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Life Sciences
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June 26, 2025
Hims & Hers Face Investor Suits Over Wegovy Collab
Telehealth company Hims & Hers Health Inc. has been hit with investors' proposed class actions accusing it of exploiting its partnership with Novo Nordisk, the distributor of weight loss drug Wegovy, to sell "knockoff" drugs, causing Hims shares to fall 35% when Novo Nordisk announced earlier this week the collaboration had been terminated.
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June 26, 2025
Biotech Co. Must Face Investor Suit Over Misleading Claims
Biotech company CytoDyn and its former executives and directors cannot escape a suit accusing them of misleading shareholders about the likelihood that the U.S. Food and Drug Administration would approve its drug the company claimed had the potential to treat HIV and COVID-19.
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June 26, 2025
6th Circ. Backs Mich. Newborn Blood Testing Program
A Sixth Circuit panel reversed a win for a group of parents challenging a Michigan newborn health screening program, finding that the way blood samples are stored and used in the program does not violate the parents' right to make medical decisions for their children.
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June 26, 2025
Kimberly-Clark Inks $4.15M Deal In Gown Fraud Suit
Kimberly-Clark Corp. has agreed to pay $4.15 million to settle a suit brought by a doctor on behalf of the federal government alleging it violated the False Claims Act by falsely claiming its surgical gowns protected against contagious diseases.
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June 26, 2025
Judge Casts Doubt On Plea Deals In Blood Test Defect Case
A set of plea agreements between Massachusetts federal prosecutors and former Magellan Diagnostics executives has been thrown into uncertainty amid a dispute over whether the executives admitted to fraud related to defective blood tests or merely an intent to mislead, a question a judge said Thursday might be "a very expensive rabbit hole."
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June 26, 2025
Judge Tosses Biogen MS Drug Antitrust Suit, For Now
An Illinois federal court tossed a proposed class action accusing Biogen of reducing competition for its multiple sclerosis drug Tecfidera through payments to pharmacy benefit managers, after finding that only some drug pricing lists would have been affected.
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June 26, 2025
Ex-FDA Regulator Joins ArentFox Schiff's Pharma Practice
ArentFox Schiff LLP has hired a career U.S. Food and Drug Administration compliance professional, whose oversight focused on ensuring pharmaceutical industry participants' compliance with drug supply chain rules and other governing regulations, as counsel in the firm's food, drug, medical device and cosmetic practice in Washington.
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June 25, 2025
Stewart, APJ Leader Discretionarily Deny 33 More Petitions
The acting U.S. Patent and Trademark Office director rejected 21 petitions for Patent Trial and Appeal Board reviews on Wednesday, and the board's acting deputy chief judge denied another 12 where the acting director recused herself for the first time.
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June 25, 2025
TCPA Litigants Brace For 'Seismic Shift' After Deference Blow
The U.S. Supreme Court's backing of broad judicial review for the crush of regulatory orders interpreting the Telephone Consumer Protection Act is poised to turn the litigation landscape on its head, as key statutory determinations that have long been viewed as settled matters are suddenly ripe for scrutiny.Â
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June 25, 2025
SEC Wins Jury Verdict In $10M Blood Bank Fraud Suit
A California federal jury has found the former CEO of a blood bank business liable for securities fraud, agreeing with the U.S. Securities and Exchange Commission that the executive defrauded retirees out of more than $10 million by promising them returns he knew he could not deliver.
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June 25, 2025
Cigna Says Bristol-Myers Delayed Cancer Drug Generic
Cigna has launched an antitrust suit in New York federal court accusing Bristol-Myers Squibb Co. and its Celgene subsidiary of fraudulently obtaining patents, filing sham litigation and paying off generic-drug makers to maintain a monopoly on their blockbuster blood-cancer drug Pomalyst.
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June 25, 2025
Anti-Aging Biotech Startup Minovia Inks $180M SPAC Merger
Minovia Therapeutics Ltd., an Israeli startup developing treatments for age-related decline, plans to go public in the U.S. at a $180 million valuation by merging with special purpose acquisition company Launch One Acquisition Corp., both parties announced Wednesday.
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June 25, 2025
Fed. Circ. Won't Revive Inventor's Patent Suit Against Google
The Federal Circuit on Wednesday denied a bid to revive a patent infringement case from a man who says Google's products use aspects of his threat-detection technology.
