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Amos v. Biogen Idec Inc.

United States District Court, W.D. New York

April 10, 2017

GREGORY A. AMOS, in his capacity as Administrator of the Estate of ANDREA R. AMOS, Deceased, Plaintiff,
v.
BIOGEN IDEC INC. and ELAN PHARMACEUTICALS, INC., Defendants.

          DECISION AND ORDER

          MICHAEL A. TELESCA United States District Judge

         INTRODUCTION

         Plaintiff Gregory A. Amos (“plaintiff”), the widower of Andrea R. Amos (“Mrs. Amos”) and administrator of her estate, brings this wrongful death action against defendants Biogen Idec Inc., (“Biogen”) and Elan Pharmaceuticals, Inc. (“Elan”) (collectively “defendants”), alleging that Mrs. Amos died as the direct result of taking the prescription drug Tysabri, which was developed, marketed, and sold by the defendants. Specifically, plaintiff claims that Mrs. Amos' use of Tysabri caused her to develop a fatal infection in her brain, and that the warnings included with Tysabri failed to adequately warn of this risk.

         Defendants deny any liability and move pursuant to Rule 56 of the Federal Rules of Civil Procedure for summary judgment against the plaintiff. Defendants contend that: (1) Tysabri's warnings were adequate as a matter of law; (2) plaintiff has not produced competent evidence that the label warnings were inadequate; (3) plaintiff cannot establish proximate cause; and (4) plaintiff's claims are preempted by federal law. In addition, defendants have moved in limine to preclude certain testimony by plaintiff's expert, Eugene O. Major, Ph.D. (“Dr. Major”). Plaintiff opposes both of defendants' motions.

         For the reasons set forth below, the Court grants defendants' motion for summary judgment. Defendants' motion to preclude Dr. Major's testimony is denied as moot.

         BACKGROUND

         The following facts are taken from the respective statements of fact, affidavits, and exhibits submitted by plaintiff and defendant.

         I. Multiple Sclerosis and Tysabri

         Multiple sclerosis (“MS”) is a chronic, progressive, and disabling autoimmune disease, in which white blood cells enter the central nervous system (“CNS”) and attack myelin, a fatty substance that surrounds nerve cells and assists in the transmission of signals to and from the brain. MS gradually destroys myelin (a process known as “demyelination”), resulting in nerve damage throughout the brain and spinal cord. The damage caused by demyelination may result in brain atrophy, cognitive impairment, limited mobility, and shortened life expectancy. There are multiple types of MS, including “relapsing-remitting MS, ” wherein specific attacks are followed by remission, and “secondary progressive MS, ” wherein the disease continually worsens without identifiable periods of remission. There is no known cure for MS and all current treatments have side effects.

         Tysabri is the brand name for natalizumab, a humanized monoclonal antibody that inhibits the ability of inflammatory white blood cells to enter the CNS and thereby protects against demyelination. Tysabri decreases relapses in individuals with MS and can reduce and delay nerve damage. The Food and Drug Administration (the “FDA”) first approved Tysabri in November 2004 for treatment of relapsing forms of MS. Defendant Biogen is the FDA license holder for Tysabri.

         II. Tysabri and Progressive Multifocal Leukoencephalopathy

         Progressive multifocal leukoencephalopathy (“PML”) is an opportunistic viral infection of the brain caused by the JC virus. The JC virus is carried by the majority of adults and is usually harmless. There are no known treatments or cures for PML.

         In February 2005, defendants received reports that two patients involved in ongoing clinical trials for Tysabri used in combination with Avonex, another medication used to treat MS, had developed PML. This was the first time that PML was associated with Tysabri or MS. Biogen voluntarily withdrew Tysabri from the market on February 28, 2005, and suspended its use in clinical trials. Defendants then undertook steps to analyze the reported PML cases and to assess and quantify the risk associated with Tysabri. In April 2005, Biogen announced that a third case of PML had been identified, this time in a patient from a clinical trial studying the use of Tysabri in patients with Crohn's Disease.

         Prior to returning Tysabri to the market, the FDA requested that Biogen conduct an assessment for the presence of JC virus antibodies at baseline in patients entering clinical trials. Biogen did so and, on March 2, 2006, submitted a report to the FDA regarding the results of antibody testing. The antibody testing had been performed at a laboratory at the National Institute of Health (the “NIH”) led by plaintiff's expert, Dr. Major. The report concluded that there was no consensus on a clinically relevant cut off for JC virus antibody detection.

         On June 5, 2006, the FDA re-approved Tysabri as a treatment of relapsing forms of MS, subject to new conditions and requirements regarding the risk of PML. Specifically, the FDA required that the prescribing information for Tysabri contain a “black box” warning (a warning printed inside a black box on the first page of drug labeling) stating that Tysabri use increases the risk for PML. A black box warning is the strongest type of warning allowed in drug labeling, and to ensure their significance is undiluted, use of a black box warning is permitted only where specifically required by the FDA. The prescribing information for Tysabri further informed treating physicians that because of the increased risk of PML associated with Tysabri usage, it is generally recommended only for patients who had an inadequate response to other MS treatments. As a further condition of re-approval, the FDA required that a medication guide be provided to physicians and specially trained infusion nurses, and limited prescription of Tysabri to prescribers registered in the Tysabri Outreach: Unified Commitment to Health (“TOUCH”) Prescribing Program, a special restricted distribution program. The TOUCH Prescribing Program requires that prior to prescribing Tysabri a physician both acknowledge in writing that he or she understands the PML risk and obtain a written acknowledgment from the patient that the patient understands the PML risk.

         III. Tysabri ...


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