Life Sciences

  • July 01, 2024

    Feds Say Ex-Magellan Officer's Atty May Have Conflict

    A Donnelly Conroy & Gelhaar LLP attorney's prior representation of co-defendants in a pending fraud case against former executives of medical device company Magellan Diagnostics may have created a disqualifying conflict of interest, lawyers for the government told a Massachusetts federal judge.

  • July 01, 2024

    Supreme Court Widens Window To Challenge Federal Regs

    Legal challenges to federal regulations can be brought outside the normal statute of limitations if someone isn't adversely affected until after the six-year window of time to file suit, the U.S. Supreme Court ruled Monday.

  • June 28, 2024

    Chevron's End Is Just The Start For Energized Agency Foes

    By knocking down a powerful precedent that has towered over administrative law for 40 years, the U.S. Supreme Court's right wing Friday gave a crowning achievement to anti-agency attorneys. But for those attorneys, the achievement is merely a means to an end, and experts expect a litigation blitzkrieg to materialize quickly in the aftermath.

  • June 28, 2024

    Will 'Moral Victory' In Purdue Ruling Help Plaintiffs?

    The U.S. Supreme Court's decision that the Sackler family members who own Purdue Pharma LP cannot be shielded by the bankruptcy code from lawsuits over the opioid crisis reflects the widespread public outrage over their role in the epidemic, but experts say it remains unclear what will happen next for the individuals and governments that have sued the company.

  • June 28, 2024

    CUNY Medical Prof Accused Of Fabricating NIH Grant Apps

    A medical professor at the City College of New York and paid adviser to Cassava Sciences has been indicted on allegations he falsified scientific data in grant applications submitted to the National Institutes of Health on behalf of himself and Cassava, prosecutors announced Friday.

  • June 28, 2024

    In Chevron Case, Justices Trade One Unknown For Another

    The U.S. Supreme Court's decision to overrule a decades-old judicial deference doctrine may cause the "eternal fog of uncertainty" surrounding federal agency actions to dissipate and level the playing field in challenges of government policies, but lawyers warn it raises new questions over what rules courts must follow and how judges will implement them.

  • June 28, 2024

    Health Regulators Likely To Tread Carefully Post-Chevron

    The demise of Chevron deference at the U.S. Supreme Court on Friday will likely encourage or fortify challenges to agency rulemaking on matters of health policy in the U.S., from Medicare reimbursement decisions to FDA rules on laboratory-developed tests.

  • June 28, 2024

    Shkreli Asks High Court To Toss $64M Disgorgement Order

    Former pharmaceutical executive Martin Shkreli, who gained notoriety for hiking the price of HIV/AIDS medication before serving more than four years in prison for securities fraud, is asking the U.S. Supreme Court to toss a disgorgement order requiring him to pay $64 million for monopolistic price-gouging.

  • June 28, 2024

    Rite Aid Ch. 11 Plan OK'd With Insurers' Objections Resolved

    A New Jersey bankruptcy judge Friday approved pharmacy chain Rite Aid's Chapter 11 restructuring plan after the company said it had resolved objections from its insurance carriers to how the plan treats their policies.

  • June 28, 2024

    Philips Gets OK For $25M Med Monitoring Deal In CPAP MDL

    A Pennsylvania federal judge has given the go-ahead to a $25 million medical monitoring settlement in multidistrict litigation stemming from a recall of ventilator machines by Koninklijke Philips NV and some of its American subsidiaries.

  • June 28, 2024

    Nationwide Cert. Rejected In Suit Over Stolen Curaleaf Tips

    An Illinois federal judge conditionally certified a class of Curaleaf hourly employees in Illinois, Arizona and Massachusetts, but denied a bid to certify a nationwide class of all Curaleaf hourly employees "based on pure speculation," in a suit alleging managers at its cannabis dispensary locations around the country stole the contents of tip jars.

  • June 28, 2024

    Judge Finalizes $4M Deal In Eye Doc Ransomware Dispute

    A North Carolina federal judge has signed off on a $4 million deal to resolve two class actions over an electronic patient recordkeeping and billing company allegedly failing to give truthful, timely notice to ophthalmology practices and their patients about ransomware attacks that damaged its software for months.

  • June 28, 2024

    4 Things To Know As New SPAC Rules Take Effect

    The U.S. Securities and Exchange Commission's new rules governing special-purpose acquisition companies take effect on Monday, marking an expansive attempt to strengthen oversight of SPAC deals. Here, Law360 examines what to expect as the agency's 581-page rule package goes live.

