Expert Analysis

Trump's Psychedelics EO Creates A Regulatory Collision

Sponsors pursuing U.S. Food and Drug Administration approval for psychedelic drug access must tackle how to genera... (more story)

A Fed. Circ. Blueprint For Drafting Medical Device Patents

The Federal Circuit's decision in Constellation Designs v. LG last month, among other recent rulings, underscores ... (more story)

AI Regulatory Gaps May Fuel FCA Enforcement Action

The intersection of artificial intelligence and False Claims Act enforcement presents legal risk for government co... (more story)

Deals & Corporate Governance More

Fed. Circ. Restores 2 Patent Suits On Same Standing Issue

The Federal Circuit on Tuesday reinstated a pair of patent infringement suits from patent owners that licensed their intellectual property to other parties, finding that the companies met the minimum constitut... (more story)

Takeda To Pay $13.6M Over Antidepressant Drug Kickbacks

Takeda Pharmaceuticals will pay $13.6 million to end allegations that it caused false Medicaid claims by providing kickbacks to healthcare providers to push prescriptions of its antidepressant drug Trintellix,... (more story)

Med Device Co.'s CEO Touted Growth, Netted $39M, Suit Says

Medical device maker Integer Holdings Corp.'s former CEO overstated growth prospects of a manufacturing program for the company's electrophysiology business, inflating the firm's stock price and allowing him t... (more story)

Takeda Cashed In From Delay Of Generic IBS Drug, Jury Told

Drug buyers urged a Massachusetts federal jury on Thursday to find that Takeda Pharmaceuticals conspired with another drugmaker to keep a generic version of anticonstipation drug Amitiza off the market in orde... (more story)

Beauty Tech Co. Execs Beat Investor Suit For Good

A California federal judge Monday tossed a proposed class action accusing beauty technology firm Cutera and its executives of misleading investors about its acne treatment launch and financial results, finding... (more story)

Judge Probes Cert. For Diverse Worker Class In No-Poach Suit

An Illinois federal judge considering whether to certify a class of former health care employees claiming their wages were suppressed by alleged no-poach agreements between DaVita, UnitedHealth Group's Surgica... (more story)

Digital Health & Technology More

Apple's Fed. Circ. Review Bid Gets Support In Watch Ban Feud

Technology industry groups and an organization that often files patent challenges have thrown their support behind Apple's fight against a Federal Circuit panel's finding that the U.S. International Trade Comm... (more story)

Squires Ends Samsung-Requested IPR Over Related PGR

The Patent Trial and Appeal Board will no longer conduct an inter partes review into the validity of an Omni MedSci wearable device patent, now that there will be a separate post-grant review.

TikTok Says 'Market Exploitation' Doesn't Give NC Jurisdiction

TikTok is pushing the North Carolina Supreme Court to throw out claims by the state's attorney general alleging it deceptively marketed its platform as safe for minors, saying the "market exploitation" theory ... (more story)

Health Co. Wants Kirkland Off IP Case For 'Cardinal Sin'

A healthcare company suing medical technology company Commure Inc. over alleged trade secret theft has said Kirkland & Ellis LLP should be disqualified from representing Commure because the healthcare company ... (more story)

Revised Suit Against Healthcare Data Co. Still Fails, Court Told

A former healthcare data platform chief strategy officer's amended complaint against the employer failed again to justify bringing three out-of-state individuals into the litigation, the company told a North C... (more story)

Med Device Groups 'Overshot' In Fair Use Args, Judge Says

A judge on a D.C. Circuit panel said a set of industry groups covering the advanced medical device industry might have "overshot" in a challenge to a Library of Congress exemption that said use of copyrighted ... (more story)

Policy & Compliance More

Bass Berry Adds Crowell & Moring Healthcare Atty In DC

Bass Berry & Sims PLC has hired a former Crowell & Moring LLP partner, who in her last role represented a healthcare insurer against whistleblower claims that it participated in a kickback scheme involving Med... (more story)

New Suits Target Fed. Loan Rule, CVS 340B Rates And More

Law360 Healthcare Authority looks at new lawsuits targeting a U.S. Department of Education rule limiting loans available to students in nursing and other healthcare programs, CVS reimbursement practices for sa... (more story)

Cigna Can't Knock Out 401(k) Forfeiture, Fund Suit

Cigna can't escape a proposed class action alleging that underperforming investment offerings and misallocated forfeitures in its employee 401(k) plan cost workers millions, after a Pennsylvania federal judge ... (more story)

9th Circ. Reopens Ex-Transit Manager's Vaccine Bias Suit

The Ninth Circuit breathed new life into a Washington transit system manager's lawsuit alleging she was fired for requesting a religious exemption from a county's COVID-19 vaccine requirement, ruling Tuesday t... (more story)

3 Things To Know As Distributors Test Conn. Drug Price Law

The Second Circuit will hear arguments in a suit filed by a wholesale drug distributor group seeking to take down —​​​​​​​ or at least hold up —​​​​​​​ a Connecticut law tying price increases for generics to inflation.

States Sue Over Student Loan Limits On Professional Degrees

A coalition of 24 attorneys general and two governors are challenging a rule recently promulgated by the U.S. Department of Education, alleging in a complaint in Maryland federal court Tuesday that it unlawful... (more story)