Class Dismissed

October 04, 2022 - FDA
Water Is In, White Bread Is Out: “Healthy” Gets a New Look in 2023
By: Claudia M. Vetesi, Lena Gankin and Nick R. Dyess
For decades, health-conscious consumers have argued about what it really means for a food to be “healthy.” Is dark chocolate “healthy”? How about breakfast cereal, coffee, or fruit gummies? At the same time, class action litigants have seized on ever-evolving and subjective definitions of “healthy,” pursuing claims
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April 18, 2022 - FDA, Drug & Medical Device, Product Liability
Pleading and Preemption: Immunization Against Vaccine Products Liability Claims
By: Julie Y. Park and Alexandra Preece Barlow
In a recent win for vaccine manufacturers, a district court found that federal law preempted claims against Merck, arising out of alleged injuries from the Gardasil vaccine. Herlth v. Merck & Co., Inc. , No. 3:21-cv-438 (JAM), 2022 WL 788669 (D. Conn., Mar. 15,
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April 13, 2022 - False Advertising, FDA, Product Liability, Consumer Products, Retail
Rulings, FDA Guidance May Help Food Cos. In Protein Suits
By: Claudia M. Vetesi and Lena Gankin
Originally published by Law360 , Claudia Vetesi, Nicole Ozeran, and Lena Gankin authored an article discussing a wave of protein-labeling lawsuits hitting food manufacturers, alleging that their products’ front-label protein content statements violate U.S. Food and Drug Administration (FDA) regulations, and mislead consumers by overstating the amount
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January 20, 2022 - FDA, Food Misbranding, Consumer Products
FDA Ends Regulation of "French Dressing"
By: Claudia M. Vetesi
Last week the FDA announced that it would lift regulations controlling what can be called “French dressing.” The regulations—which had been in place since 1950—previously required that a product contain 35% vegetable oil and vinegar, lemon, or lime juice to be marketed as “French
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July 16, 2021 - False Advertising, FDA, Food Misbranding, Consumer Products
Manuka Honey and Waterslides
By: James R. Sigel
This week, we take a look at a decision addressing what a “reasonable” consumer will know in purchasing a product (and distinguishing the Seventh Circuit in the process), and at another assessing the legality of Washington’s pandemic-related shutdown of a waterpark. MOORE v. TRADER
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May 18, 2021 - Coronavirus (COVID-19), FDA
New Face Mask Performance Standard Has Consumers Covered
ASTM International recently approved a new performance standard that will tell consumers just how much protection their cloth face masks offer. Some face coverings like N-95 respirators and surgical masks must meet certain filtration requirements enforced by government agencies like the U.S. Occupational Safety
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December 28, 2020 - Coronavirus (COVID-19), FDA, Product Liability
FDA’s COVID-19 Product Regulation Enforcement Roadmap
By: Erin M. Bosman and Julie Y. Park
Navigating FDA’s regulatory enforcement strategies is paramount to successfully marketing health and medical products for COVID‑19—especially since the pandemic has dominated FDA’s enforcement activity this year. Understanding the patterns and principles behind FDA’s efforts can provide the insight product manufacturers need to avoid FDA
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September 17, 2020 - Coronavirus (COVID-19), FDA, Drug & Medical Device, Product Liability
First Decisions Limit PREP Act Immunity in Coronavirus Context
By: Erin M. Bosman and Julie Y. Park
When we discussed the Public Readiness and Emergency Preparedness (PREP) Act earlier this year, we predicted that its tort liability protections would reassure manufacturers and distributors of novel COVID-19 drugs and medical products. So far, so good: the first court decisions interpreting PREP Act
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May 26, 2020 - Coronavirus (COVID-19), FDA, Drug & Medical Device, Product Liability, Emergency Use Authorization (EUA)
FDA Signals Flexibility with COVID-19 Tests
By: Erin M. Bosman and Julie Y. Park
A bipartisan group of experts in economics, health, technology, and ethics recommended that the U.S. scale up COVID-19 testing—5 million per day by June, 20 million per day by midsummer—in order to fully re-mobilize the economy. Consistent with this, FDA has taken various steps
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May 08, 2020 - Coronavirus (COVID-19), FDA, Emergency Use Authorization (EUA)
COVID-19 Alert: FDA Updates Antibody Test Policy
By: Erin M. Bosman and Julie Y. Park
Serology tests could play a critical role in the fight against COVID-19. Serology tests may help determine who can donate convalescent plasma—a part of the blood containing antibodies—which is currently being explored as an investigational treatment for those with COVID-19. Convalescent plasma has been
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