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Health
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August 29, 2024
Pacira To Appeal Generic's Win In Pain Drug Patent Fight
Pacira Pharmaceuticals Inc. says it is appealing a New Jersey federal judge's decision invalidating its patent on a nonopioid painkiller and opening the way for generic versions of its drug Exparel, a long-acting injectable for managing postsurgical pain.
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August 29, 2024
Convicted Drexel Prof Says Records Would've Swayed Jury
A Drexel University accounting professor convicted on charges of tax evasion and filing false tax returns after the government accused him of failing to report $3.3 million in income from a Trenton pharmacy has asked a New Jersey federal judge for a new trial.
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August 29, 2024
Conn. ER Docs Ask To Drop Harvard Pilgrim Insurance Fight
A staffing company covering six Connecticut emergency rooms has asked a federal judge to dismiss its lawsuit against Harvard Pilgrim Health Care of Connecticut Inc. after the state's highest court last week ruled in the insurer's favor on three certified questions of law regarding a surprise billing statute.
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August 29, 2024
HHS Withdraws Appeal In Hospital Web-Tracking Clash
The Biden administration on Thursday abandoned its appeal of a federal court decision that knocked down new guidance restricting how hospitals can use web-tracking tools, handing the American Hospital Association a victory in a closely watched case.
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August 29, 2024
Full 11th Circ. Won't Rehear Ala. Trans Care Ban Challenge
The Eleventh Circuit said it will not reconsider its ruling allowing Alabama to enact a ban on certain gender-affirming medical care for minors, knocking down a challenge brought by parents and those who received the treatment of the circuit's ruling, which found that the ban doesn't flout constitutional rights.
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August 29, 2024
Houston Law Firm Hit With 2nd Data Breach Suit
Houston personal injury firm Fleming Nolen & Jez has been hit with another proposed class action over a February 2023 data breach that exposed clients' personal and health information.
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August 29, 2024
GOP States Ask Justices To Undo Trans Patients' 4th Circ. Win
A group of two dozen Republican attorneys general told the U.S. Supreme Court it should review a Fourth Circuit decision barring West Virginia and North Carolina from excluding coverage of gender-affirming medical care for transgender people, arguing states need the power to control controversial nascent treatments.
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August 29, 2024
Man Gets Prison In Journalist Harassment Case
A man who pled guilty to his role in a scheme to harass two New Hampshire Public Radio journalists was sentenced to two years and three months in prison.
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August 28, 2024
CVS Can't Avoid Federal Claims In $200M FCA Suit
A former CVS Health compliance director can pursue claims the company and its subsidiaries pocketed more than $200 million in overpayments, after an Illinois federal judge on Monday tossed several other claims from a qui tam suit alleging various schemes by CVS to take money from the government.
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August 28, 2024
9th Circ. Overturns Rule Mandating Sealing Of Health Records
A Ninth Circuit panel found Wednesday that Hawaii state court rules mandating the automatic sealing of medical and health records in civil and criminal proceedings are unconstitutionally overbroad.
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August 28, 2024
Dr.'s Suit Blames Practice's Buyer For Chaos After Sale
A North Carolina doctor struck back in a lawsuit blaming him for business challenges following the sale of his practice to another physician, alleging in counterclaims that the purchasing physician lied about his intentions for the practice and ultimately led it to ruin.
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August 28, 2024
SEC Says Repeat Offenders Ran Medical Co. Investment Scam
The U.S. Securities and Exchange Commission has reached a settlement with one of two men it accused of inflating the price of a healthcare company before an initial public offering with a shell company, saying he has violated a trading bar from the agency's previous suit against him.
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August 28, 2024
Suit Against BCBS Unit Over COVID-19 Test Claims Tossed
A Florida federal judge on Wednesday nixed a laboratory's lawsuit accusing a Blue Cross Blue Shield unit of violating state and federal laws by underpaying or refusing to pay COVID-19 testing claims during the pandemic.
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August 28, 2024
Walgreens Brass Hid Pharmacy Division Woes, Suit Says
Walgreens' directors and officers have been hit with a derivative suit by a shareholder who says the company and its executives inflated stock value by publicly expressing confidence in the pharmacy division's growth while hiding its struggles adapting to industry hurdles.
