Life Sciences

  • April 02, 2025

    Bidi Vapor Says FDA Denial Of E-Cig Was Unlawful

    Vape company Bidi Vapor LLC urged the Eleventh Circuit on Wednesday to reverse a U.S. Food and Drug Administration decision denying its application to market a disposable e-cigarette, saying the agency acted unlawfully and ignored evidence the company presented.

  • April 02, 2025

    Orthodontic Software Co. Hit With Data Breach Class Action

    An orthodontic software company has been hit with a proposed class action in Georgia federal court over a November data breach in which the names, birth dates, medical records, insurance information, payment card data and Social Security numbers of its clients' patients were stolen by hackers.

  • April 02, 2025

    Justices Broaden RICO Reach To Personal Injuries

    The U.S. Supreme Court on Wednesday expanded the type of civil actions that can be brought under a federal racketeering statute, asserting that claims stemming from personal injuries are redressable if they can be shown to have caused economic harm.

  • April 02, 2025

    Supreme Court Backs FDA Block Of Flavored Vapes

    The U.S. Supreme Court on Wednesday overruled a determination that the U.S. Food and Drug Administration acted arbitrarily when it rejected an e-cigarette company's applications to market flavored vape products.

  • April 01, 2025

    FDA Beats Challenge To Approval Of Elanco's Cattle Gas Drug

    The U.S. Food and Drug Administration has defeated an administrative challenge to its approval of Elanco Health's drug meant to reduce ammonia gas emissions from beef cattle and their waste, with a California federal judge ruling Tuesday that the agency reasonably evaluated its safety based on a wide array of studies.

  • April 01, 2025

    Takeda Antitrust Trial Over Actos Generics Set For July

    A New York federal court refused a bid from Takeda Pharmaceuticals Co. to escape a long-running case accusing it of unlawfully delaying generic versions of its diabetes treatment Actos and scheduled a trial to start in July.

  • April 01, 2025

    Fla. Defends Sandoz Price-Fixing Settlement Terms

    Florida defended its deal with Sandoz Inc. on Monday, saying the other states suing the generic-drug maker over price-fixing have no right to object to the settlement, which does not require court approval and does not affect the states objecting to it.

  • April 01, 2025

    Two More Pharmacies Hit With Eli Lilly Weight Loss Drug Suits

    Eli Lilly and Co. filed another round of lawsuits Tuesday accusing compounding pharmacies of selling copycat versions of its weight loss and diabetes medications, saying in New Jersey and Delaware federal courts that two online pharmacies are deceiving consumers about their knockoff products.

  • April 01, 2025

    No Inequitable Conduct From Fresenius Foe, Judge Says

    German medical giant Fresenius has failed to convince a Delaware federal judge that any foul play could be found in the prosecution of a patent involved in a fight over selling IV bags filled with calcium supplements, used to treat hypocalcemia. 

  • April 01, 2025

    Ex-Biotech CEO Wrongly Sentenced To 7 Years, DC Circ. Told

    A former biotech executive who pled guilty to misleading investors about a blood-based COVID-19 test urged the D.C. Circuit to order a redo of his seven-year prison sentence on Tuesday, telling an appeals panel that the trial court miscalculated the sentencing guidelines.

  • April 01, 2025

    IBM And J&J Beat 'Speculative' Data Breach Suit, For Now

    A New York federal judge has tossed with leave to amend a proposed class action alleging IBM and Johnson & Johnson's healthcare arm failed to safeguard sensitive health information of thousands of patients before a 2023 data breach, finding the purported harm is "entirely speculative" as currently alleged.

  • April 01, 2025

    Talc Claimants Tell 3rd Circ. Whittaker Couldn't File Ch. 11

    Talc injury claimants on Tuesday asked the Third Circuit to dismiss Whittaker Clark & Daniels' Chapter 11 case, saying a South Carolina state judge had given control of the talc supplier to a receiver six weeks before the company filed for bankruptcy.

  • April 01, 2025

    FDA Cuts Prompt Biotech Players To Rethink Deal Strategies

    Funding cuts at the U.S. Department of Health and Human Services are sending ripples of concern through the biotech industry, as attorneys advise companies to consider a wider breadth of strategic alternatives amid fears of regulatory delays.

  • March 31, 2025

    Texas Judge Deems Lab-Test Rule Outside FDA Authority

    A Texas federal judge on Monday vacated a new U.S. Food and Drug Administration rule that would have brought lab-developed tests under its regulatory authority as "medical devices," finding that the move exceeded the agency's statutory authority and defied "common sense."

