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December 19, 2024
Addiction Group Pays $2M In Mass. AG False Billing Probe
An addiction treatment physician group with offices across western Massachusetts will pay $2 million to settle allegations that it overcharged for visits and billed for tests that were not medically necessary, the state's attorney general said Thursday.
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December 18, 2024
Pharma Trial Consultant To Pay SEC $3M Over Insider Trading
An oncologist and clinical professor at the University of California, Irvine agreed to pay the U.S. Securities and Exchange Commission $3 million to resolve allegations he purchased shares in a Massachusetts biotech company based on insider information regarding a clinical trial he was overseeing, the SEC announced Wednesday.
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December 18, 2024
Ex-US Rep. Urges 2nd Circ. To Nix Insider Trading Conviction
Former Indiana Rep. Stephen Buyer on Wednesday urged the Second Circuit to reverse his insider trading conviction or grant him a new trial, saying federal prosecutors violated his Sixth Amendment rights and failed to prove Manhattan was the right place to be tried, which led a pair of circuit judges to voice doubt about the court's standard for establishing venue.
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December 18, 2024
Vaxart Investors Win Class Cert. Over COVID Shot On 2nd Try
A California federal judge has certified a class of Vaxart investors accusing the biotechnology company's onetime controlling shareholder of dumping stock at inflated prices following deceptive headlines about a COVID-19 vaccine, saying the investors' revised motion fixes issues of predominance and the damages model.
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December 18, 2024
Patent Limits For Biosimilar Litigation Lands In Spending Bill
Congress' spending package to keep the government open through March would also limit how many patents a biologics maker can assert when trying to prevent a competitor from getting on the market.
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December 18, 2024
Monsanto Protests DNA Damage Argument In PCB Closings
An attorney in a toxic tort against Monsanto drew a sustained objection from the company's defense during closings Wednesday as he attempted to argue that some of the young girls allegedly exposed to PCBs "will give birth to children with altered DNA," as counsel sparred over whether the plaintiffs suffered "generational harm."
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December 18, 2024
FDA's Gastro Drug Fast-Track Denial Survives DC Circ.
A D.C. Circuit panel upheld federal regulators' refusal to streamline approval of a drug to treat nausea in patients with a chronic gastric condition, ruling that the U.S. Food and Drug Administration was right to consider the drug's development plan when deciding whether it qualified for fast tracking.
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December 18, 2024
Pa. Nursing Home Must Face Resident's Slip-And-Fall Suit
A Pennsylvania appeals court on Wednesday reinstated a suit seeking to hold a nursing home liable for a resident's slip-and-fall injuries due to water that allegedly leaked from her room's ceiling, saying there was insufficient evidence that the home performed monthly checks for roof leaks.
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December 18, 2024
State AGs, Generic Cos. Fight Over Price-Fixing Trial Order
A contingent of state-level enforcers told a Connecticut federal court there is no need to reconsider prioritizing a sprawling generic drug price-fixing case that involves more than 100 medications over a narrower case the drugmakers are asking to have tried first.
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December 18, 2024
Morrison Foerster Cites Tariffs As Key M&A Variable For 2025
International law firm Morrison Foerster LLP is among those citing President-elect Donald Trump's tariff plans as a key wild card that could affect mergers and acquisitions deal flow in 2025, a Wednesday report from the firm shows.
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December 18, 2024
Destroyed Docs Merit Harsher Sanctions, Mich. Panel Says
A Michigan appellate panel on Tuesday said fees awarded to the estate of a man who died after choking in an adult foster care facility were likely too low, finding a lower court erred by limiting the scope of available sanctions over the destruction of "copious amounts" of digital evidence.
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December 18, 2024
Philip Morris Sues FDA Over New Cigarette Warning Labels
Tobacco giant Philip Morris and a group of Georgia convenience store interests have sued the U.S. Food and Drug Administration over a rule that would add graphic warnings to cigarette labels, alleging the agency is exceeding its statutory authority in a move that would mark a "sea change" for the industry.
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December 18, 2024
Judge Eyes Limits To Medical Device Co.'s Poaching Verdict
A Boston federal judge on Wednesday considered interpreting twin $5 million jury awards against medical device sales employees as a subset of the $15 million in damages awarded against their employer in a rival company's poaching case.
