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Mealey's Drugs & Devices

  • June 13, 2018

    Lipitor MDL Plaintiffs Lose On Appeal As 4th Circuit Upholds Experts’ Rejection

    RICHMOND, Va. — Finding no abuse or error in a federal judge’s exclusion of the causation opinions of three experts for thousands of women seeking to hold Pfizer Inc. liable for their diabetes, which they say was caused by using the popular cholesterol drug Lipitor, the Fourth Circuit U.S. Court of Appeals on June 12 affirmed a summary judgment ruling against the plaintiffs (In Re:  Lipitor [Atorvastatin calcium] Products Liability Litigation, Nos. 17-1140, 17-1136, 17-1137, 17-1189, 4th Cir., 2018 U.S. App. LEXIS 15752).

  • June 13, 2018

    Panel Holds DA Can Seek Damages For UCL Violations Only In Elected County

    SAN DIEGO — A California appeals panel on May 31 granted a petition for relief filed by a group of pharmaceutical companies in relation to a district attorney’s allegations that they violated California’s unfair competition law (UCL) by engaging in a scheme to keep generic versions of a drug off the market, finding that a DA cannot seek monetary recovery for violations outside his elected county (Abbott Laboratories, et al. v. The Superior Court of Orange County, The People, ex rel., No. D072577, Calif. App., 4th Dist., 2018 Cal. App. LEXIS 507).

  • June 12, 2018

    6th Circuit Reverses Summary Judgment In Risperdal Gynecomastia Suit

    CINCINNATI — The Sixth Circuit U.S. Court of Appeals on June 11 reversed summary judgment in a Risperdal gynecomastia lawsuit after finding that the trial court applied the wrong Kansas statute of repose (Joseph W. Ehrenfelt v. Janssen Pharmaceuticals, Inc., et al., No. 17-5292, 6th Cir., 2018 U.S. App. LEXIS 15650).

  • June 12, 2018

    Endo Settles All Known Testosterone Drug Cases

    DUBLIN, Ireland — Endo International PLC on June 11 announced that its Endo Pharmaceuticals Inc. and Auxilium Pharmaceuticals LLP subsidiaries have entered into a master settlement agreement to resolve “all known” testosterone replacement therapy product liability claims.

  • June 11, 2018

    Pennsylvania Superior Court Affirms Preemption Of Opioid Off-Label Death Claim

    PHILADELPHIA — The Pennsylvania Superior Court on June 8 affirmed that a father’s claim that his son’s overdose death was caused by the off-label promotion of the opioid Actiq are preempted by federal law (Joseph A. Caltagirone, et al. v. Cephalon, Inc., et al., No. 1301 EDA 2017, Pa. Super., 2018 Pa. Super. LEXIS 628).

  • June 8, 2018

    Lundbeck To Pay $52.6M To Settle Federal Probe Into Patient Assistant Donations

    VALBY, Denmark — H. Lundbeck A/S on June 6 announced that its U.S. subsidiary Lundbeck LLC has reached an agreement in principle with the U.S. Department of Justice to settle an investigation into the domestic subsidiary’s donations to independent patient assistance charitable foundations for $52.6 million, according to a company press release.

  • June 6, 2018

    Mass Tort Cases For Drugs, Medical Devices

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

  • June 6, 2018

    Separate Track Created In Opioid MDL For All 567 Indian Tribes In United States

    CLEVELAND — The Ohio federal judge overseeing the opioid multidistrict litigation on June 4 assigned a magistrate judge to work with Native American tribes to develop a separate track for tribal claims (In Re:  National Prescription Opiate Litigation, MDL Docket No. 2804, No. 17-2804, N.D. Ohio, Eastern Div.).

  • June 6, 2018

    Judge: Absence Of Pradaxa Antidote Isn’t A Design Defect

    HUNTINGTON, W.Va. — A West Virginia federal judge on May 31 granted partial summary judgment in a Pradaxa death case, saying the plaintiffs cannot argue that the lack of an antidote for the anticoagulant is a design defect (Claude R. Knight, et al. v. Boehringer Ingelheim Pharmaceuticals, Inc., et al., No. 15-6424, S.D. W.Va., Huntington Div., 2018 U.S. Dist. LEXIS 92764).

  • June 6, 2018

    5th AndroGel Bellwether Trial Claiming Blood Clot Injury Under Way In MDL

    CHICAGO — An AndroGel multidistrict litigation bellwether trial got under way on June 5 in the U.S. District Court for the Northern District of Illinois (In Re:  Testosterone Replacement Therapy Products Liability Litigation, MDL Docket No. 2545, No. 14-1748, Robert Rowley, et al. v. AbbVie, Inc., et al., No. 15-2760, N.D. Ill.).

