FDA Solicits Feedback to Create Consistent Process for Labeling Devices

The Food and Drug Administration Center for Devices and Radiological Health is soliciting feedback on how materials information about medical devices should be communicated to patients and healthcare providers. On May 20, 2021, the FDA published a discussion paper titled Conveying Materials Information about Medical Devices to Patients and Healthcare Providers: Considerations for a Framework. With a goal of stimulating discussion among stakeholders, the paper outlines several factors to consider for labeling devices so that providers can make well-informed decisions about which devices may be most appropriate for their patients.

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Eleventh Circuit Holds Expert Qualified in Surgical Tool Suit Despite Lack of Experience Using the Product

The Eleventh Circuit recently reinstated a case alleging a surgical tool caused internal burns during a hysterectomy surgery, holding that the district court erred in disqualifying an expert on the basis that he had never before used the tool.  The decision is a reminder of the importance of asserting and maintaining precise and strategic Daubert challenges.

In Moore v. Intuitive Surgical, Inc., No. 19-10869, the plaintiff underwent a laparoscopic hysterectomy in which her surgeon used a robotic miniature electrified scissor tool manufactured by the defendant.  Following surgery, the plaintiff experienced, among other things, abdominal pain and eventually learned she had sustained internal burns to her left ureter during the surgical procedure.  The tool was recalled by the manufacturer a few months after the plaintiff’s procedure, and the plaintiff filed suit.

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Ninth Circuit Affirms Dismissal of Breast Implant Cases on Preemption Grounds

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

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

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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DNJ Analyzes Service via Agent and the Forum Defendant Rule in Context of a Snap Removal

A magistrate judge in the District of New Jersey recommended remand of more than one dozen lawsuits concerning allegedly defective hip implants in a June 15, 2020, decision analyzing Third Circuit precedent regarding the forum defendant rule in the context of snap removals.

Jackson v. Howmedica Osteonics Corp., et al., Civil Action No. 19-18667, is one of several cases filed by plaintiffs in New Jersey state court against the defendant Howmedica, which is incorporated and has its principal place of business in New Jersey. Pre-service, the defendant removed to federal court on the basis of diversity pursuant to Encompass Insurance Co. v. Stone Mansion Restaurant, Inc., 2018 WL 3999885 (3d Cir. Aug. 22, 2018), in which the Third Circuit held that a forum defendant may remove a case to federal court prior to being served.

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