Articles Posted in Products Liability

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The widows of deceased husbands who served in the U.S. Navy alleged that their husbands contracted cancer caused by exposure to asbestos-containing insulation and components that were added onto ship’s engines, pumps, boilers, blowers, generators, switchboards, steam traps, and other devices. The manufacturer-defendants each made their products “bare metal.” If they manufactured an engine, they shipped it without any asbestos-containing insulation materials that would later be added. Following a remand, the district court applied the bright-line rule version of the bare-metal defense and clarified that summary judgment had been entered in favor of the manufacturers on both the strict liability and negligence claims. The court reasoned that the rule approach was best because maritime law favors uniformity. The Third Circuit vacated, stating that it surveyed “bedrock principles of maritime law” and concluded that they permit a manufacturer of even a bare-metal product to be held liable for asbestos-related injuries when circumstances indicate the injury was a reasonably foreseeable result of the manufacturer’s actions, at least in the context of a negligence claim. The court affirmed summary judgment on the product liability claims. View "In re: Asbestos Products Liability Litigation" on Justia Law

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In multi-district litigation involving 315 product liability claims, plaintiffs alleged that Pfizer’s drug, Zoloft, a selective serotonin reuptake inhibitor (SSRI), caused cardiac birth defects. The Plaintiffs’ Steering Committee introduced several experts to establish causation. The testimony of each of these experts was excluded in whole or in part. In particular, Nicholas Jewell, Ph.D., a statistician, used the “Bradford Hill” criteria to analyze existing literature on the causal connection between Zoloft and birth defects. The district court conducted a Daubert hearing, excluded Jewell's testimony, and granted summary judgment to defendants, stating that Jewell: “failed to consistently apply the scientific methods he articulates, has deviated from or downplayed certain well-established principles of his field, and has inconsistently applied methods and standards to the data so as to support his a priori opinion.” The Third Circuit affirmed, holding that the district court did not require replication of significant results to establish reliability, but merely made a factual finding that teratologists generally require replication of significant results, and this factual finding did not prevent it from considering other evidence of reliability. View "In Re: Zoloft t (Sertraline Hydrochloride) Products Liability Litigation" on Justia Law

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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

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A.S., who suffers from a congenital birth defect, and his mother, Miller, who ingested Paxil while pregnant, sued GSK in the Philadelphia County Court, alleging that all parties were citizens of Pennsylvania. GSK removed the case based upon diversity. On plaintiffs’ motion, the case was consolidated with other Paxil cases before a district court judge who had previously held that GSK was a citizen of Pennsylvania and who remanded A.S.’s case and the other consolidated cases to state court. The case returned to state court on January 4, 2012. On June 7, 2013, the Third Circuit issued its opinion in Johnson, which held that GSK was a citizen of Delaware. Less than 30 days after the Johnson decision, GSK filed a second notice of removal in A.S.’s case and in eight other cases with the same procedural posture. The district court denied the motion and certified its order for interlocutory review. The Third Circuit directed remand to state court, holding that the second removal request was untimely under 28 U.S.C. 1446(b) because there had been a final order. View "A.S. v. SmithKline Beecham Corp" on Justia Law

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In 1995 the FDA approved Fosamax® to treat or prevent osteoporosis and Paget’s Disease. Teva developed alendronate sodium, a generic form of the branded drug, and obtained FDA approval on its abbreviated new drug application in 2008. Other generic manufacturers subsequently obtained approval for formulations. The drugs act by inhibiting bone resorption or absorption and suppressing bone turnover; they also inhibit primary mineralization, which is involved in the formation of new bone. Meanwhile, secondary mineralization of existing bone continues, which increases the bone’s mineral content and results in higher bone mineral density. According to the plaintiffs, higher bone mineral density does not necessarily correspond with reduction of fracture risk but can make bone highly mineralized, homogenous, brittle, and more susceptible to fracture. According to some studies, the effects of alendronate sodium linger, with one study reporting that bone turnover may be inhibited by 50% five years after discontinuing treatment. The district court granted judgment on the pleadings in favor of the generic manufacturer defendants finding that state-law strict liability claims were pre-empted by federal law. The Seventh Circuit affirmed. Manufacturers have no control over the design or labeling of generic drugs; the plaintiffs failed to identify anything the generic defendants could do to reconcile their conflicting duties under state and federal law.View "In re: Fosmax (Alendronate Sodium)" on Justia Law

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In the late 1990s, people who had taken the prescription diet-drug combination Fen-Phen began suing Wyeth, claiming that the drugs caused valvular heart disease. A 2000 settlement included creation of the Fen-Phen Settlement Trust to compensate class members who had sustained heart damage. Claims required medical evidence. Attorneys who represented certain claimants retained Tai, a board-certified Level 2-qualified cardiologist, to read tests and prepare reports. Tai read 12,000 tests and asserted that he was owed $2 million dollars for his services. Tai later acknowledged that in about 10% of the cases, he dictated reports consistent with the technicians’ reports despite knowing that the measurements were wrong, and that he had his technician and office manager review about 1,000 of the tests because he did not have enough time to do the work. A review of the forms Tai submitted found that, in a substantial number of cases, the measurements were clearly incorrect and were actually inconsistent with a human adult heart. Tai was convicted of mail and wire fraud, 18 U.S.C. 1341 and 1343, was sentenced to 72 months’ imprisonment, and was ordered to pay restitution of $4,579,663 and a fine of $15,000. The Third Circuit rejected arguments that the court erred by implicitly shifting the burden of proof in its “willful blindness” jury instruction and applying upward adjustments under the advisory Sentencing Guidelines for abuse of a position of trust and use of a special skill, but remanded for factual findings concerning whether Tai supervised a criminally culpable subordinate, as required for an aggravated role enhancement. View "United States v. Tai" on Justia Law