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

Mealey's Drugs & Devices

November 20, 2023
1st Circuit Certifies Appeal In FCA Suit Against Teva Alleging Co-Pay Kickbacks

BOSTON — The First Circuit U.S. Court of Appeals on Nov. 17 granted a petition to appeal filed by Teva Pharmaceuticals USA Inc. and Teva Neuroscience Inc., asserting that appeal should be granted due to a “substantial ground for difference of opinion” regarding causation under the Anti-Kickback Statute (AKS) as applied to a district court’s partial summary judgment ruling for the government in its suit alleging that they violated the False Claims Act (FCA) and AKS by using co-pay subsidies as kickbacks when selling a multiple sclerosis (MS) drug.
November 20, 2023
Woman Says Arguments For Dismissal Of Diabetic Drug Complaint Are Premature

LAKE CHARLES, La. — A Louisiana federal court should reject calls by the manufacturer of Ozempic to dismiss a complaint alleging that it failed to warn of risks associated with the diabetes drug, a woman argues, contending that its arguments are without merit and premature.
November 20, 2023
Texas Federal Judge Agrees To Hear Motion To Intervene In Abortion Drug Case

AMARILLO, Texas — There is no need to wait until the U.S. Supreme Court weighs in on a pending petition for a writ of certiorari in a case involving the abortion drug mifepristone before deciding if three states can intervene in a district court proceeding, a federal judge in Texas ruled, rejecting a motion by the U.S. Food and Drug Administration to hold the motion in abeyance and ordering the FDA to respond to the request to intervene within 30 days.
November 20, 2023
Arizona Company Ordered To Stop Selling Unapproved Contraceptive Cream

PHOENIX — A federal Arizona judge entered a consent decree and permanent injunction barring a company from selling a cream that it markets as a vaginal contraceptive in violation of the Federal Food, Drug and Cosmetic Act (FDCA).
November 17, 2023
High Court Asked To Resolve Dispute Of Right To Appeal Partially Dismissed Case

WASHINGTON, D.C. — The U.S. Supreme Court granted a motion to extend time for a manufacturer and seller of Zantac to respond to a petition for a writ of certiorari appealing the dismissal of her case and asking the high court to settle a jurisdictional question that has split the circuit courts.
November 16, 2023
Mass Tort Cases For Drugs, Medical Devices

New developments in the following mass tort drug and device cases are marked in boldface type.
November 16, 2023
Don’t Delay Decision On Intervening In Abortion Drug Case, States Tell Court

AMARILLO, Texas — Danco Laboratories LLC, the manufacturer of Mifeprex brand mifepristone, on Nov. 15 concurred with the U.S. Food and Drug Administration’s position that a Texas federal court should hold in abeyance a motion by three states to intervene in a lawsuit pending resolution of a petition for a writ of certiorari in the U.S. Supreme Court, but the states argue that the delay is unwarranted.
November 16, 2023
Judge Allows Expert Testimony But Pares Claims In Hip Implant Injury Case

COEUR D’ALENE, Idaho — An Idaho federal judge will allow an expert retained by a woman suing for an allegedly defective hip implant to testify but partially granted the manufacturers’ motion for summary judgment.
November 16, 2023
Mifepristone Maker Will Appeal Challenge Of West Virginia Abortion Law

HUNTINGTON, W.Va. — GenBioPro Inc. filed notice that it intends to appeal to the Fourth Circuit U.S. Court of Appeals a decision by a lower court that dismissed the abortion drug manufacturer’s claims arguing that a West Virginia law curtailing the use of the drug violated the U.S. Constitution.
November 15, 2023
Woman Agrees To Dismiss Deceptive Cold Medicine Packaging Case

CHICAGO — A woman suing Procter & Gamble Co. for allegedly deceiving its customers by packaging its cold medicine with a vitamin C supplement filed a notice of voluntary dismissal of her case in an Illinois federal court, days after a federal judge granted the manufacturer’s motion to dismiss.
November 15, 2023
States Urge High Court To Review Legislative History In Case On Abortion Drugs

WASHINGTON, D.C. — A group of states led by Mississippi filed an amicus curiae brief supporting the conditional cross-petition for a writ of certiorari filed by a group of anti-abortion advocates, urging the U.S. Supreme Court to review the U.S. Food and Drug Administration’s 2000 approval of mifepristone, but the FDA and the manufacturer of the drug argue that the petition fails to meet the high court’s traditional certiorari standards and should be denied.
November 15, 2023
6th Circuit Won’t Disqualify Opioid MDL Special Master For Reply-All Email Error

CINCINNATI — A federal judge overseeing the opioid multidistrict litigation did not abuse his discretion in refusing to disqualify the special master, who is accused of bias after he inadvertently sent a personal email to the parties, the Sixth Circuit U.S. Court of Appeals held Nov. 14, denying a petition for a writ of mandamus filed by two pharmacy benefit managers (PBMs).
November 13, 2023
FDA Asks District Court To Hold Motion To Intervene Pending High Court Decision

