Mealey's Drugs & Devices
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March 02, 2021
Incretin Mimetic MDL Judge Told Parties Are Unable To Reach A Settlement
SAN DIEGO — Parties in the incretin mimetics pancreatic cancer multidistrict litigation on Feb. 12 told the court they were unable to reach a settlement agreement and asked the court to proceed with its rulings on summary judgment and expert witness rulings.
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March 02, 2021
Hawaii State Court Judge Fines Bristol Myers, Sanofi $834M For Plavix Practices
HONOLULU — A Hawaii state court judge on Feb. 15 found that Bristol Myers Squibb Co. (BMS) and Sanofi-Aventis U.S. LLC violated the state’s unfair trade practices law by failing to warn patients of East Asia and/or Pacific Island ancestry that their genetic variants rendered the antiplatelet drug Plavix ineffective for them and ordered the defendants to pay the state $834.01 million in civil penalties for 834,012 violations.
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March 02, 2021
Medtronic Voluntarily Recalls Stent Graft System After Failures, 2 Deaths
MOUNDS VIEW, Minn. — Medtronic Inc. on Feb. 17 issued a global voluntary recall of its Valiant Navion Thoracic Stent Graft System after receiving reports of device failures, including two deaths.
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March 02, 2021
Plaintiff, Defense Leaders Named In Paragard IUD MDL
ATLANTA — The Georgia federal judge overseeing the Paragard intrauterine device (IUD) multidistrict litigation on Feb. 18 appointed plaintiff and defense attorneys to leadership positions.
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March 01, 2021
1st Circuit Affirms Guilty Verdicts, Sentences Of 3 NECC Pharmacists
BOSTON — The First Circuit U.S. Court of Appeals on Feb. 26 affirmed the convictions and sentences for three former pharmacists who worked for the former New England Compounding Center (NECC) pharmacy.
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March 01, 2021
Bayer Seeks $239,897 In Costs As Prevailing Party In Mirena Brain Injury MDL
NEW YORK — Bayer HealthCare Pharmaceuticals Inc. on Feb. 19 asked the New York federal judge presiding over the Mirena idiopathic intracranial hypertension (IIH) multidistrict litigation to award it $239,897 in deposition and document expenses as the prevailing party in the litigation.
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March 01, 2021
Fen-Phen MDL Judge Dismisses Non-Attorney’s Settlement Share Claim For Nonservice
PHILADELPHIA — The Pennsylvania federal judge overseeing the fen-phen settlement on Feb. 23 granted a motion by the American Home Products (AHP) Settlement Trust to dismiss for insufficient service a complaint filed by a pro se litigant who challenged an award to a third person and claimed that he was due a percentage of the recovery for his involvement in the claim settlement.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.”
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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.
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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.
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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.
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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.