Life Sciences

  • April 02, 2025

    CVS Asserts DOJ's Opioid Prescription Suit Lacks Facts

    CVS Pharmacy Inc. has told a Rhode Island federal judge that most of the U.S. Department of Justice's claims that it knowingly filed invalid prescriptions for opioids should be tossed, saying the agency failed to adequately allege the company willfully put profits over safety.

  • 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."

Expert Analysis

  • How Courts Can Filter Nonmeritorious Claims In Mass Torts

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    Nonmeritorious claims have been a key obstacle to settlement in many recent high-profile mass torts, but courts may be able to use tools they already have to solve this problem, says Samir Parikh at Wake Forest University.

  • Series

    Racing Corvettes Makes Me A Better Lawyer

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    The skills I use when racing Corvettes have enhanced my legal practice in several ways, because driving, like practicing law, requires precision, awareness and a good set of brakes — complete with the wisdom to know how and when to use them, says Kat Mateo at Olshan Frome.

  • Opinion

    Attorneys Must Act Now To Protect Judicial Independence

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    Given the Trump administration's recent moves threatening the independence of the judiciary, including efforts to impeach judges who ruled against executive actions, lawyers must protect the rule of law and resist attempts to dilute the judicial branch’s authority, says attorney Bhavleen Sabharwal.

  • Rethinking 'No Comment' For Clients Facing Public Crises

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    “No comment” is no longer a cost-free or even a viable public communications strategy for companies in crisis, and counsel must tailor their guidance based on a variety of competing factors to help clients emerge successfully, says Robert Bowers at Moore & Van Allen.

  • As Failure-To-Warn Preemption Wanes, Justices May Weigh In

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    Federal preemption of state failure-to-warn claims has long been a powerful defense in strict liability tort cases, but is now under attack in litigation over the weedkiller Roundup and other products — so the scope and application of preemption may require clarification by the U.S. Supreme Court, says Michael Sena at Segal McCambridge.

  • How Design Thinking Can Help Lawyers Find Purpose In Work

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    Lawyers everywhere are feeling overwhelmed amid mass government layoffs, increasing political instability and a justice system stretched to its limits — but a design-thinking framework can help attorneys navigate this uncertainty and find meaning in their work, say law professors at the University of Michigan.

  • The Fate Of Biden-Era Clinical Study Guidance Under Trump

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    Draft guidance about the study of sex and gender differences in medical product development issued by the outgoing Biden administration currently faces significant uncertainty and litigation potential due to the Trump administration's executive orders and other actions, say attorneys at Arnold & Porter.

  • Trending At The PTAB: Insights From 2024 Fed. Circ. Statistics

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    Looking at stats from the Federal Circuit's decisions in 219 Patent Trial and Appeal Board appeals last year sheds light on potential trends and strategy considerations that could improve appeals' chances of success, say attorneys at Finnegan.

  • Opinion

    Weight Drug Suits Highlight Need For Legal Work On Safety

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    The rapid ascent of glucagon-like peptide-1 receptor agonists like Ozempic has revolutionized diabetes management and weight loss — but legal wrangling over issues including off-label prescriptions, side effects and compounded versions underscores lawyers' roles in protecting patient safety, says attorney Gregg Goldfarb.

  • 10 Issues To Watch In Aerospace And Defense Contracting

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    This year, in addition to evergreen developments driven by national security priorities, disruptive new technologies and competition with rival powers, federal contractors will see significant disruptions driven by the new administration’s efforts to reduce government spending, regulation and the size of the federal workforce, say attorneys at Thompson Hine.

  • 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.

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