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Life Sciences
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July 29, 2025
9th Circ. Clarifies Kickback Boundaries For Referral Bonuses
A Ninth Circuit opinion affirming a California man's fraud conviction provides some clarity — and a warning — to the owners of medical testing laboratories wondering what sales tactics are allowed under a 2018 kickbacks law.
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July 29, 2025
Federal Cuts Shake Up Clinical Research Funding Landscape
As the Trump administration makes deep cuts to clinical research funding, healthcare attorneys worry that the delicate balance between federal grants and private investment is at risk. Crowell & Moring LLP partner Linda Malek talks to Law360 Healthcare Authority about the industry's concerns.
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July 28, 2025
Pharma Co. Alleges Clinical Trial Data Was Fabricated
A pharmaceutical research and development company sued New Jersey-based research organization Clinilabs LLC and several Florida clinical research firms Friday claiming they fabricated and covered up important clinical trial data for a new Alzheimer's disease treatment, wasting millions of dollars and setting the drug back at least five years.
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July 28, 2025
PBMs Can't Escape NY State Law Claims In Opioid MDL
Two UnitedHealth subsidiaries cannot escape claims that they exacerbated the opioid crisis by providing data analytics and consulting services to drugmakers, a federal judge overseeing the multidistrict litigation ruled on Monday, saying the New York state municipalities have adequately alleged RICO by claiming they were part of the same criminal conspiracy.
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July 28, 2025
NeoGenomics Wants Jury Trial In Natera DNA Test Patent Fight
NeoGenomics Laboratories Inc. told a North Carolina federal judge that a company suing it for patent infringement over DNA cancer test technology, Natera Inc., had no right to withdraw its demand for a jury trial and move forward with a bench trial.
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July 28, 2025
Splenda-Maker Says Emails Show NC Scientist Ignored Data
The makers of Splenda said new emails and documents unearthed in discovery for its defamation lawsuit against a scientist show that she ignored and manipulated experiment data to suggest that the artificial sweetener is dangerous for humans.
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July 28, 2025
2nd Abbott Baby Formula Bellwether Falls Before Trial
An Illinois federal judge handed Abbott Laboratories summary judgment on Monday in the second bellwether that had been set for trial in multidistrict litigation over allegations its cow's milk-based formula can cause severe gastrointestinal illness in premature babies, while saying she will leave the door open to revive and later try the case.
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July 28, 2025
Eli Lilly Alleges Pharmacy Sells Knockoff Weight-Loss Drugs
Eli Lilly and Company is accusing a Houston pharmacy of selling knockoff versions of two of its Ozempic-like weight-loss drugs.
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July 28, 2025
PREP Act Won't Save COVID Test Manufacturer From IP Suit
The maker of swabs used in COVID-19 tests can't invoke a public health law's immunity protections to avoid patent infringement litigation, a Maine federal judge has ruled.
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July 28, 2025
Cooley-Led Biotech Snags $372.5M For Latest Funding Round
Clinical-stage biopharmaceutical company MapLight Therapeutics, advised by Cooley LLP, on Monday revealed that it clinched its oversubscribed Series D funding round after raising $372.5 million from investors.
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July 28, 2025
J&J Loses Bid To Probe Beasley Allen Talc Litigation Funding
A special master found Monday there is no reason to believe third-party funders are influencing Beasley Allen Law Firm's decisions in a massive talc litigation in New Jersey, defeating a subpoena from Johnson & Johnson digging into alleged third-party litigation funding.
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July 28, 2025
Catching Up With Delaware's Chancery Court
A Delaware vice chancellor last week sent several coordinated derivative suits seeking millions of dollars in damages from AT&T to trial and also chose a boutique firm to lead a potential "blockbuster" suit challenging a take-private deal of a sports and entertainment group after "heated" attacks between competing counsel.
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July 28, 2025
Judge Again Cites Bias In NIH Fund Freeze As Gov't Appeals
A Massachusetts federal judge on Monday reiterated his conclusion that the Trump administration's freeze of $783 million worth of National Institutes of Health grants was based on "palpable" gender and racial discrimination, as he acknowledged a pending request by the government to the U.S. Supreme Court to stay his order that the money be released.
