Amos v. Biogen Idec, Inc. et al

Filing 63

DECISION AND ORDER finding as moot 55 Motion in Limine; granting 56 Defendants' Motion for Summary Judgment. The Clerk of the Court is instructed to enter judgment in favor of defendants and to close the case. Signed by Hon. Michael A. Telesca on 4/10/17. (JMC)-CLERK TO FOLLOW UP-

UNITED STATES DISTRICT COURT
WESTERN DISTRICT OF NEW YORK
________________________________________
GREGORY A. AMOS, in his capacity as
Administrator of the Estate of
ANDREA R. AMOS, Deceased,
Plaintiff,

13-CV-6375 T
DECISION
and ORDER

v.
BIOGEN IDEC INC. and
ELAN PHARMACEUTICALS, INC.,
Defendants.
________________________________________
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,

marketed, and sold by the defendants.

which

was

developed,

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.
process

known

as

MS gradually destroys myelin (a

“demyelination”),

resulting

throughout the brain and spinal cord.

in

nerve

damage

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.

Page -2-

Tysabri

is

the

brand

name

for

natalizumab,

a

humanized

monoclonal antibody that inhibits the ability of inflammatory white
blood

cells

to

demyelination.
and

can

enter

the

CNS

and

thereby

protects

against

Tysabri decreases relapses in individuals with MS

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.
In

There are no known treatments or cures for PML.

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
Page -3-

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
Page -4-

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 Labeling Changes
When Tysabri returned to the market in June 2006, defendants
and the FDA thought it was possible that PML risk might be
associated with duration of treatment, but determined that there
was insufficient data to support that conclusion.

The black box

warning required by the FDA thus stated that the relationship
between the risk of PML and the duration of treatment was unknown.
Based on additional confirmed Tysabri-related cases of PML in 2008
and 2009, in November 2009, the FDA approved an update to the label
to state that in patients treated with Tysabri, the risk of PML
increases with longer treatment duration.

In July 2010, the FDA

approved another label update, this one stating that the risk of
PML

is

increased

in

patients

who

have

been

treated

with

immunosuppressants prior to receiving Tysabri.
IV.
After

JC Virus Antibody Testing
Tysabri

was

removed

from

the

market,

defendants

researched the use of polymerase chain reaction (“PCR”) assay
testing to detect the presence of JC virus DNA in the blood.

PCR

assay testing was considered by some to be the most likely risk
stratification tool because a person must be infected with the JC
virus in order to develop PML.

However, in 2010, PCR assay testing

was determined to be unlikely to be useful in stratifying the risk
for PML.
Page -5-

Defendants also conducted research on the use of JC virus
antibody

testing

as

a

risk

stratification

tool.

Plaintiff

maintains that technology existed to test for and detect the
presence of JC virus antibodies in humans in 2005, while Defendants
argue that the test in question had not been validated.

The

parties agree that by late 2009, Biogen scientists had developed an
analytically validated assay to reliably detect JC virus antibodies
in the blood. Biogen subsequently convened an advisory board of MS
experts and regulatory experts to discuss the data it had collected
regarding testing for JC virus antibodies.
December

9,

2009

advisory

board

Summary notes from a

meeting

indicate

that

the

regulatory experts believed the data were too preliminary to be of
predictive value regarding PML at that time.

However, most of the

medical experts on the advisory board agreed that research in this
area should continue and that it was possible that JC virus
antibody testing could be of use in risk stratification.
On September 8, 2010, defendants met with the FDA to discuss
Biogen’s JC virus antibody testing and related proposed changes to
the Tysabri label.

Specifically, Biogen proposed changing the

Tysabri label to inform prescribing physicians that individual JC
virus antibody status should be considered in determining the
benefits and risks of Tysabri, that screening for serum JC virus
antibodies should be performed prior to initiating Tysabri therapy
and annually thereafter, and that there is an increased risk for
PML in JC virus antibody positive patients.
Biogen’s

proposal

on

the

basis
Page -6-

that

The FDA rejected

there

was

currently

insufficient information to support the clinical utility of the JC
virus antibody assay in determining the risk for PML.
On November 18, 2010, defendants again met with the FDA, this
time to discuss a Biogen proposal to make its JC virus antibody
assay available to Tysabri prescribers.

