Life Sciences

  • May 21, 2024

    Hawaii Wins $916M From Bristol-Myers, Sanofi Over Plavix

    Bristol-Myers Squibb Co. and Sanofi owe more than $916 million to the state of Hawaii for not warning patients of East Asian or Pacific Island ancestry of potential health risks associated with their blood thinner Plavix, a state judge ruled Tuesday, following a trip to the state's highest court.

  • May 21, 2024

    Ex-AUSA Blames Inexperience For Outcome Forfeiture Error

    Former prosecutors who pursued the $1 billion fraud trial against Outcome Health executives said Tuesday they never suspected their asset restraint efforts were an overreach, noting they lacked the expertise to notice potential mistakes themselves.

  • May 21, 2024

    Sens. Challenge Pharma Lobbyist Over Patent Abuse

    U.S. senators from both sides of the aisle took turns at a Tuesday hearing questioning the pharmaceutical industry's top lobbyist over whether patent abuse plays a role in maintaining the high price of prescription drugs.

  • May 21, 2024

    DC Circ. Says Drugmakers Can Limit Pharmacy Discounts

    The D.C. Circuit held Tuesday that a federal drug discount program does not bar manufacturers from restricting deliveries of discounted drugs to contract pharmacies, rejecting the U.S. Department of Health and Human Services' expansive interpretation of the 340B drug pricing program.

  • May 21, 2024

    MetLife Workers Tell 3rd Circ. Higher Premiums Give Standing

    A group of MetLife Group Inc. retirees insisted to the Third Circuit on Tuesday that they would have had lower health insurance premiums had MetLife not kept millions in pharmacy rebates, and that MetLife's actions gave them standing to sue — or at least to seek more information on how the company should spend the money.

  • May 21, 2024

    CohnReznick Adds PwC Partner To International Tax Practice

    CohnReznick has a new principal in its international tax practice who previously served as a partner at PwC, the firm announced.

  • May 21, 2024

    SPAC Investor's Suit Changes Came Too Late, Chancery Rules

    A shareholder of a special-purpose acquisition company that merged with a now-defunct medical technology company in 2021 waited too long to amend his year-old proposed class action and must defend the case against a motion to dismiss in June, Delaware's Court of Chancery said Tuesday.

  • May 21, 2024

    PE Firms Close Separate Funds With Nearly $1.3B Total In Tow

    Winston & Strawn LLP-advised private equity shop Paceline Equity Partners LLC and Kirkland & Ellis LLP-advised private equity firm Eir Partners on Tuesday separately announced that they have clinched funds totaling nearly $1.3 billion combined, with the former's fund focusing on corporate debt and real assets and the latter's targeting healthcare technology investments.

  • May 21, 2024

    Cooley Atty Returns From Deputy GC In-House Role In Boston

    Cooley LLP's latest emerging companies and venture capital practice partner, James Schneider, started his career as a sports journalist covering local high school football games and didn't consider shifting careers until after the final whistle of a Thanksgiving Day game while rushing to meet a deadline, he told Law360 Pulse on Tuesday.

  • May 21, 2024

    Strategic Hiring Was The New Normal For BigLaw In 2023

    The 400 largest law firms by headcount in the U.S. grew more slowly in 2023 than in the previous two years, while Kirkland & Ellis LLP surpassed the 3,000-attorney threshold, according to the latest Law360 ranking.

  • May 21, 2024

    The Law360 400: Tracking The Largest US Law Firms

    The legal market expanded more tentatively in 2023 than in previous years amid a slowdown in demand for legal services, especially in transactions, an area that has been sluggish but is expected to quicken in the near future.

  • May 21, 2024

    Paul Hastings' FDA Chair Departs For Arnold & Porter

    The chair of the U.S. Food and Drug Administration practice at Paul Hastings LLP has left for Arnold & Porter Kaye Scholer LLP just a few months after joining Paul Hastings, the firm said Tuesday.

  • May 20, 2024

    Ex-IRS Agent, Five Others Sentenced In COVID Fraud Scheme

    A former Internal Revenue Service agent, his brother and four other defendants have pled guilty to participating in a scheme that netted more than $3 million in fraudulent COVID-19 pandemic relief loans.

  • May 20, 2024

    Lab Says GSK Hid Zantac Cancer Risk From Feds For Decades

    A Connecticut laboratory claims that GlaxoSmithKline defrauded federal health insurance programs for billions by hiding for 40 years that Zantac decomposes into a carcinogen even when just sitting on the shelf, in a lawsuit filed Monday in Pennsylvania federal court.

