Justia U.S. 9th Circuit Court of Appeals Opinion Summaries

Plaintiffs filed failure-to-warn product liability claims against a medical device manufacturer based on the manufacturer’s failure to warn about certain risks of its electroconvulsive therapy (“ECT”) device. The district court granted summary judgment to the manufacturer, finding that Plaintiff’s evidence failed to show that stronger warnings from the manufacturer would have affected their physician’s decision to prescribe the product.Plaintiffs appealed, relying on testimony from their prescribing physicians that, had the manufacturer included stronger warnings, they would have communicated those warnings to Plaintiffs. Plaintiffs claimed that, in light of these warnings, they would not have given consent for the procedures.Finding that California law applies and that there is no binding precedent on the issue, the Ninth Circuit certified the following question to the California Supreme Court: Is a plaintiff required to show that a stronger risk warning would have altered the physician’s decision to prescribe the product? Or can a plaintiff establish causation by showing that the physician would have communicated the stronger risk warnings to the plaintiff and a prudent person in the patient’s position would have declined the treatment? View "MICHELLE HIMES V. SOMATICS, LLC" on Justia Law

The Ninth Circuit affirmed the district court's grant of summary judgment in favor of Intuitive Surgical, the designer and manufacturer of the da Vinci surgical robot, in a product liability action brought by plaintiff and her husband, holding that the action was time-barred under California's two-year statute of limitations under California Code of Civil Procedure 335.1.The panel concluded that the two-year California—not three-year Connecticut—statute of limitations applies to plaintiff's claim. The panel explained that, although the district court erred by failing to consider whether Connecticut had a legitimate interest in seeing its law applied, the district court correctly held that California's statute of limitations governs the claims. The panel also concluded that the Tolling Agreement does not render plaintiff's claims timely. In this case, because the Tolling Agreement expressly preserved Intuitive's statute-of-limitations defense for "the applicable" jurisdiction, Intuitive is entitled to employ its statute-of-limitations defense under California law. Finally, the panel concluded that equitable estoppel did not apply to plaintiff's claims where she failed to submit evidence identifying a misrepresentation, material omission, or false promise made on behalf of Intuitive. View "Rustico v. Intuitive Surgical, Inc." on Justia Law

The Ninth Circuit affirmed the district court's grant of summary judgment in favor of Lima Corporate in a diversity action brought by plaintiffs, alleging product liability and negligence claims relating to a hip implant. The panel held that in light of the statutory text, context, and stated purpose, Lima Corporate was a biomaterials supplier of its Hip Stem – a "component part" supplied "for use in the manufacture of an implant" pursuant to the Biomaterials Access Assurance Act (BAAA), 21 U.S.C. 1602(1)(A). In this case, Lima Corporate was immune from liability under the BAAA and, under the circumstances, could not be impleaded under section 1606. View "Connell v. Lima Corporate" on Justia Law

The Ninth Circuit affirmed the district court's denial of claimants' motions to enforce a settlement agreement that the district court approved between Volkswagen and owners and lessees of diesel cars that had defeat devices, which altered emissions profiles of the cars.The panel held that the district court had the authority to review claimants' motions to enforce the settlement agreement. Furthermore, the district court did not err in reaching the merits of claimants' motions without resolving their status as third-party beneficiaries. The panel also held that the district court had the authority to, and did, approve the amendment to the settlement agreement. The panel stated that the Framework is now an enforceable part of the settlement agreement. Given the settlement agreement's express modification procedures, the district court did not abuse its discretion by construing the Framework as such a modification and approving it in response to claimants' motions. View "In re Volkswagen "Clean Diesel" Marketing, Sales Practices, and Products Liability Litigation" on Justia Law

The Ninth Circuit affirmed the district court's judgment for plaintiff in an action alleging product-liability claims based on injuries she sustained from a medical device -- the G2 intravascular filter -- designed and manufactured by Bard. The jury found Bard liable for negligent failure to warn, awarding $1.6 million in compensatory damages and $2 million in punitive damages.The panel held that, because Bard's preemption defense presented a purely legal question, it would consider the merits of the district court's denial of its motion for summary judgment. The panel held that the preemption argument fails because Booker's claim rests on an asserted state-law duty to warn of the risks posed by the particular design of Bard's G2 Filter, and the FDA has not imposed any requirements related to the design of that device or how a device of that design should be labeled. In regard to the failure-to-warn claim, the panel held that Georgia courts had not adopted a categorical prohibition on basing a failure-to-warn claim on the absence of a comparative warning, and the district court correctly allowed the jury to decide the adequacy of the warning. Finally, the panel held that the evidence was adequate to support the jury's award of punitive damages. View "Booker v. C.R. Bard, Inc." on Justia Law

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

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

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

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

The Ninth Circuit certified the following question to the Oregon Supreme Court: Oregon's statute of repose for products liability actions, Or. Rev. Stat. 30.905(2), provides that a civil action "must be commenced before the later of . . . ten years . . . or . . . the expiration of any statute of repose for an equivalent civil action in the state in which the product was manufactured . . . ." If the state of manufacture has no relevant statute of repose, is a plaintiff entitled to an unlimited period (subject to the statute of limitations) in which to bring suit in Oregon court? View "Miller v. Ford Motor Co." on Justia Law