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Life Sciences
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August 21, 2025
CVS, Drugmakers Illegally Inflated Insulin Prices, City Claims
Drugmakers Eli Lilly and Co., Novo Nordisk Inc. and Sanofi-Aventis US LLC, pharmacy benefit managers CVS Caremark, Express Scripts and Optum Rx, and others have been hit with civil racketeering and state unfair trade practices law claims by the city of Torrington, Connecticut, over an alleged scheme to inflate insulin prices.
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August 21, 2025
High Court Allows Trump Admin To Cancel $783M In NIH Grants
The U.S. Supreme Court on Thursday allowed the Trump administration to resume the mass termination of scientific grants, overturning rulings by lower courts that had kept the funds flowing to universities and other recipients.
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August 20, 2025
Masimo Targets CBP Over Latest Apple Watch Import Ruling
Masimo sued U.S. Customs and Border Protection in D.C. federal court Wednesday, arguing the agency defied the law by issuing a ruling that found a newly redesigned version of Apple's smartwatches is not subject to an import ban in the companies' patent dispute.
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August 20, 2025
Masimo's 'Empty Voting' Suit Against Founder Gets Green Light
A California federal judge has rejected a bid to dismiss Masimo Corp.'s suit alleging the medical technology company's founder and an investment firm manipulated a shareholder vote through an "empty voting" scheme, finding there is enough evidence at this point to show the pair formed an undisclosed insider group under federal securities laws.
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August 20, 2025
Talphera Beats Investors' Bid To Save Slogan Suit At 9th Circ.
The Ninth Circuit on Wednesday refused to revive a proposed shareholder class action accusing Talphera Inc. of misleading investors about the simplicity of administering the pharmaceutical company's "Tongue and Done" opioid, saying in a published opinion that no reasonable investor would "blindly" accept the slogan without considering other information.
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August 20, 2025
Feds Lose Bid To Seal In Vax Patent Case Against Moderna
The U.S. government has failed to show why names and contact information of certain U.S. Department of the Army employees should be hidden in an mRNA vaccine developer's $5 billion patent suit over Moderna's COVID-19 vaccines, a federal judge has found.
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August 20, 2025
Texas AG Threatens Suit Over Orgs. Mailing Abortion Pills
Texas Attorney General Ken Paxton has sent cease-and-desist letters to three organizations he's accused of shipping abortion drugs to women in the state in violation of state and federal laws.
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August 20, 2025
Device Co. Pans FTC's Resistance To $945M Heart Valve Deal
Edwards Lifesciences Corp. is defending its planned $945 million purchase of JenaValve Technology Inc., telling the Federal Trade Commission the deal is the best way to bring a new lifesaving treatment for a heart valve disorder to the market.
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August 20, 2025
Fired Pharma Co. VP Must Arbitrate Sex Bias Claims
A Connecticut federal judge said a former Boehringer Ingelheim Pharmaceuticals LLC vice president must arbitrate his sex bias suit claiming his female boss mistreated him and gave him a low performance rating because he is a man, ruling his case isn't covered by a law barring sex misconduct claims from out-of-court resolutions.
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August 20, 2025
State AGs Sidelined From Sandoz Price-Fixing Deal
A group of over 40 states and territories cannot intervene in a $275 million settlement resolving generic-drug price-fixing claims against Sandoz because they only have a nominal interest in the suit that fails to confer standing, a Pennsylvania federal judge said.
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August 20, 2025
Former J&J Atty Slams Sanctions Bid Over Bias Suit
A former Johnson & Johnson data privacy attorney suing the pharmaceutical giant over alleged racial discrimination told a New Jersey federal court that the company's sanctions motion is an unfair move to "weaponize" the rules of civil procedure.
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August 20, 2025
Biotech Replimune Faces Derivative Suit Over Trial Claims
Executives and directors of biotechnology company Replimune Group Inc. face shareholder derivative claims that they concealed issues affecting a clinical trial of one of the company's lead immunotherapy candidates.
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August 20, 2025
CVS PBM Overbilling Judgment Trebled To $289M
A Pennsylvania federal judge has increased threefold a judgment against CVS Caremark from $95 million to $289 million for overbilling Medicare Part D-sponsored drugs.
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August 19, 2025
NJ Judge Files Corrected Version Of Error-Filled Opinion
A New Jersey federal judge Tuesday filed a new, corrected version of an opinion he withdrew last month in securities litigation against CorMedix Inc. after an attorney for the biopharmaceutical firm pointed out the opinion contained "a series of errors."
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August 19, 2025
3D Systems Brass Sued Over Revenue Projections
Executives and directors of 3D Systems Corp. have been hit with a shareholder derivative suit accusing them of concealing issues that negatively impacted the 3D printer company's revenue prospects, including an update to a partnership agreement with a large customer to develop artificial lungs.
