Mealey's Drugs & Devices

  • September 20, 2019

    Ex-Compounding Pharmacy President Gets 33 Months In Prison For Shipping Bad Drugs

    INDIANAPOLIS — The former president of a compounding pharmacy was sentenced Sept. 19 to 33 months in federal prison and ordered to pay a $25,000 fine for shipping untested or under- or super-potent drugs, some of which caused opioid overdoses in three infants (United States of America v. Paul J. Elmer, No. 17-cr-113, S.D. Ind., Indianapolis Div.).

  • September 19, 2019

    Opioid Maker Insys Files Liquidation Plan With Bankruptcy Court

    WILMINGTON, Del. — Opioid maker Insys Therapeutics Inc. on Sept. 17 filed a plan of liquidation that includes funds for treatment of opioid-addicted newborns, for federal claims, for state, municipal and Native American claims and for personal injury claims (In re Insys Therapeutics, Inc., et al., No. 19-11292, D. Del. Bkcy).

  • September 18, 2019

    Pfizer Asks U.S. High Court To Reverse California Ruling On Personal Jurisdiction

    WASHINGTON, D.C. — Drug maker Pfizer Inc. on Aug. 28 filed a petition for a writ of certiorari asking the U.S. Supreme Court to overturn a California court’s ruling that by removing Lipitor cases to federal court, the company forfeited its right to challenge the personal jurisdiction of California courts (Pfizer, Inc., et al. v. Superior Court of California, et al., No. 19-278, U.S. Sup., 2019 U.S. S. Ct. Briefs LEXIS 3739).

  • September 18, 2019

    Jury Will Decide Nuisance Claims In Opioid MDL Trial; Judge Will Decide Remedy

    CLEVELAND — The Ohio federal judge set to preside over the first opioid multidistrict litigation bellwether trial next month told the parties on Sept. 16 that he intends to let a jury decide whether the defendants are liable for creating a public nuisance but he will craft an “equitable abatement remedy” (In Re:  National Prescription Opiate Litigation, MDL Docket No. 2804, No. 17-md-2804, N.D. Ohio).

  • September 18, 2019

    Mass Tort Cases For Drugs, Medical Devices

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

  • September 18, 2019

    Bayer Seeks Dismissal Of Gadolinium Cases After Experts Excluded

    PHOENIX — Bayer HealthCare Pharmaceuticals Inc. on Sept. 13 moved for summary judgment in a gadolinium contrast agent injury lawsuit after a judge excluded her three general causation experts (Susan Fischer v. Bayer HealthCare Pharmaceuticals Inc., et al., No. 18-1778, D. Ariz.).

  • September 18, 2019

    Relator Awarded 15 Percent Of $59M In Settlements For Victoza Diabetes Drug

    WASHINGTON, D.C. — A District of Columbia federal judge on Sept. 11 said one relator is entitled to 15 percent of three settlements totaling $59 million but held off payment until after four other purported relators appeal the denial of their claims (United States, et al., ex rel. Lesley Ferrara, et al. v. Novo Nordisk, Inc., et al., No. 13-1529, D. D.C., 2019 U.S. Dist. LEXIS 154547).

  • September 18, 2019

    FDA Finds Potential Carcinogen In Zantac Heartburn Drug; State Class Action Filed

    SAN JOSE, Calif. — On the same day the Food and Drug Administration said it found the suspected carcinogen N-nitrosodimethylamine (NDMA) in the heartburn drug Zantac, four plaintiffs filed a class action lawsuit against the drug’s makers for allegedly failing to warn consumers about the presence of the contaminant (Christina Garza, et al. v. Sanofi-Aventis U.S. LLC, et al., No. 19-5772, N.D. Calif.).

  • September 17, 2019

    8 Opioid MDL Defendants Seek Judge’s Disqualification For Alleged Settlement Bias

    CLEVELAND — Eight defendants in the opioid multidistrict litigation on Sept. 14 filed a motion asking the judge to disqualify himself because of the judge’s alleged bias for a settlement (In Re:  National Prescription Opiate Litigation, MDL Docket No. 2804, No. 17-md-2804, N.D. Ohio, Eastern Div.).

  • September 16, 2019

    Medical Device Company Pays $8.12M For Selling Unapproved Devices

    NEW YORK — A medical device company has agreed to pay $8.12 million to settle federal and whistleblower allegations that it sold medical devices that were not grandfathered under federal law or approved by the Food and Drug Administration, the U.S. Justice Department announced Sept. 13 (United States, et al. ex rel. Mary Bixler Wood v. Avalign Technologies, Inc., et al., No. 14-4958, S.D. N.Y.).

