Life Sciences

  • March 13, 2025

    Days Into New Role, FDA's Top Lawyer Is Out

    The top lawyer of the U.S. Food and Drug Administration resigned just two days after she was selected for the role, according to a Thursday announcement by the agency on social media site X.

  • March 13, 2025

    Lacking Votes, White House Pulls Weldon Nomination At CDC

    The White House pulled Dr. Dave Weldon's nomination to lead the Centers for Disease Control and Prevention on Thursday after support among GOP lawmakers wavered, and it became clear he didn't have the votes to clear a Senate committee.

  • March 12, 2025

    Cancer Cause Or Red Herring? Jury Weighs Plant Bellwether

    A medical sterilization company told a Colorado jury Wednesday that four women can't get millions in damages based on the "possibility" that emissions from a sterilization plant caused their cancer, at the close of a six-week trial in which the plaintiffs argued the company should be punished for its negligence.

  • March 12, 2025

    Del. Justices Told Conflicts Tainted AstraZeneca Co.'s $3B Sale

    A stockholder class attorney told Delaware's Supreme Court on Wednesday that a vice chancellor never addressed the undisclosed conflicts cited in a Court of Chancery suit accusing AstraZeneca PLC of lining up a conflicted, underpriced $3 billion sale of clinical stage biopharmaceutical venture Viela Bio Inc.

  • March 12, 2025

    Labcorp Warns Fed. Circ. Of 'Balkanization' In Prenatal IP Row

    Labcorp, one of the world's largest chains of clinical lab providers, told the full Federal Circuit that a loss it incurred there over a patent tied to a $384 million judgment in Texas was the result of the "balkanization" of the court's patent obviousness jurisprudence.

  • March 12, 2025

    Law360 Cheat Sheet: Novartis' Fight Over Generic Entresto

    Novartis has led a wide-ranging litigation campaign to block generic versions of its bestselling cardiovascular drug Entresto that has involved multidistrict litigation, trips to several circuit courts and cases against the federal government. Here, Law360 breaks down how the various cases intersect and what's still playing out.

  • March 12, 2025

    SEC Says Ex-Allarity Execs Concealed Doomed FDA Approval

    The U.S. Securities and Exchange Commission sued three former executives of clinical-stage pharmaceutical company Allarity Therapeutics Inc. in Massachusetts federal court, alleging Wednesday that they schemed to conceal from the public that the company's new drug application for its flagship drug had no chance of gaining regulatory approval.

  • March 12, 2025

    Caribou Biosciences Brass Face Investor's Clinical Trials Suit

    Executives and directors of Caribou Biosciences Inc. have been hit with a shareholder's derivative suit alleging that they overstated the safety and efficacy of Caribou's cell therapy and concealed that the company was at risk of being unable to fund its operations.

  • March 12, 2025

    COVID Test Device Maker Settles Fed. Circ. Feuds With Rival

    A company that makes saliva collection devices used for COVID-19 tests says it will drop out of Federal Circuit appeals fights with Longhorn Vaccines & Diagnostics stemming from the Patent Trial and Appeal Board canceling 183 of Longhorn's patent claims as a punishment for "egregious abuse of the PTAB process."

  • March 12, 2025

    Publix Policies Don't Cover Opioid Claims, Court Says

    Insurers for Publix have no duty to defend or indemnify the supermarket chain in dozens of public nuisance lawsuits related to the opioid crisis, a Florida federal court said Wednesday, following Publix's renewed request that the court enter a final judgment so it could proceed with appeal.

  • March 12, 2025

    NC Organ Procurer Sues CMS Over Hospital Waiver

    A North Carolina-based organ procurement organization told a federal court Wednesday that the Centers for Medicare & Medicaid Services has violated federal law by giving a waiver to a hospital to work with another organ procurement service from a different region. 

  • March 12, 2025

    Cannabis Tech Co. Seeks Over $1M Interest On $4.2M Verdict

    A software company that won a $4.2 million judgment last year on claims that it was wrongly pushed out of a state government contract is urging a Pennsylvania federal court to award more than $1 million in pre- and postjudgment interest on the award.

  • March 12, 2025

    HHS To Eliminate 6 Regional Offices For Legal Staff

    The U.S. Department of Health and Human Services said Tuesday it will close six out of 10 regional offices where attorneys for the agency work.

