Policy & Compliance
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February 05, 2025
6th Circ. Urged To Revive Allergy Co.'s Antitrust Claims
An allergy company tried Wednesday to persuade a noncommittal Sixth Circuit panel to revive an antitrust suit it brought against health insurance companies it says worked together to push it out of the market.
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February 05, 2025
Sheppard Mullin Adds Healthcare Reg Partner From Troutman
Sheppard Mullin Richter & Hampton LLP on Wednesday announced the arrival of a healthcare partner joining from Troutman Pepper Locke LLP, continuing a streak of recent additions to its healthcare practice.
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February 04, 2025
9th Circ. Revives FCA Suit Over Military Meds Deliveries
The Ninth Circuit on Tuesday revived a whistleblower lawsuit accusing Express Scripts Inc. of defrauding the U.S. Department of Defense out of billions of dollars in unnecessary medications for military personnel, saying the lawsuit wasn't barred by any public disclosures of the alleged fraud.
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February 04, 2025
Meet The Attys Taking On Merck In The Gardasil Trial
An attorney at a personal injury firm with ties to Robert F. Kennedy Jr., President Donald Trump's pick for the nation's top healthcare position, is on the plaintiff team leading the first jury trial against Merck & Co. over claims the company wrongfully marketed its HPV vaccine Gardasil.
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February 04, 2025
Calif. AG Gets $25M To Fund Legal Fights Against Trump
The California Legislature greenlighted a $25 million cash infusion Monday for the state attorney general's office in a strategic effort to bolster the state's legal defenses against President Donald Trump's policy agenda, including anticipated challenges to immigration and environmental regulations.
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February 04, 2025
Trump Trans Care Order Usurps Congress' Power, Suit Says
The Trump administration overstepped when it issued an executive order cutting off gender-affirming care for people under 19, a group of transgender adolescents, young adults and their families told a Maryland federal court Tuesday, arguing the president is trying to usurp Congressional authority by forcing federally funded hospitals to discriminate.
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February 04, 2025
NY Exoneree Lands Rare 'Indifference' Win In Prison Doc Case
Antonio Mallet spent nearly 20 years in a New York prison after he was convicted of a fatal shooting. After his release, he learned he had deadly prostate cancer that he claims was exacerbated by the "deliberate indifference" of prison doctors. A Second Circuit panel recently awarded him a rare appellate court victory.
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February 04, 2025
Docs, Lawmakers Cut Away At Prior Authorization Red Tape
As physicians sounded the alarms, states have passed a patchwork of laws reining in prior authorization requirements. Health insurers say they're a necessary safeguard against unnecessary treatments and higher premiums. Healthcare professionals and legal experts argue more reforms are needed.
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February 04, 2025
4th Circ. Revives FCA Suit Alleging Faked Therapy Notes
The Fourth Circuit on Monday sided with a whistleblower who accused her former employer of creating fake notes about addiction therapy sessions that never happened, finding that she had sufficiently detailed the allegations and connected the dots to defeat a motion to dismiss.
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February 04, 2025
Doctors Org. Sues Over Health Agency Website Purges
An advocacy organization representing physicians sued the U.S. Office of Personnel Management in D.C. federal court Tuesday after it directed federal agencies to root out references to "gender ideology" on their websites — a move the physicians claim deprives doctors and researchers of needed information.
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February 04, 2025
Trump Trans Care Order Raises New Legal Risks For Providers
President Donald Trump's executive order restricting gender-affirming care for minors is likely to ignite lasting legal conflicts over the limits of presidential power and whether the policy is discriminatory. In the meantime, hospitals are wrestling with what care they can offer families right now and what comes next for those already undergoing treatment.
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February 04, 2025
Party-Line Vote Sends Kennedy's HHS Nomination To Senate
Robert F. Kennedy Jr.'s nomination to be the nation's top healthcare official cleared a key confirmation hurdle on Tuesday, setting the stage for the anti-vaccine lawyer and activist to take the helm of the U.S. Department of Health and Human Services.
