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

Mealey's Drugs & Devices

February 19, 2025
D.C. Federal Judge Finds FDA Did Not Violate Law In Approving Generic Drug

WASHINGTON, D.C. — A federal judge in the District of Columbia was unconvinced that the U.S. Food and Drug Administration violated the Administrative Procedure Act (APA) when it granted approval to a generic drug, denying a motion for summary judgment filed by a drug manufacturer and granting cross-motions filed by the FDA and the generic drug maker.
February 19, 2025
Judge Dismisses Bellwether Plaintiff’s Failure-To-Warn Claim In BioZorb Case

BOSTON — Testimony from the treating surgeon for a woman who alleges that an implanted radiographic marker used to mark soft tissue sites during cancer treatment was defective and caused injuries “cannot carry her burden at summary judgment, as it says nothing about the critical question on the issue of causation: that is, what [the surgeon] would have done if she had known of those risks,” a Massachusetts federal judge ruled.
February 18, 2025
United Appeals $300M Settlement Of Third-Party Payers’ Claims In Opioid MDL

CLEVELAND — United HealthCare Services Inc. has appealed to the Sixth Circuit U.S. Court of Appeals the final approval of a $300 million settlement that third-party payers (TPP) reached with three drug manufacturers to end claims that the opioid industry’s practices caused them to pay more for prescription opioids instead of safer, less addictive alternatives, and for the cost of funding opioid addiction-related treatments.
February 18, 2025
Mass. Federal Judge Dismisses Wrongful Death Suit, Finds Claims Are Preempted

BOSTON — A Massachusetts federal judge recognized that a mother “suffered an immeasurable loss” in the death of her son but found that her claims against the manufacturer of an injectable medication that was used to treat his migraines are preempted by federal law, dismissing without leave to amend her wrongful death lawsuit.
February 14, 2025
Massachusetts Federal Judge Dismisses Boston’s Opioid Suit Against PBMs As Untimely

BOSTON — A Massachusetts federal judge granted two pharmacy benefit managers’ motion to dismiss a complaint filed against them by Boston for their role in contributing to the opioid epidemic after finding that the asserted claims are time-barred and that the city lacks standing.
February 14, 2025
MDL Judge Partially Grants Motion To Dismiss Certain Paragard IUD Cases

ATLANTA — The judge overseeing the Paragard intrauterine device (IUD) multidistrict litigation in the U.S. District Court for the Northern District of Georgia agreed to dismiss multiple pending cases as time-barred under various states’ statutes of limitations.
February 13, 2025
Tepezza MDL Judge Selects First 4 Bellwether Plaintiffs To Head To Trial

CHICAGO — The Illinois federal judge overseeing the Tepezza hearing loss multidistrict litigation has named the first four cases that will proceed as the initial bellwether cases and instructed the parties to confer to decide on the order in which the cases will be tried.
February 13, 2025
Judge Dismisses Claims Against Novo Nordisk Over Allegedly Defective Insulin Pens

NEW HAVEN, Conn. — A Connecticut federal judge partially granted a motion to dismiss a complaint filed by a hospital system alleging that insulin pens were defective and subjected the hospital to a class action of patients who may have been exposed to blood-borne illnesses.
February 12, 2025
PBMs Say Michigan’s Suit Over Role In Opioid Crisis Belongs In Federal Court

DETROIT — Two of the nation’s largest pharmacy benefit managers (PBMs) that were sued by the attorney general for Michigan for violations of the state’s public nuisance laws and other claims that allege that the PBMs contributed to the oversupply of opioids in Michigan filed an opposition to the state’s motion to remand the case and argue that removal to federal court was proper based on the federal officer removal statute.
February 11, 2025
Cartiva Faces Allegation That Toe Cartilage Implant Device Failed, Caused Pain

CHICAGO — An Illinois man sued the manufacturer of a synthetic cartilage implant (SCI) device used to treat arthritis in a toe joint in an Illinois federal court, alleging that the device was defective and that it caused pain and had to be surgically removed.
February 11, 2025
Maine Hospitals Lose Appeal Of Dismissal Of Complaint Against Opioid Defendants

PORTLAND, Maine — The Maine Supreme Judicial Court affirmed the dismissal of a case filed by a group of hospitals in the state that sued various businesses and individuals involved in marketing and distributing prescription opioids for negligence and found no error in the lower court’s refusing to allow the hospitals to amend the complaint.
February 11, 2025
Plaintiffs Push To Move Suboxone MDL Toward Bellwether Case Selection

CLEVELAND — Plaintiffs in the Suboxone film multidistrict litigation submitted a proposed case management order on how to select cases to be worked up and tried as bellwether cases, contending “that a pool of 100 Plaintiffs is more than adequate to achieve statistical significance as to the cohort of Plaintiffs in this MDL” and that the defendants are unnecessarily delaying the process of the litigation.
February 10, 2025
Cases Alleging Depo-Provera Caused Tumors Centralized In Fla.’s Northern District

