NELSON v. BIOGENIC IDEC, INC. et al
Filing
166
OPINION. Signed by Judge John Michael Vazquez on 04/25/2018. (sms)
Not for Publication
UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY
ANDREW NELSON,
Plaintiff
Civil Action No. 12-73 17 (JMV) (MF)
V.
OPINON
IDEC,
INC.
BIOGEN
PHARMACEUTICALS, LLC,
and
ELAN
Defendants.
John Michael Vazguez, U.S.D.J.
This matter is a prescription drug product liability action. Currently pending before the
Court are two motions by Defendants Biogen Idec, Inc., and Elan Pharmaceuticals, LLC: one for
summary judgment, D.E. 154, and one to exclude expert testimony, D.E. 155.1 The product at
issue is Defendants’ multiple sclerosis drug, Tysabri. After taking Tysabri, Plaintiff Andrew
Nelson contracted progressive multifocal leukoencephalopathy (“PML”), a dreadful and
potentially fatal brain disease caused by the JC Virus. Plaintiff sued Defendants under the New
Jersey Product Liability Act for failure to adequately warn of the risks of Tysabri. The Court
reviewed the submissions made in support of and in opposition to the motion and considered the
motion without oral argument pursuant to fed. R. Civ. P. 78(b) and L. Civ. R. 78.1(b). Three other
Defendants’ Memorandum of Law in Support of Defendants’ Joint Motion for Summary
Judgment, D.E. 154-1, hereinafter “Defendants’ Brief’ or “Def Br.”; Plaintiffs Opposition to
Defendants’ Joint Motion for Summary Judgment, D.E. 158, hereinafter “Opposition” or “Opp.”;
Reply Brief in Support of Defendants’ Joint Motion For Summary Judgment and Joint Motion to
Preclude the Expert Testimony of Eugene 0. Major, Ph.D., D.E. 160; hereinafter “Reply Brief’
or “Reply Br.”
trial courts, two federal and one state, have considered the same allegations against the same
Defendants, albeit pursuant to the laws of other states. Defendants have prevailed at the summary
judgment stage in all three cases. For the reasons that follow, Defendants also prevail here.
Defendants’ motion for summary judgment is GRANTED and their Daubert motion is DENIED
as moot.
I.
Factual Background & Procedural History2
Defendants Biogen Idec, Inc. (“Biogen”) and Elan Pharmaceuticals, LLC (“Elan”)
collaborated on the research, development, and marketing of the multiple sclerosis (“MS”) drug
natalizumab, which is sold under the brand name Tysabri. Defendants’ SOMF at ¶5. Tysabri is a
humanized monoclonal antibody that protects against demyelination in those suffering from MS.
Biogen is the manufacturer of the drug and holds the FDA license for it. Id. Elan distributed
Tysabri in the United States and also marketed it as a treatment for Crohn’s disease. Id.
The Food and Drug Administration (“FDA”) approved Tysabri for treatment of relapsingremitting MS in 2004. Id. at ¶27. In 2005, Defendants withdrew Tysabri from the market and
suspended clinical trials after two patients developed PML. Id. at ¶29, 34. The JC Virus causes
PML. Id.at ¶31. Until 2010, according to Defendants, it was “generally accepted in the scientific
community that upwards of 80% of adults had been exposed to the JC Virus{.j” Id. at ¶33. Plaintiff
disputes that the number is “generally accepted,” claiming that sources differ and that the
percentage has been reported as low as 35% and as high as 90%. Plaintiffs SOMF at ¶33.
In 2006, the FDA requested that Biogen test patients for the presence of the JC Virus
antibody before the patients were entered into additional Tysabri clinical trials. Defendants’
2
The facts are taken from the parties’ respective statements of material fact: Defendants’
Statement of Material Facts Not in Dispute, D.E. 154-2 (“Defendants’ SOMF”), and Plaintiffs
Statement of Material Facts in opposition, D.E. 159 “(Plaintiffs SOMF”).
2
SOMF at ¶37. Later that year, Biogen submitted a report to the FDA stating that testing performed
at the National Institute of Health (“NIH”) did not provide a “clinically relevant cut off’ for
detecting the JC Virus antibody. Id. at ¶38. The NIH testing was led by Plaintiffs expert, Dr.
Eugene Major, Ph.D. Id. The FDA convened an Advisory Panel to consider permitting Tysabri
back on the market on March 7 and 8, 2006. Id. at ¶39.
On June 5, 2006, the FDA re-approved Tysabri with a number of new labelling
requirements regarding the PML risk, including a “black box” warning. Id. at ¶41. A “boxed” or
a “black box” warning is the “strongest warning required or permitted by the FDA,” and is used
to indicate that there is a serious risk associated with use of the drug. Id. at ¶J12-13. As of April
2008, the warning read:
PROGRESSIVE
WARNING:
LEUKOENCEPHALOPATHY
MULTIFOCAL
TYSABRI® increases the risk of progressive multifocal
leukoencephalopathy (PML), an opportunistic viral infection of the
brain that usually leads to death or severe disability. Although the
cases of PML were limited to patients with recent or concomitant
exposure to immunomodulators or immunosuppressants, there were
too few cases to rule out the possibility that PML may occur with
TYSABRI monotherapy [see Warnings and Precautions (5.1)].
