Mealey's Drugs & Devices

  • February 25, 2021

    Arkansas Federal Judge Dismisses Essure Birth Control Case As Preempted

    LITTLE ROCK, Ark. — An Arkansas federal judge on Feb. 22 granted Bayer Corp.’s motion to dismiss an Essure birth control device case as preempted by federal law.

  • February 23, 2021

    Purdue Pharma Bankruptcy Judge Partly OKs Media Access To Sackler Family Documents

    WHITE PLAINS, N.Y. — The New York federal bankruptcy judge overseeing the Purdue Pharma LP Chapter 11 bankruptcy on Feb. 22 granted in part, denied in part and continued a request by three news organizations to intervene and to unseal certain judicial records relating to the Sackler family that owns Purdue Pharma.

  • February 19, 2021

    Heart Valve Maker Awarded Summary Judgment; Unredacted Ruling Forthcoming

    BOSTON — A federal judge in Massachusetts on Feb. 12 entered judgment in favor of a heart valve maker accused by the parents of a young woman who died after undergoing surgery to have the valve removed of failing to report incidents of the product’s failure to regulators and said the parties should meet and confer so a redacted version of her decision can be made publicly available.

  • February 18, 2021

    Magistrate Judge Dismisses False Claims Act Suit Against Opioid Maker

    OAKLAND, Calif. — A federal magistrate judge in California on Feb. 16 dismissed with prejudice a False Claims Act (FCA) lawsuit brought by two former McKesson Corp. employees, finding that the allegations in their second amended complaint (SAC) did not sufficiently allege that the opioid maker submitted false claims for payment to the federal government pursuant to the U.S. Supreme Court’s 2016 ruling in Universal Health Servs. Inc. v. United States, ex rel. Escobar.

  • February 17, 2021

    New York Appeals Court Reverses Dismissal Denial For Device Part Maker, Seller

    ROCHESTER, N.Y. — A New York appellate panel on Feb. 5 reversed a trial court’s denial of a defense dismissal motion in an intraocular lens case, finding that the plaintiff failed to plead state court jurisdiction over one component maker and that the plaintiff cited no federal law requiring two defendants to report adverse events to the Food and Drug Administration.

  • February 16, 2021

    Expert Can’t Testify On Medical Causation In Hair Loss MDL, Federal Judge Rules

    NEW ORLEANS — A Louisiana federal judge on Jan. 29 limited the expert testimony in the second bellwether trial in the Taxotere hair loss multidistrict litigation, finding that the expert can’t testify that the cancer drug causes irreversible alopecia but that his opinions based on database and clinical trial analysis are admissible.

  • February 16, 2021

    Mallinckrodt Bankruptcy Judge Denies Fast Appeal For ‘Acthar Plaintiffs’

    WILMINGTON, Del. — The judge overseeing the Mallinckrodt PLC Chapter 11 bankruptcy in Delaware on Feb. 11 denied a motion by the so-called Acthar plaintiffs to an expedited appeal of the court’s denial of a motion to extend the deadline for claim bar dates in the drug maker’s case.

  • February 16, 2021

    Judge Certifies Pay-For-Delay Insurer Class For Alzheimer’s Drug Namenda, Generics

    NEW YORK — A New York federal judge on Feb. 11 granted a motion by a union health benefit fund to certify a class of purchasers of the Alzheimer’s drug Namenda who were injured by a “pay-for-delay” scheme but denied certification of a class allegedly injured by being forced to switch from an original version of the drug to a newer one.

  • February 12, 2021

    California Federal Judge OKs $40,000 Settlement Of Nerve Stimulator Lawsuit

    SANTA ANA, Calif. — A California federal judge on Feb. 4 approved a $40,000 settlement of a nerve stimulator defect case, saying the success of the suit “was far from assured.”

  • February 12, 2021

    Judge: Generic Cipro Warning Claims Can Be Pressed Against Brand-Name Maker

    MINNEAPOLIS — The Minnesota federal judge overseeing the fluoroquinolone multidistrict litigation on Feb. 4 denied a motion by defendant Bayer Corp. to dismiss a plaintiff’s failure-to-warn claims under Illinois’ consumer protection law even though the plaintiff took the generic version of the brand-name drug.

