Life Sciences

  • September 30, 2024

    Wheeling & Appealing: The Latest Must-Know Appellate Action

    The year's spookiest month is looking scary-good for appellate aficionados, as famed oral advocates joust in October over net neutrality and Uber's extraordinary bid to unravel multidistrict litigation — just two of the high-profile arguments previewed in this edition of Wheeling & Appealing. October also begins with former President Jimmy Carter turning 100, and we'll test your knowledge of his profound impact on the judiciary.

  • September 30, 2024

    Consumer 'Overslept' On Some Drowsy Cough Syrup Claims

    An Illinois federal judge said Monday a consumer can continue her suit alleging Tussin cough syrup's "non-drowsy" label is deceptive because the syrup made her sleepy, but ruled she waited too long to pursue warranty breach claims.

  • September 30, 2024

    Bristol-Myers Beats Celgene Investors' Drug Delay Suit

    A New York federal judge on Monday tossed UMB Bank's claims that Bristol-Myers Squibb improperly delayed U.S. Food and Drug Administration approval of a cancer treatment to avoid paying shareholders $6.4 billion owed from a 2019 acquisition of Celgene Corp., saying the bank lacked standing to sue.

  • September 30, 2024

    J&J Backs Off 340B Rebate Plan Following Feds' Objections

    Johnson & Johnson abandoned its plan Monday to offer rebates rather than upfront discounts for two medications under the 340B drug pricing law, contending it had no choice after a federal agency threatened to impose excessive penalties.

  • September 30, 2024

    Generic-Drug Co. Says To Think Again About 'Double Patenting'

    An Indian generic-drug maker wants the whole Federal Circuit to take a closer look at the issue of "double patenting," telling it that a recent panel ruling mistakenly breathed new life into pharmaceutical patents covering an anti-diarrhea drug.

  • September 30, 2024

    Medical Device Co. Wins $25M Verdict In Poaching Trial

    Medical device company Cynosure has won a $25 million jury award following a weekslong trial in Massachusetts federal court on its claims that a rival business raided its sales and marketing talent and caused the employees to breach their noncompete and nonsolicitation agreements.

  • September 30, 2024

    J&J Exec Accused Of File Heist Wants Pause Amid DOJ Case

    A former competitive strategy director for Johnson & Johnson accused of stealing confidential files as he left the company to work for Pfizer asked a New Jersey federal court to pause the suit after learning he is under criminal investigation.

  • September 27, 2024

    Kappos' Bayh-Dole Warning To Clients Draws Debate

    An advocate for lowering drug prices squared off Friday against a former U.S. Patent and Trademark Office director about the potential risk of accepting government funds to develop drugs, as part of a discussion at New York University School of Law.

  • September 27, 2024

    9th Circ. Says Stem Cell Treatment Not Exempt From FDA Rule

    Two California clinics' experimental stem cell treatments are "drugs" subject to Food, Drug and Cosmetic Act regulations, the Ninth Circuit ruled Friday, reviving the federal government's bid to stop the clinic from marketing the products as cures for certain diseases without U.S. Food and Drug Administration review.

  • September 27, 2024

    Why Many Drugs Remain Pricey 40 Years After Hatch-Waxman

    In the four decades since Congress passed the Hatch-Waxman Act in an effort to make generic drugs more available, the pharmaceutical industry has used patent thickets, "evergreening" and pay-for-delay tactics to block competition and keep prices of life-saving specialty drugs astronomical, several legal experts told Law360, while the industry argues other parties shoulder more of the blame.

  • September 27, 2024

    Pharma Co. Amarin Beats Class Action Over Patent Issues

    A New Jersey federal judge has tossed a proposed class action against pharmaceutical company Amarin and its top brass, alleging they misled shareholders about their products and the prospects of related patent litigation, saying the investors have failed to plead any actionable misleading statements or omissions made by the defendants.

  • September 27, 2024

    Life Sciences Firms Energize IPO Market As Recovery Builds

    Initial public offerings are closing the year's third quarter on an upswing, led mostly by pre-revenue drug developers and select large companies that are seizing opportunities in friendlier capital markets buoyed by interest-rate cuts, generating momentum that experts say could carry over into next year.

  • September 27, 2024

    Advil Owner Haleon Paying $637M To Up Stake In China JV

    British consumer healthcare giant Haleon plc said Friday that it has agreed to pay the equivalent of roughly $637 million to increase its stake in a Chinese joint venture, Tianjin TSKF Pharmaceutical Co., from 55% to 88%. 