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June 25, 2025
Aetna, CVS Slam Lab's Revised Suit Seeking $20.6M Payment
Aetna and its owner, CVS Health Corp., say a medical laboratory's revamped lawsuit alleging that $20.6 million in invoices remain unpaid fares no better than an earlier version that led a Connecticut federal judge to show the lab the courthouse door earlier this year.
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June 25, 2025
Hospital Slams Novo Nordisk's Insulin Pen Suit Sanctions Bid
Connecticut's Griffin Hospital says Novo Nordisk's attempt to score sanctions in a lawsuit about insulin pen contamination should be rejected because no law requires the healthcare facility to lay out its adversary's possible defenses when pleading its claims.
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June 25, 2025
CVS PBM Hit With $95M Judgment For Overbilling Medicare
A Pennsylvania federal judge on Wednesday ruled that CVS's pharmacy benefits manager owes the government $95 million for overbilling Medicare Part D-sponsored drugs, leaving the door open for the amount to be tripled later.
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June 25, 2025
K&L Gates Adds Powers Pyles Pharma Litigator To DC Team
K&L Gates LLP said Wednesday it has brought on a pharmaceutical attorney from Powers Pyles Sutter & Verville PC who worked for nearly a decade as a pharmacist and has handled pharmacy law matters for more than 15 years.
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June 25, 2025
EisnerAmper Adds International Tax Pro To Minneapolis Office
EisnerAmper has expanded its international tax services group with a new partner who helps individual and corporate clients navigate legislation, regulatory risks and compliance obligations.
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June 24, 2025
Minn. Water Co. Prevails In Retained Limit Coverage Row
A water purification company that's faced a bevy of product liability lawsuits over a disinfectant product needs to pay only one $5 million retained limit before a Chubb unit's coverage obligations under umbrella policies potentially kick in for one of the underlying cases, a Minnesota federal court ruled.
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June 24, 2025
Health Data Co. Must Face Revised Investor Fraud Suit
A Connecticut federal judge won't toss an amended class action claiming a healthcare technology company misled investors about a data platform it claimed to operate that didn't actually exist, ruling that statements about the platform's capabilities are not inactionable, forward-looking statements.
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June 24, 2025
Abbott Hit With Genetic Privacy Suit Over Hiring Practices
Abbott Laboratories was sued Tuesday in Illinois federal court by a former worker alleging the company's onboarding materials asked for his family's medical history in violation of a state law aimed at protecting residents' genetic information.
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June 24, 2025
Calif. AG Asks 9th Circ. To Undo Limits On Pay-For-Delay Ban
California enforcers on Monday asked the Ninth Circuit to overturn a district court's decision that a state law restricting "reverse payment" settlements between brand-name and generic-drug makers cannot be used to regulate deals that were struck outside the Golden State.
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June 24, 2025
Pollution Exclusion Applies Without Exception, AIG Unit Says
An AIG unit urged the Illinois Supreme Court to find that a permit or regulation allowing a company to discharge toxins into the environment has no bearing on the application of a pollution exclusion, saying "pollution is pollution" regardless of government authorization.
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June 24, 2025
Ex-J&J Atty's Race Bias Suit Lacks Facts, Company Argues
Johnson & Johnson Services Inc. told a New Jersey federal court this week that a former in-house data privacy attorney suing the pharmaceuticals giant for discrimination failed to plead any facts supporting her allegation that the company passed her over for a job in favor of a less qualified candidate.
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June 24, 2025
Trump Admin Must Release NIH Funds Amid Appeal
A Massachusetts federal judge on Tuesday denied the Trump administration's request to stay a recent order that it resume processing National Institutes of Health grant applications and releasing funds, warning that even one more day of delay would lead to irreparable harm.
Expert Analysis
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Opinion
NJ Should Align With Federal Rule On Expert Testimony
The time is right to amend Rule 702 of the New Jersey Rules of Evidence to align it with the recently amended Rule 702 of the Federal Rules of Evidence and clarify the standard for admissibility of expert testimony, says Timothy Freeman at Tanenbaum Keale.
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2 NY Rulings May Stem Foreign Co. Derivative Suits
In recent decades, shareholders have challenged the internal affairs doctrine by bringing a series of derivative actions in New York state court on behalf of foreign corporations, but the New York Court of Appeals' recent rulings in Ezrasons v. Rudd and Haussmann v. Baumann should slow that trend, say attorneys at Cleary.