The FDA rejected this

proposal as well, reiterating its conclusion that the usefulness of
the test had not been established.
Subsequent to these FDA rejections and throughout 2011, Biogen
continued

to

sponsor

clinical

trials

regarding

its

JC

virus

antibody assay and to work with the FDA to demonstrate the assay’s
usefulness in the clinical setting.

In October 2011, in light of

the additional evidence it had collected, Biogen again asked the
FDA to permit amendment of the Tysabri label to include information
regarding testing for JC virus antibodies.

On January 12, 2012,

the FDA cleared Biogen’s JC virus antibody assay and approved
associated changes to Tysabri’s labeling.
V.

Mrs. Amos’ Use of Tysabri and Subsequent PML

Mrs. Amos first developed symptoms of MS in 1992.
Smith,

her

treating

physician

from

March

2005

to

Dr. David
May

2011,

diagnosed her with MS in April 2005. In March 2006, Mrs. Amos
suffered an MS relapse.
MS

attacks

since

aggressive therapy.

her

By July 2006, Mrs. Amos had reported two
diagnosis,

and

expressed

a

desire

for

Due to the severity of Mrs. Amos’ MS,

Dr. Smith determined that four drugs often used to treat MS
(Avonex, Betaseron, Copaxon, and Rebif, the so-called “ABCR” drugs)
would not be the most effective treatment options.
Page -7-

Instead, on

July 28, 2006, he prescribed Tysabri.
deposition

that

he

reviewed

the

Dr. Smith testified at

Tysabri

informed

consent

information with Mrs. Amos and that there was no question she was
aware of the risk of PML.

Dr. Smith was enrolled in the TOUCH

Prescribing Program and appreciated the significance of black box
warnings.

Dr. Smith was aware that PML was a risk of Tysabri use

and that PML is caused by the JC virus.

Mrs. Amos received her

first monthly Tysabri infusion in September 2006. She continued to
receive Tysabri infusions under Dr. Smith’s care until May 2011,
during which time she tolerated the drug well, her MS symptoms were
stable, and periodic MRI exams showed no MS progression.
In May 2011, Mrs. Amos began seeing neurologist Dr. Louis
Medved.

Dr.

Medved continued to prescribe Tysabri to Mrs. Amos

due to the aggressiveness of her MS and because Tysabri had
controlled the progression of her disease. Dr. Medved testified at
deposition that he discussed the risk of PML with Mrs. Amos
relative to the risk of her MS getting worse without treatment.
Mrs. Amos received two additional Tysabri infusions in June 2011.
In mid-July 2011, Mrs. Amos was diagnosed with PML.

She died on

September 20, 2011.
VI.

Procedural History

Plaintiff commenced the instant action on July 19, 2013.
Docket No. 1.

On October 7, 2013, defendants filed a motion

seeking dismissal of counts II, III, V, VI, and VIII of the
complaint.

Docket No. 16. The Court entered a Decision and Order

on June 25, 2014, granting defendants motion in part and denying
Page -8-

defendants motion in part.

Docket No. 29.

In particular, the

Court granted defendants’ motion to dismiss plaintiff’s design
defect, New York General Business Law, and

fraud claims, and

denied defendants’ motion to dismiss plaintiff’s strict liability
and negligent misrepresentation claims.

Id.

Following completion

of discovery, defendants filed their motion for summary judgment on
January 18, 2017.

Docket No. 56.
DISCUSSION

I.

Standard of Review

Pursuant

to

Rule

56(a)

of

the

Federal

Rules

of

Civil

Procedure, the Court will grant summary judgment if the moving
party demonstrates that there is no genuine dispute as to any
material fact and the movant is entitled to judgment as a matter of
law. When considering a motion for summary judgment, all genuinely
disputed facts must be resolved in favor of the party against whom
summary judgment is sought. See Tolan v. Cotton, 134 S.Ct. 1861,
1863 (2014).

