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Life Sciences
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June 26, 2025
Bayer Investors' $38M Settlement Over Monsanto Deal OK'd
A California federal judge on Thursday preliminarily approved Bayer AG's $38 million settlement with investors who accused the German multinational of downplaying litigation risks related to the weedkiller Roundup when it acquired Monsanto in 2018, saying the deal appeared to be "fair, reasonable and adequate."
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June 26, 2025
Kirkland Stops Repping Novartis After Regeneron Sought DQ
A New York federal judge accepted the withdrawal Thursday of the entire Kirkland & Ellis LLP team that recently joined Novartis Pharma's legal team battling antitrust allegations over the eye medication Eylea, just a week after plaintiff Regeneron Pharmaceuticals sought their disqualification over an "unthinkable" conflict of interest by the lawyers, whose firm previously represented Regeneron.
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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.
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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.
Expert Analysis
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Del. Justices' D&O Ruling Clarifies 'Related' Claim Analysis
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.
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Compliance Pointers For DOJ's Sweeping Data Security Rule
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.
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Series
Competitive Weightlifting Makes Me A Better Lawyer
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.
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The Case For Compliance During The Trump Administration
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.
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A Look At HHS' New Opinion On Patient Assistance Programs
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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Opinion
Inconsistent Injury-In-Fact Rules Hinder Federal Practice
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.
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2 Anti-Kickback Developments Hold Lessons For Biopharma
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.
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In-House Counsel Pointers For Preserving Atty-Client Privilege
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.
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How SDNY US Atty Nom May Shape Enforcement Priorities
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.
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Improving Comms Between Trial Attys And Tech Witnesses
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.
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What's Next For State Regulation Of Hemp Cannabinoids
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.
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Series
Collecting Rare Books Makes Me A Better Lawyer
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.
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Opinion
New DOJ Leaders Should Curb Ill-Conceived Prosecutions
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.
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Tips For Pharma-Biotech Overlap Reporting In New HSR Form
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.
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Opinion
Judge Should Not Have Been Reprimanded For Alito Essay
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.