Product Liability & Mass Torts Digest

The Food, Drug, and Cosmetic Act (FDCA or the Act) governs safety, efficacy, and labeling over drugs, cosmetics, dietary supplements, medical devices, and other consumer products. The FDCA grants the Food and Drug Administration (FDA) the primary power to enforce the Act, including whether drugs, cosmetics, dietary supplements, and medical device manufacturers properly label their products to avoid misleading their customers. 

A recent decision from the Ninth Circuit calls into question whether the Public Readiness and Emergency (PREP) Act provides complete immunity from state law claims related to medical countermeasures against COVID-19, finding that the federal statutory scheme is not so comprehensive that it entirely supplants causes of action based on state law. Saldana v. Glenhaven Healthcare LLC, No. 20-cv-05631-FMOMAAA (9th Cir. Feb. 22, 2022).

Nursing home operators have generally been unable to remove to federal court negligence claims premised on alleged failure to take proper COVID-19 precautions.

In re: Zantac (Ranitidine) Product Liability Litigation is a coordinated multi-district litigation (MDL) centralized in the Southern District of Florida. The MDL involves allegations (which the defendants deny) that the active ingredient in Zantac (a heartburn medication) and its generic formulations are potentially carcinogenic because ranitidine can transform into the cancer-causing molecule NDMA.

The Ninth Circuit recently found that federal law preempted a consumer’s state law causes of action regarding the labeling of a hair health dietary supplement.

On January 8, 2021, the General Counsel for the Department of Health and Human Services (HHS) issued an Advisory Opinion clarifying the scope of preemption under the Public Readiness and Emergency Act (PREP Act) in response to questions as to whether the PREP Act applies where a covered person declined to use a covered countermeasure when it arguably ought to have been used.

As litigation involving the Public Readiness and Emergency Preparedness Act (PREP Act) and the Department of Health and Human Services (HHS) COVID-19 Declaration grows, some courts are following the logic set forth in two cases we previously discussed—Estate of Maglioli v. Andover Subacute Rehab. Ctr. I, 2020 WL 4671091 (D.N.J. Aug. 12, 2020) and Baskin v. Big Blue Healthcare, Inc., 2020 WL 4815074 (D. Kan. Aug. 19, 2020)—in rejecting defendants’ attempts to use the PREP Act as a basis for removal of state court actions, suggesting limitations of PREP Act immunity from state tort claims related to COVID-19.

As litigation involving the Public Readiness and Emergency Preparedness Act (PREP Act) and the Department of Health and Human Services (HHS) COVID-19 Declaration begins, two recent court decisions provide initial insights on potential limits to the scope of preemption provided by the PREP Act immunity for COVID-19 claims: Estate of Maglioli v. Andover Subacute Rehab. Ctr. I, 2020 WL 4671091 (D.N.J. Aug. 12, 2020) and Baskin v. Big Blue Healthcare, Inc., 2020 WL 4815074 (D. Kan. Aug. 19, 2020).

In the wake of the U.S. Supreme Court’s decisions in Wyeth v. Levine and Merck Sharp & Dohme Corp. v. Albrecht, drug manufacturers face challenges in establishing a preemption defense when they receive “newly acquired information” about a drug’s side effects without clear evidence that the U.S. Food and Drug Administration would have rejected a label change adding a warning of the risk of harm.

The doctrines of implied preemption and agency deference continue to develop with the Tenth Circuit’s recent decision in In re MDL 2700 Genentech Herceptin (Trastuzumab) Marketing and Sales Practice Litigation.

On June 26, 2020, GlaxoSmithKline LLC (GSK) filed a Petition for Writ of Certiorari regarding “the first—and, to date, only—appellate decision interpreting” the “fully informed” prong of the pharmaceutical preemption analysis in Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019). Pet. 2.

A California appeals court recently reversed the dismissal of a failure to warn claim based on preemption in the Risperdal and Invega Product Liability Cases, suggesting that in the wake of the Supreme Court’s decisions in Wyeth v. Levine, 129 S.Ct. 1187 (2009) and Merck Sharp & Dohme Corp. v. Albrecht, 139 S.Ct. 1668 (2019), drug manufacturers will continue to face challenges in establishing a preemption defense.