  • March 31, 2025

    Former Stimlabs Exec Must Face Trade Secrets Claims

    A former biomedical technology company executive must face claims that she absconded with thousands of internal files containing valuable product information in the days and weeks leading up to her ouster last year, a Georgia federal judge ruled.

  • March 31, 2025

    Ex-Blood Bank Atty Goes Back To Ballard Spahr In Phoenix

    Ballard Spahr LLP has picked up a former in-house intellectual property lawyer from nonprofit blood bank Vitalant who had worked at the law firm a little over a decade ago.

  • March 31, 2025

    Nasdaq's Tighter IPO Rules Raise Bar For Small Companies

    Nasdaq is seeking to weed out volatile stocks by tightening listing standards for small companies conducting initial public offerings or uplistings, although lawyers caution that new rules could prompt capital-hungry companies to pursue other listing strategies, including reverse mergers.

  • March 31, 2025

    Buyer Class Of Surgical Robots Is Certified In Antitrust Fight

    A California federal judge on Monday certified a class of thousands of hospitals alleging Intuitive Surgical monopolized the market for robotic surgical tools by blocking third-party repairs and tying services to robot purchases, finding the case raises common antitrust questions that can be resolved on a classwide basis.

  • March 31, 2025

    J&J Talc Spinoff's Ch. 11 Case Gets Tossed, Erasing $9B Deal

    A Texas bankruptcy judge rejected Johnson & Johnson's third attempt to use Chapter 11 to settle thousands of claims that its products caused cancer, dismissing J&J unit Red River Talc's Chapter 11 case on Monday and throwing out a roughly $9 billion bankruptcy deal over issues with the company's voting procedures and third-party releases.

  • March 31, 2025

    Despite 'Admirable' Effort, Vertex Kickback Challenge Fails

    A D.C. federal judge dealt a loss on Monday to gene therapy drugmaker Vertex Pharmaceuticals, ruling in favor of a U.S. Department of Health and Human Services advisory opinion that found the company's fertility preservation program could potentially violate the Anti-Kickback Statute.

  • March 31, 2025

    Pierson Ferdinand Adds Taylor English Health Pro In Atlanta

    Pierson Ferdinand LLP announced Monday that it has hired a former Taylor English Duma LLP partner who specializes in mergers and acquisitions and also has sleep medicine expertise to strengthen its healthcare practice.

  • March 31, 2025

    Cleary Gains 5-Atty Latham Team Known For Big IP Wins

    Cleary Gottlieb Steen & Hamilton LLP has welcomed a bi-coastal team of five intellectual property litigators from Latham & Watkins LLP, lauding their history leading "many of the most high-profile and complex patent and trade secrets cases of the last decade" in a statement Monday.

  • March 28, 2025

    Colo. Beats Amgen's Drug Price Cap Challenge, For Now

    A Colorado federal judge Friday threw out Amgen's challenge to the Centennial State's drug price cap system, finding that Amgen is not subject to "direct regulation" under the law it's challenging and therefore doesn't have standing to sue.

  • March 28, 2025

    Janssen Owes Additional $1.5B In HIV Prescription Trial

    A New Jersey federal judge on Friday added nearly $1.3 billion in penalties and $240 million in damages to a whistleblower False Claims Act verdict against Janssen over the off-label marketing of two HIV medicines, saying trial evidence laid out "a deliberate and calculated scheme."

  • March 28, 2025

    PE Firm Hits Back Against Medical Device Coating Challenge

    Private equity firm GTCR BC Holdings LLC told a Federal Trade Commission in-house judge Friday the commission has a warped view of the medical device coatings market, as the firm fights a bid to block its $627 million acquisition of Surmodics Inc.

Expert Analysis

  • Del. Justices' D&O Ruling Clarifies 'Related' Claim Analysis

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    In its recent decision in the Alexion Pharmaceuticals coverage case, the Delaware Supreme Court adopted a "meaningful linkage" standard for relatedness analysis, providing further guidance to Delaware policyholders on how to navigate those directors and officers insurance disputes, say attorneys at Hunton.

  • Compliance Pointers For DOJ's Sweeping Data Security Rule

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    A new Justice Department rule broadly restricts many common data transactions with the goal of preventing access by countries of concern, and with an effective date of April 8, U.S. companies must quickly assess practices related to employee, customer and vendor data, says Sam Castic at Hintze Law.

