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Life Sciences
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November 19, 2025
In-House Atty From Teva Joins Spencer Fane's DC Office
A former associate general counsel of Teva Pharmaceuticals, an Israel-headquartered biopharmaceutical company, is returning to private practice with Spencer Fane LLP, where he will work as a partner with the firm's intellectual property practice group, according to a Monday announcement.
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November 19, 2025
8th Circ. Hears PBMs' Bid To Pause FTC Insulin Pricing Case
An Eighth Circuit panel had only a handful of questions on Wednesday for the pharmacy benefit managers accused of inflating insulin prices, though one of the judges expressed skepticism about pausing the Federal Trade Commission's in-house enforcement action on constitutional grounds.
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November 19, 2025
Gilead Sciences' GC Will Leave Co. Next Month
Gilead Sciences Inc. announced Wednesday that Deborah H. Telman will no longer serve as its executive vice president for corporate affairs and general counsel as of Dec. 5, 2025.
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November 19, 2025
Pfizer To Pay $41.5M To Settle Adulterated ADHD Drug Claims
Pfizer Inc. and Tris Pharma Inc. agreed Wednesday to cough up $41.5 million to settle claims brought by Texas that it gave adulterated ADHD drugs to children, ending a lawsuit alleging the companies violated a state healthcare fraud law.
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November 18, 2025
Ex-FDA Chief Accuses J&J Of Hiding Talc Risks For 50 Years
A former head of the U.S. Food and Drug Administration spent a contentious day under cross-examination Tuesday in a Los Angeles bellwether trial over claims that Johnson & Johnson's talc products caused two women's ovarian cancer, accusing the company of hiding the products' health risks for over 50 years.
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November 18, 2025
J&J Unit Fights $12M Verdict While Rival Wants More Money
A Delaware federal jury was wrong when it determined that Johnson & Johnson subsidiary DePuy Synthes should pay RSB Spine $12 million for infringing spinal fusion patents under the doctrine of equivalents, DePuy said Monday.
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November 18, 2025
Severe SC Abortion Bill Falters in Committee
A South Carolina bill that would have further criminalized abortion and subjected patients and doctors to up to 30 years in prison failed to advance out of a Senate committee on Tuesday, with antiabortion committee members raising concerns that the bill went too far.
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November 18, 2025
Feds Say Hi-Tech 'Trampled' Trust At Close Of Fraud Trial
Federal prosecutors closed out a nearly monthlong fraud trial against Hi-Tech Pharmaceuticals and its longtime CEO by telling a Georgia jury Tuesday that they "proudly" stood by what defense attorneys for the supplement manufacturer and distributor previously derided as a "paper case."
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November 18, 2025
23andMe Seeks OK On Updated $9M Settlement
23andMe asked a Missouri bankruptcy judge to approve a deal that will modify a settlement with data breach claimants to encompass more claims and pay $9 million, saying doing so will avoid litigation.
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November 18, 2025
Merck Wins Final PTAB Fight Against Johns Hopkins
The Patent Trial and Appeal Board invalidated a cancer treatment patent owned by Johns Hopkins University, marking a full victory on the nine challenges Merck Sharp & Dohme LLC initiated against the university's patents.
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November 18, 2025
Perrigo Sued Over Misstatements On Infant Formula Business
Perrigo Company PLC faces a shareholder class action alleging the company and its top brass failed to disclose critical issues with infant formula operations that it purchased from Nestle and caused stock prices to drop as the issues came to light.
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November 18, 2025
Bristol-Myers Squibb Can Appeal Pension Suit To 2nd Circ.
Drugmaker Bristol-Myers Squibb and its investment manager can ask the Second Circuit to review a decision from September denying their motion to dismiss a pension dispute for lack of standing, a New York federal judge ruled.
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November 18, 2025
CVS Pays $18.2M To Settle False Claims Act Allegations
CVS Pharmacy Inc. paid the federal government and California a total of $18.2 million to settle allegations it submitted claims for medication reimbursements without verifying that the medications would be for approved diagnoses, the U.S. Department of Justice has announced.
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November 18, 2025
1st Circ. May Nix Trump Funding Freeze In 'Weird' Case
The First Circuit on Tuesday hinted that a federal judge may have been in bounds when blocking the Trump administration from withholding certain funds for states, expressing skepticism that the judge's order was improper or overly broad.