•
Because of the risk of PML, TYSABRI is available
only through a special restricted distribution program
called the TOUCHTM Prescribing Program. Under
only
the TOUCHTM Prescribing Program,
prescribers, infusion centers, and pharmacies
associated with infusion centers registered with the
program are able to prescribe, distribute, or infuse the
In addition, TYSABRI must be
product.
administered only to patients who are enrolled in and
met all the conditions of the TOUCHTI Prescribing
Program [see Warnings and Precautions (5.1, 5.2)J.
•
Healthcare professionals should monitor patients on
TY$ABRI for any new sign or symptom that may be
suggestive of PML. TYSABRI dosing should be
3
withheld immediately at the first sign or symptom
suggestive of PML. For diagnosis, an evaluation that
incluci a gadolinium-enhanced magnetic resonance
imaging (MRI) scan of the brain and, when indicated,
cerebrospinal fluid analysis for JC viral DNA are
recommended [see Con traindications (4), Warnings
and Precautions (5.]).]
.
Defendants’ SOMF at ¶14.
The FDA also required that a Tysabri medication guide be provided to physicians and
infusion nurses who would be administering the medication. Id. at ¶47. As noted in the warning,
the FDA permitted Tysabri to be prescribed through the Tysabri Outreach: Unified Commitment
to Health (“TOUCH”) program, an FDA-mandated “Risk Evaluation and Management Strategy,”
or “REMS,” program. Id. at ¶48. As part of the TOUCH program, the medication guide was
provided directly to patients. Id. The TOUCH program also required doctors prescribing Tysabri
to acknowledge the risk of PML as well as get written consent from the patient concerning the
risks. Id. at ¶53. The patient also had to confirm that he had read the medication guide before
each infusion as well as answer a series of questions about the risk of PML. Id. at ¶54-55. The
nurse administering the infusion also screened the patient for any warning signs of PML. Id.
In the prescribing information, the PML risk was described as follows:
Progressive multifocal leukoencephalopathy, an opportunistic
infection caused by the IC virus that typically occurs in patients that
are immunocompromised, has occurred in 3 patients who received
TYSABRI® in clinical trials (see BOXED WARNING). Two cases
This paragraph was changed in July 2010 to read:
TYSABRI® increases the risk of progressive multifocal
leukoencephalopathy (PML), an opportunistic viral infection of the
brain that usually leads to death or severe disability. Cases of PML
have been reported in patients taking TYSABRI who were recently
immunomodulators
or
concomitantly
treated
with
or
immunosuppressants, as well as in patients receiving TYSABRI as
monotherapy [see Warnings and Precautions (5.])].
Defendants’ SOMF at n. 1.
4
of PML were observed in 1869 patients with multiple sclerosis
treated for a median of 120 weeks. The third case occurred among
1043 patients with Crohn’s disease afier the patient received 8 doses.
The absolute risk for PML in patients treated with TYSABRI®
cannot be precisely estimated, and factors that might increase an
individual patient’s risk for PML have not been identified. There are
no known interventions that can reliably prevent PML or adequately
treat PML if it occurs. It is not known whether early detection of
PML and discontinuation of TYSABRI® will mitigate the disease.
There is limited experience beyond 2 years of treatment. The
relationship between the risk of PML and the duration of treatment
is unknown.
All three cases of PML occurred in patients who were concomitantly
exposed to immunomodulators (interferon beta in the patients with
multiple sclerosis) or were immunocompromised due to recent
treatment with immunosuppressants (e.g., azathioprine in the patient
with Crohn’s disease). Ordinarily, therefore, patients receiving
chronic immunosuppressant or immunomodulatory therapy or who
have systemic medical conditions resulting in significantly
compromised immune system function should not be treated with
TYSABRI®. However, the number of cases is too few and the
number of patients treated too small to reliably conclude that the risk
of PML is lower in patients treated with TYSABRI® alone than in
patients who are receiving other drugs that decrease immune
function or who are otherwise immunocompromised.
Id. at ¶45. The prescribing information also stated that
(PML), an opportunistic viral infection of the brain that usually
leads to death or severe disability (see BOXED WARNING AND
WARNINGS, Progressive Multifocal Leukoencephalopathy),
TYSABRI® is generally recommended for patients who have had
an inadequate response to, or are unable to tolerate, alternate
multiple sclerosis therapies.
Id. at ¶46 (emphasis in original).
While Plaintiff was receiving Tysabri infusions through the TOUCH program, the
medication guide provided the following:
What is the most important information I should know about
TYSABRI®?
5
•
TYSABRI® increases your chance of getting a rare brain
infection that usually causes death or severe disability.
This infection is called progressive multifocal
leukoencephalopathy (PML). PML usually happens in
people with weakened iimriune systems.
• No one can predict who will get PML.
• There is no known treatment, prevention, or cure for
PML.
Id. at ¶49 (emphasis in original). The TOUCH program acknowledgement also required patients
to sign and initial a form that contained the following acknowledgement:
I acknowledge that. TYSABRI increases your change of getting
a rare brain infection that usually causes death or severe disability.
