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Mealey's Drugs & Devices

March 13, 2025
FTC, Nasal Spray Maker Stipulate To Dismissal In COVID Prevention Claims Case

SALT LAKE CITY — The Federal Trade Commission and a company that claims to make a nasal spray that provides protection against and treatment for COVID-19 filed a joint stipulation of dismissal with prejudice that states that each party is responsible for its own costs and that no party is responsible to any other party for fines, cost or penalties arising from the case.
March 12, 2025
‘Paucity Of Evidence’ Linking Disorders To Gardasil Vaccine Bars Preemption Defense

STATESVILLE, N.C. — The manufacturer of the Gardasil vaccine could not unilaterally add warnings to the vaccine’s label, the North Carolina federal judge overseeing the Gardasil multidistrict litigation ruled, finding that the bellwether plaintiffs’ sole remaining claim is preempted by federal law.
March 12, 2025
Pharmaceutical Company To Settle Claims In National Opiate MDL; Terms Undisclosed

CLEVELAND — Zydus Pharmaceuticals (USA) Inc. and Nesher Pharmaceuticals (USA) LLC (collectively, Zydus) agreed to settle claims against them in the nationwide opioid multidistrict litigation brought by various states, subdivisions and Native American tribes, according to two orders to establish confidential qualified settlement funds signed by the Ohio federal judge overseeing the MDL on March 11.
March 12, 2025
GLP-1 Compounding Pharmacies Appeal Ruling That Denied Stay In Suit Against FDA

FORT WORTH, Texas — Companies representing the interests of drug compounders appealed to the Fifth Circuit U.S. Court of Appeals a Texas federal judge’s ruling that denied a preliminary injunction and stay on the U.S. Food and Drug Administration’s decision to remove an FDA-approved drug for diabetes and weight loss from the agency’s drug shortage list.
March 11, 2025
Magellan CEO Pleads Guilty In Connection To Malfunctioning Blood Lead Test Kits

BOSTON — The former chief executive officer of Massachusetts medical device company Magellan Diagnostics Inc. on March 10 pleaded guilty in a Massachusetts federal court to one count of introducing misbranded medical devices into interstate commerce following two other plea deals reached with other Magellan executives who were accused of concealing that blood lead testing devices malfunctioned and produced inaccurately low lead levels.
March 11, 2025
Depo-Provera MDL Judge Schedules Hearings To Select Counsel For Leadership Roles

PENSACOLA, Fla. — The 75 attorneys seeking a leadership position in the multidistrict litigation for cases alleging that a long-lasting injectable contraceptive caused women to develop intracranial meningiomas, a type of brain tumor, should be prepared to offer oral arguments at a Florida federal court on March 13 and 14, the federal judge overseeing the MDL said in a pretrial order.
March 11, 2025
Judge Allows Case Alleging Violations Of Diet Drugs’ Trademarks To Move Forward

SEATTLE — A Washington federal judge agreed that state law claims filed against medical centers and two physicians who prescribe patients compounded versions of tirzepatide, an FDA-approved drug for diabetes and weight loss, are preempted by federal law but otherwise denied a motion to dismiss.
March 10, 2025
GLP-1 Compounding Pharmacies Lose Bid To Stay Removal Of Drug From Shortage List

FORT WORTH, Texas — A Texas federal judge refused to grant a preliminary injunction and stay on the U.S. Food and Drug Administration’s decision to remove an FDA-approved drug for diabetes and weight loss from the agency’s drug shortage list, finding in an order unsealed March 7 that companies representing the interests of drug compounders failed to show a likelihood of “success on the merits of their claims, which is the most important (and usually decisive) factor.”
March 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.
March 06, 2025
CooperSurgical: Consolidated Destroyed Embryo Cases Require Separate Trials

WATERBURY, Conn. — The manufacturer of a solution used during fertility-related treatments that women allege was toxic and destroyed developing embryos agrees that cases filed in a Connecticut state court should be transferred to the state’s complex litigation docket for pretrial purposes but argues that the cases should remain separate for trial.
March 06, 2025
N.Y. Appeals Court: Device Maker Not Liable For Burns Caused By Ice On Bare Skin

NEW YORK — Because ice packs were not necessary for a medical device to function and because the manufacturer’s duty to warn extended to the provider and not the patient, a New York state court erred in denying the manufacturer’s motion for summary judgment, a state appeals court held, reversing and ordering the complaint dismissed.
March 05, 2025
Woman’s Claims Alleging Tubal Ligation Clip Injuries Are Preempted By Federal Law

KANSAS CITY, Mo. — Claims filed by a woman who alleges that she was injured by a migrated tubal ligation clip are preempted by federal law, a Missouri federal judge ruled March 4, awarding summary judgment to four defendants named in the suit.
March 05, 2025
Final Approval Of $40M Settlement Granted In Securities Fraud Class Action

BALTIMORE — A federal judge in Maryland granted final approval of a $40 million settlement in a securities fraud class action brought by investors against a COVID-19 vaccine contractor that experienced contamination issues at its Bayview, Md., manufacturing facility and several of its executives.
March 04, 2025
5th Circuit Affirms Dismissal Of Taxotere Case For Late Serving Of Complaint

NEW ORLEANS — The Fifth Circuit U.S. Court of Appeals affirmed the dismissal of a case involving a woman who took nearly five years before serving a complaint on the manufacturer of a chemotherapy drug that she alleges caused her permanent hair loss.
March 04, 2025
Md. Federal Judge Rejects Challenge To State Statute In Case Involving HeLa Cells

BALTIMORE — A Maryland statute requiring a foreign corporation that does intrastate business in Maryland to register with the state or otherwise forfeit its ability to assert a statute of limitations defense is constitutional, a Maryland federal judge held March 3, rejecting a pharmaceutical company’s motion for judgment on the pleadings in a case filed by the family of Henrietta Lacks, a Black woman whose medical tissue was taken without her consent in 1951 to create the first immortalized human cell line that has been used in various medical developments.
March 03, 2025
Putative Class Action Filed In Colorado Federal Court For Contaminated Eye Drops

DENVER — A woman who alleges that she purchased over-the-counter eye drops that were later recalled after the company discovered that certain products were contaminated with fungus sued the manufacturer in a Colorado federal court, seeking to represent a class of consumers.
March 03, 2025
Companies Move To Dismiss Case Alleging Medication Caused Stroke, Injuries

SAN FRANCISCO — An April hearing will be held in a California federal court to consider a motion filed by two drug manufacturers to dismiss a complaint alleging that Oxbryta (voxelotor), a prescription medication used for the treatment of sickle cell disease (SCD), caused a man to experience an increased rate of vaso-occlusive crises (VOCs) and to suffer a stroke.
February 28, 2025
Woman’s Claims On Defective Birth Control Device Fail On Preemption Grounds

COLUMBUS, Ohio — An Ohio federal judge granted summary judgment to the manufacturer, distributor and parent company of birth control device that a woman claimed detached and migrated through her body after finding that her remaining claim is preempted by federal law.
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.