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August 28, 2024
NC Hit With Class Action Over Foster Care System In 'Crisis'
North Carolina Gov. Roy Cooper and the state Department of Health and Human Services are to blame for a state foster care system in "crisis," according to a new federal class action alleging that children's rights have been trampled as the Tar Heel State struggles to keep pace with a ballooning foster care population.
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August 28, 2024
11th Circ. Trans Health Redo May Spark Supreme Court Fight
The Eleventh Circuit's recent decision to rehear Georgia county officials' appeal seeking to exclude gender-confirmation surgery from its employee healthcare coverage rekindles an appellate debate on the extent to which Title VII protects transgender workers that could soon reach the U.S. Supreme Court, attorneys say.
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August 28, 2024
Mont. Hospital Pays $11M In FCA Case For Doc's Fake Billing
Nonprofit healthcare center St. Peter's Health will pay nearly $11 million to settle alleged False Claims Act violations stemming from conduct by a former oncology doctor who submitted fraudulent claims to government programs for up-coded cancer treatment services and who double-billed office visits to boost his own salary, according to the U.S. Attorney's Office for the District of Montana.
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August 28, 2024
Del. Justices OK Mid-Case Appeal In Zantac Class Suit
The Delaware Supreme Court on Tuesday said it would hear a mid-case appeal in mass tort litigation over claims that the heartburn drug ranitidine, widely sold under the name Zantac, caused cancer.
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August 28, 2024
NJ Health System Repeats Call For Proskauer DQ
New Jersey health network CarePoint Health Management Associates LLC has redoubled its call for a New Jersey federal judge to disqualify Proskauer Rose LLP from representing competitor RWJBarnabas Health Inc. amid antitrust claims brought by CarePoint, arguing CarePoint's prior representation by Proskauer is substantially related to the case.
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August 28, 2024
Conn. Dental Practices Settle False Claims Case For $1.7M
Three dental practices in Connecticut and their owners have paid a $1.7 million settlement after federal and state authorities accused them of using an illegal patient recruiting tactic and paying kickbacks that ripped off Medicaid.
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August 27, 2024
Cherokee Nation's Opioid Suit Sent Back To State Court
An Oklahoma federal judge has adopted a magistrate judge's recommendation to send a Cherokee Nation opioid lawsuit against pharmaceuticals distributor Morris & Dickson back to state court, agreeing that the negligence case isn't predicated on a duty arising out of the federal Controlled Substances Act.
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August 27, 2024
Justices Told Gender Care Ban Defies Decades-Old Precedent
A group of transgender adolescents on Tuesday urged the U.S. Supreme Court to overturn a Sixth Circuit decision allowing Tennessee to enforce a state ban on certain medical procedures that they say treats individuals differently based on their assigned sex at birth.
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August 27, 2024
Alaskan Tribal Health Group Hits Feds With $390M Suit
The Alaska Native Tribal Health Consortium is asking a federal district court for at least $390 million in a challenge to the U.S. Department of Health and Human Services that claims the agency refused to pay certain contract support costs to operate its healthcare programs for seven years.
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August 27, 2024
Tenn. Medicaid Program Illegally Cut Off Health Coverage
Tennessee's Medicaid program violated the Medicaid Act, the 14th Amendment and the Americans With Disabilities Act by depriving residents of healthcare coverage, a federal judge has ruled, saying the agency was "lethargic in its response and attempts" to fix an eligibility system replete with issues.
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August 27, 2024
Judges Upend Alaska Airlines Loss, Blame Jury Instruction
A Washington state appeals court on Tuesday threw out a jury verdict granting an Alaska Airlines flight attendant workers' compensation for catching COVID-19 while away from home for her job, in an opinion that said a jury instruction misstated a legal doctrine covering traveling workers.
Expert Analysis
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Series
Teaching Yoga Makes Me A Better Lawyer
Being a yoga instructor has helped me develop my confidence and authenticity, as well as stress management and people skills — all of which have crossed over into my career as an attorney, says Laura Gongaware at Clyde & Co.
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How Clinical Trials Affect Patentability In US And Europe
A comparison of recent U.S. and European patent decisions — concerning the effect of disclosures in clinical trials on the patentability of products — offers guidance on good practice for companies dealing with public use issues and prior art documents in these commercially important jurisdictions, say lawyers at Finnegan.