• This infection is called progressive multifocal
leukoencephalopathy (PML). PML usually happens in
people with weakened immune systems
• No one can predict who will get PML There is no known
treatment, prevention, or cure for PML
.
.
Id. atlJl5.
In August 200$, the FDA approved an addition to the Tysabri label “stating that Tysabri
associated PML can occur in cases of Tysabri monotherapy.” Id. at ¶103. Two more cases of
Tysabri-associated PML were reported in 2008. Id. at ¶104. By July 24, 2009, eleven cases had
been reported. Id. at ¶105. In November 2009, the label was updated to read: “In patients treated
with Tysabri, the risk of PML increase [sic] with longer treatment duration
.
.
.
.“
Id. at ¶107. In
July 2010, another update was added, stating: “The risk of PML is also increased in patients who
have been treated with an immunosuppressant prior to receiving Tysabri.
.
.
.“
Id. at ¶108.
In 2006, Biogen was using the ELISA assay to detect JC Virus antibodies in patients who
participated in Tysabri clinical trials. Id. at ¶38. On March 2, 2006, Biogen submitted data from
a National Institute of Health (“NIH”) test—perfomLed at a lab run by Plaintiff’s proffered
expert—whose report “concluded ‘[c]urrently there is no consensus on a clinically relevant cut off
for the ELISA assay or JCV antibody detection.” Id. From 2006 through 2010, Defendants
6
developed a different assay, the Polyrnerase Chain Reaction (“PCR”) assay, which was “thought
to be the most likely risk stratification tool” to identify those with the JC Virus. Id. at ¶112.
However, in 2010, the Annals ofNettrologv indicated that PCR testing was “unlikely to be useful”
to test Tysabri patients. Id. at ¶113.
In 2009, Biogen convened an advisory board of “MS experts and regulatory experts” to
discuss Biogen’s JC Virus antibody assay. As of December 2009, the board concluded that the
“data on the assay was too preliminary to be of predictive value” as to PML. Id. at ¶i27-29. On
September 8, 2010, Defendants met with the FDA’s Center for Drug Evaluation and Research
(“CDER”) to propose “a potential labelling change” based on Biogen’s IC Virus antibody assay
and research. The FDA rejected the proposal, in part because “only [seventeen] patients had pre
PML antibody status tested.” Id. at ¶131-33.
Two months later, on November 18, 2010,
Defendants met with the FDA Center for Devices and Radiological Health (“CDRH”) with a
Biogen proposal to provide their JC Virus antibody assay to Tysabri prescribers. The FDA also
rejected this proposal as the “usefulness” of the assay “ha[d] not been established.” Id. at ¶j13435.
Over the next year, Biogen sponsored two clinical trials, STRATIFY-i and STRATIFY-2,
to study blood samples of MS patients using Tysabri. Id. at ¶13 8. Biogen requested another
labelling change in October 2011 in light of the ongoing trials, which included data on thirty-seven
Tysabri patients. Id. at ¶140. On January 20, 2012, the FDA cleared the STRATIFY JC Virus
antibody assay and approved a labelling change “regarding the significance of JCV antibodies.”
Id. at 141. In its announcement, the FDA stated that Biogen’s test was “the first
[]
for risk of rare
brain infection in some people treated with Tysabri.” Id.
Plaintiff was diagnosed with MS in October 2002. Id. at ¶6. He was prescribed Tysabri
7
by Dr. Jana Preiningerova in April 200$ and had his first infusion in May 2008. Id. at ¶J7- 8.
Before starting the infusions, Dr. Preiningerova discussed the risk of PML with Plaintiff. Id. at
¶66. When Dr. Preiningerova prescribed Tysabri, the label stated that “the relationship between
the risk of PML and the duration of treatment is unknown.” Id. at ¶100. Afier he moved, Plaintiff
continued using Tysabri with Dr. Rana Zabad, and then with Dr. Kenneth Citak. Id. at ¶J9- 10.
Like Dr. Preiningerova, Dr. Zabad discussed the risks of Tysabri with Plaintiff Id. at ¶72. Dr.
Zabad also tested Plaintiff for the JC Virus in 2009, and the result was negative. Id. at ¶74.
Plaintiff continued receiving Tysabri treatments through September 2010, when he began showing
signs of PML. Id. at ¶14. In November 2010, Plaintiffs cerebrospinal fluid was tested for the JC
Virus, but none was found. Id. at ¶79. In December 2010, Plaintiff had a brain biopsy which
“found evidence of PML[,]” and Plaintiff was diagnosed with PML. Id. at ¶79.
Plaintiff filed his Complaint on November 2$, 2012. D.E. 1. He then filed an Amended
Complaint on January 2, 2013. D.E. 4. In response, Biogen and Elan filed motions to dismiss.
D.E. 8, 21. Judge Linares granted in part and denied in part the motions, allowing Plaintiff to file
a Second Amended Complaint but dismissing Plaintiffs claim for punitive damages with
prejudice. D.E. 34. Plaintiff filed a motion for reconsideration as well as a Second Amended
Complaint. D.E. 35, 37. The Court denied the motion for reconsideration.
