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Life Sciences
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July 30, 2025
Flo Likely To Get Health Privacy Claim Tossed In Meta Case
The California federal judge overseeing a trial on allegations that Flo Health and Meta Platforms Inc. violated the privacy of millions of women who used Flo's period tracker app said Wednesday he'd likely toss the California Confidentiality of Medical Information Act claim, saying the lack of evidence is an "unsurmountable" problem.
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July 30, 2025
Illumina To Pay $9.8M To Resolve Cybersecurity Qui Tam Case
Biotechnology company Illumina Inc. has agreed to pay $9.8 million in a settlement with the U.S. Department of Justice to put to rest a first-of-its-kind False Claims Act suit alleging the company violated cybersecurity regulations for medical devices, according to an announcement Wednesday.
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July 30, 2025
No Philly Clause Is Valid In Med Mal Case, Pa. Panel Says
A Pennsylvania appellate panel said Wednesday that a contract a patient signed before surgery mandating that any legal actions must be heard in Bucks County is valid and enforceable, affirming a trial court's transfer of the medical malpractice suit from plaintiff-friendly Philadelphia County.
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July 30, 2025
CVS Can't Arbitrate RICO Suit Over Alleged 'No Generic' Policy
CVS effectively forfeited its arbitration rights in proposed class action litigation accusing it of conspiring to block Medicare beneficiaries from accessing generic versions of prescription drugs, a Pennsylvania federal judge ruled in denying the company's bid to enforce an arbitration agreement.
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July 30, 2025
FDA's Vaccine Chief Is Out After Loyalty To Trump Questioned
Dr. Vinay Prasad's tenure as the top vaccine regulator at the U.S. Food and Drug Administration ended abruptly this week following intense criticism from conservative activists who questioned his loyalty to President Donald Trump.
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July 30, 2025
Mich. PBM Opioid Suit Belongs In State Court, Judge Told
Counsel for the State of Michigan argued Wednesday that a lawsuit accusing pharmacy benefit managers Express Scripts and OptumRx of fueling the opioid crisis is not subject to federal officer removal and should be sent back to state court.
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July 30, 2025
ImmunityBio Investors Nab Initial OK On Derivative Suit Deal
A California federal judge has granted initial approval to a deal ending derivative claims that ImmunityBio executives failed to disclose manufacturing deficiencies that doomed the company's lead cancer drug application.
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July 30, 2025
GTCR Denied Rival's Old Sales Prospects Data In FTC Case
An Illinois federal judge refused Tuesday to force a rival medical device coatings company to cough up old sales projections data so private equity firm GTCR BC Holdings can defend against a Federal Trade Commission challenge to its $627 million purchase of Surmodics.
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July 30, 2025
DHS Sinks Docs' Free Speech Suit Over COVID Policies
A Texas federal judge on Wednesday dismissed free speech claims brought against the U.S. Department of Homeland Security and three specialty medical boards by a doctor group claiming the government and boards punished them for disapproving of COVID-19 vaccines and mandates.Â
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July 30, 2025
Fla. AG Allowed To Drop Sandoz Generics Price-Fixing Claims
After several months of wrangling over the terms of a $10 million generic drug price-fixing settlement, a Connecticut federal judge on Wednesday granted Florida's request to permanently drop its claims against Sandoz, finding that it would be an abuse of discretion to hold up the resolution any longer.
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July 30, 2025
Pharma Tech Co. Diaceutics Hires Former Sandoz Atty As GC
Pharmaceutical technology company Diaceutics PLC has hired a lawyer with in-house experience at Sandoz and Novartis as its general counsel.
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July 30, 2025
WilmerHale Taps Life Science Pro To Chair Transactions Dept.
WilmerHale announced Wednesday that the former Latham & Watkins LLP attorney it hired last year to co-chair its life sciences practice is taking over as the chair of its transactional department.
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July 29, 2025
Fed. Circ. Backs Rejection Of Man's HPV Vaccine Claims
A man who claimed vaccines he received as a teen, including one meant to guard against HPV, caused him to develop inflammatory bowel disease will receive no payments under the National Vaccine Injury Compensation Program, the Federal Circuit ruled on Tuesday, affirming a determination that his theory that vaccines caused his illness is unsupported.
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July 29, 2025
Trump Says High Court Rulings Undermine Wash. Halt On EOs
Recent decisions by the U.S. Supreme Court undermine a Washington federal judge's finding that portions of two executive orders concerning gender-affirming care and transgender identity likely violate the Constitution, the Trump administration argued in recent filings.
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July 29, 2025
Teva, Amneal End Case Over Listing Inhaler IP In Orange Book
A New Jersey federal judge on Tuesday closed litigation between Teva and Amneal, which had led to the Federal Circuit's major decision that patents for Teva's inhalers don't belong in the U.S. Food and Drug Administration's Orange Book.Â
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July 29, 2025
Reported Plan For Value-Based Patent Fees Unnerves Experts
A proposal reportedly under consideration by the Trump administration to charge patent owners a new fee based on the value of their patents has spurred numerous questions and concerns among experts, who say the idea appears nearly unworkable and could hinder innovation.
