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Health
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August 12, 2024
Fusion Tech Co. Finds GC In Ex-MacAndrews & Forbes Exec
Wisconsin-based SHINE Technologies has found its new top attorney in a veteran in-house leader who previously worked at billionaire investor Ronald O. Perelman's MacAndrews & Forbes Inc.
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August 12, 2024
Big Tobacco To Pay $600M In 'Historic' Mass. Deal
Philip Morris Inc. and RJ Reynolds Tobacco Co. will pay nine-figure sums as part of a $600 million settlement between Massachusetts and major tobacco companies that resolves yearslong disputes about how much the cigarette makers owe, the state attorney general announced Monday.
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August 09, 2024
Takeda Should Face Certified Antitrust Classes, Judge Says
A New York federal judge on Friday recommended certifying two classes of direct purchasers and end payors in consolidated antitrust actions accusing Takeda Pharmaceuticals Co. of unlawfully inflating the price of its diabetes treatment Actos by delaying entry of generic alternatives.
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August 09, 2024
Split 9th Circ. Affirms Ax Of Meta Anti-Vax Censorship Suit
A split Ninth Circuit panel Friday affirmed the dismissal of Children's Health Defense's lawsuit challenging Meta's policy of censoring its anti-vaccine Facebook posts, with the majority concluding that the Robert F. Kennedy Jr.-founded nonprofit failed to show Meta was acting on the government's behalf to state viable constitutional claims.
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August 09, 2024
Delaware Jury Says Fecal Treatment Patents Are Worth $25M
A Delaware federal jury decided Friday that a Swiss drugmaker owes a smaller drug rival at least $25 million in a patent case involving an experimental enema used to treat a particularly deadly form of diarrhea.
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August 09, 2024
Valeant's Legal Gripe A Total 'Nothingburger,' Justices Told
A lawyer who assembled a whistleblower lawsuit against a major pharmaceutical company using publicly available patent board filings says the larger legal question of whether he can do that is way too niche for the U.S. Supreme Court to bother thinking about.
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August 09, 2024
Medicare Drug Price Suit Nixed Over 'Forum Shopping' In Ohio
The Department of Health and Human Services has notched yet another win in litigation challenging the constitutionality of the Medicare drug price negotiation program, securing the dismissal of a suit brought by several chambers of commerce.
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August 09, 2024
DC Circ. Pans Suit Claiming HHS Caused Health Aid Shortage
The D.C. Circuit said Friday that a judge properly dismissed a proposed class action blaming the U.S. Department of Health and Human Services for a lack of home health aides willing to assist Medicare beneficiaries with chronic illnesses, saying the private providers aren't required to accept those patients.
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August 09, 2024
Conn. Hospital Must Give Data To Competitor, Judge Says
Connecticut's Bristol Hospital must turn over a brand survey for use in Saint Francis Hospital and Medical Center Inc.'s antitrust lawsuit against Hartford HealthCare Corp., but the data can be redacted and restricted to attorneys only, a federal magistrate judge ruled Friday.
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August 09, 2024
Biotech Firms Mull Acquisition Offers Amid Shaky IPO Climate
Amid a shaky outlook for initial public offerings, more private biotechnology firms are exploring acquisition offers from larger pharmaceutical companies as a more certain exit strategy, according to experts who advise emerging drug developers.
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August 09, 2024
Wash. Hospital Patients Can't Certify 'Fail Safe' Classes
A Washington federal judge on Friday rejected a certification attempt in a proposed class action accusing a hospital system of incentivizing two of its doctors to perform medically unnecessary surgeries, but said the plaintiffs would have the chance to address the litany of defects by amending their suit.
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August 09, 2024
FDA Rejects Latest Effort To Treat PTSD With MDMA
The U.S. Food and Drug Administration has rejected a new drug application to treat post-traumatic stress disorder with the psychedelic drug MDMA, an entactogen also known as ecstasy or molly, the company that backed the effort announced Friday.
