Justia Products Liability Opinion Summaries

Several plaintiffs alleged that they suffered injuries, such as renal, bone, or tooth damage, from taking a drug manufactured by Gilead Sciences, Inc. known as tenofovir disoproxil fumarate (TDF). Plaintiffs conceded that TDF was not defective but claimed that Gilead had developed an alternative drug, tenofovir alafenamide fumarate (TAF), which was equally effective and less toxic. Plaintiffs argued that Gilead unreasonably delayed bringing TAF to market, allegedly to maximize profits, and that this delay deprived them of a safer drug option, causing their injuries.In the San Francisco City and County Superior Court, Gilead moved for summary judgment, asserting that negligence liability could not attach for injuries caused by a nondefective product. The trial court denied Gilead’s motion. Gilead then petitioned the Court of Appeal, First Appellate District, Division Four, which partially granted the petition. The Court of Appeal directed summary adjudication on the fraudulent concealment claim but allowed the negligence claim to proceed. It held that drug manufacturers may owe a duty of reasonable care to users of a nondefective drug in deciding whether and when to commercialize a safer alternative.The Supreme Court of California reviewed the case and reversed the Court of Appeal’s judgment. The court held that, even assuming drug manufacturers might owe a broader duty of care beyond marketing nondefective drugs, the factors set forth in Rowland v. Christian justify an exception in this context. Specifically, the court determined that a manufacturer’s decision to delay commercialization of a safer drug during early development stages is too remote and unforeseeable to establish a duty of care, and imposing such liability would unduly burden innovation and public health. The Supreme Court directed the trial court to grant summary judgment for Gilead on all claims. View "Tenofovir Cases" on Justia Law

After the death of their fourteen-year-old daughter Taylor Rose Sookra in December 2021, four months after she received Pfizer’s COVID-19 vaccine, Arthur Sookra and April Burch-Sookra filed a lawsuit. They alleged willful misconduct under the Public Readiness and Emergency Preparedness Act (PREP Act) against Pfizer, federal officials, the physician who administered the vaccine, and the pediatric practice. Their claims included both federal law claims and state-law tort claims.Initially, the case was filed in the United States District Court for the Eastern District of New York. When the Sookras added a PREP Act willful-misconduct claim, they requested and obtained a transfer to the United States District Court for the District of Columbia, as required by the statute. The defendants moved to dismiss, and the motions were referred to a magistrate judge who recommended dismissal of the claims against the federal government on sovereign immunity grounds and against Pfizer for failure to exhaust administrative remedies. The magistrate also recommended dismissal of Pfizer’s state-law claims based on immunity and advised that the court decline supplemental jurisdiction over the remaining state-law claims. The district court adopted these recommendations, dismissed the case, and denied as moot the plaintiffs’ later request for a three-judge court.On appeal, the United States Court of Appeals for the District of Columbia Circuit held that the district court erred by dismissing the complaint without first convening a three-judge court, as required by 42 U.S.C. § 247d-6d(e)(5) for willful-misconduct claims under the PREP Act. The appellate court vacated the district court’s judgment and remanded with instructions to initiate procedures for convening a three-judge court. The court did not address the other arguments raised by the parties. View "Sookra v. Pfizer Inc." on Justia Law

Buyers of over-the-counter nasal decongestants containing oral phenylephrine brought numerous class actions against drug manufacturers and retailers, alleging that for years these companies sold and advertised decongestant products they knew to be ineffective. The plaintiffs claimed that scientific studies, particularly since 2016, had shown oral phenylephrine to be no better than a placebo at relieving congestion, yet the companies continued to market their products as effective decongestants and complied with Food and Drug Administration (FDA) labeling requirements. The FDA, despite mounting evidence, did not remove oral phenylephrine’s designation as an effective decongestant under its regulations.The Judicial Panel on Multidistrict Litigation consolidated nearly one hundred class actions and transferred them to the United States District Court for the Eastern District of New York. Plaintiffs filed a complaint asserting New York statutory and common-law claims as well as a federal RICO claim. The district court granted the defendants’ motion to dismiss, holding that the Federal Food, Drug, and Cosmetic Act (FDCA) expressly preempted the state law claims because the drugs’ labels complied with FDA requirements, and that the plaintiffs lacked standing to bring the RICO claim. The court also dismissed a Lanham Act claim brought by one pharmacy plaintiff.On appeal, the United States Court of Appeals for the Second Circuit held that the FDCA expressly preempts most of the state law claims because the federal regime requires manufacturers to follow the FDA-approved labeling, but it vacated the dismissal for claims regarding “Maximum Strength” labeling and brand-name drugs approved via the New Drug Application process, remanding those for further proceedings. The court affirmed dismissal of the RICO claim, adopting the indirect purchaser rule, and upheld denial of the pharmacy’s motion for reconsideration regarding its Lanham Act claim. View "Yousefzadeh v. Johnson & Johnson Consumer Inc." on Justia Law