  • Series

    Competitive Weightlifting Makes Me A Better Lawyer

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    The parallels between the core principles required for competitive weightlifting and practicing law have helped me to excel in both endeavors, with each holding important lessons about discipline, dedication, drive and failure, says Damien Bielli at VF Law.

  • The Case For Compliance During The Trump Administration

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    Given the Trump administration’s shifting white collar enforcement priorities, C-suite executives may have the natural instinct to pare back compliance initiatives, but there are several good reasons for companies to at least stay the course on their compliance programs, if not enhance them, say attorneys at Riley Safer.

  • A Look At HHS' New Opinion On Patient Assistance Programs

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    A recent advisory opinion from the U.S. Department of Health and Human Services' Office of Inspector General follows a recent trend of blessing patient assistance program arrangements that implicate the Anti-Kickback Statute, as long as they are structured with appropriate safeguards to minimize the risk of fraud and abuse, say attorneys at Sheppard Mullin.

  • Opinion

    Inconsistent Injury-In-Fact Rules Hinder Federal Practice

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    A recent Third Circuit decision, contradicting a previous ruling about whether consumers of contaminated products have suffered an injury in fact, illustrates the deep confusion this U.S. Supreme Court standard creates among federal judges and practitioners, who deserve a simpler method of determining which cases have federal standing, says Eric Dwoskin at Dwoskin Wasdin.

  • 2 Anti-Kickback Developments Hold Lessons For Biopharma

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    The U.S. Department of Justice's Anti-Kickback Statute settlement with QOL Medical and a favorable advisory opinion from the U.S. Department of Health and Human Services provide a study in contrasts, but there are tips for biopharma manufacturers trying to navigate the vast compliance space between them, says Mary Kohler at Kohler Health Law.

  • In-House Counsel Pointers For Preserving Atty-Client Privilege

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    Several recent rulings illustrate the challenges in-house counsel can face when attempting to preserve attorney-client privilege, but a few best practices can help safeguard communications and effectively assert the privilege in an increasingly scrutinized corporate environment, says Daniel Garrie at Law & Forensics.

  • How SDNY US Atty Nom May Shape Enforcement Priorities

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    President Donald Trump’s nominee for U.S. attorney in the Southern District of New York, former U.S. Securities and Exchange Commission Chair Jay Clayton, will likely shift the office’s enforcement priorities, from refining whistleblower policies to deemphasizing novel prosecutorial theories, say attorneys at Cohen & Gresser.

  • Improving Comms Between Trial Attys And Tech Witnesses

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    In major litigation involving complex technology, attorneys should employ certain strategies to collaborate with companies' technical personnel more effectively to enhance both the attorney's understanding of the subject matter and the expert's ability to provide effective testimony in court, say attorneys at Buchalter.

  • What's Next For State Regulation Of Hemp Cannabinoids

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    Based on two recent federal court cases that indisputably fortify broad state authority to regulate intoxicating hemp cannabinoid products, 2025 will feature continued aggressive state regulation of such products as industry stakeholders wait for Congress to release its plans for the next five-year Farm Bill, say attorneys at Foley Hoag.

  • Series

    Collecting Rare Books Makes Me A Better Lawyer

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    My collection of rare books includes several written or owned by prominent lawyers from early U.S. history, and immersing myself in their stories helps me feel a deeper connection to my legal practice and its purpose, says Douglas Brown at Manatt Health.

  • Opinion

    New DOJ Leaders Should Curb Ill-Conceived Prosecutions

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    First-of-their-kind cases have seemingly led to a string of overly aggressive prosecutions in recent years, so newly sworn-in leaders of the U.S. Department of Justice should consider creating reporting channels to stop unwise prosecutions before they snowball, says Jonathan Porter at Husch Blackwell.

  • Tips For Pharma-Biotech Overlap Reporting In New HSR Form

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    While there’s no secret recipe for reporting overlaps to the Federal Trade Commission in the new Hart-Scott-Rodino Act form, there are several layers of considerations for all pharma-biotech companies and counsel to reflect on internally before reporting on any deal, say attorneys at A&O Shearman.

  • Opinion

    Judge Should Not Have Been Reprimanded For Alito Essay

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    Senior U.S. District Judge Michael Ponsor's New York Times essay critiquing Supreme Court Justice Samuel Alito for potential ethical violations absolutely cannot be construed as conduct prejudicial to the administration of the business of the courts, says Ashley London at the Thomas R. Kline School of Law of Duquesne University.

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