Justia Products Liability Opinion Summaries

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

In 2012, 41-year-old Karen Hubbard suffered a catastrophic stroke caused by a blood clot to her brain--a venous sinus thrombosis, a type of venous thromboembolism (VTE). She had been taking Beyaz, a birth control pill manufactured by Bayer. While she first received a prescription for Beyaz on December 27, 2011, Karen had been taking similar Bayer birth control products since 2001. The pills are associated with an increased risk of blood clots. The Beyaz warning label in place at the time of Karen’s Beyaz prescription warned of a risk of VTEs and summarized studies.The Eleventh Circuit affirmed summary judgment in favor of Bayer. Georgia’s learned intermediary doctrine controls this diversity jurisdiction case. That doctrine imposes on prescription drug manufacturers a duty to adequately warn physicians, rather than patients, of the risks their products pose. A plaintiff claiming a manufacturer’s warning was inadequate bears the burden of establishing that an improved warning would have caused her doctor not to prescribe her the drug in question. The Hubbards have not met this burden. The prescribing physician testified unambiguously that even with the benefit of the most up-to-date risk information about Beyaz, he considers his decision to prescribe Beyaz to Karen to be sound and appropriate. View "Hubbard v. Bayer Healthcare Pharmaceuticals Inc." on Justia Law

This appeal stemmed from a group of fourteen diversity cases that were consolidated by the Judicial Panel on Multidistrict Litigation and transferred to the Northern District of Oklahoma. The plaintiffs in all fourteen cases were cancer treatment providers who purchased multi-dose vials of Herceptin, a breast cancer drug, from defendant Genentech, Inc. (Genentech). Plaintiffs alleged that Genentech violated state law by failing to ensure that each vial of Herceptin contained the labeled amount of the active ingredient, and by misstating the drug concentration and volume on the product labeling. After the cases were consolidated, Genentech moved for summary judgment, arguing that plaintiffs’ claims were pre-empted by federal law. The district court agreed with Genentech and granted its motion for summary judgment. Plaintiffs appealed. The Tenth Circuit disagreed with the district court's conclusion that plaintiffs' claims were preempted, and consequently, reversed summary judgment and remanded for further proceedings. View "In re: MDL 2700 Genentech" on Justia Law

Appellants Jonathan Saksek and Joshua Winter challenged a superior court decision to affirm summary judgment in favor of Appellees Janssen Pharmaceuticals, Inc., Johnson & Johnson Company, and Janssen Research and Development, LLC (collectively, “Janssen”). Saksek and Winter were two of a large number of men who filed suit against Janssen, alleging that they developed gynecomastia as a result of their ingestion of Risperdal, an antipsychotic drug manufactured by Janssen. In 2014, Janssen filed two motions for summary judgment, which were nominally directed at Saksek’s and Winter’s cases, but had language affecting all Risperdal plaintiffs: the companies sought a global ruling that all claims accrued for statute of limitations purposes no later than October 31, 2006, when Janssen changed the Risperdal label to reflect a greater association between gynecomastia and Risperdal. The trial court ruled that all Risperdal-gynecomastia claims accrued no later June 31, 2009. The superior court disagreed, ruling that all such claims accrued no later than Janssen’s preferred date (October 31, 2006). Concluding that the superior court erred in granting summary judgment at all in Saksek’s and Winter’s cases, the Pennsylvania Supreme Court vacated its decision and remanded to the trial court for further proceedings. View "In Re: Risperdal Litig." on Justia Law