If, after considering the evidence in the light most

favorable to the nonmoving party, the court finds that no rational
jury could find in favor of that party, a grant of summary judgment
is appropriate.

See Scott v. Harris, 550 U.S. 372, 380 (2007),

citing Matsushita Elec. Industrial Co. v. Zenith Radio Corp., 475
U.S. 574, 586-587 (1986).
II.

Plaintiff’s
Warnings

Claims

Turn

on

the

Sufficiency

of

the

In support of their motion for summary judgment, defendants
argue that all of plaintiff’s claims rise or fall based on the

Page -9-

adequacy

of

maintaining

the

warnings

for

his

claims

that

Tysabri.

disagrees,

negligence,

for

Plaintiff

negligent

misrepresentation, strict liability, and breach of implied warranty
may proceed independent of his failure to warn claim.

The Court

therefore must determine as a threshold issue whether a failure of
proof with respect to failure to warn is determinative of all
plaintiff’s claims.
Under New York law, which the parties agree governs this case,
“the adequacy of the warnings, as a matter of law, precludes any
related

claims

for

negligence,

strict

liability,

breach

of

warranties, or fraud.” McDowell v. Eli Lilly & Co., 58 F. Supp. 3d
391, 410 (S.D.N.Y. 2014) (internal quotation omitted); see also In
re Accutane Prod. Liab., 2012 WL 3194954, at *6 (M.D. Fla. July 24,
2012) (“[U]nder New York law, the adequacy of the warnings, as a
matter of law, precludes any related claims for negligence, strict
liability, breach of warranties, or fraud.”); Gentile v. Biogen
Idec, Inc., 2016 WL 4168942, at *9 (Mass. Super. July 28, 2016)
(“under New York law, where a failure to warn claim cannot succeed,
the court must dismiss any related claims for negligence, strict
liability,

breach

of

warranties,

or

fraud”).

Plaintiff

has

identified no cases holding to the contrary, nor has he proffered
a viable explanation how his claims, all of which involve in some
fashion the adequacy of the warnings, can survive if the warnings
were adequate as a matter of law.
In addition, plaintiff’s claim for negligent misrepresentation
is barred by New York’s “learned intermediary” rule, pursuant to
Page -10-

which “[w]arnings for prescription drugs are intended for the
physician, whose duty it is to balance the risks against the
benefits of various drugs and treatments and to prescribe them and
supervise their effects,” and “the manufacturer’s duty to caution
against a drug’s side effects is fulfilled by giving adequate
warning through the prescribing physician, not directly to the
patient.”

Martin v. Hacker, 83 N.Y.2d 1, 9 (1993).

A plaintiff

alleging negligent misrepresentation “must establish reliance upon
a false statement or material misrepresentation or omission,” and
the learned intermediary rule eliminates the possibility of any
such reliance.

See Prohaska v. Sofamor, S.N.C., 138 F. Supp. 2d

422, 447 (W.D.N.Y. 2001).
As a result of the foregoing, it is clear that all of
plaintiff’s claims in this matter rise or fall upon the adequacy of
defendants’ warnings. As a result, and because (as set forth in
detail in below) the Court finds that the warnings were adequate as
a matter of law, defendants are entitled to judgment in their favor
on all plaintiff’s claims.

III. The warnings were adequate as a matter of law
As discussed above, New York follows the learned intermediary
rule, pursuant to which a drug manufacturer’s duty to warn is
fulfilled by providing adequate warning of potential side effects
to a treating physician.

See Martin, 83 N.Y.2d at 9.

Page -11-

“A warning

is adequate as a matter of law if it provides specific detailed
information on the risks of the drug.”
403 (internal quotation omitted).

McDowell, 58 F. Supp. 3d at

In assessing a warning, the

Court must evaluate it as a whole, and “not through the nitpicking
prism of an interested legal advocate after the fact.”

Id.

The

Court considers factors “including whether the warning is accurate,
clear, consistent

on

its

face,

and

whether

it

portrays with

sufficient intensity the risk involved in taking the drug.”
(internal quotation omitted).
the law

in

New

York

adequate when . .

that

Id.

