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

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

Amiodarone was developed in the 1960s for the treatment of angina and was released in other countries. Amiodarone is associated with side effects, including pulmonary fibrosis, blindness, thyroid cancer, and death. In the 1970s, U.S. physicians began obtaining amiodarone from other countries for use in patients with life-threatening ventricular fibrillation or ventricular tachycardia who did not respond to other drugs. In 1985, the FDA approved Wyeth’s formulation of amiodarone, Cordarone, as a drug of last resort for patients suffering from recurring life-threatening ventricular fibrillation and ventricular tachycardia. The FDA’s “special needs” approval issued without randomized clinical trials. In 1989, the FDA described Wyeth’s promotional activities as promoting an unapproved use of the drug. In 1992, the FDA objected to promotional labeling pieces for Cordarone. Other manufacturers developed generic amiodarone, which has been available since 1998.Consolidated lawsuits alleged that plaintiffs suffered unnecessary, serious side effects when they took amiodarone, as prescribed by their doctors, for off-label use to treat atrial fibrillation, a more common, less serious, condition than ventricular fibrillation. The FDA never approved amiodarone for the treatment of atrial fibrillation, even on a special-needs basis. The court of appeal affirmed the dismissal of the lawsuits. The claims are preempted as attempts to privately enforce the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301, regulations governing medication guides and labeling and have no independent basis in state law. The court also rejected fraud claims under California’s unfair competition law and Consumers Legal Remedy Act. View "Amiodarone Cases" on Justia Law

Smith’s hip resurfacing implant consists of a metal ball that covers the top of the femur and a cup that fits inside the hip socket. When a surgeon puts these ball-and-cup surfaces in the joint, the polished metal surfaces are supposed to allow smoother movement than the damaged bone or cartilage they replace. Gall, who had hip resurfacing surgery for his left hip, recovered and became physically active. Years later, convinced his implant was unsatisfactory, Gall sued Smith.Gall argued that Smith failed to properly warn Gall’s surgeon, Dr. Hernandez, about the risks of using Smith’s product. The trial court granted Smith summary judgment because Hernandez independently knew these risks and whether Smith gave Hernandez redundant warnings did not matter. Gall also argued that Smith’s product was defective. The trial court granted summary judgment because Gall did not show anything was wrong with his implant. Gall did show Smith’s quality control procedures once failed to satisfy regulatory authorities, but the court concluded this fact did not imply the parts Gall received were defective. The court of appeal affirmed. Gall’s claims share the same causation element and Gall did not establish causation. View "Gall v. Smith & Nephew, Inc." on Justia Law

Linda Black sustained second-degree burns on her back while undergoing electrotherapeutic treatment at Superior Physical Therapy (“SPT”). Black’s treatment was performed by Bart McDonald, a licensed physical therapist and the sole owner of SPT. Black brought a product liability claim against the manufacturer and seller of the self- adhesive carbon electrode pads used during her treatment. The manufacturer moved for summary judgment on the grounds that Black was unable to prove that the electrode pads were defective or that the injuries Black sustained were proximately caused by its negligence. The district court ruled that: (1) McDonald’s conclusory statements that the electrode pads were defective were inadmissible because he was not a qualified expert; (2) the doctrine of res ipsa loquitur did not apply to Black’s case; and (3) Black’s prima facie case failed because there was evidence of abnormal use of the electrode pads and other reasonable secondary causes that could have contributed to Black’s injury. The district court granted summary judgment in favor of the manufacturer. Finding no reversible error, the Idaho Supreme Court affirmed the district court’s decision. View "Black v. DJO Global" on Justia Law

Plaintiffs Amber Brooks and Jamie Gale brought tort claims based on injuries they sustained when their breast implants began to deteriorate. The district court found they failed to state a claim upon which relief could be granted, and dismissed their complaint with prejudice. Plaintiffs appealed, arguing that though Congress heavily regulated the production and use of medical devices, there was a narrow preemption by which plaintiffs could plead their claim arising from the failure of that medical device. They also alleged the district court abused its discretion by denying their motion for leave to amend their complaint. The Tenth Circuit agreed with the district court that federal law preempted all of plaintiffs' claims, and any any state-law claims were insufficiently pled. With respect to the trial court's dismissal of plaintiffs' complaint with prejudice, the Tenth Circuit determined plaintiffs elected to "stand by their 'primary position,' and took no available avenue to amend their complaint. Therefore, the Tenth Circuit declined to grant their request now, and found the trial court did not abuse its discretion in denying Plaintiffs' request for leave to amend. View "Brooks v. Mentor Worldwide" on Justia Law