Mealey's Drugs & Devices
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August 29, 2025
Judge Dismisses FCA Suit Against Publix Super Markets For Opioid Prescriptions
TAMPA, Fla. — A Florida federal judge dismissed with prejudice a second amended complaint filed by two former Publix Super Market pharmacists who allege that the grocery chain violated the False Claims Act by knowingly filling prescriptions for opioids and other controlled substances that it knew were improper.
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August 29, 2025
Clinics Move To Dismiss Case Saying Its Embryo Tests Were Faulty, Misleading
DENVER — The allegations in a class action filed by three women in a Colorado federal court “fundamentally mischaracterize the purpose and limits of preimplantation genetic testing for aneuploidy (‘PGT-A’),” a group of physician-owned fertility clinics argue in a motion to dismiss.
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August 29, 2025
2nd Circuit Says Marketing, Sales Claims In Rapid Release Tylenol Class Preempted
NEW YORK — A federal court properly found that the marketing and pricing claims alleging that Johnson & Johnson Consumer Inc. (JJCI) improperly advertised that its Tylenol Rapid Release Gelcaps worked faster than cheaper tablet alternatives are preempted by federal law, the Second Circuit U.S. Court of Appeals held.
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August 28, 2025
Cook County, Ill., Jury Gives Defense Another Win In Zantac Injury Case
CHICAGO — An Illinois jury on Aug. 27 rejected arguments from a man who claimed that his colorectal cancer was caused by ingesting over-the-counter Zantac and returned a verdict for Boehringer Ingelheim Pharmaceuticals Inc., according to the court docket.
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August 28, 2025
Boston Scientific Secures Summary Judgment In Defective Medical Device Case
NEW YORK — The manufacturer of a medical device used to treat urinary incontinence was awarded summary judgment by a New York federal judge, who found that claims brought by a man who contends that the device repeatedly failed are preempted by federal law.
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August 26, 2025
Lilly, Medical Centers Agree To Settle Diet Drugs Trademark Case In Federal Court
SEATTLE — Eli Lilly and Co., two medical centers and two of their physicians who prescribe patients compounded versions of tirzepatide, a Food and Drug Administration-approved drug for diabetes and weight loss, told a Washington federal judge that they have reached an agreement to end a trademark case filed by Lilly.
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August 20, 2025
COMMENTARY: A Survey Of State Laws Regulating Third-Party Litigation Funding
By Mark A. Behrens and Christopher E. Appel
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August 25, 2025
Texas, Florida Ask To Intervene In Mifepristone Case To Protect States’ Interests
AMARILLO, Texas — Texas and Florida say the three states that intervened in a case originated by a group of antiabortion advocates challenging the U.S. Food and Drug Administration’s approval of the abortion drug mifepristone can no longer represent their interests and on Aug. 22 moved in a Texas federal court for permission to intervene.
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August 22, 2025
Compounding Pharmacies: Judge Erred In Allowing Drug’s Removal From Shortage List
NEW ORLEANS — Upholding a Texas federal judge’s “wayward view” in granting summary judgment to the U.S. Food and Drug Administration and Eli Lilly and Co. in a dispute over whether the agency properly determined that the shortage of tirzepatide, a drug for diabetes and weight loss, would “end judicial review of agency action as it has existed for generations,” companies representing the interests of drug compounders tell the Fifth Circuit U.S. Court of Appeals in an opening brief made public on Aug. 21.
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August 21, 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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August 21, 2025
More States Tell FDA That Mifepristone Restrictions Are Unneeded, Should Be Removed
A coalition of states on Aug. 20 submitted a citizen petition to the U.S. Food and Drug Administration urging the agency to remove the Risk Evaluation and Mitigation Strategy (REMS) restrictions on mifepristone, one of the two drugs prescribed for medication abortions, joining four other states that filed a similar petition in June.
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August 21, 2025
N.Y. Federal Judge Finds Claims In Defective Heart Device Case Are Preempted
NEW YORK — A New York federal judge granted a motion to dismiss a lawsuit filed by the estate of a woman who allegedly died as a result of heart defibrillator device failing to function as intended after finding that the claims are preempted by federal law.
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August 21, 2025
Hologic Loses Bid For Summary Judgment In Bellwether BioZorb Cases
BOSTON — The federal judge in Massachusetts overseeing a group of cases in which women allege that an implanted radiographic marker used to mark soft tissue sites during cancer treatment was defective and caused injuries denied a motion for summary judgment filed by the device manufacturer, which argued that two bellwether plaintiffs failed to prove causation.
