Subject: Medical Devices

Ninth Circuit Affirms Dismissal of Breast Implant Cases on Preemption Grounds

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The Ninth Circuit has confirmed in quadrophonic sound that plaintiffs cannot avoid preemption by relying on vague and speculative allegations to establish a parallel claim.  The court affirmed the dismissal of four lawsuits by plaintiffs claiming they were injured by breast implants on the grounds that their claims are barred by the 1976 Medical Device Amendment to the Food, Drug and Cosmetic Act (MDA).  Sewell v. Mentor Worldwide, LLC, et al., no. 19-56393; Vieira v. Mentor Worldwide, LLC, et al., no. 19-56394; Billetts v. Mentor Worldwide, LLC, et al., no. 19-56398; Nunn v. Mentor Worldwide, LLC, et al., no. 19-56391.

In each case, California plaintiffs alleged their breast implants were defective and caused them to experience fatigue, muscle pain, and migraines.  The district courts dismissed the complaints for failure to state a claim on grounds of preemption, and plaintiffs appealed.

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Second Circuit Affirms Mirena MDL Court’s “Hard Look” at Plaintiffs’ Experts’ Methodology

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On December 8, 2020, the Second Circuit Court of Appeals affirmed the Southern District of New York’s granting of summary judgment in favor of Bayer — and resulting closure of all cases against Bayer — in the Mirena multidistrict litigation (MDL). In re Mirena IUS Levonorgestrel-Related Prod. Liab. Litig. (No. II), No. 19-2155, 2020 WL 7214264 (2d Cir. Dec. 8, 2020).

In the MDL, the plaintiffs alleged that the Mirena Intrauterine System had caused them to develop idiopathic intracranial hypertension (IIH). The District Court elected to focus first on whether the plaintiffs had evidence sufficient to establish general causation. The District Court held a Daubert hearing that lasted three days and featured testimony by 19 general causation witnesses — 7 for the plaintiffs and 12 for Bayer. On October 24, 2018, the District Court entered a detailed 156-page opinion granting Bayer’s Daubert motion as to all of the plaintiffs’ experts and denying as moot plaintiffs’ motion to preclude Bayer’s experts. In re Mirena IUS Levonorgestrel-Related Prods. Liab. Litig., 341 F. Supp. 3d 213 (S.D.N.Y. 2018). Bayer then filed a motion for summary judgment, which the District Court granted for lack of general causation and dismissed all cases in the Mirena MDL.

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California’s Parallel State Law Duty to Report Adverse Events to U.S. Food and Drug Administration Cannot Be Reconciled with Legal Precedent

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Earlier this year, the California Court of Appeals in Mize v. Mentor Worldwide LLC, 51 Cal.App.5th 850 (2020), reversed a trial court’s dismissal of failure to warn and other claims against a medical device manufacturer, holding that “California law recognizes a manufacturer’s duty to warn the [U.S. Food and Drug Administration] of adverse events.” Mize concluded that California’s duty to warn FDA was “parallel” to the requirements of federal law, and therefore not expressly preempted.

Cases like Mize involving medical devices approved for sale through the FDA’s Premarket Approval (PMA) process are generally subject to the U.S. Supreme Court’s decision in Riegel v. Medtronic, 552 U.S. 312 (2008). Riegel held that the federal Medical Device Amendments preempt state tort laws if they are “different from, or in addition to” the requirements imposed by federal law. Riegel bars state tort law claims because PMA devices are subject to specific requirements adopted by FDA through the rigorous PMA approval process. However, Riegel left open the possibility, based on an articulated judicially imposed policy, that a state might “[provide] a damages remedy for claims premised on a violation of FDA regulations” because “the state duties in such a case ‘parallel’ federal law.” 552 U.S. at 329.

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Florida Appellate Court Authorizes the Use of the Risk-Utility Test in Complex Medical Device Cases

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On October 7, 2020, Florida’s Fourth District Court of Appeal affirmed a defense verdict in favor of a medical device manufacturer and in doing so approved of the trial court’s use of the risk-utility test and not the consumer expectations test in the jury instructions. Cavanaugh v. Stryker Corp., — So. 2d —, 2020 WL 5937405 (Fla. 4th DCA Oct. 7, 2020). The wrongful death lawsuit was filed against multiple defendants, including the manufacturer of a medical device used to remove blood and clear the surgical field, following the death of a patient during lung removal surgery. The claims against the medical device manufacturer included strict liability design defect, strict liability failure to warn, and negligence.

The plaintiff settled with several health care professionals and only the claims against the manufacturer proceeded to trial. At trial, the plaintiff proposed a jury instruction where the jury could find that the product was unreasonably dangerous if the plaintiff established either the consumer expectations test (which determines liability based on whether the product fails to perform as safely as an ordinary consumer would expect when used as intended or when used in a manner reasonably foreseeable by the manufacturer) or the risk-utility test (which determines liability based on whether the risk of danger in the design outweighs the benefit). The defendant manufacturer, however, proposed that the jury instruction include only the risk-utility test (a product is unreasonably dangerous if the risk of danger in the design outweighs the benefit). The trial court rejected the plaintiff’s proposed instruction and adopted the defendant’s risk-utility instruction.

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Plaintiff’s Firm Pays the Price for Dismissing Bellwether Cases

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On August 25, 2020, Judge Richard L. Young, S.D. Indiana, granted Cook Medical Inc.’s motion for sanctions against the plaintiff’s law firm in Burrage v. Cook Medical Inc. et al.

This case was one of many “no-injury” claims in the Cook IVC Filter MDL, meaning that the plaintiff did not claim any symptomatic injuries related to his IVC filter. It was selected as a bellwether case in August 2019 following a selection process that required substantial time and effort from the parties and the court. In June 2020, plaintiff’s counsel moved to voluntarily dismiss his claims with prejudice on the grounds that they have a “negative value” (meaning that the costs of litigating the case exceed the anticipated recovery), and Burrage never anticipated that the case would go to trial.

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Potential Embarrassment Insufficient to Enable Plaintiffs to Litigate Anonymously in Breast Implant MDL

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A New Jersey federal court has held that potential embarrassment is not enough to permit plaintiffs to litigate anonymously in a fight over breast implants.

In an August 13, 2020 letter order, the Hon. Joseph A. Dickson, U.S.M.J., ruled that the plaintiffs alleging that defendant Allergan Inc. hid health risks associated with its textured breast implants must reveal their identifies in court filings in the MDL litigation captioned In re: Allergan BIOCELL Textured Breast Implant Prods. Liab. Litig., No. 19-MD-2121.

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