to atypical femoral fractures.The United States Court of Appeals for the Third Circuit reviewed the case and vacated the District Court's judgment. The Third Circuit concluded that the District Court erred in its preemption analysis by giving too little weight to the presumption against preemption. The appellate court found that the FDA's Complete Response Letter was ambiguous and that the District Court placed too much reliance on informal FDA communications and an amicus brief to interpret the letter. The Third Circuit emphasized that the presumption against preemption is strong and that Merck did not meet the demanding standard of showing that federal law prohibited it from adding any and all warnings that would satisfy state law. The case was remanded for further proceedings. View "In re: Fosamax" on Justia Law

David Schaffner, Jr. and Theresa Sue Schaffner filed a lawsuit against Monsanto Corporation, alleging that Monsanto violated Pennsylvania law by failing to include a cancer warning on the label of its weed-killer, Roundup. The Schaffners claimed that this omission caused Mr. Schaffner to develop non-Hodgkin’s lymphoma due to his exposure to Roundup. The case was initially filed in the Court of Common Pleas of Allegheny County, Pennsylvania, and was later removed to the United States District Court for the Western District of Pennsylvania. The Judicial Panel on Multi-District Litigation (JPML) then transferred the case to the Northern District of California for consolidated pretrial proceedings.In the Northern District of California, the MDL Court had previously ruled in similar cases that the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) did not preempt state-law tort duties to include a cancer warning on Roundup’s label. Following this precedent, the MDL Court denied Monsanto’s motion for summary judgment on preemption grounds. The case was subsequently remanded to the Western District of Pennsylvania, where the parties stipulated to a judgment in favor of the Schaffners, reserving Monsanto’s right to appeal the preemption issue.The United States Court of Appeals for the Third Circuit reviewed the case and focused on whether FIFRA preempted the Pennsylvania duty to warn. The court held that FIFRA’s preemption provision, which prohibits states from imposing labeling requirements different from those required under federal law, did preempt the state-law duty to include a cancer warning. The court reasoned that the Environmental Protection Agency (EPA) had approved Roundup’s label without a cancer warning, and FIFRA regulations require pesticide labels to conform to the EPA-approved label. Therefore, the Pennsylvania duty to warn was not equivalent to the federal requirements and was preempted by FIFRA. The Third Circuit reversed the judgment of the District Court. View "Schaffner v. Monsanto Corporation" on Justia Law

“Old Consumer,” a wholly owned subsidiary of J&J, sold healthcare products such as Band-Aid, Tylenol, Aveeno, and Listerine, and produced Johnson’s Baby Powder for over a century. The Powder’s base was talc. Concerns that the talc contained asbestos resulted in lawsuits alleging that it has caused ovarian cancer and mesothelioma. With mounting payouts and litigation costs, Old Consumer, through a series of intercompany transactions, split into LTL, holding Old Consumer’s liabilities relating to talc litigation and a funding support agreement from LTL’s corporate parents, and “New Consumer,” holding virtually all the productive business assets previously held by Old Consumer. J&J’s goal was to isolate the talc liabilities in a new subsidiary that could file for Chapter 11 without subjecting Old Consumer’s entire operating enterprise to bankruptcy proceedings.Talc claimants moved to dismiss LTL’s subsequent bankruptcy case as not filed in good faith. The Bankruptcy Court denied those motions and extended the automatic stay of actions against LTL to hundreds of non-debtors, including J&J and New Consumer. In consolidated appeals, the Third Circuit dismissed the petition. Good intentions— such as to protect the J&J brand or comprehensively resolve litigation—do not suffice. The Bankruptcy Code’s safe harbor is intended for debtors in financial distress. LTL was not. Ignoring a parent company’s safety net shielding all foreseen liability would create a legal blind spot. View "In re: LTL Management LLC" on Justia Law

