Mealey's Drugs & Devices

  • December 15, 2017

    With Last 2 Cases Gone, Pradaxa MDL Judge Again Recommends Termination

    EAST ST. LOUIS, Ill. — With the last two pending cases now closed, the Illinois federal judge overseeing the Pradaxa multidistrict litigation on Dec. 11 again recommended that the Judicial Panel on Multidistrict Litigation (JPMDL) terminate the MDL (In Re:  Pradaxa [Dabigatran Etexilate] Products Liability Litigation, MDL Docket No. 2385, No. 12-md-2385, S.D. Ill.).

  • December 15, 2017

    Pennsylvania Supreme Court Won’t Hear Appeal Of Zoloft Expert’s Exclusion

    PHILADELPHIA — The Pennsylvania Supreme Court on Dec. 13 denied a petition to review a Zoloft birth defect case that was dismissed when the plaintiffs’ causation expert was excluded by the trial court (Robert and Katherine Porter, et al. v. SmithKline Beecham Corporation, et al., No. 257 EAL 2017, Pa. Sup., Eastern Dist., 2017 Pa. LEXIS 3661).

  • December 15, 2017

    DaVita Pharmacy To Pay $63.7M To Settle Allegations Of False Claims, Kickbacks

    DALLAS — Nationwide pharmacy DaVita Rx LLC has agreed to pay $63.7 million to resolve federal false claims and kickback allegations that it billed federal health care programs for drugs it never shipped and for taking kickbacks in the form of patient assistance programs, the U.S. attorney for the Northern District of Texas announced Dec. 14 (United States of America, ex rel. Patsy Gallian, et al. v. DaVita Rx, LLC, et al., No. 3:16-cv-943, N.D. Texas).

  • December 15, 2017

    New Jersey State Court Jury Returns $15M Verdict In Ethicon Pelvic Mesh Trial

    HACKENSACK, N.J. — A New Jersey state court jury on Dec. 14 awarded $15 million to a plaintiff and her husband in the state’s second pelvic mesh trial (Elizabeth Hrymoc, et al. v. Ethicon, Inc., et al., No. L-13686-14, N.J. Super., Bergen Co.). VIDEO FROM THE TRIAL IS AVAILABLE

  • December 14, 2017

    Medtronic Pays $12M To 5 States For Deceptive Marketing Of Infuse Bone Graft

    BOSTON — Medtronic Inc. has agreed to pay $12 million to five states to resolve allegations that it engaged in deceptive marketing of the company’s Infuse bone graft, according to a consent judgment entered Dec. 13 in the Suffolk County, Mass., Superior Court (Commonwealth of Massachusetts v. Medtronic Sofamor Danek, Inc., et al., No. 17-4030D, Mass. Super., Suffolk Co.).

  • December 12, 2017

    Investor Group Named Lead Plaintiff In Drug Company’s Stock Drop Suit

    SAN FRANCISCO — An investor group is the most appropriate candidate for lead plaintiff because it has the largest financial stake in the litigation and meets all other statutory requirements to serve in the role, a federal judge in California ruled Dec. 8 in appointing the investor group as lead plaintiff (Inchen Huang v. Depomed Inc., et al., No. 17-4830, N.D. Calif., 2017 U.S. Dist. LEXIS 202580).

  • December 7, 2017

    Preemption Summary Judgment Reversed By 9th Circuit In Incretin Mimetic MDL Appeal

    SAN FRANCISCO — The Ninth Circuit U.S. Court of Appeals on Dec. 6 unsealed its Nov. 28 opinion reversing summary judgment in the incretin mimetic multidistrict litigation, saying the MDL judge misapplied a U.S. Supreme Court precedent, improperly blocked discovery, misinterpreted what constituted new evidence and improperly disqualified a plaintiff expert (In Re:  Incretin-Based Therapies Products Liability Litigation, Jean Adams, et al. v. Merck Sharp & Dohme Corp., et al., No. 15-56997, 9th Cir., 2017 U.S. App. LEXIS 24674).

  • December 6, 2017

    9th Circuit Denies Try By Ex-InterMune CEO To Revisit Expert Witness Issue

    SAN FRANCISCO — Former InterMune Inc. CEO W. Scott Harkonen, M.D., on Dec. 4 lost another attempt to vacate his 2009 wire fraud conviction when the Ninth Circuit U.S. Court of Appeals said he and his trial counsel voluntarily decided not to present testimony by their own biostatistician and pulmonologist and there was no ineffective counsel (United States of America v. W. Scott Harkonen, M.D., No. 15-16844, 9th Cir., 2017 U.S. App. LEXIS 24475).

  • December 6, 2017

    About 180 Federal Opioid Cases Centralized In MDL Assigned To Ohio Court, Judge

    WASHINGTON, D.C. — A federal judicial panel on Dec. 5 centralized almost 180 federal lawsuits against opioid manufacturers and distributers by cities, counties and state before U.S. Judge Dan A. Polster of the Northern District of Ohio (In Re:  National Prescription Opiate Litigation, MDL Docket No. 2804, JPMDL).

