Mealey's Drugs & Devices
-
December 19, 2023
Health Care Tech Company Settles FCA Claims Over Heart Monitoring Fraud For $14.7M
WASHINGTON, D.C. — The U.S. Department of Justice (DOJ) on Dec. 18 announced that BioTelemetry Inc. and its subsidiary LifeWatch Services Inc. have agreed to pay more than $14.7 million to resolve claims that they violated the federal False Claims Act (FCA) by knowingly submitting claims to government insurers for a higher level of remote cardiac monitoring than intended by physicians or that was medically necessary, resulting in higher reimbursements to LifeWatch.
-
December 19, 2023
Excluded Expert Witness Can’t Testify As Fact Witness In Device Injury Case
PHOENIX — A man alleging that a defective “metal-on-metal” hip replacement device caused an injury cannot present as a fact witness a person who has been excluded from testifying as an expert witness, an Arizona federal judge ruled, agreeing to strike his testimony.
-
December 14, 2023
Judge Grants Manufacturer Summary Judgment In Remanded Prosthetic Shoulder Case
NEW ORLEANS — A federal judge in Louisiana again awarded summary judgment to the manufacturer of a shoulder prosthesis after the case was remanded by the Fifth Circuit U.S. Court of Appeals, which vacated the previous summary judgment decision after finding that the question of whether the plaintiff’s claim had prescribed under Louisiana state law is “best left for the jury.”
-
December 14, 2023
Mass Tort Cases For Drugs, Medical Devices
New developments in the following mass tort drug and device cases are marked in boldface type.
-
December 14, 2023
Suboxone Film Manufacturers Agree That MDL Coordination Is Needed
WASHINGTON, D.C. — The manufacturer of Suboxone film facing allegations that the prescription drug used to treats opioid use disorder caused extensive dental decay agreed in responses to a motion for transfer that the U.S. Judicial Panel on Multidistrict Litigation should consolidate the cases for pretrial purposes.
-
December 13, 2023
Acetaminophen Autism/ADHD MDL Judge Renews Plaintiffs’ Leadership Team, Adds Members
NEW YORK — The New York federal judge overseeing the acetaminophen autism spectrum disorder-attention deficit hyperactivity disorder (ASD-ADHD) multidistrict litigation has renewed and appointed members of the plaintiffs’ leadership team.
-
December 13, 2023
High Court Agrees To Hear Dispute Over Abortion Drug Regulations
WASHINGTON, D.C. — The U.S. Supreme Court will determine whether the Fifth Circuit U.S. Court of Appeals erred in upholding a district court’s stay of the Food and Drug Administration’s 2016 amendments to mifepristone’s approval and the agency’s 2021 decision not to enforce its regulations during the COVID-19 pandemic, the court announced Dec. 13, granting a petition for a writ of certiorari.
-
December 12, 2023
Federal Magistrate Judge Recommends Partial Dismissal Of Surgical Mesh Injury Case
SCRANTON, Pa. — A federal magistrate judge in Pennsylvania on Dec. 11 recommended partially granting a motion to dismiss filed by a surgical mesh manufacturer and its distributor facing claims that a man was injured after its product was used during surgery.
-
December 11, 2023
Louisiana Federal Judge Allows Most Of Diabetes Drug Complaint To Move Forward
LAKE CHARLES, La. — In separate orders, one signed Dec. 11 and another on Dec. 8, a Louisiana federal judge largely denied motions to dismiss filed by two drug manufacturers facing claims that a woman suffered gastrointestinal and other injuries after taking Ozempic and Mounjaro diabetes drugs.
-
December 11, 2023
High Court Won’t Hear Appeal In Case Alleging Injury From CoolSculpting Procedure
WASHINGTON, D.C. —The U.S. Supreme Court on Dec. 11 denied a petition for a writ of certiorari filed by a man who argued that an appellate court erred in granting summary judgment to the company that created the CoolSculpting process after finding that he was warned about the risk of paradoxical adipose hyperplasia (PAH) and that his design defect claims failed under the risk-utility or consumer expectations tests.
-
December 08, 2023
Woman Says Manufacturer Knew Tepezza Could Cause Hearing Loss
CHICAGO — A case alleging that the manufacturer of Tepezza, a prescription drug that treats thyroid eye disease, knowingly concealed information that the drug causes hearing loss has been assigned to U.S. Thomas M. Durkin in the U.S. District Court for the Northern District of Illinois, who ordered the parties to file a joint status report by Jan. 14.
-
December 08, 2023
MDL Judge Transfers Last Of Testosterone Replacement Therapy Cases
CHICAGO — The judge overseeing the testosterone replacement therapy (TRT) multidistrict litigation ordered that all remaining cases be transferred to other district courts, declaring that the “purposes of the MDL proceeding have been completed.”
