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September 24, 2025
SILVER SPRING, Md. — The U.S. Food and Drug Administration has begun the process to change the warning label for acetaminophen “to reflect evidence suggesting that the use of acetaminophen by pregnant women may be associated with an increased risk of neurological conditions such as autism and ADHD in children,” the agency said in a press release and issued a letter to physicians.
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September 23, 2025
PENSACOLA, Fla. — Plaintiffs in the Depo-Provera multidistrict litigation, a group of cases alleging that a long-lasting injectable contraceptive caused women to develop intracranial meningiomas, a type of brain tumor, urged the Florida federal judge overseeing the MDL to reject the drug manufacturers’ argument that the claims are preempted by federal law.
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September 23, 2025
WASHINGTON, D.C. — Pharmacy benefit managers (PBMs) facing allegations of contributing to a public nuisance in California for their role in the opioid epidemic asked the U.S. Supreme Court to expedite its consideration of their petition for a writ of certiorari, which argues that the Ninth Circuit U.S. Court of Appeal erred in finding that a remand order is not subject to an automatic stay under the federal officer removal statute.
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September 18, 2025
WILMINGTON, Del. — A pharmaceutical company that sought “equitable relief that is unprecedented under” federal law “has not established that its story warrants such relief,” a Delaware federal judge said, denying a motion that sought to bar a competitor from seeking approval from the U.S. Food and Drug Administration for a drug to treat narcolepsy.
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September 18, 2025
New developments in the following mass tort drug and device cases are marked in boldface type.
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September 17, 2025
SAN DIEGO — The manufacturer of Ozempic, Wegovy and Rybelsus, fended off a motion to dismiss after a California federal judge found that a weight loss company facing claims of trademark infringement and unfair competition did not show that its application of the trademarks was within the nominative fair use doctrine.
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September 17, 2025
WILMINGTON, Del. — A Delaware federal judge found that a group of consumers alleging that they would not have purchased preimplantation genetic testing for aneuploidy (PGT-A) if they had known of its failure rates lacked standing for failing to state an injury and dismissed the putative class complaint without prejudice.
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September 16, 2025
SILVER SPRING, Md. — Philips Respironics has recalled certain continuous positive air pressure (CPAP) and bi-level positive air pressure (BiPAP) sleep apnea devices because of a software error, the U.S. Food and Drug Administration said.
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September 16, 2025
CHICAGO — The Seventh Circuit U.S. Court of Appeals affirmed a final judgment of $193 million against Eli Lilly & Co. stemming from a False Claims Act jury verdict for reporting falsely deflated drug prices to the government.
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September 15, 2025
CAMDEN, N.J. — The special master in the valsartan, losartan and irbesartan hypertension drugs multidistrict litigation pending in a New Jersey federal court denied a motion to exclude an expert retained by a bellwether plaintiff, finding that the expert’s citation to nonexistent sources due to his use of artificial intelligence did not warrant exclusion.
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September 11, 2025
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
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
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
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
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
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
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
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
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
New developments in the following mass tort drug and device cases are marked in boldface type.
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September 04, 2025
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
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
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
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
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.