Additionally, “[i]t has long been
prescription

medicine

warnings

are

information regarding ‘the precise malady

incurred’ was communicated in the prescribing information.” Alston
v. Caraco Pharm., Inc., 670 F. Supp. 2d 279, 284 (S.D.N.Y. 2009)
(quoting
1979).

Wolfgruber v. Upjohn Co., 72 A.D.2d 59, 60 (4th Dep’t
As a result, “when a plaintiff claims to be injured in a

manner that is addressed by warnings provided to his physician,
summary judgment is granted on failure to warn claims.”

Id.

In the instant case, there is no dispute that at the time Mrs.
Amos was prescribed Tysabri, its label specifically warned treating
physicians of an increased risk of PML.

Indeed, Tysabri’s label

contained this information in a black box warning, the strongest
warning available.

Moreover, Dr. Smith testified at deposition

that he was fully aware that PML was a risk of Tysabri use, further

Page -12-

supporting the conclusion that the warnings were adequate.

See

Gentile, 2016 WL 4168942, at *7 (treating physician’s “testimony
that she was aware that Tysabri increased a patient’s risk of
developing PML further demonstrates the adequacy of the warning”).

Plaintiff maintains that Tysabri’s warnings were inadequate
because they did not include information regarding the correlation
between JC virus antibodies and PML, nor did they inform physicians
of the risks associated with duration of treatment and prior
treatment with immunosuppressant. The Gentile court rejected these
precise arguments in a matter also involving claims by a widower
whose wife developed PML and died after Tysabri treatment.
granting

summary

judgment

to

defendants,

the

Gentile

In

court

concluded that Tysabri’s warnings were adequate as a matter of law
under New York law because “even without [the details regarding
specific

risk

factors],

when

read

as

a

whole,

the

warnings

unmistakably conveyed the seriousness of PML and its association
with Tysabri treatment.” Id. The Gentile court further noted that
New York law

does

not require

drug

manufacturers

to

include

specific information regarding the frequency of adverse events, and
that Tysabri’s packaging “unambiguously assumed that anyone who
took Tysabri increased their risk of developing PML.”
Court

agrees

additional

with

the

information

reasoning
regarding

in

Gentile.

specific

Page -13-

risk

Even

Id.

The

without

factors,

the

warnings for Tysabri clearly, directly, and unequivocally informed
treating

physicians

of

the

increased

risk

for

PML

and

the

seriousness of that condition. See Christison v. Biogen Idec Inc.,
199 F. Supp. 3d 1315, 1345 (D. Utah 2016) (“The Tysabri label
clearly conveys a warning that taking Tysabri would increase the
risk of PML, and that due to the preliminary nature of the research
in 2006, there was no reliable correlation between length of
treatment, use with other immunosuppressant drugs, or a positive
indication of JC Virus antibodies. [Plaintiff’s] request that that
information be placed on the label is aided by hindsight rather
than the scientific information available at the time.”) (emphasis
in original).

Under these circumstances, the Court finds that the

warnings were adequate as a matter of law.
III. Plaintiff’s Claims are Preempted by Federal Law
Defendants also argue that plaintiff’s claims are preempted by
federal

law.

It

is

well-established

that,

pursuant

to

the

Supremacy Clause of th United States Constitution (U.S. Const.,
Art. VI, Cl. 2), federal law preempts conflicting state law.

In

the specific context of drug manufacturing, the Supreme Court has
held

that

while

the

Food,

Drug,

and

Cosmetics

Act

and

its

associated regulations do not expressly preempt state tort law,
where a plaintiff’s theory of the case requires a drug manufacturer
to have taken an action that it could not lawfully take under
federal law, conflict preemption bars that particular claim.