  • March 12, 2025

    Harvard Docs Say Gov't Censored Articles With Gender Terms

    A pair of Harvard Medical School researchers sued the Trump administration in Massachusetts federal court on Wednesday, claiming their work was erased from a government-run patient safety website because their articles contained terms like "LGBTQ" and "transgender."

  • March 12, 2025

    Mallinckrodt Investors Ask NJ Court To Approve $46M Deal

    A group of Mallinckrodt PLC investors has asked a New Jersey federal judge to grant final approval to a $46 million settlement they reached with executives and directors of the pharmaceutical company to resolve claims that they misrepresented the prospects of a drug the company developed.

  • March 12, 2025

    McCarter & English Wins $3.77M From Ex-Client In Billing Spat

    McCarter & English LLP is entitled to nearly $3.77 million from Jarrow Formulas Inc., a nutritional supplement company that refused to pay its legal bills after losing a trade secrets trial and a subsequent malpractice claim against the firm, a Connecticut federal judge has ruled.

  • March 11, 2025

    Medical Device Co. Seeks Fed. Circ. Redo Over Patent Trial

    A medical device manufacturer is asking a Federal Circuit panel to reconsider a decision reviving a patent infringement case against it, arguing a lower court judge was fine to allow tardy testimony from a witness who took its side.

  • March 11, 2025

    Kenvue Unit Can't Nix BIPA Suit Over Neutrogena Skin360 App

    A Kenvue unit can't escape a proposed class action alleging it unlawfully stores facial scans of people who use its Neutrogena Skin360 tool in violation of Illinois' biometric privacy statute, after a New Jersey federal judge said those users are not "patient[s] in a healthcare setting" under the statute's healthcare exemption.

  • March 11, 2025

    'Paucity' Of Proof Thwarts NC State Law Claims In Gardasil MDL

    A North Carolina federal judge has found that Merck did not violate state law by not including warnings about its Human Papillomavirus vaccine Gardasil, saying there was a "paucity" of evidence that the vaccines cause certain injuries to recipients.

  • March 11, 2025

    More ITC Patent Cases Expected After Fed. Circ. 'Sea Change'

    A recent Federal Circuit decision discarding the U.S. International Trade Commission's limits on what types of domestic expenses qualify a company to bring a patent suit at the agency marks a pronounced shift that will likely spur considerably more ITC cases, attorneys say.

  • March 11, 2025

    Pharmacies To Appeal In Bid To Keep Making Weight Loss Drug

    A group of compounding pharmacies said Monday they would appeal to the Fifth Circuit after a Texas federal judge denied an injunction that would allow compounding pharmacies to produce a lucrative weight loss drug.

  • March 11, 2025

    J&J Tells 3rd Circ. No Price Impact In Talc Concealment Suit

    Johnson & Johnson urged the Third Circuit on Tuesday to undo class certification of investor claims that the company inflated its stock price by failing to disclose cancer risks associated with its talcum powder products, arguing that the investors could not have relied upon its alleged misrepresentations because there was no impact on the stock market's price.

  • March 11, 2025

    Brazilian 'Drug King' Ran Black Market Pharmacy, Feds Say

    Federal prosecutors said a Brazilian national living in the United States without permission falsely portrayed himself as a pharmacist to sell members of a large Portuguese-speaking community west of Boston an array of medications, including painkillers, steroids and other controlled drugs.

  • March 11, 2025

    Zydus Cuts Deal With States, Tribes In Opioid Nuisance Suit

    Zydus Pharmaceuticals Inc. has reached a deal in principle with states and Native American tribes that should quash claims related to the company's alleged role in exasperating the opioid crisis.

  • March 11, 2025

    Eli Lilly Suit Over Compounded Drugs Survives Dismissal

    A Washington federal judge has trimmed Eli Lilly's lawsuit against two Seattle-area clinics and the doctors who run them for allegedly duping consumers into buying copycat versions of its diabetes and weight loss medications Mounjaro and Zepbound, nixing the pharmaceutical giant's consumer protection claim while preserving its trademark infringement and false advertising allegations.

Expert Analysis

  • Considering The Status Of The US Doctrine Of Patent Misuse

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    A recent Ninth Circuit decision and a U.K. Court of Appeal decision demonstrate the impact that the U.S. Supreme Court's 2015 decision in Kimble v. Marvel Entertainment has had on the principle that post-patent-expiration royalty payments amount to patent misuse, not only in the U.S. but in English courts as well, say attorneys at Covington.

