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Compliance
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May 22, 2025
Calif. Docs Bring FDA Stem Cell Regulation Fight To Top Court
Two California clinics that provide stem cell treatments are urging the U.S. Supreme Court to review a Ninth Circuit panel's finding that their treatments are "drugs" subject to Food, Drug and Cosmetic Act regulations.
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May 22, 2025
Justices Urged To Undo Denial Of Fast Track For Gastro Drug
Vanda Pharmaceuticals Inc. is asking the U.S. Supreme Court to reverse the Food and Drug Administration's decision denying fast-track approval for its gastroparesis drug tradipitant, saying it meets the statutory standard for fast-track review as a new treatment with the "potential to address unmet medical needs."
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May 22, 2025
Calif. Judge Likely To Extend Block On Gov't Reorg, Job Cuts
A California federal judge indicated Thursday she'll likely convert her temporary restraining order into a preliminary injunction against President Donald Trump's executive order to reduce the federal workforce, saying the law "seems clear" that presidents cannot issue large-scale agency reductions without congressional approval and "to hold otherwise" would contradict nine previous presidents and 21 congresses.
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May 22, 2025
EpiPen Direct Buyers, Mylan Get Final OK On Antitrust Deal
Mylan Pharmaceuticals' $73.5 million settlement with a class of direct EpiPen buyers has received final approval from a Kansas federal judge, closing out claims from institutional drug resellers that Mylan worked with Pfizer to forestall an EpiPen generic from hitting the market and artificially inflating prices for the emergency injectable.
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May 22, 2025
As Trump Wields FCA, Whistleblowers May See 'Dollar Signs'
The Trump administration's plan to use the False Claims Act to target diversity programs and alleged civil rights fraud steers a well-worn statute into uncharted territory, and could spur significant whistleblower activity amid high-profile battles with Harvard University, BigLaw firms and other institutions, experts told Law360.
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May 22, 2025
Life Insurer Strikes $335K Deal In Data Breach Suit
A woman who said her personal information was potentially compromised in a 2023 data breach at a life insurance and financial planning company asked a Connecticut federal court to sign off on the parties' settlement agreement, which would create a $335,000 settlement fund to resolve her proposed class action.
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May 22, 2025
Ill. AG, Trump Tower Strike $4.8M Deal To End Wastewater Row
Illinois' attorney general announced Thursday that the state has struck a deal with the owners of Trump International Hotel and Tower in Chicago to resolve litigation over the hotel's continual underreporting of the amount of wastewater it discharges into the Chicago River, in violation of environmental laws.
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May 22, 2025
No COVID-19 Coverage For Hotel REIT, Texas Panel Affirms
A group of insurers has no obligation to cover an Austin, Texas-based real estate investment trust's pandemic-related losses, a state appellate court ruled Thursday, finding that a contamination exclusion in the REIT's policies unambiguously bars coverage.
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May 22, 2025
Fla. Man Gets 6 Years For Laundering $1M Into Bitcoin
A Florida man was sentenced Thursday to six years in prison for running a "no questions asked" business that converted more than $1 million into bitcoin to help others — including romance scammers and a drug dealer — hide their funds, federal prosecutors in Massachusetts said.
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May 22, 2025
Federal Gov't Backs States' BlackRock Coal Investments Suit
The federal government on Thursday threw its support behind a case from Texas and several other states that accuses investment groups including BlackRock Inc. of using their energy holdings to drive up coal prices under the guise of environmental concerns.
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May 22, 2025
Neb. Gov. Rejects Letting Districts Tax Outside Property
A Nebraska bill to let some local taxing districts impose taxes on property outside their boundaries, and to create statewide standards for inspections by public housing authorities, was vetoed by the state's governor.
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May 22, 2025
Congress Kills Calif. EV Program Waiver, Other Climate Rules
Congress on Thursday sent President Donald Trump four resolutions undoing U.S. Environmental Protection Agency actions, including the Biden-era approval of California's effort to ban the sale of gas-powered vehicles in the state, drawing a promise of litigation from the state.
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May 22, 2025
Justices Allow Trump To Fire NLRB, MSPB Members, For Now
The U.S. Supreme Court on Thursday ruled two fired members of the National Labor Relations Board and the Merit Systems Protection Board cannot return to work while they challenge President Donald Trump's authority to fire them without cause, handing the president a win in his crusade against a 90-year-old precedent limiting his power to fire employees at independent agencies.