Page -14-

See

Mut. Pharm. Co. v. Bartlett, 133 S. Ct. 2466, 2477, 186 L. Ed. 2d
607 (2013) (state law design-defect cause of action based on
warning was preempted with respect to FDA-approved drugs sold in
interstate commerce because it was impossible for drug manufacturer
to comply with both state and federal law).
“Impossibility pre-emption is a demanding defense.” Wyeth v.
Levine, 555 U.S. 555, 573 (2009). In the context of claims against
drug

manufacturers

for

allegedly

inadequate

warnings,

a

drug

manufacturer may show preemption in two ways: (1) by showing that
it was prohibited by federal law from modifying the FDA-approved
labeling; or (2) by presenting clear evidence that the FDA would
not have approved a change to the drug’s label.

See PLIVA, Inc. v.

Mensing, 564 U.S. 604, 619 (2011); Wyeth, 555 U.S. at 571.

In this

case, defendants have demonstrated both that they could not have
unilaterally added the warning plaintiff argues was required and
that the FDA would have rejected the proposed change to Tysabri’s
label.

Because plaintiff has failed to adduce any evidence to

contradict

this

showing,

no

reasonable

jury

could

find

in

plaintiff’s favor, and summary judgment is required.
First, with respect to defendants’ ability to unilaterally
change Tysabri’s label, pursuant to certain FDA regulations known
as Changes Being Effected or “CBE” regulations, a drug manufacturer
may change a product label without prior FDA approval if the change
in

question

(1)

reflects

newly

Page -15-

acquired

information

and

(2) accomplishes one of five specific objectives set forth in the
regulations.

See 21 C.F.R. § 314.70(c)(6)(iii).

However, a drug

manufacturer cannot add or change a black box warning without
permission from the FDA, because the FDA determines the contents of
such warnings.

See Schedin v. Ortho-McNeil-Janssen Pharm., Inc.,

776 F. Supp. 2d 907, 912 (D. Minn. 2011); Rheinfrank v. Abbott
Labs., Inc., No. 1:13-CV-144, 2015 WL 5258858, at *2 (S.D. Ohio
Sept. 10, 2015).

In this case, the FDA-approved labeling included

a black box warning regarding the increased risk of PML that made
no mention of testing for the presence of JC virus antibodies.
Defendants’ Ex. 5, Docket No. 56-5 at 77.
proffered

any

explanation

how

defendants

See

Plaintiffs have not
could

have

lawfully

modified the black box warning absent approval from the FDA.
Second, the evidence of record leads inescapably to the
conclusion that the FDA would not have approved a change to
Tysabri’s label prior to 2012.
judgment

with

respect

to

the

In deciding a motion for summary
preemption

defense,

the

Court

“compare[s] the evidence presented with the evidence in Wyeth, to
determine whether it is more or less compelling,” and “[a] trial by
jury [is] only . . . necessary in those cases where the evidence
presented is more compelling than that in Wyeth but no ‘smoking
gun’ rejection letter from the FDA is available.”

In re Fosamax

(Alendronate Sodium) Prod. Liab. Litig., __ F.3d __, 2017 WL
1075047, at *18 (3d Cir. Mar. 22, 2017).

Page -16-

“{T]he question for

summary judgment purposes is . . . whether a reasonable juror could
find that it is highly probable that the FDA would have rejected
the warning.”

Id. at *19.

In this case, there exists not one but

two “smoking gun” rejections from the FDA.

It is undisputed that

on September 8, 2010, Biogen proposed to the FDA that Tysabri’s
labeling be

modified

to

state

that:

(1)

individual

JC virus

antibody should be considered in determining the risk/benefit of
Tysabri; (2) screening for serum JC virus antibody should be
performed prior to initiating therapy and annually thereafter,; and
(3) there is an increased risk for PML in JC virus antibody
positive patients.

It is further undisputed that the FDA rejected

that proposal, stating that it did not believe that there was
currently sufficient information to support the clinical utility of
testing for JC virus antibodies.

Plaintiff also does not dispute

that on November 18, 2010, Biogen proposed making its JC virus
antibody assay available to Tysabri prescribers, and that the FDA
again rejected Biogen’s proposal on the basis that the utility of
the test had not been established.

It was not until February 2012,

after completion of additional clinical trials and testing, and as
a result of ongoing communications between Biogen and the FDA, that
the FDA finally agreed to approve a Tysabri labeling change.