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July 28, 2025
Novo Nordisk Faces Possible Mass Tort Over Ozempic In NJ
Over 20 plaintiffs who have sued Novo Nordisk in New Jersey state court alleging its popular weight loss drugs caused them to lose their vision have filed an application to designate their cases as multicounty litigation, according to a notice to the bar posted on Monday.
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July 28, 2025
Biotech GC Says She Was Ousted Amid 'Systemic' Bias
A former general counsel at Massachusetts life sciences firm Repligen has filed a lawsuit in state court claiming that a pervasive culture of gender bias led to her and other women being treated differently and paid less.
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July 25, 2025
​In New Twist, W.Va. Judges Suddenly At Odds In Opioid Suits
A new ruling in West Virginia opioid crisis litigation is revealing sharp divisions among the Mountain State's federal judges regarding a pivotal legal theory, potentially boosting a Fourth Circuit appeal by beleaguered municipalities aiming to erase a landmark win for drug distributors.
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July 25, 2025
Reviewing Stewart's Latest Discretionary Denial Decisions
Acting U.S. Patent and Trademark Office Director Coke Morgan Stewart issued just eight discretionary denial decisions over the last week, including one that addressed arguments tying in the Biologics Price Competition and Innovation Act for the first time.
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July 25, 2025
Fluoride Fans Tell 9th Circ. To Preserve Drinking Water Use
A pro-fluoride group is supporting the U.S. Environmental Protection Agency's fight to overturn a California federal judge's ruling that current limits on the chemical in drinking water aren't protective enough.
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July 25, 2025
NGM Biopharma Investors Take $6M Deal To End Sale Suit
The Column Group and former stockholders of NGM Biopharmaceuticals have agreed to settle for $6 million a Delaware Court of Chancery lawsuit challenging NGM's $135 million, $1.55-per-share sale to The Column Group, its pre-deal venture capital controller.
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July 25, 2025
Fed. Circ. Punts $17M Drug Arbitration Case To 2nd Circ.
The Federal Circuit said Friday it lacked jurisdiction over a dispute over a $16.6 million arbitral award between two drugmakers, ruling that because it was being asked to consider an arbitration issue and not a patent law issue, the Second Circuit must hear the case.
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July 25, 2025
Health Data Co. Investor Fraud Suit Headed To Mediation
The parties in a putative class action claiming a healthcare technology company misled investors about a data platform it claimed to operate, but which didn't actually exist, told a Connecticut federal court that they "agree this case is well suited for mediation."
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July 25, 2025
1st Circ. Backs Ex-Pharma Director's $24M Disability Bias Win
The First Circuit declined to scrap a $24 million verdict for a former lab director of a Thermo Fisher Scientific Inc. subsidiary who claimed she was fired for seeking alternative public speaking arrangements due to her anxiety, ruling the evidence presented supported the jury's verdict.
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July 25, 2025
Boutique Upadhye Tang Gets McDermott Life Sciences Partner
A six-year veteran of McDermott Will & Emery LLP's Washington, D.C., team has moved his pharmaceutical patent litigation practice to Upadhye Tang LLP, a boutique that focuses on intellectual property and U.S. Food and Drug Administration matters.
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July 24, 2025
Trump Admin Asks Justices To Stay Block On NIH Grant Cuts
The Trump administration on Thursday urged the U.S. Supreme Court to stay a district court's preliminary injunction so that the National Institutes of Health can resume terminating $783 million in grants, saying the lower court, under a recent high court ruling, lacked jurisdiction to make the government pay the grants.
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July 24, 2025
Genentech Seeks Win After $122M Biogen Royalties Mistrial
Genentech Inc. urged a California federal court Wednesday to rule that Biogen MA Inc. owes $122 million in patent royalties and interest under the "only coherent construction" of their licensing deal, in a rare post-mistrial arrangement that will see the judge step in to deliver the verdict.
Expert Analysis
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What US Medicine Onshoring Means For Indian Life Sciences
Despite the Trump administration's latest moves to onshore essential medicine manufacturing, India will likely remain an indispensable component of the U.S. drug supply chain, but Indian manufacturers should prepare for stricter compliance checks, says Jashaswi Ghosh at Holon Law Partners.
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Series
Law School's Missed Lessons: Skillful Persuasion
In many ways, law school teaches us how to argue, but when the ultimate goal is to get your client what they want, being persuasive through preparation and humility is the more likely key to success, says Michael Friedland at Friedland Cianfrani.
