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.
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.
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.
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.
Last week, FDA released guidance for life sciences manufacturers that produce medical devices and components “critical to public health,” including materials that support or sustain life, or are used in emergency care or surgery. If there is an anticipated (or actual) disruption that may result in a shortage based on increased demand or supply-side interruption, the FDA must be notified no later than seven calendar days from the onset. The requirement to notify the Agency applies to a broad range of devices and equipment, and lasts for the duration of the COVID-19 emergency.
The FDA’s guidance on this topic arises out of the March 27, 2020, CARES Act amendments to the Food, Drug and Cosmetic Act. Those updates, codified at 21 U.S.C. § 356j, mirror similar provisions for prescription drug shortages implemented in December 2016. While the statutory provisions contemplate that a device manufacturer would provide notice to the FDA of an anticipated shortage or interruption at least six months in advance, or “as soon as is practicable,” the recent guidance recognizes that this may not be possible under current market conditions.
For at least two decades, Pennsylvania law has recognized an exemption from strict liability for prescription drug manufacturers based on the state Supreme Court’s interpretation of the Restatement (Second) of Torts Sec. 402A cmt. k. Comment k carves out an exception to traditional strict product liability claims for “unavoidably unsafe products,” or those which bear inherent risks—such as medicines which must be prescribed by a doctor. A less settled question is whether that exemption extends to manufacturers of prescription medical devices, specifically regarding manufacturing defect claims. On June 25, 2019, Judge Robreno of the U.S.D.C. Eastern District of Pennsylvania asked the Third Circuit to answer it.
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