Expert Analysis

FDA Closeout Letter Suggests Relaxing Stance On Wearables

The U.S. Food and Drug Administration's recent decision not to pursue enforcement action against Whoop's wearable ... (more story)

Justices' Hikma Reasoning May Extend Well Beyond Pharma

The active steps framework announced by the U.S. Supreme Court in its Hikma v. Amarin decision, finding that Amari... (more story)

Teva MDL Loss Shows DPAs Can Return To Haunt Civil Suits

Teva’s recent partial summary judgment loss in antitrust multidistrict litigation reinforces the importance of car... (more story)

Deals & Corporate Governance More

FTC Chucks Biden-Era Health App Breach Notification Rule

The Federal Trade Commission, as part of its regulatory streamlining, has rescinded a Biden-era policy requiring health applications and smart devices that collect information to warn users when their medical ... (more story)

Biogen Must Face Pharmacies' MS Drug Monopoly Suit

An Illinois federal judge on Tuesday refused to dismiss Walgreens and Kroger's lawsuit accusing Biogen Inc. of illegally stifling competition for its multiple sclerosis drug Tecfidera, saying they've made suff... (more story)

Prepping Health Businesses For Sale In A Data-Driven Market

In a thinner market for healthcare transactions, with both regulators and buyers using artificial intelligence to inspect data in great detail, the margin for error in sellers' financials and legal diligence h... (more story)

American Healthcare Buys $572M Senior Housing Portfolio

American Healthcare REIT Inc. has paid $572 million to Kensington Senior Living for six luxury senior housing communities that have 464 units in total, the clinical healthcare-focused real estate investment trust announced.

Rejection Of NLRB Successor Bar Renews An Employer Tool

Although the D.C. Circuit's recent ruling in Hospital Menonita v. National Labor Relations Board does not allow purchasers to disregard incumbent unions, employers acquiring a unionized business have regained ... (more story)

REIT Pays $200M For 4-Site Minn. Senior Housing Portfolio

Senior housing and healthcare-focused real estate investment trust LTC Properties said Wednesday that it has acquired four senior housing properties in Minnesota for $200 million.

Digital Health & Technology More

Calif. Judge Hands Eli Lilly Mixed Bag In Compound Drug Row

Eli Lilly failed to plausibly allege that a physician group and pharmacy conspired to falsely advertise compounded versions of its diabetes and weight loss drugs, but can continue with allegations they conspir... (more story)

Calif. Judge Seeks Clearer Limits On ICE Use Of Medicaid Data

A California federal judge ordered 22 states and the Trump administration to reach an agreement on the proper scope of his injunction limiting Medicaid data use for immigration enforcement, saying he's unsure ... (more story)

Courts Rule On Fertility Aid, HHS Data Sharing And More

Law360 Healthcare Authority looks at a D.C. Circuit decision partially reversing a biotech company's loss, a New York judge's declining to enjoin plans by the U.S. Department of Health and Human Services, and ... (more story)

Apple Fights Masimo Bid To Add $243M To $634M Patent Win

Apple has pressed a California federal judge to reject Masimo's request for nearly $243 million in interest atop a $634 million patent jury verdict on the Apple Watch's heart rate feature, saying the "staggeri... (more story)

NY Judge Won't Block HHS Sharing Of Aid Recipients' Info

A New York federal judge refused to block a U.S. Department of Health and Human Services plan to share aid recipients' information with other agencies, including the U.S. Department of Homeland Security, rulin... (more story)

Ky. AG Sues NY Abortion Rights Org. Over Gas Station Ads

A New York-based abortion advocacy nonprofit is violating Kentucky's consumer protection laws by illegally advertising mail-order abortion pills at gas stations throughout the state and flying ads over the sta... (more story)

Policy & Compliance More

5th Circ. Appears Skeptical Of La. Abortion Pill Suit

Louisiana's solicitor general faced tough questions Wednesday from a Fifth Circuit panel about the state's standing to challenge federal regulations that allow abortion medication to be mailed to patients in the state.

Hogan Lovells Cadwalader Hires FDA Chief Counsel

Hogan Lovells Cadwalader has hired a former U.S. Food and Drug Administration leader, who has more than 35 years of experience at the agency and worked as chief counsel, as a new member of its Washington, D.C.... (more story)

11th Circ. Says ACA Trans Care Rule Fight Is Moot

The Eleventh Circuit refused to revive a challenge to a gender-affirming care rule from the Biden administration that was later reversed by the Biden administration, concluding that the issue has become moot w... (more story)

State Coalition Can Pursue Challenge To HHS Vax Overhaul

A California federal judge allowed a coalition of states to proceed with their challenge to the Trump administration's decision to cut vaccine recommendations for children, ruling Tuesday the states plausibly ... (more story)

Auto Industry Group Gets DOL Green Light For Health Plan

The U.S. Department of Labor's employee benefits arm said Tuesday that a group of retailers and repair centers associated with Napa Auto Parts is clear to establish a group health plan for its member employers... (more story)

Anti-Fraud Health Weapon Survives Constitutional Fight

The Eleventh Circuit decision backing the constitutionality of the False Claims Act's qui tam mechanism isn't the end of challenges to the whistleblower bar and healthcare enforcement.