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March 22, 2024
Judge Cuts ICE Contractor, Keeps US In Medical Abuse Suit
A Georgia federal judge on Friday left standing only a narrow sliver of class claims against the federal government from immigrant women alleging they underwent invasive, unnecessary medical procedures while in federal custody, dismissing the bulk of their lawsuit.
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March 22, 2024
$900M Trade Secrets Case Against Kaiser Foundation Flops
A California state judge has ruled that, after more than five years of litigation against the Kaiser Foundation, a pastor's small medical technology startup cannot "explain what was unique or secret about its conception for transmitting patient data" that was purportedly worth beyond $900 million.
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March 22, 2024
Final OK Sought For Economic Loss Deal In CPAP Recall MDL
Users of Philips' recalled CPAP breathing machines have asked a Pennsylvania federal judge to give her final OK to their $467.5 million settlement with the company to cover economic loss claims, arguing only a few objections to the deal remain.
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March 22, 2024
Kaiser's Ozempic Coverage Denial Is Discriminatory, Suit Says
Two Kaiser plans' refusal to cover new prescription weight loss drugs like Ozempic and Wegovy is "without any medical or scientific basis," a Washington state resident told a state court, alleging disability discrimination.
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March 22, 2024
Detroit Hospital, Deaf Patient Can't Avoid Trial In Disability Suit
Detroit's Henry Ford Health System may face a jury trial in a deaf patient's lawsuit claiming she was denied an American Sign Language interpreter, with a Michigan federal judge refusing to grant summary judgment to either the hospital or the patient.
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March 22, 2024
US Trustee Says Fla. Healthcare Co. Can't Seal Stock Sale Bid
The U.S. Trustee's Office has urged a Delaware bankruptcy judge to deny a Miami-based primary healthcare group's request in its Chapter 11 case to redact information in the debtor's motion to sell its shares in a healthcare claims reimbursement servicer.
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March 22, 2024
Vanda's Obviousness Appeal Isn't Worthwhile, Teva Tells Justices
Teva Pharmaceuticals and Apotex have said the U.S. Supreme Court should reject a petition from Vanda Pharmaceuticals, which said the Federal Circuit "charted its own course" when it invalidated its sleep drug patents as obvious.
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March 22, 2024
FCC Ready To Propose Local Georouting For 988 Calls
The Federal Communications Commission is preparing to take action to make sure that calls coming into the 988 Suicide and Crisis Lifeline are being routed to the nearest call center and not another one states away.
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March 22, 2024
6th Circ. Says Fired Doctor Got Enough Due Process
The Sixth Circuit backed two Ohio healthcare companies and Wright State University's early wins against a former resident doctor's claims that she was improperly fired for unprofessional conduct, stating that all the parties involved engaged in "more than enough due process" before terminating her.
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March 22, 2024
High Court Mifepristone Battle Goes Beyond Abortion
The first major abortion battle to reach the U.S. Supreme Court since the Dobbs decision is about a lot more than abortion.
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March 22, 2024
Ex-Ga. Insurance Head Cops To Healthcare Kickback Scheme
Former Georgia Insurance Commissioner John Oxendine pled guilty Friday to working with an Atlanta-area doctor to run a multimillion-dollar medical testing kickback scheme just weeks before he was set to face trial in federal court.
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March 22, 2024
Congress Spares Employee Benefits From $400M DOL Cut
A commitment from Congress to keep funding level for the U.S. Department of Labor's sub-agency that oversees employee benefits despite a $400 million agency-wide cut was one of the highlights for benefits attorneys in a new fiscal year 2024 spending deal. Here are three takeaways from attorneys on the funding agreement.
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March 22, 2024
Calif. Releases Interim Guidelines On GenAI Use
The state of California on Thursday released interim guidelines for public-sector procurement, uses and training of generative artificial intelligence by state leaders in preparation for all state agencies to consider pilot projects using the technology by July, per Gov. Gavin Newsom's executive order issued last year.
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March 22, 2024
Ex-Drug Rep Won't Serve More Time After 1st Circ. Victory
The second sentencing of a former Aegerion Pharmaceuticals Inc. salesman did not add a day in prison to the roughly seven months he served before the First Circuit wiped away his initial conviction on charges he schemed to fraudulently sell the company's cholesterol treatment.