  • Series

    Playing Rugby Makes Me A Better Lawyer

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    My experience playing rugby, including a near-fatal accident, has influenced my legal practice on a professional, organizational and personal level by showing me the importance of maintaining empathy, fostering team empowerment and embracing the art of preparation, says James Gillenwater at Greenberg Traurig.

  • Looking Back At 2024's Noteworthy State AG Litigation

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    State attorneys general across the U.S. took bold steps in 2024 to address unlawful activities by corporations in several areas, including privacy and data security, financial transparency, children's internet safety, and other overall consumer protection claims, say attorneys at Troutman Pepper.

  • Opinion

    No, Litigation Funders Are Not 'Fleeing' The District Of Del.

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    A recent study claimed that litigation funders have “fled” Delaware federal court due to a standing order requiring disclosure of third-party financing, but responsible funders have no problem litigating in this jurisdiction, and many other factors could explain the decline in filings, say Will Freeman and Sarah Tsou at Omni Bridgeway.

  • Patent Policy Changes To Track Under New Gov't Leadership

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    The new federal government will likely bring pivotal shifts in U.S. patent policy through legislation and initiatives that reflect a renewed focus on strengthening intellectual property rights, fostering innovation and enhancing the nation's competitive edge, says PK Chakrabarti at Butzel Long.

  • Liability Risk For AI In Medical Devices Demands Greater Care

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    As regulators push for legal reform surrounding artificial intelligence and cases implicating product liability for AI in medical technology continue to rise, manufacturers must adapt and implement new strategies to accommodate evolving risks, say attorneys at Crowell & Moring.

  • 5 E-Discovery Predictions For 2025 And Beyond

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    In the year to come, e-discovery will be shaped by new and emerging trends, from the adoption of artificial intelligence provisions in protective orders, to the proliferation of emojis as a source of evidence in contemporary litigation, say attorneys at Littler.

  • 4 Trade Secret Developments To Follow This Year

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    Significant developments in trade secret law are likely in 2025, and areas to watch include protection of AI-related innovations, the fate of the Federal Trade Commission's noncompete ban, and questions of the federal Defend Trade Secrets Act's extraterritorial reach, say attorneys at Faegre Drinker.

  • Republican Trifecta Amplifies Risks For Cos. In 3 Key Areas

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    Expected coordination between a Republican Congress and presidential administration may expose companies to simultaneous criminal, civil and congressional investigations, particularly with regard to supply chain risks in certain industries, government contracting and cross-border investment, say attorneys at Morgan Lewis.

  • 7 Ways 2nd Trump Administration May Affect Partner Hiring

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    President-elect Donald Trump's return to the White House will likely have a number of downstream effects on partner hiring in the legal industry, from accelerated hiring timelines to increased vetting of prospective employees, say recruiters at Macrae.

  • How Trump 2.0 May Change Business In Latin America

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    Companies in Latin America should expect to face more trade restrictions, tighter economic sanctions and enhanced corruption risks, as the incoming administration shifts focus to certain non-U.S. actors, most notably China, says Matteson Ellis at Miller & Chevalier.

  • Opinion

    Courts Must Curb The Drug Price Negotiation Program

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    The Inflation Reduction Act's drug price negotiation program upends incentive structures that drive medical innovation, and courts must act appropriately to avoid devastating consequences for American healthcare and the pharmaceutical industry, says Jeff Stier at the Consumer Choice Center.

  • E-Discovery Quarterly: Rulings On Custodian Selection

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    Several recent rulings make clear that the proportionality of additional proposed custodians will depend on whether the custodians have unique relevant documents, and producing parties should consider whether information already in the record will show that they have relevant documents that otherwise might not be produced, say attorneys at Sidley.

  • Series

    Exercising On My Peloton Bike Makes Me A Better Lawyer

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    While I originally came to the Peloton bike for exercise, one cycling instructor’s teachings have come to serve as a road map for practicing law thoughtfully and mindfully, which has opened opportunities for growth and change in my career, says Andrea Kirshenbaum at Littler.

  • 5 Drug And Device Developments That Shaped 2024

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    The last year saw significant legal developments affecting drug and device manufacturers, with landmark decisions and regulatory changes that require vigilance and agility from the industry, say attorneys at Faegre Drinker.

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