Justia Government & Administrative Law Opinion Summaries

Articles Posted in Products Liability
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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

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Olson and Zdroik sustained injuries while volunteering at municipal fireworks displays in 2018. Fireworks distributed by Spielbauer Fireworks exploded prematurely at both events, severely burning the two. Both towns used teams of volunteers to operate their Fourth of July displays. Olson opened and closed a bin from which other volunteers retrieved fireworks during the Rib Lake show. Zdroik worked at the Land O’Lakes event as a “shooter,” manually lighting the fuses on mortar shells.Spielbauer’s insurer, T.H.E. Insurance, contested coverage under Spielbauer’s general and excess liability policies, which stated: This policy shall NOT provide coverage of any kind ... for any claims arising out of injuries or death to shooters or their assistants hired to perform fireworks displays or any other persons assisting or aiding in the display of fireworks whether or not any of the foregoing are employed by the Named Insured, any shooter or any assistant. The issue was whether the exclusion extends to all volunteers or only to those assisting hired shooters or hired assistants.The Seventh Circuit affirmed, in favor of T.H.E. Insurance. The Shooters Endorsement plainly and unambiguously excludes from coverage hired shooters and their hired assistants and “any other persons” who assist the fireworks display, regardless of whether they assist hired persons. View "T.H.E. Insurance Co. v. Olson" on Justia Law

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The United States sued Honeywell International Inc. for providing the material in allegedly defective bulletproof vests sold to or paid for by the government. Among other relief, the government sought treble damages for the cost of the vests. It has already settled with the other companies involved, and Honeywell seeks a pro tanto, dollar for dollar, credit against its common damages liability equal to those settlements. For its part, the government argues Honeywell should still have to pay its proportionate share of damages regardless of the amount of the settlements with other companies. The district court adopted the proportionate share rule but certified the question for interlocutory review under 28 U.S.C. Section 1292(b).   The DC Circuit reversed the district court’s ruling and held the pro tanto rule is the appropriate approach to calculating settlement credits under the False Claims Act. The court explained that in the False Claims Act, Congress created a vital mechanism for the federal government to protect itself against fraudulent claims. The FCA, however, provides no rule for allocating settlement credits among joint fraudsters. Because the FCA guards the federal government’s vital pecuniary interests, and because state courts widely diverge over the correct rule for settlement offsets, the court found it appropriate to establish a federal common law rule. The pro tanto rule best fits with the FCA and the joint and several liability applied to FCA claims. Thus, Honeywell is entitled to offset its common damages in the amount of the government’s settlements from the other parties. View "USA v. Honeywell International, Inc." on Justia Law

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Zen Magnets, LLC's small rare-earth magnets were shiny and smooth, resembling candies that commonly garnish cookies and desserts. The appearance sometimes leads young children to put the magnets in their mouths. Older children also sometimes put the magnets in their mouths to magnetize braces or mimic facial piercings. When put in children’s mouths, the magnets were sometimes swallowed, lodging in the digestive system and causing serious injury or death. The Consumer Product Safety Commission tried to address this danger through both rulemaking and adjudication. The Commission conducted two proceedings involving the making of small rare-earth magnets: (1) a rulemaking affecting all manufacturers of these magnets; and (2) an adjudication affecting only one manufacturer: Zen Magnets, LLC. For the adjudication, the Commission needed to provide Zen with a fair proceeding under the Fifth Amendment’s Due Process Clause. Zen contended the adjudication was unfair for two reasons: (1) the Commissioners conducted the adjudication after engaging in a rulemaking on closely related issues; and (2) three Commissioners participated in the adjudication after making public statements showing bias. The district court found: (1) the Commission had not denied due process by simultaneously conducting the adjudication after the related rulemaking; (2) two of the Commissioners had not shown bias through their public statements; but (3) one Commissioner did show bias through a public statement specifically about Zen. Both parties appealed: the Commission appealed the district court's decision as to the third Commissioner's statements; Zen cross-appealed, arguing a due process violation, and that the district court issued an advisory opinion on the merits. After its review, the Tenth Circuit concluded the Commissioners’ participation in the rulemaking and their statements did not result in a denial of due process, so the district court's judgment as to Commissioners Robinson and Kaye were affirmed. The Court reversed, however, as to Commissioner Adler. The Court concluded it lacked jurisdiction to decide whether the district court rendered an advisory opinion. View "Zen Magnets v. Consumer Product Safety" on Justia Law

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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

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The Cervenys sued the manufacturer of Clomid (Aventis, Inc.), asserting various tort claims under Utah law: failure to warn under theories of strict liability and negligence, breach of implied warranty, negligent misrepresentation, and fraud. They presented two theories, pointing to two types of warning labels that Aventis had allegedly failed to provide: (1) a label that warned of risks to the fetus when a woman takes Clomid before becoming pregnant; and (2) a label that unmistakably warned about harm to the fetus when Clomid is taken during pregnancy. The district court rejected the Cervenys’ claims based on preemption. The Tenth Circuit held that the district court ruling was correct on the Cervenys’ first theory, because the undisputed evidence showed that the FDA would not have approved a warning about taking Clomid before pregnancy. But on the second theory, the Tenth Circuit found the district court did not explain why a state claim based on the FDA’s own proposed language would be preempted by federal law. The district court also erred in failing to distinguish the remaining claims (breach of implied warranty, negligent misrepresentation, and fraud) from the failure-to-warn claims. These claims are based at least partly on affirmative misrepresentations rather than on a failure to provide a warning. The district court failed to explain why claims involving affirmative misrepresentations would have been preempted. View "Cerveny v. Aventis, Inc." on Justia Law