IImerys sought Chapter 11 bankruptcy protection in response to mounting asbestos and talc personal injury claims. Many of the claimants who will suffer harm from asbestos exposure traceable to the debtor will not manifest those injuries until long after the reorganization process has concluded. Cases involving asbestos liability, therefore, use trusts designed to compensate present and future asbestos claimants, coupled with an injunction against future asbestos liability to allow the debtor to emerge from bankruptcy without the uncertainty of future asbestos liabilities while ensuring claimants would not be prejudiced just because they had not yet manifested injuries at the time of the bankruptcy, 11 U.S.C. 524(g), The provision requires the appointment of a legal representative (FCR) to protect the rights of future claimants. The FCR participates in the negotiation of the reorganization plan and objects to terms that unfairly disadvantage future claimants.A group of insurance companies appealed the appointment of an FCR in the Ilmerys bankruptcy, arguing that the FCR had a conflict of interest because the FCR’s law firm also represented two of the insurance companies in a separate asbestos-related coverage dispute. The Third Circuit affirmed the appointment. The Bankruptcy Court did not abuse its discretion in appointing the FCR. it gave due consideration to the purported conflict and correctly determined that the interests of both the insurance companies and the future claimants were adequately protected. View "In re: Imerys Talc America, Inc" on Justia Law

Hamer underwent open-heart surgery using LivaNova’s 3T Heater-Cooler System. He developed an infection in the incision, which his physicians suspected stemmed from a non-tuberculosis mycobacterium (NTM). The hospital had experienced an outbreak of NTM infections in other patients who had undergone surgery using the 3T System. Hamer’s treatment team never isolated NTM from any of the swabs or cultures. Hamer, alleging that his treatment caused him lasting injuries, filed suit under the Louisiana Products Liability Act (LPLA) for failure to warn and inadequate design.Hamer’s case was transferred to Multidistrict Litigation case 2816, along with other cases alleging damages from the NTM infection caused by the 3T System. Case Management Order 15 (CMO 15) required plaintiffs to show “proof of NTM infection” through “positive bacterial culture results.” Hamer did not comply but opposed dismissal, claiming he had stated a prima facie claim under Louisiana law and sought remand.The Third Circuit reversed the dismissal. The court could have dismissed Hamer’s claims without prejudice, could have suggested remand, or could have dismissed Hamer’s claims with prejudice, if it found that Hamer had not stated a prima facie case under Louisiana law. .Under the LPLA, Hamer’s facts might state a prima facie case for defective design. Hamer’s allegations may diverge from those of other cases in MDL 2816 in which an NTM infection was verified but stating alternative theories of liability cannot justify foreclosing his claims. View "Hamer v. LivaNova Deutschland GMBH" on Justia Law

Sun made news ink at its East Rutherford facility and purchased a dust-collection system that included a Fike suppression system to contain explosions in case of a fire in the collection system. On the first day the system was fully operational, the dust-collection system caught fire. The suppression system activated an alarm that workers did not hear. After workers saw flames and extinguished the fire, an explosion sent flames out of the dust-collector system’s ducts, severely injuring several Sun employees and causing significant property damage. The ensuing government investigations caused Sun to end production at the facility.Sun sued Fike under the New Jersey Consumer Fraud Act (CFA), N.J. Stat. 56:8-1, alleging that Fike misrepresented that: the suppression-system alarm would be audible and would comply with a specific industry standard; Fike would provide training to Sun employees; the suppression system had never experienced failures in the field; and the system was capable of preventing an explosion from entering the facility. The Third Circuit certified an issue to the New Jersey Supreme Court, then, consistent with the response, held that some of Sun’s CFA claims are absorbed and precluded by the New Jersey Products Liability Act, N.J. Stat. 2A:58C-1, and some are not. As to Sun’s remaining CFA claims, the court concluded that Sun demonstrated a genuine issue of material fact and remanded for further proceedings. View "Sun Chemical Corp v. Fike Corp" on Justia Law

Adams had a long history with hip pain and, in September 2010, was diagnosed with advanced degenerative arthritis. The doctor recommended a total hip replacement, expected to last 15-20 years, Her Zimmer hip device was implanted in January 2011. In late 2012, she started experiencing severe pain. The cause was not clear. Her February 2015 revision surgery revealed that the implant had been discharging excessive and potentially toxic metal debris into Adams’s hip. Pennsylvania’s discovery rule delays the start of the statute-of-limitations period until a plaintiff knows or reasonably should know she has suffered an injury caused by another. Adams claimed that she reasonably did not know until February 2015 that the implant caused the injuries for which she filed suit in February 2017. Zimmer contended she should have discovered her injury when she agreed to undergo revision surgery. The district court rejected Adams’s claim as untimely under the two-year statute of limitations. The Third Circuit reversed. In entering summary judgment, the district court resolved issues of fact regarding the timing of Adams’s discovery that her pain was caused not by her poor adjustment to the implant but instead by the implant itself. Pennsylvania law delegates to a factfinder any genuine dispute over when a plaintiff should reasonably have discovered her injury. View "Adams v. Zimmer US, Inc." on Justia Law

