Expert Analysis

What's At Stake In High Court Transgender Care Suit

The outcome of U.S. v. Skrmetti will have critical implications for the rights of transgender youth and their acce... (more story)

6 Laws Transforming Calif.'s Health Regulatory Framework

Attorneys at Hooper Lundy discuss a number of new California laws that raise pressing issues for independent physi... (more story)

Recent Cases Clarify FCA Kickback Pleading Standards

Two recently resolved cases involving pharmaceutical manufacturers may make it more difficult for False Claims Act... (more story)

Deals & Corporate Governance More

Fed. Circ. Affirms No Block On Amgen's Eye Med Biosimilar

The Federal Circuit on Friday agreed with a lower court decision declining to temporarily block Amgen's biosimilar of Regeneron's blockbuster eye medication Eylea, affirming that court's application of claim c... (more story)

Fed. Circ. Sides With Merck In Reissued Patent Debate

The Federal Circuit isn't buying that a reissued patent was actually "issued" at the time it was originally awarded, dashing generic-drug makers' hopes of breaking pharmaceutical giant Merck's hold on a blockb... (more story)

Judge Won't Toss $35M Ch. 11 Bank Fee Clawback Lawsuit

A Delaware bankruptcy judge has denied a summary judgment bid to dismiss a lawsuit alleging that an $1.8 billion loan set medical testing company Millennium Laboratories on course for its 2015 Chapter 11.

Full 4th Circ. Urged To Rethink Drug Price-Fixing Class Action

The Fourth Circuit's dismissal of a proposed class action accusing drug companies of conspiring to inflate the price of a drug for Huntington's disease has deepened a circuit split on proving injury under the ... (more story)

Law360 Cheat Sheet: Novartis' Fight Over Generic Entresto

Novartis has led a wide-ranging litigation campaign to block generic versions of its bestselling cardiovascular drug Entresto that has involved multidistrict litigation, trips to several circuit courts and cas... (more story)

Caribou Biosciences Brass Face Investor's Clinical Trials Suit

Executives and directors of Caribou Biosciences Inc. have been hit with a shareholder's derivative suit alleging that they overstated the safety and efficacy of Caribou's cell therapy and concealed that the co... (more story)

Digital Health & Technology More

4th Circ. Won't Undo Health Data Access Order

A Fourth Circuit panel issued a ruling Wednesday that affirmed a lower court's order requiring PointClickCare to allow Real Time Medical Systems to access patient data that it uses to provide nursing facilitie... (more story)

Cannabis Tech Co. Seeks Over $1M Interest On $4.2M Verdict

A software company that won a $4.2 million judgment last year on claims that it was wrongly pushed out of a state government contract is urging a Pennsylvania federal court to award more than $1 million in pre... (more story)

VA Did Not Pre-Select Awardee For $257M Telehealth Contract

A Court of Federal Claims judge has rejected a protest over a $256.8 million U.S. Department of Veterans Affairs telehealth program support contract, saying the protester hadn't shown the VA "pre-selected" the... (more story)

Look To Recent FDA Trends For Drug Ad Guidance, Attys Say

Following campaign-season promises about banning drug advertising on television, the pharmaceutical industry is closely watching for signs of tighter enforcement. Food and drug attorneys caution against overlo... (more story)

Latham-Led Physical Therapy Startup Hinge Health Files IPO

Artificial intelligence-focused physical therapy startup Hinge Health Inc. on Monday filed plans for an initial public offering, represented by Latham & Watkins LLP and underwriters counsel Davis Polk & Wardwe... (more story)

GAO Says NIH Treated Bidders Disparately On $20M IT Deal

The U.S. Government Accountability Office has sustained a protest over a $19.9 million National Institutes of Health software development task order, finding the NIH unreasonably treated similar aspects of the... (more story)

Policy & Compliance More

Ga. Panel Says COVID-Era Legal Shield Blocks Amputee's Suit

A divided Georgia Court of Appeals on Friday said a trial court should have dismissed a wrongful amputation suit against a Marietta hospital, holding that the patient who lost his right leg after being admitte... (more story)

Md. Judge Joins Calif. In Reversing Federal Workers' Firing

A Maryland federal judge has ordered the reinstatement of thousands of probationary employees who were abruptly fired from 18 federal agencies, saying the Trump administration's lack of required notice left st... (more story)

NC Ex-Doctor Gets 2.5 Years For Drug Test Billing Scheme

A 72-year-old doctor in North Carolina was sentenced Friday to two and a half years in prison and ordered to hand over $2 million in restitution for a fraudulent billing scheme involving medically unnecessary ... (more story)

FTC Urges 8th Circ. Not To Pause Insulin Pricing Case

The Federal Trade Commission has urged the Eighth Circuit not to pause its in-house case accusing Caremark Rx, Express Scripts and OptumRx of artificially inflating insulin prices, telling the appeals court th... (more story)

Dr. Oz Pledges 'Upcoding' Crackdown If Confirmed At CMS

Dr. Mehmet Oz told lawmakers he would combat rising healthcare costs by showing there's a "new sheriff in town" opposed to so-called upcoding by Medicare Advantage plans, as he sought support Friday for his no... (more story)

Sutter Health Reaches $4.3M Deal To End Retirement Suit

Nonprofit healthcare system Sutter Health will pay $4.3 million to settle a class action from workers alleging their employee retirement plan was saddled with excessive fees and poorly performing investments, ... (more story)