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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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SEC's Crypto Statement Offers Clarity On Disclosures
While the crypto industry awaits a definitive rule from the U.S. Securities and Exchange Commission on whether a crypto-asset is a security, its recent guidance provides a road map for registrants seeking to comply with current disclosure requirements and shows the commission is working toward a comprehensive regulatory framework, say attorneys at Debevoise.
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Disparate Impact Theory Lives On Despite Trump Order
Although President Donald Trump's recent executive order directed federal agencies to stop pursuing disparate impact claims, employers may still be targeted by private litigants' claims and should therefore stay alert to the risk that their practices may produce a disparate impact on members of a protected group, say attorneys at Duane Morris.
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Choosing A Road To Autonomous Vehicle Compliance
As autonomous vehicle manufacturers navigate the complex U.S. regulatory landscape, they may opt for different approaches to following federal, state and local rules and laws, as they balance the tradeoffs between innovation, compliance and speed of deployment, say attorneys at Sidley.
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Navigating The Expanding Frontier Of Premerger Notice Laws
Washington's newly enacted law requiring premerger notification to state enforcers builds upon a growing trend of state scrutiny into transactions in the healthcare sector and beyond, and may inspire other states to enact similar legislation, say attorneys at Simpson Thacher.
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Jurisdictional Issues At Play In 9th Circ.'s FCA Trade Case
A decision by the Ninth Circuit in Island Industries v. Sigma Corp. could result in the U.S. Court of International Trade’s exclusive jurisdiction over trade-related FCA cases, a big shift in the enforcement landscape just as tariffs take center stage in trade policy, say attorneys at Haynes Boone.
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Evolving Federal Rules Pose Further Obstacles To NY LLC Act
Following the Financial Crimes Enforcement Network's recent changes to beneficial ownership information reporting under the federal Corporate Transparency Act — dramatically reducing the number of companies required to make disclosures — the utility of New York's LLC Transparency Act becomes less apparent, say attorneys at Pillsbury.
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Deregulation Memo Presents Risks, Opportunities For Cos.
A recent Trump administration memo providing direction to agencies tasked with rescinding regulations under an earlier executive order — without undergoing the typical notice-and-review process — will likely create much uncertainty for businesses, though they may be able to engage with agencies to shape the regulatory agenda, say attorneys at Blank Rome.
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4th Circ. 'Actionable Inaccuracy' Finding Deepens FCRA Split
The Fourth Circuit's March finding in Roberts v. Carter-Young Inc. that an actionable inaccuracy under the Fair Credit Reporting Act can be both legal and factual widens an existing circuit split and should prompt furnishers to review their processes for investigating readily verifiable information, say attorneys at Blank Rome.
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Action Steps To Prepare For Ramped-Up Export Enforcement
In light of recent Bureau of Industry and Security actions and comments, companies, particularly those with any connection to China, should consider four concrete steps to shore up their compliance programs given the administration's increasingly aggressive approach to export enforcement, say attorneys at Gibson Dunn.
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Series
Law School's Missed Lessons: Mastering Discovery
The discovery process and the rules that govern it are often absent from law school curricula, but developing a solid grasp of the particulars can give any new attorney a leg up in their practice, says Jordan Davies at Knowles Gallant.
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DOJ Signals Major Shift In White Collar Enforcement Priorities
In a speech on Monday, an official outlined key revisions to the U.S. Department of Justice’s voluntary self-disclosure, corporate monitorship and whistleblower program policies, marking a meaningful change in the white collar enforcement landscape, and offering companies clearer incentives and guardrails, say attorneys at McGuireWoods.
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Breaking Down 4th Circ. 'Actual Knowledge' Ruling For Banks
A recent decision from the Fourth Circuit finding that banks must have "actual knowledge" to be found liable for losses arising from an automated clearinghouse transfer warns that the more financial institutions know about a name mismatch issue for any particular transaction, the more liability they may face, say attorneys at Katten.
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What New Study Means For Recycling Compliance In Calif.
Companies must review the California recycling agency's new study to understand its criteria for assessing claims of product and packaging recyclability under a law that takes effect next year, and then decide whether the risks of making such claims in the state outweigh the benefits, say attorneys at Keller & Heckman.
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Maneuvering The Weeds Of Cannabis Vertical Integration
The conversation around vertical integration has taken on new urgency as the cannabis market expands, despite federal reform remaining a distant dream, so the best strategy for cannabis operators is to approach vertical integration on a state-by-state basis, say attorneys at Sweetspot Brands.
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Russia Sanctions Spotlight: Divergent Approaches Emerge
With indications of greater divergence and uncertainty in Russia sanctions policy between the U.K., European Union and U.S., there are four general principles and a range of compliance steps that businesses should bear in mind when assessing the impact of a potentially shifting landscape, says Alexandra Melia at Steptoe.