Mealey's Drugs & Devices
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November 21, 2025
Texas Supreme Court Won’t Reconsider Review Denial In Counties’ Opioid Suit
AUSTIN, Texas — The Texas Supreme Court on Nov. 21 denied a motion for rehearing filed by a group of pharmacies, letting stand its decision to refuse to review a lower court’s ruling that allowed a case filed against them by Texas counties for their role in the opioid epidemic to proceed, rejecting arguments by the pharmacies that the case will leave those counties “emboldened to find another set of businesses to target” and “could cause serious harm to people across this State.”
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November 20, 2025
Judge OKs Purdue Pharma’s $7.4 Billion Settlement In Opioid Bankruptcy Case
NEW YORK — The judge in the U.S. Bankruptcy Court for the Southern District of New York overseeing the Purdue Pharma LP case has signed off on a $7.4 billion agreement to settle claims that the company and its owners, the Sackler family, contributed to creating the opioid crisis.
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November 20, 2025
Mass Tort Cases For Drugs, Medical Devices
New developments in the following mass tort drug and device cases are marked in boldface type.
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November 19, 2025
Widow: Contaminated Saline Solution That Was Recalled Led To Infection, Death
BIRMINGHAM, Ala. — Health care providers unknowingly used a contaminated saline solution to flush a man’s catheter following surgery, causing the man to develop sepsis and die, his widow alleges in a complaint filed in an Alabama federal court against the manufacturer and distributors of the solution.
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November 19, 2025
Abbott Moves To Dismiss Suit Alleging FDA-Approved Trifecta Heart Valve Failed
LEXINGTON, Ky. — A man’s claims that an implantable medical device for the heart failed and required surgical removal and replacement “face an insurmountable threshold problem: federal preemption,” the device manufacturer argues in a motion to dismiss.
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November 19, 2025
Federal Circuit: Jury Should Have Found Eyelash Med Patent Claim Invalid
WASHINGTON, D.C. — A Federal Circuit U.S. Court of Appeals panel said on Nov. 18 that a generic drug maker “has overcome the doubly high burden of persuading us to overturn a jury verdict of no invalidity” in a dispute over a patent relating to a medication for eyelash growth, reversing a Colorado federal jury’s infringement finding and $39 million in damages.
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November 19, 2025
Generic Mifepristone Maker Voluntarily Dismisses Complaint Against FDA, DOJ
GREENBELT, Md. — A federal judge in Maryland has closed a case filed by the generic manufacturer of mifepristone, one of two drugs used to induce early termination of pregnancy, against the U.S. Food and Drug Administration and the U.S. Department of Justice to enjoin the agency from making any changes to the approval of the drug after the manufacturer filed a notice of dismissal.
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November 19, 2025
Judge Dismisses Third-Party Defendants From Alleged Toxic Embryo Solution Case
SAN FRANCISCO — The manufacturer of a solution used during fertility-related treatments that couples claim was toxic and destroyed their developing embryos has not shown the “more” that is required to exercise personal jurisdiction over third-party defendants, a California federal judge held in granting two motions to dismiss.
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November 19, 2025
CVS, Woman Agree To Settle Misleading ‘Non-Drowsy’ Medicine Label Case
ST. LOUIS — A settlement has been reached between CVS Pharmacy Inc. and a woman who claims that she was misled into purchasing over-the-counter CVS-branded medicines that were labeled “non-drowsy” when in fact they cause drowsiness, according to a federal judge in Missouri.
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November 19, 2025
Insulin Pricing MDL Magistrate Judge Won’t Allow Puerto Rico’s Amended Complaint
NEWARK, N.J. — A New Jersey federal magistrate judge denied a motion filed by Puerto Rico for permission to file an amended complaint after its case was transferred to the multidistrict litigation over the pricing of insulin, citing a ruling by a Puerto Rico federal judge before the case was transferred.
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November 18, 2025
9th Circuit Amends Order To Clarify Position On Other Preemption Arguments
SAN FRANCISCO — The Ninth Circuit U.S. Court of Appeals on Nov. 17 amended a previous opinion to clarify that it took no position on other arguments on preemption that a pharmaceutical company may assert in a case brought by former members of the U.S. military who allege that they were injured after ingesting military-prescribed mefloquine products, an anti-malarial medication.
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November 18, 2025
Reconsideration Of Lack Of Standing Ruling Denied In COVID Vaccine Injury Case
WASHINGTON, D.C. — A District of Columbia federal judge denied the motion to alter or amend judgment of a man seeking to force the U.S. Department of Health and Human Services to add the COVID-19 vaccine to the Vaccine Injury Table (VIT) so he can be compensated by the National Vaccine Injury Compensation Program (VICP) after the judge granted the government’s motion to dismiss for lack of standing.
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November 17, 2025
U.S. Supreme Court Won’t Review FDA’s Denial Of Drug’s Fast-Track Application
WASHINGTON, D.C. — The U.S. Supreme Court on Nov. 17 denied a petition for writ of certiorari filed by a pharmaceutical company that argued that a lower court erred in affirming a decision by the U.S. Food and Drug Administration that denied the company’s application for a fast-track approval of its new drug.
