FDA Classification Setback Bodes Well For Wound Care Cos.

A Georgia federal court's recent decision in MiMedx v. U.S. Food and Drug Administration constrains the FDA's analytical framework for classifying certain wound care products as biological products, carrying important ramifications for manufacturers seeking to avoid heightened regulatory requirements, say attorneys at Hyman Phelps.

Logistics Update: Handling Iran War Supply Chain Limitations

The war in Iran is straining global logistics by introducing practical, commercial, legal and claims limitations for both operators and customers — so all supply chain participants must understand the resulting legal issues, and how to respond to them, says Jonathan Todd at Benesch.

9th Circ. Waters Ruling Shows Sackett's Ripple Effects

The Ninth Circuit's recent decision in Inland Empire Waterkeeper v. Corona Clay demonstrates that the U.S. Supreme Court's "waters of the U.S." ruling in Sackett v. U.S. Environmental Protection Agency can reopen cases already tried to verdict, thus changing expectations around citizen suits and stormwater enforcement in California, says Jacob Lubarsky at Rogers Joseph.

FTC Highlights Path To Preserve Board Rights In A Rival Co.

The Federal Trade Commission's move to add key guardrails permitting firearms manufacturer Beretta to retain two directors as it takes a 25% stake in competitor Ruger illustrates how parties may maintain board rights in certain circumstances without running afoul of Section 8 of the Clayton Act, say attorneys at Davis Polk.

Opinion

A Capital Markets Agenda For The New Congress

When the 120th Congress convenes in January, it should place capital markets issues near the top of its to-do list, with a focus on legislation that can make the public company model more competitive, says David Kaufman at Thompson Coburn.

A Defense Attorney Playbook For Challenging Flock Evidence

As law enforcement continues to bring charges based on evidence from Flock cameras and other automated license plate readers, defense counsel should consider four key categories for discovery requests and motions to compel such evidence, says Tamar Lerer at the New Jersey Office of the Public Defender.

FinCEN Scam Alerts Push Banks To Rethink AML Monitoring

Recent Financial Crimes Enforcement Network guidance on digital asset scams suggests that future anti-money laundering examinations may focus less on whether institutions detect the movement of criminal proceeds and more on whether they can identify fraud schemes before victims suffer catastrophic losses, say attorneys at Ballard Spahr.

How AI Could Help Judges Spot Their Own Biases

In close cases where there’s room for discretion, artificial intelligence could challenge judges’ implicit biases by running counterfactual tests at scale — but any judicial use of such tools would need guardrails, say Arnold Peter at Peter Law and Nancy Rapoport at University of Nevada.

Assessing Hidden Risk Of Administrative Agency Settlements

Though administrative resolutions of U.S. Securities and Exchange Commission investigations may seem preferable to settled federal court actions, the possibility that private plaintiffs may use commission orders in follow-on litigation poses an extra risk, increasing the importance of negotiating the settlement's form and language, say attorneys at Debevoise.

State Of Insurance: Q3 Notes From Pennsylvania

Pennsylvania courts issued several noteworthy insurance decisions last quarter, offering practical guidance for insurers evaluating public policy coverage disputes, drafting umbrella policy language and defending litigation involving claim file discoverability, says Todd Leon at Marshall Dennehey.

Risk Management Tips For Cos. Deploying Open-Weight AI

While many enterprises building out their artificial intelligence strategies are considering open-weight models, the Open-Source AI Leadership Act and accompanying congressional oversight letters to prominent tech and consumer companies signal that opportunity and legal risk are being discovered and evaluated on the same timeline, say attorneys at Cooley.

West Point Prof's Suit Tests Public Employee Speech Limits

A recent complaint in New York federal court alleging that West Point unlawfully terminated a professor who challenged a directive banning references to human causes of climate change could illuminate how academic freedom and public employee speech protections apply at a military academy, say attorneys at Foley & Lardner.

Compete Act Reinforces Calif.'s Antitrust Leadership Role

California's recent passage of the Compete Act, which expands the state's principal antitrust statute's focus on concerted multifirm conduct to business dealings between two or more firms, underscores California's leadership in state antitrust enforcement as attorneys general move to fill perceived gaps left by reduced federal oversight, say attorneys at Skadden.

NHTSA Vehicle Recorder Rule Highlights Crash Data Protocols

An amended rule from the National Highway Traffic Safety Administration will soon require vehicle event data recorders to capture more information about crashes — but to turn that data into evidence, attorneys, claims professionals and fleet managers must properly obtain and preserve it after an incident occurs, says Andrew Haling at Pathway Law.

What Expanded CMS Authority Means For Health Compliance

A recent delegation gives the Centers for Medicare & Medicaid Services independent authority to impose permissive exclusions, creating a more active federal enforcement system with heightened risks for healthcare organizations, says Jose Vela at Clark Hill.