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December 03, 2024
9th Circ. Ponders AIDS Generic Drug Reimbursement
A Ninth Circuit panel heard arguments Tuesday on a Seattle pharmacy's dispute with a benefits manager over reimbursements for the generic version of the HIV/AIDS drug Truvada, with one judge asking if the pharmacy was stuck with a lopsided deal, but also questioning if the contract obligated the payments.
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December 03, 2024
J&J's Neosporin Forever Discolored Man's Groin, Suit Says
Johnson & Johnson and its consumer health spinoff were sued in California state court over claims that Neosporin antibiotic ointment badly infected a Los Angeles man's scrotum and permanently discolored his groin.
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December 03, 2024
Chancery Orders Revenue Trust For Healthcare Co. 'Poaching'
A home health company formed through secret poaching by an allegedly disloyal former CEO, two officers and two private equities has been ordered to earmark much of its future revenue to a trust for the corporate victims, in a Delaware Court of Chancery ruling that described the subterfuge as "stunning."
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December 03, 2024
$1B Sandoz Placeholder Bid Needs More Support, Judge Says
A Connecticut federal judge on Tuesday said he cannot force Novartis spinoff Sandoz Inc. to set aside a $1 billion litigation placeholder in a generic drug pricing lawsuit without hearing whether the state attorney general can enforce possible orders in other states where the pharmaceutical company keeps assets.
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December 03, 2024
Wheeling & Appealing: The Latest Must-Know Appellate Action
December's appellate forecast calls for a squall of showdowns in a tiny time period before the holidays, including arguments involving recent U.S. Supreme Court cases, Big Tech's patents and popular purveyors of health food. In addition, winds of change are swirling around the White House's litigation posture and judicial nominations, and we'll quiz you on the latter in this edition of Wheeling & Appealing.
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December 03, 2024
Deaf Patient Drops Henry Ford Health System Bias Suit
A deaf patient has resolved claims that Detroit's Henry Ford Health System discriminated against her when the hospital failed to provide her with American Sign Language interpreters, according to a Monday order.
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December 03, 2024
Vidal Aimed To Put USPTO Rulemaking In The Spotlight
Kathi Vidal's tenure as director of the U.S. Patent and Trademark Office has been marked by dedication to making the agency's decisions and processes more transparent, attorneys said ahead of her mid-December departure.
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December 03, 2024
PE-Backed Anesthesia Giant Can't Duck Antitrust Claims
A New York federal judge refused to nix a Syracuse hospital's antitrust damages claims against North America's largest anesthesia provider, finding the alleged multimillion-dollar costs incurred from understaffing and overpayment can be traced to noncompete agreements locking in anesthesiologists and nurse anesthetists.
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December 03, 2024
4 Mass. State Court Rulings You May Have Missed In Nov.
An age discrimination case was undone by the fine print of an employment agreement, while an "utterly inadequate" document search led to a five-figure sanctions order, among other notable recent decisions in Massachusetts state court.
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December 03, 2024
VA Announces Study On MDMA-Assisted Therapy For Vets
The U.S. Department of Veterans Affairs announced Tuesday it will fund a study on psychedelic-assisted therapy for veterans with post-traumatic stress disorder and alcohol use disorder, alongside researchers from Brown University and Yale University.
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December 03, 2024
Veterans Group Challenges Exclusion From DEA Pot Hearing
A veterans group is challenging the U.S. Drug Enforcement Administration's decision to deny it a spot among 25 participants in hearings exploring whether to reschedule cannabis under the Controlled Substances Act, saying veterans have been deprived of an advocate for a conclusion that would best suit their needs.
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December 03, 2024
NC Mental Health Provider Inks $2.5M Medicaid Fraud Deal
A North Carolina mental health care agency has agreed to pay $2.5 million to resolve civil claims that it defrauded the state's Medicaid program by billing for nonexistent services, the state's attorney general and incoming Gov. Josh Stein announced.
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December 02, 2024
House COVID-19 Probe Points to China 'Lab Leak'
The Republican-led House Select Subcommittee on the Coronavirus Pandemic published the results of its two-year investigation into the origins of the COVID-19 pandemic Monday, concluding that COVID-19 "most likely" emerged from a laboratory in Wuhan, China, and heavily criticizing the Biden administration, Anthony Fauci and left-leaning organizations for their responses.