  • May 20, 2024

    Teladoc Faces Suit Over Mental Health Platform's Losses

    Telemedicine giant Teladoc Health Inc. and two of its executives face a proposed investor class action alleging trading prices for Teladoc shares fell after the company disclosed that its flagship mental health counseling platform saw membership and revenue declines despite increased advertising costs.

  • May 20, 2024

    Ultragenyx Must Face Suit Over Use Of Henrietta Lacks' Cells

    The family of the late Henrietta Lacks, a Black woman whose cells were harvested without her knowledge to create the first immortalized human cell line, can pursue their suit alleging Ultragenyx Pharmaceutical "made a fortune" using her stolen cells to develop gene therapy treatments, a Maryland federal judge ruled Monday.

  • May 20, 2024

    USPTO Clarifies Means-Plus-Function Claims For Antibodies

    The U.S. Patent and Trademark Office's new Appeals Review Panel clarified the use of means-plus-function claiming when patenting antibodies, while continuing to reject claims of a Xencor Inc. patent application related to treating autoimmune diseases.

  • May 20, 2024

    McKinsey Can't Nix Pregnant Women's Claims In Opioid MDL

    A California federal judge has cut some claims from multidistrict litigation seeking to hold McKinsey & Co. Inc. liable for infant neonatal abstinence syndrome caused by pregnant women's use of opioids, trimming fraud and nuisance-based claims, but allowing conspiracy and aiding-and-abetting claims to proceed against the consulting firm.

  • May 20, 2024

    Judge Tosses Acuitas' COVID Biotech IP Suit

    A New Jersey federal judge on Monday threw out a lawsuit from a maker of a component of a COVID-19 vaccine relating to patent infringement litigation brought by two other companies against Pfizer and BioNTech.

  • May 20, 2024

    Local Governments Seek Sanctions For PBMs In Opioid MDL

    Four municipalities are asking an Ohio federal court overseeing the national opioid litigation to sanction pharmacy benefit managers Express Scripts Inc. and OptumRX Inc., saying they've willfully defied the court's order to provide complete responses to discovery requests.

  • May 20, 2024

    iRhythm Brass Face Suit Over FDA's Heart Monitor Inquiry

    Several current and former directors and executives of medical technology company iRhythm are named in a shareholder derivative suit alleging they failed to disclose an inquiry by the Food and Drug Administration that found iRhythm's heavily touted and high-cost real-time heart monitoring device failed to meet the company's claims.

  • May 20, 2024

    J&J Says Beasley Allen Looking To 'Bias' Vote On $6.5B Plan

    Johnson & Johnson's bankrupt talc unit accused the Beasley Allen Law Firm of attempting to intentionally "bias" the vote against its recently announced proposal to pay out $6.5 billion in a prepackaged reorganization plan to resolve claims that its talc-based baby powder causes ovarian cancer.

  • May 20, 2024

    Latham Hires 2 Skadden Healthcare Partners In DC

    Latham & Watkins LLP has picked up two healthcare and life sciences partners from Skadden Arps Slate Meagher & Flom LLP in Washington, D.C., the firm announced Monday.

  • May 20, 2024

    Catching Up With Delaware's Chancery Court

    Delaware was full of drama last week, as proposed changes to the state's corporate law statutes raised eyebrows and a professor's friend-of-the-court brief sparked a very unfriendly public exchange. Delaware's court of equity banged the gavel on pipeline and social media disputes, and shareholders filed new suits alleging insider trading, vote bungling, unfair stock buybacks and merger shenanigans. In case you missed any of it, here's the recap of all the top news last week from Delaware's Chancery Court.

  • May 20, 2024

    Ga. Judge OKs $5M Atty Fees In $41M Acella Thyroid Deal

    A Georgia federal judge has signed off on a nearly $41.5 million class action settlement with Acella Pharmaceuticals LLC over faulty thyroid medication, while awarding the class attorneys another $5 million in legal fees courtesy of the pharma company.

Expert Analysis

  • Opinion

    State-Regulated Cannabis Can Thrive Without Section 280E

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    Marijauna's reclassification as a Schedule III-controlled substance comes at a critical juncture, as removing marijuana from being subjected to Section 280E of the Internal Revenue Code is the only path forward for the state-regulated cannabis industry to survive and thrive, say Andrew Kline at Perkins Coie and Sammy Markland at FTI Consulting.

