Articles Posted in U.S. Court of Appeals for the Third Circuit

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Hundreds of plaintiffs sued the drug manufacturer Merck, alleging that the osteoporosis drug Fosamax caused them to suffer serious thigh bone fractures. Each brought a state-law tort claim alleging that Merck failed to add an adequate warning of the risk to Fosamax’s FDA-approved drug label. Many also brought claims including defective design, negligence, and breach of warranty. Plaintiffs’ suits were consolidated in multi-district litigation in the District of New Jersey. Following discovery and a bellwether trial, the court granted Merck summary judgment, based on the Supreme Court’s holding in Wyeth v. Levine, that state-law failure-to-warn claims are preempted when there is “clear evidence” that the FDA would not have approved the warning that plaintiffs claim was necessary. The Third Circuit vacated. Preemption is an affirmative defense; Merck did not carry its burden to prove that it is entitled to that defense. The Wyeth “clear evidence” standard is demanding and fact-sensitive. It requires a court sitting in summary judgment to anticipate the range of conclusions that a reasonable juror might reach and the certainty with which the juror would reach them. Here, plaintiffs produced sufficient evidence for a reasonable jury to conclude that the FDA would have approved a properly-worded warning about the risk of thigh fractures—or to conclude that the odds of FDA rejection were less than highly probable. View "In Re: Fosamax Products Liability Litigation" on Justia Law

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Papp alleged that his late wife suffered secondary “take home” asbestos exposure while washing the work clothes of her first husband, Keck. Keck had several jobs that exposed him to asbestos. Papp sued multiple companies in New Jersey. In a deposition, he indicated that the landing gear Keck sandblasted was for a C-47 military cargo plane, built by Boeing’s predecessor. Boeing removed the case, citing the federal officer removal statute, 28 U.S.C. 1442(a)(1). Boeing asserted that it was entitled to government contractor immunity because the C-47 was produced for, and under the specific supervision of, the U.S. military and that the supervision extended to labels and warnings for all parts of the aircraft, including those parts laden with the asbestos to which Keck would later be exposed. The district court remanded, reasoning that Boeing, as a contractor and not a federal officer, had a “special burden” to demonstrate “that a federal officer or agency directly prohibited Boeing from issuing, or otherwise providing, warnings as to the risks associated with exposure to asbestos contained in products on which third-parties … worked or otherwise provided services.” The Third Circuit reversed, holding that the statute extends to contractors who possess a colorable federal defense and that Boeing made a sufficient showing of such a defense. View "Papp v. Fore-Kast Sales Co Inc" on Justia Law

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Between 1945 and the mid-1970s, Hassell was employed as an electrician by the Railroad, responsible for the maintenance and repair of passenger railcars designed and manufactured by defendants' predecessors. Steam pipes running underneath those railcars were insulated with material containing asbestos. As a consequence of his exposure to asbestos, Hassell contracted asbestosis and mesothelioma. He died in 2009, during the pendency of his lawsuit. Defendants argued that state law claims were preempted by the Locomotive Boiler Inspection Act (LIA), 49 U.S.C. 20701, the Safety Appliance Act, 49 U.S.C. 20301, and the Federal Railroad Safety Act (FRSA), 49 U.S.C. 20101. The district court held that Hassell’s claims were preempted by the LIA. The Third Circuit vacated, noting the lack of evidence supporting defendants’ assertion that the railcar pipes at issued formed an “interconnected system” with the locomotive. Even assuming that evidence for the “interconnected system” could have been gleaned from the record, Hassell produced evidence from a former Railroad supervisor showing that, instead of being connected to locomotives, the pipes were connected to “power cars” that separately supplied steam heat to the passenger coaches. There was a genuine dispute material fact precluding summary judgment. View "In Re: Asbestos Prods. Liability Litig." 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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Whether a third-party payer (TPP) will cover the cost of a member’s prescription depends on whether that drug is listed in the TPP’s formulary. Pharmacy Benefit Managers prepare TPPs’ formularies of drugs approved for use by TPP members by analyzing research regarding a drug’s cost effectiveness, safety and efficacy. In 1999, the FDA approved Avandia as a prescription for type II diabetes. TPPs included Avandia in their formularies and covered Avandia prescriptions at a favorable rate. GSK downplayed concerns about Avandia’s heart-related side effects. In 2010, the FDA restricted access to Avandia in response to increasing evidence of its cardiovascular risks. TPPs (union health and welfare funds) sued GSK on behalf of themselves and similarly situated TPPs. asserting that GSK’s failure to disclose Avandia’s significant heart-related risks violated the Racketeer Influenced and Corrupt Organizations Act based on predicate acts of mail fraud, wire fraud, tampering with witnesses, and use of interstate facilities to conduct unlawful activity. They also claimed unjust enrichment and violations of the Pennsylvania Unfair Trade Practices and Consumer Protection Law and other states’ consumer protection laws. The Third Circuit affirmed the district court’s finding that the TPPs adequately alleged the elements of standing. View "In Re: Avandia Mktg.,Sales Practices & Prod. Liab." on Justia Law