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

Mealey's Drugs & Devices

April 30, 2025
Judge Denies Stay Of Semaglutide’s Removal From FDA’s Drug Shortage List

FORT WORTH, Texas — A Texas federal judge on April 29 set a briefing schedule for 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 after the judge denied a motion for a preliminary injunction and a stay filed by a drug compounder and an association representing the interests of drug compounders.
April 30, 2025
Opioid MDL Judge Won’t Recuse Over Ex Parte Communication Allegations

CLEVELAND — The Ohio federal judge overseeing the opioid multidistrict litigation on April 29 refused to recuse himself from the case, denying a request by pharmacy benefit managers (PBMs) that argued that recusal was necessary because of reports that an attorney regularly communicates ex parte with the court to get “inside information.”
April 29, 2025
Generic Mifepristone Maker Allowed To Intervene In States Case Against FDA

AMARILLO, Texas — A Texas federal judge on April 28 granted a motion by GenBioPro Inc., the maker of generic mifepristone, one of two drugs used to induce early termination of pregnancy, to intervene in a case challenging the U.S. Food and Drug Administration’s approval of the abortion drug, finding that an amended complaint by intervening states Missouri, Kansas and Idaho directly challenges the generic approval.
April 29, 2025
Walgreens Opposes Consolidation Of ‘Non-Drowsy’ OTC Medication Labeling Cases

CHICAGO — Walgreens Boots Alliance Inc. and Walgreen Co. (collectively, Walgreens) oppose consolidating two pending cases in Illinois federal court alleging that Walgreens’ generic antitussives are mislabeled because they contain the phrase “non-drowsy” when dextromethorphan hydrobromide (DXM), the active ingredient in the antitussives, can make users drowsy.
April 29, 2025
Judge Says Some OPLA Claims Fail But Allows Case Against Device Maker To Proceed

CLEVELAND — A woman who sued the manufacturer of an endotracheal tube (ETT) alleging that the device failed and caused a man’s death failed to adequately plead to certain claims for violation of Ohio product liability statutes, a federal judge in Ohio found, but the judge allowed the manufacturing defect and defective device clams to move forward.
April 29, 2025
Magistrate: Relator Must Provide All Alleged False Claims In FCA Kickback Suit

SAN DIEGO — A California federal magistrate judge granted Abbott Laboratories’ motion to compel discovery into all the alleged false claims it purportedly submitted to the government in a suit alleging Abbott violated the False Claims Act (FCA) and state false claim laws regarding Abbott’s purported kickback scheme to induce hospitals and physicians to use an Abbott cardiac medical device, finding that Abbott is “entitled to know the specific false claims” against it.
April 28, 2025
Judge Dismisses Defective Implant Case, Finds Amended Complaint Still Fails

TOLEDO, Ohio — An Ohio federal judge agreed to dismiss an amended complaint alleging that a woman suffered injuries due to a defective spinal implant after finding that there were no substantial changes made to the amended complaint after the judge dismissed the original with leave to amend.
April 28, 2025
Weight Loss Center Settles False Advertising,Trademark Claims With Ozempic Maker

ATLANTA — A weight loss center in Georgia that sells and promotes compounded drug products that purport to contain semaglutide has reached a confidential settlement agreement with the manufacturer of Ozempic, Wegovy and Rybelsus, according to an April 25 joint notice filed in a Georgia federal court.
April 25, 2025
Suboxone MDL Judge Names Cases For Bellwether Discovery

CLEVELAND — The judge overseeing the Suboxone film multidistrict litigation has identified the 500 cases that were randomly selected for case-specific discovery.
April 24, 2025
Lilly Sues 4 Telehealth Companies For Selling Compounded Weight Loss Drugs

SAN FRANCISCO — Eli Lilly and Co. on April 23 sued four telehealth companies in a federal court alleging that they violated California’s unfair competition and false advertising laws by selling “knockoff compounded tirzepatide drugs,” FDA-approved drugs for diabetes and weight loss.
April 24, 2025
Drug Makers Move To Dismiss Complaint Saying Sickle Cell Medication Caused Stroke

SAN FRANCISCO — Global Blood Therapeutics Inc. (GBT) and Pfizer Inc. tell a California federal court in an April 23 motion that an amended 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 should be dismissed for failure to state a claim.
April 23, 2025
Woman Claims Ozempic Caused Permanent Vision Loss In New Jersey Federal Complaint

NEWARK, N.J. — A woman’s use of Ozempic led to an irreversible condition that caused sudden and permanent vision loss, she alleges in a complaint filed in a New Jersey federal court against the manufacturer of the diabetes and diet drug.
April 23, 2025
9th Circuit Reverses Summary Judgment Award In IVC Design Defect Case

PASADENA, Calif. — A California federal court erred in granting summary judgment to an inferior vena cava (IVC) filter manufacturer and seller, the Ninth Circuit U.S. Court of Appeals held, because whether a man had notice that the filter was defectively designed is a genuine dispute of material fact.
April 23, 2025
Woman Says Contaminated Sterile Solution Caused Infection During Wound Care

