Mealey's Drugs & Devices

  • June 05, 2019

    Valsartan MDL Judge Names Plaintiff, Defense Leadership

    CAMDEN, N.J. — The New Jersey federal judge overseeing the valsartan multidistrict litigation on May 6 appointed plaintiff and defense counsel to leadership positions (In Re:  Valsartan Products Liability Litigation, MDL Docket No. 2875, No. 19-md-2875, D. N.J., Camden Vicinage).

  • June 05, 2019

    Gadolinium Claim Time-Barred By Plaintiff’s Admission To FDA Committee

    CLEVELAND — An Ohio federal judge on May 15 dismissed a woman’s gadolinium contrast agent injury lawsuit as time-barred after defendant Bayer Healthcare Pharmaceuticals Inc. turned up the plaintiff’s public testimony that she knew her physical problems were allegedly caused by Magnevist (Lori Combs v. Bayer Healthcare Pharmaceuticals Inc., et al., No. 18-802, N.D. Ohio, Eastern Div., 2019 U.S. Dist. LEXIS 82268).

  • June 05, 2019

    Zofran MDL Birth Defect Parties Debate Effect Of Albrecht Preemption Ruling

    BOSTON — Parties in the Zofran birth defect multidistrict litigation on June 3 submitted briefs on the applicability of the U.S. Supreme Court’s recent ruling in Merck Sharp & Dohme v. Albrecht, 587 U.S. ____ (2019) (In Re:  Zofran [Ondansetron] Products Liability Litigation, MDL Docket No. 2657, No. 15-md-2657, D. Mass.).

  • June 04, 2019

    Taxotere MDL Magistrate Finds No Improper Facebook Posts, Quashes Defense Subpoena

    NEW ORLEANS — A special master in the Taxotere hair-loss multidistrict litigation on May 29 said his in camera review of emails about an alleged request to delete Facebook comments about the chemotherapy drug and hair loss in female patients showed “no improper communications, instructions or guidance provided by counsel” and that the documents are not discoverable by defendant Sanofi-Aventis U.S. LLC (In Re:  Taxotere [Docetaxel] Product Liability Litigation, MDL Docket No. 2740, No. 16-md-2740, E.D. La.).

  • June 04, 2019

    Florida Stem Cell Clinic Enjoined By Federal Judge For FDA Violations

    FORT LAUDERDALE, Fla. — A Florida federal judge on June 3 entered an injunction against a stem cell treatment clinic after agreeing with the Food and Drug Administration that the clinic is subject to the Food, Drug and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq., and that its products are adulterated and misbranded drugs (United States v. US Stem Cell Clinic, LLC, et al., No. 18-61047, S.D. Fla.).

  • June 04, 2019

    Judge In Bard IVC Filter MDL Closes Docket To New Cases With 7,370 Remaining

    PHOENIX — The Arizona federal judge overseeing the C.R. Bard inferior vena cava (IVC) filter multidistrict litigation on May 31 ordered the MDL closed to new cases with 7,370 cases remaining on the docket as of May 15 (In Re:  Bard IVC Filters Products Liability Litigation, MDL Docket No. 2641, No. 15-md-2641, D. Ariz.).

  • June 03, 2019

    2 Indicted For Allegedly Profiting Off Pelvic Mesh Removal Surgery, Settlements

    BROOKLYN, N.Y. — The United States on May 23 indicted a doctor and a funding consultant for allegedly defrauding women with pelvic mesh implants by arranging for removal surgery in exchange for shares of settlements (United States v. Wesley Blake Barber, et al., No. 19-cr-239, E.D. N.Y.).

  • June 03, 2019

    Generic Drug Maker Defers Antitrust Prosecution, Pays $7.32M In Settlements

    PHILADELPHIA — Generic drug maker Heritage Pharmaceuticals Inc. entered into a deferred prosecution agreement on a criminal charge of price fixing and agreed to pay a total of $7.32 million for a criminal penalty and civil settlement of false claims allegations, the U.S. Justice Department said in a May 30 press release (United States v. Heritage Pharmaceuticals Inc., No. 19-cr-316, E.D. Pa.).

  • May 31, 2019

    Illinois Appeals Court:  State Court Has Jurisdiction In Nonresident Essure Cases

    MOUNT VERNON, Ill. — An Illinois state appeals court panel on May 29 said that because Bayer Corp. purposefully availed itself to Illinois during development of the Essure birth control device, 87 nonresident plaintiffs made a prima facie showing of personal jurisdiction (Christy Rios, et al. v. Bayer Corporation, et al., No. 5-18-0278, Ill. App., 5th Dist., 2019 Ill. App. Unpub. LEXIS 972).

  • May 31, 2019

    Ex-NECC Pharmacist Gets 8 Months’ House Arrest, 2 Years’ Probation

    BOSTON — A former pharmacist at the New England Compounding Center (NECC) was sentenced May 30 to eight months of home confinement, two years of probation and 100 hours of community service for his conviction on charges stemming from the shipment of nonsterile and sub-potent drugs from the former compounding pharmacy (United States of America v. Christopher M. Leary, No. 14-cr-10363, D. Mass.).