Two individuals died in a 2012 plane crash involving a Piper PA-32-300 Cherokee 6 aircraft powered by a Lycoming engine manufactured by Avco Corporation in the early 1970s. The engine had undergone overhauls in 1983 and 2004, with several component parts serviced or replaced during those processes. The estates and families of the decedents brought suit in Rhode Island Superior Court against Avco, alleging strict liability, negligence, breach of warranty, and negligent infliction of emotional distress. Avco asserted a defense under the General Aviation Revitalization Act of 1994 (GARA), which bars certain claims against aircraft manufacturers after eighteen years, subject to specific exceptions for misrepresentation and newly installed parts.The Providence County Superior Court addressed the applicability of GARA’s exceptions. The court found that the plaintiffs’ amended complaint failed to plead, with the required specificity, facts showing that Avco knowingly misrepresented or withheld information from the FAA as required by GARA’s misrepresentation exception. As a result, discovery on this theory was limited. On the rolling provision, the court allowed discovery on specific parts allegedly replaced within eighteen years prior to the crash but found plaintiffs failed to prove that any such part was both manufactured by Avco and causally related to the accident. The trial justice granted summary judgment for Avco on all claims.The Supreme Court of Rhode Island reviewed the lower court’s grant of summary judgment de novo. The court held that GARA requires plaintiffs to plead specific facts to invoke the misrepresentation exception, which the plaintiffs had not done. The court also held that the plaintiffs failed to prove the application of GARA’s rolling provision, as they did not establish that any newly installed part made by Avco caused the crash. The Supreme Court affirmed the Superior Court’s judgment in favor of Avco. View "Williams v. Avco Corporation" on Justia Law

The key facts concern allegations that Lockheed Martin improperly handled volatile organic compounds at its Orlando facility, resulting in environmental contamination that plaintiffs claim caused neurological illnesses, including multiple sclerosis and Parkinson’s disease, among workers and nearby residents. Plaintiffs relied on expert testimony to show that exposure to specific chemicals could cause the diseases in question.In the United States District Court for the Middle District of Florida, the plaintiffs presented two general causation experts who used epidemiological and other scientific methodologies to link the chemicals to the illnesses. Lockheed Martin challenged the admissibility of these experts’ opinions, arguing they were unreliable. The district court agreed, finding that the first expert failed to adequately explain or reliably apply his “weight of the evidence” methodology and did not sufficiently analyze the Bradford Hill factors. The second expert’s opinions were largely based on the first expert’s report and a statistical analysis that did not properly assess background risk. As a result, the district court excluded both experts’ testimony and granted summary judgment for Lockheed Martin, concluding that plaintiffs lacked admissible general causation evidence. In the related DeMilt case, the summary judgment was partial, but the district court certified it for immediate appeal under Rule 54(b).The United States Court of Appeals for the Eleventh Circuit reviewed whether the district court abused its discretion in excluding the experts and granting summary judgment. The appellate court held that the district court acted within its discretion, as the experts did not adequately explain or reliably apply their methodologies, and their testimony was thus properly excluded. Without this expert evidence, plaintiffs could not establish general causation. The Eleventh Circuit affirmed the district court’s orders excluding the experts and granting summary judgment in favor of Lockheed Martin. View "Davis v. Lockheed Martin Corp." on Justia Law