AMARILLO, Texas — The U.S. Food and Drug Administration urged a Texas district court to hold in abeyance a motion filed by three states to intervene in a lawsuit challenging the FDA’s approval of mifepristone and misoprostol pending resolution of its petition for writ of certiorari pending in the U.S. Supreme Court.
November 13, 2023
Irish Court OKs Arrangement With Mallinckrodt, Creditors In Reorganization Plan

DUBLIN, Ireland — The High Court of Ireland on Nov. 10 confirmed a proposed scheme of arrangement between drugmaker Mallinckrodt PLC and its creditors and shareholders, ordering that the scheme will become effective on the same date the company’s plan of reorganization pending in U.S. Bankruptcy Court for the District of Delaware becomes effective and that the company will no longer be under the protection of the Irish High Court.
November 10, 2023
$500,000 Verdict Returned For Bellwether Plaintiff In Hernia Mesh Case

COLUMBUS, Ohio — A jury in an Ohio federal court has awarded $500,000 to a man who alleges that he suffered permanent injuries and significant pain and suffering when the hernia mesh used during surgery failed.
November 09, 2023
Ankle Monitoring Device Maker Moves To Dismiss Claims Alleging Injuries To Skin

DENVER — The manufacturer of an ankle monitoring device moved to dismiss a putative class complaint alleging that the device caused skin injuries, arguing that the laws of the state in which the arrest occurred should apply and that the plaintiff fails to state a claim.
November 09, 2023
Ex-DePuy Consultant Out As Plaintiffs’ Expert, D.C. Federal Judge Says

WASHINGTON, D.C. — A federal judge in the District of Columbia joined other district courts in finding that an expert retained by a plaintiff in a defective “metal-on-metal” (MoM) hip replacement device case cannot testify because he previously served as a consultant for the device manufacturer.
November 09, 2023
Fla. Federal Judge: Claims Of Unapproved Compounded Drugs Preempted By FDCA

TAMPA, Fla. — A pharmaceutical company accused of selling unapproved compounded drugs containing semaglutide won its bid to dismiss the complaint, with a Florida federal judge finding Nov. 8 that Novo Nordisk Inc.’s claims against the company are preempted by federal law and that Novo Nordisk failed to state a claim under the Florida Deceptive and Unfair Trade Practices Act (FDUTPA).
November 08, 2023
Judge Allows Case Against AmerisourceBergen For Lax Opioid Monitoring To Continue

PHILADELPHIA — A Pennsylvania federal judge largely denied a motion to dismiss filed by drug distributor AmerisourceBergen Corp. and related entities facing allegations that they violated the Controlled Substances Act (CSA) by failing to monitor and control suspicious orders of opioids by pharmacies.
November 07, 2023
Man Alleging Injury Through CoolSculpting Appeals To U.S. Supreme Court

WASHINGTON, D.C. — CoolSculpting manufacturer Zeltiq Aesthetics Inc. on Nov. 6 waived its right to file a response to a petition for a writ of certiorari filed by a man who argues that an appellate court erred in granting the company summary judgment after finding that he was warned about the risk of paradoxical adipose hyperplasia (PAH) and that his claim fails under the risk-utility or consumer expectations tests.
November 07, 2023
Anti-Abortion States Move To Intervene In Texas Suit Opposing FDA Changes

AMARILLO, Texas — Missouri, Kansas and Idaho moved to intervene in a lawsuit challenging the U.S. Food and Drug Administration’s approval of mifepristone and misoprostol, arguing that the current plaintiffs cannot adequately represent the states’ interest and that “there is a serious risk of judicial inefficiency if not all interests are presented at once.”
November 06, 2023
Opioid Distributor Agrees To $12M Consent Decree For Improper Monitoring

SAN JUAN, Puerto Rico — The U.S. Department of Justice on Nov. 6 announced that one of Puerto Rico’s largest distributors of pharmaceutical drugs has entered into a consent decree to pay $12 million to settle allegations that it failed to report suspicious orders for opioids and other controlled substances.
November 06, 2023
Diabetes Drug Manufacturer Moves To Dismiss Suit In Louisiana Federal Court

LAKE CHARLES, La. — The manufacturer of Ozempic on Nov. 3 asked a Louisiana federal court to dismiss claims against it alleging that it failed to warn of risks associated with the diabetes drug.
November 06, 2023
High Court OKs Motion For Divided Argument In Purdue Bankruptcy Plan Dispute

WASHINGTON, D.C. — The U.S. Supreme Court on Nov. 6 approved a motion for divided argument filed by Purdue Pharma LP and the creditors that are part of the multibillion-dollar opioid bankruptcy settlement that included a liability release for members of the formerly controlling Sackler family.
November 02, 2023
Mass Tort Cases For Drugs, Medical Devices

New developments in the following mass tort drug and device cases are marked in boldface type.