Justia U.S. 6th Circuit Court of Appeals Opinion Summaries

Genentech manufactured and sold the psoriasis medication Raptiva, approved by the FDA in 2003. Raptiva works by suppressing T-cells ; because T-cells help fight infections, suppression has the potential to cause potentially life-threatening side effects. Following reports of adverse health effects, including a rare brain infection, Genentech voluntarily removed Raptiva from the market in 2009. Marsh began using Raptiva in 2004 and subsequently suffered viral meningitis and a collapsed lung. She sued in 2011, alleging strict products liability under design-defect and failure-to-warn theories, negligence, breach of warranty, and fraud. She claimed that, before and after FDA approval, Genentech knew of dangerous side effects that it concealed and did not include in the drug’s label. The district court dismissed, holding that Genentech was immune from suit because neither statutory exception to immunity for drug manufacturers applied. Marsh argued that immunity does not apply because failure to submit updated information rendered Raptiva noncompliant with FDA approval when it left Genentech’s control and that her claim was not preempted because it was premised on non-compliance rather than fraud or bribery. The Sixth Circuit affirmed. Allegations underlying Marsh’s argument that immunity does not apply are essentially the type of claim that is preempted.View "Marsh v. Genetech Inc." on Justia Law

The named plaintiffs are Ohio residents who purchased front-loading washing machines manufactured by defendant. Within months after their purchases, the plaintiffs noticed the smell of mold or mildew emanating from the machines and from laundry washed in the machines. One plaintiff found mold growing on the sides of the detergent dispenser, another saw mold growing on the rubber door seal, despite allowing the machine doors to stand open. They filed suit, alleging tortious breach of warranty, negligent design, and negligent failure to warn. The district court certified a class comprised of Ohio residents who purchased one of the specified machines in Ohio primarily for personal, family, or household purposes and not for resale (Federal Rule of Civil Procedure 23(a) and (b)(3)). The Sixth Circuit affirmed class certification, with proof of damages reserved for individual determination. Plaintiffs’ proof established numerosity, commonality, typicality, and adequate representation. Common questions predominate over individual ones and class action is a superior method to adjudicate the claims.

While working for plaintiff, Hashman was standing in the open compartment, driving a forklift manufactured by Raymond when she either fell or stepped from the open side of the compartment. Her foot was trapped. She suffered severe injuries resulting in partial amputation. After settling Hashman's workers' compensation claim, plaintiff sought subrogation from Raymond, claiming that a design defect, failure to include a rear guard door on the forklift, caused the injuries. The district court granted summary judgment for Raymond, finding that plaintiff could not sustain a design defect claim without expert testimony and that the methods of its proposed expert were not sufficiently reliable to support the proffered opinions. The Sixth Circuit affirmed. There were at least four problems with the expert's methodology: anecdotal evidence, improper extrapolation, failure to consider other possible causes, and lack of testing. Although plaintiff could argue a "consumer expectations" theory without expert testimony, there was insufficient evidence to support the claim.

Plaintiff, a pipefitter, worked with asbestos-containing gaskets made by defendant from 1962 until 1970. From 1962 until 1975, he also sustained significant exposure to asbestos insulation. He died in 2008, of mesothelioma, a cancer of the lining of the lung. Before his death, plaintiff sued under theories including strict liability and negligence. Defendant does not dispute that asbestos-containing products likely caused the mesothelioma, but argues that the mesothelioma was caused by exposure to asbestos insulation, and that its own gaskets were not a substantial factor. A jury awarded plaintiff $516,094. The Sixth Circuit reversed. Given that plaintiff failed to quantify the exposure to asbestos from defendant's gaskets and concedes that plaintiff sustained massive exposure to asbestos from non-defendant sources, there was insufficient evidence to infer that defendant's gaskets probably, as opposed to possibly, were a substantial cause of plaintiff's mesothelioma.

Plaintiffs developed tardive dyskinesia as a result of use of generic metoclopramide, a drug prescribed for treatment of gastroesophageal reflux disease. They filed individual suits against manufacturers, alleging failure include adequate information on product labels concerning the risks of taking the drug long-term. They also named as parties manufacturers of the name-brand form of metoclopramide, alleging fraud and tortious misrepresentation. The district court dismissed plaintiffs' tort claims against the generic defendants on preemption grounds, finding conflict with federal regulation of generic drugs. The court also dismissed claims against name-brand defendants for failure to allege that they had ingested Reglan, a threshold requirement for a products-liability action under Kentucky law. The Sixth Circuit affirmed, stating that name-brand manufacturers have no duty to individuals who have never taken the drug they manufacture.