Oberdorf walked her dog with a retractable leash. Unexpectedly, the dog lunged. The D-ring on the collar broke and the leash recoiled and hit Oberdorf’s face and eyeglasses, leaving Oberdorf permanently blind in her left eye. Oberdorf bought the collar on Amazon.com. She sued Amazon.com, including claims for strict products liability and negligence. The district court found that, under Pennsylvania law, Amazon was not liable for Oberdorf’s injuries. A third-party vendor, not Amazon itself, had listed the collar on Amazon’s online marketplace and shipped the collar directly to Oberdorf. The court found that Amazon was not a “seller” under Pennsylvania law and that Oberdorf’s claims were barred by the Communications Decency Act (CDA) because she sought to hold Amazon liable for its role as the online publisher of third-party content. The Third Circuit vacated and remanded. Amazon is a “seller” under section 402A of the Second Restatement of Torts and thus subject to the Pennsylvania strict products liability law. Amazon’s involvement in transactions extends beyond a mere editorial function; it plays a large role in the actual sales process. Oberdorf’s claims against Amazon are not barred by section 230 of the CDA except as they rely upon a “failure to warn” theory of liability. The court affirmed the dismissal under the CDA of the failure to warn claims. View "Oberdorf v. Amazon.com Inc" on Justia Law

In the mid-1980s, merchant mariners filed thousands of lawsuits in the Northern District of Ohio against shipowners, asserting that the mariners had been injured due to exposure to asbestos onboard ships. The District Court for the Eastern District of Pennsylvania ultimately presided over a nationwide asbestos products multidistrict litigation (MDL) and dismissed claims against numerous defendants for lack of personal jurisdiction. In a third appeal, the Third Circuit concluded that dismissal for lack of personal jurisdiction was inappropriate. The shipowner-defendants timely moved for dismissal for lack of personal jurisdiction in the Northern District of Ohio, after which they had to choose between waiving their personal jurisdiction defenses and remaining in the Northern District of Ohio, or submitting to transfer to a court where personal jurisdiction existed. By objecting to transfer, the defendants constructively opted to waive their personal jurisdiction defenses. The court noted that the shipowners also filed answers in the Northern District of Ohio after the parties expressly agreed that they could demonstrate a waiver of the defense by filing an answer. View "In re: Asbestos Products Liability Litigation (No. VI)" on Justia Law

Sikkelee was killed when a Cessna aircraft he was piloting crashed after taking off from North Carolina's Transylvania County Airport. The aircraft had a Lycoming engine; Sikkelee's widow alleged the aircraft lost power due to a defect in the design of the engine and its carburetor. The FAA had issued Lycoming a type certificate for the engine, certifying that the design performs properly and satisfies federal regulations. Sikkelee’s widow brought strict liability and negligence claims against Lycoming, alleging design defect. The Third Circuit held that Sikkelee’s state-law claims are not barred based on the doctrine of field preemption. On remand, the district court concluded the claims were conflict-preempted and that Lycoming was entitled to summary judgment on Sikkelee’s strict liability and negligence claims based on Pennsylvania law. The court granted Lycoming summary judgment on Sikkelee’s claim that Lycoming violated 14 C.F.R. 21.3 by failing to notify the FAA of the alleged defect. The Third Circuit reversed in part, rejecting an argument that Sikkelee’s claims were conflict-preempted because FAA regulations made it impossible for Lycoming to unilaterally implement design changes Pennsylvania law allegedly would have required. Lycoming has not produced clear evidence that the FAA would not have allowed it to change the design set forth in the type certificate. Summary judgment on Sikkelee’s strict liability and negligence claims was inappropriate because there are genuine disputes of material fact concerning causation. Summary judgment was proper on the failure-to-notify-the-FAA claim. View "Sikkelee v. Precision Airmotive Corp" on Justia Law