NASHVILLE, Tenn. — A woman alleges in a complaint filed in a Tennessee federal court that she suffered injuries stemming from an infection that was caused by contaminated sterile saline and water solutions used for medical irrigation.
April 22, 2025
United States, Walgreens Settle Suit Involving Alleged Invalid Opioid Prescriptions

CHICAGO — An Illinois federal judge on April 21 dismissed with prejudice claims against Walgreens Boots Alliance Inc., Walgreen Co., and various subsidiaries (collectively, Walgreens) after the United States announced that Walgreens has agreed to pay $300 million to resolve claims that the pharmacy chains violated federal law by filling millions of invalid controlled-substance prescriptions and seeking payment through Medicare and other federal health care programs.
April 22, 2025
Novo Nordisk, Pharmacy Reach Agreement In Suit Over Compounded Semaglutide Drugs

HOUSTON — Novo Nordisk Inc. and a compounding pharmacy accused of selling unlicensed compounded drugs that contain semaglutide have reached a settlement agreement in Texas federal court under which the pharmacy is permanently barred from selling the compounded drugs.
April 17, 2025
PBMs Lose Bid To Dismiss County’s Suit Against Them For Role In Opioid Crisis

SEATTLE — A Washington federal judge rejected arguments from two pharmacy benefits managers (PBMs) that a county in the state failed to state a claim in its suit alleging that the PBMs helped create and perpetuate the opioid epidemic and denied a motion to dismiss.
April 17, 2025
Mass Tort Cases For Drugs, Medical Devices

New developments in the following mass tort drug and device cases are marked in boldface type.
April 16, 2025
Philips Objects To Special Master’s Report That Says Summary Judgment Motion Fails

PITTSBURGH —The manufacturer of recalled continuous positive air pressure (CPAP) sleep apnea devices and respirators facing a false claims lawsuit filed by SoClean Inc., which makes equipment that uses ozone to clean and disinfect CPAP devices, objected to a special master’s recommendation that its motion for summary judgment be denied, arguing that “black-letter federal law” dictates that SoClean lacks standing because it never had preapproval from the U.S. Food and Drug Administration to sell those products.
April 15, 2025
Gardasil Bellwether Plaintiffs Appeal Multiple Adverse Rulings To 4th Circuit

RICHMOND, Va. — The bellwether plaintiffs in the Gardasil multidistrict litigation have appealed to the Fourth Circuit U.S. Court of Appeals a series of rulings that led to the North Carolina federal judge overseeing the MDL entering final judgment against the plaintiffs.
April 14, 2025
Theranos’ Holmes Says 9th Circuit En Banc Review, Rehearing Needed

SAN FRANCISCO — Theranos Inc. founder and CEO Elizabeth Holmes argues that the Ninth Circuit U.S. Court of Appeals erred in affirming her conviction, sentence and restitution order and the “panel’s flawed opinion calls out for en banc review.”
April 14, 2025
Organizations Tell High Court It Must Review Preemption Ruling In Fosamax Case

WASHINGTON, D.C. — Three amicus curiae briefs were filed April 11 in support of the U.S. Supreme Court granting a petition for certiorari to correct an alleged erroneous application of preemption law by the Third Circuit U.S. Court of Appeals when it reversed a district court’s decision that awarded a drug manufacturer summary judgment in 1,046 cases in the long-running Fosamax femur fracture multidistrict litigation.
April 14, 2025
Insured Appeals No Coverage Ruling In Dispute Arising From Opioid Epidemic

TAMPA, Fla. — An insured told Florida federal court that it is asking the 11th Circuit U.S. Court of Appeals to review the court’s judgment in favor of insurers in its lawsuit seeking coverage for underlying actions arising from the opioid epidemic, challenging the court’s finding that the insurers have no duty to defend or indemnify because the opioid lawsuits fail to allege damages “for bodily injury” or “because of bodily injury.”
April 11, 2025
3rd Circuit Affirms Dismissal Of FCA Suit Over ‘Hiding’ Antibiotics’ Side Effects

PHILADELPHIA — The Third Circuit U.S. Court of Appeals on April 10 affirmed a lower court’s dismissal of a qui tam relator’s suit against Bayer Corp., Johnson & Johnson, Merck & Co. and other pharmaceutical companies, alleging that “hiding” side effects of their antibiotics from the U.S. Food and Drug Administration “caused fraudulent claims to be submitted to Medicaid and Medicare,” finding that the relator failed to satisfy the essential elements of a False Claims Act (FCA) violation.
April 11, 2025
Judge Says Man’s Defective Hip Implant Case Time-Barred Under New York Law

ROCHESTER, N.Y. — A man’s claims that his hip implant fractured and caused injuries are time-barred, a New York federal judge ruled April 10, granting the manufacturers’ motion for summary judgment.