Justia Drugs & Biotech Opinion SummariesArticles Posted in Personal Injury
Perham v. GlaxoSmithKline, LLC
In this appeal arising out of a multidistrict litigation concerning the pharmaceutical drug ondansetron hydrochloride, better known as Zofran, the First Circuit affirmed the order of the district court granting summary judgment in favor of GlaxoSmithKline (GSK), holding that there was no error or abuse of discretion.Various plaintiffs filed separate lawsuits alleging that the use of Zofran during pregnancy caused birth defects and that GSK engaged in an intentionally misleading plan to market Zofran for pregnancy in violation of state law. The district court granted summary judgment in favor of GSK, holding that federal law preempted Plaintiffs' state law claims. The First Circuit affirmed, holding that federal law preempted Plaintiffs' state law claims that GSK should have warned both prescribing doctors and pregnant people that "animal studies showed harm to the fetus when Zofran was ingested during pregnancy." View "Perham v. GlaxoSmithKline, LLC" 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
Blackburn v. Shire U.S., Inc., et al.
The United States Court of Appeals for the Eleventh Circuit certified a question of law to the Alabama Supreme Court. Dr. Dino Ferrante, a gastroenterologist, prescribed LIALDA, which is manufactured by Shire U.S., Inc., and Shire, LLC (referred to collectively as "Shire"), to help patient Mark Blackburn with his Crohn's disease. "LIALDA is the brand name for Shire's mesalamine drug, which is an anti-inflammatory drug specifically aimed at the gut. LIALDA is not approved by the FDA to treat Crohn's, but it is approved to treat ulcerative colitis, Crohn's 'sister' disease." After taking LIALDA for between 12 to 16 months, Blackburn discovered that he had developed kidney disease, specifically advanced chronic interstitial nephritis, which had resulted in irreversible scarring and had diminished his kidney function to 20% of normal capacity. As a result, Blackburn is awaiting a kidney transplant. The federal appellate court asked: (1) consistent with the learned intermediary doctrine, may a pharmaceutical company's duty to warn include a duty to provide instructions about how to mitigate warned-of risks?; and (2) might a plaintiff establish that a failure to warn caused his injuries by showing that his doctor would have adopted a different course of testing or mitigation, even though he would have prescribed the same drug? The Supreme Court answered both questions in the affirmative. View "Blackburn v. Shire U.S., Inc., et al." on Justia Law
Thacker v. Ethicon, Inc.
Ethicon manufactures a mesh sling, used to treat stress urinary incontinence, and a posterior mesh “Prolift, “designed to treat pelvic organ prolapse. In 2009, Dr. Guiler surgically implanted both devices to treat Thacker. Before the surgery, Thacker reviewed and signed an informed consent form that listed several risks, including: “infections and/or erosions of the mesh” which could require additional follow-up surgeries, urinary retention, “[p]ainful intercourse and vaginal shortening,” and treatment failure. After the surgery, Thacker’s incontinence worsened, and she suffered from shooting pain in her groin area and severe abdominal swelling and bloating. In 2010, Thacker started experiencing severe and unbearable pain during intercourse.Thacker ultimately sued Ethicon, alleging strict liability and negligence claims under the Kentucky Product Liability Act for design defect and failure to warn. The district court granted Ethicon summary judgment. The Sixth Circuit reversed. Dr. Guiler’s testimony suggested that he likely would have recommended a different course of treatment had Ethicon given adequate information. Thacker’s expert testified that no reasonable physician would have used the Pelvic Mesh Devices to treat Thacker had Ethicon given adequate information in 2009. A jury could accept that expert’s opinion that a feasible alternative design would have prevented Thacker’s injuries. View "Thacker v. Ethicon, Inc." on Justia Law
Terry Paulsen v. Abbott Laboratories
To treat her endometriosis, Paulsen received Lupron injections in 2004 from her physician in Georgia. Shortly afterward she began experiencing health problems, including severe bone and joint pain, memory loss, and fevers. In April 2010, Paulsen filed a personal injury suit. Paulsen voluntarily dismissed her claims in 2014. In 2015, Paulsen filed a second lawsuit asserting product liability, negligence, breach of warranty, and misrepresentation. After several amended complaints and the addition of a defendant, two claims remained: a strict liability failure-to-warn claim against AbbVie and Abbott; and a negligent misrepresentation claim against Abbott. Limited discovery was permitted.The district court subsequently applied Illinois procedural law and Georgia substantive law, reasoning that Paulsen’s injury occurred in Georgia, and Illinois lacked a stronger relationship to the action, then granted the defendants summary judgment. The court ruled that Paulsen’s strict liability failure-to-warn claim was time-barred by Georgia’s 10-year statute of repose. Georgia does not recognize a stand-alone misrepresentation claim in product liability cases. Even if this cause of action did exist, the court reasoned, Paulsen’s misrepresentation claim would fail because “the undisputed evidence show[ed] that Abbott did not make any representations regarding Lupron.” The Seventh Circuit affirmed. The court noted extensive evidence that Paulsen’s claims accrued before April 2008 and are barred by the Illinois two-year statute of limitations for personal injuries. View "Terry Paulsen v. Abbott Laboratories" on Justia Law