  • September 27, 2024

    Medical Equipment Co., Founder Settle FCA Suit For $20M

    A Florida-based medical equipment company and its founder will pay $20 million to settle claims under the federal False Claims Act that they improperly billed government healthcare plans for duplicated and unnecessary sales of devices meant to offer pain relief through electrical stimulation, Pennsylvania prosecutors said Friday.

  • September 26, 2024

    SEC Fines Cassava $40M Over Alzheimer's Treatment Claims

    Neuroscience-focused biopharmaceutical company Cassava Sciences Inc. and two of its former executives agreed to pay over $40 million to resolve U.S. Securities and Exchange Commission claims related to allegedly misleading statements about clinical trial results for a potential Alzheimer's disease therapeutic, the regulator announced on Thursday.

  • September 26, 2024

    11th Circ. Affirms Convictions In Fla. Shark Rescue Case

    The Eleventh Circuit upheld felony theft convictions for two Florida tour boat divers who were prosecuted for freeing sharks they believed were illegally poached, but turned out to be part of a research project conducted with a permit granted by the National Oceanic and Atmospheric Administration.

  • September 26, 2024

    2nd Circ. Denies Jury Trial In Abbott Labs Gray Market Case

    A man and his wife involved in the sale of gray market diabetes test strips on Tuesday were unable to persuade the Second Circuit to undo the $33.4 million judgment they owe to Abbott Laboratories after a federal judge stripped them of their right to a jury trial.

  • September 26, 2024

    New Report Urges Feds To Take Larger Role In Pot Policy

    The rise of state-sanctioned cannabis markets amid the absence of federal regulation has prioritized policies intended to launch marijuana sales over those focused on public health, according to a government-sponsored report made public Thursday.

  • September 26, 2024

    Walgreens Struggles To Exit 'Non-Drowsy' Label Suit In Wash.

    The Washington State Supreme Court questioned Thursday whether Walgreens could avoid state consumer protection claims over its "non-drowsy" cough medicine label by pointing to a lack of federal labeling requirements for the drug, with one justice calling the argument a non sequitur.

  • September 26, 2024

    NC Medical Equipment Maker Can't Ditch Unfair Biz Suit

    The North Carolina Business Court has denied a medical equipment maker's bid to get a win based on the pleadings in a fraudulent concealment and unfair trade practices lawsuit alleging that it stole the business model and a pregnancy support garment design from a rival.

  • September 26, 2024

    Obesity Drug Developer Leads 2 Upsized IPOs Totaling $310M

    Obesity-focused drug developer BioAge Labs Inc. gained in debut trading Thursday after raising $198 million through an upsized initial public offering, leading one of two new listings that netted a combined $310 million under the guidance of four law firms.

  • September 26, 2024

    Virtua Discriminates Against Pregnant Patients, NJ Alleges

    Virtua Health discriminates against pregnant patients by forcing them to undergo drug testing for inpatient admission to its hospitals — a policy that does not apply universally to other patients, New Jersey Attorney General Matthew J. Platkin alleged in a lawsuit filed Thursday in New Jersey state court.

  • September 26, 2024

    Senate Patent Bill Markups Delayed Until After Election

    Congressional hearings scheduled for Thursday to mark up several bills related to patents, including measures dealing with patent eligibility, validity challenges and drug patents, have been postponed until after Election Day due to the Senate's adjournment.

  • September 26, 2024

    Nobel Winners Behind Gene Editor Seek To Nix Own Patents

    The scientists credited with inventing the gene-editing tool CRISPR have voluntarily requested that two key patents be revoked in Europe, after officials suggested they might get nixed over technical issues.

  • September 26, 2024

    Quest Diagnostics Escapes 401(k) Mismanagement Suit

    A New Jersey federal judge tossed a proposed class action alleging Quest Diagnostics Inc. mismanaged its $5 billion retirement plan by failing to chop under performing investment funds from its lineup, pointing to proof that the company acted to rein in questionable funds.

Expert Analysis

  • Series

    Playing Golf Makes Me A Better Lawyer

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    Golf can positively affect your personal and professional life well beyond the final putt, and it’s helped enrich my legal practice by improving my ability to build lasting relationships, study and apply the rules, face adversity with grace, and maintain my mental and physical well-being, says Adam Kelly at Venable.

  • Law Firms Should Move From Reactive To Proactive Marketing

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    Most law firm marketing and business development teams operate in silos, leading to an ad hoc, reactive approach, but shifting to a culture of proactive planning — beginning with comprehensive campaigns — can help firms effectively execute their broader business strategy, says Paul Manuele at PR Manuele Consulting.