D.E. 44. Both
Defendants filed a motion to dismiss Count One of the Second Amended Complaint and the
demand for punitive or multiple damages on July 19, 2013. D.E. 48. The motion was granted,
and the Court ordered Plaintiff to withdraw Court One and his requests for treble and/or punitive
damages. D.E. 51. Plaintiff then filed his Third Amended Complaint on September 20, 2013.
D.E. 52.
The case was transferred to the undersigned on February 25, 2015. D.E. 129. Afler
8
discovery began in earnest, the Court granted Plaintiffs motion to file a Fourth Amended
Complaint, which was filed on June 13, 2016. D.E. 121, 141, 142. Defendants filed a motion to
set aside the Court’s decision to allow Plaintiff to file a Fourth Amended Complaint, or in the
alternative, to dismiss Count Two, for negligent undertaking. D.E. 144. The Court denied the
motion to set aside but granted the motion as to Count Two, dismissing it with prejudice. D.E.
150, 151. As a result, only one count remains against both Defendants for violations of the New
Jersey Products Liability Act (“NJPLA”), N.J.S.A. 2A:58C-2. Plaintiffs count is premised on a
failure to warn.
Defendants filed the instant motions on May 15, 2017: one for summary judgment, D.E.
154, and one to preclude the expert testimony of Eugene 0. Major, Ph.D. D.E. 154, 155. Plaintiff
filed opposition, D.E. 157, 158, to which Defendants have replied. D.E. 160.
II.
Standard of Review
Summary judgment is proper where the moving party “shows that there is no genuine
dispute as to any material fact,” and the moving party is entitled to judgment as a matter of law.
fed. R. Civ. P. 56(a); Abraham v. Raso, 183 F.3d 279, 287 (3d Cir. 1999). A fact in dispute is
material when it “might affect the outcome of the suit under the governing law” and is genuine “if
the evidence is such that a reasonable jury could return a verdict for the nonmoving party.”
Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986).
Disputes over irrelevant or
unnecessary facts will not preclude granting a motion for summary judgment. Id. “In considering
a motion for summary judgment, a district court may not make credibility determinations or engage
in any weighing of the evidence; instead, the nonmoving party’s evidence ‘is to be believed and
all justifiable inferences are to be drawn in his favor.” Marino v. Indits. Crating Co., 358 F.3d
241, 247 (3d Cir. 2004) (quoting Anderson, 477 U.S. at 255)). A court’s role in deciding a motion
9
for summary judgment is not to evaluate the evidence and decide the truth of the matter but rather
“to detennine whether there is a genuine issue for trial.” Anderson, 477 U.S.
at
249.
A party moving for summary judgment has the initial burden of showing the basis for its
motion and must demonstrate that there is an absence of a genuine issue of material fact. Celotex
Corp. v. Catrett, 477 U.S. 317, 323 (1986). After the moving party adequately supports its motion,
the burden shifts to the nonmoving party to “go beyond the pleadings and by her own affidavits,
or by the depositions, answers to interrogatories, and admissions on file, designate specific facts
showing that there is a genuine issue for trial.” Id. at 324 (internal quotation marks omitted). To
withstand a properly supported motion for summary judgment, the nonmoving party must identify
specific facts and affirmative evidence that contradict the moving party. Anderson, 477 U.S. at
250. “[I]f the non-movant’s evidence is merely ‘colorable’ or is ‘not significantly probative,’ the
court may grant summary judgment.” Messa v. Omaha Prop. & Cas. Ins. Co., 122 F. Supp. 2d
523, 528 (D.N.J. 2000) (quoting Anderson, 477 U.S. at 249-50)).
Ultimately, there is “no genuine issue as to any material fact” if a party “fails to make a
showing sufficient to establish the existence of an element essential to that party’s case.” Celotex
Corp., 477 U.S. at 322. “If reasonable minds could differ as to the
import of
the evidence,”
however, summary judgment is not appropriate. See Anderson, 477 U.S. at 250-5 1.
III.
Analysis
At the outset, neither party disputes that New Jersey law applies. Def Br. at 18, Opp. at
10. In their motion for summary judgment, Defendants make several arguments. Defendants
argue that the Tysabri label is entitled to a “super-presumption” of adequacy under the NJPLA
because it was FDA-approved. Def. Br. at 19-20. They also assert that Plaintiff was adequately
informed of the risk of PML by his prescribing doctors. Id. at 22. Defendants further indicate that
10
Plaintiff lacks necessary expert testimony regarding the adequacy of the label. Id. at 23-26.
Defendants add that Plaintiff cannot prove proximate cause. Id. at 28-31. Tn addition, Defendants
state that Plaintiffs NJPLA claim is preempted by federal law. Id. at 3 1-37. finally, Elan argues
that it could not have sought a change in the labeling because it is not the license holder for Tysabri,
and, as a result, it is entitled to summary judgment. Id. at 3 9-40.
Plaintiff responds that there are genuine issues of material fact which preclude summary
judgment. Plaintiff argues that, at this stage, the evidence sufficiently rebuts the presumption that
the label was adequate.
