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    • COSMETICS—S.D.N.Y.: Amendment of acne product complaint leaves blemishes for dismissal in unapproved areas
    • ADMINISTRATION OF MEDICARE/MEDICAID PROGRAMS—D.D.C.: Physician’s claim against DEA challenging delay in agency action was moot
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    • ADMINISTRATION OF MEDICARE/MEDICAID PROGRAMS—OIG REPORTS: MAOs paid $72M to revoked providers for services
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    • CIVIL MONEY PENALTIES—DAB DECISIONS: Inconsistent supervision supports immediate-jeopardy penalty for resident abuse
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    • COST REPORTS—PRRB DECISIONS: PRRB rejects hospital’s appeal of unclaimed capital lease interest
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    • EXPERT INSIGHTS—Janssen Granted Preliminary Injunction Against Golimumab Biosimilar
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    • FALSE CLAIMS ACT—D. N.J.: Court grants motion to dismiss in false claims action against pharmaceutical company
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    • LABELING AND PACKAGING (FOOD, DRUGS & MEDICAL DEVICES)—S.D. Cal.: ‘Made with Real Fruit Juice’ not misleading where gummy snack product contained pear juice concentrate
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    • MEDICAL DEVICES—FINAL RULES: Certain Class II clinical toxicology test systems exempted from premarket notification
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    • MEDICAL DEVICES—FINAL RULES: Classification of the focused ultrasound system for non-thermal, mechanical tissue ablation
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    • MEDICAL DEVICES—FINAL RULES: Classification of the high throughput DNA sequencing for hereditary cancer predisposition assessment test system
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    • PREEMPTION OF STATE LAW—3rd Cir.: Manufacturing defect and negligence claims against medical device manufacturer were not preempted by federal law
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    Health Law Daily Wrap Up, PREEMPTION OF STATE LAW—3rd Cir.: Manufacturing defect and negligence claims against medical device manufacturer were not preempted by federal law, (Oct 7, 2026)

    Law Firms Mentioned:Harold R. Berk, P.C. | Tucker Ellis LLP
    Organizations Mentioned:Terumo Medical Corporation

    By Nicholas Kaster, J.D.

    A 2024 inspection report presented by the claimant supported a plausible inference that the Angio-Seal was not produced pursuant to the rigorous PMA requirements imposed on the manufacturer by the FDA.

    The U.S. Court of Appeals for the Third Circuit h ...

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