News & Analysis as of

Statutory Interpretation Manufacturers

Bergeson & Campbell, P.C.

Setting the Record Straight: New Chemical Review Needs Scientists

On May 2, 2025, U.S. Environmental Protection Agency (EPA) Administrator Lee Zeldin announced the “[n]ext phase of organizational improvements to better integrate science into agency offices.” As part of this reorganization...more

Seyfarth Shaw LLP

THC Found in CBD Tincture ‘Sparks’ Statutory Debate: SCOTUS Permits Fired Employee To Sue Cannabis Businesses Under CIVIL RICO Law

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In Medical Marijuana, Inc. et al v. Horn, 604 U.S. ___ (2025), the Supreme Court of the United States (SCOTUS) engaged in a lively statutory interpretation debate over the reach of the civil provisions of the Racketeer...more

Husch Blackwell LLP

Guns, Liability, and the Law: Why the Gustafson Decision Matters

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The Protection of Lawful Commerce in Arms Act (PLCAA) has long been a cornerstone of protection for firearms manufacturers and sellers, shielding them from liability when their products are misused in crimes. But recent...more

ArentFox Schiff

Vertex’s Attempt to Redefine AKS Falls Short: Key Insights for Pharma Manufacturers

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In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General (OIG), manufacturers have contested the OIG’s...more

Baker Donelson

HHS and HRSA Defend 340B Discount Model Against Pharma Rebate Plan

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Summary of Changes - In the fall of 2024, several pharmaceutical companies – specifically, Eli Lilly and Company, Sanofi-Aventis U.S. LLC, Bristol Myers Squibb Company, and Novartis Pharmaceuticals Corporation – reacted to...more

Faegre Drinker Biddle & Reath LLP

Software Liability: Why a Michigan Federal Court Decision is Relevant to Product Manufacturers Nationwide

Numerous products in our day-to-day lives incorporate or consist of software. The legal system, however, has been hesitant (at best) to bring software within traditional product liability regimes. Courts have grappled with...more

Hogan Lovells

Federal Circuit Acetris Decision Changes Procurement Country of Origin Landscape

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On Monday, in the much-anticipated decision in Acetris Health, LLC v. U.S. 18-2399, the Court of Appeals for the Federal Circuit (the “Federal Circuit”) ruled that U.S. manufacture of a drug is sufficient to confer U.S....more

Wilson Sonsini Goodrich & Rosati

Court Holds the FDA Cannot Classify an Imaging Agent Medical Device as a Drug

The legal definitions of a drug and a medical device set forth in the Food, Drug, and Cosmetic Act have some important overlapping provisions. Because of the overlapping provisions, theoretically the U.S. Food and Drug...more

Pullman & Comley, LLC

United States Supreme Court Denies Cert. in Remington Arms Co. LLC v. Soto

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The United States Supreme Court has denied certiorari in Remington Arms Co. LLC v. Soto, No. 19-168.  While the focus of this case ought to remain on the families and the Newtown community, this decision has broad...more

Wilson Sonsini Goodrich & Rosati

Microbes and Medical Foods: A Growing Area of Commercial Importance

The 2nd Annual Microbiome Movement conference, recently held in San Diego, California, highlighted the growing importance of microbes as the basis for various commercial products. Microbe-containing products regulated by the...more

Steptoe & Johnson PLLC

EPA to Cease Issuing Notice of Deficiencies for TSCA

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As of August 15, 2019, the United States Environmental Protection Agency (“EPA”) will no longer issue notice of deficiencies to affected businesses that manufacture and/or process chemicals covered under the Toxic Substances...more

Butler Snow LLP

Express Preemption of Consumer Protection Actions: Preventing a Patchwork of State Drug and Device Regulations

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The Supremacy Clause of the United States Constitution declares federal law to be the “supreme Law of the Land.” Thus, when federal law and state law conflict, the state law is “preempted,” or rendered without effect. Under...more

Foley & Lardner LLP

When Even the Regulations Are Bigger in Texas: Limitations on Court Deference

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Manufacturers considering operations in Texas may be surprised to discover that, despite the state’s desired reputation as a “light regulation” and “free market” environment, comprehensive regulatory statutes exist for most...more

Robinson+Cole Health Law Diagnosis

OIG Advisory Opinion No. 19-02 Allows Pharmaceutical Manufacturer to Temporarily Loan Smartphones to Financially Needy Patients to...

On January 24, 2019, the Office of Inspector General (“OIG”) issued a favorable advisory opinion allowing a pharmaceutical manufacturer (“Manufacturer”) to temporarily loan limited-functionality smartphones to financially...more

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