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

Mealey's Drugs & Devices

November 30, 2023
Mass Tort Cases For Drugs, Medical Devices

New developments in the following mass tort drug and device cases are marked in boldface type.
November 30, 2023
Zostavax MDL Judge Orders Expert Declaration From Group Of Plaintiffs

PHILADELPHIA — The Pennsylvania federal judge presiding over the Zostavax multidistrict litigation on Nov. 29 agreed to require a group of plaintiffs alleging that the shingles vaccine caused injuries other than shingles or hearing loss to produce a declaration from a causation expert stating that the vaccine caused the injuries.
November 30, 2023
Ohio Supreme Court Agrees To Hear Certified Question In Opioid Verdict Appeal

COLUMBUS, Ohio — The Ohio Supreme Court on Nov. 29 agreed to answer a certified question from the Sixth Circuit U.S. Court of Appeals regarding whether a common-law public nuisance claim is permitted under the Ohio Product Liability Act in an appeal of a $650 million verdict awarded to two counties filed by a trio of pharmacies.
November 30, 2023
FDA Warns Users Of Reports Of Overheating CPAP Machines

SILVER SPRING, Md. — The U.S. Food and Drug Administration through a safety communication warned users of Philips DreamStation 2 continuous positive airway pressure (CPAP) machines to watch for signs of overheating.
November 29, 2023
FDA Moves For Dismissal Of Drug Compounder’s Suit To Stop Press Release

NEW HAVEN, Conn. — The U.S. Food and Drug Administration moved to dismiss a complaint filed by a pharmaceutical compounder asking that a federal court enjoin the agency from publishing a press release or statement regarding an investigation of its facility.
November 29, 2023
Acetaminophen Autism/ADHD MDL Judge Agrees To Sever Rite Aid From Cases

NEW YORK — The New York federal judge overseeing the acetaminophen autism spectrum disorder-attention deficit hyperactivity disorder (ASD-ADHD) multidistrict litigation granted a request by the plaintiffs to sever Rite Aid Corp. from all cases where Rite Aid is not the only named defendant.
November 29, 2023
Woman’s IVC Filter Injury Case Dismissed For Filing Outside Statute Of Limitations

PHOENIX — A woman claiming that she was injured by an inferior vena cava (IVC) filter acknowledged that she was aware of her injuries in 2020 and contacted other attorneys in an attempt to file a lawsuit, defeating her defense to a motion to dismiss filed by the manufacturer on statute-of-limitation grounds, an Arizona federal judge ruled.
November 29, 2023
Man Alleging Injuries From Ankle Monitoring Device Says Colorado Law Applies

DENVER — A man suing the manufacturer of an alcohol tracking ankle monitor for injuries to his skin rejected arguments that the laws of the state in which the arrest occurred should apply or that he failed to state a claim and urged a federal court in Colorado to deny a motion to dismiss.
November 29, 2023
Dismissal Of Diabetes Drug Complaint Not Warranted, Louisiana Woman Says

LAKE CHARLES, La. — Arguments for dismissal made by the manufacturer of Ozempic, which is facing claims that it failed to warn of risks associated with the diabetes drug, are premature and without merit, a woman argues in a Louisiana federal court.
November 28, 2023
SoClean To Update User Manual, Provide Adapter For CPAP Cleaning Device

WASHINGTON, D.C. — The U.S. Food and Drug Administration has provided additional information regarding a voluntary product recall related to the use of SoClean2 and SoClean3 equipment that is used to clean, sanitize or disinfect CPAP devices and accessories.
November 21, 2023
MDL Sought For Plaintiffs Alleging Dental Injuries From Suboxone Film

WASHINGTON, D.C. — A group of plaintiffs who sued the manufacturer of Suboxone film allege that the use of the prescription drug to treats opioid use disorder caused extensive dental decay have asked the U.S. Judicial Panel on Multidistrict Litigation to consolidate the cases for pretrial purposes.
November 21, 2023
Dismissal Denied In FCA Suit Against Maker Of Alleged Defective Knee Replacements

TUSCALOOSA, Ala. — An Alabama federal judge on Nov. 20 denied a motion to dismiss and for judgment on the pleadings by an orthopedic device manufacturer in relators’ suit asserting that the manufacturer violated the federal False Claims Act (FCA) by submitting for reimbursement to government health care programs claims for knee replacement devices it knew were defective, finding that the manufacturer’s argument that the court lacks jurisdiction due to the unconstitutionality of provisions of the FCA “lack[s] merit.”
November 20, 2023
1st Circuit Certifies Appeal In FCA Suit Against Teva Alleging Co-Pay Kickbacks

