Justia Drugs & Biotech Opinion Summaries

Articles Posted in US Court of Appeals for the Ninth Circuit
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After the State of Hawaii filed suit against several pharmaceutical companies in state court for allegedly deceptive drug marketing related to the medication Plavix, the companies turned to federal court, seeking an injunction against the state court litigation based on a violation of their First Amendment rights.The Ninth Circuit agreed with the district court that the state court litigation is a quasi-criminal enforcement proceeding and that Younger v. Harris, 401 U.S. 37 (1971), bars a federal court from interfering with such a proceeding. The panel explained that, even though the state proceeding is being litigated by private counsel, it is still an action brought by the State of Hawaii. The panel stated that what matters for Younger abstention is whether the state proceeding falls within the general class of quasi-criminal enforcement actions—not whether the proceeding satisfies specific factual criteria. Looking to the general class of cases of which this state proceeding is a member, the panel concluded that Younger abstention is appropriate here. In this case, the State's action has been brought under a statute that punishes those who engage in deceptive acts in commerce, and the State seeks civil penalties and punitive damages to sanction the companies for their allegedly deceptive labeling practices. Because the companies' First Amendment concerns do not bring this case within the scope of Younger's extraordinary circumstances exception, they have no bearing on the application of Younger. Accordingly, the panel affirmed the district court's dismissal of the action. View "Bristol-Myers Squibb Co. v. Connors" on Justia Law

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The Ninth Circuit reversed the district court's dismissal of a putative class action against CVS based on Federal Food, Drug, and Cosmetic Act (FDCA) preemption of California state law claims. Plaintiff alleged that the supplement he purchased, and five additional CVS glucosamine-based supplements, did not provide the advertised benefits. The FDCA distinguishes between "disease claims" and "structure/function claims" that manufacturers make about their products, applying different regulatory standards to each.The panel held that the district court erred in concluding that the FDCA preempts plaintiff's state law causes of action simply because CVS's glucosamine-based supplements present only structure/function claims. The panel explained that Dachauer v. NBTY, Inc., 913 F.3d 844 (9th Cir. 2019), was distinguishable from this case and the district court erred by applying it. Furthermore, the district court erred by greatly expanding the present state of federal preemption jurisprudence under the FDCA, contrary to public policy. The panel also held that the district court erred in dismissing the complaint without granting plaintiff leave to amend to add allegations regarding an implied disease claim. In this case, plaintiff may have been able to "bolster" his complaint with allegations of extra-label evidence showing that CVS's glucosamine-based supplements present implied disease claims. Accordingly, the panel remanded for further proceedings. View "Kroessler v. CVS Health Corp." on Justia Law

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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

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The Ninth Circuit affirmed in part and reversed in part the district court's dismissal of a third amended complaint (TAC) brought by plaintiffs, a putative class of former NFL players, alleging that the NFL negligently facilitated the hand-out of controlled substances to dull players' pain and to return them to the game in order to maximize profits. The NFL allegedly conducted studies and promulgated rules regarding how Clubs should handle distribution of the medications at issue, but failed to ensure compliance with them, with medical ethics, or with federal laws such as the Controlled Substances Act and the Food, Drug, and Cosmetic Act.The panel agreed with the district court that two of plaintiffs' theories of negligence, negligence per se and special relationship, were insufficiently pled. However, the panel held that plaintiff's voluntary undertaking theory survives dismissal, given sufficient allegations in the TAC of the NFL's failure to "use its authority to provide routine and important safety measures" regarding distribution of medications and returning athletes to play after injury. Furthermore, if proven, a voluntary undertaking theory could establish a duty owed by the NFL to protect player safety after injury, breach of that duty by incentivizing premature return to play, and liability for resulting damages. View "Dent v. National Football League" on Justia Law

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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

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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

