Policy & Compliance

  • November 13, 2024

    TikTok Asks To Keep NC AG's Addiction Complaint Redacted

    TikTok Inc. is asking a North Carolina state court to keep redacted portions of a complaint by the state alleging that it targets youth to make them compulsive and addicted users, saying parts of the complaint include information from confidential documents and trade secrets.

  • November 13, 2024

    Outgoing DOJ Antitrust Head Wants To Unstack Healthcare

    The U.S. Department of Justice's top antitrust official looked to the future Tuesday, of both healthcare and his own exit with the change in presidential administration, as he defended the Biden era's more aggressive, nuanced approach to merger enforcement that wouldn't allow massive insurers and others to stack up the industry like Tetris.

  • November 13, 2024

    Biotech Brass Misled Investors About Cancer Drugs, Suit Says

    Executives and directors of biotechnology company Agenus Inc. have been hit with a shareholder derivative suit in Massachusetts federal court alleging that the company misled investors about the effectiveness of its mainstay cancer treatments.

  • November 13, 2024

    Mass. AG Ready To Reprise Office's Role As Trump Foil

    Taking a page from her predecessor's book, Massachusetts Attorney General Andrea Joy Campbell told Law360 she is hoping to work with the incoming Trump administration, but the Democrat said she is nevertheless prepared to use her office's "significant tools and power" to challenge actions she feels are at odds with her constituents' interests.

  • November 12, 2024

    Trump Taps Elon Musk To Head New 'Gov't Efficiency' Dept.

    President-elect Donald Trump announced Tuesday that billionaire Elon Musk and former presidential candidate Vivek Ramaswamy will lead a newly created "Department in Government Efficiency" for his administration come January.

  • November 12, 2024

    Idaho Says Any Health Risk Could Be Used To Justify Abortion

    In his opening statement Tuesday in a trial weighing whether Idaho's abortion bans are forcing women to carry dangerous, nonviable pregnancies to term, a state attorney hypothetically quipped that to abortion rights advocates, even stepping on a "rusty nail" could be considered a health risk that could require an abortion.

  • November 12, 2024

    Judge Sends Malpractice Cap Question To Mich. High Court

    A Michigan federal judge has certified questions to the state's Supreme Court asking if caps on noneconomic medical malpractice damages are constitutional, in a case in which a cancer patient's estate was awarded $8.6 million for a missed diagnosis.

  • November 12, 2024

    J&J Says HHS Is Thwarting Transparency Of Drug Discounts

    Johnson & Johnson claims the U.S. Department of Health and Human Services is thwarting its efforts to crack down on hospitals the company alleges are "reaping immense profits" on reduced-price medications without passing those discounts on to patients, according to a lawsuit filed Tuesday in D.C. federal court.

  • November 12, 2024

    GOP Reps. Propose Another Bill On TRIPS Waivers

    A new bill from Republicans in the U.S. House of Representatives seeks to force the Office of the U.S. Trade Representative to file a report "before the negotiation of any international agreement relating to an intellectual property right."

  • November 12, 2024

    University Of Washington Scores Worker Vax Suit Dismissal

    A Washington federal judge has thrown out a lawsuit by a group of healthcare workers who alleged the University of Washington denied their religious exemptions from a COVID-19 vaccination requirement, saying the university was justified in firing the workers to prevent patients and employees from being exposed to the virus.

  • November 12, 2024

    Why The CDC May Look Very Different In Trump's 2nd Term

    As the healthcare industry braces for significant policy changes under a second Trump administration, some experts say the Centers for Disease Control and Prevention could see the most significant alterations both in mission and structure, in part because of the agency's unique, and vulnerable, position under the law.

  • November 12, 2024

    Wash. Ballot Win Gives States Blueprint For 'Age Wave' Care

    Washington's first-in-the-nation program to provide long-term care insurance backed by a payroll tax won a decisive victory at the polls last week, offering a potential model for other states as baby boomers age out of the workforce and more families seek eldercare.

  • November 08, 2024

    Cigna Agrees To End Behavioral Health Underpayment Suit

    Cigna and a billing contractor have agreed to resolve claims that they violated federal benefits law by colluding to underpay out-of-network claims for substance use disorder treatments, according to a filing in California federal court.