  • June 28, 2024

    Nixed Purdue Ch. 11 Plan May Leave States Ready For A Fight

    State attorneys general across the country could be gearing up for more opioid-related litigation against the Sackler family after the U.S. Supreme Court wiped out a $5.5 billion third-party release for the owners of bankrupt drugmaker Purdue Pharma LP, experts told Law360.

  • June 28, 2024

    Supreme Court Strikes Down Chevron Deference

    The U.S. Supreme Court on Friday overturned a decades-old precedent that instructed judges about when they could defer to federal agencies' interpretations of law in rulemaking, depriving courts of a commonly used analytic tool and leaving lots of questions about what comes next.

  • June 27, 2024

    4 Firms Guide Pair Of IPOs Totaling $457M

    Venture-backed drug developer Alumis Inc. and oil-land acquirer LandBridge LLC on Thursday priced initial public offerings, raising a combined $456.5 million, under the guidance of four law firms.

  • June 27, 2024

    Biden, Trump Spar On Abortion Access In The Wake Of Dobbs

    The U.S. Supreme Court's Dobbs decision upending Americans' access to abortion care made an early appearance at Thursday night's presidential debate, with President Joe Biden lamenting the end of Roe v. Wade and former President Donald Trump taking credit for handing the issue of abortion rights "back to the states."

  • June 27, 2024

    OptumRx Agrees To Pay $20M To Resolve DOJ Opioid Claims

    OptumRx Inc. has reached a $20 million deal with the U.S. Department of Justice to end allegations the company improperly filled opioid prescriptions in combination with other drugs, the Justice Department announced Thursday.

  • June 27, 2024

    State AGs Want Stay Lifted In Generic Drug Pricing Suit

    The attorneys general of New York and Connecticut have asked a federal judge to lift a partial discovery stay in three state-led generic drug pricing lawsuits against the pharmaceutical industry, saying it is no longer necessary because sentencing is complete in a parallel U.S. Department of Justice proceeding.

  • June 27, 2024

    Judge Blasts Prisons Bureau, Sends Exec To Halfway House

    An Illinois federal judge said Thursday he felt he needed to protect Outcome Health's co-founder from the Bureau of Prisons' "ridiculous" policy barring her from a low security camp just because she isn't a citizen, sentencing her to time served and three years' supervision in a Chicago halfway house instead. 

  • June 27, 2024

    Insurers Call Rite Aid Ch. 11 Opioid Deal Unfair

    Counsel for bankrupt drugstore chain Rite Aid told a New Jersey bankruptcy judge Thursday that it hopes to reach an agreement with at least some of its insurers on payments into an opioid settlement fund before closing arguments in its Chapter 11 plan confirmation Friday.

  • June 27, 2024

    Rape Kit Co. Wants Wash. Ban Lifted During Free Speech Suit

    A company that sells self-administered sexual assault DNA collection kits is urging a Washington federal judge to stop the enforcement of a new state law that it claims stifles its First Amendment rights by barring the marketing of its kits as an alternative to resources offered by law enforcement and the government.

  • June 27, 2024

    Fed. Circ. Backs Ax Of United Therapeutics' Drug Patent

    The Federal Circuit has affirmed a Patent Trial and Appeal Board finding that claims in a United Therapeutics Corp. high blood pressure drug patent challenged by Liquidia Technologies were invalid as obvious, even though Liquidia's petition included an expert declaration that did not have a required oath.

  • June 27, 2024

    Titanic Purdue Ruling Shifts The Balance Of Power In Ch. 11

    The U.S. Supreme Court's decision to strike down the Sackler family's liability shield in the Chapter 11 plan of Purdue Pharma LP not only eliminates a key tool to resolve mass tort liabilities through bankruptcy, it gives claimants more leverage and fundamentally changes the insolvency landscape in future cases, experts tell Law360.

  • June 27, 2024

    EU High Court Upends Servier Decrease Of Pay-For-Delay Fine

    French pharmaceutical giant Servier is back on the hook for all but €2.4 million ($2.57 million) of a more than €300 million European Union antitrust fine after the European Court of Justice upended a lower court decision that had reduced the penalty by over €100 million.

Expert Analysis

  • What Rescheduling Could Mean For Cannabis Bankruptcies

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    Bankruptcy courts have historically been closed for cannabis-related businesses, but recent case law coupled with a possible reclassification of cannabis provides cautious optimism, say attorneys at Duane Morris.

  • Opinion

    Pharmacies Need More Protection Against PBM Fee Practices

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    The Centers for Medicare & Medicaid Services' recent reform regarding direct and indirect remuneration fees will mitigate the detrimental effects that pharmacy benefit manager policies have on struggling pharmacies, but more is needed to prevent PBMs from exploiting loopholes, says Bhavesh Desai at Mazina Law.