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August 19, 2025
Sotera Urges 6th Circ. To Toss Investors' Toxic Gas Suit
Sotera Health Co. urged the Sixth Circuit to affirm the dismissal of a lawsuit accusing it of concealing the carcinogenic nature of a gas used at its sterilization plants, saying "defending yourself in litigation is not securities fraud."
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August 19, 2025
Lab Owner Gets 3 Years For $40M COVID-19 Test Fraud
A co-founder of a laboratory accused of submitting $40 million in unnecessary COVID-19 and genetic testing claims to healthcare benefit programs was sentenced to three years in prison Tuesday, after a Florida federal judge credited him for the extensive cooperation he provided the government before and during a trial against his co-defendants.
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August 19, 2025
Novo Nordisk Gets Forfeiture Claims Cut From 401(k) Suit
A New Jersey federal judge on Tuesday dismissed workers' allegations that Novo Nordisk unlawfully used forfeited funds in its $2.3 billion 401(k) plan for its own benefit and kept a shoddy fund on its investment roster, leaving an excessive fee claim in play.
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August 19, 2025
21 AGs Push DEA To Schedule 'Designer Xanax'
Kentucky Attorney General Russell Coleman and 20 other state attorneys general are urgently asking the U.S. Drug Enforcement Administration to schedule an unregulated substance known as "designer Xanax" under the Controlled Substances Act, saying it is contributing to overdose deaths and posing a growing threat to public health.
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August 19, 2025
Panel Weighs Ga. High Court Ruling In Sham Donor Suit
Customers who accused a sperm bank of selling sperm without disclosing the true medical and criminal histories of donors urged the Georgia Court of Appeals to revive their lawsuits Tuesday, arguing the dismissals were based on a misreading of a 2020 decision from the state's high court.
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August 19, 2025
Generic-Drug Makers To Pay $71M To End Price-Fixing Claims
Glenmark Pharmaceuticals Inc. USA has offered to pay approximately $38 million, and Pfizer Inc. and its generic-drug unit Greenstone LLC have promised to pay roughly $33 million, to settle price-fixing claims by the direct purchasers of generic drugs.
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August 19, 2025
Fed. Circ. Backs PTAB Ax Of DexCom Glucose Patent Claims
The Federal Circuit won't disturb a Patent Trial and Appeal Board finding that a DexCom patent on glucose monitoring systems is unpatentable, saying the medical device company misread the board's decision.
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August 18, 2025
HHS Says Layoffs, Reorganization Are Within Its Authority
The Trump administration urged a Rhode Island federal judge to toss claims that massive cuts to the Health and Human Services Department violate the U.S. Constitution and usurp congressional authority, arguing the state plaintiffs don't have the authority to dictate how the executive branch manages its personnel.
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August 18, 2025
'Ketamine Queen' Takes Plea Deal In Matthew Perry Case
The woman known as the "Ketamine Queen" of North Hollywood has agreed to plead guilty to providing the ketamine that led to the 2023 death of "Friends" star Matthew Perry, according to a plea agreement filed in California federal court on Monday.
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August 18, 2025
Pharma Company Beats Investor Suit Over Drug Safety Claims
ChemoCentryx, a California-based pharmaceutical company, has secured summary judgment in shareholder litigation accusing it of overstating the efficacy of its newly developed treatment for an autoimmune disease called ANCA vasculitis, with a California court ruling that the ultimate regulatory approval of the drug may show that the company was not intentionally overhyping it.
Expert Analysis
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High Court Cert Spotlights Varying Tests For Federal Removal
A recent decision by the U.S. Supreme Court to review Chevron v. Plaquemines Parish, a case involving the federal officer removal statute, highlights three other recent circuit court decisions raising federal removal questions, and serves as a reminder that defendants are the masters of removal actions, says Varun Aery at Hollingsworth.
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How To Increase 3rd-Party Preissuance Patent Submissions
Attorneys Marian Underweiser and Marc Ehrlich, who helped draft the America Invents Act, discuss changes that the U.S. Patent and Trademark Office could potentially implement to facilitate its hopes for increased participation in front-end patent challenges.
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Trump Air Emissions Carveouts Cloud The Regulatory Picture
President Donald Trump's new proclamations temporarily exempting key U.S. industries from air toxics standards, issued under a narrow, rarely-used provision of the Clean Air Act, will likely lead to legal challenges and tighter standards in some states, contributing to further regulatory uncertainty, say attorneys at GableGotwals.
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Series
Playing Baseball Makes Me A Better Lawyer
Playing baseball in college, and now Wiffle ball in a local league, has taught me that teamwork, mental endurance and emotional intelligence are not only important to success in the sport, but also to success as a trial attorney, says Kevan Dorsey at Swift Currie.
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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.