  • September 16, 2019

    Reuters Seeks To Unseal Propecia MDL Documents After Redacted Data Revealed

    BROOKLYN, N.Y. — Reuters news service on Sept. 12 asked a New York federal court overseeing the Propecia erectile dysfunction multidistrict litigation to unseal a motion in limine to exclude three plaintiff experts in an upcoming bellwether trial after an electronic glitch revealed redacted material (Paul Dawson v. Merck & Co., Inc., et al., No. 12-1876, E.D. N.Y.).

  • September 16, 2019

    Purdue Pharma Claims $10B Opioid Settlement, Files For Chapter 11 Bankruptcy

    NEW YORK — OxyContin maker Purdue Pharma L.P. on Sept. 15 announced that it has reached an agreement in principle to settle its opioid litigation for more than $10 billion and filed for reorganization under Chapter 11 of the U.S. Bankruptcy Code (In Re:  Purdue Pharma L.P., et al., No. 19-23649, U.S. Bkcy. S.D. N.Y.).

  • September 13, 2019

    Opioid MDL Judge Certifies Negotiations Class For Counties, Cities

    CLEVELAND — An Ohio federal judge presiding over the opioid multidistrict litigation on Sept. 11 certified a “negotiation class” of all counties, cities and other municipalities against 13 drug manufacturers and distributors (In Re:  National Prescription Opiate Litigation, MDL No. 2804, No. 17-md-2804, N.D. Ohio, Eastern Div.).

  • September 12, 2019

    Untimely Claims In Investor Suit Against Drug Maker, Others Dismissed

    TRENTON, N.J. — A federal judge in New Jersey on Sept. 10 ruled that dismissal of a securities class action lawsuit against specialty pharmaceutical and medical device company Valeant Pharmaceuticals International Inc. and certain of its former senior executives is necessary because the shareholders’ claims are untimely and not subject to tolling pursuant to the American Pipe & Construction Co. v. Utah tolling doctrine (Bahaa Aly, et al. v. Valeant Pharmaceuticals International Inc., et al., No. 18-17393, D. N.J., 2019 U.S. Dist. LEXIS 155223).

  • September 09, 2019

    Mallinckrodt Settles Opioid MDL Bellwether Cases For $24M Cash, $6M In Drugs

    STAINES-UPON-THAMES, England — Mallinckrodt PLC on Sept. 6 announced that it has reached an agreement in principal to settle the opioid multidistrict litigation lawsuits by Cuyahoga and Summit counties in Ohio for $24 million and $6 million in in-kind drug supplies.

  • September 05, 2019

    Judge: Plaintiffs’ Punitive Damage Claim Does Not Show Damages Exceed $75,000

    LAS VEGAS — A federal judge in Nevada on Aug. 26 remanded a lawsuit brought by patients who feared they became infected with hepatitis B, hepatitis C or HIV after receiving injections for propofol prior to colonoscopies performed at a clinic that reused injection syringes and anesthesia bottles, finding that it was not facially apparent that the plaintiffs sought more than $75,000 in damages and that their claim for punitive damages and request for attorney fees did not demonstrate that the requested damages exceeded the jurisdictional threshold (Yvette Adams, et al. v. Teva Parenteral Medicines Inc., et al., No. 18-cv-02305-GMN-BNW, D. Nev., 2019 U.S. Dist. LEXIS 145131).

  • September 04, 2019

    Opioid MDL Judge Denies Summary Judgment Ahead Of 1st Bellwether Trial

    CLEVELAND — The Ohio federal judge overseeing the opioid multidistrict litigation on Sept. 3 issued six opinions denying defendants’ motions for summary judgment on issues such as preemption, causation and civil liability (In Re:  National Prescription Opiate Litigation, MDL Docket No. 2804, No. 17-md-2804, N.D. Ohio, Eastern Div.).

  • September 04, 2019

    Mallinckrodt Pays $15.4M For Questcor Actions While Opposing False Claims Suit

    STAINES-UPON-THAMES, England — British drug maker Mallinckrodt PLC on Sept. 3 said it has finalized a $15.4 million agreement to settle a false claims investigation by the U.S. Justice Department into “legacy sales and marketing activities” by Questcor Pharmaceuticals Inc. before Questcor was bought by Mallinckrodt.

  • September 04, 2019

    Mass Tort Cases For Drugs, Medical Devices

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

  • September 04, 2019

    Consent Decree Entered Against Dietary Supplement Companies, Principals

    NASHVILLE, Tenn. — A Tennessee federal judge on Sept. 3 entered a consent decree of permanent injunction against two companies and their principals for allegedly violating the Food, Drug and Cosmetic Act (FDCA), 21 U.S. Code § 301 et seq., by distributing drugs, dietary supplements and devices that are unapproved, adulterated or misbranded (United States  v. Basic Reset, et al., No. 19-752, M.D. Tenn.).