Mealey's Drugs & Devices
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September 11, 2025
Health Care Products Distributor Agrees To Settle Virginia Claims In Opioid MDL
CLEVELAND — A distributor of health care products and services on Sept. 10 reached a settlement with a group of Virginia counties and cities to resolve claims that its practices contributed to the nationwide opioid epidemic; terms of the settlement were not disclosed.
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September 11, 2025
Compounding Pharmacies Urge Reversal Of Summary Judgment Award in Semaglutide Case
NEW ORLEANS — Companies representing the interests of drug compounders tell the Fifth Circuit U.S. Court of Appeals in an opening brief that a Texas district court erred in awarding summary judgment to the U.S. Food and Drug Administration in a dispute over whether the agency violated the law when it removed semaglutide, an FDA-approved drug for diabetes and weight loss, from the agency’s drug shortage list.
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September 11, 2025
9th Circuit Affirms District Court Properly Remanded California’s Opioid Case
SAN FRANCISCO — The Ninth Circuit U.S. Court of Appeals held that a California federal court properly remanded a public nuisance suit filed by California against a group of pharmacy benefit managers (PBMs) facing allegations of contributing to the opioid epidemic after finding that the federal officer removal statute does not apply.
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September 10, 2025
Illinois Federal Judge Finds Defective Filshie Clip Claims Are Preempted
CHICAGO — A woman’s claims that a defective birth control device caused injuries are preempted by federal law, an Illinois federal judge held Sept. 9, granting the manufacturer, distributor and parent company of the device summary judgment and ordering the case closed.
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September 09, 2025
Wound Dressing Maker Removes Complaint Alleging Infection To N.C. Federal Court
WINSTON-SALEM, N.C. — The manufacturer of a wound and burn dressing that was the subject of a voluntary recall has removed to a federal court in North Carolina a complaint filed by woman who alleges that her foot became severely infected after using the product.
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September 09, 2025
6th Circuit Won’t Force Opioid MDL Recusal From Case, Disclosure Of Communications
CINCINNATI — The Sixth Circuit U.S. Court of Appeals refused to force a district court judge to recuse himself from all pending and future proceedings involving certain pharmacy benefits managers (PBMs) and to order the disclosure of ex parte communications, denying a writ of mandamus petition that was filed by the PBMs.
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September 09, 2025
Texas High Court Won’t Decide If Counties Are Claimants Under Law In Opioid Case
AUSTIN, Texas — The Texas Supreme Court has denied the petition for review of two appellate cases in which a group of pharmacies sued by Texas counties for their role in the opioid epidemic argued that an appellate court erred in rejecting its arguments that the counties are claimants under the Texas Medical Liability Act (TMLA) and that their cases should be dismissed.
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September 09, 2025
6th Circuit Challenge To Ruling That PBM Is Partly Preempted Draws Amicus Input
CINCINNATI — An appeal of a ruling that parts of a Tennessee law regarding pharmacy benefit managers (PBMs) are “preempted to the extent they purport to govern self-funded [Employee Retirement Income Security Act] plans” has drawn input from numerous advocacy organizations, with two amicus curiae briefs supporting the appellee in urging the Sixth Circuit U.S. Court of Appeals to affirm the decision.
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September 05, 2025
4th Circuit: Gardasil Cases Found Untimely In Vaccine Court Properly Dismissed
RICHMOND, Va. — The addition of the Gardasil vaccine to the Vaccine Injury Table is not unconstitutional, and “timely participation in the Vaccine Act compensation program is a prerequisite to bringing a tort suit,” the Fourth Circuit U.S. Court of Appeals held Sept. 4 in affirming a district court’s ruling that dismissed a group of women’s claims from a multidistrict litigation.
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September 04, 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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September 04, 2025
Generic Drug Maker Agrees To $200 Million Settlement With End Payers In MDL
PHILADELPHIA — End-payer plaintiffs (EPPs) in the generic drug pricing antitrust multidistrict litigation pending in a Pennsylvania federal court on Sept. 3 moved for preliminary approval of a settlement for up to $200 million with two manufacturers who allegedly conspired with others to artificially inflate the cost of prescription medications.
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September 03, 2025
Conn. City Sues Drug Makers, PBMs Over Alleged Scheme To Inflate Drug Prices
NEW HAVEN, Conn. — A Connecticut city has sued drug manufacturers and pharmacy benefit managers (PBMs) in a Connecticut federal court, alleging that the companies worked together to artificially raise the price of insulin and other medications to treat diabetes, including glucagon-like peptide-1 receptor agonist (GLP-1) drugs that help control insulin levels.
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September 03, 2025
Judge Sets Trial Date For Case Alleging Sickle Cell Medication Was Ineffective
SAN FRANCISCO — A California federal judge set an August 2027 trial date for a case filed by seven individuals who allege that Oxbryta (voxelotor), a prescription medication used for the treatment of sickle cell disease (SCD), was ineffective and will hear arguments on whether class certification is warranted in June 2026.
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September 03, 2025
Gardasil Maker: Court Properly Dismissed Claims For Adverse Reaction To Vaccine
RICHMOND, Va. — The maker of the Gardasil human papillomavirus vaccine urged the Fourth Circuit U.S. Court of Appeals to uphold a series of rulings that led to a North Carolina federal judge entering final judgment against the plaintiffs in a multidistrict litigation involving claims that the vaccine caused postural orthostatic tachycardia syndrome (POTS) and primary ovarian insufficiency (POI).
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September 03, 2025
Preemption Laws Doom Potential Cochlear Implant Class Action In Calif. Federal Court
LOS ANGELES — A California federal judge on Sept. 2 dismissed a putative class action against the manufacturer of a cochlear implant system after finding that claims raised by a parent that his son’s implant failed to perform as expected are preempted by federal law.
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September 02, 2025
9th Circuit Refuses To Rehear Arguments In Decision That Remanded Opioid Case
SAN FRANCISCO — A panel of judges in the Ninth Circuit U.S. Court of Appeals on Aug. 29 denied a petition filed by a group of pharmacy benefits managers (PBMs) facing allegations of contributing to the opioid epidemic for rehearing or rehearing en banc of the court’s ruling that the U.S. Supreme Court’s holding in Coinbase, Inc. v. Bielski does not extend to an automatic stay in the federal officer removal context.
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August 29, 2025
Opioid MDL Judge Denies Ex Parte Communications Ban After Misdirected Email
CLEVELAND — The Ohio federal judge overseeing the opioid multidistrict litigation on Aug. 28 denied a motion filed by a pharmacy benefit manager (PBM) to bar ex parte communications between the appointed special master in the case and the court, finding that such communication is expressly permitted by a court order and Federal Rule of Civil Procedure 53.
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August 29, 2025
Putative Class Action Against Ankle Monitor Maker Filed In Colo. Federal Court
DENVER — A man who claims that he developed chronic pressure injuries as a result of wearing a court-ordered alcohol monitoring ankle bracelet sued the device manufacturer on Aug. 28 in a Colorado federal court and seeks to represent a nationwide class of individuals alleging similar injuries.
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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