United States District Court, W.D. New York
GREGORY A. AMOS, in his capacity as Administrator of the Estate of ANDREA R. AMOS, Deceased, Plaintiff,
BIOGEN IDEC INC. and ELAN PHARMACEUTICALS, INC., Defendants.
DECISION AND ORDER
MICHAEL A. TELESCA United States District Judge
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.
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.
reasons set forth below, the Court grants defendants'
motion for summary judgment. Defendants' motion to
preclude Dr. Major's testimony is denied as moot.
following facts are taken from the respective statements of
fact, affidavits, and exhibits submitted by plaintiff and
Multiple Sclerosis and Tysabri
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
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.
Tysabri and Progressive Multifocal
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
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.
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.
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.