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November 14, 2025
Separate N.J. Multicounty Litigation Tracks Created For Injuries From GLP-1 Drugs
TRENTON, N.J. — The New Jersey Supreme Court will create separate multicounty litigation (MCL) designations for state court cases alleging that permanent vision loss and gastrointestinal injuries were caused by the use of glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications, according to a notice to the bar.
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November 13, 2025
Amici Urge 7th Circuit To Rehear Medicare Drug Rebate False Claims Case
CHICAGO — Four organizations filed separate amicus curiae briefs in the Seventh Circuit U.S. Court of Appeals, urging the court to grant Eli Lilly & Co.’s petition for rehearing of a decision in which the Seventh Circuit affirmed a final judgment of $193 million stemming from a False Claims Act jury verdict for reporting falsely deflated drug prices to the government.
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November 13, 2025
Appeal Of FCA Suit Against Publix Super Markets For Opioid Prescriptions Dismissed
ATLANTA — The 11th Circuit U.S. Court of Appeals has ordered the dismissal of an appeal filed by an organization comprising two former Publix Super Markets pharmacists that alleges that the grocery chain violated the False Claims Act (FCA) by filling prescriptions for opioids and other controlled substances that it knew were improper after the parties filed a notice of stipulation of dismissal.
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November 12, 2025
FDA To Remove Warnings From Hormone Replacement Therapy Products
SILVER SPRING, Md. — The U.S. Food and Drug Administration will begin to remove the “black box” warnings on hormone replacement therapy (HRT) products after recent studies showed that previous reports that the products can increase the risk of breast cancer were based on faulty data.
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November 11, 2025
Judgment Entered For Novo Nordisk In FCA Dispute Over Hemophilia Drug
TACOMA, Wash. — A Washington federal court jury found in favor of Novo Nordisk Inc. (NNI) in a qui tam suit accusing it of violating the federal False Claims Act (FCA) and similar state and city laws by allegedly submitting fraudulent claims for payment to government insurers via a “scheme” to persuade patients to seek prescriptions for a Novo Nordisk drug to treat hemophilia rather than a less expensive drug manufactured by another pharmaceutical company.
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November 11, 2025
Valsartan MDL Judge Excludes Causation Expert, Dismisses 1st Bellwether Case
CAMDEN, N.J. — The first bellwether case in the valsartan, losartan and irbesartan hypertension drugs multidistrict litigation was dismissed with prejudice on Nov. 10 after the New Jersey federal judge overseeing the MDL found that testimony from the plaintiff’s expert that ruled out other causes of a man’s liver cancer was “nothing more than speculative ipse dixit.”
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November 11, 2025
Florida Sues Planned Parenthood, Says Mifepristone Safety Statements Are Misleading
MILTON, Fla. — Planned Parenthood misleads women in Florida by deceptively marketing mifepristone, one of two drugs used to induce early termination of pregnancy, as “safer than Tylenol,” the state’s attorney general says in a complaint filed in a state court.
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November 11, 2025
Texas Magistrate Judge Sends Faulty Birth Control Device Suit Back To State Court
AMARILLO, Texas — The distributor of a birth control device that a woman alleges failed and caused her to become pregnant did not provide sufficient evidence on which to base citizenship, a Texas federal magistrate judge said in finding that the court lacks subject matter jurisdiction and remanding the case.
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November 10, 2025
Delaware Judge Signs Order Dismissing Excess Insurers’ Opioid Coverage Suit
WILMINGTON, Del. — A Delaware judge signed an order granting a management consulting firm insured’s motion to dismiss a lawsuit brought by its excess commercial general liability insurers seeking a declaration that they have no duty to defend and indemnify against more than 260 underlying lawsuits seeking to hold the insured accountable for contributing to and profiting from the opioid epidemic.
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November 07, 2025
PBMs Granted Extension In Appeal Over Arkansas Law Limiting Who Can Own Pharmacies
. LOUIS — Pharmacy benefits managers (PBMs) that convinced an Arkansas federal judge that a law that barred PBMs from owning a pharmacy business in the state likely violates the U.S. Constitution’s commerce clause and is likely preempted by federal law have until Dec. 29 to respond to an appellant brief filed by the state in the Eighth Circuit U.S. Court of Appeals contending that the judge erred in granting motions for a preliminary injunction.
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November 06, 2025
Mass Tort Cases For Drugs, Medical Devices
New developments in the following mass tort drug and device cases are marked in boldface type.
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November 06, 2025
6th Circuit Sets Argument For Challenge To Ruling That PBM Is Partly Preempted
CINCINNATI — The Sixth Circuit U.S. Court of Appeals has scheduled oral argument for Dec. 10 in a challenge to a ruling that parts of a Tennessee law regarding pharmacy benefit managers (PBMs) are “preempted to the extent they purport to govern self-funded” health plans that are subject to the Employee Retirement Income Security Act; the appeal has drawn amicus curiae input from numerous advocacy organizations.