Policy & Compliance

  • April 05, 2024

    Judge Lourie's Dissent Revives Debate Over FDA Safe Harbor

    U.S. Circuit Judge Alan Lourie has urged the Federal Circuit to reconsider its precedent over a safe harbor that allows infringement when companies are developing products regulated by the U.S. Food and Drug Administration, and many attorneys agreed with him that the appeals court has been improperly expanding the safe harbor for decades.

  • April 05, 2024

    Mich. Plaintiffs Bar Prepares For Growth After Policy Shifts

    After decades of the deck stacked against them, Michigan's plaintiffs attorneys are poised to take advantage of a more hospitable environment for personal injury cases and pharmaceutical class actions, though experts caution the learning curve will be steep.

  • April 05, 2024

    Ex-Marine, Jan. 6 Rioter Gets 21 Months In Vax Card Scam

    A former U.S. Marines reservist was sentenced Friday to 21 months in prison after pleading guilty to scheming to distribute fraudulent COVID-19 vaccine cards.

  • April 05, 2024

    Judge Won't Recuse Herself From Doctor's NBA Fraud Trial

    A Manhattan federal judge has refused to step away from the case of a Seattle doctor accused of participating in a scheme to defraud the National Basketball Association's health plan, saying there was "no basis" for his bid to oust her after he took issue with the trial schedule and what he described as systemic barriers.

  • April 05, 2024

    Ohio Families Can Bolster Bid To End Transgender Law

    An Ohio judge said a pair of Buckeye State families can bolster their constitutional challenge to a new law banning gender-affirming healthcare for minors and blocking trans girls from competing in school-age women's sports, issuing an order allowing the families to file briefs beyond the normal length limit.

  • April 04, 2024

    NY AG Asked To Weigh In On Multiple Sclerosis Drug Fight

    The Federal Circuit is asking New York Attorney General Letitia James to weigh in on a patent dispute over a multiple sclerosis drug after it emerged that Acorda Therapeutics' challenge to an underlying arbitral award raises questions about the constitutionality of New York's voluntary payment doctrine.

  • April 04, 2024

    HHS Asks Justices To Review 5th Circ. Abortion Ruling

    The Biden administration has asked the U.S. Supreme Court to add a Texas legal clash to its review of whether a federal law requiring emergency medical care can preempt state-level abortion bans, a question before the justices in a separate case.

  • April 04, 2024

    NYC Sues 11 Vape Shops Over Sales Of Flavored E-Cigarettes

    The city of New York on Thursday sued 11 e-cigarette wholesalers, saying they're in violation of both city and federal regulations by selling disposable, flavored vapes, which the city said are responsible for a boom of youth vape use.

  • April 03, 2024

    Healthcare Company Hid Rising Costs Before IPO, Suit Says

    Elder-focused healthcare company Agilon Health was hit with an investor's proposed class action in New York federal court alleging that the company failed to acknowledge ahead of its initial public offering that it had been affected by rising medical costs for providers.

  • April 03, 2024

    Philly Injection Site Org. Isn't Religious, Judge Rules

    A Pennsylvania federal judge on Wednesday ruled that an overdose prevention organization planning to open a supervised safe-injection site in Philadelphia is not a religious entity, delivering a win to the U.S. Department of Justice, which opposed the site.

  • April 03, 2024

    Hospital Workers' Vax Free Speech Suit Falls Flat At 6th Circ.

    The Sixth Circuit backed the dismissal of two workers' claims that a children's hospital violated their constitutional rights when it rejected their religious objections to a COVID-19 vaccine mandate, saying Wednesday they failed to show the hospital was a government actor.

  • April 03, 2024

    Mayo Clinic Stuck Workers With Hefty Medical Bills, Suit Says

    A medical claims administrator steered Mayo Clinic health plan participants toward out-of-network healthcare providers and then forced them to foot the bulk of the bill, a proposed class action filed in Minnesota federal court said.

  • April 03, 2024

    Ex-NBA Guard's Health Fraud Perjury Merits Prison, Feds Say

    Manhattan federal prosecutors said a former Detroit Pistons point guard who was convicted on one of two counts over an alleged scheme to defraud the NBA's healthcare plan should be sentenced to 27 to 33 months in prison, claiming he lied during his testimony.