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November 18, 2025
Fed. Circ. Voids Allergan's $39M Trial Win Over Eyelash Patent
The Federal Circuit on Tuesday reversed a $39 million verdict against Sandoz in Allergan's suit accusing it of infringing an eyelash growth drug patent, finding a Colorado federal jury should have found the patent claim at issue invalid for inadequate written description.
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November 18, 2025
IBM, Qualcomm Lead Public Cos. In Patented Inventions
IBM Corp. holds the most patent families of all S&P 100 companies, followed by Qualcomm Inc. and Microsoft Corp., according to an IFI Claims Patent Services report released Tuesday.
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November 18, 2025
Purdue's $7.4B Ch. 11 Plan Jibes With New Release Paradigm
A New York bankruptcy judge gave a bench ruling Tuesday explaining his decision to confirm Purdue's $7.4 billion Chapter 11 plan, which transforms the pharmaceutical giant into a public benefit company, ruling that liability releases fully comply with new restrictions imposed by the U.S. Supreme Court last year.
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November 18, 2025
Ill. Justices Mull If Permits Override Pollution Exclusions
Counsel for a sterilization company and its former parent seeking defense costs for hundreds of lawsuits over ethylene oxide emissions at a suburban Chicago facility urged the Illinois Supreme Court on Tuesday to find a pollution exclusion in their insurance policy doesn't apply to emissions allowed under a state permit, insisting the policyholders are not polluters under Illinois law or "in the general sense of the word."
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November 18, 2025
Lower Costs No Cause For VA To Shirk Trade Act, Judge Says
A federal judge said the U.S. Department of Veterans Affairs can't use the lower cost of drugs from countries not designated under the Trade Agreements Act to reject the higher prices of companies that propose to source them from compliant countries.
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November 18, 2025
Agilent Wants Justices To Eye Invalidation Of CRISPR Patents
Agilent Technologies wants the U.S. Supreme Court to take up its challenge to a Federal Circuit finding that claims in a pair of its patents on the gene-editing tool CRISPR were invalid, arguing the decision conflicts with rules on which side faces the burden of proving invalidity.
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November 17, 2025
DC Circ. Mulls If Gov't Can Say No To 340B Rebate Program
The D.C. Circuit is set to decide "who's the decision-maker" in a fight brought by drugmakers over the federal government's efforts to reshape the way they do drug rebates after spending more than an hour and a half Monday morning hearing out all sides.
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November 17, 2025
Advocacy Groups Push 9th Circ. To Uphold Fluoride Ruling
Advocacy groups that convinced a California federal judge to rule that the U.S. Environmental Protection Agency's "optimal" level for fluoride in drinking water is not protective enough for children, told the Ninth Circuit Monday that there's no reason to disturb the decision.
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November 17, 2025
B. Braun Unit Inks $38.5M Deal To End FCA Knee Implant Case
The U.S. Department of Justice on Monday announced a $38.5 million False Claims Act settlement with a subsidiary of German medical device giant B. Braun Melsungen AG resolving accusations it sold a knee replacement implant allegedly known to fail prematurely after surgery.
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November 17, 2025
2nd Circ. Questions Experts' Rejection In Tylenol Autism Suits
A Second Circuit panel on Monday appeared skeptical of a lower-court order that barred every expert witness set to testify for families who allege that patients taking Tylenol while pregnant can cause autism or attention deficit hyperactivity disorder in their children.
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November 17, 2025
Medtronic Can't Nix FCA Claims Despite 1st Circ. Precedent
A Massachusetts federal judge reconsidered reviving Medtronic's bid to defeat claims it violated the False Claims Act in light of new First Circuit precedent on a causation standard, but ruled that a whistleblower's evidence warranted keeping the claims alive for now.
Expert Analysis
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AI Product Safety Insights May Expand Foreseeability
Product liability law has long held that companies are responsible for risks they knew about or should have known about — and with AI systems now able to assess and predict hazards during the design process, companies should expect that courts will likely treat such hazards as foreseeable, says Donald Fountain at Clark Fountain.
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Series
Law School's Missed Lessons: Educating Your Community
Nearly two decades prosecuting scammers and elder fraud taught me that proactively educating the public about the risks they face and the rights they possess is essential to building trust within our communities, empowering otherwise vulnerable citizens and preventing wrongdoers from gaining a foothold, says Roger Handberg at GrayRobinson.