  • December 6, 2017

    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, 2017

    Philippines FDA Orders Sanofi Pasteur To Pull New Dengue Fever Vaccine

    MUNTINLUPA, Philippines — The Philippines Food and Drug Administration on Dec. 4 ordered Sanofi Pasteur Inc. to suspend the sale and distribution of its Dengvaxia dengue fever vaccine in the wake of a post-marketing clinical study indicating that the vaccine poses a potential risk to patients who have not previously been infected by the virus.

  • December 5, 2017

    Pennsylvania Jury Awards $27.8M In State’s 1st Xarelto Trial

    PHILADELPHIA — A Pennsylvania state court jury on Dec. 5 awarded an Indiana woman and her husband $27.8 million for injuries allegedly caused by the anticoagulant drug Xarelto, a source told Mealey Publications (Lynn Hartman, et al. v. Janssen Pharmaceuticals, Inc., et al., No. 160503416, Pa. Comm. Pls., Philadelphia Co.).

  • December 5, 2017

    Medtronic Insulin Pump Case Dismissed As Preempted, But Plaintiff Can Refile

    CAMDEN, N.J. — A New Jersey federal judge on Nov. 30 said that a plaintiff’s claims involving an allegedly defective Medtronic Inc. insulin pump are preempted but that in light of the seriousness of the plaintiff’s alleged injuries, the plaintiff can file an amended complaint to assert claims that will parallel federal regulations (Kevin Hart v. Medtronic, Inc., et al., No. 16-5404, D. N.J.).

  • December 5, 2017

    Mentor Asks Judicial Panel To End ObTape Pelvic Mesh MDL After Zero Cases Remain

    COLUMBUS, Ga. — One of the oldest active pelvic mesh multidistrict litigations has no more cases, and the MDL should be closed, defendant Mentor Worldwide LLC told the U.S. District Court for the Middle District of Georgia on Dec. 4 (In Re:  Mentor Corp. ObTape Transobturator Sling Products Liability Litigation, MDL Docket No. 2004, No. 08-md-2004, M.D. Ga.).

  • December 5, 2017

    Opioid False Claims Lawsuit Voluntarily Dismissed By Relator; U.S. Motion Still Sealed

    SYRACUSE, N.Y. — A whistleblower on Nov. 30 was allowed by a New York federal court to voluntarily dismiss without prejudice her five-month-old federal False Claims Act lawsuit against six large opioid manufacturers in light of a federal government investigation, according to a court order (State of New York, ex rel. Laurie Khanzadian v. Purdue Pharma, Inc., et al., No. 17-742, N.D. N.Y., 2017 U.S. Dist. LEXIS 197239).

  • December 4, 2017

    Parties Ask 9th Circuit To Unseal Nov. 28 Ruling In Incretin Mimetics MDL Case

    SAN FRANCISCO — Defendants and plaintiffs on Dec. 1 and Nov. 30 urged the Ninth Circuit U.S. Court of Appeals to unseal its Nov. 28 order in their appeal of the dismissal of claims involving incretin mimetic diabetes drugs (Jean Adams, et al. v. Merck Sharpe & Dohme Corp., et al., No. 15-56997, 9th Cir.).

  • December 4, 2017

    U.S. Supreme Court Asks Solicitor General To Weigh In On Fosamax Preemption

    WASHINGTON, D.C. — The U.S. Supreme Court on Dec. 4 invited the U.S. solicitor general to express the views of the United States on whether there is “clear and convincing evidence” that the Food and Drug Administration would have rejected a stronger warning about femur fractures from the osteoporosis drug Fosamax (Merck Sharpe & Dohme Corp. v. Doris Albrecht, et al., No. 17-290, U.S. Sup.).

  • December 4, 2017

    Washington Supreme Court Won’t Be Asked To Rule On City’s Opioid Suit

    SEATTLE — A Washington federal judge on Nov. 30 denied a motion by opioid maker Purdue Pharma LP to certify to the state Supreme Court its challenge of a city’s use of the municipal cost-recovery rule for costs that the defendant says are not a cognizable tort injury (City of Everett v. Purdue Pharma L.P., et al., No. 17-209, W.D. Wash., Seattle Div.).

  • December 1, 2017

    OIG Rescinds Approval Of Drug Patient Assistance Program For Privacy Breaches

    WASHINGTON, D.C. — The Office of Inspector General (OIG) on Nov. 28 rescinded a 2006 advisory opinion for the drug patient assistance program Caring Voice Coalition Inc. after determining that the program provided patient-specific data to one or more supporting drug companies, according to an OIG letter and a company statement.

  • December 1, 2017

    Cherokee Nation’s Actos ‘Lien’ Transferred From MDL To Oklahoma Federal Court

    LAFAYETTE, La. — Although she said she has “grave doubts” about whether the Cherokee Nation has a substantive claim to a third-party lien in the Actos settlement, the Louisiana judge overseeing the multidistrict litigation on Nov. 28 issued a final ruling that the court lacks venue and granted a motion by defendant Takeda Pharmaceuticals USA Inc. to transfer the case to a federal court in Oklahoma where the tribe and its allegedly injured members are located (In Re:  Actos [Pioglitazone] Products Liability Litigation, MDL No. 2299, No. 11-md-2299, Cherokee Nation v. Takeda Pharmaceuticals U S A Inc et al., No. 15-1485, W.D. La., 2017 U.S. Dist. LEXIS 196577).