-
December 08, 2023
MDL Sought For Alleged Stomach Injuries From Diabetes, Diet Drugs
WASHINGTON, D.C. — Attorneys representing nine individuals who allege that they suffered gastrointestinal and other injuries from diabetes and diet drugs such as Ozempic, Wegovy and Mounjaro have asked the U.S. Judicial Panel for Multidistrict Litigation (JPMDL) to transfer all currently filed and any subsequently filed cases and centralize them in the U.S. District Court for the Western District of Louisiana.
-
December 08, 2023
Woman Sues CVS For Contaminated Eye Drops, Proposes Class Action
WILMINGTON, N.C. — A woman filed a complaint in North Carolina federal court seeking to represent a class of consumers who purchased over-the-counter lubricating eyedrop products at CVS stores that were later recalled by the U.S. Food and Drug Administration.
-
December 07, 2023
OTC Cold Medicine Cases Centralized In MDL Before Judge Cogan In New York
WASHINGTON, D.C. — The Judicial Panel on Multidistrict Litigation on Dec. 6 agreed to centralize cases alleging that over-the-counter cough and cold medications containing the active ingredient phenylephrine (PE) are ineffective at relieving nasal congestion and assigned the multidistrict litigation to Judge Brian M. Cogan of the U.S. District Court for the Eastern District of New York.
-
December 07, 2023
Federal Circuit Finds 3rd Filed Vaccine Complaint Is Untimely
WASHINGTON, D.C. — The Federal Circuit U.S. Court of Appeals on Dec. 6 dismissed the appeal of man who alleges that a lower court erred in finding untimely his complaint that a seasonal influenza vaccination caused him to develop Guillain-Barré syndrome (GBS).
-
December 05, 2023
Hernia Mesh MDL Judge Grants Motion To Dismiss 224 Settled Cases
ATLANTA — The federal judge overseeing the Ethicon Physiomesh hernia patch multidistrict litigation granted a joint motion to dismiss with prejudice 224 cases after the parties agreed to settle all claims.
-
December 04, 2023
Justices Mull Whether Purdue Bankruptcy Plan Can Allow Sackler Family Releases
WASHINGTON, D.C. — The U.S. Supreme Court on Dec. 4 heard oral arguments in a dispute that would upend a multibillion-dollar opioid bankruptcy settlement reached by Purdue Pharma L.P. that included a liability release for members of the formerly controlling Sackler family, with multiple justices noting that the vast majority of claimants overwhelmingly approved of the plan.
-
December 01, 2023
Woman Says Merck Followed Vioxx Handbook In Marketing Gardasil In Injury Suit
CHARLOTTE, N.C. — A woman on Nov. 30 filed a direct complaint in a North Carolina district court, alleging that she suffers from constant seizures and other injuries as a result of receiving the Gardasil vaccine and alleges that the manufacturer has a history of concealing a drug’s risks.
-
November 30, 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 30, 2023
Zostavax MDL Judge Orders Expert Declaration From Group Of Plaintiffs
PHILADELPHIA — The Pennsylvania federal judge presiding over the Zostavax multidistrict litigation on Nov. 29 agreed to require a group of plaintiffs alleging that the shingles vaccine caused injuries other than shingles or hearing loss to produce a declaration from a causation expert stating that the vaccine caused the injuries.
-
November 30, 2023
Ohio Supreme Court Agrees To Hear Certified Question In Opioid Verdict Appeal
COLUMBUS, Ohio — The Ohio Supreme Court on Nov. 29 agreed to answer a certified question from the Sixth Circuit U.S. Court of Appeals regarding whether a common-law public nuisance claim is permitted under the Ohio Product Liability Act in an appeal of a $650 million verdict awarded to two counties filed by a trio of pharmacies.
-
November 30, 2023
FDA Warns Users Of Reports Of Overheating CPAP Machines
SILVER SPRING, Md. — The U.S. Food and Drug Administration through a safety communication warned users of Philips DreamStation 2 continuous positive airway pressure (CPAP) machines to watch for signs of overheating.
-
November 29, 2023
FDA Moves For Dismissal Of Drug Compounder’s Suit To Stop Press Release
NEW HAVEN, Conn. — The U.S. Food and Drug Administration moved to dismiss a complaint filed by a pharmaceutical compounder asking that a federal court enjoin the agency from publishing a press release or statement regarding an investigation of its facility.
-
November 29, 2023
Acetaminophen Autism/ADHD MDL Judge Agrees To Sever Rite Aid From Cases
NEW YORK — The New York federal judge overseeing the acetaminophen autism spectrum disorder-attention deficit hyperactivity disorder (ASD-ADHD) multidistrict litigation granted a request by the plaintiffs to sever Rite Aid Corp. from all cases where Rite Aid is not the only named defendant.