Expert Analysis

To Survive FCA Actions, Small Cos. Must Take Offensive Steps

A fumbled response to False Claims Act allegations can doom lower-middle-market businesses, and with FCA enforceme... (more story)

Record FCA Recoveries Signal Intensified Healthcare Focus

In its recently released False Claims Act statistics, the U.S. government's emphasis on record healthcare recoveri... (more story)

Methods For Challenging State Civil Investigative Demands

Ongoing challenges to enforcement actions underscore the uphill battle businesses face in arguing that a state inv... (more story)

Deals & Corporate Governance More

Novo's $2.1B Vivtex Deal Boosts Obesity Drug Pipeline

Novo Nordisk said on Wednesday it is partnering with Vivtex Corp. on a deal worth up to $2.1 billion to develop drugs for obesity and related conditions, pressing ahead with a weight loss-drug franchise that h... (more story)

8th Circ. Won't Revive Iowa Pathology Lab's Antitrust Claims

The Eighth Circuit has affirmed a lower court ruling that tossed a case accusing Iowa Pathology Associates of monopolizing pathology services in central Iowa, finding the rival never explained why doctors can'... (more story)

Justices Want Natera's Take On CareDx's False Ad Petition

The U.S. Supreme Court on Monday asked for Natera's position on a petition from rival CareDx asking the high court to review a Third Circuit decision that erased a $45 million jury award stemming from CareDx's... (more story)

NJ Watchdog Takes File Fight In Hospital Row To 3rd Circ.

A New Jersey watchdog will take its bid to shield investigative files from discovery in a hospital's antitrust suit to the Third Circuit, according to a court notice.

Ropes, Wilson Sonsini Guide Gilead's $7.8B Arcellx Buy

Gilead Sciences Inc. announced Monday that it has agreed to acquire clinical-stage biotechnology company Arcellx Inc. for $115 per share in cash plus one contingent value right worth $5 per share, reflecting a... (more story)

Taxation With Representation: Freshfields, Simpson Thacher

In this week's Taxation With Representation, science and technology company Danaher Corp. acquires medical technology company Masimo Corp., Covetrus merges with a unit of fellow animal health technology compan... (more story)

Digital Health & Technology More

Abortion Pill Access, Tariff Questions And More In Court

Law360 Healthcare Authority looks at drugmakers' intervention in federal litigation concerning mail-order abortion medication, questions left open by the U.S. Supreme Court's decision striking down tariffs and... (more story)

Meta Pixel Tracking Suit Tossed Over Lack Of Standing

A North Carolina federal judge has ruled that a prospective class of Nurse.com users lacked standing to sue the website's operator for Video Privacy Protection Act violations for allegedly sharing customers' i... (more story)

What FDA Guidance Means For Future Of Health Software

Two significant final guidance documents released by the U.S. Food and Drug Administration last month reflect a targeted effort to ease innovation friction around specific areas, including singular clinical de... (more story)

Neutrogena Paying $4.7M To Settle BIPA Suit Over App

A former Johnson & Johnson subsidiary has agreed to pay $4.7 million to settle a potential class action claiming it unlawfully stored and collected facial scans of people who used its Neutrogena Skin360 tool, ... (more story)

Federal Preemption In AI And Robotics Is Essential

Federal preemption offers a unified front at a decisive moment that is essential for safeguarding America's economic edge in artificial intelligence and robotics against global rivals, harnessing trillions of ... (more story)

Pa. Providers Say They Lost Billions In Change Health Breach

The health payment platform Change Health Inc., which was at the center of the nation's largest healthcare data breach two years ago, is facing a fresh lawsuit from a proposed class of Pennsylvania healthcare ... (more story)

Policy & Compliance More

Ariz., Calif. Lead Suit Over 'Senseless' HHS Vaccine Overhaul

Arizona and California are leading a coalition of states challenging the U.S. Department of Health and Human Services' decision to cut vaccine recommendations for American children, alleging in a lawsuit Tuesd... (more story)

6th Circ. Affirms Dismissal Of Sotera Toxic Gas Investor Suit

The Sixth Circuit on Tuesday affirmed a lower court's dismissal of an investor lawsuit accusing Sotera Health Co. of concealing the carcinogenic nature of a gas used at its sterilization plants, finding Sotera... (more story)

Texas Panel Skeptical That Doctor's Hands Are Property

A Texas appellate court appeared dubious at a claim that a doctor's hands count as personal property in a case accusing a state-owned hospital of healthcare negligence, asking Tuesday what to do with the state... (more story)

How To Read FDA's Flip-Flop On Moderna Flu Vaccine

An unusual FDA reversal on a new flu vaccine is raising alarm bells for health experts and attorneys.

Ariz. Bill To Limit 'No Surprises' Arbitration Offers Put On Hold

A powerful Arizona state lawmaker this week agreed to pause his proposal to establish limits on how much medical providers can seek under the No Surprises Act arbitration system, saying the legislation needs m... (more story)

FDA Expert Panels May Exploit A Legal 'Loophole,' Atty Says

Law360 Healthcare Authority talks to attorney Joseph Daval about the rise of FDA expert panels, federal law, and blurring the lines between expert and stakeholder.