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

Mealey's Drugs & Devices

June 10, 2025
Novo Nordisk Says Summary Judgment Award In Semaglutide Spat Needs Amending

TAMPA, Fla. — Novo Nordisk Inc. on June 9 urged a Florida federal court to amend its order granting summary judgment in favor of a pharmaceutical company accused of selling unapproved compounded drugs containing semaglutide, arguing that because the court held that the drug manufacturer’s claims were moot, the court erred in analyzing the merits of the case and should amend the judgment to dismiss the case without prejudice.
June 10, 2025
Federal Judge Refuses To Send Mississippi’s Case Against PBMs Back To State Court

JACKSON, Miss. — A Mississippi federal judge on June 9 denied the state’s motion to remand its complaint alleging that various pharmacy benefit managers (PBMs) contributed to the opioid epidemic in the state, finding that Mississippi’s waiver of certain claims “cannot stave off federal officer removal.”
June 10, 2025
United States Declines Response To Petition Debating Whether Stem Cells Are Drugs

WASHINGTON, D.C. — The government on June 9 waived its right to respond to a petition for a writ of certiorari filed by a stem cell clinic and its owners that argues that the Ninth Circuit U.S. Court of Appeals erred in finding that a stem cell mixture used by clinics is a drug under the federal Food, Drug and Cosmetic Act (FDCA).
June 06, 2025
Woman’s Expert In Device Defect Case Properly Excluded, 8th Circuit Affirms

MINNEAPOLIS — The Eighth Circuit U.S. Court of Appeals ruled that a district court properly awarded summary judgment to a knee replacement system manufacturer after finding that testimony by a woman’s retained expert on her design defect claim was properly excluded.
June 06, 2025
4 States Tell FDA That REMS Restrictions Are Unneeded For Mifepristone

The attorneys general of California, Massachusetts, New Jersey and New York on June 5 submitted a citizen petition to the U.S. Food and Drug Administration urging the agency to remove the Risk Evaluation and Mitigation Strategy (REMS) restrictions on mifepristone, one of the two drugs prescribed for medication abortions.
June 05, 2025
Mass Tort Cases For Drugs, Medical Devices

New developments in the following mass tort drug and device cases are marked in boldface type.
June 04, 2025
6th Circuit Denies PBMs’ Mandamus Petition For Discovery Order In Opioid MDL

CINCINNATI — The Sixth Circuit U.S. Court of Appeals on June 3 denied a petition for a writ of mandamus filed by a group of pharmacy benefit managers (PBMs) in the nationwide opioid multidistrict litigation, rejecting arguments that the trial court’s discovery orders are “the kind of extraordinary abuses of discretion that justify mandamus relief.”
June 03, 2025
9th Circuit Affirms Removal Of Opioid Nuisance Case, Says Nken Factors Control

SAN FRANCISCO — The Ninth Circuit U.S. Court of Appeals on June 2 rejected arguments that the high court’s holding in Coinbase, Inc. v. Bielski extends to an automatic stay in the federal officer removal context, affirming that a lower court did not err in granting remand to California in its suit alleging that a group of pharmacy benefits managers (PBMs) contributed to the public nuisance of the opioid epidemic.
June 02, 2025
FDA Argues Summary Judgment Warranted In Mifepristone Restrictions Case

YAKIMA, Wash. — The U.S. Food and Drug Administration argues in a May 30 reply brief on its cross-motion for summary judgment filed in a Washington federal court that only the state established that it is entitled to seek judicial relief in a suit filed by a group of states over the agency’s decision to add Risk Evaluation and Mitigation Strategy (REMS) restrictions on mifepristone, one of the two drugs prescribed for medication abortions.
June 02, 2025
PBMs Ask Court To Enjoin Law Barring Them From Operating Pharmacies in Arkansas

LITTLE ROCK, Ark. — A group of pharmacy benefits managers (PBMs) argue that a law recently signed by the Arkansas governor that bans PBMs from owning a pharmacy business in the state “will have devastating consequences” and urged a federal court to enjoin the act and declare it unlawful.
June 02, 2025
Parties Tell Illinois Federal Judge Settlement Reached In Nondrowsy Label Dispute

CHICAGO — The manufacturer of a nondrowsy cold medicine has reached a settlement agreement with a woman who alleges that she was misled in purchasing the product because its active ingredient is dextromethorphan hydrobromide, which can cause drowsiness, according to a joint motion filed in an Illinois federal court.
May 30, 2025
Counties Tell Texas High Court In Opioid Case That Counties Are Not Persons

AUSTIN, Texas — Texas counties that sued pharmacies for their role in the opioid epidemic tell the Texas Supreme Court that the only issue before the court on appeal is whether the county is a person under the Texas Medical Liability Act (TMLA) and that a lower court correctly ruled that it is not.
May 29, 2025
Parties Ask For Summary Judgment In Drug’s Removal From FDA’s Shortage List Case