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Organ Transplant System Reforms Mark Regulatory Overhaul
Recent oversight, enforcement and operational developments in the U.S. organ procurement and transplantation system, alongside challenges like the federal shutdown, highlight heightened regulatory scrutiny and the need for compliance to maintain public trust, say attorneys at Hall Render.
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Adapting To USPTO's Reduction Of Examiner Interview Time
Reported changes to the U.S. Patent and Trademark Office's examiner performance appraisal plan will likely make interviews scarcer throughout the application process, potentially influencing patent allowance rates and increasing the importance of approaching each interview with a clear agenda and well-defined goals, say attorneys at Polsinelli.
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Federal Grantees May Soon Face More Limitations On Speech
If courts accept the administration’s new interpretation of preexisting case law, which attempts to graft onto grant recipients the existing limitations on government contractors' free speech, a more deferential standard may soon apply in determining whether an agency’s refusal or termination of a grant was in violation of the First Amendment, say attorneys at Venable.
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5 Crisis Lawyering Skills For An Age Of Uncertainty
As attorneys increasingly face unprecedented and pervasive situations — from prosecutions of law enforcement officials to executive orders targeting law firms — they must develop several essential competencies of effective crisis lawyering, says Ray Brescia at Albany Law School.
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Anticipating FTC's Shift On Unfair Competition Enforcement
As the Federal Trade Commission signals that it will continue to challenge unfair or deceptive acts and practices under Section 5 of the FTC Act, but with higher evidentiary standards, attorneys counseling healthcare, technology, energy or pharmaceuticals clients should note several practice tips, says Thomas Stratmann at George Mason University.
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Insights From Recent Cases On Navigating Snap Removal
Snap removal, which allows defendants to transfer state court cases to federal court before a forum defendant is properly joined and served, is viewed differently across federal circuits — but keys to making it work can be drawn from recent decisions critiquing the practice, say attorneys at Perkins Coie.
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Opinion
It's Time For The Judiciary To Fix Its Cybersecurity Problem
After recent reports that hackers have once again infiltrated federal courts’ electronic case management systems, the judiciary should strengthen its cybersecurity practices in line with executive branch standards, outlining clear roles and responsibilities for execution, says Ilona Cohen at HackerOne.
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Series
Writing Novels Makes Me A Better Lawyer
Writing my debut novel taught me to appreciate the value of critique and to never give up, no matter how long or tedious the journey, providing me with valuable skills that I now emphasize in my practice, says Daniel Buzzetta at BakerHostetler.
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SDNY OpenAI Order Clarifies Preservation Standards For AI
The Southern District of New York’s recent order in the OpenAI copyright infringement litigation, denying discovery of The New York Times' artificial intelligence technology use, clarifies that traditional preservation benchmarks apply to AI content, relieving organizations from using a “keep everything” approach, says Philip Favro at Favro Law.
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What 9th Circ.'s Rosenwald Ruling Means For Class Actions
The Ninth Circuit's recent decision in Rosenwald v. Kimberly-Clark has important implications around the Class Action Fairness Act and traditional diversity jurisdiction — both for plaintiff-side and defense-side class action litigators — and deepens the circuit split concerning the use of judicial notice to establish diversity, says Grace Schmidt at DTO Law.
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Trends In Post-Grant Practice Since USPTO Denial Guidance
Six months after the U.S. Patent and Trademark Office updated its guidance on discretionary denial of inter partes review and post-grant review, noteworthy trends in denial statistics have emerged, warranting a reassessment of strategies for parallel proceedings, says Andrew Ramos at Bayes.
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USPTO Under Squires: A Look At The First Month
New U.S. Patent and Trademark Office Director John Squires' opening acts — substantive and symbolic — signal a posture that is more welcoming to technological improvements and focused on rebalancing the office's gatekeeping role, say attorneys at Seyfarth.
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Opinion
Expert Reports Can't Replace Facts In Securities Fraud Cases
The Ninth Circuit's 2023 decision in Nvidia v. Ohman Fonder — and the U.S. Supreme Court's punt on the case in 2024 — could invite the meritless securities litigation the Private Securities Litigation Reform Act was designed to prevent by substituting expert opinions for facts to substantiate complaint assertions, say attorneys at A&O Shearman.