  • The Regulatory Headwinds Facing Lab-Developed Tests

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    Though the U.S. Food and Drug Administration's final rule regarding regulation of laboratory-developed tests outlines a four-year plan for ending enforcement discretion, and though this rule is currently being challenged in courts, manufacturers should heed compliance opportunities immediately as enforcement actions are already on the horizon, say attorneys at Kirkland & Ellis.

  • 3 High Court Rulings May Shape Health Org. Litigation Tactics

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    Three separate decisions from the U.S. Supreme Court's most recent term — Loper Bright, Corner Post and Jarkesy — will likely strengthen healthcare organizations' ability to affirmatively sue executive agencies to challenge regulations governing operations and enforcement actions, say attorneys at McDermott.

  • Opinion

    A New Way Forward For COVID Vaccine Lawsuit Immunity

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    As Public Readiness and Emergency Preparedness Act protections for COVID-19 vaccines wane, adding those vaccines to coverage by the National Vaccine Injury Compensation Program would bolster defenses for administrators and manufacturers while also providing stronger remedies for those injured by vaccines, says Altom Maglio at MCT Law.

  • Opinion

    The Big Issues A BigLaw Associates' Union Could Address

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    A BigLaw associates’ union could address a number of issues that have the potential to meaningfully improve working conditions, diversity and attorney well-being — from restructured billable hour requirements to origination credit allocation, return-to-office mandates and more, says Tara Rhoades at The Sanity Plea.

  • Opinion

    It's Time For A BigLaw Associates' Union

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    As BigLaw faces a steady stream of criticism about its employment policies and practices, an associates union could effect real change — and it could start with law students organizing around opposition to recent recruiting trends, says Tara Rhoades at The Sanity Plea.

  • How Justices Upended The Administrative Procedure Act

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    In its recent Loper Bright, Corner Post and Jarkesy decisions, the U.S. Supreme Court fundamentally changed the Administrative Procedure Act in ways that undermine Congress and the executive branch, shift power to the judiciary, curtail public and business input, and create great uncertainty, say Alene Taber and Beth Hummer at Hanson Bridgett.

  • Parsing FY 2024 DOJ Criminal Healthcare Fraud Enforcement

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    While the U.S. Department of Justice's Criminal Division's strike force on healthcare fraud enforcement action shows an impressive doubling of criminal indictments, a closer look at the data offers important clues about underlying trends, including the comparably modest, accompanying increase in associated intended loss, say Roderick Thomas and Kathleen Cooperstein at Wiley.

  • How Cos. With Chinese Suppliers Should Prep For Biotech Bill

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    A proposed bill to prohibit government-affiliated life sciences companies from contracting with Chinese biotech companies of concern may necessitate switching to other sources for research and supplies, meaning they should begin evaluating supply chains now due to the long lead times of drug development, say John O'Loughlin and Christina Carone at Weil Gotshal.

  • Mirror, Mirror On The Wall, Is My Counterclaim Bound To Fall?

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    A Pennsylvania federal court’s recent dismissal of the defendants’ counterclaims in Morgan v. Noss should remind attorneys to avoid the temptation to repackage a claim’s facts and law into a mirror-image counterclaim, as this approach will often result in a waste of time and resources, says Matthew Selmasska at Kaufman Dolowich.

  • Can Chapter 15 Bankruptcy Help Cannabis Businesses?

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    Attorneys at Fox Rothschild consider whether Chapter 15 may be used as a tool to liquidate U.S. assets of cannabis companies in foreign bankruptcy proceedings, and look at the statutory provisions that may have a bearing on the successful liquidation of assets under the Bankruptcy Code.

  • FTC's Drug Middlemen Probe Highlights Ongoing Scrutiny

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    The Federal Trade Commission's interim staff report on its inquiry into pharmacy benefit managers suggests that the industry will remain under an enforcement microscope for the foreseeable future due to concerns about how PBMs affect drug costs and accessibility, say attorneys at Arnold & Porter.

  • Series

    Playing Dungeons & Dragons Makes Me A Better Lawyer

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    Playing Dungeons & Dragons – a tabletop role-playing game – helped pave the way for my legal career by providing me with foundational skills such as persuasion and team building, says Derrick Carman at Robins Kaplan.

  • Del. Dispatch: Director Caremark Claims Need Extreme Facts

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    The Delaware Court of Chancery recently dismissed Caremark claims against the directors of Centene in Bricklayers Pension Fund of Western Pennsylvania v. Brinkley, indicating a high bar for a finding of the required element of bad faith for Caremark liability, and stressing the need to resist hindsight bias, say attorneys at Fried Frank.

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