Mealey's Drugs & Devices : Mealey's : Legal News & Analysis

Mealey's Drugs & Devices

April 01, 2025
Texas Federal Judge Vacates FDA’s Final FDCA Regulation Rule On Lab Test Services

SHERMAN, Texas — A final rule by the U.S. Food and Drug Administration that laboratory-developed testing services can be regulated as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA) exceeds the agency’s statutory authority, a Texas federal judge held March 31 and vacated the rule.
April 01, 2025
Minn. Ends Claims Against Novo Nordisk After It Agrees To Cap Insulin Costs At $35

NEWARK, N.J. — Minnesota on March 31 moved to dismiss, with prejudice, all of its claims against Novo Nordisk Inc. after a drugmaker signed a settlement agreement, release and order and agreed to make its insulin products available to consumers in Minnesota for no more than $35 for a monthly prescription.
March 31, 2025
Woman Suing Heart Device Manufacturer Seeks Leave To Amend Dismissed Complaint

BOSTON — A woman who claims she was injured when her heart device malfunctioned filed a second motion for leave to file an amended complaint on March 30, days after a Massachusetts federal judge ruled that her first attempt “omitted any cause as to why the motion should be allowed” in response to the judge’s ruling granting the device manufacturer’s motion to dismiss.
March 31, 2025
Women Tell 4th Circuit Gardasil Claims Not Untimely; Merck Urges Court To Affirm

RICHMOND, Va. — Three women whose cases were dismissed in the Gardasil multidistrict litigation for failing to timely file a required petition in the Vaccine Court tell the Fourth Circuit U.S. Court of Appeals that the act’s timing requirement is not jurisdictional; oral arguments are scheduled for May 15.
March 31, 2025
Judge: Taxotere Plaintiffs Failed To Timely Identify Correct Manufacturer

NEW ORLEANS — The Louisiana federal judge overseeing the Taxotere hair loss multidistrict litigation granted two motions to dismiss, finding that the women in those cases failed to properly file their complaints against the proper manufacturers within the applicable statute of limitations.
March 28, 2025
CooperSurgical Says Other Companies Are Responsible For Destroyed Embryos

WATERBURY, Conn. — The manufacturer of a solution used during fertility-related treatments that women allege was toxic and destroyed developing embryos filed an apportionment complaint in a Connecticut court against two companies that it alleges are liable to the women for failure to adequately test the solution.
March 27, 2025
Judge Refuses GLP-1 Compounding Pharmacies’ Request For Injunction Pending Appeal

FORT WORTH, Texas — A Texas federal judge on March 26 said he “is increasingly exasperated by” the attempts of companies representing the interests of drug compounders “to dictate to the undersigned how to manage this case” and denied a motion for an injunction pending their appeal of the judge’s refusal to convert his preliminary injunction order into a final judgment.
March 27, 2025
Federal Judge Agrees With Magistrate Judge That Filshie Clip Claims Are Preempted

HOUSTON — A Texas federal judge adopted a report and recommendation from a federal magistrate judge and agreed that state law claims that a migrated tubal ligation clip caused injuries are federally preempted and ordered the complaint dismissed with prejudice.
March 27, 2025
Mass. Federal Judge Appoints Leadership Positions For BioZorb Cases

BOSTON — A federal judge in Massachusetts who is 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 has appointed counsel to leadership positions.
March 25, 2025
Magistrate Judge: Motion To Dismiss Should Be Granted In Medical Device Case

SACRAMENTO, Calif. — A federal magistrate judge in California recommended that a motion to dismiss filed by a diabetes monitor manufacturer be granted for failure to state a claim and that a pro se plaintiff be allowed 30 days to amend his complaint for a second time.
March 24, 2025
Judge: Medical Director Not Manufacturer, Seller Under Michigan Statutes

FLINT, Mich. — An employee who approved donor tissue or participated in quality control of that tissue is not a manufacturer or seller under Michigan’s product liability statutes, a Michigan federal judge said March 21, granting a partial motion to dismiss.
March 24, 2025
11th Circuit Dismisses Complaint Accusing Depo-Provera MDL Judge Of Misconduct

ATLANTA — The chief judge of the 11th Circuit U.S. Court of Appeals found that the “voluntary corrective actions” by the judge overseeing the Depo-Provera multidistrict litigation who faced a complaint that her encouragement of women to apply for leadership positions in the MDL constituted impermissible bias and judicial misconduct “warrant the conclusion of this proceeding.”
March 24, 2025
Washington Law Does Not Shield Walgreens From OTC Claims, State High Court Says