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Defendant Carus Corp. (Carus) was an international company that developed and sold chemical products for municipal and industrial applications. Defendant's products included a chemical called Totalox, which essentially, was designed as a deodorizer for sewer systems. The Town of Lexington (Town) used Totalox in its sewer treatment plants. In 2010, Plaintiff John Machin, a Town employee, was exposed to Totalox when a storage container valve broke during the delivery of Totalox to one of the Town's wastewater stations. Plaintiff suffered reactive airways syndrome, which was also known as chemically induced asthma or obstructive lung disease. As a result of his injuries, Plaintiff filed a workers' compensation claim and was awarded workers' compensation benefits. The South Carolina Supreme Court accepted four certified questions from the United States District Court for the District of South Carolina: (1) Under South Carolina law, when a Plaintiff seeks recovery from a person, other than his employer, for an injury sustained on the job, may the jury hear an explanation of why the employer is not part of the instant action?; (2) when a Plaintiff seeks recovery from a person, other than his employer, for an injury sustained on the job, may a defendant argue the empty chair defense and suggest that Plaintiff's employer is the wrongdoer?; (3) In connection with Question 2, if a defendant retains the right to argue the empty chair defense against Plaintiff's employer, may a court instruct the jury that an employer's legal responsibility has been determined by another forum, specifically, the South Carolina Workers' Compensation Commission?; and (4) when a Plaintiff seeks recovery from a person, other than his employer, for an injury sustained on the job, may the Court allow the jury to apportion fault against the nonparty employer by placing the name of the employer on the verdict form? The South Carolina Supreme Court answered these questions in the abstract, without any suggestion as to the resolution of the post-trial motion before the federal court: Questions 1, 2, and 3 "yes," provided a defense seeks to assign fault to the plaintiff's employer. The Court answered Question 4, "no." View "Machin v. Carus Corporation" on Justia Law

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Petitioner Zen Magnets, LLC (“Zen”) challenged a regulation promulgated by Respondent Consumer Product Safety Commission (“the Commission”) restricting the size and strength of the rare earth magnets that Zen sold. The sets consisted of small, high-powered magnets that users could arrange and rearrange in various geometric designs. The component magnets are unusually small (their diameters are approximately five millimeters) and unusually powerful. Magnets of this type have been marketed and sold to consumers (by Zen and other distributors) as desktop trinkets, stress-relief puzzles, and toys, and apparently also for educational and scientific purposes. Although the strength of these magnets was part of their appeal, it could also pose a grave danger when the magnets are misused, particularly if two or more magnets were ingested. During 2011, in response to reports of injured children, Commission staff began evaluating whether the magnet sets currently on the market complied with ASTM F963 (“the toy standard”). In May 2012, the Commission required the thirteen leading magnet set distributors to report any information of which they were aware reasonably supporting the conclusion that their magnets did not comply with an applicable safety standard, contained a defect, or created an unreasonable risk of serious injury. Four months after eliminating ten of the leading magnet set distributors, the Commission proposed a new safety standard aimed at regulating the size and strength of all magnet sets. Unlike the toy standard, the final rule was not limited to magnets designed or marketed as toys for children under fourteen years of age, but rather applied to all magnet sets. Zen was the only remaining importer and distributor of the magnet sets targeted by the final rule. Over the years, Zen made efforts to comply with the toy standard by implementing age restrictions and placing warnings on its website and packaging, as well as by imposing sales restrictions on its retail distributors. Its magnet sets, however, did not comply with the strength and size restrictions of the final rule. Zen sought judicial review of that safety standard. The Tenth Circuit Court of Appeals concluded that the Commission’s prerequisite factual findings, which were compulsory under the Consumer Product Safety Act, were incomplete and inadequately explained. Accordingly, the Court vacated and remanded this case back to the Commission for further proceedings. View "Zen Magnets v. Consumer Product Safety Comm'n" on Justia Law

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The Textron Lycoming engine, manufactured in 1969, was installed on a Cessna aircraft in 1998. It was overhauled in 2004, with a carburetor in accordance with Lycoming’s type-certificated design. Sikkelee was piloting the aircraft when it crashed shortly after taking off. Sikkelee died. His estate sued, claiming that the aircraft lost power as a result of a malfunction or defect in the carburetor. The court held that Sikkelee’s claims, which were premised on state law standards of care, fell within the preempted “field of air safety.” An amended complaint incorporated federal standards of care by alleging violations of FAA regulations. Before trial, the court concluded that the federal standard of care was established in the type certificate. Reasoning that the FAA issues a type certificate based on its determination of compliance with pertinent regulations, it held that the FAA’s issuance of a type certificate for the engine meant that the federal standard of care had been satisfied as a matter of law. The court granted Lycoming partial summary judgment and certified an immediate appeal. The Third Circuit reversed, concluding that federal statutes and FAA regulations reflect that Congress did not intend to categorically preempt aircraft products liability claims. Subject to traditional principles of conflict preemption, including concerning specifications included in a type certificate, aircraft products liability cases may proceed using a state standard of care. View "Sikkelee v. Precision Airmotive Corp" on Justia Law

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Medtronic, Inc. produced "Infuse," a device that stimulates bone growth to repair damaged or diseased vertebrae. When it approved the device for sale, the FDA required the company to include a warning label instructing that Infuse should "be implanted via an anterior" surgical approach. Patricia Caplinger brought a state law tort suit against Medtronic, alleging that Medtronic promoted Infuse for use in a posterior surgical approach, which was considered an off-label" use. Caplinger alleged that Medtronic’s conduct exposed the company to liability under a variety of state tort theories. But the district court held all of these state law claims either insufficiently pleaded or preempted. Agreeing with the district court's conclusion that Caplinger's state law claims were insufficiently pleaded or preempted, the Tenth Circuit affirmed. View "Caplinger v. Medtronic" on Justia Law