Several parents whose premature infants developed necrotizing enterocolitis (NEC) after being fed cow’s milk-based formula at Pennsylvania Hospital sued the manufacturers of the formula, as well as the hospital, in Pennsylvania state court. The parents alleged that the manufacturers’ products caused NEC and that the hospital failed to warn of the risks and implement policies to protect patients. Some plaintiffs were Pennsylvania citizens and others from New Jersey. The hospital and its related entities were named as defendants, and the claims against them were based on state law.After the lawsuits were filed, the manufacturers removed the cases to federal court. The United States District Court for the Eastern District of Pennsylvania transferred the cases to a multidistrict litigation proceeding in the Northern District of Illinois. The plaintiffs’ initial motion to remand was granted after the district court found that the claims against the hospital were potentially viable, defeating removal on diversity grounds. The cases returned to Pennsylvania state court, where discovery proceeded and the hospital was later dismissed with prejudice after the state court sustained preliminary objections. The plaintiffs did not immediately appeal. The manufacturers then removed the cases a second time, arguing that the hospital had been fraudulently joined solely to defeat diversity jurisdiction. The district court denied the plaintiffs’ motion to remand, this time concluding that the plaintiffs’ lack of active pursuit of claims against the hospital showed “no real intention in good faith to prosecute the action,” amounting to fraudulent joinder.On interlocutory appeal, the United States Court of Appeals for the Seventh Circuit reversed. The Seventh Circuit held that fraudulent joinder exists only where a plaintiff makes false jurisdictional allegations or has no chance of success against the non-diverse defendant, taking all facts and law in the plaintiff’s favor. The court held that the plaintiffs’ litigation conduct and subjective intent are not proper bases for finding fraudulent joinder. The case was remanded for further proceedings. View "Abdullah v Mead Johnson & Company LLC" on Justia Law

A premature infant was born in West Virginia in 2014 and, after initially being fed her mother’s milk, was switched to a cow’s-milk-based infant formula manufactured by Abbott Laboratories when her mother could no longer produce usable breast milk and no donor milk was available. The hospital, following policy, did not allow sharing of untested breast milk. Shortly after being fed the formula, the infant was diagnosed with necrotizing enterocolitis (NEC) and died the next day. The infant’s mother alleged that Abbott failed to adequately warn about the risks of NEC associated with its formula.The mother brought suit in the United States District Court for the Northern District of Illinois, Eastern Division, as part of a multidistrict litigation. After discovery, the district court granted summary judgment for Abbott. The court found that the plaintiff had not shown a feasible alternative design for the formula and, on the failure-to-warn claim, concluded there was insufficient evidence that a different warning would have prevented the infant’s death. The court also denied a Rule 59(e) motion to reconsider, as the plaintiff’s new witnesses were available during discovery.The United States Court of Appeals for the Seventh Circuit reviewed the case. It affirmed the district court’s grant of summary judgment, holding that the plaintiff had not provided sufficient evidence that an alternative warning would have changed the outcome, given that the hospital had no donor milk and enforced a policy against sharing untested milk. The court also affirmed the denial of the Rule 59(e) motion, finding no abuse of discretion because the proposed new evidence was not newly discovered. The judgment of the district court was affirmed. View "Mar v Abbott Laboratories" on Justia Law

After a motor vehicle collision, the plaintiff sued both the driver, who was allegedly intoxicated, and five bars under Utah’s Alcoholic Product Liability Act, claiming the bars overserved the driver prior to the crash. The plaintiff settled with the driver and three of the bars for a combined $1 million, resulting in dismissal of all claims against those parties. Two of the bars that participated in the settlement then sought contribution from the driver under Utah Code section 32B-15-302(1)(a), arguing they were entitled to recover part of the settlement amount from him.The Third District Court granted summary judgment in favor of the driver, finding that the term “award” in the Dramshop Act’s contribution provision refers to an amount imposed by a court or authority, not to payments made in voluntary settlements. Since the bars settled the claims, the court concluded no “award” was made against them, and dismissed their crossclaims. The Utah Court of Appeals affirmed, determining that “award” in the statute does not encompass voluntary settlements and supporting its interpretation with reference to the statute’s language and context.The Supreme Court of the State of Utah granted certiorari and reviewed the statutory interpretation de novo. The Court held that the Dramshop Act’s contribution provision permits contribution claims only when a party has an award imposed against them, not when they make voluntary settlement payments. The Court rejected arguments that common law or policy required a broader reading. Accordingly, it affirmed the appellate court’s judgment, holding that parties who settle claims under the Act cannot pursue contribution against other alleged wrongdoers. View "RMB v. Celotto" on Justia Law

