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

Mealey's Drugs & Devices

October 17, 2024
FiberCel Maker Wins Bid To Dismiss Breach Of Warranty Claims In Injury Case

CINCINNATI — An Ohio federal judge granted a manufacturer’s partial motion to dismiss, finding that certain claims asserted by a man who says he suffered postsurgical complications due to a medical product that was contaminated with tuberculosis are barred under the state’s blood and tissue shield statute.
October 17, 2024
High Court Denies Petition Filed By Executives Convicted Of Off-Label Marketing

WASHINGTON, D.C. — Two former Acclarent Inc. executives convicted of distributing and misbranding medical devices sold in interstate commerce lost their bid for a U.S. Supreme Court review of their convictions when the court on Oct. 7 denied their petition to review whether the U.S. Food and Drug Administration’s “intended use” regulations violated their constitutional rights.
October 17, 2024
Novartis To Appeal FDA’s Summary Judgment Award In Generic Drug Approval Case

WASHINGTON, D.C. — Novartis Pharmaceuticals Corp. filed notice that it intends to appeal a decision by a District of Columbia district court judge to deny its motion for summary judgment and find that the U.S. Food and Drug Administration did not violate federal law in approving a generic version of its heart failure drug Entresto.
October 16, 2024
Magistrate Finds Some Motions To Compel Documents Need Revising In Exactech MDL

BROOKLYN, N.Y. — A New York federal magistrate judge granted in part and denied in part motions to compel the production of documents filed by plaintiffs in the Exactech orthopedic device multidistrict litigation, finding that while some of the documents are relevant to the proceedings, other requests are overbroad and too burdensome.
October 16, 2024
States Opposing Mifepristone Restrictions Tell Court To Send Case To FDA

YAKIMA, Wash. — Washington and other states that sued the U.S. Food and Drug Administration over the agency’s decision to add Risk Evaluation and Mitigation Strategy (REMS) restriction on mifepristone, one of the two drugs prescribed for medication abortions, say summary judgment is warranted now that the case has restarted after being placed on hold awaiting the U.S. Supreme Court’s decision in a related mifepristone case.
October 16, 2024
Pa. Federal Judge Agrees To Trim Counterclaims Filed Against CPAP Equipment Maker

PITTSBURGH — A federal judge in Pennsylvania partially adopted a magistrate judge’s recommendation to deny a motion filed by SoClean Inc., a manufacturer of equipment that uses ozone to clean and disinfect continuous positive air pressure (CPAP) sleep apnea devices and respirators, to dismiss counterclaims filed by Koninklijke Philips N.V., Philips North America LLC and Philips RS North America LLC (collectively, Philips) but agreed to dismiss the Lanham Act trademark dilution counterclaim and found another claim time-barred.
October 16, 2024
Taxotere MDL Judge Won’t Reconsider Lone Pine Order Requiring Proof Of Diagnosis

NEW ORLEANS — The federal judge overseeing the Taxotere hair loss multidistrict litigation refused to reconsider her Lone Pine order requiring that plaintiffs, including representatives of plaintiffs who have died, show proof of a diagnosis of permanent chemotherapy-induced alopecia (PCIA).
October 16, 2024
Over-The-Counter Pill Labeled Maximum Strength Was Not, Man Alleges In Complaint

NEW YORK — A New York man filed a complaint in New York federal court seeking to represent a class action of consumers who purchased Target Corp.-branded gas relief pills and were led to believe that the product was “maximum strength” when in fact stronger products are on the market.
October 15, 2024
NECC Pharmacist Sentenced In Michigan State Court In Involuntary Manslaughter Case

HOWELL, Mich. — Former New England Compounding Center (NECC) chief pharmacist Glenn A. Chin has been sentenced to 7-1/2 to 15 years in prison after pleading no contest in a Michigan state court to 11 counts of involuntary manslaughter in connection with a 2012 fungal meningitis outbreak traced to a contaminated drug compounded by the company.
October 15, 2024
Sackler Family To Bankruptcy Court: Liability In Opioid Cases ‘Cannot Be Assumed’

NEW YORK — The Raymond Sackler family says in a statement filed Oct. 14 in a New York federal bankruptcy court that it takes no position on the Official Committee of Unsecured Creditors (UCC) motion for standing to pursue estate claims because it argues that the proposed claims “are utterly meritless regardless of who brings them,” citing rulings from various courts that found that state public nuisance laws don’t apply to the manufacturing of opioids.
October 15, 2024
Walgreens To Pay $80M In Settlement With Baltimore For Role In Opioid Crisis

BALTIMORE — Walgreens has agreed to an $80 million settlement to resolve Baltimore’s claims against the company for its role in fueling the opioid epidemic in the city, according to a press release from the city and Mayor Brandon M. Scott, bringing the total amount of recoveries for the city from opioid defendants to $402.5 million.
October 11, 2024
Doctor, North Carolina A.G. Say All Restrictions On Mifepristone Are Preempted

