Policy & Compliance
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February 25, 2025
1st Circ. Decision Adds To Defense Momentum In FCA Clash
A First Circuit decision extended a winning streak for the False Claims Act defense bar. The decision's ultimate impact on fraud prosecutions will be shaped by how whistleblowers adjust their legal strategy.
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February 24, 2025
PBMs To Challenge FTC Case At 8th Circ., But Without Pause
A Missouri federal judge summarily refused, again, on Monday to temporarily block the Federal Trade Commission's in-house case accusing Caremark Rx, Express Scripts and OptumRx of artificially inflating insulin prices, letting the case proceed while the pharmacy benefits managers appeal to the Eighth Circuit.
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February 24, 2025
Feds Fight Reinstatement Of Ousted Inspectors General
The Trump administration fired back at a lawsuit brought by eight inspectors general who were fired last month, telling a D.C. federal judge that federal law does not require the president to hold off on the terminations for 30 days after notifying Congress.
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February 24, 2025
Elizabeth Holmes Loses 9th Circ. Appeal Over Theranos Fraud
A Ninth Circuit panel on Monday affirmed the criminal fraud convictions of former Theranos CEO Elizabeth Holmes and former Theranos executive Ramesh "Sunny" Balwani along with their respective 11-year and nearly 13-year prison sentences, rejecting arguments that the lower court made multiple evidentiary errors that unfairly swayed jurors.
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February 24, 2025
Thomas Pans High Court For Skipping Abortion Buffer Zones
The U.S. Supreme Court declined Monday to consider a constitutional challenge to an Illinois city's now-repealed ordinance that created 100-foot speech buffer zones around healthcare facilities providing abortions, shooting down a case aimed at overturning a 20-year-old ruling that such zones don't violate the First Amendment.
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February 24, 2025
Justices Won't Review NJ Town Abortion Buffer Zone Law
A split U.S. Supreme Court said Monday it will not review the Third Circuit's decision to let Englewood, New Jersey, continue enforcing eight-foot "buffer zones" around abortion facilities that protesters are not permitted to enter, in a case brought by an activist who said the zones infringed her free speech.
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February 24, 2025
Supreme Court Won't Revisit Contentious Feres Doctrine
The U.S. Supreme Court on Monday rejected a former Air National Guard reservist's suit seeking damages for a military hospital surgery that left him paralyzed, declining to revisit a doctrine barring injury claims considered "incident to" military service.
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February 21, 2025
Drugmakers Slam 'Untimely' Claims In Employers' Antitrust Suit
Pharmaceutical companies targeted by sweeping antitrust lawsuits from major employers, including Target, Lowe's and American Airlines, have asked a Pennsylvania federal judge to trim conspiracy claims from a lawsuit accusing them of orchestrating illegal agreements for price-fixing and customer allocation, arguing the allegation was unsupported and untimely.
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February 21, 2025
Watchdog Says DOL Struggles To Enforce Mental Health Law
Workers with mental health conditions and substance use disorders are at higher risk of not receiving treatment or having to pay out of pocket for care that should be covered because of the U.S. Department of Labor's limited ability to enforce federal mental health parity laws, an agency watchdog said Friday.
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February 21, 2025
Wash. Health System Says Nurse Must Arbitrate Wage Claims
A Washington-based healthcare system facing a proposed class and collective wage action in Seattle federal court contends the plaintiff nurse agreed to arbitrate any claims with the third-party staffing agencies he contracted with to work at its facilities.
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February 21, 2025
LGBTQ+ Health Orgs Aim To Halt Trump DEI, Gender Orders
Three executive orders by President Donald Trump barring federal contractors from pushing "gender ideology" and diversity-related programs violate the U.S. Constitution, a group of nonprofit LGBTQ+ organizations told a California federal court.
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February 21, 2025
NIH Research Cuts Stay On Hold As Judge Mulls Objections
A Boston federal judge on Friday extended her hold on a Trump administration proposal to slash reimbursements from the National Institutes of Health for research grant costs, a move colleges, hospitals and other institutions have said would wreak havoc on scientific research.