  • November 08, 2024

    3rd Texas Doc Sued For Providing Kids Gender-Affirming Care

    Texas Attorney General Ken Paxton announced a third lawsuit against a doctor who has allegedly provided gender transition services to 15 North Texas minors in violation of state law, calling the Dallas doctor a "scofflaw" who is "harming the health and safety of Texas children."

  • November 08, 2024

    Conn. AG Building Abortion Rights 'Firewall' With Firms' Help

    Connecticut's Democratic attorney general has joined a multistate partnership with a pro-choice nonprofit and law firms including Silver Golub & Teitell LLP and Koskoff Koskoff & Bieder PC as part of what he described Friday as a "firewall" to protect abortion access during a second Trump administration.

  • November 07, 2024

    Sutter Health Could Face Retrial On Antitrust Claims In March

    Sutter Health is headed back to trial after the Ninth Circuit said "highly relevant" evidence was excluded from the 2022 trial where the hospital chain defeated claims that it had driven up the cost of insurance, and the court overseeing the matter says March is the earliest it can do.

  • November 07, 2024

    Albany, NY, Nursing Home Hit With $2M Verdict Over Death

    A New York federal jury has hit the Albany County Nursing Home with a $2 million verdict in a suit by a woman alleging the staff neglected her father and did nothing as he lay dying in bed.

  • November 07, 2024

    DOL Secretary Seeks Unpaid OT From Health Staffing Cos.

    A pair of health care staffing companies in Massachusetts and Pennsylvania failed to pay overtime to a group of employees it classified as independent contractors, the U.S. Department of Labor alleged Thursday.

  • November 07, 2024

    Teva Can't End Inhaler Antitrust Suit But Gets Claim Nixed

    A Massachusetts federal court refused Teva Pharmaceutical Industries Ltd.'s attempt to end a case accusing it of orchestrating a decade-long scheme to delay generic competition for its QVAR asthma inhalers, but cut allegations that Teva paid Amneal Pharmaceuticals Inc. not to launch its version.

  • November 07, 2024

    Same PBM Conduct Means Same Insulin Price Trial, FTC Says

    Federal Trade Commission staffers want Caremark Rx, Express Scripts and OptumRx kept together in a single in-house case accusing the pharmacy benefit managers of artificially inflating insulin prices through unfair rebate schemes, arguing they are all "accused of violating the same laws by engaging in the same type of conduct."

  • November 07, 2024

    Calif. Gov. Lays Groundwork To Fight Trump Policies In Court

    California Gov. Gavin Newsom called a special legislative session on Thursday to fund litigation against President-elect Donald Trump's potential erosion of abortion rights, immigration protections and environmental progress, saying lawyers for the blue state have already begun preparing "to challenge in court unconstitutional and unlawful federal policies."

  • November 06, 2024

    Feds Fight Philly Injection Site Group's 3rd Circ. Appeal

    The U.S. Department of Justice has urged the Third Circuit to preserve its win in preventing an overdose prevention organization from opening a supervised safe-injection site in Philadelphia, arguing that a lower court correctly ruled that the group is not a religious organization eligible for federal protection.

  • November 06, 2024

    Montana Voters Approve Constitutional Right To Abortion

    Montana voters approved a constitutional amendment Tuesday that protects the right to abortion until fetal viability, around the 23rd or 24th week of pregnancy, and bars the government from punishing doctors or those who receive abortions.

  • November 05, 2024

    How The Patent System May Look After Trump's Return

    The U.S. Patent and Trademark Office during Donald Trump's first term as president focused on making the invalidation of patents more difficult, and attorneys say his second administration is likely to do the same following his projected reelection. 

  • November 05, 2024

    An Early Look At Trump's Supreme Court Shortlist

    With former President Donald Trump projected to win the 2024 presidential election and the Republicans' success in securing the U.S. Senate majority, Trump may now get the chance to appoint two more justices to the U.S. Supreme Court, cementing the court's conservative tilt for decades to come.

Expert Analysis

  • FDA's Multifaceted Role On Display In MDMA Therapy Scrutiny

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    Ongoing deliberations at the U.S. Food and Drug Administration regarding MDMA-assisted therapy for post-traumatic stress disorder serves as a window into the intricate balance of scientific innovation and patient safety oversight, and offers crucial insights into regulatory nuances, say Kimberly Chew at Husch Blackwell and Kevin Lanzo at Pharmaka Clinical Consulting.