RICHMOND, Va. — A doctor who sued North Carolina over its laws regulating mifepristone, one of the two drugs prescribed for medication abortions, and the state’s attorney general, who did not object to the doctor’s arguments, on Oct. 10 filed separate opening briefs in the Fourth Circuit U.S. Court of Appeals, urging the appellate court to not only affirm that a district court was correct in holding that certain restrictions on mifepristone are preempted by federal law but also to expand the ruling and find that the restrictions that were upheld are also preempted.
October 10, 2024
GSK To Pay $$2.2 Billion To Settle Majority Of Zantac Cases In United States

LONDON — GSK PLC announced Oct. 9 that it has reached settlement agreements to end approximately 80,000 Zantac (ranitidine) state court product liability cases pending against the pharmaceutical company in the United States.
October 10, 2024
Janssen, Bayer Say It Is Time To End Fluoroquinolone MDL

MINNEAPOLIS — The Janssen and Bayer defendants named in the fluoroquinolone multidistrict litigation asked the court to terminate the MDL, arguing that the MDL “has fulfilled its original purpose and that maintaining the MDL no longer promotes the just and efficient conduct of litigation.”
October 10, 2024
Alabama Federal Judge Grants Summary Judgment To Birth Control Device Companies

MONTGOMERY, Ala. — An Alabama federal judge granted two motions for summary judgment filed by the manufacturer, distributor and parent company of an allegedly defective birth control device after finding that a couple’s claims are barred by the state’s statute of limitations and preempted by federal law.
October 09, 2024
FDA: District Court Should Dismiss Mifepristone Case; Intervening States Say No

AMARILLO, Texas — Parties in a lawsuit challenging the U.S. Food and Drug Administration’s approval of abortion drug mifepristone offered the district court varying opinions on how to proceed in light of the U.S. Supreme Court’s finding that a group of anti-abortion advocates lacked standing in its challenge to the approval because they had no injury.
October 07, 2024
JPMDL Won’t Centralize Cases Stemming From Alleged Toxic Embryo Solution

WASHINGTON, D.C. — The U.S. Judicial Panel on Multidistrict Litigation on Oct. 4 denied a motion to centralize cases filed by couples who sued a manufacturer of a solution used during fertility-related treatments that they claim was toxic and destroyed their developing embryos.
October 07, 2024
JPMDL Centralizes Defective Port Cases In California’s Southern District

WASHINGTON, D.C. — The U.S. Judicial Panel on Multidistrict Litigation agreed to centralize cases alleging that chemotherapy ports were defective and caused a multitude of injuries, assigning the litigation to U.S. Judge Jinsook Ohta of the Southern District of California.
October 07, 2024
U.S. Supreme Court Denies Cert In FCA, Anti-Kickback Violations Row

WASHINGTON, D.C. — The U.S. Supreme Court on Oct. 7 denied certiorari of a qui tam relator’s petition seeking review of a Second Circuit U.S. Court of Appeals ruling affirming a district court’s dismissal of federal False Claims Act (FCA) suit alleging violations of the Anti-Kickback Statute (AKS), where the relator argued for review to resolve the split between circuit courts regarding whether knowledge that a party’s conduct violates the law is required to show willfulness pursuant to the AKS.
October 07, 2024
U.S. Supreme Court Denies Certiorari In FCA Public Disclosure Bar Dispute

WASHINGTON, D.C. — The U.S. Supreme Court on Oct. 7 denied a petition for certiorari filed by pharmaceutical companies seeking review of the Ninth Circuit U.S. Court of Appeals’ ruling that the public disclosure bar was not triggered in a case where it reversed a district court’s dismissal of a suit accusing the companies of violating the False Claims Act (FCA) by artificially inflating drug prices.
October 02, 2024
Mass Tort Cases For Drugs, Medical Devices

New developments in the following mass tort drug and device cases are marked in boldface type.
October 02, 2024
Federal Judge Allows Nondrowsy Label Dispute To Move Forward But Limits Claims

CHICAGO — An Illinois federal judge ruled that a woman “overslept on her rights” to pursue breach of warranty claims against the maker of a nondrowsy cold medicine but also found that her claims are not preempted by federal law and that she can, for the time being, represent a nationwide class of purchasers.
October 02, 2024
Pa. Federal Judge Adopts Dismissal Recommendations In Surgical Mesh Injury Case

SCRANTON, Pa. — A federal judge in Pennsylvania has adopted a magistrate judge’s report and recommendation and partially granted a motion to dismiss filed by a surgical mesh manufacturer and its distributor facing claims that a man was injured after the product was used during surgery.
October 02, 2024
Stem Cell Company Owner Sentenced For Violating FDCA In Marketing, Sale Of Product

LOS ANGELES — The founder and CEO of a company that manufactured and distributed injectable stem cell products made from human umbilical cord blood was sentenced in a California federal court to 36 months in prison after he pleaded guilty to violating the federal Food, Drug and Cosmetic Act (FDCA).
October 02, 2024
Manufacturer Largely Loses Bid To Toss 4 Cases Alleging Defective Device Injuries

BOSTON — A federal judge in Massachusetts denied three motions for summary judgment filed by a device manufacturer in cases in which women allege that an implanted radiographic marker used to mark soft tissue sites during cancer treatment was defective and caused injuries but partially granted a fourth motion, finding that the woman failed to identify a genuine dispute of material fact as to causation on her failure-to-warn claim under Florida law.