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

Mealey's Drugs & Devices

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.
January 09, 2024
Philips Says SoClean Products Destroyed Foam In CPAP Machines, Not FDA-Approved

PITTSBURGH — Koninklijke Philips NV and its affiliates answered a complaint filed against it by the manufacturer of equipment that uses ozone to clean or disinfect CPAP devices and accessories and filed counterclaims alleging that SoClean Inc. “has known all about the destructive properties of ozone for years” and that its sale of the products violated federal law.
January 08, 2024
Anti-Abortion States Say FDA, Danco Wrong In Objections To Motion To Intervene

AMARILLO, Texas — The three states that moved to intervene in a lawsuit challenging the U.S. Food and Drug Administration’s approval of mifepristone and misoprostol say the arguments that intervention should be denied “rest on a string of dubious speculations and the strange assertion that it would be more convenient to the Federal Government to litigate in multiple forums.”
January 08, 2024
9th Circuit Denies Rehearing, Files Amended Opinion In FCA Drug Pricing Suit

SAN FRANCISCO — The Ninth Circuit U.S. Court of Appeals on Jan. 5 denied a petition for a panel rehearing and a rehearing en banc, issuing an amended opinion of its decision reversing a district court’s dismissal of a relator’s qui tam suit alleging violations of the federal False Claims Act (FCA) against pharmaceutical companies related to their alleged fraud by artificially inflating drug prices, finding “that the qualifying public disclosures here do not collectively disclose a combination of facts sufficient to permit a reasonable inference of fraud.”
January 08, 2024
Couples Sue Embryo Solution Manufacturer For Claims Related To Recalled Product

LOS ANGELES — Two couples filed separate complaints in a California court against the manufacturer of a solution used during fertility-related treatments that they claim was toxic and destroyed their developing embryos.
January 04, 2024
9th Circuit Finds No Discrimination In Policy For Filling Opioid Prescriptions

SAN FRANCISCO — The Ninth Circuit U.S. Court of Appeals affirmed that a district court properly dismissed a woman’s class action that alleged that Walgreens’ policy for dispensing opioid prescriptions was discriminatory against the disabled.
January 04, 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 03, 2024
Pharmaceutical Company To Pay $6M To End Kickback Claims In Marketing Plan

BOSTON — Pharmaceutical company Ultragenyx Pharmaceutical Inc. will pay $6 million to settle claims that it violated the False Claims Act (FCA) in its marketing efforts for its drug Crysvita, which treats a rare inherited disorder.
January 03, 2024
Judge Wolfson Appointed Special Master In Prescription Saving Program Dispute

NEWARK, N.J. — Freda L. Wolfson, who in early 2023 retired as a chief judge of the U.S. District Court for the District of New Jersey, has been appointed special master in a case pending in the District Court in which a Johnson & Johnson affiliate alleges that a prescription saving program improperly offloads costs onto the drugmaker’s discount drug program.
January 02, 2024
Ozempic Manufacturer Says Consolidation In MDL Is Appropriate

WASHINGTON, D.C. — Novo Nordisk A/S, the manufacturer of Ozempic, tells the U.S. Judicial Panel for Multidistrict Litigation (JPMDL) that consolidation of cases from consumers who allege that they suffered gastrointestinal and other injuries from diabetes and diet drugs in a multidistrict litigation is proper but argues that the U.S. District Court for the Middle District of North Carolina is a more appropriate venue than the one suggested by the plaintiffs.
January 02, 2024
McKinsey To Pay $78 Million To Settle Third-Party Payers’ Claims In MDL

SAN FRANCISCO — McKinsey & Co. Inc. has agreed to pay $78 million to settle claims from third-party payers (TPP) in an opioid multidistrict litigation.
December 22, 2023
Zantac Maker, Retailer: Petition Does Not Address Question On Circuit Split

WASHINGTON, D.C. — The manufacturer of Zantac and a retailer in a Dec. 21 opposition brief tell the U.S. Supreme Court that it should deny a petition for a writ of certiorari filed by a woman appealing the dismissal of her case and asking the high court to settle a jurisdictional question that has split the circuit courts because the “‘question presented’ is not actually presented in this case.”
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.
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.