Expert Analysis

Trans Care Enforcement Landscape Is Evolving Quickly

The recent coordinated federal effort to reshape pediatric gender-affirming care through enforcement and funding p... (more story)

11th Circ. May Bring Tectonic Shift To FCA Qui Tam Actions

The Eleventh Circuit's upcoming decision in Zafirov v. Florida Medical Associates, assessing whether the False Cla... (more story)

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)

Deals & Corporate Governance More

Justices Told 'Skinny Label' Case Puts Generic Drugs At Risk

The U.S. government, one named sponsor of the Hatch-Waxman Act, a generic-drug industry group and more have warned the U.S. Supreme Court that a decision that allowed a patent case involving a so-called "skinn... (more story)

9th Circ. Undoes $278M Eli Lilly Payment In Insulin Case

The Ninth Circuit ruled against a lower court Wednesday in saying pharmaceutical giant Eli Lilly does not owe $278 million in royalties to an Arizona company for insulin-brands sales, saying an agreement betwe... (more story)

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.

Digital Health & Technology More

Kochava, FTC Near Deal To End Geolocation Privacy Suit

The Federal Trade Commission and Kochava Inc. told an Idaho federal judge Thursday that they have negotiated a final deal to resolve claims alleging the mobile app analytics provider illegally sold geolocation... (more story)

Centene Says Filed Rate Doctrine Dooms RICO, Fraud Claims

Centene Corp. urged an Illinois federal judge Tuesday to grant it partial judgment in a proposed class action by patients alleging the company violated racketeering laws and cheated them out of billions with b... (more story)

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)

Methods For Challenging State Civil Investigative Demands

Ongoing challenges to enforcement actions underscore the uphill battle businesses face in arguing that a state investigation is prohibited by federal law, but when properly deployed, these arguments present a ... (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)

Policy & Compliance More

$95M Kaiser Row Tees Up Challenge For Fund Returns

Kaiser Foundation Health Plan’s lawsuit seeking $95 million in coverage for a recently settled whistleblower action raises an important challenge to policy language that limits coverage for claims related to r... (more story)

Feds Back Pharma In 340B Contract Pharmacy Disputes

State laws that block drugmakers from imposing restrictions on federally funded hospitals and the contract pharmacies they use to dispense discounted drugs under the 340B drug discount program are violating fe... (more story)

Online Abortion Pill Provider Illegally Ships To Texas, AG Says

Texas Attorney General Ken Paxton sued Aid Access, its founder and a California doctor in state court Tuesday alleging they operate an "abortion-by-mail enterprise" that ship abortion-inducing drugs to Texas r... (more story)

White House Cites Fraud, Freezes $259M In Minn. Medicaid

The Trump administration on Wednesday said it would hold back $259.9 million in Medicaid funding for Minnesota as part of what it called an unprecedented effort to combat fraud in programs that support low-income families.

Fla. Court Blocks Doctor Dispensing Rules For Worker Claims

A Florida panel on Wednesday set aside a state agency's proposed rules that would include doctors in a workers' compensation law that gives patients an "absolute choice" over which pharmacist can fill their pr... (more story)

Pakistan Native Pleads Not Guilty To $10M Healthcare Fraud

A native of Pakistan who is living in Texas pled not guilty Wednesday to a Chicago indictment claiming he participated in an alleged $10 million healthcare fraud and money laundering scheme involving fake medi... (more story)