  • Key Takeaways From FDA Final Rule On Lab-Developed Tests

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    Michele Buenafe and Dennis Gucciardo at Morgan Lewis discuss potential consequences of the U.S. Food and Drug Administration's recently finalized rule regulating lab-developed tests as medical devices, and explain the rule's phaseout policy for enforcement discretion.

  • Assessing HHS' Stance On Rare Disease Patient Assistance

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    The U.S. Department of Health and Human Services' recent advisory opinion, temporarily blessing manufacturer-supported copay funds for rare disease patients, carves a narrow path for single-donor funds, but charities and their donors may require additional assistance to navigate programs for such patients, says Mary Kohler at Kohler Health Law.

  • Opinion

    Feds' Biotech Enforcement Efforts Are Too Heavy-Handed

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    The U.S. Department of Justice's recent actions against biotech companies untether the Anti-Kickback Statute from its original legislative purpose, and threaten to stifle innovation and undermine patient quality of care, say attorneys at Ropes & Gray.

  • Regulating Resurrected Species Under The ESA

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    As the prospect of extinct species being resurrected from DNA and reintroduced into the wild grows closer, an analysis of the Endangered Species Act suggests that it could provide a thoughtful, flexible governance framework for such scenarios, say Caroline Meadows and Shelby Bobosky at the SMU Dedman School of Law.

  • E-Discovery Quarterly: Recent Rulings On Text Message Data

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    Electronically stored information on cellphones, and in particular text messages, can present unique litigation challenges, and recent court decisions demonstrate that counsel must carefully balance what data should be preserved, collected, reviewed and produced, say attorneys at Sidley.

  • What CRA Deadline Means For Biden Admin. Rulemaking

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    With the 2024 election rapidly approaching, the Biden administration must race to finalize proposed agency actions within the next few weeks, or be exposed to the chance that the following Congress will overturn the rules under the Congressional Review Act, say attorneys at Covington.

  • 5 Takeaways From FDA's Biosimilars Promotion Guidance

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    New draft guidance from the U.S. Food and Drug Administration expands upon other recent efforts to clarify expectations for biosimilar and interchangeable labeling, highlighting a number of potential missteps that could draw attention from regulators, say attorneys at Arnold & Porter.

  • Dual-Track IPO-M&A Exit Strategies For Life Science Cos.

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    A dual-track process for life sciences companies offers a proven path to securing favorable deal terms for an exit, and strategic moves can include running a crossover financing round in the lead-up, say attorneys at McDermott.

  • Does Expert Testimony Aid Preliminary IPR Responses?

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    Dechert attorneys analyze six years of patent owners' preliminary responses to inter partes review petitions to determine whether the elimination of the presumption favoring the petitioner as to preinstitution testimonial evidence affected the usefulness of expert testimony in responses.

  • Are Concessions In FDA's Lab-Developed Tests Rule Enough?

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    Although the U.S. Food and Drug Administration's new policy for laboratory-developed tests included major strategic concessions to help balance patient safety, access and diagnostic innovation, the new rule may well face significant legal challenges in court, say Dominick DiSabatino and Audrey Mercer at Sheppard Mullin.

  • Rebuttal

    Double-Patenting Ruling Shows Terminal Disclaimers' Value

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    While a recent Law360 guest article seems to argue that the Federal Circuit’s Cellect decision last year robs patent owners of lawful patent term, the ruling actually identifies how terminal disclaimers are the solution to the problem of obviousness-type double patenting, say Jane Love and Robert Trenchard at Gibson Dunn.

  • Series

    Swimming Makes Me A Better Lawyer

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    Years of participation in swimming events, especially in the open water, have proven to be ideal preparation for appellate arguments in court — just as you must put your trust in the ocean when competing in a swim event, you must do the same with the judicial process, says John Kulewicz at Vorys.

  • Mid-2024 FCA Enforcement And Litigation Trends To Watch

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    Reviewing notable False Claims Act trends and enforcement efforts in the last year and a half reveals that healthcare is a key enforcement priority for the U.S. Department of Justice, and the road ahead may bring clarification on Anti-Kickback Statute causation and willfulness standards, along with increased focus on private equity, cybersecurity and self-disclosure, say attorneys at Epstein Becker.

  • What 100 Federal Cases Suggest About Changes To Chevron

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    With the U.S. Supreme Court poised to overturn or narrow its 40-year-old doctrine of Chevron deference, a review of 100 recent federal district court decisions confirm that changes to the Chevron framework will have broad ramifications — but the magnitude of the impact will depend on the details of the high court's ruling, say Kali Schellenberg and Jon Cochran at LeVan Stapleton.

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