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The Ninth Circuit affirmed the district court's grant of summary judgment for defendants, makers of vitamin E supplements, in an action alleging that the labels on the supplements violated California laws against false advertising. The panel held that section 343-1(a)(5) of the Federal Food, Drug, and Cosmetic Act (FDCA) expressly preempts state law requirements for claims about dietary supplements that differ from the FDCA's requirements. In this case, the panel held that section 343-1(a)(5) preempted most of plaintiff's claims.The panel held that because the FDCA and California law have the same labeling requirement with respect to failing to disclose an increased risk of death, section 343-1(a)(5) did not preempt this part of plaintiff's action. The panel held that the record lacked evidence that vitamin E supplements were actually harmful, as opposed to simply useless at reducing all-cause mortality (which they did not claim to reduce). Therefore, there was no genuine issue of material fact as to whether defendants' immune-health structure/function claim was misleading. View "Dachauer v. NBTY, Inc." on Justia Law

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The Ninth Circuit reversed the dismissal of an action alleging California consumer claims against MusclePharm Corporation, a manufacturer of nutritional supplements. The complaint alleged that MusclePharm made false or misleading statements about the protein in one of its products.The Ninth Circuit held that the Food, Drug, and Cosmetic Act (FDCA) and its implementing regulations concerned only the calculation and disclosure of protein amount; the FDCA preempted a state-law misbranding theory premised on the supplement's use of nitrogen-spiking agents to inflate the measurement of protein for the nutrition panel; but the FDCA did not preempt a state-law misbranding theory premised on the label's allegedly false or misleading implication that the supplement's protein came entirely from two specifically named, genuine protein sources. In this case, plaintiff's claims were not preempted to the extent they arose under this theory. View "Durnford v. MusclePharm Corp." on Justia Law

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Solis alleged that his former employers violated the federal False Claims Act (FCA) by promoting dangerous off-label uses of a cardiovascular drug, Integrilin, and by paying physicians kickbacks to prescribe Integrilin and an antibiotic drug, Avelox. The district court found that Solis’s FCA claims were foreclosed by the public disclosure bar, which deprives federal courts of subject matter jurisdiction over FCA suits when the alleged fraud has already been publicly disclosed unless the relator is deemed an original source. The Ninth Circuit affirmed in part, holding that Solis’s Integrilin claims were substantially similar to those in prior public disclosures, and were close enough in kind and degree to have put the government on notice to investigate the alleged fraud before Solis filed his complaint. The court vacated the dismissal of Solis’s Integrilin claims and remanded for a determination of whether Solis qualified for the “original source” exception, 31 U.S.C. 3730(e)(4). Concerning Solis’s Avelox claims, the court held that the district court clearly erred in finding that the Avelox claims were publicly disclosed based on court complaints that never mentioned Avelox but affirmed the dismissal of Solis’s Avelox claims on the alternative ground of failure to plead with particularity as required by Fed.R.Civ.P. 9(b). View "Solis v. Millenium Pharmaceuticals, Inc." on Justia Law

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Solis alleged that his former employers violated the federal False Claims Act (FCA) by promoting dangerous off-label uses of a cardiovascular drug, Integrilin, and by paying physicians kickbacks to prescribe Integrilin and an antibiotic drug, Avelox. The district court found that Solis’s FCA claims were foreclosed by the public disclosure bar, which deprives federal courts of subject matter jurisdiction over FCA suits when the alleged fraud has already been publicly disclosed unless the relator is deemed an original source. The Ninth Circuit affirmed in part, holding that Solis’s Integrilin claims were substantially similar to those in prior public disclosures, and were close enough in kind and degree to have put the government on notice to investigate the alleged fraud before Solis filed his complaint. The court vacated the dismissal of Solis’s Integrilin claims and remanded for a determination of whether Solis qualified for the “original source” exception, 31 U.S.C. 3730(e)(4). Concerning Solis’s Avelox claims, the court held that the district court clearly erred in finding that the Avelox claims were publicly disclosed based on court complaints that never mentioned Avelox but affirmed the dismissal of Solis’s Avelox claims on the alternative ground of failure to plead with particularity as required by Fed.R.Civ.P. 9(b). View "Solis v. Millenium Pharmaceuticals, Inc." on Justia Law