Justia Products Liability Opinion Summaries

Several counties and municipalities in New York initiated lawsuits in state courts against two pharmacy benefit managers, Express Scripts, Inc. and OptumRx, Inc., alleging that these companies contributed to the opioid epidemic in their communities. The claims are based on state law and center on the defendants’ alleged practices in negotiating with opioid manufacturers and managing prescription formularies, which plaintiffs contend led to an oversupply of prescription opioids and caused substantial public harm and government expense.The defendants removed the cases to federal court—the United States District Courts for the Southern and Eastern Districts of New York—arguing removal was proper under the federal officer removal statute, 28 U.S.C. § 1442(a)(1), because some of the challenged conduct was performed under contracts with federal agencies, such as the Department of Defense (TRICARE), the Office of Personnel Management (FEHBP), and the Veterans Health Administration. After removal, the plaintiffs amended their complaints to disclaim any claims based on the defendants’ work for federal clients, seeking to have the cases remanded to state court. The district courts accepted the disclaimers and remanded the cases.The United States Court of Appeals for the Second Circuit reviewed the district courts’ decisions. It concluded that the disclaimers were ineffective because the alleged wrongful conduct and resulting harms could not be separated between federal and non-federal clients; the conduct was indivisible. Relying on the Supreme Court's decision in Chevron USA Inc. v. Plaquemines Parish, the Second Circuit held that the defendants satisfied all statutory requirements for federal officer removal: they acted under federal direction, were sued for acts relating to federal authority, and asserted colorable federal defenses. The Second Circuit therefore reversed the remand orders and returned the cases to the district courts for further proceedings. View "County of Westchester v. Express Scripts" 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 professional track and field athlete received a bottle of Gatorade Recovery Gummies at an award ceremony hosted by Gatorade, which were labeled as “NSF Certified for Sport,” indicating independent testing for banned substances. After consuming the gummies, the athlete submitted a routine drug test that later returned positive for cardarine, a banned performance-enhancing drug, resulting in immediate suspension from elite competition. Subsequent investigation revealed that the gummies lot the athlete received had never been NSF certified, and Gatorade was aware of the mislabeling before distributing the product. The athlete suffered significant consequences, including loss of eligibility to compete, loss of a scholarship, and forfeiture of endorsement opportunities.The athlete initiated legal action in the United States District Court for the Southern District of New York, alleging strict products liability, negligence, negligent misrepresentation, violation of Texas’s Deceptive and Unfair Trade Practices Act, tortious interference with contract, and intentional infliction of emotional distress. The district court dismissed all claims. It found no “cognizable injury outside of purely economic damages” for the strict liability, negligence, and misrepresentation claims, applying New York’s economic loss doctrine. Additional claims were dismissed based on statutory definitions and insufficient allegations of extreme conduct or distress.On appeal, the United States Court of Appeals for the Second Circuit reviewed the dismissal de novo. It affirmed the district court’s dismissal of the tortious interference, consumer protection, and emotional distress claims. However, the court recognized uncertainty in New York law regarding tort recovery for nonconsensual bodily changes detectable only by laboratory testing and the boundaries of the economic loss doctrine. Accordingly, the Second Circuit deferred decision and certified two questions to the New York Court of Appeals concerning the scope of the economic loss doctrine and whether the athlete’s injury is cognizable in tort under New York law. View "Asinga v. Gatorade Co." on Justia Law

Parents, guardians, and children brought state law claims against manufacturers, pharmacies, and retailers of acetaminophen products, alleging that prenatal exposure to acetaminophen caused ADHD and/or autism spectrum disorder (ASD). The plaintiffs contended that the defendants failed to warn about these risks. Acetaminophen is commonly used during pregnancy, but the FDA only requires a general warning for pregnant women and does not mandate warnings about ADHD or ASD. Scientific debate exists regarding any causal relationship between prenatal acetaminophen exposure and neurodevelopmental disorders, with studies and expert opinions both supporting and questioning such links.After these cases were consolidated in the U.S. District Court for the Southern District of New York, the court excluded all general causation expert testimony offered by plaintiffs in Rutledge (Drs. Baccarelli, Hollander, Pearson, Cabrera, Louie) and Phippen (Dr. Ness), determining their opinions were unreliable and not based on sufficient scientific methodology under Rule 702 and Daubert v. Merrell Dow Pharms., Inc. The district court then granted summary judgment for the defendants. It also rejected defendants’ arguments that federal law preempted the plaintiffs’ failure-to-warn claims, holding that federal drug labeling regulations did not prohibit supplemental warnings.The United States Court of Appeals for the Second Circuit reviewed the district court’s decisions. It held that the district court erred in excluding the testimony of Drs. Baccarelli, Hollander, and Pearson, as their methodologies and interpretations were consistent with accepted scientific practices and the ongoing debate in the field. The district court did not abuse its discretion in excluding the testimony of Drs. Cabrera and Louie. The Second Circuit also held that reconsideration of Dr. Ness’s testimony in Phippen was warranted. The court affirmed the district court’s rejection of the federal preemption defense. The judgments in both cases were vacated and remanded for further proceedings. View "Rutledge v. Walgreen Co." on Justia Law

