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Mealey's Drugs & Devices

  • December 10, 2018

    Judge Dismisses Defect- Related Claims Against Vena Cava Filter Maker

    SAN JOSE, Calif. — A California federal judge on Dec. 3 dismissed claims for violation of California’s unfair competition law (UCL), negligent misrepresentation and other causes of action asserted by a patient who alleged that she was injured by a defective device that was implanted to treat deep vein thrombosis and pulmonary embolism, holding that she failed to assert sufficient facts to show that the maker of the product knew that it was defective (Sandra Broge v. ALN International Inc., No. 17-cv-07131, N.D. Calif., 2018 U.S. Dist. LEXIS 204486).

  • December 7, 2018

    Opioid Infant MDL Denied As Duplicating National MDL; Panel Suggests Listening

    WASHINGTON, D.C. — The Judicial Panel on Multidistrict Litigation (JPMDL) on Dec. 6 denied a motion to create a new, separate “opioid baby” multidistrict litigation, saying it would overlap with the current national opioid MDL (In Re:  Infants Born Opioid-Dependent Products Liability Litigation, MDL Docket No. 2872, JPMDL).

  • December 6, 2018

    Actelion To Pay $360M To Settle Federal Drug Co-Pay Kickback Allegations

    BOSTON — Actelion Pharmaceuticals US Inc. has agreed to pay $360 million plus interest to resolve federal allegations that it paid kickbacks through a charitable foundation to illegally pay drug co-pays for Medicare patients taking the company’s pulmonary arterial hypertension (PAH) drugs, the U.S. attorney for the District of Massachusetts announced in a settlement released Dec. 6.

  • December 6, 2018

    Jury Deliberating Fate Of 6 Defendants In NECC Drug Compounding Criminal Case

    BOSTON — A Massachusetts federal jury on Dec. 5 began deliberations in the trial of six defendants in the New England Compounding Center (NECC) criminal case after the defendants presented no witnesses or evidence (United States v. Barry J. Cadden, et al., No. 14-cr-10363, D. Mass.).

  • December 6, 2018

    Covidien, Subsidiary To Pay $17.9M, $13M For Adulterated Device, False Claims

    BOSTON — Medical device maker ev3 Inc. agreed to plead guilty to a misdemeanor federal criminal charge of distributing an adulterated device and to pay $17.9 million in fines and forfeiture, the U.S. Justice Department said Dec. 4 in a press release (United States v. ev3, Inc., No. 18-cr-10461, D. Mass.).

  • December 5, 2018

    Medical Journal: SGLT2 Diabetic Drugs Carry Risk Of Amputation, Ketoacidosis

    LONDON — Diabetes drugs belonging to the sodium glucose cotransporter 2 (SGLT2) class are associated with an increased risk of lower limb amputation and diabetic ketoacidosis (DKA) compared to drugs of the preceding class, known as glucagon-like peptide-1s (GLP1s), according to a cohort study published in the Nov. 14 issue of the British Medical Journal (BMJ 2018; 363:k4365).

  • December 5, 2018

    Mirena MDL Judge Chooses Summary Judgment Path Forward Over Interlocutory Appeal

    NEW YORK — The New York federal judge overseeing the Mirena brain injury multidistrict litigation on Nov. 13 said the litigation should proceed to summary judgment in light of his exclusion of the plaintiffs’ general causation experts (In Re:  Mirena IUS Levonorgestrel-Related Products Liability Litigation [No. II], MDL Docket No. 2767, No. 17-md-2767, S.D. N.Y.).

  • December 5, 2018

    EpiPen MDL Judge Dismisses Some West Virginia Claims In Class Action

    KANSAS CITY, Kan. — The Kansas federal judge overseeing the EpiPen multidistrict litigation on Nov. 21 dismissed West Virginia state consumer law, antitrust and unjust enrichment class action claims after the plaintiffs failed to identify an in-state defendant (In Re:  EpiPen Marketing, Sales Practices and Antitrust Litigation, MDL Docket No. 2785, No. 17-md-2785, D. Kan., 2018 U.S. Dist. LEXIS 198462).

  • December 5, 2018

    United States Tells High Court Not To Take Up Gilead False Claims Case

    WASHINGTON, D.C. — The U.S. solicitor general on Nov. 30 urged the U.S. Supreme Court not to review a federal circuit court ruling that sent a whistleblower case against HIV drug maker Gilead Sciences back to a federal district court (Gilead Sciences, Inc. v. United States ex rel. Jeffrey Campie, et al., No. 17-936, U.S. Sup.).

  • December 5, 2018

    Magistrate Judge Recommends That Most Pelvic Mesh Claims Survive Dismissal Motion

    SCRANTON, Pa. — A Pennsylvania federal magistrate judge on Nov. 29 recommended that the court deny dismissal of a pelvic mesh case against Boston Scientific Corp., at one point rejecting the defense’s suggestion that the device’s risks and complications are so well known that the plaintiff should have filed suit after implantation (Tonya Wallace v. Boston Scientific Corp., et al., No. 18-1839, M.D. Pa., 2018 U.S. Dist. LEXIS 203441).