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March 22, 2024
Del. Courts Examining 'Colonoscopy'-Like Bylaw Rules
Invasive advance-notice bylaws that some observers say make shareholder board nominations as intrusive as a "colonoscopy" are reviving old questions in Delaware courts about how far boards can go to protect themselves against shareholder activism.
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March 22, 2024
LifeCell Cleared Of Liability In NJ Strattice Hernia Mesh Trial
New Jersey state jurors on Friday cleared LifeCell of liability in a Kentucky woman's suit alleging the design of its Strattice surgical mesh is defective and caused a hernia to reoccur and ultimately resulted in "life-altering" surgery, giving the medical device company the first win in a venue with at least 93 pending cases with tort claims over the mesh.
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March 21, 2024
SEC's 'Shadow Trading' Trial To Test Insider Info Boundaries
If the U.S. Securities and Exchange Commission can convince jurors hearing its first-ever "shadow trading" case next week to find a former executive in the wrong for buying up a competitor's securities while having insider information about his own company, the floodgates could open to civil and criminal prosecution of other corporate insiders under the novel legal theory, attorneys told Law360.
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March 21, 2024
5th Circ. Backs FDA's Vivid Warnings Of Cigarette Dangers
Government mandated text warnings and graphic images on cigarette packs to advertise the health risks of smoking do not violate the free speech rights of R.J. Reynolds Tobacco Co. and other cigarette manufacturers, the Fifth Circuit ruled Thursday, saying the warnings are "factual and uncontroversial" and pass constitutional muster.
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March 21, 2024
Schumer Urges Texas District To Adopt Judge-Shopping Rule
Senate Majority Leader Chuck Schumer on Thursday urged the chief judge of the Northern District of Texas to quickly implement the Judicial Conference of the United States' updated policy that looks to prevent litigants from judge shopping, arguing that the district's current practices are "dangerous."
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March 21, 2024
Ill. Judge Leaves Outcome Health Execs' Convictions Intact
An Illinois federal judge said Thursday that he wouldn't disturb three former Outcome Health executives' convictions for carrying out a massive billion-dollar fraud scheme to grow their health advertising business, saying the jury heard enough evidence to support its verdict.
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March 21, 2024
MDL Claims Over Merck's Gardasil Vax Get Trimmed
Pharmaceutical giant Merck need not face many of the claims by patients who allege their autoimmune conditions were caused by its HPV vaccine, a North Carolina federal judge overseeing multidistrict litigation ruled, saying the National Childhood Vaccine Injury Act bars most claims made in the first two bellwethers.
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March 21, 2024
Wash. Judge Says Debt Collector Owes $827K For Violations
A Washington state judge has ordered a medical debt collector to pay more than $827,000 in penalties for failing to include certain debtor's rights information in collection notices sent to tens of thousands of Washingtonians for outstanding balances tied to Providence Health & Services hospitals.
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March 21, 2024
Cigna Slams Suit's Claims Of Algorithm-Led Coverage Denials
Insurance giant Cigna Group wants a Connecticut federal court to toss a proposed class action alleging that an algorithm unlawfully rejected hundreds of thousands of claims en masse and without a proper review, arguing the suit is based on a "misleading" news article and shows a misunderstanding of the health insurer's claim denial process.
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March 21, 2024
UpHealth Claims $110M Win In Glocal Control Fight
Global digital health company UpHealth Inc. says an arbitral panel has awarded it more than $110 million following a dispute that arose out of its subsidiary's acquisition of Glocal Healthcare Systems in 2020 — even as Glocal decried the award as "one-sided and perverse."
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March 21, 2024
Tribe's Opioid Suit Can Head To State Court, Okla. Judge Says
An Oklahoma federal magistrate judge has granted the Cherokee Nation's bid to move to state court its suit accusing pharmaceuticals distributor Morris & Dickson of flooding the tribe's communities with opioids, saying the company only fulfilled one of four prongs necessary for establishing federal jurisdiction.
Expert Analysis
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Earnout Contract Considerations After NC Good Faith Ruling
The North Carolina Supreme Court's recent Value Health Solutions v. Pharmaceutical Research decision, holding the implied covenant of good faith and fair dealing did not apply in an earnout dispute related to an asset sale, demonstrates the need for practitioners to pay careful attention to milestone concepts in M&A transactions, says Benjamin Hicks at Wagner Hicks.