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December 02, 2024
11th Circ. Axes Failed Med Student's Disability Suit
The Eleventh Circuit on Monday affirmed a win for Florida International University in a dispute with a disabled medical student, ruling that the student's removal was not due to disability discrimination but rather to his failure to meet the minimum academic standards even with accommodations.
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December 02, 2024
Judge Isn't Seeing 'Good Faith' Compliance In Probiotic Feud
A Maryland federal judge said Monday that a drug company is, yet again, failing to make "good faith substantial compliance" with the terms of an injunction that followed a $15 million jury verdict in a dispute over a proprietary probiotic formula.
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December 02, 2024
Newsom Wants $25M For Expected Legal Fights With Trump
California Gov. Gavin Newsom announced Monday that he wants up to $25 million for litigation and legal fights he foresees with the administration of President-elect Donald Trump, kicking off the first day of a special session the state Legislature held at the governor's request after Trump's win.
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December 02, 2024
Kyrie Irving Owes $400K For Retreat Services, Therapist Says
A psychotherapist sued Dallas Mavericks star Kyrie Irving in New York state court alleging he owes nearly $400,000 for services she provided for a North Dakota retreat this past summer, including additional counseling services after one of the participants tragically died during the event.
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December 02, 2024
Hagens Berman Sued For Slice Of Atty Fee From Effexor Deal
A pharmaceutical reseller's in-house counsel and founder lodged a breach of contract suit against Hagens Berman in Mississippi federal court, accusing the law firm of refusing to pay him his share of a $13 million attorney fees award stemming from an antitrust class settlement with Pfizer Inc. unit Wyeth.
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December 02, 2024
GoodRx Inks $25M Deal With Users Over Alleged Data-Sharing
A proposed class alleging GoodRx breached privacy laws by sharing users' sensitive health data with advertisers asked a California federal judge Friday for preliminary approval of a proposed $25 million settlement with the company, saying it still leaves the potential for additional recoveries from co-defendants Meta Platforms, Google and Criteo Corp.
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December 02, 2024
9th Circ. Partially Upholds Block Of Idaho Abortion Travel Ban
A split Ninth Circuit panel on Monday upheld part of a lower court's temporary injunction to an Idaho law that criminalizes helping minors travel out of state to receive abortions without parental permission, finding the "recruiting" portion of the law is unconstitutional.
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December 02, 2024
Heritage's $10M Generic Drugs Deal With AGs Gets 1st OK
A Connecticut federal judge gave his initial approval on Monday to Heritage Pharmaceuticals Inc.'s $10 million settlement agreement with state attorneys general to resolve allegations it took part in an anticompetitive, price-fixing scheme focused on generic drugs.
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December 02, 2024
NY Doctor To Admit Role In Brain Scan Kickback Scheme
A New York doctor has agreed to plead guilty to taking part in a kickback scheme that allegedly billed insurers approximately $1 million for unnecessary brain scans, Massachusetts federal prosecutors said Monday.
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December 02, 2024
DEA Asserts Its Role As Proponent Of Pot Rescheduling Plan
The Drug Enforcement Administration on Monday affirmed it was acting as the proponent of a proposal to loosen federal restrictions on marijuana, and the administrative law judge said supporters of rescheduling would not get an opportunity to cross-examine DEA witnesses.
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December 02, 2024
Healthcare Biz Atty Rejoins Dentons As Partner In Dallas
Dentons announced Monday that an attorney who spent years in-house in the healthcare industry has rejoined the firm as a partner in Dallas to enhance its efforts servicing clients in health insurance regulation and other healthcare matters.
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December 02, 2024
Bankrupt Dental Co. To Repay Customers $4.8M, NY AG Says
Dental telehealth company SmileDirectClub has agreed to pay $4.8 million in refunds to customers who were improperly charged after the company went bankrupt and shut down in 2023, according to a settlement announced Monday by New York Attorney General Letitia James.
Expert Analysis
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Takeaways From Texas AG's Novel AI Health Settlement
The Texas attorney general's recent action against a health tech company marks another step in rapidly proliferating enforcement against artificial intelligence and privacy issues across multiple states, and highlights important risk mitigation considerations for health companies that implement AI systems, say attorneys at Troutman Pepper.
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Class Actions At The Circuit Courts: September Lessons
In this month's review of class action appeals, Mitchell Engel at Shook Hardy identifies practice tips from four recent class certification rulings involving denial of Medicare reimbursements, automobile insurance disputes, veterans' rights and automobile defects.