WASHINGTON, D.C. — The U.S. Judicial Panel on Multidistrict Litigation on Feb. 8 agreed to centralize cases alleging that a long-lasting injectable contraceptive caused women to develop intracranial meningiomas, a type of brain tumor, in the U.S. District Court for the Northern District of Florida.
February 10, 2025
Woman Seeks To Represent Nationwide Class Against Toxic Embryo Solution Maker

NEW HAVEN, Conn. — A woman who alleges that her developing embryos were destroyed by a toxic solution used during fertility-related treatments that was later recalled filed a putative nationwide class action in a Connecticut federal court against the manufacturer of the solution.
February 06, 2025
Federal Judge Cites Royal Canin In Allowing Post-Removal Amendment In Opioid Case

NASHVILLE, Tenn. — A group of plaintiffs representing the interests of babies born addicted to opioids may amend their complaint in an effort to remand the case to state court, a Tennessee federal judge ruled, noting that a recent U.S. Supreme Court decision held that “post-removal amendments removing federal law claims can defeat jurisdiction.”
February 06, 2025
Mass Tort Cases For Drugs, Medical Devices

New developments in the following mass tort drug and device cases are marked in boldface type.
February 05, 2025
Learned-Intermediary Doctrine Dooms Failure To Warn Claim In BioZorb Case

BOSTON — A woman who was selected as a bellwether plaintiff in a group of cases alleging that an implanted radiographic marker used to mark soft tissue sites during cancer treatment was defective and caused injuries was unable to show that her doctor would have acted differently if there was an adequate warning on the device, a Massachusetts federal judge said and granted summary judgment to the device manufacturer on her negligence for failure to warn claim based on the learned-intermediary doctrine.
February 05, 2025
Danco: Intervening States Cannot Pursue Mifepristone Case In Texas Federal Court

AMARILLO, Texas — Danco Laboratories LLC, the maker of Mifeprex brand of mifepristone, told a Texas federal court that “[m]ultiple independent grounds compel dismissal” of an amended complaint filed by Missouri, Kansas and Idaho in a case originated by a group of antiabortion advocates challenging the Food and Drug Administration’s approval of the abortion drug, 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.
February 05, 2025
Drug Manufacturers Move To Dismiss ‘Extraneous’ Claims In GLP-1 MDL

PHILADELPHIA — The manufacturers of diabetes and diet drugs that consumers allege cause gastrointestinal and other injuries moved to dismiss certain claims from a master long-form complaint against the drug manufacturers in the multidistrict litigation that they allege “are extraneous to the core issues in the litigation, inadequately pleaded, or plainly foreclosed.”
February 05, 2025
6th Circuit Vacates $650M Judgment After Ohio High Court Finds OPLA Bars Claims

CINCINNATI — The Sixth Circuit U.S. Court of Appeals vacated a $650 million judgment awarded to two Ohio counties that alleged that Walgreens, CVS and Walmart helped fuel the nationwide opioid epidemic after the Ohio Supreme Court ruled that public nuisance claims are abrogated under the Ohio Product Liability Act (OPLA) in answering a certified question from the appellate court.
February 04, 2025
Federal Judge Awards Some Costs To Mylan In EpiPen Misrepresentation Suit

NEW YORK — A federal judge in New York issued a memorandum and order awarding some costs to drugmaker Mylan N.V. and certain of its current and former executives after previously granting summary judgment to Mylan and against stockholders who filed a class action suit against it alleging that the drugmaker made misrepresentations regarding its classification of the EpiPen and concealed its involvement in an anticompetitive rebate scheme that allowed Mylan to inflate the price of EpiPen.
February 04, 2025
Judge: Man Failed To Show Others Were Harmed By Device Maker’s Misrepresentations

TACOMA, Wash. — A Washington federal judge held that a man failed to adequately satisfy the “public impact” element of his claim under Washington’s Consumer Protection Act (CPA) and granted a motion for summary judgment filed by a medical device maker.
February 03, 2025
Judge Dismisses 2 Cases Against Compounding Pharmacies In Semaglutide Disputes

ORLANDO, Fla. — In a pair of nearly identical orders, a Florida federal judge dismissed two complaints against compounding pharmacies filed by Novo Nordisk Inc., the manufacturer of three FDA-approved medicines for weight management and diabetes that contain semaglutide, finding that its claims are preempted by the Food, Drug and Cosmetic Act (FDCA).
January 31, 2025
Zimmer Removes Man’s Metal-On-Metal Complaint To New York Federal Court

NEW YORK — Zimmer Biomet Holdings Inc. and its affiliates removed to a New York federal court and answered a complaint filed by a man who alleges that he suffered severe and permanent injuries as a result of a defective metal-on-metal hip replacement, contending that a hospital was fraudulently joined.
January 30, 2025
Opioid MDL Judge Finds Tarrant County Has Standing In Case Against Albertsons

CLEVELAND — The Ohio federal judge overseeing the opioid multidistrict litigation denied Albertsons’ motion for summary judgment in the bellwether case filed by Tarrant County, Texas, rejecting arguments that the county lacks standing to bring its public nuisance claims.