  • April 02, 2024

    Alaska Judge Tosses Opioid Nuisance Case Against Pharmacies

    Retail pharmacies including Walgreens Co. and Walmart Inc. have escaped a suit brought by Alaska in state court over their role in the opioid epidemic after a judge found the state's public nuisance claims were a "bridge too far."

  • April 02, 2024

    3rd Circ. Preview: Black Lung, Back Pay On Tap In April

    The Third Circuit this month will consider Keystone Coal Mining Co.'s contention that a lower court erred in deeming a miner's black lung a "total disability," while a shuttered rehabilitation facility has asked the court to undo the National Labor Relations Board's determination that it owes unionized employees back pay and bonuses for work done during the COVID-19 pandemic.

  • April 02, 2024

    Healthcare In Court: Idaho AG Not 'Cute' On Abortion Ban

    Idaho's solicitor general had a hard day at the Ninth Circuit, where a panel tried and failed to get a lock on the state attorney general's stance on Idaho's abortion ban. Home Depot pressed the U.S. Supreme Court to review a $2.67 billion settlement in antitrust litigation against the Blue Cross Blue Shield Association. And in Texas, a woman charged with murder for inducing her own abortion sued the prosecutors behind the case.

  • April 02, 2024

    3 Sentenced To Prison In Fla. Fake Nursing Diploma Case

    A Florida judge sentenced three people to federal prison time Tuesday after they were convicted for their roles in a multimillion-dollar fake nursing diploma scheme following a jury trial in December

  • April 02, 2024

    NC GOP Pols Stress Health In Bid To Keep Abortion Law Intact

    Two North Carolina abortion law provisions that Attorney General Josh Stein deems unconstitutional are necessary to protect women's health, Republican leaders have argued in a bid to keep hospitalization and fetus-location requirements in the statute.

  • April 02, 2024

    Conn. Dentists Used Illegal Patient Recruiting, Suit Says

    Federal and state authorities filed a kickback and false claims lawsuit in Connecticut federal court on Tuesday against two dental practices in the state and their co-owners for allegedly paying a patient recruiter to generate business through Medicaid.

  • April 02, 2024

    IVF Ruling Leaves Lawyers Puzzling Over 'Fetal Personhood'

    A recent decision from Alabama's top court that frozen embryos are legally children raises a host of thorny questions that touch some surprising areas of the law, from the criminal code and public benefits to surrogacy contracts and even tax deductions. A rash of new "personhood" legislation promises to be a challenge for lawyers working in areas well beyond healthcare.

  • April 02, 2024

    NM Medical Cannabis Insurance Row To Stay In Federal Court

    The federal court is the proper place for a proposed class action seeking to make Blue Cross and Blue Shield and other insurers cover medical cannabis, a New Mexico federal judge has ruled, rejecting objections by patients who said the state's high court will eventually need to get involved.

  • April 02, 2024

    For Medicare Drug Cost Suits, Final Price Could Be Key

    Drugmakers and industry groups arguing that the Medicare drug price negotiation program amounts to an unconstitutional taking of their property have an uphill battle. Experts say their claims can be either fortified or undercut by the final price of the selected prescription drugs.

  • April 02, 2024

    HHS Underlines Consent Priority For Pelvic, Prostate Exams

    New federal guidance that teaching hospitals and medical schools must have written consent before conducting pelvic, prostate, and other sensitive medical exams is a signal the agency has drawn a line on patient privacy and control, experts say.

  • April 02, 2024

    Medical Advocacy Orgs Ascend Amid Healthcare Court Battles

    The rapid ascent of an abortion case filed by the Alliance for Hippocratic Medicine illustrates the growing power of physician and provider advocacy groups to shape the nation's healthcare policy and legal debates.

  • April 02, 2024

    DOJ Sets Sights On 3rd Parties In Managed Care FCA Claims

    The Justice Department has sent a message in recent months, both in litigation and public speeches, that it plans to target third-party contractors and vendors whose actions contribute to the government being overbilled for medical care, even if they didn't submit those claims directly.

