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Mealey's Drugs & Devices

  • January 21, 2025

    FDA Says Antiabortion States Still Lack Standing To Sue In Amended Complaint

    AMARILLO, Texas — The U.S. Food and Drug Administration on Jan. 18 asked a federal court in Texas to dismiss an amended complaint filed by Missouri, Kansas and Idaho in a case originated by a group of antiabortion advocates challenging the FDA’s approval of the abortion drug mifepristone, a case that eventually reached the U.S. Supreme Court, which found that the group lacked standing and in which the original plaintiffs have now voluntarily dismissed all of their claims.

  • January 21, 2025

    United States Says Walgreens Knowingly Filled Invalid Opioid Prescriptions

    CHICAGO — The United States filed a complaint in intervention in four qui tam cases against Walgreen Co. and its affiliates, alleging that the pharmacy chains violated federal law by filling millions of invalid controlled-substance prescriptions, fueling the opioid epidemic throughout the country, according to the complaint filed in an Illinois federal court.

  • January 21, 2025

    Couple, Manufacturer Work Toward Settlement For Embryo Loss During IVF Procedure

    CHARLOTTE, N.C. — A North Carolina federal magistrate judge on Jan. 20 partially granted a motion to stay filed in a case against a manufacturer of sterile mineral oil by a couple who allege that the solution was toxic and led to the destruction of their embryos, noting that the parties are attempting to finalize a settlement.

  • January 17, 2025

    Opioid Plaintiff Says PBMs Unlikely To Win Privilege Order Row On Appeal

    CINCINNATI — Rochester, N.Y., a plaintiff in the nationwide opioid multidistrict litigation, on Jan. 16 opposed a motion for an emergency stay filed by two pharmacy benefit managers (PBMs) in the Sixth Circuit U.S. Court of Appeals, arguing that the PBMs are unlikely to succeed on their efforts to bar certain documents from being produced during discovery and that the city will be harmed by the stay.

  • January 16, 2025

    Heart Pump Maker Says Wrongful Death Case Cannot Survive Preemption Argument

    ST. LOUIS — A husband and daughter failed to allege how a surgically implanted heart pump was defectively designed or how that alleged defect caused a woman’s death, the manufacturer of the device argues in a reply brief to its motion for judgment on the pleadings, urging the Missouri federal court to find that the claims are preempted by federal law.

  • January 16, 2025

    Discovery Referee Rules On Motions To Compel In Coverage Suit Over Opioid Epidemic

    WINSTON-SALEM, N.C. — A discovery referee granted in part insureds’ and insurers’ motions to compel discovery in a coverage dispute arising from the opioid epidemic brought in a North Carolina court.

  • January 16, 2025

    Mass. Federal Judge: Learned-Intermediary Doctrine Doesn’t Apply To BioZorb Case

    BOSTON — A federal judge in Massachusetts on Jan. 15 rejected arguments that the learned-intermediary doctrine warranted summary judgment for claims filed by a woman selected as a bellwether plaintiff in cases alleging that an implanted radiographic marker used to mark soft tissue sites during cancer treatment was defective and caused injuries.

  • January 15, 2025

    Taxotere MDL Judge: Deceased Woman Lacked Standing; Substitution Improper

    NEW ORLEANS — A woman who was dead when her short-form complaint was filed lacked standing to sue, and a motion for substitution could not cure that jurisdictional defect, the federal judge overseeing the multidistrict litigation for cases alleging that the chemotherapy drug Taxotere caused eye injuries ruled in granting a motion to dismiss.

  • January 15, 2025

    Ozempic Maker Sues Seller Of Compounded Drugs, Alleging Trademark Infringement

    ATLANTA — The manufacturer of Ozempic, Wegovy and Rybelsus sued a weight-loss center in Georgia that sells and promotes compounded drug products that purport to contain semaglutide for false advertising and trademark infringement in a Georgia federal court.

  • January 13, 2025

    Pharmacy Appeals Decision Tossing Its Lanham Act Claims In OTC Cold Medicine MDL

    BROOKLYN, N.Y. — A pharmacy that argued that its Lanham Act claims were wrongfully dismissed in the multidistrict litigation stemming from allegations that over-the-counter cough and cold medications containing the active ingredient phenylephrine (PE) are ineffective at relieving nasal congestion on Jan. 10 filed a notice of appeal to the Second Circuit U.S. Court of Appeals.

  • January 13, 2025

    Kroger Settles Claims With Ky., Faces New Complaint In Calif. Over Opioid Sales

    The Kentucky Attorney General announced that The Kroger Co. has agreed to a $110 million settlement to end claims that the grocery chain, whose pharmacies filled 11% of all opioid pills sold in the state from 2006 to 2019, helped fuel the opioid crisis; the announcement came two days after California filed its own complaint against Kroger, asserting that the chain ignored red flags that showed that opioid drugs were being diverted.

  • January 13, 2025

    Texas Appeals Dismissal Of Case Alleging Pfizer Misled COVID-19 Vaccine Efficacy

    LUBBOCK, Texas — Texas filed a notice of appeal to the Fifth Circuit U.S. Court of Appeals after a Texas federal judge granted a motion to dismiss the state’s lawsuit alleging that Pfizer Inc. made false and misleading claims about the COVID-19 vaccine’s efficacy in violation of the Texas Deceptive Trade Practices Act (DTPA).