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December 18, 2024
CVS Fueled Opioid Epidemic In Rush For Profits, Feds Say
The U.S. Department of Justice unveiled a suit Wednesday accusing CVS, the nation's largest pharmacy chain, of knowingly filling invalid prescriptions for powerful opioids and ignoring internal pleas from its pharmacists as it allegedly put profits over safety.
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December 18, 2024
Amgen Hit With $50M Infringement Verdict Over Leukemia Drug
Germany's Lindis Biotech has persuaded a Delaware federal jury that Amgen should pay $50.3 million in damages for encouraging healthcare providers to infringe the Munich company's immunotherapy patents through administering the leukemia drug Blincyto.
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December 18, 2024
Homeless Woman's Residency Unclear In Inter-Insurer Dispute
A Michigan state appeals court has vacated a trial court order finding the insurer for a homeless woman's parents must cover injuries she suffered after being run over by a semitruck, ruling that questions remain over whether the woman had another established residence.
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December 18, 2024
FTC Wants Express Scripts' Defamation Suit Tossed
The Federal Trade Commission told a Missouri federal court that Express Scripts Inc. has no basis to challenge an interim agency report that only offered "qualified conclusions" from an ongoing study about how pharmacy benefit managers affect prescription drug prices.
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December 18, 2024
Medical Center Escapes COVID Outbreak Blame-Trading Suit
A Michigan state appeals panel nixed a wedding venue's defamation suit alleging it was falsely blamed after several guests at a reception contracted COVID-19, handing a win to a healthcare provider the venue pointed to as the source of the outbreak.
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December 18, 2024
Senate Sends $895B Defense Bill To Biden's Desk
The U.S. Senate on Wednesday easily passed an $895.2 billion defense policy and budget bill for 2025, despite criticism over a contentious clause effectively barring gender-affirming healthcare coverage for service members' transgender children.
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December 18, 2024
Yale Eyes Quick Win In $435M Conn. Hospital Purchase Suit
Yale New Haven Health Services Corp. has asked a Connecticut state court judge for permission to file a summary judgment motion in a feud with Prospect Medical Holdings Inc. over the sale of several hospitals in the state, saying Prospect's "stunning" failure to fund pensions and pay taxes resulted in property liens that breached the $435 million deal.
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December 18, 2024
SiteOne Gets $100M To Advance Non-Opioid Pain Treatments
SiteOne Therapeutics Inc., a biopharmaceutical company focusing on pain treatment, on Wednesday announced that it clinched a Series C funding round after securing $100 million from investors.
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December 18, 2024
Top Conn. Cases Of 2024: Kickbacks, Paybacks And Bribes
Judges and juries in Connecticut awarded several multimillion-dollar verdicts against companies big and small in 2024, socking Johnson & Johnson in a talc case in which the already substantial damages could multiply and ordering a pharmacy that paid kickbacks to cough up nearly four times the money it cost the state.
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December 18, 2024
Justices Will Decide If Medicaid Recipients Can Pick Providers
The U.S. Supreme Court on Wednesday partially granted the state of South Carolina's petition to review a Fourth Circuit decision blocking its Medicaid program from ending its provider agreement with Planned Parenthood, agreeing to determine if the Medicaid Act allows a beneficiary to choose a specific provider.
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December 17, 2024
NC Panel Revives Negligence Suit Against State Health Dept.
An adult care center's constitutional claims accusing the North Carolina Department of Health and Human Services of negligently asserting bogus penalties and unfairly suspending admissions at the facility are timely, a North Carolina state appellate panel ruled Tuesday, reviving a case that previously landed before the North Carolina Supreme Court.
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December 17, 2024
UNC Doctor Can't Shield Minor Transgender Patients' Records
A University of North Carolina doctor cannot assert privilege over medical records sought from the university by state Republicans fighting a suit by the physician and others seeking to enjoin a law imposing limits on transgender care for minors, a federal magistrate judge has ruled.
Expert Analysis
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Mental Health Parity Rules: Tips For Plans And Issuers
Following federal agencies' release of final mental health parity rules, plan sponsors and health insurance issuers should develop protocols for preparing compliant nonquantitative treatment limitation comparative analyses, say attorneys at Ropes & Gray.