FORT WORTH, Texas — Motions for summary judgment in a dispute over the U.S. Food and Drug Administration’s removal of semaglutide, an FDA-approved drug for diabetes and weight loss, from the agency’s drug shortage list were made public on May 28, debating whether the agency’s actions violated federal law.
May 29, 2025
Woman Says Spinal Cord Stimulator Device Failed, Sues Manufacturer And FDA

LOS ANGELES — A woman alleges in a complaint filed in a California federal court that a spinal cord stimulator (SCS) system manufactured by Nevro Corp. was defectively designed and that the U.S. Food and Drug Administration violated federal law when it allowed the company “to bypass statutory safeguards and enabled widespread distribution of a materially modified and inadequately tested device.”
May 28, 2025
High Court Asked To Review Whether Fosamax MDL Ruling On Preemption Is Wrong

WASHINGTON, D.C. — A petition for certiorari will be distributed for conference on June 12 on whether the high court should review a Third Circuit U.S. Court of Appeals decision in the long-running Fosamax femur fracture multidistrict litigation, with the drug manufacturer arguing that the petitioners misrepresented the appellate court’s ruling that reversed a decision that awarded a drug manufacturer summary judgment in 1,046 cases.
May 28, 2025
Philips Loses Bid To Dismiss Complaint Alleging That CPAP Machine Caught Fire

RALEIGH, N.C. — A federal judge in North Carolina refused to dismiss a complaint brought against a manufacturer of a continuous positive air pressure (CPAP) sleep apnea device that allegedly caught fire, causing a woman to suffer second degree burns on her face and her home to burn down, after finding that the woman’s daughter is the duly authorized representative of her estate.
May 28, 2025
Vanda Challenges FDA’s Denial Of Drug’s Fast-Track Application In High Court

WASHINGTON, D.C. — The U.S. Food and Drug Administration moved “the legal goalposts” when it denied a pharmaceutical company’s application for a fast-track approval of its new drug, and the District of Columbia Circuit U.S. Court of Appeals erred in finding that the decision was not arbitrary and capricious, the company argues in a petition for writ of certiorari filed in the U.S. Supreme Court.
May 27, 2025
McKinsey Executive Sentenced To 6 Months For Deleting Files, Emails In Purdue Work

ABINGDON, Va. — A former McKinsey & Co. Inc. senior partner has been sentenced to six months in federal prison after pleading guilty to obstruction of justice for deleting folders, documents and emails from his McKinsey-issued laptop on matters relating to an investigation into the firm’s consulting work for the opioid manufacturer Purdue Pharma LP, the government said in a press release.
May 23, 2025
Stem Cells Are Not Drugs Under FDCA, Clinic Tells High Court In Urging Review

WASHINGTON, D.C. — The Ninth Circuit U.S. Court of Appeals erred in finding that a stem cell mixture used by clinics is a drug under the U.S. Federal Food, Drug, and Cosmetic Act (FDCA), a stem cell clinic and its owners tell the U.S. Supreme Court in a petition for a writ of certiorari.
May 23, 2025
Depo-Provera MDL Judge Says Complaints Must Identify Requisite Injury And Product

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, outlined what complaints must contain to be included in the MDL and identified potential deficiencies in complaints that have been filed.
May 22, 2025
Judge Dismisses Complaint Alleging That Medication Contained Benzene As Preempted

CHICAGO — A group of consumers who allege that over-the-counter medicine sold by Walgreens Inc. contained benzene have standing to sue, an Illinois federal judge found, but he agreed to dismiss the complaint after finding that federal law prohibited Walgreens from changing the drug’s label.
May 22, 2025
Judge Signs Off On Final Approval Of $73M Settlement For EpiPen Antitrust Claims

KANSAS CITY, Kan. — A Kansas federal judge on May 21 granted final approval to a $73 million settlement reached with Mylan NV, Mylan Specialty LP and Mylan Pharmaceuticals Inc. (collectively, Mylan) to end claims that they conspired with others in an attempt to delay entry of generic competitors for the EpiPen epinephrine autoinjector (EAI) into the market.
May 21, 2025
Woman’s Taxotere Case Tossed For Failing To Timely Name Proper Defendants

NEW ORLEANS — The judge overseeing multidistrict litigation for cases alleging that a chemotherapy drug caused permanent hair loss granted a motion to dismiss a Florida woman’s complaint, finding that her claims are time-barred under Florida law.
May 21, 2025
Women Say Implantable BioZorb Marker Device Was Defective, Sue Manufacturer

BOSTON — Six women who allege that an implanted radiographic marker used to mark soft tissue sites during cancer treatment was defective and caused injuries filed a combined complaint against the manufacturer in a Massachusetts federal court.
May 20, 2025
Man Sues Medtronic, FDA For Injuries Caused By Defective Spinal Cord Device

MINNEAPOLIS — A man who claims in a Minnesota federal court that two spinal cord stimulation (SCS) devices manufactured by Medtronic Inc. failed and caused pain sued the manufacturer and the U.S. Food and Drug Administration, alleging that the agency violated federal law in approving the devices.