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August 09, 2024
DC Circ. Says Mining Cos. Can't Appeal Retiree Health Win
Four former subsidiaries of the now-defunct coal company Consol Energy Inc. can't challenge an arbitration award that banned unilateral changes to union-represented retirees' health benefits plan, the D.C. Circuit held Friday, saying the ex-subsidiaries weren't parties to the award and aren't injured by it.
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August 09, 2024
Novartis Wants DC Judge To Quickly Block Entresto Generic
Novartis Pharmaceuticals urged a D.C. federal judge Friday to temporarily restrain the U.S. Food and Drug Administration from officially approving a generic version of the company's blockbuster heart failure medication Entresto.
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August 09, 2024
The Long Road To Legalizing Pot In Florida And South Dakota
Voters in Florida and South Dakota will have the opportunity this Election Day to legalize recreational marijuana for adults 21 and over, and while the two efforts vary in their particulars, they both follow years of work by legalizers to craft a proposal that could gain court approval.
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August 09, 2024
Pharmacy Escapes Recklessness Claim In Septic Shock Suit
A Pennsylvania federal judge has dismissed a claim seeking punitive damages from a northern Pennsylvania pharmacist brought by a patient who alleges that her endocrinologist and the pharmacy overprescribed corticosteroids that opened holes in her intestines and subsequently made her go into septic shock and become suicidal.
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August 09, 2024
Aetna Illegally Axed Exec's Disability Benefits, Judge Says
A California federal judge said Aetna was wrong to end an executive's disability benefits after it found he suffered from a mental illness instead of a physical disability, stating the insurer used flawed doctor opinions and may have been motivated by cutting costs.
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August 09, 2024
Wash. AG Says Kroger Refusing To Delay Merger For Ruling
The Washington Attorney General's Office told a state court that Kroger will not agree to put off closing its planned merger with Albertsons until after a final ruling in the state's merger challenge, but the companies say they've already agreed not to finalize the deal until litigation plays out in another state.
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August 09, 2024
Jury's $1M Paralysis Verdict Against Insurer Overturned
A Texas federal judge overturned a jury's verdict and decided an insurer didn't have to cover a $1 million settlement between a former high school gymnast who became quadriplegic after taking LSD and the owners of the home where he ingested the drugs.
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August 09, 2024
Merck To Buy Autoimmune Treatment Drug For Up To $1.3B
Pharmaceutical giant Merck, advised by Hogan Lovells, said Friday it has agreed to buy a novel, investigational, clinical-stage, bispecific antibody used to treat B cell-associated diseases from Goodwin Procter LLP-led Curon Biopharmaceutical for up to $1.3 billion.
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August 09, 2024
Fannie Mae Seeks Memory Care Receiver After $28.3M Default
Fannie Mae asked a federal judge to appoint a receiver for three North Carolina senior living facilities after arguing that borrower Affinity Living Communities defaulted on $28.3 million worth of loans from the government-backed lender by missing three months of payments.
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August 09, 2024
Off The Bench: NCAA Antitrust Woes, Ohio Trans Sports Ban
In this week's Off The Bench, the NCAA still faces pushback from athletes after an NIL settlement, transgender youth athletes in Ohio lost their legislative battle, and the Seventh Circuit set an insurance broker straight on its actions in an NFL team's settlement with a former player.
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August 09, 2024
Trulieve Settles Fired Retail Worker's Race Bias Suit
Florida-based cannabis company Trulieve has agreed to settle a mixed-race former employee's suit alleging he was fired after complaining that a manager repeatedly made racist comments, including calling him a slur, the worker told a Florida federal court.
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August 08, 2024
15 Red-State AGs Sue To Block ACA Coverage For Dreamers
Fifteen states led by Kansas Attorney General Kris Kobach sued the Biden administration Thursday over a new regulation that is expected to allow about 100,000 immigrants brought to the U.S. as children without authorization to enroll in federal health insurance programs through Affordable Care Act exchanges.
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August 08, 2024
4th Circ. Upholds Asylum Denial Over Forced Hospitalizations
The Fourth Circuit on Thursday refused to revive an Indian foreign exchange student's bid for asylum, saying in a published opinion that his multiple involuntary hospitalizations in India and the administration of electroshock therapy to treat diagnosed mental illnesses did not amount to persecution.
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.