Forest Laboratories, LLC ("Forest"), filed a permissive appeal pursuant to Rule 5, Ala. R. App. P., of an Alabama circuit court's order denying it summary judgment. Forest manufactured and marketed Lexapro, a drug prescribed for depression, and Forest Pharmaceuticals, Inc. ("FPI") sold and distributed Lexapro. In 2015, Elias Joubran's physician prescribed Lexapro for Elias's depression. Elias's prescription was filled with generic escitalopram that was manufactured and sold by a company other than Forest. On December 30, 2015, Elias entered the house belonging to him and his wife, Sheila Joubran; he shot and killed Sheila, then shot and killed himself. Kevin Feheley, Sr., serving as personal representative of Shiela's estate, sued Mary Jourbran in her capacity as the personal representative of Elias's estate. Forest, FPI and several fictitiously named defendants were included in the suit. The complaint alleged that, at the time of the murder/suicide, Elias was under prescription for pharmaceuticals manufactured by defendants, including Forest and FPI, and that "Forest's Lexapro[] enhanced, enabled and aggravated [Elias's] depression and violent behaviors." The Alabama Legislature enacted section 6-5-530, Ala. Code 1975, "on the heels" of the Alabama Supreme Court's decision in Wyeth, Inc. v. Weeks, 159 So. 3d 649 (2014). In addressing the Weeks decision, section 6-5-530 specifically provided that a plaintiff who is suing based on personal injury, death, or property damage caused by a product "must prove ... that the defendant designed, manufactured, sold, or leased the particular product the use of which is alleged to have caused the injury on which the claim is based" regardless of the type of claims or theory of liability the plaintiff asserts. Because this case was a permissive appeal, the questions before the Supreme Court were limited to whether 6-5-530 effectively overruled Weeks, and whether a manufacturer could be held liable for an injury caused by a product it did not manufacture. The Court determined Section 6-5-530 abrogated Weeks: a pharmaceutical manufacturer cannot be held liable for injury caused by a product it did not manufacture. Based on the Court's answer to the trial court's certified question in the permissive appeal, it reversed the trial court's order denying Forest's motion for a summary judgment and remanded this case for further proceedings. View "Forest Laboratories, LLC v. Feheley, Sr." on Justia Law

The State of California prevailed in a representative public nuisance action against ConAgra, NL, and Sherwin-Williams. The trial court ordered the defendants to pay $1.15 billion into a fund to be used to abate the public nuisance created by interior residential lead paint in the ten counties represented by the state. The court of appeal affirmed in part, noting that the absence of a regulation or statute declaring interior residential lead paint to be unlawful does not bar a court from declaring it to be a public nuisance. The court reversed in part, holding that substantial evidence did not support causation as to residences built after 1950, and remanded to the trial court with directions to recalculate the amount of the abatement fund to limit it to the amount necessary to cover the cost of remediating pre-1951 homes, and hold an evidentiary hearing regarding the appointment of a suitable receiver. View "People v. ConAgra Grocery Products Co." on Justia Law

To seek redress for an opioid epidemic, characterized by the Court of Appeal as having placed a financial strain on state and local governments dealing with the epidemic’s health and safety consequences, two California counties sued (the California Action) various pharmaceutical manufacturers and distributors, including the appellants in this matter, Actavis, Inc., Actavis LLC, Actavis Pharma, Inc., Watson Pharmaceuticals, Inc., Watson Laboratories, Inc., and Watson Pharma, Inc. (collectively, “Watson”). The California Action alleged Watson engaged in a “common, sophisticated, and highly deceptive marketing campaign” designed to expand the market and increase sales of opioid products by promoting them for treating long-term chronic, nonacute, and noncancer pain - a purpose for which Watson allegedly knew its opioid products were not suited. The City of Chicago brought a lawsuit in Illinois (the Chicago Action) making essentially the same allegations. The issue presented by this appeal was whether there was insurance coverage for Watson based on the allegations made in the California Action and the Chicago Action. Specifically, the issue was whether the Travelers Property Casualty Company of America (Travelers Insurance) and St. Paul Fire and Marine Insurance Company (St. Paul) owe Watson a duty to defend those lawsuits pursuant to commercial general liability (CGL) insurance policies issued to Watson. Travelers denied Watson’s demand for a defense and brought this lawsuit to obtain a declaration that Travelers had no duty to defend or indemnify. The trial court, following a bench trial based on stipulated facts, found that Travelers had no duty to defend because the injuries alleged were not the result of an accident within the meaning of the insurance policies and the claims alleged fell within a policy exclusion for the insured’s products and for warranties and representations made about those products. The California Court of Appeal concluded Travelers had no duty to defend Watson under the policies and affirmed. View "The Traveler's Property Casualty Company of America v. Actavis, Inc." on Justia Law