  • May 31, 2019

    Missouri Federal Judge OKs Causation Expert For Woman’s Vioxx MDL Case

    KANSAS CITY, Mo. — A Missouri federal judge on May 28 declined a request by drugmaker Merck & Co. Inc. to exclude expert testimony linking a woman’s heart attacks to the arthritis pain drug Vioxx, saying the expert’s opinions “rest upon good grounds” under Eighth Circuit U.S. Court of Appeals precedent (Jo Levitt v. Merck & Company, Inc., No. 4:06-cv-00818, W.D. Mo., 2019 U.S. Dist. LEXIS 88454).

  • May 30, 2019

    Former NECC Pharmacist Gets 2-1/2 Years In Prison For Racketeering, Fraud

    BOSTON — A Massachusetts federal judge on May 29 sentenced a former pharmacist at the New England Compounding Center (NECC) to 2-1/2 years in jail following his conviction on charges of racketeering, mail fraud and violating the Food, Drug and Cosmetic Act (FDCA) (United States v. Gene Svirskiy, No. 14-cr-10363-RGS-3, D. Mass.).

  • May 30, 2019

    Drug Distributor Pays $22M For Not Flagging Suspect Opioid Orders By Pharmacies

    SHREVEPORT, La. — A company described by the federal government as the largest privately owned wholesale drug distributor in the United States has agreed to pay $22 million in civil penalties to resolve federal allegations that it violated the Controlled Substances Act by failing to report suspicious orders of the opioids hydrocodone and oxycodone, the parties announced May 24.

  • May 29, 2019

    Johnson & Johnson Counsel Tells Oklahoma Judge Company Didn’t Start Opioid Crisis

    NORMAN, Okla. — An attorney for Johnson & Johnson and subsidiary Janssen Pharmaceuticals Inc. on May 28 told an Oklahoma federal judge that the companies’ Duragesic pain patch and its former Nucynta opioid pill are regulated by the federal and Oklahoma governments and did not cause or contribute to the state’s opioid epidemic (Oklahoma, et al. v. Purdue Pharma L.P., et al., No. CJ-2017-816, Okla. Dist., Cleveland Co.).  VIDEO FROM THE TRIAL IS AVAILABLE.

  • May 28, 2019

    Supreme Court Won’t Review Paxil Suicide Preemption Case After Albrecht Decision

    WASHINGTON, D.C. — The U.S. Supreme Court on May 28 denied review of a circuit court of appeals ruling vacating a $3 million Paxil suicide verdict on the grounds of federal preemption (Wendy B. Dolin, et al. v. GlaxoSmithKline, LLC, et al., No. 18-803, U.S. Sup.).

  • May 28, 2019

    Opening Arguments Begin In Oklahoma Opioid Trial Against Johnson & Johnson

    NORMAN, Okla. — An attorney for the state of Oklahoma on May 28 told a state court judge that Johnson & Johnson knew that opioids are addictive but still created a demand for them and created a supply that led to the state’s opioid crisis and death (Oklahoma, et al. v. Purdue Pharma L.P., et al., No. CJ-2017-816, Okla. Dist., Cleveland Co.).

  • May 28, 2019

    Teva Settles Oklahoma Opioid Lawsuit For $85M 2 Days Before Start Of Trial

    Opioid defendant Teva Pharmaceuticals USA and the Oklahoma attorney general on May 26 announced an $85 million settlement of the state’s public nuisance lawsuit against the company (Oklahoma, et al. v. Purdue Pharma L.P., et al., No. CJ-2017-816, Okla. Dist., Cleveland Co.).

  • May 24, 2019

    Michael Avenatti May Be Out As Class Counsel In MicroCool Surgical Gown Class Action

    LOS ANGELES — A California federal judge on May 23 issued an “indicative ruling” that if a $24.53 million verdict in a statewide surgical gown class action is reversed on appeal and returned to the trial court, she will remove plaintiff attorney Michael J. Avenatti as class counsel and replace him with two other lawyers (Bahamas Surgery Center, LLC v. Kimberly-Clark Corporation, et al., No. CV 14-8390-DMG, C.D. Calif.).

  • May 23, 2019

    Olympus Executive Gets $5,000 Fine, Probation For Misbranding Duodenoscope

    NEWARK, N.J. — A New Jersey federal judge on May 22 sentenced a Japanese executive of Olympus Medical Systems Corp. to one year of probation and a $5,000 fine for allowing the sale of a misbranded duodenoscope linked to patient lung infections (United States v. Hisao Yabe, No. 18-cr-726, D. N.J.).

  • May 23, 2019

    Texas Compounding Pharmacy, Owners Sign Consent Decree After Failed FDA Inspections

    HOUSTON — A Texas federal judge on May 22 issued a consent decree of permanent injunction against Houston drug compounder Pharm D Solutions LLC and its two pharmacist-owners after the United States accused them of compounding drugs under unsanitary conditions, making sub-potent drugs and making unapproved new drugs (United States of America v. Pharm D Solutions LLC, et al., No. 19-cv-1813, S.D. Texas).

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