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Proposed Legislation May Crack Down On Online Drug Ads
A bill recently proposed in Congress could serve as a sea change in how the U.S. Food and Drug Administration regulates drug-related speech, with significant trickle-down effects on various corners of not only the drug industry but also on consumers and providers themselves, say Dominick DiSabatino and Arushi Pandya at Sheppard Mullin.
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Series
Round-Canopy Parachuting Makes Me A Better Lawyer
Similar to the practice of law, jumping from an in-flight airplane with nothing but training and a few yards of parachute silk is a demanding and stressful endeavor, and the experience has bolstered my legal practice by enhancing my focus, teamwork skills and sense of perspective, says Thomas Salerno at Stinson.
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Navigating Restrictions Following Biotech Bill House Passage
Ahead of the BIOSECURE Act’s potential enactment, companies that obtain equipment from certain Chinese biotechnology companies should consider whether the act would restrict their ability to enter into contracts with the U.S. government and what steps they might take in response, say attorneys at Ropes & Gray.
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What's In Colorado's 1st-Of-Its-Kind Neural Privacy Law
Colorado recently became the first U.S. state to directly regulate neurotechnology with new legislation amending the Colorado Privacy Act to specifically protect biological and neural data, offering an example of how lawmakers can tackle the perceived regulation gaps in this area, say attorneys at Goodwin.
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What To Expect From Calif. Bill Regulating PE In Healthcare
A California bill currently awaiting Gov. Gavin Newsom's approval, intended to increase oversight over private equity and hedge fund investments in healthcare, is emblematic of recent increased scrutiny of investments in the space, and may affect transactions and operations in California in a number of ways, say attorneys at Ropes & Gray.
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Why Now Is The Time For Law Firms To Hire Lateral Partners
Partner and associate mobility data from the second quarter of this year suggest that there's never been a better time in recent years for law firms to hire lateral candidates, particularly experienced partners — though this necessitates an understanding of potential red flags, say Julie Henson and Greg Hamman at Decipher Investigative Intelligence.
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Considering Possible PR Risks Of Certain Legal Tactics
Disney and American Airlines recently abandoned certain litigation tactics in two lawsuits after fierce public backlash, illustrating why corporate counsel should consider the reputational implications of any legal strategy and partner with their communications teams to preempt public relations concerns, says Chris Gidez at G7 Reputation Advisory.
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It's No Longer Enough For Firms To Be Trusted Advisers
Amid fierce competition for business, the transactional “trusted adviser” paradigm from which most firms operate is no longer sufficient — they should instead aim to become trusted partners with their most valuable clients, says Stuart Maister at Strategic Narrative.
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Vertex Suit Highlights Issues For Pharma Fertility Support
Vertex Pharmaceuticals' recent lawsuit challenging the U.S. Department of Health and Human Services' interpretation of the Anti-Kickback Statute is influenced by a number of reproductive rights and health equity issues that the Office of Inspector General should address more concretely, including in vitro fertilization and fertility preservation programs, says Mary Kohler at Kohler Health Law.
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Opinion
CMS' New 'Breakthrough' Device Policy Shows Little Promise
The Centers for Medicare & Medicaid Services’ recent procedural notice outlining a new Medicare coverage pathway for breakthrough medical devices will, at best, be a failed experiment and, at worst, result in Medicare beneficiaries denied access to innovative treatments, say attorneys at King & Spalding.
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Assessing Algorithmic Versus Generative AI Pricing Tools
A comparison of traditional algorithmic pricing models and those powered by generative artificial intelligence can help regulators and practitioners weigh the pros and cons of relying on large language models to price products or services, say Maxime Cohen at McGill University, and Tim Spittle and Jimmy Royer at Analysis Group.
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SBA Proposal Materially Alters Contractor Recertification
The Small Business Administration's new proposed rule on recertification affects eligibility for set-aside contracts, significantly alters the landscape for mergers and acquisitions in the government contracts industry, and could have other unintended downstream consequences, says Sam Finnerty at PilieroMazza.
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A Preview Of AI Priorities Under The Next President
For the first time in a presidential election, both of the leading candidates and their parties have been vocal about artificial intelligence policy, offering clues on the future of regulation as AI continues to advance and congressional action continues to stall, say attorneys at Mintz.