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Opinion
State-Regulated Cannabis Can Thrive Without Section 280E
Marijauna's reclassification as a Schedule III-controlled substance comes at a critical juncture, as removing marijuana from being subjected to Section 280E of the Internal Revenue Code is the only path forward for the state-regulated cannabis industry to survive and thrive, say Andrew Kline at Perkins Coie and Sammy Markland at FTI Consulting.
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Key Takeaways From FDA Final Rule On Lab-Developed Tests
Michele Buenafe and Dennis Gucciardo at Morgan Lewis discuss potential consequences of the U.S. Food and Drug Administration's recently finalized rule regulating lab-developed tests as medical devices, and explain the rule's phaseout policy for enforcement discretion.
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Examining Illinois Genetic Privacy Law Amid Deluge Of Claims
After a federal court certified an Illinois Genetic Information Privacy Act class action in August, claims under the law have skyrocketed, so employers, insurers and others that collect health and genetic information should ensure compliance with the act to limit litigation risk, say attorneys at Squire Patton.
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Assessing HHS' Stance On Rare Disease Patient Assistance
The U.S. Department of Health and Human Services' recent advisory opinion, temporarily blessing manufacturer-supported copay funds for rare disease patients, carves a narrow path for single-donor funds, but charities and their donors may require additional assistance to navigate programs for such patients, says Mary Kohler at Kohler Health Law.
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Opinion
Feds' Biotech Enforcement Efforts Are Too Heavy-Handed
The U.S. Department of Justice's recent actions against biotech companies untether the Anti-Kickback Statute from its original legislative purpose, and threaten to stifle innovation and undermine patient quality of care, say attorneys at Ropes & Gray.
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Del. Ruling Highlights M&A Deal Adviser Conflict Disclosures
The Delaware Supreme Court recently reversed the Court of Chancery's dismissal of challenges to Nordic Capital's acquisition of Inovalon, demonstrating the importance of full disclosure of financial adviser conflicts when a going-private merger seeks business judgment rule review, say attorneys at Debevoise.
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Action Steps To Address New Restrictions On Outbound Data
Companies should immediately assess all their data-based operations so they can consider strategies to effectively mitigate new compliance risks brought on by recently implemented transaction restrictions, including a Justice Department proposal and landmark data legislation, say attorneys at Wiley.
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E-Discovery Quarterly: Recent Rulings On Text Message Data
Electronically stored information on cellphones, and in particular text messages, can present unique litigation challenges, and recent court decisions demonstrate that counsel must carefully balance what data should be preserved, collected, reviewed and produced, say attorneys at Sidley.
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What CRA Deadline Means For Biden Admin. Rulemaking
With the 2024 election rapidly approaching, the Biden administration must race to finalize proposed agency actions within the next few weeks, or be exposed to the chance that the following Congress will overturn the rules under the Congressional Review Act, say attorneys at Covington.
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Are Concessions In FDA's Lab-Developed Tests Rule Enough?
Although the U.S. Food and Drug Administration's new policy for laboratory-developed tests included major strategic concessions to help balance patient safety, access and diagnostic innovation, the new rule may well face significant legal challenges in court, say Dominick DiSabatino and Audrey Mercer at Sheppard Mullin.
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8 Questions To Ask Before Final CISA Breach Reporting Rule
The Cybersecurity and Infrastructure Security Agency’s recently proposed cyber incident reporting requirements for critical infrastructure entities represent the overall approach CISA will take in its final rule, so companies should be asking key compliance questions now and preparing for a more complicated reporting regime, say Arianna Evers and Shannon Mercer at WilmerHale.
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Series
Swimming Makes Me A Better Lawyer
Years of participation in swimming events, especially in the open water, have proven to be ideal preparation for appellate arguments in court — just as you must put your trust in the ocean when competing in a swim event, you must do the same with the judicial process, says John Kulewicz at Vorys.
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Mid-2024 FCA Enforcement And Litigation Trends To Watch
Reviewing notable False Claims Act trends and enforcement efforts in the last year and a half reveals that healthcare is a key enforcement priority for the U.S. Department of Justice, and the road ahead may bring clarification on Anti-Kickback Statute causation and willfulness standards, along with increased focus on private equity, cybersecurity and self-disclosure, say attorneys at Epstein Becker.