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February 20, 2025
COVID Fraud Drove Record FCA Caseload, Gov't Officials Say
Federal officials said that the record-setting number of whistleblower False Claims Act cases filed in 2024 was likely driven by COVID-19-related fraud, with the use of data mining having an outsized role in those cases.
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February 20, 2025
Boston, Other Cities And MassBio Back Challenge To NIH Cuts
The city of Boston and 44 other cities, counties and elected officials around the country and, separately, the life sciences industry group Massachusetts Biotechnology Council asked a Massachusetts federal judge on Thursday to extend a temporary restraining order blocking steep cuts to National Institutes of Health reimbursement for research projects.
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February 20, 2025
Feds Say DC Judge Can't Bar 'Hypothetical' Spending Freezes
A Justice Department attorney argued before a D.C. federal judge Thursday that there is no basis to continue blocking the Trump administration from implementing a blanket suspension on federal spending, saying the court cannot bar "hypothetical" future freezes.
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February 20, 2025
Dems Seek Answers, Reversals For 'Reckless' VA Cuts
Democrats in Congress asked Secretary of Veterans Affairs Doug Collins to justify how firing 1,000-plus VA employees could possibly benefit veterans, and they called on him to reverse the cuts, stating that they are causing negative impacts.
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February 20, 2025
AmerisourceBergen Strikes Settlement In 401(k) Fee Suit
AmerisourceBergen and a proposed class of workers who alleged their employee 401(k) plan was saddled with excessive recordkeeping and administrative costs have struck a settlement deal to resolve the dispute, according to a filing in Kentucky federal court.
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February 20, 2025
HHS Rescinds Guidance On Gender-Affirming Care For Minors
The U.S. Department of Health and Human Services on Thursday rescinded guidance for health plans and insurers on complying with the Affordable Care Act's nondiscrimination provisions with regard to gender-affirming care for minors, which President Donald Trump called on the agency to do in a January executive order.
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February 20, 2025
DOJ Official Flags 'Aggressive' FCA Approach Under Trump
A senior U.S. Department of Justice official said Thursday that the Trump administration's focus on government efficiency will include "aggressively" enforcing the False Claims Act, including a strong focus on FCA enforcement of foreign trade issues amid recently imposed tariffs.
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February 20, 2025
Drug Buyers Get OK On $275M Sandoz Antitrust Settlement
Swiss drugmaker Sandoz and its subsidiaries will pay consumers, insurers and other "end payer plaintiffs" $275 million to settle class action claims that it conspired with other companies to fix the price of certain generic drugs, under a deal that got preliminary approval from a Pennsylvania federal court Wednesday.
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February 19, 2025
Contractors' Group Asks DC Judge To Halt Gutting Of USAID
A group representing U.S. citizen personal services contractors working for the U.S. Agency for International Development is the latest to ask a federal judge to step in and block the Trump administration's push to gut the agency and its operations.
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February 19, 2025
Judge Probes Vagueness In Suit Over Trump's Anti-DEI Orders
A Baltimore federal judge on Wednesday pressed a U.S. Department of Justice attorney to spell out what would constitute so-called illegal DEI under Trump administration executive orders that aim to root out diversity, equity and inclusion programs in the public and private sectors.
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February 19, 2025
Michigan Expert Defends State's Abortion Counseling Law
Michigan kicked off its defense of a waiting period and mandatory counseling requirements for abortions Wednesday with a physician's testimony that abortion seekers should receive information about parenting and adoption before undergoing the procedure.
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February 19, 2025
Judge Won't Halt PBM Case Over Attack On FTC Independence
A Missouri federal judge refused to temporarily block the Federal Trade Commission's in-house case accusing pharmacy benefits managers of artificially inflating insulin prices through unfair rebate schemes, rejecting the PBMs' claims that the Trump administration's attempt to eliminate safeguards protecting FTC members from at-will presidential removal favors their attempt to stop the case.
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February 19, 2025
LA Gardasil Trial Against Merck Bagged After 3 Weeks
A Los Angeles state court trial over the alleged dangers of Merck & Co. Inc.'s human papillomavirus vaccine Gardasil was abruptly called off after three weeks of testimony, with a new panel of jurors slated to hear the case next fall instead.