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August 20, 2025
COMMENTARY: Pharmaceutical Ad Proposals Target Wrong Malady
By Mark A. Behrens and Cary Silverman
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August 20, 2025
Express Scripts: Order In W.Va. Opioid Case Violates Constitutional Rights
WHEELING, W.Va. — A pharmacy benefits manager facing allegations that its actions contributed to an “oversupply” of prescription opioids throughout West Virigina asks a federal court in the state to reconsider its order to expedite a two-phase bench trial on public nuisance liability.
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August 20, 2025
GLP-1 MDL Judge Partially Grants Drug Makers’ Motion To Dismiss Master Complaint
PHILADELPHIA — The Pennsylvania federal judge overseeing the multidistrict litigation involving diabetes and diet drugs that consumers allege caused gastrointestinal and other injuries largely denied a motion to dismiss certain claims from a master long-form complaint.
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August 19, 2025
Delaware High Court Affirms Ruling In Insurers’ Favor In Opioid Coverage Dispute
WILMINGTON, Del. — The Delaware Supreme Court on Aug. 18 affirmed a lower court’s ruling that denied CVS Health Corp.’s motion for partial summary judgment and granted its insurers’ motion for partial summary judgment in their lawsuit disputing coverage for 218 underlying opioid lawsuits, agreeing with the lower court that, under ACE American Insurance Co. v. Rite Aid Corp., the underlying lawsuits fail to seek damages because of any specific bodily injury or damage to any specific property to trigger coverage.
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August 19, 2025
D.C. Circuit: FDA Erred In Denying Drug Application Without Holding Hearing
WASHINGTON, D.C. — The U.S. Food and Drug Administration erred in refusing to hold a hearing before denying Vanda Pharmaceuticals Inc.’s application for approval to market the drug tasimelteon as a treatment for jet lag, the District of Columbia Circuit U.S. Court of Appeals said.
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August 19, 2025
PBM Asks For Order Barring Ex Parte Communications After Email Error In Opioid MDL
CLEVELAND — A pharmacy benefit manager (PBM) involved in the opioid multidistrict litigation pending in a federal court in Ohio moved for an order “prohibiting ex parte communications between the Special Masters and the Court regarding the Special Masters’ rulings.”
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August 18, 2025
Court Told Excluded Expert Penned Study Linking Acetaminophen With Autism/ADHD
NEW YORK — An attorney representing parents who allege that prenatal exposure to acetaminophen causes autism or attention deficit hyperactivity disorder (ADHD) but saw their claims dismissed after a New York federal judge in two separate orders excluded their causation experts filed a letter on Aug. 15 with the Second Circuit U.S. Court of Appeals, alerting the court to a recent study co-authored by one of its experts that linked the drug to the disorders.
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August 15, 2025
Woman Sues Cartiva For Faulty Toe Implant, Says Company Hid Information
PITTSBURGH — A woman alleges that the manufacturer of a synthetic cartilage implant (SCI) device used to treat arthritis in a toe joint misled the public and the U.S. Food and Drug Administration about the safety of the device, which caused the woman to suffer pain after the device failed.
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August 15, 2025
Parties Debate If Theranos’ Balwani’s Appeal Warrants 2nd Look By 9th Circuit
SAN FRANCISCO — Former Theranos Chief Operating Officer Ramesh “Sunny” Balwani argues that the government’s opposition to his motion filed in the Ninth Circuit U.S. Court of Appeals for a rehearing or a rehearing en banc of the court’s decision that the government’s failure to correct false testimony during his criminal trial does not warrant a new trial “underscores the need for” a review.
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August 14, 2025
Singapore Court Maintains Freeze Of Bioscience Company Assets Pending Arbitration
SINGAPORE — A judge of the Singapore International Commercial Court granted an ex parte application by a Danish company brought against a Singaporean bioscience company and its founder for a worldwide asset freeze pending arbitration in New York regarding an $830 million dispute over a drug for hypertension and kidney disease.
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August 14, 2025
Texas Says Lilly Violated State Law To Induce Providers To Prescribe Its Drugs
MARSHALL, Texas — Texas has sued Eli Lilly & Company Inc. in a state court, alleging that the pharmaceutical company violated the Texas Health Care Program Fraud Prevention Act (THFPA) through programs used to induce providers to prescribe its medications, including its GLP-1 medications Mounjaro and Zepbound.
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August 13, 2025
8th Circuit Finds District Court Did Not Fully Consider Jurisdiction Arguments
ST. LOUIS — The Eighth Circuit U.S. Court of Appeals remanded a product liability case involving an allegedly defective medical device for a district court to conduct a new forum non conveniens analysis after finding that the court erred in granting a motion to dismiss.