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.
The U.S. Food & Drug Administration’s (FDA’s) Least Burdensome Provisions: Concept and Principles: Guidance for Industry and Food and Drug Administration Staff, February 5, 2019, states that “medical device regulation should be least burdensome across the total product life cycle.” This means that manufacturers are expected to provide “the minimum amount of information necessary to adequately address a relevant regulatory question or issue through the most efficient manner at the right time.” The FDA observed that this approach should “ensure that patients have access to high-quality, safe and effective medical devices.”