Expert Analysis

  • How To Navigate The FTC's New Private Equity Frontier

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    The Federal Trade Commission's recent district court complaint against an anesthesia firm and its private equity partner tests key bounds of the agency's stand-alone authority, and defense strategies can include challenges to both the geographic and the service market fronts, say attorneys at Baker McKenzie.

  • Newman Suspension Shows Need For Judicial Reform

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    The recent suspension of U.S. Circuit Judge Pauline Newman following her alleged refusal to participate in a disability inquiry reveals the need for judicial misconduct reforms to ensure that judges step down when they can no longer serve effectively, says Aliza Shatzman at The Legal Accountability Project.

  • An Overview Of Congress' Proposed Drug Shortage Solutions

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    Recently, Congress has seen a number of bipartisan bills that seek to prevent and respond to national drug shortages, though disagreements over the right vehicle and timeline have slowed progress, says Miranda Franco at Holland & Knight.

  • SEC's Life Sciences Actions Utilize Novel Tools And Theories

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    Recent enforcement actions show that the U.S. Securities and Exchange Commission is employing new forms of data analytics and noteworthy applications of insider trading laws in its scrutiny of fraud within the life sciences and health industries, say Edward Imperatore and Jina Choi at MoFo.

  • ESG Around The World: Japan

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    Japan is witnessing rapid developments in environmental, social and corporate governance policies by making efforts to adopt a soft law approach, which has been effective in encouraging companies to embrace ESG practices and address the diversity of boards of directors, say Akira Karasawa and Landry Guesdon at Iwata Godo.

  • How And Why Your Firm Should Implement Fixed-Fee Billing

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    Amid rising burnout in the legal industry and client efforts to curtail spending, pivoting to a fixed-fee billing model may improve client-attorney relationships and offer lawyers financial, logistical and stress relief — while still maintaining profit margins, say Kevin Henderson and Eric Pacifici at SMB Law Group.

  • Potential Broader Effects Of FDA's Lab-Developed Test Rule

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    Though it's unclear whether the U.S. Food and Drug Administration's proposed rule for regulating lab-developed tests will ever go into effect, it nonetheless functions as a threatened hammer that may make legislative efforts to regulate such tests more palatable, say attorneys at King & Spalding.

  • Judicial Independence Needs Defense Amid Political Threats

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    Amid recent and historic challenges to the judiciary from political forces, safeguarding judicial independence and maintaining the integrity of the legal system is increasingly urgent, says Robert Peck at the Center for Constitutional Litigation.

  • 2 New Ways FDA Is Changing Lab-Developed Test Regulation

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    The U.S. Food and Drug Administration's recently announced rulemaking and voluntary pilot program signal the agency's dedication to ramping up oversight of lab-developed tests, which have been largely unregulated by the FDA until now, say attorneys at Sidley.

  • How Law Firms Can Use Account-Based Marketing Strategies

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    Amid several evolving legal industry trends, account-based marketing can help law firms uncover additional revenue-generating opportunities with existing clients, with key considerations ranging from data analytics to relationship building, say Jennifer Ramsey at stage LLC and consultant Gina Sponzilli.

  • AGs' Distaste For Food Bill May Signal Other State Issues

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    States' recent opposition to a proposed federal law that would block them from regulating out-of-state agricultural production could affect issues beyond this narrow debate, such as the balance of state and federal regulatory power, reproductive rights post-Dobbs, and energy production and water use, say Christopher Allen and Stephen Cobb at Cozen O'Connor.

  • Strategic Succession Planning At Law Firms Is Crucial

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    Senior partners' reluctance to retire, the rise of the nonequity partner tier and generational differences in expectations are all contributing to an increasing number of departures from BigLaw, making it imperative for firms to encourage retirement among senior ranks and provide clearer leadership pathways to junior attorneys, says Laura Leopard at Leopard Solutions.

  • What An NCAA Drug Test Change Could Mean For Cannabis

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    If the NCAA follows through with its decision to remove cannabis from its banned list of substances, it will affect college athletes, athletic directors, public relations employees, and marketing departments at universities and colleges, and it will have a significant economic effect on the cannabis industry, say Stanley Jutkowitz and Sydney Jenkins at Seyfarth.