Expert Analysis

DOJ Actions Suggest Expansion Of Healthcare Enforcement

Recent actions by the U.S. Department of Justice and U.S. Food and Drug Administration suggest that federal health... (more story)

New Orphan Drug Law Provides A Key Fix For Pharma Cos.

The Consolidated Appropriations Act enacted last month restores the U.S. Food and Drug Administration's long-stand... (more story)

FDA User Fee Talks Offer Clues On Upcoming Reforms

As the U.S. Food and Drug Administration undergoes the User Fee Act reauthorization process and renegotiates its u... (more story)

Deals & Corporate Governance More

Co.'s Dual Citizenship Doesn't Kill Jurisdiction, 4th Circ. Told

A medical supply company urged the Fourth Circuit on Wednesday to revive its suit against a U.K. company over COVID-19 test kits, arguing the Chinese citizenship of one of its members doesn't destroy a North C... (more story)

Covington, Freshfields Advise On $6.7B Merck Oncology Deal

Merck & Co. said Wednesday it will acquire clinical-stage oncology company Terns Pharmaceuticals Inc. for $53 per share in cash, giving the deal an equity value of $6.7 billion.

Sarepta Urges Full Fed. Circ. To Wipe Out Gene Therapy IP

Sarepta Therapeutics Inc. wants the full Federal Circuit to rethink a decision reviving a University of Pennsylvania gene therapy patent, saying a panel got its analysis of patent eligibility wrong.

ITC Says Hydrafacial Patent Infringed, But Won't Ban Imports

The U.S. International Trade Commission has found that an aesthetics medical device company infringed a Hydrafacial LLC skin treatment patent, but stopped short of enforcing a ban on imports.

Genesis Gets OK For $7.3M Employee Bonus Plan

A Texas bankruptcy judge Tuesday gave Genesis Healthcare permission to pay up to $7.3 million in bonuses to executives and other employees, agreeing with the nursing home chain that the workers are needed to k... (more story)

Eldercare Atty On $110M Verdict After Nursing Home Death

The liability landscape for investors in the long-term care industry shifted with a big-dollar California jury verdict. Law360 talked to plaintiffs counsel Ed Dudensing about the trial and legal accountability... (more story)

Digital Health & Technology More

Biopharma's Brass Hid Anxiety Drug Trial Risks, Investor Says

Vistagen Therapeutics' current and former top brass have been hit with a derivative shareholder suit in California federal court alleging they overstated its clinical trial for a novel, anti-anxiety drug while... (more story)

Imaging Practice Data Breach Class Actions Hit NC Biz Court

A series of putative class actions resulting from a data breach at imaging practice Triad Radiology Associates PLLC hit North Carolina Business Court this week, with a couple of the cases naming hospitals that... (more story)

Jury Doubles Damages Against Meta, Google In LA Bellwether

A California state jury that found Meta and Google liable Wednesday for harming the mental health of a woman who says she became addicted to their social media platforms as a child delivered a second blow late... (more story)

Drug Co. Atara Hit With Investor Suit Over FDA Denial

Drug company Atara Biotherapeutics Inc. has been hit with a proposed class action accusing it of harming investors by not disclosing certain manufacturing problems and research study deficiencies that made it ... (more story)

Novartis Faces Class Suit Over Patient Health Info Disclosure

Drugmaker Novartis collected patients' personal and health information through pharmaceutical marketing websites and transmitted it to third parties including Google using "surreptitious online tracking tools"... (more story)

Pediatric Data Breach Class Action Can Stay In NC Biz Court

A consolidated class action alleging a pediatric medical practice failed to protect minor patients' data from hackers can remain in the North Carolina Business Court, a judge ruled in finding the lawsuits were... (more story)

Policy & Compliance More

Pa. Health Network's $1.15M 401(k) Suit Deal Gets Final OK

A Pennsylvania federal judge gave the green light to a $1.15 million deal resolving a proposed class action alleging a healthcare system misused workers' forfeited employee retirement plan funds and failed to ... (more story)

Insurer Rips Sanctions Bid In Opioid Coverage Dispute

An insurer asked an Illinois federal court to reject a drug wholesaler's bid for sanctions in a dispute over coverage for underlying opioid litigation, saying the accusations that it intentionally destroyed pe... (more story)

Hospital Escapes Ex-Workers' 401(k) Forfeiture, Fund Suit

A New York federal judge on Friday tossed a proposed class action against a healthcare company alleging mismanagement of an employee 401(k) plan, concluding that ex-workers who sued lacked standing to bring so... (more story)

Elanco Beats Investor Suit Over Dog Drug's Reg Challenges

A Maryland federal judge Thursday dismissed a proposed securities class action against Elanco Animal Health Inc. that claimed the animal pharmaceuticals company misled investors about the safety of a canine de... (more story)

DOJ Says NY-Presbyterian Blocked Lower-Cost Health Plans

New York-Presbyterian Hospital is forcing major health insurers to contract with it on an "all-or-nothing" basis, which is driving up healthcare costs in New York City and violates federal antitrust law, the U... (more story)

AbbVie, Novartis Sue Wash. Over New 340B Drug-Pricing Law

Pharmaceutical giants Novartis and AbbVie say a new Washington state law illegally expands drugmakers' obligations to provide deeply discounted medications under the federal government's 340B Drug Pricing Prog... (more story)