Court’s Decision Affects Evidence Involving Industry & Gov’t Standards

By Alan Klein, Duane Morris LLP

A recent Pennsylvania Supreme Court decision has reaffirmed the applicability of strict liability standards under Restatement Second’s §402(a) in products liability cases filed in the State, and has barred evidence of compliance with industry or governmental standards to demonstrate that a product was safe and not defective. While clarifying these issues for trial courts and litigants, the Court’s plurality decision creates a potential unbalanced playing field for defendant manufacturers relying upon such standards in the design of their products.

Continue reading “Court’s Decision Affects Evidence Involving Industry & Gov’t Standards”

Pa. Supreme Court Rules on Proper Venue Standards

By Alan Klein and Ethan Feldman

In Hangey v. Husqvarna, the Pennsylvania Supreme Court recently ruled that the percentage of a corporate defendant’s total revenue generated from a forum county alone is insufficient to support the proposition that a defendant does not “regularly conduct business” in the county when analyzing whether a lawsuit’s venue is proper. This long awaited decision provides much needed clarity for trial courts that previously wrestled with the question of how much business must a defendant have in the forum for venue to attach. Continue reading “Pa. Supreme Court Rules on Proper Venue Standards”

Deadline for MoCRA Facility Registration and Product Listing Requirements Pushed Back to July 1, 2024

Today, FDA announced updated guidance regarding its MoCRA rollout.

FDA  does not intend to enforce the requirements related to cosmetic product facility registration and cosmetic product listing for an additional six months after the December 29, 2023, statutory deadline, or until July 1, 2024, to provide regulated industry additional time to comply with these requirements.

To read the full text of this post by Kelly Bonner,  please visit the Duane Morris Fashion, Retail and Consumer Branded Products Blog.

The Unseen Legal Turmoil Driving Beauty Brands to Shutter in 2023

Despite positive projections about the future of the beauty industry, insiders say brands of all sizes are quietly grappling with unseen legal struggles.

[Founders] blamed, in large part, the California Safe Drinking Water and Toxic Enforcement Act of 1986, better known as Prop 65.

“[Prop 65] requires products sold in California to have a special warning label if use of the product causes an exposure to one or more chemicals identified as causing cancer, birth defects or other reproductive harms,” Duane Morris partner Robert Kum told Glossy. Continue reading “The Unseen Legal Turmoil Driving Beauty Brands to Shutter in 2023”

Why Talc Claimants’ Experts Should Fear New Jersey Courts

Sharon Caffrey,  co-chair of Duane Morris’  Trial Practice Group,  is quoted in the Law360 article “Why Talc Claimants’ Experts Should Fear New Jersey Courts.”

From the article:

Cleavage fragments, or mineral particles that are found in rocks, can look like asbestos chemically, but they don’t have the same cancer-causing fibrogenic characteristics that asbestos does, Duane Morris LLP partner Sharon Caffrey told Law360.

“It’s not asbestos, and it’s … never been established as a cause of mesothelioma,” Caffrey said.

Visit the Law360 website to read the full article. 

 

After MoCRA, Federal Cosmetics Regulatory Laws Due Overhaul

On December 23, 2022, Congress enacted the Modernization of Cosmetics Regulation Act (MoCRA)—the first major statutory change to the U.S. federal government’s ability to regulate cosmetics since 1938. Passed with bipartisan
and industry support, MoCRA expands the Food and Drug Administration’s authority over cosmetics, and creates substantial new obligations for manufacturers, packers and distributors of cosmetics intended for sale in
the United States. Here’s what beauty companies need to know.

To read the full text of this article by Duane Morris attorney Kelly Bonner, please visit the firm website,

FDA Draft Guidance Recommends Info to Include in Patient-Matched Guides to Orthopedic Implants

This summer, the U.S. Food and Drug Administration (FDA) issued draft guidance regarding patient-matched guides to orthopedic implants, which are intended to assist in the execution of a pre-surgical plan concurred upon by the patient’s healthcare professional to position an orthopedic implant in a way consistent with the implant’s indicated use. In the draft guidance, FDA recommends information to include in pre-market submissions for patient-matched guides to orthopedic implants. FDA also suggests information for manufacturers to consider when creating the design process for patient-matched guides.

View the full Alert on the Duane Morris LLP website.

FDA Issues New Nitrosamine Impurities Guidance

By Alan Klein, Patrick Gallagher and Michael Fox

On August 4, 2023, the FDA issued a new Guidance to the pharmaceutical industry relating to large molecule drugs left unaddressed in its earlier nitrosamine Guidance publications. (Access the complete Guidance or the abbreviated version.)

Reacting to considerable input from the pharmaceutical industry, both brand and generic, following the agency’s Federal Register request for and receipt of extensive comments on these issues, including scientific data furnished to the agency by NDA and ANDA sponsors over the past year and a half, FDA has now provided drug manufacturers with critical guidelines for conforming their products to what the agency has determined to be safe nitrosamine exposure limits for patients. This comes on the heels of setting similar exposure limits for these products late last month by the European Union’s chief drug regulator, the European Medicines Agency. In its current Guideline, FDA has ranked impacted prescription drugs into 5 categories depending upon their carcinogenic potency, with “1” being the most potent, and “5” the least. Instructing the industry on their responsibility to minimize or eliminate nitrosamine impurities in their products to the extent feasible, the agency has extended the timeline for this task to August 2025, recognizing the complexity of this process and the need to avoid recalls and market disruptions of widely prescribed and important medications.

© 2009- Duane Morris LLP. Duane Morris is a registered service mark of Duane Morris LLP.

The opinions expressed on this blog are those of the author and are not to be construed as legal advice.

Proudly powered by WordPress