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FDA's Off-Label Comms Guidance Is A Reluctant Step Forward
The U.S. Food and Drug Administration's latest draft guidance expands its safe harbor for health care providers that communicate information about their products' off-label uses, but does not fully resolve the First Amendment disconnect between federal courts and the agency's regulatory goals, say Jeffrey Shapiro and Lisa Dwyer at King & Spalding.
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White House AI Order Balances Innovation And Regulation
President Joe Biden’s recently issued executive order on artificial intelligence lays out a sprawling list of directives aimed at establishing standards for safety, security and privacy protection, and may help strike the balance between the freedom to innovate and the need to impose regulation in this rapidly evolving space, say Kristen Logan and Martin Zoltick at Rothwell Figg.
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How Biden's AI Order Stacks Up Against Calif. And G7 Activity
Evaluating the federal AI executive order alongside the California AI executive order and the G7's Hiroshima AI Code of Conduct can offer a more robust picture of key risks and concerns companies should proactively work to mitigate as they build or integrate artificial intelligence tools into their products and services, say attorneys at Jenner & Block.
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Reading Between The Lines Of HHS' National Lab Opinion
The U.S. Department of Health and Human Services' Office of Inspector General recently rejected a national laboratory's request to pay a referring lab to process specimens, but the request might have been an attempt to exploit the OIG's advisory opinion process for a competitive advantage, says Mary Kohler at Kohler Health Law.
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ITC Ban On Apple Watch Could Still Be Reversed
The U.S. International Trade Commission's recent final decision that the Apple Watch infringed two patents owned by Masimo Corp. was a rare instance of a popular consumer product being hit with an absolute importation ban, but it's possible that President Joe Biden could assert his power to reverse the ITC decision, says Benjamin Horton at Marshall Gerstein.
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A Closer Look At Proposed HHS Research Misconduct Rule
The U.S. Department of Health and Human Services' proposed updates to its policies on research misconduct codify many well-known best practices, but also contain some potential surprises for the research community and counsel, say attorneys at Hogan Lovells.
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Handling Religious Objections To Abortion-Related Job Duties
While health care and pharmacy employee religious exemption requests concerning abortion-related procedures or drugs are not new, recent cases demonstrate why employer accommodation considerations should factor in the Title VII standard set forth by the U.S. Supreme Court’s 2023 Groff v. DeJoy ruling, as well as applicable federal, state and local laws, say attorneys at Epstein Becker.
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Why Hemp-Synthesized Intoxicants Need Uniform Regs
State laws regulating hemp-synthesized intoxicants are a patchwork with little consistency between any given state, and without the adoption of a uniform regulatory framework, producers and consumers alike will need to be very cautious, say Dylan Anderson and Seth Goldberg at Duane Morris.
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Opinion
Life Sciences Regulators Must Write Cloud-Specific Guidance
As cloud services continue to revolutionize the life sciences industry's ability to conduct regulated activities, the U.S. Food and Drug Administration and other regulators should update their data management policies to clearly support and encourage use of cloud technology, say Nate Brown and Marlee Gallant at Akin.
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Attorneys, Law Schools Must Adapt To New Era Of Evidence
Technological advancements mean more direct evidence is being created than ever before, and attorneys as well as law schools must modify their methods to account for new challenges in how this evidence is collected and used to try cases, says Reuben Guttman at Guttman Buschner.
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The Self-Funded Plan's Guide To Gender-Affirming Coverage
Self-funded group health plans face complicated legal risks when determining whether to cover gender-affirming health benefits for their transgender participants, so plan sponsors should carefully weigh how federal nondiscrimination laws and state penalties for providing care for trans minors could affect their decision to offer coverage, say Tim Kennedy and Anne Tyler Hall at Hall Benefits Law.
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Series
ESG Around The World: The UK
Following Brexit, the U.K. has adopted a different approach to regulating environmental, social and governance factors from the European Union — an approach that focuses on climate disclosures by U.K.-regulated entities, while steering clear of the more ambitious objectives pursued by the EU, say attorneys at Dechert.
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3 Tips For Defending Against Data Breach Litigation
As cyberattacks become more prevalent, companies responding to data breaches must consider several strategies to better position themselves in the event of litigation even during their preliminary investigations and breach notifications, say attorneys at Davis Wright.
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Tips For Litigating Against Pro Se Parties In Complex Disputes
Litigating against self-represented parties in complex cases can pose unique challenges for attorneys, but for the most part, it requires the same skills that are useful in other cases — from documenting everything to understanding one’s ethical duties, says Bryan Ketroser at Alto Litigation.