  • December 5, 2018

    Mass Tort Cases For Drugs, Medical Devices

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

  • December 5, 2018

    Yasmin/Yaz MDL Judge Discharges Plaintiffs’ Steering Committee, Winds Down MDL

    EAST ST. LOUIS, Ill. — Saying there are only 12 active cases remaining out of an initial 11,800, the Illinois federal judge overseeing the Yasmin/Yaz multidistrict litigation on Nov. 20 discharged the Plaintiffs’ Steering Committee (PSC) and said he will wind down the MDL by January (In Re:  Yasmin and Yaz Products Liability Litigation, MDL Docket No. 2100, No. 09-md-2100, S.D. Ill., E. St. Louis Div.).

  • December 5, 2018

    Valsartan Defendants Support Economic-Loss MDL, Want Injury Cases Excluded

    WASHINGTON, D.C. — Drug manufacturers sued because they make drugs containing valsartan on Nov. 20 supported centralization of federal lawsuits alleging economic injuries but not those alleging personal injuries in a multidistrict litigation (In Re:  Valsartan NDMA Contamination Litigation, MDL Docket No. 2875, JPMDL).

  • December 4, 2018

    Teva Latest To Recall Valsartan-Containing Hypertension Drug

    SILVER SPRING, Md. — Teva Pharmaceuticals on Nov. 27 became the eighth drug company to voluntarily recall valsartan-containing drugs because of the presence of N-nitrosodimethylamine (NDMA), a possible human carcinogen, the Food and Drug Administration announced.

  • December 4, 2018

    ASR MDL Court Told To Sort Out Texas Arbitration Award For Former Attorney

    CINCINNATI — The Sixth Circuit U.S. Court of Appeals on Nov. 30 remanded to the DePuy ASR hip multidistrict litigation court a dispute over whether a master settlement agreement governs an attorney fee application and supersedes a state court arbitration award of more than 62 percent (Andrea K. Drake, et al. v. DePuy Orthopaedics, Inc., et al., No. 18-3020, 6th Cir., 2018 U.S. App. LEXIS 33631).

  • December 4, 2018

    Judge Denies Dismissal Of False Claims Case Against Bristol-Myers Squibb

    PHILADELPHIA — A Pennsylvania federal judge on Nov. 29 denied a motion by Bristol-Myers Squibb Corp. (BMS) to dismiss a False Claims Act, 31 U.S. Code § 3729, lawsuit alleging that it engaged in two schemes to underpay statutorily required drug rebates to Medicaid (United States of America, ex rel. Ronald J. Streck v. Bristol-Myers Squibb Company, No. 13-7547, E.D. Pa., 2018 U.S. Dist. LEXIS 203656).

  • December 4, 2018

    DePuy Opposes Increase In Pinnacle Hip MDL Holdback, Warns Of Settlement ‘Hijack’

    DALLAS — DePuy Orthopaedics Inc. on Nov. 30 told the Pinnacle hip multidistrict litigation it opposes the Plaintiff Executive Committee’s (PEC) request to increase the 10 percent holdback from recent case inventory settlements, saying the PEC is attempting to “hijack and disrupt these settlements just to enrich its members at the expense of the rest of the MDL lawyers” (In Re:  DePuy Orthopaedics, Inc., Pinnacle Hip Implant Product Liability Litigation, MDL Docket No. 2244, No. 11-2244, N.D. Texas, Dallas Div.).

  • December 3, 2018

    Mother Decries Rulings On Experts In Depakote Birth Defect Case

    WASHINGTON, D.C. — Contrary to a drug company’s assertion, a Second Circuit U.S. Court of Appeals’ decision affirming exclusion of a mother’s causation experts in her attempt to hold the drugmaker liable for her child’s birth defects “creates a wide divergence from other courts” and will have “a profound effect upon thousands of litigants,” making certiorari proper, the mother argues in her Nov. 27 reply brief to the U.S. Supreme Court (N.K. v. Abbott Laboratories, No. 18-327, U.S. Sup., 2018 U.S. S. Ct. Briefs LEXIS 4422).

  • December 3, 2018

    U.S. High Court To Hear Fosamax Preemption Case Jan. 7; Solicitor General Included

    WASHINGTON, D.C. — Arguments about whether the Food and Drug Administration rejected a stronger warning about leg fractures on the label of the osteoporosis drug Fosamax will be heard by the U.S. Supreme Court on Jan. 7, according to an argument schedule released Dec. 3 (Merck Sharp & Dohme Corp. v. Doris Albrecht, et al., No. 17-290, U.S. Sup.).

  • November 30, 2018

    Judge Says DePuy Is Settling 2,965 Pinnacle Hip Cases; Amount Must Be Disclosed

    DALLAS — DePuy Orthopaedics Inc. is settling 2,965 cases involving the Pinnacle metal-on-metal hip, according to a Nov. 29 order by the Texas federal judge who is overseeing the multidistrict litigation (In Re:  DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation, MDL Docket No. 2244, No. 11-md-2244, N.D. Texas, Dallas Div.).