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FDA Gives Guidance on Reporting Medical Device Shortages

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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.

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Effectively Navigating PREP Act Case Law – The Products Liability Perspective

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Since the federal Public Readiness and Emergency Preparedness Act (the PREP Act) was enacted by Congress in 2005, only a few courts have substantively commented on the Act’s requirements. The PREP Act provides federal immunity against state law tort claims to covered entities that manufacture covered countermeasures used to fight diseases and viruses declared as national emergencies, such as COVID-19.

The pivotal case substantively applying the PREP Act’s immunity defense is Parker v. St. Lawrence County Pub. Health Dept., 102 A.D.3d 140 (N.Y. App. Div. 2012). The Parker court held that because the plaintiffs’ daughter was administered a covered countermeasure to prevent the H1N1 virus, their state law claims for negligence were preempted and barred by the PREP Act’s immunity provisions. To date, no reported decision has permitted traditional state law tort claims against a manufacturer for the alleged use of a covered countermeasure under the PREP Act.

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District of Kansas Confirms Plaintiffs Cannot Expand Scope of EpiPen MDL Litigation Via Motion to Transfer and Consolidate

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A Kansas District Court recently reinforced that cases alleging claims outside the Judicial Panel on Multidistrict Litigation (JPML) Transfer Order cannot be employed to broaden the scope of the MDL litigation. In reaching that conclusion, the court denied a motion to consolidate a new class-plaintiffs’ lawsuit with a mature multidistrict litigation (MDL).

In August 2017, the JPML created MDL 2785, In re: EpiPen (Epinephrine Injection, USP) Marketing Sales Practices and Antitrust Litigation (EpiPen® MDL). The EpiPen MDL is made up of cases asserting claims of anticompetitive conduct and unfair competition by defendants Pfizer, King Pharmaceuticals, Meridian Medical Technologies and multiple Mylan entities in their marketing and sale of the EpiPen. EpiPen is an epinephrine auto-injector used to treat anaphylaxis — a severe, potentially life-threatening allergic reaction that can occur within minutes of exposure to an allergen. The JPML assigned the EpiPen MDL to the District of Kansas.

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