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

Mealey's Drugs & Devices

February 27, 2025
Compounding Pharmacies Sue FDA For Removal Of Semaglutide From Drug Shortage List

FORT WORTH, Texas — The U.S. Food and Drug Administration, in “a reckless and arbitrary decision,” removed semaglutide, an FDA-approved drug for diabetes and weight loss, from the agency’s drug shortage list in violation of the Administrative Procedure Act (APA), a drug compounder and an association representing the interests of drug compounders allege in a complaint filed in a Texas federal court.
February 27, 2025
Judge Partially Dismisses Hip Replacement Patient’s Suit Over Defective Implant

SAN FRANCISCO — A California federal judge found that a man’s third amended complaint failed to cure deficiencies in his claims that a defective prosthetic hip replacement released toxic metals into his body, granting the manufacturer’s partial motion to dismiss.
February 27, 2025
Generic Mifepristone Maker Moves To Intervene In States Case Against FDA

AMARILLO, Texas — GenBioPro Inc., the maker of generic mifepristone, one of two drugs used to induce early termination of pregnancy, moved to intervene in a case challenging the U.S. Food and Drug Administration’s approval of the abortion drug, a case that eventually reached the U.S. Supreme Court, which found that the plaintiffs lacked standing and in which the original plaintiffs have now voluntarily dismissed all of their claims but that has been kept alive by a Texas federal judge’s decision to allow intervening states Missouri, Kansas and Idaho to file an amended complaint.
February 27, 2025
Woman, Manufacturers Agree To Dismiss Appeal Of Case Alleging Drug Risk

PHILADELPHIA — A woman who claims that she was misled into purchasing a weight loss medication that was associated with a known cancer risk and the drug manufacturers filed a joint stipulation to dismissal of the woman’s appeal in the Third Circuit U.S. Court of Appeals.
February 26, 2025
Newly Named MDL Judge Selects 5 Pilot Cases For Depo-Provera Litigation

PENSACOLA, Fla.— The Florida federal judge who in early February was appointed to oversee a multidistrict litigation of cases alleging that a long-lasting injectable contraceptive caused women to develop intracranial meningiomas, a type of brain tumor, said in a case management order that she has selected five pilot cases “to proceed through discovery and trial.”
February 26, 2025
Cook County, Ill., Jury Returns Defense Verdict In Zantac Injury Retrials

CHICAGO — A Cook County Circuit Court jury returned a verdict for Boehringer Ingelheim Pharmaceuticals Inc. in a retrial for two men who alleged that their prostate cancer was caused by ingesting over-the-counter Zantac.
February 26, 2025
Couple, Manufacturer Agree To End Case Over Loss Of Embryos During IVF Procedure

CHARLOTTE, N.C. — A manufacturer of sterile mineral oil and a couple who allege that the solution was toxic and led to the destruction of their embryos filed a joint stipulation to the dismissal of the case with prejudice in a North Carolina federal court.
February 25, 2025
FDA: Preliminary Injunction Not Needed In GLP-1 Compounding Pharmacies’ Suit

FORT WORTH, Texas — The U.S. Food and Drug Administration opposed a motion for a preliminary injunction filed 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, arguing that the companies are unlikely to succeed in its suit against the agency.
February 25, 2025
9th Circuit Finds No Error In Convictions, Sentencing Of Theranos’ Holmes, Balwani

SAN FRANCISCO — The Ninth Circuit U.S. Court of Appeals on Feb. 24 affirmed the convictions, sentences and restitution orders against Theranos Inc. founder Elizabeth Holmes and former Theranos Chief Operating Officer Ramesh “Sunny” Balwani, finding no error in multiple decisions by the trial court that the pair raised as arguments on appeal.
February 20, 2025
Singapore Court Freezes Bioscience Company’s Assets Pending $830M Arbitration

SINGAPORE — A judge of the Singapore International Commercial Court granted an ex parte application by a Danish company brought against a Singaporean bioscience company and its founder for a worldwide asset freeze pending arbitration in New York regarding an $830 million dispute over a drug for hypertension and kidney disease.
February 20, 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 20, 2025
Company, Owner Agree To $1M Fine For Selling Altered Products Purchased Overseas

CHICAGO — An Illinois medical device company and its owner will pay a $1 million fine to end a federal criminal investigation into allegations that the company purchased products overseas and concealed that information when reselling the products (United States v. Advanced Inventory Management, Inc., et al., No. 25-18, N.D. Ill.).
February 19, 2025
1st Circuit Affirms Ruling In DOJ ‘First Impression’ FCA Suit Against Regeneron

BOSTON — The First Circuit U.S. Court of Appeals on Feb. 18 affirmed a lower court ruling granting summary judgment to Regeneron Pharmaceuticals in a U.S. Department of Justice (DOJ) suit alleging violations of the federal False Claims Act (FCA) and the Anti-Kickback Statute (AKS) regarding purported improper funding of the Chronic Disease Fund (CDF) to subsidize patient copays for a Regeneron macular degeneration drug, finding that in this case of “first impression” regarding a 2010 amendment to the AKS, to show falsity under the amendment, the government must prove “that an illicit kickback was the but-for cause of a submitted claim.”
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.