SEATTLE — A drug manufacturer labeling an over-the-counter cough medicine as nondrowsy does not fall within the statutory safe harbor of the Washington Consumer Protection Act (CPA), the state Supreme Court said in answering a certified question from a district court.
March 20, 2025
Opioid MDL Judge Denies Albertsons’ Motion For Interlocutory Appeal

CLEVELAND — The Ohio federal judge overseeing the opioid multidistrict litigation on March 19 denied pharmacy defendant Albertsons’ motion for an interlocutory appeal of his ruling that denied its motion for summary judgment, “concluding that the motion is better presented to the transferor court on remand.”
March 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.
March 20, 2025
Judge: Woman’s Taxotere Hair Loss Case Barred By N.C.’s Statute Of Limitations

RALEIGH, N.C. — A federal judge in North Carolina found that a woman’s case that was remanded from the Taxotere hair loss multidistrict litigation was not filed within the state’s three-year statute of limitations for product liability claims and granted a manufacturer’s motion for judgment on the pleadings.
March 19, 2025
Purdue Pharma Files Amended Plan Of Reorganization In New York Bankruptcy Court

NEW YORK — Purdue Pharma L.P. filed its 13th amended Chapter 11 plan in the U.S. Bankruptcy Court for the Southern District of New York on March 18 following a recent agreement between the Sackler family and Purdue to contribute $7.4 billion to settle claims that they contributed to creating the opioid crisis.
March 19, 2025
GLP-1 MDL Plaintiffs Say Drug Makers’ Motion To Dismiss Must Be Denied

PHILADELPHIA — Plaintiffs in the multidistrict litigation involving diabetes and diet drugs that consumers allege caused gastrointestinal and other injuries urged a Pennsylvania federal judge on March 18 to deny the drug manufacturers’ motion to dismiss certain claims from a master long-form complaint.
March 19, 2025
Fen-Phen Drug Manufacturers Lose Bid To Toss Injury Case In Calif. Federal Court

LOS ANGELES — A California federal judge denied a motion to dismiss the second amended complaint of a woman who says she was injured after ingesting fen-phen diet drugs and found that a case cited by the drug manufacturer defendants actually “reinforces the court’s conclusion that plaintiffs’ claims are adequately pled.”
March 19, 2025
Judgment Entered In Insurers’ Favor In Coverage Dispute Prompted By Opioid Epidemic

TAMPA, Fla. — A federal judge in Florida on March 18 entered judgment in favor of insurers in an insured’s lawsuit seeking coverage for underlying actions arising from the opioid epidemic, finding that the insurers have no duty to defend or indemnify because the opioid lawsuits fail to allege damages “for bodily injury” or “because of bodily injury.”
March 18, 2025
Up To 100 Suboxone Plaintiffs Can File Suit In Single Complaint, MDL Judge Says

CLEVELAND — The judge overseeing the Suboxone film multidistrict litigation ruled in a March 17 case management order that lawsuits with up to 100 plaintiffs can be filed in a single complaint with one filing fee for the lead plaintiff.
March 18, 2025
Plaintiffs Leadership Named For Depo-Provera MDL

PENSACOLA, Fla. — The Florida federal judge overseeing 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, has appointed Christopher Seeger of Seeger Weiss LLP as plaintiffs’ lead counsel.
March 18, 2025
Mass. Federal Judge Allows Design Defect Claims To Move Forward In BioZorb Cases

BOSTON — A group of cases alleging that an implanted radiographic marker used to mark soft tissue sites during cancer treatment was defective and caused injuries survived a motion to dismiss filed by the device manufacturer, which argued that the plaintiffs failed to state a claim for defective design.
March 17, 2025
Fosamax Manufacturer Urges High Court Review Of ‘Outlier’ Preemption Ruling

WASHINGTON, D.C. — High court review is needed again in the long-running Fosamax femur fracture multidistrict litigation, the drug manufacturer says in a petition for certiorari, arguing that the Third Circuit U.S. Court of Appeals “defied” a 2019 U.S. Supreme Court ruling, “gutting drug preemption and rendering itself an outlier among the Circuits” when it found that state law claims are not preempted and reversed the decision that awarded the drug manufacturer summary judgment in 1,046 cases.
March 17, 2025
Boston Appeals Dismissal Of Opioid Suit Against PBMs; PBM Appeals Counsel Ruling

BOSTON — Boston has filed notice that it is appealing to the First Circuit U.S. Court of Appeals an order dismissing its case against two pharmacy benefit managers (PBMs) in which a Massachusetts federal judge found that the city’s claims against the PBMs for their role in contributing to the opioid epidemic are time-barred and that the city lacks standing; separately, one of the PMBs on March 14 filed a notice of cross-appeal, saying the judge erred in refusing to disqualify Motley Rice LLC from representing Boston and others in the suit.