Mealey's Drugs & Devices

  • March 23, 2017

    3rd Circuit Overturns Merck’s Preemption Win In Fosamax Cases

    PHILADELPHIA — A Third Circuit U.S. Court of Appeals panel on March 22 reversed a federal judge in New Jersey’s ruling awarding summary judgment to the maker of the osteoporosis drug Fosamax, finding that the manufacturer was unable to produce evidence showing that the Food and Drug Administration would not have approved a stronger warning on the drug’s label regarding the risk of femoral fracture (In re Fosamax [Alendronate Sodium] Products Liability Litigation, No. 14-1900, 3rd Cir., 2017 U.S. App. LEXIS 5075).

  • March 22, 2017

    Former NECC Head Found Not Guilty Of Murder In Fungal Meningitis Outbreak

    BOSTON — A Massachusetts federal jury on March 22 found the former head of the New England Compounding Center (NECC) not guilty of murder in connection with a deadly fungal meningitis outbreak tied to contaminated compounded drugs, but found him guilty of racketeering and fraud (United States of America v. Barry J. Cadden, No. 14-10363, D. Mass.).

  • March 22, 2017

    ICSID Dismisses Eli Lilly's Claims Against Canada For Patent Invalidation

    WASHINGTON, D.C. — A tribunal for the International Centre for Settlement of Investment Disputes (ICSID) on March 20 issued its final award in a dispute over Canadian drug patents, dismissing all of a pharmaceutical company's claims and finding that the invalidation of the patents by Canadian courts did not constitute violations of the North American Free Trade Agreement (NAFTA) (Eli Lilly and Company v. Government of Canada, No. UNCT/14/2, ICSID).

  • March 22, 2017

    Novartis Wants To Bar United States From Using ‘Markers’ In Fraud Case

    NEW YORK — Novartis Pharmaceuticals Corp. (NPC) on March 14 asked a federal court to conduct a pre-motion conference, saying it wants partial summary judgment preventing the United States from using “markers” to show the drug company conducted sham medical education events and paid unlawful kickbacks to health care providers (United States of America, ex rel. Oswald Bilotta v. Novartis Pharmaceuticals Corp., No. 11-71, S.D. N.Y.).

  • March 22, 2017

    Actos MDL Judge Tells JPMDL To Stop Transferring New Cases, Citing Settlement

    LAFAYETTE, La. — A Louisiana federal judge on March 14 recommended that a judicial panel transfer no new cases into the Actos multidistrict litigation, a docket once home to 5,185 cases and one that generated a $9 billion verdict in its first bellwether trial (In Re:  Actos [Pioglitazone] Products Liability Litigation, MDL Docket No. 2299, No. 11-md-2299, W.D. La., Lafayette Div.).

  • March 21, 2017

    Judge Refuses To Strike Widow’s Expert’s Testimony On Access To Data

    CHICAGO — A federal judge in Illinois overseeing a trial claiming that a former Reed Smith partner’s use of the antidepressant Paxil caused him to commit suicide in 2010 on March 20 denied the drug maker’s motion to strike portions of testimony from a plaintiff’s expert of the amount of data he had access to that purportedly showed that suicidal events were underreported during studies (Wendy Dolin v. SmithKline Beechman Corporation, d/b/a GlaxoSmithKline, No. 12-cv-6403, N.D. Ill.).

  • March 17, 2017

    Eliquis MDL Parties Disagree Whether Preemption Ruling Would Be A Silver Bullet

    NEW YORK — Parties in the 37-day-old Eliquis multidistrict litigation on March 16 told the judge they disagree whether a preemption ruling in one case will be dispositive of all cases in the litigation (In Re:  Eliquis [Apixaban] Products Liability Litigation, MDL Docket No. 2754, No. 17-md-2754, S.D. N.Y.).

  • March 17, 2017

    New York Informed Intermediary Doctrine Results In Dismissal Of Orthopedic Cable Case

    NEW YORK — A New York federal judge on March 16 granted summary judgment to Zimmer Inc. and Pioneer Surgical Technology Inc. after finding that a doctor was an informed intermediary and knew that a cable used in a femur fracture repair could break (Mary Tomaselli, et al. v. Zimmer, Inc., et al., No. 14-4474, S.D. N.Y., 2017 U.S. Dist. LEXIS 37203).

  • March 17, 2017

    FDA Warns IBS Drug Viberzi May Cause Pancreatitis In Patients Without Gallbladder

    SILVER SPRING, Md. — The Food and Drug Administration on March 15 issued a drug safety communication warning that the irritable bowel syndrome (IBS) drug Viberzi has been associated with reports of hospitalizations and deaths in patients who do not have a gallbladder.