  • Contract Disputes Recap: Facts Differ But Same Rules Apply

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    Zachary Jacobson and Sarah Barney at Seyfarth examine two decisions illustrating that reliance on a technicality may not save an otherwise untimely appeal, and that enforcement of commercial terms and conditions under a federal supply schedule contract may be possible.

  • Series

    Spray Painting Makes Me A Better Lawyer

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    My experiences as an abstract spray paint artist have made me a better litigator, demonstrating — in more ways than one — how fluidity and flexibility are necessary parts of a successful legal practice, says Erick Sandlin at Bracewell.

  • Takeaways From The 2023 DOJ Fraud Section Report

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    Attorneys at Wiley discuss notable trends from the U.S. Department of Justice's recently reported Fraud Section activity last year and highlight areas of enforcement to watch for in the future, including healthcare fraud and Foreign Corrupt Practices Act violations.

  • Judge-Shopping Policy Revisal May Make Issue Worse

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    The Judicial Conference at its March meeting unveiled a revised policy with the stated goal of limiting litigants’ ability to judge-shop in patent cases, but the policy may actually exacerbate the problem by tying the issue to judge-shopping in polarizing political cases, making reform more difficult, say Robert Niemeier and William Milliken at Sterne Kessler.

  • 2nd Circ. Baby Food Ruling Disregards FDA's Expertise

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    The Second Circuit's recent decision in White v. Beech-Nut Nutrition, refusing to defer litigation over heavy metals in baby food until the U.S. Food and Drug Administration weighs in on the issue, provides no indication that courts will resolve the issue with greater efficiency than the FDA, say attorneys at Phillips Lytle.

  • Assessing FDA Pathways For Genome-Edited Plant Foods

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    The U.S. Food and Drug Administration's recent clarification of the regulatory pathways for foods produced from genome-edited plants seeks to strike a balance between public health and innovation, and may hold broader significance for developers of novel human foods subject to voluntary notification programs, say Emily Marden and Diane McEnroe at Sidley Austin.

  • Opinion

    Proposed MDL Management Rule Needs Refining

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    Proponents of the recently proposed Federal Rule of Civil Procedure 16.1 believe it may enhance efficiency in multidistrict litigation proceedings if adopted, but there are serious concerns that it could actually hinder plaintiffs' access to justice through the courts — and there are fundamental flaws that deserve our attention, says Ashleigh Raso at Nigh Goldenberg.

  • Why Oncology Deal Making Continues To Fuel Biotech M&A

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    The biotech sector's potential for advancements in cancer care continues to attract deal-maker interest, and the keys to successful mergers and acquisitions include the ability to integrate innovative therapies, leverage technological advancements and respond to the dynamic needs of patients, say Bryan Luchs and Mike Weir at White & Case.

  • Opinion

    Judicial Independence Is Imperative This Election Year

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    As the next election nears, the judges involved in the upcoming trials against former President Donald Trump increasingly face political pressures and threats of violence — revealing the urgent need to safeguard judicial independence and uphold the rule of law, says Benes Aldana at the National Judicial College.

  • Opinion

    NIST March-In Framework Is As Problematic As 2021 Proposal

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    While the National Institute of Standards and Technology's proposed march-in framework on when the government can seize patents has been regarded as a radical departure that will support lowering prescription drug costs, the language at the heart of it is identical to a failed 2021 notice of proposed rulemaking, says attorney Kelly Morron.

  • Document Retention Best Practices To Lower Litigation Risks

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    As new technologies emerge and terabytes of data can be within the purview of a single discovery request, businesses small and large should take four document management steps to effectively minimize risks of litigation and discovery sanctions long before litigation ensues, says Kimbrilee Weber at Norris McLaughlin.

  • Series

    Riding My Peloton Bike Makes Me A Better Lawyer

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    Using the Peloton platform for cycling, running, rowing and more taught me that fostering a mind-body connection will not only benefit you physically and emotionally, but also inspire stamina, focus, discipline and empathy in your legal career, says Christopher Ward at Polsinelli.

  • Ala. Frozen Embryo Ruling Creates Risks for Managed Care Orgs

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    The Alabama Supreme Court's decision in LePage v. Center for Reproductive Medicine last month, declaring that frozen embryos count as children, has not only upended the abortion debate but also raised questions for managed care organizations and healthcare providers that provide, offer or facilitate fertility treatment nationwide, say attorneys at Reed Smith.

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