After a motor vehicle accident in Knoxville, Tennessee, a child sustained serious injuries while riding in a booster seat secured with a seatbelt extender. The seatbelt extender, manufactured by Ford Motor Company, was purchased and installed by the child’s father to address difficulties buckling the booster seat in their Nissan Juke. Both the booster seat and the seatbelt extender were not inherently defective for their intended purposes, but the plaintiff alleged that using the two products together created a dangerous condition. The plaintiff filed a product liability action under the Tennessee Products Liability Act, asserting that Ford failed to adequately warn against the risks of using its seatbelt extender in combination with a booster seat.The Circuit Court for Knox County initially granted summary judgment to Dorel Juvenile Group, the booster seat manufacturer, but denied Ford’s motion for summary judgment, finding Ford to be a manufacturer or seller under the Act. After a mistrial in the plaintiff’s claim against Ford, the trial court allowed an interlocutory appeal to address whether the Tennessee Supreme Court’s prior decision in Coffman v. Armstrong International, Inc. required dismissal of the failure-to-warn claims. The Court of Appeals reversed the trial court, holding that Coffman barred the plaintiff’s claims as a matter of law.The Supreme Court of Tennessee reviewed the certified question and clarified that Coffman, which involved post-sale integration of inherently dangerous asbestos-containing materials into a sound product, does not require dismissal as a matter of law of failure-to-warn claims when two independently sound products are used together and create a dangerous condition. The Court reversed the judgment of the Court of Appeals and remanded the case to the trial court for further proceedings, holding that Coffman does not foreclose the plaintiff’s failure-to-warn claims under these circumstances. View "Woodruff v. Ford Motor Co." on Justia Law

A serious automobile accident in Knoxville, Tennessee resulted in the death of Benjamin Woodruff and severe injuries to his six-year-old son, Ethan. At the time of the crash, Ethan was in a high-backed booster seat manufactured by Dorel Juvenile Group and was restrained using a seatbelt extender made by Ford Motor Company, which had been purchased separately to address difficulties in buckling the booster seat in the family’s Nissan Juke. The booster seat’s manual referenced the possible use of a seatbelt extender, while the vehicle’s manual warned against using extenders to install child restraints. After the accident, Sarah Woodruff filed a product liability lawsuit under the Tennessee Products Liability Act, alleging that both Dorel and Ford failed to adequately warn of the dangers of using a seatbelt extender with the booster seat.The Circuit Court for Knox County initially granted summary judgment to Dorel, finding it had no duty to warn about another manufacturer’s product, but denied summary judgment to Ford. After an intervening decision by the Tennessee Supreme Court in Coffman v. Armstrong International, Inc., the trial court vacated its grant of summary judgment to Dorel, then later reinstated it after further motions. The Court of Appeals affirmed the grant of summary judgment for Dorel, holding that Coffman barred the plaintiff’s failure-to-warn claim as a matter of law since Dorel’s product was only allegedly dangerous when used with another manufacturer’s product.The Supreme Court of Tennessee reviewed the case and clarified that its prior holding in Coffman does not mandate dismissal as a matter of law of the plaintiff’s failure-to-warn claim against Dorel. The Court explained that Coffman was limited to situations involving the integration of inherently dangerous components into another product post-sale, and does not foreclose failure-to-warn claims where two sound products together create a risk. The Supreme Court of Tennessee reversed the Court of Appeals and remanded for further proceedings. View "Woodruff ex rel. Woodruff v. Ford Motor Co." on Justia Law