  • March 16, 2017

    Lead Plaintiffs Seek Class Certification In Puma Biotech Securities Suit

    SANTA ANA, Calif. — Lead plaintiffs in a securities class action lawsuit against a drug maker and certain of its executive officers asked a federal judge in California on March 15 to certify a class of investors, arguing that class certification is statutorily appropriate (Hsingching Hsu v. Puma Biotechnology Inc., et al., No. 15-0865, C.D. Calif.).

  • March 15, 2017

    Mentor Pelvic Mesh MDL Judge Disagrees With 11th Circuit Time-Bar Ruling

    A Georgia federal judge overseeing the Mentor ObTape pelvic mesh multidistrict litigation on March 14 openly disagreed with a March 9 11th Circuit U.S. Court of Appeals decision reversing the MDL judge’s statute-of-limitations ruling against 12 plaintiffs (Deborah Ann Rogers v. Mentor Corporation, et al., No 16-10119, et al., 11th Cir., 2017 U.S. App. LEXIS 4184, In Re:  Mentor Corp. ObTape Transobturator Sling Products Liability Litigation, MDL Docket No. 2004, No. 08-2004, M.D. Ga., Columbus Div., 2017 U.S. Dist. LEXIS 35833).

  • March 15, 2017

    7th Circuit Vacates Class Certification In Eye Drop Size Suit, Orders Dismissal

    CHICAGO — A Seventh Circuit U.S. Court of Appeals panel on March 6 vacated the grant of class certification in a lawsuit over the size of eye drops and remanded with directions to dismiss the lawsuit with prejudice, opining that there is no cause of action (Charlene Eike, et al v. Allergan, Inc., et al., No. 16-3334, 7th Cir., 2017 U.S. App. LEXIS 3954).

  • March 15, 2017

    Medtronic Tells 5th Circuit That Plaintiffs’ New Evidence Won’t Make A Difference

    NEW ORLEANS — Medtronic Inc. on March 9 told the Fifth Circuit U.S. Court of Appeals that a plaintiff failed to exercise due diligence about other possible causes of his injury and that his “newly discovered evidence” would not have changed the outcome of his case (Bryant Lyles v. Medtronic Sofamor Danek USA, Inc., Nos. 16-30517 and 16-31044, 5th Cir.).

  • March 15, 2017

    Mass Tort Cases For Drugs, Medical Devices

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

  • March 15, 2017

    MDL Sought For Recalled Ethicon Physiomesh Hernia Mesh Patch

    WASHINGTON, D.C. — Nine plaintiffs on March 9 asked a federal judicial panel to centralize federal lawsuits alleging injury from the Physiomesh Flexible Composite hernia patch (In Re:  Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation, MDL Docket No. 2782, JPMDL).

  • March 15, 2017

    Consent Decree Entered Against Denver Supplement Maker For Unapproved New Drugs

    DENVER — A Colorado federal judge on March 13 entered a consent decree of permanent injunction against EonNutra LLC., CDSM LLC, HAWB LLC and owner Michael Floren for distributing unapproved drugs and dietary supplements (United States of America v. EonNutra, LLC, et al., No. 17-633, D. Colo.).

  • March 14, 2017

    Benicar MDL Plaintiff Experts Must Produce Patient Records Relied On In Reports

    CAMDEN, N.J.  — A New Jersey federal magistrate judge overseeing the Benicar multidistrict litigation on March 13 ordered plaintiffs to produce redacted records of Benicar patients on which two experts relied (In Re:  Benicar [Olmesartan] Products Liability Litigation, MDL Docket No. 2606, No. 15-2606, D. N.J.).

  • March 14, 2017

    Jury Selection To Begin In Suicide Case Based On Paxil Warning Label

    CHICAGO — Jury selection is scheduled to begin March 14 in a wrongful death case in which GlaxoSmithKline PLC (GSK) is accused of failing to update its Paxil label to warn about the risk of suicide (Wendy Dolin, et al. v. SmithKline Beecham Corporation, et al., No. 12-6403, N.D. Ill., Eastern Div.).

  • March 14, 2017

    Defense Rests In Murder Trial Of Former NECC Head For Fungal Meningitis Outbreak

    BOSTON — The defense in the federal murder trial of the former head of the New England Compounding Center (NECC) rested March 13 after 44 days of testimony but only three days of defense witnesses (United States of America v. Barry J. Cadden, No. 14-10363, D. Mass.).

  • March 13, 2017

    11th Circuit: ObTape Claims By 12 Minnesota Residents Are Not Time-Barred

    ATLANTA — The 11th Circuit U.S. Court of Appeals on March 9 said a multidistrict litigation court erred in dismissing as time-barred the claims of 12 Mentor Corp. pelvic mesh plaintiffs, finding that Minnesota law requires plaintiffs to know about a causal connection between a device and their injury before the statute of limitations begins to run (Deborah Ann Rogers v. Mentor Corporation, et al., No 16-10119, et al., 11th Cir., 2017 U.S. App. LEXIS 4184).