Product Liability

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As we previously discussed, MoCRA requires cosmetic product manufacturer and processors to register their facilities with the U.S. Food and Drug Administration (FDA). On August 7, 2023, FDA announced that it had published a draft guidance on cosmetic product facility registration and product listings, as required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The draft guidance intends to help the industry by providing relevant requirements and definitions, explaining who is responsible for making submissions, what details to include, and how and when to make the submissions. It also provides information on exemptions, such as those for certain small businesses.

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Continue Reading MoCRA: FDA Draft Guidance on Facility Registration and Product Listing

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As discussed in the Product Perspective, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a major shift in cosmetic industry regulations. This article, in our continuing series of posts diving into each aspect of MoCRA, covers the process for substantiating safety of cosmetic products.

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Continue Reading MoCRA: Updates to FDA Safety Substantiation Requirements

Missouri State Law Legal System Concept

In reversing nearly $700,000 in post-judgment interest, the Missouri Court of Appeals for the Western District clarified that post-judgment interest can be recovered only after the trial court enters a final judgment. Notably, in wrongful death cases, a trial court’s failure to apportion damages among beneficiaries renders a judgment not final and precludes post-judgment interest.…

Continue Reading Missouri Court of Appeals Reverses $700,000 Post-Judgment Interest Award in Wrongful Death Case

The Middle District of Pennsylvania’s opinion in Gorton v. Warren Pumps, LLC supported the government contractor defense and set forth a road map for defendants to follow to win summary judgment. The court, relying on the Supreme Court case, Boyle v. United Technologies Corporation, and applying admiralty law, held the government contractor defense was applicable to Plaintiff’s claims for product liability, breach of implied warranty, and negligence. In Groton, Defendant Warren Pumps moved for summary judgment asserting the government contractor defense. The court, after analyzing the record and standards for the defense, granted summary judgment in Warren Pumps’ favor.…

Continue Reading Middle District of Pennsylvania Sets out a Road Map for Defendants to Assert the Government Contractor Defense in Asbestos Cases

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As discussed in the Product Perspective, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a major shift in cosmetic industry regulations. This article is one of a series of posts diving into each aspect of MoCRA as we await its full implementation. We will focus on MoCRA’s mandate requiring the Federal Drug Administration (FDA) to establish Good Manufacturing Practices (“GMP”) that the cosmetic industry will have to follow going forward.

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Continue Reading MoCRA: Good Manufacturing Practices – Why Should You Care?

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As deadlines approach for cosmetic manufactures to comply with all requirements of MoCRA, there might be some worry on where to start. Husch Blackwell’s chapter by chapter breakdown of MoCRA provides guidance on where to begin. This chapter discusses the requirements of facility registration and product listing with compliance due date of December 29, 2023.

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Continue Reading MoCRA: Facility Registration and Product Listing – Where to Begin?

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As discussed in the Product Perspective, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a major shift in cosmetic industry regulations. This article is one of a series of posts diving into each aspect of MoCRA as we await its full implementation. To begin, we will discuss whether MoCRA applies to your product and, if so, which entity should serve as the responsible person for ongoing compliance.  

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Continue Reading MoCRA: Is My Product a “Cosmetic” and Who Is My “Responsible Person”?

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The Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”) was signed into law on December 29, 2022. MoCRA expands the authority of the U.S. Food and Drug Administration (“FDA”) to regulate cosmetics and serves as the most significant change to the regulation of cosmetics since the passage of the Federal Food, Drug, and Cosmetic (FD&C) Act in 1938. MoCRA is a seismic shift in the world of cosmetic regulation, bringing new authorities to the FDA that are similar to those that currently exist for food, drugs and medical devices, among other regulated products. MoCRA has sweeping implications for domestic and international cosmetics manufacturers that market products in the U.S.

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Continue Reading MoCRA: A New Era in the Regulation of Cosmetic Products

On March 9, 2023, a federal judge granted summary judgment on causation to three manufacturers of asbestos-containing products in a maritime lawsuit arising from the death of Thomas Deem from mesothelioma. The judge held that Ms. Deem had failed to put on evidence sufficient to show that Decedent’s exposure to the products manufactured by three defendants—John Crane, Inc. (“JCI”), Crosby Valves, LLC, and the William Powell Company—was a substantial contributing factor to his developing mesothelioma. See Sherri L. Deem v. Air & Liquid Systems Corp., et al., No. 17-5965BHS (W.D. Wash. Mar. 9, 2023). …

Continue Reading Frequency, Regularity, Proximity: The Western District of Washington Requires More Than a Product’s Presence to Find Causation

A breast cancer lawsuit based on trace levels of benzene in aerosol antiperspirant was dismissed with prejudice by a federal judge in Louisiana, because causation was not sufficiently pled. In particular, the plaintiffs failed to plead that (1) the plaintiff used a product that actually contained benzene and (2) benzene exposure can cause the plaintiff’s specific type of cancer. See Rooney v. Procter & Gamble Co., No. 22-11654, 2023 WL 1419870 (E.D. La. Jan. 31, 2023).…

Continue Reading Lawsuit Based on Benzene in Aerosol Antiperspirant Dismissed with Prejudice