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

Mealey's Drugs & Devices

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.”
December 30, 2024
Pfizer: MDL For Cases Alleging Depo-Provera Caused Tumors Belongs In New York

WASHINGTON, D.C. — The manufacturer of Depo-Provera, a long-lasting injectable contraceptive, agreed that cases alleging that the product caused women to develop intracranial meningiomas, a type of brain tumor, should be centralized by the U.S. Judicial Panel on Multidistrict Litigation but argued that the Southern District of New York is the most appropriate forum.
December 30, 2024
4 Bellwether Plaintiffs Identified In Implantable BioZorb Marker Device Cases

BOSTON — A device manufacturer and counsel for women who allege that an implanted radiographic marker used to mark soft tissue sites during cancer treatment was defective and caused injuries submitted a joint proposal naming the four bellwether cases with plans for the first trial to begin in September.
December 20, 2024
CPAP MDL Judge Dismisses Actions Against SoClean, Says Not Appropriately Filed

PITTSBURGH — A Pennsylvania federal judge who oversees the two related multidistrict litigations involving the recall of approximately 10.8 million continuous positive air pressure (CPAP) sleep apnea devices dismissed a third-party complaint filed in one of the MDLs by the manufacturer of recalled CPAP machines, which asked that the manufacturer of equipment that uses ozone to clean and disinfect the machines be forced to contribute to settlement agreements and ruled that a putative class action against the same party “is an entirely new lawsuit” and dismissed it from the MDL docket.
December 20, 2024
Government Intervenes In Suit Alleging CVS’s Opioid Distribution Violated Law

PROVIDENCE, R.I. — CVS Pharmacy Inc. and its subsidiaries violated the False Claims Act (FCA) and the Controlled Substances Act (CSA) by filling “prescriptions for controlled substances that lacked a legitimate medical purpose, were not valid, and/or were not issued in the usual course of professional practice,” the government alleges in a complaint that was ordered to be unsealed by a Rhode Island federal judge.
December 19, 2024
Mass Tort Cases For Drugs, Medical Devices

New developments in the following mass tort drug and device cases are marked in boldface type.
December 19, 2024
Ala. Federal Judge Dismisses Suit Alleging Woman Was Killed By Faulty Heart Device

BIRMINGHAM, Ala. — Because a wrongful death complaint failed to “mention any federal requirement that was allegedly violated” by the manufacturer of a heart defibrillator, an Alabama federal judge granted Boston Scientific’s motion to dismiss based on federal preemption.
December 19, 2024
Denial Of Drug’s Fast Track Application Was Not An Error, D.C. Circuit Affirms

WASHINGTON, D.C. — The U.S. Food and Drug Administration’s denial of a pharmaceutical company’s application for a fast-track approval of its new drug was not arbitrary and capricious, the District of Columbia Circuit U.S. Court of Appeals held, affirming a summary judgment award to the FDA.
December 19, 2024
Parties Debate Whether Mifepristone Case Can Continue With Intervening States

AMARILLO, Texas — Missouri, Kansas and Idaho “have no plausible connection” to the federal court in Texas in which a lawsuit filed by a group of antiabortion advocates challenging the U.S. Food and Drug Administration’s approval of abortion drug mifepristone originated, a case that eventually reached the U.S. Supreme Court, which found that the group lacked standing, the FDA argued in a reply brief supporting its motion to dismiss.
December 19, 2024
Federal Judge: Bair Hugger Bellwether Plaintiff Can Partially Amend Complaint

CLEVELAND — A woman whose case was selected as a bellwether action in the Bair Hugger multidistrict litigation can partially amend her complaint to add claims under Ohio laws, but amending the complaint to add claims under Minnesota law is futile, a federal judge in Ohio ruled.
December 18, 2024
JPMDL Hearing Set To Mull Centralizing Cases Alleging Depo-Provera Caused Tumors

WASHINGTON, D.C. — The U.S. Judicial Panel on Multidistrict Litigation will hear arguments in January on whether to centralize cases filed by women who allege that they developed intracranial meningiomas, a type of brain tumor, from their use of Depo-Provera, a long-lasting injectable contraceptive.
December 18, 2024
OTC Cold Medicine MDL Judge Won’t Reconsider Dismissal Of Lanham Act Claims

BROOKLYN, N.Y. — A pharmacy’s argument “misses the mark” in contending that its Lanham Act claim should be reinstated because the claim was not in the initial streamlined complaint filed in 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, the judge overseeing the MDL said.
December 17, 2024
Hernia Mesh MDL Judge Issues Case Management Order After Settlement Announced

COLUMBUS, Ohio — The Ohio federal judge overseeing the Davol hernia mesh multidistrict litigation on Dec. 16 issued case management orders to establish a qualified settlement fund and an order to protect identifiable health information after the device maker announced that it has reached a settlement to resolve the majority of the claims in the MDL and similar cases consolidated in a Rhode Island state court.
December 17, 2024
Oral Arguments Heard On Indivior’s Motion To Dismiss Suboxone Case

CLEVELAND — Parties in the Suboxone film multidistrict litigation on Dec. 16 presented oral arguments on whether the MDL judge should grant a motion to dismiss filed by the drug’s manufacturer.
December 16, 2024
McKinsey To Pay $650M To Resolve Purdue Investigation; Executive To Plead Guilty

ABINGDON, Va. — A former McKinsey & Co. Inc. senior partner who worked on matters involving Purdue Pharma L.P. is expected to plead guilty next month to obstruction of justice for allegedly deleting folders, documents and emails from his McKinsey-issued laptop, the government said in court filings on Dec. 13, separately announcing that the company has agreed to a $650 million settlement to resolve criminal and civil investigation into the firm’s consulting work with Purdue.
December 12, 2024
CPAP Judge Gives Final OK To Medical Monitoring Settlement, Attorney Fees Awards

PITTSBURGH — The federal judge overseeing the multidistrict litigation involving the recall of approximately 10.8 million continuous positive air pressure (CPAP) sleep apnea devices has given final approval to a $25 million settlement to resolve medical monitoring claims and awarded $4.8 million for attorney fees and costs.