Donaldson v. Johnson & Johnson
Donaldson sought treatment for stress urinary incontinence and anterior pelvic organ prolapse. In 2010, to remedy these conditions, Dr. Schultheis surgically implanted in Donaldson two transvaginal polypropylene mesh medical devices. Both were manufactured by a subsidiary of Johnson & Johnson. In 2014, Donaldson sought treatment for injuries resulting from erosion of the mesh into her bladder, vagina, and adjacent tissues, causing scarring, bladder stones, and abdominal pain, among other problems. Information sheets packaged with the devices warned of the risks of erosion but Donaldson never saw the warnings and contends that Dr. Schultheis did not inform her of these risks. Dr. Schultheis testified that he was aware of the possible complications and that he believed that the benefits of the devices outweighed the risks. He also testified that, in implanting the devices, he followed all of the manufacturer’s instructions.The Seventh Circuit affirmed summary judgment in favor of the manufacturers. Although there is no doubt that Donaldson suffered severe and painful complications after the devices were implanted, she failed to produce sufficient evidence to avoid summary judgment in her case for non-specific defects under Illinois product liability law. There was no evidence eliminating abnormal use or secondary causes, or that the device failed to perform as expected. View "Donaldson v. Johnson & Johnson" on Justia Law
ACE American Insurance Company v. Rite Aid Corporation
Appellees, Rite Aid Corporation, Rite Aid Hdqtrs. Corp., and Rite Aid of Maryland, Inc. (collectively, “Rite Aid”), held a general liability insurance policy underwritten by defendany Chubb, Limited ("Chubb"). Rite Aid and others were defendants in multi-district litigation before the United States District Court for the Northern District of Ohio (the “MDL Opioid Lawsuits”). Plaintiffs in that suit filed over a thousand suits in the MDL Opioid Lawsuits against companies in the pharmaceutical supply chain for their roles in the national opioid crisis. Certain suits were bellwether suits - including the complaints of Summit and Cuyahoga Counties in Ohio (“the Counties”) which were at issue here. The question this case presented for the Delaware Supreme Court was whether insurance policies covering lawsuits “for” or “because of” personal injury required insurers to defend their insureds when the plaintiffs in the underlying suits expressly disavowed claims for personal injury and sought only their own economic damages. The Superior Court decided that Rite Aid’s insurance carriers were required to defend it against lawsuits filed by two Ohio counties to recover opioid-epidemic-related economic damages. As the court held, the lawsuits sought damages “for” or “because of” personal injury because there was arguably a causal connection between the counties’ economic damages and the injuries to their citizens from the opioid epidemic. The Supreme Court reversed, finding the plaintiffs, governmental entities, sought to recover only their own economic damages, specifically disclaiming recovery for personal injury or any specific treatment damages. Thus, the carriers did not have a duty to defend Rite Aid under the governing insurance policy. View "ACE American Insurance Company v. Rite Aid Corporation" on Justia Law
Blackburn v. Shire US Inc.
Blackburn, who has Crohn’s disease, was prescribed LIALDA, an anti-inflammatory drug specifically aimed at the gut. LIALDA is not FDA-approved to treat Crohn’s, but it is approved to treat ulcerative colitis, Crohn’s “sister” disease. Blackburn was subsequently diagnosed with advanced-stage kidney disease. Blackburn does not claim that Shire, LIALDA’s manufacturer failed to warn of the risk of kidney disease; he and his doctor knew that the drug might impair his kidney function. Blackburn contends that Shire should have more explicitly warned his doctor about how regularly to monitor his kidney function after prescribing LIALDA. He contends that, if LIALDA’s warning label had been better, his physician would have discovered the effect on his kidneys sooner and prevented his injury.The Eleventh Circuit identified two unsettled, dispositive questions of Alabama law, which it certified to the state’s highest court. May a pharmaceutical company’s duty to warn include a duty to provide instructions about how to mitigate warned-of risks? May a plaintiff establish that an improper warning caused his injuries by showing that his doctor would have adopted a different course of testing or mitigation, even though he would have prescribed the same drug? View "Blackburn v. Shire US Inc." on Justia Law
Oklahoma ex rel. Attorney General of Oklahoma v. Johnson & Johnson
An opioid manufacturer appealed a $465 million verdict following a bench trial in a public nuisance lawsuit. The district court held the opioid manufacturer liable under Oklahoma's public nuisance statute for its prescription opioid marketing campaign. The State of Oklahoma counter-appealed. The Oklahoma Supreme Court retained the appeal and held that the opioid manufacturer's actions did not create a public nuisance. The district court erred in extending the public nuisance statute to the manufacturing, marketing, and selling of prescription opioids. View "Oklahoma ex rel. Attorney General of Oklahoma v. Johnson & Johnson" on Justia Law
Gall v. Smith & Nephew, Inc.
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