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

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.

DOJ Fraud Declination Highlights Self-Disclosure Tradeoffs

As exemplified by the U.S. Department of Justice's declination of charges against Campus Eye Management under its new corporate enforcement policy, self-disclosure can be an attractive option for healthcare co... (more story)

Digital Health & Technology More

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)

Contractor Seeks Redo After Fed. Circ. Vacates $12.7M Award

A software developer has urged the en banc Federal Circuit to rethink a panel's decision vacating a $12.7 million award against the federal government over unauthorized copies of the company's software, saying... (more story)

DC Circ. Backs Fair Use Repairs On Med Device Software

The D.C. Circuit on Tuesday ruled that using copyrighted data and computer programs for the purpose of repairing medical devices falls under the fair use exemption, rejecting a challenge from two industry grou... (more story)

Zimmer Wins Hip Implant Suit After Expert Testimony Tossed

A New York federal judge handed Zimmer Inc. an early win in a multidistrict litigation case alleging its hip prosthetics are faulty, after finding that the plaintiff's only expert witness could not testify bec... (more story)

Policy & Compliance More

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.

DOL Issues Mental Health Parity Enforcement Guidance

The U.S. Department of Labor's employee benefits arm issued guidance Tuesday on how to comply with federal laws that require employer health plans to produce an analysis of their mental health and substance us... (more story)

$2.3M Nemours Foundation's ERISA Deal Clears 1st Hurdle

A Florida federal judge has granted initial approval to a $2.3 million deal the Nemours Foundation reached with ex-workers who claimed their retirement plan was weighed down by excessive fees, nearly a year af... (more story)

Idaho Supreme Court OKs Revised Abortion Ballot Language

The Idaho Supreme Court has agreed to revised ballot language for an abortion amendment scheduled to be in front of voters this November. 

Humana Says $7.3B Roundup Deal Sidelines Health Insurers

Humana Inc. alleged in New Jersey federal court that Monsanto Co. is attempting to skirt its obligation to reimburse health insurers for medical expenses stemming from exposure to its Roundup product.