BOSTON — The First Circuit U.S. Court of Appeals on Nov. 17 granted a petition to appeal filed by Teva Pharmaceuticals USA Inc. and Teva Neuroscience Inc., asserting that appeal should be granted due to a “substantial ground for difference of opinion” regarding causation under the Anti-Kickback Statute (AKS) as applied to a district court’s partial summary judgment ruling for the government in its suit alleging that they violated the False Claims Act (FCA) and AKS by using co-pay subsidies as kickbacks when selling a multiple sclerosis (MS) drug.
November 20, 2023
Woman Says Arguments For Dismissal Of Diabetic Drug Complaint Are Premature

LAKE CHARLES, La. — A Louisiana federal court should reject calls by the manufacturer of Ozempic to dismiss a complaint alleging that it failed to warn of risks associated with the diabetes drug, a woman argues, contending that its arguments are without merit and premature.
November 20, 2023
Texas Federal Judge Agrees To Hear Motion To Intervene In Abortion Drug Case

AMARILLO, Texas — There is no need to wait until the U.S. Supreme Court weighs in on a pending petition for a writ of certiorari in a case involving the abortion drug mifepristone before deciding if three states can intervene in a district court proceeding, a federal judge in Texas ruled, rejecting a motion by the U.S. Food and Drug Administration to hold the motion in abeyance and ordering the FDA to respond to the request to intervene within 30 days.
November 20, 2023
Arizona Company Ordered To Stop Selling Unapproved Contraceptive Cream

PHOENIX — A federal Arizona judge entered a consent decree and permanent injunction barring a company from selling a cream that it markets as a vaginal contraceptive in violation of the Federal Food, Drug and Cosmetic Act (FDCA).
November 17, 2023
High Court Asked To Resolve Dispute Of Right To Appeal Partially Dismissed Case

WASHINGTON, D.C. — The U.S. Supreme Court granted a motion to extend time for a manufacturer and seller of Zantac to respond to a petition for a writ of certiorari appealing the dismissal of her case and asking the high court to settle a jurisdictional question that has split the circuit courts.
November 16, 2023
Mass Tort Cases For Drugs, Medical Devices

New developments in the following mass tort drug and device cases are marked in boldface type.
November 16, 2023
Don’t Delay Decision On Intervening In Abortion Drug Case, States Tell Court

AMARILLO, Texas — Danco Laboratories LLC, the manufacturer of Mifeprex brand mifepristone, on Nov. 15 concurred with the U.S. Food and Drug Administration’s position that a Texas federal court should hold in abeyance a motion by three states to intervene in a lawsuit pending resolution of a petition for a writ of certiorari in the U.S. Supreme Court, but the states argue that the delay is unwarranted.
November 16, 2023
Judge Allows Expert Testimony But Pares Claims In Hip Implant Injury Case

COEUR D’ALENE, Idaho — An Idaho federal judge will allow an expert retained by a woman suing for an allegedly defective hip implant to testify but partially granted the manufacturers’ motion for summary judgment.
November 16, 2023
Mifepristone Maker Will Appeal Challenge Of West Virginia Abortion Law

HUNTINGTON, W.Va. — GenBioPro Inc. filed notice that it intends to appeal to the Fourth Circuit U.S. Court of Appeals a decision by a lower court that dismissed the abortion drug manufacturer’s claims arguing that a West Virginia law curtailing the use of the drug violated the U.S. Constitution.
November 15, 2023
Woman Agrees To Dismiss Deceptive Cold Medicine Packaging Case

CHICAGO — A woman suing Procter & Gamble Co. for allegedly deceiving its customers by packaging its cold medicine with a vitamin C supplement filed a notice of voluntary dismissal of her case in an Illinois federal court, days after a federal judge granted the manufacturer’s motion to dismiss.
November 15, 2023
States Urge High Court To Review Legislative History In Case On Abortion Drugs

WASHINGTON, D.C. — A group of states led by Mississippi filed an amicus curiae brief supporting the conditional cross-petition for a writ of certiorari filed by a group of anti-abortion advocates, urging the U.S. Supreme Court to review the U.S. Food and Drug Administration’s 2000 approval of mifepristone, but the FDA and the manufacturer of the drug argue that the petition fails to meet the high court’s traditional certiorari standards and should be denied.
November 15, 2023
6th Circuit Won’t Disqualify Opioid MDL Special Master For Reply-All Email Error

CINCINNATI — A federal judge overseeing the opioid multidistrict litigation did not abuse his discretion in refusing to disqualify the special master, who is accused of bias after he inadvertently sent a personal email to the parties, the Sixth Circuit U.S. Court of Appeals held Nov. 14, denying a petition for a writ of mandamus filed by two pharmacy benefit managers (PBMs).
November 13, 2023
FDA Asks District Court To Hold Motion To Intervene Pending High Court Decision

AMARILLO, Texas — The U.S. Food and Drug Administration urged a Texas district court to hold in abeyance a motion filed by three states to intervene in a lawsuit challenging the FDA’s approval of mifepristone and misoprostol pending resolution of its petition for writ of certiorari pending in the U.S. Supreme Court.