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

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)

Justices Urged To Bar Passive Infringement For Skinny Labels

The Federal Circuit cleared the path for branded-drug makers to claim a rival induced infringement of a patent without taking any active steps to do so, Hikma told the U.S. Supreme Court in a case over so-call... (more story)

Digital Health & Technology More

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)

California's New Privacy Laws Demand Preparation From Cos.

An increase in breach disclosures is coinciding with California's most comprehensive privacy and artificial intelligence legislation taking effect, illustrating the range of vulnerabilities organizations in th... (more story)

Policy & Compliance More

AbbVie Tests Exclusion Strategy In Drug Price Fight

Following a series of drugmaker losses in suits challenging Medicare drug price negotiations, AbbVie Inc. is trying something new in a challenge focused on Botox and a legal exclusion for drugs made from human plasma.

AstraZeneca Drug Price Challenge Falls Short In Hawaii

A federal judge in Hawaii temporarily upheld the state's law that prevents drug manufacturers from blocking safety-net hospitals from contracting with an unlimited number of outside pharmacies to dispense disc... (more story)

DC Circ. Talks Sharks, Moats In Vertex HHS Kickback Appeal

Sharks and moats were top of mind Monday morning for one judge on the D.C. Circuit, as gene therapy drugmaker Vertex Pharmaceuticals attempted to convince the court that its fertility preservation program does... (more story)

Zynex Faces Securities Suit Following Arrest Of Former Execs

After being arrested last month on charges of securities fraud and conspiracy, the former CEO and ex-chief compliance officer of bankrupt medical device maker Zynex have been hit with a securities class action... (more story)

Ferguson Braswell Adds Healthcare Practice With 2 In Texas

Ferguson Braswell Fraser Kubasta PC announced Monday that it has opened a healthcare practice with a pair of new shareholders in Houston, expanding the firm's corporate platform.

DOJ Says Ohio Health System's Contracts Violate Antitrust

The U.S. Department of Justice and Ohio's attorney general's office sued OhioHealth Corp. Friday in federal court, accusing the healthcare system of using contractual restrictions to block insurers from offeri... (more story)