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July 29, 2025
Ocugen Beats Investor Suit Over Financial Controls
Biopharmaceutical company Ocugen Inc. on Tuesday won permanent dismissal from an investor's class action accusing it of concealing weak financial controls that led to it refiling accounting statements for several periods, with a Pennsylvania federal judge determining that Ocugen's stock price recovered from the announcement it had erred in its reports.
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July 29, 2025
J&J Owes $43M For 30-Year Talc User's Mesothelioma
A Massachusetts state court jury ordered Johnson & Johnson Tuesday to pay more than $42.6 million to a former talc user with mesothelioma and his wife, following a trial in which the man's lawyer told jurors the alleged cancer-causing effects of the company's baby powder were its "dirty little secret."
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July 29, 2025
RFK Jr. Slams Vaccine Injury Program: 3 Things To Know
U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. is taking aim at the national program that compensates people for vaccine injuries, calling it a "heartless" system that he intends to fix.
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July 29, 2025
22 States Sue To Block Defunding Of Planned Parenthood
California and more than 20 other states on Tuesday launched their own legal challenge to budget legislation that halts federal Medicaid funding for Planned Parenthood, alleging the measure illegally targets the organization and violates its First Amendment rights.
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July 29, 2025
Jones Day Hires Former Pharma Co. Counsel In DC
Jones Day has hired a former Morgan Lewis & Bockius LLP partner, who has also worked in-house at two pharmaceutical companies and with the U.S. Drug Enforcement Administration, the firm announced Tuesday.
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July 29, 2025
Seeger Weiss Named Lead Negotiation Counsel In J&J MDL
A New Jersey federal judge overseeing long-running multidistrict federal litigation against Johnson & Johnson over its talcum powder products has appointed Christopher A. Seeger of Seeger Weiss LLP to lead a negotiation team to guide plaintiffs through settlement talks.
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July 29, 2025
Pharma Co. Blasts Adversary For Nudging Judge Assignment
A pharmaceutical solutions group has assailed its opponent's "hurry-up-court" motion nudging the appointment of a new judge after the previous judge overseeing their contract fight retired, saying its adversary "has only itself to blame" for the alleged delays that have put off a final resolution.
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July 29, 2025
NY Judge Faces Recusal Request Over Gilead Stock Holdings
A criminal defendant who admitted to taking part in a black market HIV drug scam has asked the Manhattan federal judge presiding over his case to step away after the judge disclosed brief ownership of nearly 9,000 shares of Gilead Sciences Inc., while the defendant was fighting her $2 million restitution order.
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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.
Expert Analysis
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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.
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Does Research Tool Safe Harbor Cover AI Drug Development?
As artificial intelligence increasingly takes root in drug development, many questions may emerge regarding current gaps in courts' application of the research tool exception to the safe harbor defense against patent infringement, and whether that defense applies to AI-based tools, say attorneys at Arnold & Porter.
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Series
Law School's Missed Lessons: Navigating Client Trauma
Law schools don't train students to handle repeated exposure to clients' traumatic experiences, but for litigators practicing in areas like civil rights and personal injury, success depends on the ability to view cases clinically and to recognize when you may need to seek help, says Katie Bennett at Robins Kaplan.
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Opinion
4 Former Justices Would Likely Frown On Litigation Funding
As courts increasingly confront cases involving hidden litigation finance contracts, the jurisprudence of four former U.S. Supreme Court justices establishes a constitutional framework that risks erosion by undisclosed financial interests, says Roland Eisenhuth at the American Property Casualty Insurance Association.
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How Attys Can Use AI To Surface Narratives In E-Discovery
E-discovery has reached a turning point where document review is no longer just about procedural tasks like identifying relevance and redacting privilege — rather, generative artificial intelligence tools now allow attorneys to draw connections, extract meaning and tell a coherent story, says Rose Jones at Hilgers Graben.
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Leveraging Diligence Findings For Better Life Sciences Deals
Life sciences parties should utilize due diligence strategically to review and draft deal documents, address issues identified during the diligence, and craft solutions to achieve the party's transactional goals, says Anna Zhao at Gunner Cooke.
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IP Due Diligence Tips For AI Assets In M&A Transactions
Artificial intelligence systems' integration into business operations creates new considerations for intellectual property due diligence in mergers and acquisitions and financing transactions, and implementing a practical approach to identifying AI assets can help avoid litigation and losses, say Armin Ghiam and Senna Hahn at Hunton.
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How McKesson Ruling Will Inform Interpretations Of The TCPA
Amid the U.S. Supreme Court's ruling in McLaughlin Chiropractic Associates v. McKesson, we can expect to see both plaintiffs and defendants utilizing the decision to revisit the Federal Communications Commission's past Telephone Consumer Protection Act interpretations and decisions they did not like, says Jason McElroy at Saul Ewing.