Opp. at
10-17. He also asserts that Dr. Major’s testimony appropriately
addresses the adequacy of the Tysabri label. Plaintiff continues that there is a genuine issue of
material fact as to whether he would have continued his course of treatment with Tysabri had the
label been different. Id. at 17-28. Plaintiff further argues that Defendants’ preemption argument
fails because Defendants could have changed the label without FDA approval and that Elan cannot
avoid liability even though it did not hold the license to Tysabri. Id. at 29-44.
a. Amos, C’hristison, & Gentile
Three courts in other jurisdictions have addressed the adequacy of the Tysabri label as it
relates to PML: Amos v. Biogen IDEC Inc. and Elan Pharmaceuticals, Inc., 249 F.Supp.3d 690
(W.D.N.Y. 2017); christison v. Biogen Idec. Inc. and Elan Pharmaceuticals, LLC, 199 F.Supp.3d
1315 (D. Utah 2016); Gentile v. Biogen Idec, Inc., et al, 2016 Mass. Super. LEXIS 238 (Mass.
Super. Ct. Feb. 14, 2014). The cases involved different plaintiffs, but the facts and legal issues
were very similar to the case at bar, and the defendants in all three were Biogen and Elan. In
addition, Dr. Major was the plaintiffs expert in each case. All three cases were decided in favor
of Defendants. None of the decisions are binding on this Court because they were not decided by
the Third Circuit or the United States Supreme Court. However, they can be considered persuasive
11
authority to the extent the relevant law of each jurisdiction is consistent with the NJPLA.
i. Gentile
The plaintiff in Gentile received Tysabri infusions from January 2007 to September 2009.
Gentile, 2016 Mass. Super. LEXIS at *$• She was diagnosed with PML in October 2009 and died
two months later. Id. Her husband brought a case against Biogen and Elan in Massachusetts,
alleging a number of claims including failure to warn under New York law.
The court in Gentile dismissed the failure to warn claim, writing that the duty to warn of
potential dangers
did not impose on defendants an obligation to research and develop
technologies to address the consequences or risks of taking the drug.
The relevant question is whether Tysabri’s warnings were adequate
to warn a physician of the precise malady [plaintiff] developed.
“{W]hen 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. at * 14-15 (internal citations omitted).
Although the matter was brought in Massachusetts, New York law applied. Id. at *1213.
New York, adheres to the “learned intermediary” rule: “the warnings about a prescription drugs
‘are intended for the physician, whose duty it is to balance the risks against the benefits of various
drugs.” Id. at * 14 (internal citations omitted). The Gentile court held that the Tysabri label in the
years Mrs. Gentile received the medication, from January 2007 to September 2009, was adequate
as a matter of law because it “warned against the precise risk (developing PML)” and “fully
disclosed the serious consequences of the disease.” Id. at *16.
Despite its determination that the warning was adequate, the court also found that
plaintiffs claim failed for lack of expert testimony “[b]ecause the adequacy of the warnings cannot
be evaluated by a layperson.” Id. at *18. The court acknowledged that, “if accepted as true, [Dr.
12
Major’s testimonyJ establishes that defendants did not efficiently investigate risk factors that could
have been revealed sooner” as to the risk of developing PML. However, because Dr. Major
admitted during his deposition that he is not familiar with prescription drug labeling, and is not a
medical doctor who prescribes medication to patients, the Gentile court ruled his opinion
inadmissible. Id. at *1920
The court in Gentile also granted defendants summary judgment on the ground that plaintiff
could not demonstrate that the alleged inadequate warning was the cause of the harm, i.e. plaintiff
could not show proximate cause. Id. at *2023. The court reasoned that “[t]he unavailability of
technology
.
.
.
does not fall within a failure to warn claim, which evaluates whether the
information provided was sufficient to caution against the injury at issue.” Id. at *22. In addition,
the Gentile court noted that the prescribing physician testified that “she [plaintiffs doctor] was
aware that Tysabri” increased the risk of PML. Id. at *l6.l7. The plaintiff argued that the three
risk factors (JC Virus antibodies, duration of treatment, and prior immunosuppressant exposure)
should have been included on the label, but the court held that even without these specific
warnings, the label “when read as a whole,” “unmistakably conveyed the seriousness of PML.”
Id. The court in Gentile added that plaintiffs prescribing doctor indicated that she would have
prescribed Tysabri even if she had been informed of the additional warnings. Id. at *21.
The court in Gentile further ruled that defendants had no duty to warn the plaintiff directly
under the learned intermediary rule. Id. at *23. Thus, the negligent undertaking claim was
dismissed. Id. at *24. The court also found that plaintiffs failure to warn claims against both
Biogen and Elan were preempted because the FDA did not allow Biogen to revise the label to
include the JC Virus risk, and Elan could not have requested such a change. Id. at *2528. In
response to plaintiffs argument that defendants could have developed the JC Virus antibody assay
13
sooner, the court noted that rather than acquiescing to the FDA, defendants “continued to research
the JCV antibody correlation until the FDA finally approved the modified warning.” Id. at 27.
ii. Christison
In Christison, Mrs. Christison received infusions of Tysabri from February 2007 to June
2009. Christison, 199 F.Supp.3d 1315, at 1330-31. She was diagnosed with PML in July 2009
and died the next month. Id. at 1330. Her husband brought claims of negligence, negligent failure
to warn, and negligent misrepresentation against Biogen and Elan in federal court in Utah. Id. at
1319. The Christison court granted summary judgment to defendants on all counts. Id. at 131$.
Utah also used the “learned intermediary” rule. Id. at 13 19-20.
