Mealey's Drugs & Devices
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September 29, 2025
Oral Arguments Postponed In Appeal Of Autism-ADHD MDL Expert Exclusion
NEW YORK — The Second Circuit U.S. Court of Appeals has rescheduled oral arguments in an appeal over whether a district court erred in excluding testimony from experts retained by parents who allege that prenatal exposure to acetaminophen causes autism or attention deficit hyperactivity disorder (ADHD) after receiving letters from the parties in the wake of the U.S. Food and Drug Administration recently announcing a possible link between the use of the drug and the disorders.
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September 29, 2025
D.C. Circuit Upholds FDA’s Summary Judgment In Generic Drug Approval Case
WASHINGTON, D.C. — Novartis Pharmaceuticals Corp.’s arguments on appeal, disputing a district court judge’s denial of its motion for summary judgment in a case contesting the U.S. Food and Drug Administration’s approval of a generic version of its heart failure drug Entresto, gave the District of Columbia Circuit U.S. Court of Appeals “no reason to question the FDA’s expert judgment regarding these scientific issues,” the court said in a Sept. 26 opinion.
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September 26, 2025
HHS, FDA To Conduct Review Of Abortion Drug Mifepristone Safety, REMS Requirements
The secretary of the U.S. Department of Health and Human Services and the commissioner of the U.S. Food and Drug Administration told attorneys general from 22 states that the government will be “conducting its own review of the evidence, including real-world outcomes and evidence, relating to the safety and efficacy of” mifepristone, one of the two drugs prescribed for medication abortions.
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September 25, 2025
Manufacturer Of Embryo Culture Media Loses Bid To Dismiss Case Brought By Couple
ALBUQUERQUE, N.M. — A lawsuit against the manufacturer of an embryo culture media that a couple alleges was defective and led to the failure of their in vitro fertilization (IVF) procedure can move forward, a New Mexico federal judge ruled, denying the manufacturer’s motion to dismiss but holding that the couple failed to plead the claims against its parent company.
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September 25, 2025
Pharmacies Urge 2nd Look By Texas Supreme Court In Counties’ Opioid Suit
AUSTIN, Texas — The misreading of a Texas Supreme Court decision by Texas counties that sued a group of pharmacies for their role in the opioid epidemic will leave those counties “emboldened to find another set of businesses to target” and “could cause serious harm to people across this State,” the pharmacies argue in asking for a rehearing of their denied petition for review.
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September 24, 2025
Judge Tosses FCA Suit Related To Drug Patent Pursuant To Public Disclosure Bar
BOSTON — A Massachusetts federal judge on Sept. 23 dismissed a qui tam relator’s suit alleging violations of the federal False Claims Act (FCA) and related state laws regarding pharmaceutical companies’ purported fraudulently obtained patents for the drug Xyrem resulting in government health insurers reimbursing Xyrem prescriptions “at inflated prices,” finding that facts in the complaint were previously disclosed and that the public disclosure bar applies.
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September 24, 2025
Pfizer Agrees To End 2 Groups’ Zantac Claims In Connecticut State Court
WATERBURY, Conn. — Pfizer Inc. has reached a settlement to end claims brought by two groups who allege injuries from ingestion of generic ranitidine products, according to notices of settlement filed in a Connecticut state court.
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September 24, 2025
Lilly, Medical Centers’ Trademark Dispute Settlement Halted By Federal Judge
SEATTLE — A Washington federal judge refused to sign off on a joint motion filed by 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, for a consent judgment and permanent injunction to end a trademark case, finding that the motion “suffers from numerous defects.”
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September 24, 2025
FDA Warns About Possible Link Between Acetaminophen And Autism, ADHD
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
Depo-Provera MDL Parties Debate Whether Federal Preemption Laws Bar Cases
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
PBMs Want Expediated Review Of Certiorari Petition In Remanded Opioid Case
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
Del. Federal Judge Won’t Order Permanent Injunction Barring Bid For FDA Approval
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
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 17, 2025
Weight Loss Company Loses Motion To Dismiss Trademark Infringement Case
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
Judge Dismisses Putative Class Over Alleged Faulty Genetic Testing For Embryos
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
Philips Recalls Batch Of Sleep Apnea Devices, Citing Software Issues
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
7th Circuit Affirms $193M Medicare Drug Rebate False Claims Judgment Against Lilly
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
Valsartan Special Master Won’t Exclude Expert Who Cited AI-Generated Sources
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
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.