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

A plaintiff alleged that she suffered serious eye injuries, including blindness in one eye, after receiving an injection of a pharmaceutical product manufactured by the defendant. The specific unit used was from a lot later recalled due to the possible presence of silicone particulates. The plaintiff had a history of eye conditions and prior treatments but argued that her injuries followed the use of the recalled product. She presented two experts on causation: a retained ophthalmologist who provided a report and deposition, and her treating physician, who did not provide a written expert report.The Superior Court, Law Division, denied the defendant’s motions to bar the experts’ testimony and for summary judgment. The court did not conduct the “gatekeeping” inquiry regarding expert reliability required by New Jersey law. The defendant appealed, and the Appellate Division reversed. It found the experts’ opinions to be inadmissible net opinions, lacking evidentiary support for the proposed theory of causation and methodology. The Appellate Division thus also reversed the denial of summary judgment, holding the plaintiff had not established causation.The Supreme Court of New Jersey reviewed the case and held that its decision in In re Accutane Litigation requires trial courts to resolve disputes about the reliability of expert testimony by undertaking a “rigorous” gatekeeping analysis, potentially including a hearing under N.J.R.E. 104. The Supreme Court found the record insufficient for this determination and ordered a remand so the trial court could conduct the proper reliability inquiry. The Court held the retained expert’s report was not a net opinion but left open whether the treating physician’s testimony could be admitted, depending on whether a proper expert report is served. The Supreme Court reversed the Appellate Division’s judgment and remanded the matter to the trial court for proceedings consistent with its opinion. View "Beavan v. Allergan U.S.A., Inc." on Justia Law

The City of Boston, along with its Public Health Commission and Housing Authority, brought suit against two pharmacy benefit managers (PBMs), OptumRx and Express Scripts, alleging that the PBMs had worked with opioid manufacturers to misrepresent the risks of opioid drugs. The City claimed that this conduct violated Massachusetts public nuisance law and resulted in harm to the City. The PBMs removed the case to federal court and argued that the suit was untimely because it was brought after the three-year statute of limitations had expired. The City responded by asserting that its complaint sufficiently alleged a continuing nuisance and that the statute of limitations should be tolled due to the PBMs’ fraudulent concealment of their wrongdoing.The United States District Court for the District of Massachusetts granted the PBMs’ motion to dismiss, finding that the City either knew or should have known of its injuries and of the PBMs’ alleged role before 2021, based on public records and prior litigation, and thus failed to file suit within the statutory period. The district court further ruled that the City had not adequately pled a continuing nuisance, as it did not allege any specific, recent unlawful acts within the limitations period, and rejected the City’s claim of fraudulent concealment, determining that the City had the means to discover the facts needed for its claim. The district court also denied a motion by the PBMs to disqualify the City's law firm, Motley Rice.On appeal, the United States Court of Appeals for the First Circuit affirmed both the dismissal of the City’s state law claim and the denial of the motion to disqualify Motley Rice. The court held that the action was time-barred and that the City had not met the requirements for tolling the statute of limitations or for pleading a continuing nuisance under Massachusetts law. View "The City of Boston v. OptumRx, Inc." on Justia Law

A patient with a long history of severe depression and multiple suicide attempts underwent 95 electroconvulsive therapy (ECT) treatments at a Nebraska hospital between 2014 and 2016. The ECT was administered using a device manufactured by Somatics, LLC. After the treatments, the patient experienced significant memory loss and was diagnosed with a neurocognitive disorder. In 2020, he filed suit against Somatics in the United States District Court for the Middle District of Florida, alleging negligence, strict product liability, breach of warranties, violation of Nebraska’s Consumer Protection Act, and fraudulent misrepresentation, primarily claiming that Somatics failed to adequately warn of the risks associated with ECT.The district court dismissed the claims under Nebraska’s Consumer Protection Act and for fraudulent misrepresentation, merged the strict liability and breach of implied warranty claims, and granted summary judgment to Somatics on the design defect, manufacturing defect, and breach of express warranty claims. The remaining claims for negligence and strict liability, both based on failure to warn, were merged for trial. The jury found that while Somatics failed to provide adequate warnings, this failure was not the proximate cause of the plaintiff’s injuries, and awarded no damages. The district court denied the plaintiff’s post-trial motions, including for a new trial.On appeal, the United States Court of Appeals for the Eleventh Circuit reviewed the district court’s decisions de novo for summary judgment and for abuse of discretion on evidentiary and procedural rulings. The Eleventh Circuit held that the district court properly granted summary judgment on the design defect claim, correctly merged the negligence and strict liability claims, gave an appropriate jury instruction on proximate cause, and did not abuse its discretion in excluding certain evidence and expert testimony. The judgment of the district court was affirmed. View "Thelen v. Somatics, LLC" on Justia Law