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February 03, 2025
Crowell & Moring Lands Former DOJ Assistant Chief For FCPA
A former assistant chief in the U.S. Department of Justice's Foreign Corrupt Practices Act unit has joined Crowell & Moring LLP as a partner in the firm's white collar and regulatory enforcement group, according to an announcement made Tuesday.
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February 03, 2025
5th Circ. Won't Revisit HHS Win On Scope Of ACA
The Fifth Circuit has declined to conduct an en banc rehearing after an appellate panel upheld a U.S. Department of Health and Human Services rule that said the Affordable Care Act forbids against transgender bias in healthcare, but one judge argued the court got its analysis wrong.
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February 03, 2025
Allergan Tells 4th Circ. Medicaid Pricing Suit Rightly Tossed
Allergan told the Fourth Circuit that a district court judge was right to dismiss a whistleblower's claims that its predecessor overcharged Medicaid by not aggregating discounts, saying the Medicaid Rebate Statute doesn't require it to do so.
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February 03, 2025
DC Judge Joins RI In Blocking Trump Funding Freeze
A D.C. federal judge on Monday temporarily blocked the Trump administration from implementing a freeze on federal spending while a group of nonprofits sue over the move, ruling the pause appears to "suffer from infirmities of a constitutional magnitude."
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January 31, 2025
New York Scores Win In Reproductive Rights Labor Law Suit
A New York federal judge Friday tossed an anti-abortion group's lawsuit challenging a New York state law that bars employers from penalizing workers for making certain reproductive health decisions, saying on the five-year anniversary of the case that the group lacked standing to assert its last remaining claim.
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January 31, 2025
Express Scripts Says FTC Tried To Swamp It With Lawsuits
The Federal Trade Commission was trying to "paint a target on [pharmacy benefit managers'] backs" when it released a report that accused the pharmaceutical middlemen of inflating the cost of drugs, one such PBM told a federal court in defense of its suit against the agency.
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January 31, 2025
NY Doctor Charged In La. For Prescribing Abortion Pill Online
A Louisiana grand jury indicted a New York doctor on Friday, alleging she prescribed abortion drugs online to a Louisiana woman who then provided the pills to her teenage daughter to induce an abortion, a violation of the state's law.
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January 31, 2025
Supreme Court Eyes Its 'Next Frontier' In FCC Delegation Case
A case about broadband subsidies will give the U.S. Supreme Court the chance to revive a long-dormant separation of powers principle that attorneys say could upend regulations in numerous industries and trigger a power shift that would make last term's shake-up of federal agency authority pale in comparison. And a majority of the court already appears to support its resurrection.
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January 31, 2025
After High Court, SuperValu's $123M FCA Case Heads To Trial
SuperValu is bound for trial in February over whistleblower claims that it billed the government higher-than-customary prices for millions of prescriptions, marking an important test of a recent U.S. Supreme Court ruling that revived the case and redefined the standard of proof under the False Claims Act.
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January 31, 2025
Trump Funding Freeze Blocked As Court Doubts Reversal
A Rhode Island federal judge on Friday issued a temporary restraining order barring the Trump administration from freezing spending on federal grant and aid programs, calling the move illegal and saying the issue was not mooted by a White House memo claiming the directive had been rescinded.
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January 31, 2025
JAMS Adds AI-Focused Litigation Vet To Arbitration Team
The alternative dispute resolution service JAMS has expanded its arbitration and mediation team with the addition of an attorney with over three decades of experience spanning complex commercial litigation, independent arbitration and leadership positions at the American Bar Association.
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January 31, 2025
RFK Jr. Says He'll Give Stake In Merck Vaccine Case To Son
Robert F. Kennedy Jr., President Donald Trump's pick for the nation's top healthcare position, said Friday that he would hand his financial stake in personal injury litigation against vaccine maker Merck over to an adult son.
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January 30, 2025
Plaintiffs, Pfizer Spar Over Where To Join Depo-Provera Suits
Consumers who claim Pfizer Inc. failed to adequately warn patients and doctors about the risk of brain tumors associated with the hormonal contraceptive drug Depo-Provera urged the U.S. Judicial Panel on Multidistrict Litigation on Thursday to consolidate their cases but sparred over whether to move them to California or New York.