  • Analyzing FDA Draft Guidance On Clinical Trial Diversity

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    In light of the U.S. Food and Drug Administration's draft guidance on clinical trial diversity action plans, there are several important considerations for sponsors and clinical researchers to keep in mind to prevent delay in a drug or device application, say attorneys at Crowell & Moring.

  • In The CFPB Playbook: Making Good On Bold Promises

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    The U.S. Supreme Court's decision upholding the Consumer Financial Protection Bureau's funding structure in the second quarter cleared the way for the bureau to resume a number of high-priority initiatives, and it appears poised to charge ahead in working toward its aggressive preelection agenda, say Andrew Arculin and Paula Vigo Marqués at Blank Rome.

  • Critical Questions Remain After High Court's Abortion Rulings

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    The U.S. Supreme Court's decisions in two major abortion-related cases this term largely preserve the status quo for now, but leave federal preemption, the Comstock Act and in vitro fertilization in limbo, say attorneys at Jenner & Block.

  • Navigating FDA Supply Rule Leeway For Small Dispensers

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    As the November compliance deadline for the U.S. Food and Drug Administration's new pharmaceutical distribution supply chain rules draws closer, small dispensers should understand the narrow flexibilities that are available, and the questions to consider before taking advantage of them, say attorneys at Faegre Drinker.

  • 1st Gender Care Ban Provides Context For High Court Case

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    The history of Arkansas' ban on gender-affirming medical care — the first such legislation in the U.S. — provides important insight into the far-reaching ramifications that the U.S. Supreme Court's decision in U.S. v. Skrmetti next term will have on transgender healthcare, says Tyler Saenz at Baker Donelson.

  • 6 Lessons From DOJ's 1st Controlled Drug Case In Telehealth

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    Following the U.S. Department of Justice’s first-ever criminal prosecution over telehealth-prescribed controlled substances in U.S. v. Ruthia He, healthcare providers should be mindful of the risks associated with restricting the physician-patient relationship when crafting new business models, says Jonathan Porter at Husch Blackwell.

  • After Chevron: Scale Tips Favor Away From HHS Agencies

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    The loss of Chevron deference may indirectly aid parties in challenging the U.S. Department of Health and Human Services' interpretations of regulations and could immediately influence several pending cases challenging HHS on technical questions and agency authority, say attorneys at Ropes & Gray.

  • After Chevron: FDA Regulations In The Crosshairs

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    The U.S. Supreme Court's overturning of the Chevron doctrine is likely to unleash an array of challenges against the U.S. Food and Drug Administration, focusing on areas of potential overreach such as the FDA's authority under the Federal Food, Drug and Cosmetic Act, say attorneys at Debevoise.

  • USPTO Disclaimer Rule Would Complicate Patent Prosecution

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    The U.S. Patent and Trademark Office's proposed changes to terminal disclaimer practice could lead to a patent owner being unable to enforce a valid patent simply because it is indirectly tied to a patent in which a single claim is found anticipated or obvious in view of the prior art, say attorneys at Sterne Kessler.

  • Navigating Scrutiny Of Friendly Professional Corps. In Calif.

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    In light of ongoing scrutiny and challenges to private equity participation in the California healthcare marketplace, particularly surrounding the use of the friendly professional corporation model, management services organizations should consider implementing four best practices, say attorneys at Holland & Knight.

  • Takeaways From New HHS Substance Use Disorder Info Rules

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    A new U.S. Department of Health and Human Services rule continues the agency's efforts to harmonize complex rules surrounding confidentiality provisions for substance use disorder patient records, though healthcare providers will need to remain mindful of different potentially applicable requirements and changes that their compliance structures may require, say attorneys at Ropes & Gray.

  • Calif. Banking Brief: All The Notable Legal Updates In Q2

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    The second quarter of 2024 in California, which saw efforts to expand consumer protection legislation and enforcement actions in areas of federal focus like medical debt and student loans, demonstrated that the state's role as a trendsetter in consumer financial protection will continue for the foreseeable future, say attorneys at Sheppard Mullin.