The court in Christison described the two relevant assays that defendants attempted to
develop: the PCR assay and the JC Virus antibody assay. Id. at 1334-5. After Tysabri was taken
off the market in 2005, “Defendants’ scientists and others in the field pursued what they thought
to be the most likely risk stratification tool by devoting research efforts to finding JC virus in the
blood and periphery through [PCR] assay testing.” Id. at 1334. However, in 2010, the Christison
court noted, the Annals of Neurology published data demonstrating that the PCR assay was
“unlikely to be useful” as a PML risk stratification tool. Id. By 2009, Biogen scientists developed
the JC Virus antibody assay, which was analytically, but not clinically, validated meaning that it
-
accurately showed the relevant markers of the virus but did not identify those patients “at increased
risk for a serious adverse effect.” Id. Even after Mrs. Christison passed away, regulators stated
that the JC Virus antibody assay was “too preliminary to be of predictive value” as to PML. Id. at
1334.
The Christison court initially found that plaintiffs’4 case failed because they did not present
‘
There were technically two plaintiffs in Christison because Mr. Christison sued on his own
14
expert testimony as to the “alleged inadequacies” of the Tysabri label, and thus could not show
causation. Id. at 1340-42. The plaintiffs had argued that a jury was capable of analyzing the label
themselves; the Christison court disagreed. Id. Rather, the court explained: “[The case] requires
an expert who is familiar with drug labeling and the process by which a drug is prescribed to a
patient.” id. at 1342. Plaintiffs’ expert, Dr. Major, was not familiar with either area. Id. at 1339.
The Christison court also held that regardless of the lack of expert testimony, the Tysabri
label in 2007 through 2009 was adequate as a matter of law. Id. at 1346. The court explained that
given the black box warning as mandated by the FDA, along with the prescribing physician’s
testimony that the warning was adequate, the label “clearly convey[ed] a warning that taking
Tysabri would increase the risk of PML” Id. at 1345. Because the warnings were adequate as a
matter of law, the remaining state law claims failed. Id.5
The Christison court further found that plaintiffs’ claims were preempted by federal law
because, before 2012, it was clear the FDA would not have approved a label change. Id. at 13464$. The court in Christison noted that a manufacturer generally must seek FDA approval to change
a drug label that has already been approved but that manufacturers can add or strengthen a label
without prior approval under the “changes being effected” or “CBE” exception. Id. at 1347.
However, the court continued, if the manufacturer can show clear evidence that the FDA would
behalf and on behalf of his wife’s estate.
The Christison court denied Biogen and Elan summary judgment as to the argument that they
did not have a legal duty to develop an assay. Id. at 1345-46. The court found that the standard
for reviewing defendants’ duty is not whether they “had an obligation to engage in a specific act,
such as developing an assay,” but rather whether they “engaged in ‘reasonable conduct in light of
the apparent risk.” Id. at 1346 (emphasis in original). The court did note that Dr. Major’s
testimony was admissible on the issue of “the state of technology and research” on the assay. Id.
Even though Biogen and Elan were denied summary judgment on this ground, the court in
Christison nevertheless dismissed the plaintiffs’ entire case on other grounds.
15
not have approved the change, the CBE exception does not apply. Id. at 1346-47. The christison
court found clear evidence existed from CDER and CDRH’s rejection of Biogen’s requests in
2010. See Id. (citing In re Depakote, $7 F.Supp.3d 916 (S.D. Iii., 2015); Rheinfrank v. Abbott
Labs, 119 F.Supp.3d 749 (S.D. Ohio 2015)).
iii. Amos
Mrs. Amos took Tysabri from September 2006 to June 2011. See Amos, 249 f.Supp. 3d
at 696. Afier being diagnosed with PML in July 2011, she died in September of that year. Id. at
693. Her husband sued Biogen and Elan on behalf of Mrs. Amos’ estate, alleging inadequate
warnings as to the risk of PML. Id.
As in Gentile and C’hristison. the learned intermediary rule applied in Amos. The court
dismissed the failure to warn claims, finding that the warnings were “adequate as a matter of law.”
id. at 697-692. The Amos court held that, read as a whole, “the warnings for Tysabri clearly,
directly, and unequivocally informed treating physicians of the increased risk for PML.” Id. at
698. The warnings were “the strongest.
.
.
available” and described the “precise malady incurred.”
Id. at 697-698 (internal citations omitted).
The court in Amos also found that the failure to warn claims were preempted because
defendants could not have changed the label without FDA approval, and the evidence
demonstrated that FDA would not have approve the proposed change before 2012. Id. at 699. In
support, the court cited to the “two ‘smoking gun’ rejections from the FDA”, in September and
November 2010. Id. at 699-700. The court in Amos additionally found that any state claim as to
Elan was preempted because it could not have changed the Tysabri label under any circumstances
because it was not the drug’s license holder. Id. at 700.