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FCA Working Group Reboot Signals EHR Compliance Risk
The revival of the False Claims Act working group is an aggressive expansion of enforcement efforts by the Justice Department and the U.S. Department of Health and Human Services targeted toward technology-enabled fraud involving electronic health records and other data, say attorneys at ArentFox Schiff.
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Litigation Inspiration: How To Respond After A Loss
Every litigator loses a case now and then, and the sting of that loss can become a medicine that strengthens or a poison that corrodes, depending on how the attorney responds, says Bennett Rawicki at Hilgers Graben.
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While On Firmer Ground, Uncertainty Remains For SEC's ALJs
The U.S. District Court for the District of Columbia's recent opinion in Lemelson v. U.S. Securities and Exchange Commission affirmed the legitimacy of the SEC's administrative proceedings, but pointedly left unanswered the constitutional merits of tenure protection enjoyed by SEC administrative law judges — potentially the subject of future U.S. Supreme Court review, says Dean Conway at Carlton Fields.
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FDA's Hasty Policymaking Approach Faces APA Challenges
Though the U.S. Food and Drug Administration has abandoned its usual notice-and-comment process for implementing new regulatory initiatives, two recent district court decisions make clear that these programs are still susceptible to Administrative Procedure Act challenges, says Rachel Turow at Skadden.
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Legal Considerations Around Ibogaine As Addiction Therapy
Recent funding approval in Texas pertaining to the use of ibogaine for the potential treatment of substance use disorders signals a growing openness to innovative addiction treatments, but also underscores the need for rigorous compliance with state and federal requirements and ethical research standards, say attorneys at Husch Blackwell.
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How Patent Attys Can Carefully Integrate LLMs Into Workflows
With artificial intelligence-powered tools now being developed specifically for the intellectual property domain, patent practitioners should monitor evolving considerations to ensure that their capabilities are enhanced — rather than diminished — by these resources, say attorneys at McDonnell Boehnen.
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The Metamorphosis Of The Major Questions Doctrine
The so-called major questions doctrine arose as a counterweight to Chevron deference over the past few decades, but invocations of the doctrine have persisted in the year since Chevron was overturned, suggesting it still has a role to play in reining in agency overreach, say attorneys at Crowell & Moring.
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New PTAB Denial Processes Grow More And More Confusing
Guidance from the U.S. Patent and Trademark Office about the Patent Trial and Appeal Board's new workload management and discretionary denial processes has been murky and inconsistent, and has been further muddled by the acting director's seemingly contradictory decisions, say attorneys at Finnegan.
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Arguing The 8th Amendment For Reduction In FCA Penalties
While False Claims Act decisions lack consistency in how high the judgment-to-damages ratio in such cases can be before it becomes unconstitutional, defense counsel should cite the Eighth Amendment's excessive fines clause in pre-trial settlement negotiations, and seek penalty decreases in post-judgment motions and on appeal, says Scott Grubman at Chilivis Grubman.
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9th Circ. Decisions Help Clarify Scope Of Legal Lab Marketing
Two Ninth Circuit decisions last week provide a welcome development in clarifying the line between laboratories' legal marketing efforts and undue influence that violates the Eliminating Kickbacks in Recovery Act, and offer useful guidance for labs seeking to mitigate enforcement risk, says Joshua Robbins at Buchalter.
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$95M Caremark Verdict Should Put PBMs On Notice
A Pennsylvania federal judge’s recent ruling that pharmacy benefits manager CVS Caremark owes the government $95 million for overbilling Medicare Part D-sponsored drugs highlights the effectiveness of the False Claims Act, as scrutiny of PBMs’ outsized role in setting drug prices continues to increase, say attorneys at Duane Morris.
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Biotech Collaborations Can Ease Uncertainty Amid FDA Shift
As concerns persist that the U.S. Food and Drug Administration's reduced headcount will impede developments at already-strapped biotech companies, licensing and partnership transactions can provide the necessary funding and pathways to advance innovative products, say attorneys at Troutman.
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Series
Playing Mah-Jongg Makes Me A Better Mediator
Mah-jongg rewards patience, pattern recognition, adaptability and keen observation, all skills that are invaluable to my role as a mediator, and to all mediating parties, says Marina Corodemus.