Justia Products Liability Opinion SummariesArticles Posted in US Court of Appeals for the Ninth Circuit
Painters and Allied Trades District Council 82 Health Care Fund v. Takeda Pharmaceuticals Co.
The Ninth Circuit reversed the district court's dismissal of civil Racketeer Influenced and Corrupt Organizations Act (RICO) claims based on lack of RICO standing in a putative class action brought against pharmaceutical companies. Plaintiffs filed suit alleging that the companies refused to change the warning label of their drug Actos or otherwise inform the public after they learned that the drug increased a patient’s risk of developing bladder cancer. The panel held that patients and health insurance companies who reimbursed patients adequately alleged the required element of proximate cause where they alleged that, but for defendant's omitted mention of a drug's known safety risk, they would not have paid for the drug. The panel agreed with the First and Third Circuits that plaintiffs' damages were not too far removed from defendants' alleged omissions and misrepresentations to satisfy RICO's proximate cause requirement. In this case, plaintiffs sufficiently alleged a direct relationship, and the Holmes factors weighed in favor of permitting their RICO claims to proceed. The panel explained that, although prescribing physicians served as intermediaries between defendants' fraudulent omission of Actos's risk of causing bladder cancer and plaintiffs' payments for the drug, prescribing physicians did not constitute an intervening cause to cut off the chain of proximate causation. The panel also held that plaintiffs have adequately alleged the reliance necessary to satisfy RICO's proximate cause requirement. View "Painters and Allied Trades District Council 82 Health Care Fund v. Takeda Pharmaceuticals Co." on Justia Law
Weber v. Allergan, Inc.
The Ninth Circuit affirmed the district court's grant of summary judgment to Allergan in an action under state law alleging that plaintiff suffered injuries when her breast implants bled silicone into her body. Through the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetic Act (FDCA), Congress permitted FDA oversight of medical devices; the MDA expressly preempts state law regulation of medical devices; and for a state law claim regarding a Class III medical device to survive express preemption by the MDA, a plaintiff must establish that the defendant violated an FDA requirement. In this case, the panel held that plaintiff failed to show that Allergan violated a federal requirement for its Style 20 breast implant. The panel held that plaintiff failed to raise a genuine dispute of material fact that Allergan violated the FDA's pre-market approval and Current Good Manufacturing Practices. Therefore, plaintiff has now shown a violation of an FDA requirement, which she must for her state law claims to fit through the narrow exception to MDA preemption. View "Weber v. Allergan, Inc." on Justia Law
Hawkins v. The Kroger Co.
FDA trans fat regulations governing the contents of the Nutrition Facts Panel did not preempt California's unfair competition laws proscribing false or misleading advertising elsewhere on a food product's label. The Ninth Circuit reversed the district court's dismissal of a putative consumer class action alleging that The Kroger Company sold Kroger Bread Crumbs that included misleading labels in violation of California law. The panel held that plaintiff had standing to challenge the legitimacy of defendant's product advertising on the face of the label that it contained "0g Trans Fat per serving." The panel took the occasion to reinforce and apply it's holding in Reid v. Johnson & Johnson,780 F.3d 952, 960 (9th Cir. 2015), that a requirement to state certain facts in the nutrition label was not a license to make that statement elsewhere on the product. The panel also held that plaintiff's labeling claims were not preempted because the FDA regulations did not authorize the contested statements. View "Hawkins v. The Kroger Co." on Justia Law
Shaibi v. Berryhill
The Ninth Circuit amended the opinion filed on August 22, 2017, and affirmed the denial of an application for disability insurance benefits. The panel held that the ALJ's residual functional capacity determination was supported by substantial evidence. The panel held that a Social Security claimant who wishes to challenge the factual basis of a vocational expert's estimate of the number of available jobs in the regional and national economies must raise this challenge before administrative proceedings have concluded in order to preserve the challenge on appeal in federal district court. In this case, claimant forfeited his challenge to the vocational expert's job numbers. View "Shaibi v. Berryhill" on Justia Law