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Series
Playing Diplomacy Makes Us Better Lawyers
Similar to the practice of law, the rules of Diplomacy — a strategic board game set in pre-World War I Europe — are neither concise nor without ambiguity, and weekly gameplay with our colleagues has revealed the game's practical applications to our work as attorneys, say Jason Osborn and Ben Bevilacqua at Winston & Strawn.
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Mental Health First Aid: A Brief Primer For Attorneys
Amid a growing body of research finding that attorneys face higher rates of mental illness than the general population, firms should consider setting up mental health first aid training programs to help lawyers assess mental health challenges in their colleagues and intervene with compassion, say psychologists Shawn Healy and Tracey Meyers.
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Opinion
FTC's Report Criticizing Drug Middlemen Is Flawed
The Federal Trade Commission's July report, which claims that pharmacy benefit managers are inflating drug costs, does not offer a credible analysis of PBMs, and its methodology lacks rigor, says Jay Ezrielev at Elevecon.
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Series
Collecting Art Makes Me A Better Lawyer
The therapeutic aspects of appreciating and collecting art improve my legal practice by enhancing my observation skills, empathy, creativity and cultural awareness, says attorney Michael McCready.
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Plan Sponsors Must Prep For New Mental Health, Drug Rules
To comply with newly published health insurance rules requiring parity between access to mental health and substance use services compared to medical and surgical services, employers with self-insured plans will need to update third-party administrator agreements and collect data, among other compliance steps, say attorneys at Kilpatrick.
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Navigating The Complexities Of Cyber Incident Reporting
When it comes to cybersecurity incident response plans, the uptick in the number and targets of legal and regulatory actions emphasizes the necessity for businesses to document the facts underlying the assumptions, complexities and obstacles of their decisions during the incident response, say attorneys at Troutman Pepper.
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Takeaways From Novo Nordisk's Fight For Market Exclusivity
Generic competitors’ challenge to Novo Nordisk’s patents in hopes of capturing a portion of the rapidly expanding Type 2 diabetes and obesity treatment market highlights the role of abbreviated new drug application litigation, inter partes review and multidistrict litigation in patent defense, says Pedram Sameni at Patexia.
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Secret Service Failures Offer Lessons For Private Sector GCs
The Secret Service’s problematic response to two assassination attempts against former President Donald Trump this summer provides a crash course for general counsel on how not to handle crisis communications, says Keith Nahigian at Nahigian Strategies.
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A Primer On Navigating The Conrad 30 Immigration Program
As the Conrad 30 program opens its annual window to help place immigrant physicians in medically underserved areas, employers and physicians engaged in the process must carefully understand the program's nuanced requirements, say Andrew Desposito and Greg Berk at Sheppard Mullin.
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Defending AI, Machine Learning Patents In Life Sciences
Ten years after the U.S. Supreme Court's decision in Alice v. CLS Bank, artificial intelligence and machine learning technology remain at risk for Alice challenges, but reviewing recent cases can help life sciences companies avoid common pitfalls and successfully defend their patents, say attorneys at Mintz.
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Litigation Inspiration: Honoring Your Learned Profession
About 30,000 people who took the bar exam in July will learn they passed this fall, marking a fitting time for all attorneys to remember that they are members in a specialty club of learned professionals — and the more they can keep this in mind, the more benefits they will see, says Bennett Rawicki at Hilgers Graben.
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FTC Focus: How Scrutiny Of PBMs And Insulin May Play Out
Should Express Scripts' recent judicial challenge to the Federal Trade Commission succeed, any new targets could add litigation and choice of forum to their playbooks, and potential FTC court action on insulin could be forced to parallel venues as the issues between the commission and PBMs evolve, say attorneys at Proskauer.
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Opinion
AI May Limit Key Learning Opportunities For Young Attorneys
The thing that’s so powerful about artificial intelligence is also what’s most scary about it — its ability to detect patterns may curtail young attorneys’ chance to practice the lower-level work of managing cases, preventing them from ever honing the pattern recognition skills that undergird creative lawyering, says Sarah Murray at Trialcraft.
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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.