  • February 11, 2021

    Cancer Drug Supplier Pleads Guilty To Destroying Records, Pays $50M To United States

    LAS VEGAS — The U.S. Justice Department on Feb. 9 announced in a press release that Fresenius Kabi Oncology Ltd. (KFOL) pleaded guilty to a misdemeanor charge of failing to provide records to Food and Drug Administration plant inspectors and to pay $50 million in fines and forfeiture.

  • February 10, 2021

    Split 8th Circuit: Learned Intermediary Applies In Nebraska Paragard IUD Case

    ST. LOUIS — The Eighth Circuit U.S. Court of Appeals on Feb. 8 affirmed dismissal of a Paragard intrauterine device (IUD) injury case, finding that the Nebraska Supreme Court would apply the state’s learned intermediary doctrine to prescription medical devices.

  • February 08, 2021

    5th Circuit Affirms Dismissal Of Claims Against 5 Brand, Generic Drug Makers

    NEW ORLEANS — The Fifth Circuit U.S. Court of Appeals on Feb. 5 affirmed dismissal of a pro se drug liability case against five brand-name and generic pharmaceuticals companies, saying the plaintiff’s claims are barred by federal law, federal preemption or Texas state law.

  • February 04, 2021

    McKinsey To Pay $573M To Settle States’ Probes Into Its Opioids Consulting Roles

    NEW YORK — Management consulting company McKinsey & Co. Inc. on Feb. 4 agreed to pay $573,919,331 to 49 states, the District of Columbia and five U.S. territories to settle attorneys general investigations into the company’s role in advising opioids manufacturers, including Purdue Pharma LP, Johnson & Johnson and Endo International PLC, on how to sell more of the addictive drugs even during the opioid epidemic.

  • February 03, 2021

    Opioids MDL Judge Denies Class Certification For Guardians Of ‘Opioid Babies’

    CLEVELAND — The Ohio federal judge overseeing the opioids multidistrict litigation on Feb. 1 denied a motion to certify a class of guardians of children with neonatal abstinence syndrome (NAS) allegedly caused by their mothers’ use of opioids.

  • February 02, 2021

    Mass Tort Cases For Drugs, Medical Devices

    New developments in the following mass tort drug and device cases are marked in boldface type.

  • February 02, 2021

    Federal Circuit Vacates Attorney Fee Denial In Gardasil Injury Case

    WASHINGTON, D.C. — The Federal Circuit U.S. Court of Appeals on Jan. 8 ruled that a vaccine court special master erred in finding that there was no reasonable basis for a mother to file a compensation petition for a Gardasil vaccine injury and for denying the mother’s subsequent motion for statutory attorney fees.

  • February 02, 2021

    EpiPen MDL Judge Unseals Summary Judgment, Daubert Opinions After 44 Days

    KANSAS CITY, Kan. — Forty-four days after they were issued, a Kansas federal judge overseeing the EpiPen multidistrict litigation on Jan. 29 ordered his Dec. 17 summary judgment and expert witness opinions unsealed and partially redacted copies released by the court clerk (In Re:  EpiPen [Epinephrine Injection, USP] Marketing, Sales Practices and Antitrust Litigation, MDL Docket No. 2785, No. 17-md-2785, D. Kan.).

  • February 02, 2021

    Valsartan MDL Judge Denies, Grants Dismissal Of Some Claims On Pleadings

    CAMDEN, N.J. — The New Jersey federal judge overseeing the valsartan multidistrict litigation on Jan. 29 issued an opinion granting and denying defense motions to dismiss the plaintiffs’ fraudulent misrepresentation and failure-to-warn claims for alleged pleading deficiencies.

  • February 02, 2021

    Bankruptcy Judge Confirms Liquidation Plan For Opioids Maker Insys

    WILMINGTON, Del. — A Delaware federal bankruptcy judge on Jan. 16 issued findings of fact, conclusions of law and an order confirming a joint Chapter 11 bankruptcy liquidation plan for former opioids manufacturer Insys Therapeutics Inc. and its related companies.