Expert Analysis
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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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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.
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Online Portal Helps Fortify Feds' Unfair Health Practices Fight
The Federal Trade Commission, U.S. Justice Department and the U.S. Department of Health and Human Services recently launched an online portal where the public can report potentially unfair healthcare practices, effectively maximizing enforcers' abilities to police anti-competitive actions that can drive up healthcare costs and chill innovation, say attorneys at Seyfarth.
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McKesson May Change How AKS-Based FCA Claims Are Pled
The Second Circuit’s analysis in U.S. v. McKesson, an Anti-Kickback Statute-based False Claims Act case, provides guidance for both relators and defendants parsing scienter-related allegations, say Li Yu at Dicello Levitt, Ellen London at London & Stout, and Erica Hitchings at Whistleblower Law.
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9th Circ. Ruling Puts Teeth Into Mental Health Parity Claims
In its recent finding that UnitedHealth applied an excessively strict review process for substance use disorder treatment claims, the Ninth Circuit provided guidance on how to plead a Mental Health Parity and Addiction Equity Act violation and took a step toward achieving mental health parity in healthcare, says Mark DeBofsky at DeBofsky Law.
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Breaking Down DOJ's Individual Self-Disclosure Pilot Program
The U.S. Department of Justice’s recently announced pilot program aims to incentivize individuals to voluntarily self-disclose corporate misconduct they were personally involved in, complementing a new whistleblower pilot program for individuals not involved in misconduct as well as the government's broader corporate enforcement approach, say attorneys at Paul Weiss.
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FDA Warning Letter Tightens Reins On 'Research Only' Labels
A recent warning letter from the U.S. Food and Drug Administration to Agena Bioscience alleged the company’s diagnostic devices were labeled for research use only, but improperly promoted for human clinical purposes, signifying a reinforcement — and a potential narrowing — of the agency's policy on products labeled “research only,” say attorneys at Sheppard Mullin.
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First 10b5-1 Insider Trading Case Raises Compliance Issues
The ongoing case against former Ontrak CEO Terren Peizer is the U.S. Department of Justice's first insider trading prosecution based primarily on the filing of 10b5-1 plans, and has important takeaways for attorneys reviewing corporate policies on the possession of material nonpublic information, say attorneys at Cadwalader.
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Policy Misrepresentations Carry Insurance Rescission Risks
The Second Circuit's recent decision in Medical Mutual v. Gnik, finding that material misrepresentation in a clinic's insurance applications warranted policy rescission, is a clear example of the far-reaching effects that misrepresentations can have and provides a reminder that policyholders should employ relatively straightforward steps to decrease risks, say attorneys at Hunton.
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The Pros And Cons Of NIST's Proposed March-In Framework
Recent comments for and against the National Institute of Standards and Technology’s proposed guidance on march-in rights — which permit the government to seize federally funded patents — highlight how the framework may promote competition, but could also pose a risk to contractors and universities, say Nick Lee and Paul Ragusa at Baker Botts.
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2 Recent Suits Show Resiliency Of Medicare Drug Price Law
Though pharmaceutical companies continue to file lawsuits challenging the Inflation Reduction Act, which enables the federal government to negotiate for lower prescription drug prices, recent decisions suggest that the reduced drug prices are likely here to stay, says Jose Vela Jr. at Clark Hill.
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Defense Attys Must Prep For Imminent AI Crime Enforcement
Given recent statements by U.S. Department of Justice officials, white collar practitioners should expect to encounter artificial intelligence in federal criminal enforcement in the near term, even in pending cases, say Jarrod Schaeffer and Scott Glicksman at Abell Eskew.
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Lessons For Nursing Facilities From DOJ Fraud Settlement
The U.S. Department of Justice's recent settlement with the owner of skilled nursing and assisted living facilities in Florida provides a cautionary tale of potential fraud risks, and lessons on how facilities can mitigate government enforcement actions, say Callan Stein and Rebecca Younker at Troutman Pepper.