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May 22, 2025
Judge Asks If DEI Is Now 'Homogeneity, Inequity And Exclusion'
A Massachusetts federal judge considering a challenge to the Trump administration's cuts to hundreds of National Institutes of Health grants pressed the U.S. Department of Justice on Thursday for its definition of diversity, equity and inclusion, at one point asking hypothetically whether the government's policy is now "homogeneity, inequity and exclusion."
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May 22, 2025
Michigan Seeks 6th Circ. Rehearing In Enbridge Pipeline Row
Michigan Gov. Gretchen Whitmer has asked the full Sixth Circuit to find she is protected by sovereign immunity from an Enbridge Energy lawsuit to halt her efforts to shut down an oil and natural gas pipeline.
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May 22, 2025
GOP FTC Drops Dems' Pepsi Price Discrimination Suit
The Republican-controlled Federal Trade Commission on Thursday dropped one of the last cases approved by agency Democrats before they handed over the gavel, abandoning a New York federal court complaint accusing Pepsi of giving a big box retailer better terms and promotional payments than smaller competitors.
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May 22, 2025
Silvergate Estate To Chip In For $37.5M Investor Settlement
Silvergate Capital and investors suing over its collapse have reached a $37.5 million deal with a "rare" source of partial funding to resolve claims that the failed crypto-focused bank misrepresented its safeguards against onboarding customers like FTX, the fraud-ridden crypto exchange that made up roughly a sixth of the bank's deposit base.
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May 22, 2025
Conn. AG Targets 'Bootleg' Weight Loss Drug Sellers
Connecticut has launched a consumer protection lawsuit in state court against a Florida-based company and its owner, accusing them of peddling untested and unsafe, research-level, "bootleg" GLP-1 weight loss drugs to customers.
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May 22, 2025
Contractor Settles DOJ's Aircraft Adhesive FCA Allegations
A federal contractor paid to make an external pod to carry communications equipment on military aircraft agreed to pay $512,000 to resolve allegations that it misrepresented or omitted important information regarding the adhesive used in a prototype as well as the testing procedures used on that prototype.
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May 22, 2025
Mass. Justices Say Worker's Raise Doesn't Doom Bias Claim
Massachusetts' top court on Thursday found that an employer may still face a discrimination claim for an alleged retaliatory action for union activity, even if the move left the worker with a pay bump.
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May 22, 2025
Senior FCC Democrat Attends Final Monthly Meeting
Geoffrey Starks, the senior Democrat on the Federal Communications Commission, participated in his last agency meeting Thursday, where he announced he will leave the agency sometime within the next month.
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May 22, 2025
High Court Declines To Narrow Reach Of Federal Fraud Law
The U.S. Supreme Court on Thursday held that using deceptive means to induce a business transaction may still be a crime even if the defendant doesn't seek to cause economic loss, a departure from earlier decisions that have narrowed the scope of federal fraud statutes.
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May 21, 2025
OCC 'Erred Across The Board,' Ex-Wells Fargo Exec Says
A former Wells Fargo risk officer has asked the Eighth Circuit to vacate steep sanctions that a top U.S. regulator imposed over her alleged role in the bank's fake accounts scandal, arguing she has been unfairly scapegoated and unconstitutionally prosecuted.
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May 21, 2025
Fox Accuses Smartmatic Of Destroying 'Critical' Evidence
Fox News on Wednesday called for Smartmatic to be sanctioned, claiming that nearly two-dozen executives and other employees at the voting tech company destroyed "critical" evidence related to the company's defamation case against the television network, an accusation that comes a week after Smartmatic said Fox deleted relevant texts.
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May 21, 2025
Judge Prolongs Pause On Trump's HUD, DOT Grant DEI Limits
A Washington federal judge Wednesday extended a block on federal grant conditions limiting homelessness aid and transportation funding to recipients who align with the Trump administration's policies against diversity and inclusion programming, as nearly two dozen localities joined New York, San Francisco and others challenging the terms.
Expert Analysis
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Series
Adapting To Private Practice: From NY Fed To BigLaw
While the move to private practice brings a learning curve, it also brings chances to learn new skills and grow your network, requiring a clear understanding of how your skills can complement and contribute to a firm's existing practice, and where you can add new value, says Meghann Donahue at Covington.