Expert Analysis
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10 Noteworthy CFPB Developments From 2024
In a banner year for consumer finance regulation, the Consumer Financial Protection Bureau made significant strides in its efforts to rein in Big Tech and nonbank financial firms, including via rules regarding open banking, credit card late fees, and buy now, pay later products, say attorneys at Wiley.
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The Future Of GLP-1 Policy After Drug Shortage Ends
If and when the U.S. Food and Drug Administration determines that GLP-1 RA drugs are no longer in short supply, regulators will face questions of how to balance access to GLP-1 RAs with statutory and policy considerations applicable to compounded drugs, say attorneys at Skadden.
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Top 10 Whistleblowing And Retaliation Events Of 2024
From a Florida federal court’s ruling that the False Claims Act’s qui tam provision is unconstitutional to a record-breaking number of whistleblower tips filed with the U.S. Commodity Futures Trading Commission, employers saw significant developments in the federal and state whistleblower landscapes this year, say attorneys at Proskauer.
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How White Collar Defense Attys Can Use Summary Witnesses
Few criminal defense attorneys have successfully utilized summary witnesses in the past, but several recent success stories show that it can be a worthwhile trial tactic to help juries understand the complex decision-making at issue, says Jonathan Porter at Husch Blackwell.
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Nutraceutical Patent Insights As Market Heats Up
Companies entering the expanding nutraceutical market and seeking patents to protect their innovations should evaluate successful nutraceutical claim language and common patent challenges in this field, say attorneys at Sterne Kessler.
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How White Collar Attys Can Use Mythic Archetypes At Trial
A careful reading of a classic screenwriting guide shows that fairy tales and white collar trials actually have a lot in common, and defense attorneys would do well to tell a hero’s journey at trial, relying on universal character archetypes to connect with the jury, says Jack Sharman at Lightfoot Franklin.
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What 2024 Election Means For Drugs, Medicare And Medicaid
With Republicans running the White House, U.S. House of Representatives and U.S. Senate, the incoming administration is likely to provide pathways — through new initiatives and others returning from Trump's previous presidency — for a range of potential changes to drug pricing, Medicare and Medicaid, say attorneys at Morgan Lewis.
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Justices Mull Sex-Based Classification In Trans Law Case
After the U.S. Supreme Court heard oral argument in U.S. v. Skrmetti this week, it appears that the fate of the Tennessee law at the center of the case — a law banning gender-affirming healthcare for transgender adolescents — will hinge on whether the majority read the statute as imposing a sex-based classification, says Alexandra Crandall at Dickinson Wright.
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Key Takeaways From FDA's Latest Social Media Warnings
The U.S. Food and Drug Administration's latest untitled letter concerning a drug company's social media promotion provides lessons for how companies should navigate risk presentation, FDA labeling requirements and superiority claims, say attorneys at Sheppard Mullin.
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Rank-And-File DOJ Attorneys Will Keep Calm And Carry On
Career prosecutors at the U.S. Department of Justice often pride themselves on their ability to remain apolitical in order to ensure consistency and keep the department’s mission afloat, and the incoming Trump administration is unlikely to upend this tradition, says Michael Landman at Bird Marella.
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Unpacking Arguments From High Court's Rural Hospital Case
During oral arguments in Advocate v. Becerra, the U.S. Supreme Court justices focused questions on the meaning of being "entitled to" supplementary security income assistance, and there's reason for optimism that the likely split decision will break in favor of hospitals, say attorneys at King & Spalding.
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Health Policy Predictions For Trump's Second Administration
As President-elect Donald Trump's nominations for health policy and enforcement heads work their way through the confirmation process, healthcare organizations can look at nominee backgrounds, campaign statements and actions from Trump's previous presidency to predict incoming priorities, say attorneys at McDermott.
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What Trump's Next Term May Mean For Biz Immigration
Leonard D'Arrigo at Harris Beach discusses the employment-based immigration policies businesses can potentially expect during President-elect Donald Trump’s second term, based on policies enacted during his first administration, statements made during his campaign and proposals in Project 2025.