Mealey's Drugs & Devices
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December 22, 2023
JPMDL Schedules Hearing To Decide On Creation Of Suboxone MDL
WASHINGTON, D.C. — The U.S. Judicial Panel on Multidistrict Litigation will meet in Santa Barbara, Calif., on Jan. 25 to decide, among other petitions, whether to consolidate for pretrial purposes cases that allege that Suboxone film, a prescription drug used to treat opioid use disorder, causes extensive dental decay.
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December 22, 2023
Citing CPAP Recall, Senators Ask For Update On FDA’s Process On Oversight
WASHINGTON, D.C. — Two senators sent a letter to the U.S. Government Accountability Office asking for an update to its 2011 report on “Medical Devices: FDA Should Enhance Its Oversight of Recalls” in light of the rising amount of recalls and adverse event reports, citing the recall of approximately 10.8 million Philips continuous positive air pressure (CPAP) sleep apnea devices and respirators.
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December 21, 2023
Louisiana Federal Judge Won’t Stay Diabetes Drug Case Pending MDL Decision
LAKE CHARLES, La. — A Louisiana federal judge denied a motion filed by the manufacturer of Ozempic to stay proceedings while the parties await a decision on whether similar cases will be consolidated in a multidistrict litigation.
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December 21, 2023
JPMDL Hearing On Diabetes Drug MDL Scheduled; Deadline For Response Extended
WASHINGTON, D.C. — The U.S. Judicial Panel for Multidistrict Litigation (JPMDL) granted a motion for an extension to respond to a motion filed by attorneys representing nine individuals who allege that they suffered gastrointestinal and other injuries from diabetes and diet drugs such as Ozempic, Wegovy and Mounjaro who want 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.
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December 21, 2023
Pa. Woman Accuses Ozempic Maker Of Deceptive Marketing Of Weight Loss Drug
PHILADELPHIA — A woman alleges in a complaint in Pennsylvania federal court that she was injured as a result of a drug manufacturer’s “widespread, deceptive and unfair marketing” of Wegovy and Ozempic and through the use of the diabetes and weight loss drugs (Laura Marrero v. Novo Nordisk A/S, et al., No. 23-5036, E.D. Pa.).
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December 20, 2023
Amendments To Rule 702 For Expert Witness Testimony Go Into Effect
Amendments to Federal Rule of Evidence 702, Fed. R. Evid. 702, went into effect to clarify how courts should decide the admissibility of expert testimony.
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December 20, 2023
Causation Experts Found Inadmissible In Acetaminophen Autism/ADHD MDL
NEW YORK — The New York federal judge overseeing the acetaminophen autism spectrum disorder-attention deficit hyperactivity disorder (ASD-ADHD) multidistrict litigation found that the general causation experts retained by plaintiffs alleging that prenatal exposure to acetaminophen causes the disorders are inadmissible under Federal Rule of Evidence 702.
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December 20, 2023
1st Circuit Affirms Conviction, Fines For 2 Execs Convicted Of Off-Label Marketing
BOSTON — The First Circuit U.S. Court of Appeals rejected arguments from former Acclarent Inc. executives who argued on appeal that their convictions for distributing and misbranding medical devices sold in interstate commerce violated the First Amendment to the U.S. Constitution and that the district court erred in its instructions to the jury.
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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.
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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.
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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.”
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.”
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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.
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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.
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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.
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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).
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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.