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Reviewing Trump Admin's Rapid Pro-Crypto Regulatory Pivot
The digital asset industry has received a boost from the explicitly pro-crypto Trump administration, which in its first few months reversed Biden-era rules and installed industry proponents at regulatory agencies, marking one of the biggest regulatory about-faces by a government in recent memory, says Robert Appleton at Olshan Frome.
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7 Considerations For Conducting Drug Clinical Trials Abroad
With continuing cuts to U.S. Food and Drug Administration staffing motivating some pharmaceutical companies to consider developing drugs abroad, it's important to understand the additional risks and compliance requirements associated with conducting clinical studies in other countries, say attorneys at Morgan Lewis.
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Trump's 1st 100 Days Show That Employers Must Stay Nimble
Despite the aggressive pace of the Trump administration, employers must stay abreast of developments, including changes in equal employment opportunity law, while balancing state law considerations where employment regulations are at odds with the evolving federal laws, says Susan Sholinsky at Epstein Becker.
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Cos. Face Enviro Justice Tug-Of-War Between States, Feds
The second Trump administration's sweeping elimination of environmental justice policies, programs and funding, and targeting of state-level EJ initiatives, creates difficult questions for companies on how best to avoid friction with federal policy, navigate state compliance obligations and maintain important stakeholder relationships with communities, say attorneys at Arnold & Porter.
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Top 3 Litigation Finance Deal-Killers, And How To Avoid Them
Like all transactions, litigation finance deals can sometimes collapse, but understanding the most common reasons for failure, including a lack of trust or a misunderstanding of deal terms, can help both parties avoid problems, say Rebecca Berrebi at Avenue 33 and Boris Ziser at Schulte Roth.
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A 2-Step System For Choosing A Digital Asset Reporting Path
Under the Internal Revenue Service's new digital asset reporting regulation, each type of asset may have three potential reporting destinations, so a detailed testing framework can help to determine the appropriate path, says Keval Sonecha at Sonecha & Amlani.
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NEPA Repeal Could Slow Down Environmental Review
As the Trump administration has rescinded the Council on Environmental Quality's long-standing National Environmental Policy Act regulations, projects that require NEPA review may be bogged down by significant regulatory uncertainty and litigation risks, potentially undermining the administration's intent to streamline the permitting process, say attorneys at Mayer Brown.
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Compliance Lessons From Warby Parker's HIPAA Fine
The U.S. Department of Health and Human Services' civil money penalty against Warby Parker highlights the emerging challenges that consumer-facing brands encounter when expanding into healthcare-adjacent sectors, with Health Insurance Portability and Accountability Act compliance being a potential focus of regulatory attention, say attorneys at Saul Ewing.
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5th Circ. Ruling Is Latest Signal Of Shaky Qui Tam Landscape
In his recent concurring opinion in U.S. v. Peripheral Vascular Associates, a Fifth Circuit judge joined a growing list of jurists suggesting that the False Claims Act's whistleblower provisions are unconstitutional, underscoring that acceptance of qui tam relators can no longer be taken for granted, say attorneys at Miller & Chevalier.
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Foreign Countries Have Strong Foundation To Fill FCPA Void
Though the U.S. has paused enforcement of the Foreign Corrupt Practices Act, liberal democracies across the globe are well equipped to reverse any setback in anti-corruption enforcement, potentially heightening prosecution risk for companies headquartered in the U.S., says Stephen Kohn at Kohn Kohn.
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How Attys Can Use A Therapy Model To Help Triggered Clients
Attorneys can lean on key principles from a psychotherapeutic paradigm known as the "Internal Family Systems" model to help manage triggered clients and get settlement negotiations back on track, says Jennifer Gibbs at Zelle.
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A Tale Of Two Admins: Parsing 1st Half Of SEC's FY 2025
The first half of the U.S. Securities and Exchange Commission's fiscal year 2025, which ended March 31, was unusually eventful, marked by a flurry of enforcement actions in the last three months of former Chair Gary Gensler's tenure and a prompt pivot after Inauguration Day, say attorneys at Jones Day.
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How Banks Can Manage Risk As AI Adoption Expands
Following new, supportive comments from financial regulatory leaders about the use of artificial intelligence in the industry, banks may move toward wider, less-tentative adoption of the technology, but will also need to deploy important risk management measures, say attorneys at WilmerHale.
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Medicare Advantage Enforcement Strong Amid Agency Cuts
The second Trump administration's actions thus far suggest that Medicare Advantage enforcement remains a bipartisan focus despite challenges presented by evolving trends in federal agency staffing and resources, say attorneys at Ropes & Gray.