  • June 6, 2018

    Health Insurer, Pharmacy Benefit Manager Must Comply With EpiPen MDL Subpoenas

    KANSAS CITY, Kan. — A Kansas magistrate judge overseeing the EpiPen multidistrict litigation on May 31 ordered nonparty United Healthcare Services Inc. and its pharmacy benefit manager Optum Rx. Inc. to produce rebate and incentive information that plaintiffs say may show anti-competitive practices with EpiPen manufacturer Mylan N.V. (In Re:  EpiPen [Epinephrine Injection, USP] Sales Practices and Antitrust Litigation, MDL Docket No. 2785, No. 17-md-2785, United Healthcare Services, Inc. v. Consumer Class Plaintiffs, No. 18-md-205, D. Kan.).

  • June 6, 2018

    FDA Warns Websites To Stop Marketing Unapproved, Misbranded Opioids

    SILVER SPRING — The U.S. Food and Drug Administration on June 5 warned nine online networks operating a total of 53 websites that they must stop illegally marketing potentially dangerous, unapproved and misbranded versions of opioid medications, including tramadol and oxycodone, or face injunctions or product seizures.

  • June 5, 2018

    Generic Imitrex Warning, Design Claims Are Preempted, Judge Rules

    GREENVILLE, S.C. — A South Carolina federal judge on May 31 dismissed a generic Imitrex case, saying the plaintiff’s warning and design defect claims are clearly preempted by U.S. Supreme Court rulings (Jennifer Galloway v. Aurobindo Pharma Limited Inc., et al., No. 17-1076, D. S.C., Greenville Div., 2018 U.S. Dist. LEXIS 90494).

  • June 5, 2018

    7th Circuit: Plaintiff Needs Expert To Pursue Broken IUD Complaint

    CHICAGO — The Seventh Circuit U.S. Court of Appeals on June 4 affirmed a lower court ruling that a plaintiff must designate an expert to testify as to why an intrauterine device (IUD) broke while it was being removed (Cheryl Dalton v. Teva North America, et al., No. 17-1990, 7th Cir., 2018 U.S. App. LEXIS 14709).

  • June 4, 2018

    2nd Bard IVC Filter MDL Bellwether Trial Ends In Defense Verdict

    PHOENIX — The second C.R. Bard Inc. inferior vena cava (IVC) filter multidistrict litigation bellwether trial ended June 1 in a defense verdict (In Re:  Bard IVC Filters Product Liability Litigation, MDL Docket No. 15-2641, Doris Jones v. C.R. Bard, Inc., No. 16-782, D. Ariz.).

  • June 4, 2018

    Plaintiff Leadership Named In Sorin 3T MDL

    HARRISBURG, Pa. — The Pennsylvania federal judge overseeing the Sorin 3T heater-cooler multidistrict litigation on May 31 appointed plaintiff attorneys to leadership positions (In Re:  Sorin 3T Heater-Cooler System Products Liability Litigation (No. II), MDL Docket No. 2816, No. 18-md-2816, M.D. Pa.).

  • June 1, 2018

    Right To Access Experimental Drugs Signed Into Law; Lawsuits Are Barred

    WASHINGTON, D.C. — President Donald J. Trump on May 30 signed into law the Right to Try Act of 2017 that gives patients with life-threatening conditions the ability to access investigational drugs or biological products as a last-ditch effort. 

  • June 1, 2018

    6th Circuit Affirms Injunction Against Lawyer’s Asset Shuffle In Fen-Phen Case

    CINCINNATI — Saying that former famed plaintiff attorney Stanley M. Chesley has been orchestrating a “high-stakes shell game” to escape a $42 million judgment by Kentucky fen-phen plaintiffs, the Sixth Circuit U.S. Court of Appeals on May 31 affirmed a trial court’s preliminary injunction freezing Chesley’s assets from further transfer and distribution (Connie McGirr, et al. v. Thomas F. Rehme, et al., No. 17-3519, 6th Cir., 2018 U.S. App. LEXIS 14329).

  • June 1, 2018

    ‘Opioid Baby’ Track Sought In Opioid MDL

    CLEVELAND — Eight plaintiffs on May 31 asked the opioid multidistrict litigation court to create a track for cases involving neonatal abstinence syndrome (NAS), or what the plaintiffs call “opioid babies” (In Re:  National Prescription Opioid Litigation, MDL Docket No. 2804, Rees v. McKesson Corporation, et al., No. 18-45252, N.D. Ohio, Eastern Div.).

  • May 31, 2018

    Ex-Insys Sales Representative Pleads Guilty In New Jersey For Opioid Kickbacks

    NEW BRUNSWICK, N.J. — A former sales representative for opioid maker Insys Therapeutics Inc. pleaded guilty on May 30 to conspiracy to bribe doctors who prescribed the company’s Subsys fentanyl-based pain drug for off-label uses, according to a press release from the New Jersey attorney general’s office.