16
b. The New Jersey Products Liability Act
The NJPLA provides:
A manufacturer or seller of a product shall be liable in a product
liability action only if the claimant proves by a preponderance of the
evidence that the product causing the harm was not reasonably fit,
suitable or safe for its intended purpose because it: a. deviated from
the design specifications, formulae, or performance standards of the
manufacturer or from otherwise identical units manufactured to the
same manufacturing specifications or formulae, or b. failed to
contain adequate warnings or instructions, or c. was designed in a
defective manner.
N.J.S.A. 2A:58C-2.
As noted, the current matter concerns the adequacy of Tysabri’s warning. In such cases,
“the defect is in the failure to warn unsuspecting users that the product can potentially cause
injury.” Zaza v. Marquess and Nell, inc., 144 N.J. 34, 58 (1996). Under the NJPLA, a legally
“adequate warning is one that a reasonably prudent person in the same or similar circumstances
would have provided.” Id. The “label does not have to have the best possible warning, but it must
be sufficient to adequately convey the nature, extent, and seriousness of the risk in a clear
unambiguous way to the prescribers of the drug.” In re Accutane Litigation, 2017 WL 3138003,
at *18 (App. Div. July 25, 2017). As to prescription medications, New Jersey also uses the
“learned intermediary” rule. This means that the duty to warn is owed to the prescribing physician
rather than the patient. See Neimiera by Neimeira v. Schneider, 114 N.J. 550, 552 (1989); see also
Seavev v. Globus Med. Inc., 2014 U.S. Dist. LEXIS 65985, at *32 (D.N.J. Mar. 11, 2014) (“When
the learned intermediary doctrine applies, a drug or medical device manufacturer fulfills its duty
to warn
.
.
.
when it provides a physician with an adequate warning about any dangerous
propensities that product may have.”); Banner v. Hoffman-La Roche Inc., 891 A.2d 1229, 1236
(App. Div. 2006).
Under the NJPLA, a pharmaceutical warning is presumed to be adequate as a matter of law
17
if it is FDA-approved. N.J.S.A. 2A:5$C-4; Perez v. Wyeth Laboratories Inc., 161 N.J. 1, 24
(1999). The New Jersey Supreme Court has ruled that the presumption can be overcome in two
instances: “For all practical purposes, absent deliberate concealment or nondisclosure of afier
acquired knowledge of harmful effects, compliance with FDA standards should be virtually
dispositive of such [failure to warn] claims.” Perez, 161 N.J. at 25. The Supreme Court has further
described the presumption as a “super-presumption,” that can be rebutted only in “rare” cases.
Kendall v. Hoffman-La Roche, Inc., 209 N.J. 173, 197 (2012).
Here, Plaintiff fails to point to a genuine issue of material fact that will overcome the
presumption of adequacy afforded by the NJPLA. Before Plaintiff began using Tysabri, the drug
carried a “black box” warning, the strongest possible warning required or permitted by the FDA.
The label specifically warned of the precise malady, PML, from which Plaintiff now suffers and
indicated that Tysabri increases the risk of PML. The label clearly stated the dire consequences
of PML, noting that the disease “usually leads to death or severe disability[.]” The label was also
written clearly and required the additional safeguard of the TOUCH program. The TOUCH
program ensured that only qualified physicians who are aware of the risks associated with Tysabri
could administer it. The program likewise required that the patients themselves be regularly
informed of the risk. In doing so, patients acknowledged not only the risks of PML but also that
there is no known cure for the disease. As noted, the learned intenriediary doctrine applies here,
as it did in Gentile, Christison, and Amos. The Court agrees that, as matter of law, the label before
Plaintiff began treatment was adequate as a matter of law concerning the prescribing physicians.
In fact, the Tysabri warnings went beyond the norm of advising only the learned intermediary; the
TOUCH program required direct warnings to the patient, including Plaintiff.
Plaintiff attempts to distinguish Gentile, Christison, and Amos by claiming that New Jersey
18
law contains a different standard. Specifically, Plaintiff argues that the reasonableness of the
warning must be viewed through the lens of the warning’s sender, not its recipient, see Opposition
at 10-11. Plaintiff, however, does not adequately explain how this difference materially impacts
the Court’s analysis. Plaintiff also asserts that Dr. Major’s testimony can overcome the superpresumption in favor of Defendants. The argument as to Dr. Major is addressed below.
Plaintiffs primary argument relies mainly on McDarby
Merck & Co., Inc., 401 N.J.
Super. 10 (App. Div. 2008), a products liability action concerning the prescription drug Vioxx.
The McDarbv court recognized an exception to the presumption where a drug manufacturer has
engaged in “economically-driven manipulation of the post-market regulatory process,” because
the pre-market approval process the FDA engages in is far more stringent than their oversight role
after a drug has entered the market. Id. at 63-64.
At the outset, in setting forth the economically-driven manipulation test, McDarbp broke
from the New Jersey Supreme Court’s two instances to overcome the statutory presumption:
deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects. Perez,
161 N.J. at 25 (1999). Plaintiff fails to cite to a Supreme Court of New Jersey decision that has
adopted the McDarby variation.6 Thus, it is not clear that the economically-driven manipulation
exception applies.
