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

Mealey's Drugs & Devices

January 26, 2024
Shkreli Lifetime Ban From Drug Industry Affirmed By Appeals Court

NEW YORK — The Second Circuit U.S. Court of Appeals has affirmed a lifetime ban on former drug executive and convicted securities fraudster Martin Shkreli from the pharmaceutical industry.
January 25, 2024
Johnson & Johnson To Pay $149.5 Million To Washington In Opioid Settlement

SEATTLE — Washington and Johnson & Johnson have reached an agreement in which the opioid manufacturer and raw material supplier will pay $149.5 million to the state for its role in fueling the opioid epidemic, the state announced Jan. 24.
January 24, 2024
FDA, Danco Urge High Court To Reverse 5th Circuit’s Abortion Drug Decision

WASHINGTON, D.C. — The U.S. Food and Drug Administration and Danco Laboratories LLC, the manufacturer of Mifeprex-brand mifepristone, on Jan. 23 filed separate opening briefs in the U.S. Supreme Court, arguing that 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.
January 24, 2024
N.C. Federal Judge Finds Claims Against Drugmaker Preempted, Dismisses Case

ASHEVILLE, N.C. — A North Carolina federal judge granted a motion to dismiss a second complaint filed by a woman who alleges that her arthritis medication damaged her kidneys after finding that her claims are preempted by the Food, Drug and Cosmetic Act (FDCA).
January 19, 2024
Settlement Reached In Class Alleging Injuries From Ankle Monitoring Device

DENVER — A man seeking to represent a class of individuals who allege that they were injured by an alcohol tracking ankle monitor and the device’s manufacturer notified a Colorado federal court that the parties have reached a confidential settlement to resolve all claims.
January 17, 2024
High Court Told ‘Chaos’ Will Ensue ‘In A World Without Chevron’ Deference

WASHINGTON, D.C. — The U.S. Supreme Court was told Jan. 17 that “chaos” will ensue “in a world without Chevron” deference by government attorneys, who urged it to apply stare decisis and uphold Chevron, which is being challenged in two cases arising out of federal fishing regulations.
January 18, 2024
Mass Tort Cases For Drugs, Medical Devices

New developments in the following mass tort drug and device cases are marked in boldface type.
January 18, 2024
New York Federal Judge Finds Motions Don’t Meet Court Rules, Allows Refiling

UTICA, N.Y. — A New York federal judge ordered the manufacturer of an allegedly defective hip implant to refile motions to exclude expert witnesses and for summary judgment within 30 days in a case recently transferred from the Pinnacle hip implant products liability multidistrict litigation pending in the Northern District of Texas.
January 18, 2024
Federal Judge Tosses Express Warranty Claim Against Ozempic, Mounjaro Makers

LAKE CHARLES, La. — A federal judge in Louisiana on Jan. 17 dismissed the express warranty claims against Eli Lilly & Co. after a woman who alleges that the drugmaker failed to warn her about the risk of gastroparesis, or delayed stomach emptying, failed to amend her complaint; the judge dismissed the same claim against Novo Nordisk A/S on Jan. 9 in a nearly identical ruling.
January 18, 2024
Judge Remands Knee Replacement Injury Case To Louisiana State Court

NEW ORLEANS — A Louisiana federal judge granted a motion to remand a man’s case alleging that he was injured by a defective artificial knee replacement device after finding that there are viable claims against a sales representative and distributor.
January 17, 2024
Paragard MDL Judge Pushes Back Discovery, Expert Disclosure Deadlines

ATLANTA — The first bellwether case for the Paragard IUD multidistrict litigation centered in a Georgia federal court, which was to be held in October 2024, has been pushed back, with a federal judge announcing that she has granted a joint motion for an extension of time for various deadlines.
January 17, 2024
Louisiana Federal Judge Tosses Express Warranty Claim Against Ozempic Maker

LAKE CHARLES, La. — A federal judge in Louisiana dismissed an express warranty claim against Novo Nordisk A/S and its affiliates after a woman who alleges that the drugmaker failed to warn her about the risk of gastroparesis, or delayed stomach emptying, failed to amend her complaint.
January 17, 2024
3M Loses Bid To Keep Bair Hugger Case Out Of Texas State Court

MINNEAPOLIS — The judge overseeing the Bair Hugger multidistrict litigation granted a man’s motion to remand his case to a Texas court after finding that 3M Co. failed to demonstrate that certain defendants were fraudulently joined.
January 16, 2024
Va. Federal Judge Stays Mifepristone Regulation Case Pending High Court Decision

CHARLOTTESVILLE, Va. — A Virigina federal judge on Jan. 12 agreed to stay a case filed by a group of abortion providers who want the U.S. Food and Drug Administration to remove all legislative barriers to the abortion drug mifepristone pending the resolution of a U.S. Supreme Court case on whether the FDA acted unlawfully in removing certain safety measures for the drug.
January 16, 2024
Judge Denies Walgreen’s Dismissal Motion In FCA Suit On Remand From 4th Circuit