On

this record, no reasonable jury could conclude that the FDA would
have approved a labeling change for Tysabri prior to Mrs. Amos’
death. This is not a case where there was a mere quibble over

Page -17-

language (see In re Fosamax, 2017 WL

1075047 at *21) - to the

contrary, the record is clear that the FDA did not believe that the
data sufficiently established the utility of testing for JC virus
antibodies.
A federal court in the District of Utah recently reached a
similar conclusion in a factually analogous case.
199 F. Supp. at 1347.

See Christison,

As in this case, the plaintiff in Christison

was the widower of an individual who died of PML after being
treated for MS with Tysabri.

Id. at 1319.

Also like the plaintiff

in this case, the Christison plaintiff argued the Biogen and Elan
should have updated the Tysabri label to warn about the increased
risk of developing PML for patients who had tested positive for JC
virus antibodies.

Id.

The court in Christison, on the same

administrative record as in the instant matter, concluded that the
plaintiff’s

claims

were

preempted

because

the

FDA

expressly

rejected Biogen’s request to change Tysabri’s label in September
and November 2010.

Id. at 1347.

As a result, the court concluded

that there was “‘clear evidence’ that the FDA would not have
approved a change to the Tysabri label regarding JCV antibodies
before 2012.”

Id.

Gentile, which is discussed at length above, is another
factually analogous case in which a court determined that the
plaintiff’s claims were preempted by federal law.

In Gentile, as

in the instant case and Christison, the plaintiff’s wife developed

Page -18-

PML and died after treatment

with Tysabri.

Id. at *3. The

Massachusetts Superior Court granted summary judgment to Biogen and
Elan, explaining that plaintiff’s claims were preempted because
“[Biogen

and

Elan]

continued

to

research

the

JCV

antibody

correlation until the FDA finally approved the modified warning”
and that “[the] FDA rejected defendants’ proposed change in the
warning

not

because

of

the

language

used,

but

because

supporting data was not yet sufficiently persuasive.”

the

Id. at *10.

For the reasons set forth above, the Court agrees with the holdings
in Christison and Gentile.
The Court also holds that plaintiff’s claims against Elan are
preempted

because

Elan

is

not

the

holder

of

the

approved

application for Tysabri in the United States. “A distributor, even
of a brand name drug, has no power to change. . . labeling.

That

power lies with the applicant who filed the New Drug Application
(NDA).”

Brazil v. Janssen Research & Dev. LLC, 196 F. Supp. 3d

1351, 1365 (N.D. Ga. 2016) (internal quotation omitted).

In

Mensing, the Supreme Court held that claims against a manufacturer
of generic drugs were preempted because such a manufacturer has no
authority under federal regulations to modify labeling.

564 U.S.

at 618-19. The same reasoning compels the Court to find preemption
here. Federal regulations do not permit Elan, as a distributor, to
change labeling.

Any claim that state law compelled it to do so is

therefore preempted.

See Gentile, 2016 WL 4168942, at * 11

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(finding claims against Elan preempted because “Elan could not have
sought modifications of the label”).
IV.

The Court Need not Reach Defendants’ Remaining Arguments

Defendants have also argued that Dr. Major’s testimony is
unrelated to the adequacy of Tysabri’s warnings and that plaintiff
cannot show proximate cause. Because the Court has determined that
defendants are entitled to summary judgment for the reasons set
forth above, it need not and does not reach these arguments.
The Court’s decision also renders moot defendants’ request
that Dr. Major be precluded from testifying as to certain subjects.
As a result, defendants’ motion in limine is denied as moot.
CONCLUSION
For the reasons set forth above, the Court grants defendants’
motion for summary judgment (Docket No. 56) and denies defendants’
motion in limine (Docket No. 55) as moot.

The Clerk of the Court

is instructed to enter judgment in favor of defendants and to close
the case.
ALL OF THE ABOVE IS SO ORDERED.
S/ Michael A. Telesca
MICHAEL A. TELESCA
United States District Judge
DATED:

Rochester, New York
April 10, 2017

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