Subject: Preemption

PREP Act Does Not Require Federal Forum for State Law Negligence Claims Related to COVID-19

Share

A New Jersey District Court Judge has ruled that the March 2020 federal liability immunity statute for pandemic-related countermeasures does not create a basis for federal jurisdiction, resulting in the remand of two COVID-19-related personal injury actions.

Continue reading “PREP Act Does Not Require Federal Forum for State Law Negligence Claims Related to COVID-19”

Certain Express Misrepresentation Consumer Fraud Act Claims and Product Liability Claims May Coexist According to NJ Supreme Court

Share

In the case on certification from the Third Circuit, the New Jersey Supreme Court ruled that claims for express or affirmative misrepresentations under New Jersey’s Consumer Fraud Act (NJCFA) may be brought simultaneously with claims under the New Jersey Product Liability Act (NJPLA).

In Sun Chemical Corp. v. Fike Corp., plaintiff Sun Chemical Corporation purchased an explosion suppression system from defendant Fike Corporation. The system was to prevent and contain potential explosions in a new dust collection system. On the system’s first day of operation, a fire occurred, and the system’s alarm was activated but inaudible, resulting in an explosion that injured Sun Chemical employees and damaged its facility.

Continue reading “Certain Express Misrepresentation Consumer Fraud Act Claims and Product Liability Claims May Coexist According to NJ Supreme Court”

“Vanilla” Ice Cream Deceptive Labeling Case Melts on Motion to Dismiss

Share

A federal court in New York recently granted a motion to dismiss claims that ice cream labeled “vanilla” misleads consumers into believing the product’s flavor comes exclusively from vanilla beans or extract, when in fact other natural flavors contribute to the vanilla taste. The decision may be a harbinger of what is to come in similar cases challenging the label description of vanilla and other flavors in products ranging from ice cream to soy milk to energy drinks. The decision also shows that alleged regulatory violations and product testing do not necessarily support a plausible claim of consumer deception.

Continue reading ““Vanilla” Ice Cream Deceptive Labeling Case Melts on Motion to Dismiss”

Preparing for the COVID-19 Immunity Preemption Defense

Share

As manufacturers of vaccines, pharmaceutical medicines, ventilators and respirators engage substantial resources and ramp up production to help fight COVID-19, many have presumably done so under the immunity protections afforded by the federal Public Readiness and Emergency Preparedness Act (the PREP Act codified at 42 USC §247d-6d), and Coronavirus Aid, Relief, and Economic Security Act (the CARES Act). Because of industry-wide uncertainty surrounding PREP Act immunity and the need for immediate and urgent action on the part of manufacturers, the U.S. Department of Health and Human Services (HHS) recently issued a non-binding Advisory Opinion explaining the scope of PREP Act coverage, its immunity provisions in the context of COVID-19 countermeasures, and informal guidance on the preemptive effect of the federal law.

Continue reading “Preparing for the COVID-19 Immunity Preemption Defense”

Circuit Does Not Quite Clarify the Supreme Court’s Not-Quite-Clarification of “Clear Evidence” in Albrecht

Share

The U.S. Supreme Court’s 2019 decision in Merck Sharp & Dohme, Inc. v. Albrecht, 139 S.Ct. 1668 (2019), discussed here and here addressed impossibility preemption in label change lawsuits. In Albrecht, the Supreme Court purported to clarify the standard arising from Wyeth v. Levine, 555 US 555 (2009) that a labeling claim against a manufacturer is preempted for “impossibility” if there is “clear evidence” that the FDA would have rejected a manufacturer’s proposed label change. Albrecht explained that impossibility preemption requires the “manufacturer to show that it fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve changing the drug’s label to include that warning.” But Albrecht left unclear what the “clear evidence” showing entails and left open several important questions about how it is to be applied.

Continue reading “Circuit Does Not Quite Clarify the Supreme Court’s Not-Quite-Clarification of “Clear Evidence” in Albrecht”

Third Circuit Clarifies Next Steps in Fosamax Decision

Share

On remand from the U.S. Supreme Court, the U.S. Court of Appeals for the Third Circuit has in turn remanded the case to the district court to determine whether state law claims are preempted by federal law in the 500+ lawsuits pending regarding the medication Fosamax in Merck Sharpe & Dohme v. Albrecht. As previously discussed on this blog in May 2019, the United States Supreme Court held that the issue of federal preemption is one to be decided by the court and not a jury, while somewhat clarifying the “clear evidence” standard governing the analysis.

Continue reading “Third Circuit Clarifies Next Steps in Fosamax Decision”