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Recent Reports Shed Light On Section 340B's Effectiveness
Recent analyses of the Section 340B program's effectiveness in helping patients afford drugs in Minnesota reinforce concerns about the program's lack of transparency and underscore the need for further evaluation of whether legislative reform should be enacted, say William A. Sarraille at the University of Maryland, and Andrée-Anne Fournier and Molly Frean at Analysis Group.
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Opinion
Congress Should Pass IP Reform, Starting With 3 Patent Bills
Congress is considering a trio of bipartisan bills to fix patent law problems that have cropped up over the past two decades, and it shouldn't stop there — addressing two other intellectual property issues is critical for America's economy, says retired Judge Kathleen O'Malley at the Council for Innovation Promotion.
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Class Standing Issues Still Murky After Justices Punt LabCorp
While litigants and district courts had hoped the U.S. Supreme Court's ruling in LabCorp v. Davis would provide much-needed clarity on the interplay between Article III standing and class certification, the court's failure to rule on the issue leaves disagreement, confusion and uncertainty for stakeholders, says Erica Rutner at Cozen O'Connor.
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When Reshoring, IP Issues Require A Strong Action Plan
With recent headlines highlighting tariffs as high as 3,521%, more firms will contemplate reshoring manufacturing to the U.S., and they will need to consider important intellectual property issues as part of this complex, expensive and lengthy undertaking, say attorneys at Norton Rose.
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Series
Volunteering At Schools Makes Me A Better Lawyer
Speaking to elementary school students about the importance of college and other opportunities after high school — especially students who may not see those paths reflected in their daily lives — not only taught me the importance of giving back, but also helped to sharpen several skills essential to a successful legal practice, says Guillermo Escobedo at Constangy.
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5 Open Questions About FDA's AI-Assisted Review Plans
The U.S. Food and Drug Administration recently touted the completion of a generative artificial intelligence program for scientific reviewers and plans for agencywide deployment to speed up reviews of premarket applications, but there is considerable uncertainty surrounding the tools' ability to protect trade secrets, avoid bias and more, say attorneys at King & Spalding.
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Prospects And Challenges For Expert Evidence At The UPC
Expert testimony on economic or damages-related issues will likely play a larger part in Unified Patent Court proceedings in the near future, potentially presenting unique challenges for experts, counsel and judges alike, say analysts at Charles River.
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Attacks On Judicial Independence Tend To Manifest In 3 Ways
Attacks on judicial independence now run the gamut from gross (bald-faced interference) to systemic (structural changes) to insidious (efforts to undermine public trust), so lawyers, judges and the public must recognize the fateful moment in which we live and defend the rule of law every day, says Jim Moliterno at Washington and Lee University.
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Series
Law School's Missed Lessons: Appreciating Civil Procedure
If you’re like me, law school’s often complex and theoretical approach to teaching civil procedure may have contributed to an early struggle with the topic, but when seen from a practical perspective, new lawyers may find they enjoy mastering these rules, says Chloe Villagomez at Foster Garvey.
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Calif. Bar Exam Fiasco Shows Why Attys Must Disclose AI Use
The recent revelation that a handful of questions from the controversial California bar exam administered in February were drafted using generative artificial intelligence demonstrates the continued importance of disclosure for attorneys who use AI tools, say attorneys at Troutman.
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In 2nd Place, Va. 'Rocket Docket' Remains Old Reliable
The U.S. District Court for the Eastern District of Virginia was again one of the fastest civil trial courts in the nation last year, and an interview with the court’s newest judge provides insights into why it continues to soar, says Robert Tata at Hunton.
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Parsing A Lack Of Antitrust Info-Sharing Enforcement Clarity
Information sharing among competing firms has recently faced dramatic changes in antitrust agency guidance, while courts grapple with the permissible scope of pricing algorithms, leaving companies in limbo, but potential Trump administration changes could offer some reprieve, say attorneys at Axinn.
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What FCA Liability Looks Like In The Cybersecurity Realm
​Two recent settlements highlight how whistleblowers and the U.S. Department of Justice have been utilizing the False Claims Act to allege fraud predicated on violations of cybersecurity standards — timely lessons given new bipartisan legislation introducing potential FCA liability for artificial intelligence use, say​ attorneys Rachel Rose and Julie Bracker.