A licensed veterinarian developed and manufactured undetectable performance enhancing drugs (PEDs) for use in professional horse racing, selling them to trainers who administered them to horses to gain a competitive edge. His salesperson assisted in these activities, operating a company that distributed the drugs without prescriptions or FDA approval. The drugs were misbranded or adulterated, and the operation involved deceptive practices such as misleading labeling and falsified customs forms. The PEDs were credited by trainers for their horses’ successes, and evidence showed the drugs could be harmful if misused.The United States District Court for the Southern District of New York presided over two separate trials, resulting in convictions for both the veterinarian and his salesperson for conspiracy to manufacture and distribute misbranded or adulterated drugs with intent to defraud or mislead, in violation of the Food, Drug, and Cosmetic Act. The district court denied motions to dismiss the indictment, admitted evidence from a prior state investigation, and imposed sentences including imprisonment, restitution, and forfeiture. The court calculated loss for sentencing based on the veterinarian’s gains and ordered restitution to racetracks based on winnings by a coconspirator’s doped horses.On appeal, the United States Court of Appeals for the Second Circuit held that the statute’s “intent to defraud or mislead” element is not limited to particular categories of victims; it is sufficient if the intent relates to the underlying violation. The court found no error in the admission of evidence from the 2011 investigation or in the use of gain as a proxy for loss in sentencing. However, it vacated the restitution order to racetracks, finding no evidence they suffered pecuniary loss, and vacated the forfeiture order, holding that the relevant statute is not a civil forfeiture statute subject to criminal forfeiture procedures. The convictions and sentence were otherwise affirmed. View "United States v. Fishman" on Justia Law

Three plaintiffs alleged they suffered injuries after receiving the Gardasil vaccine, which is designed to prevent certain strains of human papillomavirus. Each plaintiff experienced adverse symptoms following their Gardasil injections, but the onset of these symptoms occurred more than three years before they filed petitions for compensation under the National Vaccine Injury Compensation Program. The plaintiffs acknowledged to the special master that their petitions were untimely and sought equitable tolling of the Vaccine Act’s limitations period.The special master in the United States Court of Federal Claims found the petitions untimely and denied equitable tolling, resulting in dismissal of the claims. The plaintiffs then filed suit against Merck & Co. and Merck Sharp & Dohme LLC in the United States District Court for the Western District of North Carolina, which was handling multi-district litigation related to Gardasil. Merck moved to dismiss, arguing that the plaintiffs had failed to timely pursue their remedies under the Vaccine Act. The district court dismissed the complaints, holding that the proper forum for challenging the special master’s timeliness rulings was the Court of Federal Claims and the Federal Circuit, not the district court. The court also rejected a constitutional challenge to the process by which Gardasil was added to the Vaccine Injury Table.On appeal, the United States Court of Appeals for the Fourth Circuit affirmed the district court’s rulings. The Fourth Circuit held that the addition of Gardasil to the Vaccine Injury Table did not violate the Constitution. It further held that timely participation in the Vaccine Act compensation program is a prerequisite to bringing a tort suit, and that courts hearing vaccine-related tort suits may not reconsider the timeliness of a Vaccine Act petition once the special master has made a finding. The court affirmed the dismissal of the plaintiffs’ complaints. View "Needham v. Merck & Company Inc." on Justia Law

The case involves Eastern Maine Medical Center and eight other Maine hospitals (the Hospitals) who filed a 509-page complaint against various businesses and individuals (the Opioid Sellers) involved in the marketing and distribution of prescription opioids. The Hospitals alleged that the Opioid Sellers created illegitimate demand for opioids and unlawfully increased supply, leading to an opioid epidemic that caused the Hospitals to incur high costs for treating patients with opioid misuse, addiction, and dependency, with only partial reimbursement from insurance.The Business and Consumer Docket (Duddy, J.) dismissed the Hospitals' complaint. The court found that the complaint did not comply with the requirement for a "short and plain statement" of the claim but chose to dismiss it based on the legal insufficiency of the claims. The court concluded that the Hospitals could not recover under any of their legal theories, including negligence, public nuisance, unjust enrichment, fraud and negligent misrepresentation, fraudulent concealment, and civil conspiracy. The court also denied the Hospitals' request for leave to amend their complaint.The Maine Supreme Judicial Court reviewed the case and affirmed the lower court's dismissal. The court held that the Hospitals' claims were legally insufficient. Specifically, the court found that the Hospitals did not have a direct negligence claim, as they did not suffer harm directly caused by the Opioid Sellers. The fraud and misrepresentation claims failed due to lack of reliance by the Hospitals on the Opioid Sellers' misrepresentations. The unjust enrichment claim was dismissed because the Hospitals did not confer a benefit on the Opioid Sellers. The public nuisance claim failed as the Hospitals did not suffer a special injury different in kind from the public. Lastly, the civil conspiracy claim was dismissed as it required an underlying tort, which was not present. The court concluded that the deficiencies in the complaint could not be remedied by amendment. View "Eastern Maine Medical Center v. Walgreen Co." on Justia Law

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