A group of parents, guardians, and children alleged that prenatal exposure to acetaminophen, the active ingredient in Tylenol and similar over-the-counter drugs, caused attention-deficit/hyperactivity disorder (ADHD) and/or autism spectrum disorder (ASD) in children. The defendants were manufacturers, pharmacies, and retailers of acetaminophen products. The plaintiffs’ claims centered on the companies’ alleged failure to warn about the risk of these neurodevelopmental disorders associated with prenatal acetaminophen use.These cases were consolidated and transferred to the United States District Court for the Southern District of New York. In the Rutledge action, the district court excluded all five of plaintiffs’ expert witnesses on general causation, concluding their methodologies were unreliable, and granted summary judgment to defendants. In the Phippen action, which involved only ADHD claims, the district court excluded another expert, Dr. Ness, and again granted summary judgment to defendants. The district court also rejected defendants’ arguments that federal drug labeling law preempted the plaintiffs’ claims, holding that federal law did not bar additional, specific pregnancy-related warnings.On appeal, the United States Court of Appeals for the Second Circuit reviewed whether the district court properly exercised its gatekeeping role under Federal Rule of Evidence 702 in excluding the plaintiffs’ expert testimony. The Second Circuit held that the district court exceeded its discretion in excluding the testimony of Drs. Baccarelli, Hollander, and Pearson, because their methodologies were consistent with those generally accepted in their fields and their reasoning was within the range of scientific debate. The appellate court affirmed the exclusion of testimony from Drs. Cabrera and Louie. In light of its rulings, the Second Circuit vacated the summary judgments, remanded both cases for further proceedings, and directed reconsideration of Dr. Ness’s exclusion in Phippen. The court also affirmed that federal law did not preempt the plaintiffs’ state-law failure-to-warn claims. View "Rutledge v. Walgreen Co." on Justia Law

A police sergeant was injured when his department-issued pistol accidentally discharged during a training exercise. He did not know what caused the trigger to actuate but testified that the pistol fired while holstered and his hand was not on the weapon. The injured officer and his spouse sued the firearm manufacturer, alleging that the pistol was defectively designed because it lacked an external safety, and claimed that this defect caused the injury. They sought to support their claims with expert testimony asserting that the pistol’s design was unreasonably dangerous due to its lack of external safety features and that an external safety would have prevented the incident.The United States District Court for the Northern District of New York excluded the causation opinions of the plaintiffs’ experts, finding that these experts could not reliably explain how the accident happened or how an external safety would have prevented it. The district court then granted summary judgment to the manufacturer, holding that, under New York law, expert testimony was required to establish proximate causation because the issue was too complex for a jury.The United States Court of Appeals for the Second Circuit reviewed the case. It held that the district court did not abuse its discretion in excluding the experts’ causation opinions, as they were insufficiently linked to the specifics of the accident. However, the appellate court determined that the district court erred in granting summary judgment. The Second Circuit clarified that New York law does not require expert testimony to establish proximate causation in all product liability cases; jurors may use their common sense and the available evidence, including unchallenged expert opinions about the product’s design, to decide if the alleged defect caused the injury. The appellate court also rejected the manufacturer’s argument based on New York’s optional equipment doctrine. The judgment was vacated and the case remanded for further proceedings. View "The Satanic Temple, Inc. v. Newsweek Digital LLC" on Justia Law

A police sergeant suffered a gunshot injury to his leg when his department-issued Sig Sauer P320 pistol discharged while he was conducting a training exercise. He did not know what caused the trigger to move, but testified that the pistol was holstered and his hand was not on the gun at the time. Emergency responders’ documentation, however, suggested the gun discharged while he was still holstering it. The injured officer and his spouse brought strict products liability and negligence claims against the manufacturer, alleging that the P320 was defectively designed because it lacked an external safety, making it prone to accidental discharges.The United States District Court for the Northern District of New York excluded the causation opinions of the plaintiffs’ experts, finding their analysis unreliable because they did not explain how the accident happened or how an external safety would have prevented it. The district court then granted summary judgment for the manufacturer, concluding New York law required expert testimony to establish proximate causation in a case involving the operation of a complex product like a firearm, and the plaintiffs could not meet that burden without admissible expert causation opinions.The United States Court of Appeals for the Second Circuit reviewed the case and held that the district court did not abuse its discretion by excluding the experts’ causation opinions, as they were not sufficiently grounded in the facts of the accident. However, the Second Circuit ruled that the district court erred in granting summary judgment. The appellate court held that, under New York law, expert testimony on causation is not always required if a jury can determine causation based on its own judgment, the characteristics of the product, and the evidence presented. The court vacated the district court’s judgment and remanded the case for further proceedings. View "Colwell v. Sig Sauer, Inc." 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

After Old GM filed for bankruptcy, New GM emerged. This case involves one of the consequences of the GM bankruptcy. Beginning in February 2014, New GM began recalling cars due to a defect in their ignition switches. Many of the cars in question were built years before the GM bankruptcy. Where individuals might have had claims against Old GM, a ʺfree and clearʺ provision in the bankruptcy courtʹs sale order barred those same claims from being brought against New GM as the successor corporation. Various individuals nonetheless initiated class action lawsuits against New GM, asserting ʺsuccessor liabilityʺ claims and seeking damages for losses and injuries arising from the ignition switch defect and other defects. The bankruptcy court enforced the Sale Order to enjoin many of these claims against New GM. The court concluded that the bankruptcy court had jurisdiction to interpret and enforce the Sale Order; the ʺfree and clearʺ provision covers pre‐closing accident claims and economic loss claims based on the ignition switch and other defects, but does not cover independent claims or Used Car Purchasersʹ claims; the court found no clear error in the bankruptcy court's finding that Old GM knew or should have known with reasonable diligence about the defect, and individuals with claims arising out of the ignition switch defect were entitled to notice by direct mail or some equivalent, as required by procedural due process; because enforcing the Sale Order would violate procedural due process in these circumstances, the bankruptcy court erred in granting New GMʹs motion to enforce and these plaintiffs cannot be bound by the terms of the Sales Order; and the bankruptcy courtʹs decision on equitable mootness was advisory. Accordingly, the court affirmed in part, reversed in part, vacated in part, and remanded. View "In re Motors Liquidation Co." on Justia Law