  • January 09, 2025

    Mass Tort Cases For Drugs, Medical Devices

    New developments in the following mass tort drug and device cases are marked in boldface type.

  • January 09, 2025

    Optum Loses Bid To Dismiss County’s Suit Against It For Role In Opioid Crisis

    SEATTLE — A Washington federal judge found that a county adequately established that the court may exercise personal jurisdiction over a pharmacy benefits manager (PBM) that the county alleges helped create and perpetuate the opioid epidemic and denied a motion to dismiss.

  • January 09, 2025

    Judge Adopts Recommendation, Grants Motion To Dismiss Defective Device Case

    MONROE, La. — A Louisiana federal judge agreed that a man who alleges that a defectively designed knee implant device cause injuries failed to state a claim under the Louisiana Products Liability Act and adopted the report and recommendation of a magistrate to grant a motion to dismiss filed by the device’s manufacturer.

  • January 09, 2025

    Conn. Federal Judge Dismisses Gadolinium Injury Case, Finds Claims Time-Barred

    NEW HAVEN, Conn. — A Connecticut federal judge agreed to dismiss a couple’s lawsuit claiming that a woman suffered injuries after exposure to harmful levels of gadolinium, finding that woman’s injuries accrued no later than 2009 and that the case was barred under the state’s statute of limitations.

  • January 08, 2025

    6th Circuit Won’t Compel Opioid MDL Judge To Certify Questions To Ga. High Court

    CINCINNATI — The Sixth Circuit U.S. Court of Appeals denied Publix Super Markets Inc.’s petition for a writ of mandamus to order a series of questions certified to the Georgia Supreme Court for it to determine how the state’s public nuisance laws apply in a nationwide opioid multidistrict litigation, finding “that the extraordinary remedy of mandamus” is not warranted.

  • January 07, 2025

    N.J. Federal Judge Partially Dismisses Claims In Amended Insulin Pricing Dispute

    NEWARK, N.J. — A New Jersey federal judge denied a motion to strike a fourth amended complaint alleging that three drug manufacturers engaged in an unfair and unconscionable pricing scheme for their analog insulin products but agreed to dismiss certain claims.

  • January 06, 2025

    Opioid MDL Judge OKs Stay On Privilege Order, Denies Stay For Personnel Records

    CLEVELAND — The Ohio federal judge overseeing the opioid multidistrict litigation on Jan. 6 released an amended order that granted two pharmacy benefit managers (PBMs) a temporary stay on an order finding that certain documents were not privileged but denied the motion to stay the release of personnel files.

  • January 06, 2025

    Device Manufacturer Moves To Dismiss Case; Parents Say It Should Be In State Court

    GREAT FALLS, Mont. — The manufacturer of a patient return electrode pad that a couple alleges caused their daughter to suffer second- and third-degree skin burns during a tonsillectomy surgery moved to dismiss the case on Jan. 3, a day after the parents argued that the case was wrongly removed to the Montana federal court.

  • January 06, 2025

    Judgment Granted for Insurers In Dispute Over MDL Opioid Liability Coverage

    NEW CASTLE, Del. — A Delaware state court judge granted summary judgment for insurers in their declaratory judgment action seeking a judgment that they have no duty to indemnify or defend insured AmerisourceBergen, a distributor of prescription opioids, in multidistrict litigation, finding that because the suits seeking to recover economic losses do not seek damages related to bodily injury, the insurers have no duty to defend or indemnify under the policies.

  • January 03, 2025

    Lilly Moves To Intervene In GLP-1 Compounding Pharmacies’ Suit Against FDA

    FORT WORTH, Texas — Objections to a motion to intervene filed by Eli Lilly and Co. in a suit  brought by companies representing the interests of drug compounders that challenge the U.S. Food and Drug Administration’s decision to remove two FDA-approved drugs for diabetes and weight loss from the agency’s drug shortage list must be filed by Jan. 15, a Texas federal judge ordered Jan. 2.

  • January 02, 2025

    Suboxone MDL Judge Finds Some Claims Are Preempted But Others Can Move Forward

    CLEVELAND — The judge overseeing the Suboxone film multidistrict litigation on Dec. 31 partially granted a motion to dismiss filed by the drug’s manufacturer but allowed a man’s preapproval design defect and certain failure-to-warn claims to move forward.

  • January 02, 2025

    CVS Health Corp. Dismissed From Misleading ‘Non-Drowsy’ Medicine Label Case

    ST. LOUIS — A federal judge in Missouri dismissed without prejudice a woman’s claims against CVS Health Corp. in a lawsuit in which she alleges that she was misled into purchasing over-the-counter (OTC) CVS-branded medicines that were labeled nondrowsy when in fact they cause drowsiness.

  • January 02, 2025

    2nd Circuit Vacates In FCA Case Of First Impression Over Alleged Drug Kickbacks

    NEW YORK — The Second Circuit U.S. Court of Appeals vacated and remanded in part a district court’s ruling dismissing a qui tam plaintiff’s complaint alleging that Novartis Pharmaceuticals Corp. violated the federal False Claims Act (FCA) by engaging in kickbacks in violation of the federal Anti-Kickback Statute (AKS) through offering “illicit renumeration” to physicians prescribing the multiple sclerosis drug Gilenya, finding “as a matter of first impression in this Circuit that a plaintiff states an AKS violation so long as she alleges with the requisite particularity that at least one purpose of the purported scheme was to induce fraudulent conduct.”