Justia Products Liability Opinion Summaries

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

This case involves a dispute over the interpretation of the "learned intermediary doctrine" in a product liability case involving a medical device. The plaintiff, Michelle Himes, sued the defendant, Somatics, LLC, alleging that the company failed to provide adequate warning about the risks associated with electroconvulsive therapy (ECT), a treatment she underwent for severe depression. Himes claimed that she was only warned about the possibility of short-term memory loss, and not about the potential for permanent brain damage, severe permanent retrograde and anterograde amnesia, and acute and/or chronic organic brain syndrome, which she alleges she suffered as a result of the treatment.The district court granted summary judgment in favor of Somatics, finding that Himes failed to present evidence showing that a more detailed warning would have changed her physician's decision to administer ECT. The Ninth Circuit Court of Appeals agreed with the district court's finding but noted a genuine dispute of material fact as to whether the physician would have communicated a stronger warning to Himes.The Supreme Court of California was asked to clarify the causation standard under the learned intermediary doctrine. The court held that a plaintiff is not required to show that a stronger warning would have altered the physician’s decision to prescribe the product to establish causation. Instead, a plaintiff may establish causation by showing that the physician would have communicated the stronger warning to the patient and an objectively prudent person in the patient’s position would have thereafter declined the treatment. The court emphasized that the causation analysis must take into consideration whether the physician would still recommend the prescription drug or medical device for the patient, even in the face of a more adequate warning. View "Himes v. Somatics, LLC" on Justia Law

The case involves four plaintiffs who took docetaxel, a chemotherapy drug, as part of their treatment for early-stage breast cancer and subsequently suffered permanent chemotherapy-induced alopecia (PCIA). The plaintiffs allege that the manufacturers of the drug, Hospira, Inc., Hospira Worldwide, LLC, and Accord Healthcare, Inc., violated state law by failing to warn them that docetaxel could cause PCIA.The case was initially heard in the United States District Court for the Eastern District of Louisiana, where the defendants moved for summary judgment on the basis that the plaintiffs' state law failure-to-warn claims were preempted by federal law. The district court denied the motion, and the defendants appealed.The United States Court of Appeals for the Fifth Circuit was tasked with determining whether federal law preempts the plaintiffs' state law failure-to-warn claims against the defendant drug manufacturers. The court found that the district court had erred in its interpretation of what constitutes "newly acquired information" under the changes-being-effected (CBE) regulation, which allows manufacturers to file a supplemental application with the FDA and simultaneously implement a labeling change before obtaining FDA approval. The court held that the district court failed to enforce the requirement that newly acquired information must "reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA."The court vacated the district court's judgment on the plaintiffs' failure-to-warn claims and remanded the case for further consideration of one outstanding issue: whether the Bertrand Abstract, a scientific study, constituted "newly acquired information" that revealed a greater risk of PCIA than previously known. If the Bertrand Abstract does not meet this standard, the court held that the defendants would not be liable to the plaintiffs on their state law failure-to-warn claims. View "Hickey v. Hospira" on Justia Law

The case involves a dispute over whether a hospital that supplies and administers a drug that causes harm can be considered a "seller" under Oregon's strict product liability statute, ORS 30.920(1). The plaintiffs, Brown and Gomez, are the parents of a child who suffered irreparable heart defects as a result of in utero exposure to the drug Zofran, which Providence Health System - Oregon administered to Gomez. The plaintiffs sued Providence, asserting a claim for strict liability under ORS 30.920, alleging that Providence was a "seller" of Zofran and that the drug was "unreasonably dangerous and defective."The trial court granted Providence's motion for summary judgment, concluding that the statute was inapplicable under the circumstances. The Court of Appeals reversed the trial court's decision, disagreeing with the trial court’s interpretation of the statute. The Supreme Court of Oregon granted review.The Supreme Court of Oregon affirmed the decision of the Court of Appeals. The court concluded that the legislature did not intend to exclude hospitals from the scope of ORS 30.920(1); a hospital that supplies and administers a dangerously defective drug in conjunction with providing a healthcare service can be a "seller" that is "engaged in the business of selling" for purposes of liability under ORS 30.920; and, consequently, the trial court erred in granting the motion for summary judgment. The court reversed the trial court’s judgment and remanded the case for further proceedings. View "Brown v. GlaxoSmithKline, LLC" on Justia Law

In the case before the Court of Appeal of the State of California First Appellate District Division Four, the plaintiffs, thousands of individuals who suffered adverse effects from the use of a prescription drug, TDF, made by Gilead Life Sciences, Inc., brought a claim of negligence and fraudulent concealment against Gilead. The plaintiffs alleged that while Gilead was developing TDF, it discovered a similar, but chemically distinct and safer potential drug, TAF. However, Gilead allegedly decided to defer development of TAF because it was concerned that the immediate development of TAF would reduce its financial return from TDF. Gilead sought summary judgment on the ground that in order to recover for harm caused by a manufactured product, the plaintiff must prove that the product was defective. The trial court denied Gilead's motion for summary judgment in its entirety.In reviewing this case, the appellate court held that the trial court was correct to deny Gilead's motion for summary judgment on the negligence claim. The court reasoned that a manufacturer's duty of reasonable care can extend beyond the duty not to market a defective product. The court found that the factual basis of the plaintiffs' claim was that Gilead knew TAF was safer than TDF, but decided to defer development of TAF to maximize its profits. The court held that if Gilead's decision to postpone development of TAF indeed breached its duty of reasonable care to users of TDF, then Gilead could potentially be held liable.However, the appellate court reversed the trial court's decision regarding plaintiffs' claim for fraudulent concealment. The court concluded that Gilead's duty to plaintiffs did not extend to the disclosure of information about TAF, as it was not available as an alternative treatment for HIV/AIDS at the time the alleged concealment occurred. Consequently, the court granted in part and denied in part Gilead's petition for a writ of mandate, directing the superior court to vacate its order denying Gilead's motion for summary judgment and to enter a new order denying summary adjudication of the negligence claim but granting summary adjudication of the fraudulent concealment claim. View "Gilead Tenofovir Cases" on Justia Law

The United States District Court for the District of New Hampshire certified two questions of law for the New Hampshire Supreme Court's consideration. Plaintiffs, individuals who presently or formerly lived in the Merrimack area, brought tort claims, including negligence, nuisance, trespass, and negligent failure to warn, alleging that defendants’ manufacturing process at its facility in the Town of Merrimack used chemicals that included perfluorooctanoic acid (PFOA). They alleged PFOA was a toxic chemical that was released into the air from the Merrimack facility and has contaminated the air, ground, and water in Merrimack and nearby towns. As a result, plaintiffs alleged the wells and other drinking water sources in those places were contaminated, exposing them to PFOA, placing them at risk of developing health problems, including testicular cancer, kidney cancer, immunotoxicity, thyroid disease, high cholesterol, ulcerative colitis, and pregnancy induced hypertension. The first question from the federal circuit court asked whether New Hampshire recognized “a claim for the costs of medical monitoring as a remedy or as a cause of action” in plaintiffs' context. Depending on the answer to the first question, the second question asked, “what are the requirements and elements of a remedy or cause of action for medical monitoring” under New Hampshire law. Because the Supreme Court answered the first question in the negative, it did not address the second question. View "Brown, et al. v. Saint-Gobain Performance Plastics Corporation, et al." on Justia Law