ABINGDON, Va. — A Virginia federal judge on Jan. 13 denied Walgreen’s motion to dismiss after the Fourth Circuit U.S. Court of Appeals reversed and remanded the judge’s previous dismissal of a suit filed by federal and state governments alleging violations of the False Claims Act (FCA) and Virginia law, finding in part that the federal and state governments “have plausibly alleged a materially false representation” regarding Walgreens’ alleged misrepresentation that certain patients met Medicaid eligibility requirements for hepatitis C drugs.
January 16, 2024
Anti-Abortion States Can Intervene In Case Over FDA’s Approval Of Mifepristone

AMARILLO, Texas — A Texas federal judge on Jan. 12 agreed to allow three states to intervene in a lawsuit challenging the U.S. Food and Drug Administration’s approval of mifepristone and misoprostol after finding that their motion was timely and that the opposing parties would not be unduly prejudiced by allowing them to join.
January 12, 2024
Woman’s Case Reinstated After It Was Tossed For Mississippi Statute Of Limitations

NEW ORLEANS — Finding a that “single clerical error” by a woman’s counsel that led to her case being dismissed constituted “excusable neglect,” the Louisiana federal judge overseeing the Taxotere hair loss multidistrict litigation agreed to reinstate her case.
January 12, 2024
Woman: Zantac Maker, Retailer Trying ‘To Scare The Court’ From Granting Cert

WASHINGTON, D.C. — The U.S. Supreme Court will consider at its Feb. 16 conference a petition for a writ of certiorari filed by a woman who is appealing the dismissal of her case against the maker of Zantac and asking the high court to settle a jurisdictional question on whether her design-defect claim was dismissed when the multidistrict litigation court dismissed the claim in the master complaint; the woman rejected the respondents’ argument that her case is not the proper vehicle in a reply brief.
January 12, 2024
Arbitration Denied In Class Suit Against Walgreens Over Lidocaine Labeling

CHICAGO — Walgreen Co., doing business as Walgreens, waived its right to arbitration in a putative class complaint alleging that the labels on certain lidocaine products are misleading when it did not assert an arbitrability defense until after its motion to dismiss was ruled on, a federal judge in Illinois ruled, denying the pharmacy chain’s motion to compel arbitration and stay.
January 12, 2024
FDA Evaluating Reports Of Adverse Reactions To Diabetes, Diet Drugs

SILVER SPRINGS, Md. — The U.S. Food and Drug Administration said it “is evaluating the need for regulatory action” after receiving reports that diabetes and diet drugs such as Ozempic, Wegovy and Mounjaro may cause alopecia, aspiration and suicidal ideation.
January 11, 2024
Judge Grants Ethicon Another Shot At Partial Expert Exclusion In Pelvic Mesh Case

LEXINGTON, Ky. — A Kentucky federal judge rejected efforts from a pelvic mesh manufacturer to exclude testimony on what information was provided to a woman’s doctor but will grant Ethicon Inc. 30 days to move to exclude the expert’s causation testimony under Daubert v. Merrell Dow Pharmaceuticals Inc. in a long-running case.
January 11, 2024
Pharmacies Argue $650M Verdict In Opioid Case Invalid Under Ohio State Law

COLUMBUS, Ohio — The Ohio Product Liability Act (OPLA) “unambiguously bars” a common-law public nuisance claim brought by two Ohio counties that won a $650 million verdict after alleging that national pharmaceutical chains, including Walgreens, CVS and Walmart, helped fuel the nationwide opioid epidemic, a trio of pharmacies argues in a petitioners brief filed in the Ohio Supreme Court, which agreed to answer a certified question from the Sixth Circuit U.S. Court of Appeals.
January 11, 2024
Tepezza Hearing Loss MDL Parties Agree To Delay In Naming Bellwether Cases

CHICAGO — Parties in the Tepezza hearing loss multidistrict litigation filed a joint stipulation agreeing to a 60-day extension for the selection of the initial bellwether discovery cases and associated deadlines.
January 10, 2024
Woman Says She Has Established Jurisdiction In Suit Against Ozempic Maker

LAKE CHARLES, La. — A Louisiana woman urged a federal judge to reject a motion filed by the manufacturer of Ozempic to dismiss her complaint that the drugmaker failed to warn her about the risk of gastroparesis, or delayed stomach emptying, arguing that she has established jurisdiction over the foreign entity.
January 10, 2024
CPAP Plaintiffs’ Counsel Ask For $95M In Attorney Fees As Part Of Settlement

PITTSBURGH — Plaintiffs’ counsel in a multidistrict litigation involving the recall of approximately 10.8 million continuous positive air pressure (CPAP) sleep apnea devices and respirators have asked the court to approve $95 million for attorney fees and costs in connection with the settlement reached to end all economic claims.