Yet, assuming that the economically-driven manipulation standard applies, there is no
genuine issue of material fact to support such a finding here. To the contrary, Biogen was
attempting to develop two different assays to detect the JC Virus. Biogen also employed an
The New Jersey Supreme Court acknowledged in Kendall v. Hoffman-La Roche, Inc., that
lower courts have “suggest[edj that circumstances less egregious than deliberate concealment
could overcome the presumption,” citing to McDarby. 209 N.J. 173, 195 & n.6 (2017).
However, the court did “not resolve that issue” in Kendall. Id.
6
19
advisory board and sponsored two clinical trials, STRATIFY-i and STRATIfY-2. In addition,
Biogen publically disclosed the additional cases of PML. Finally, in 2010, Biogen sought FDA
approval (by way of CDER and CDRH) for both a label change and approval of its assay, but the
FDA rejected both requests.
As a result, the facts in McDarby are easily distinguishable. There, the FDA was the
motivating force behind the label changes to Vioxx. In fact, an article even characterized the FDA
at having “force[d] Merck, the manufacturer of Vioxx, to add a warning of the risks of heart attack
and stroke to Vioxx’s label.” McDarby, 401 N.J. Super at 65 (citation omitted). The McDarby
court also noted that Merck’s marketing staff “engaged in strenuous efforts” to make sure that the
results of one of their studies “were not communicated to prescribing physicians,” and worse, that
there was evidence Merck may have lied to doctors who asked them questions about the harmful
effects of Vioxx. Id. at 68. Merck also downplayed adverse cardiovascular events and attributed
differences between Vioxx and anther product, Naproxen, to a scientifically unsubstantiated
property in Naproxen. Id. Plaintiff can point to no such evidence here to overcome the McDarby
exception.
Besides their separate Daithert motion, Defendants raise several issues with the testimony
of Dr. Major in their motion for summary judgment. Defendants argue that without a competent
neurologist’s testimony, Plaintiff cannot prove the label was inadequate or show proximate cause.
Dr. Major is not a neurologist nor a medical doctor, and Plaintiff has proffered no other expert
evidence. Plaintiff nevertheless argues that Dr. Major’s testimony raises a “genuine issue of
material fact” that precludes summary judgment. Opp. at 22-23.
As noted, New Jersey adheres to the learned intermediary rule. Thus, Plaintiff has to show
20
that the warning was inadequate as to the treating physician, rather than to Plaintiff.7 The court in
Christison addressed the same issue, finding that an expert had to testify as to the adequacy of the
label because it is outside the ken ofajuror’s “own life experiences.” Christison, 119 f.Supp. at
1340-1. When interpreting the NJPLA, other courts in this District have similarly stated that expert
testimony is required as part of a failure to warn claim, and without it, the claims “must ultimately
fail.” See, e.g., Jones v. Synthes USA Sales, LLC, 2010 U.S. Dist. LEXIS 85744, at *32 (D.N.J.,
Aug. 19, 2010). In other words, expert testimony is required when “the subject matter is so esoteric
that jurors of common judgment and experience are unable to make a determination without the
benefit of the information and opinions possessed by a person with specialized knowledge.”
*4..5 (D.N.J. May 22,
Grobelny v. Baxter Healthcare Corp., 200$ U.S. Dist. LEXIS 41115, at
200$) (holding that an expert witness was required in a case about a “complex pharmaceutical
compound”); cf Macri
V.
Ames McDonoztgh C’o., 211 N.J. Super. 636, 642 (App. Div. 1986)
(holding that an expert witness was not required to testify about the adequacy of a warning for a
household hammer).
Under the NJPLA, in addition to proving the product was defective, a plaintiff must also
show that “the defect was the proximate cause of the plaintiffs damages.” London v. Lederle
Laboratories, Div. of American Cyanamid Co., 290 N.J. Super. 318, 326-7 (App. Div. 1996);
N.J.S.A. 2A:5$C-2. “Where the failure-to-warn case involves a prescription drug, the issue is
whether the warning should have been given to the prescribing physician,” and the “plaintiff must
prove that the warning’s absence was the proximate cause of the hanm” Id. (citing Coffman v.
Keene Corp., 133 N.J. 581, 593-4 (1993)); see also Perez, 161 N.J. at 25-30.
As also noted, however, Plaintiff was directly advised of, and acknowledged, the risk of
Tysabri through the TOUCH program. Defendants’ SOMF at ¶15.
21
Thus, pursuant to New Jersey law, in a case involving the adequacy of a prescription
medication’s label and warnings, expert testimony is necessary for Plaintiff to prove his case. The
issue here is whether Plaintiffs proffered expert, Dr. Major, can fulfill this requirement. Plaintiff
claims that Dr. Major is qualified to testify as to the adequacy of the warnings, see
Opp. at 17, 20,
but then later states that Dr. Major could opine on issues “directly relevant” to the adequacy of the
label itself, Id. at 20. However, testimony on issues “relevant” to the adequacy of the label is not
the same as testifying to the adequacy of the warning itself. It appears that Plaintiffs argument is
that Dr. Major will testify that Biogen could have developed the JC Virus antibody assay earlier,
resulting in Plaintiff being tested for JC Virus antibodies before he developed PML.
This
testimony, according to Plaintiff, bears not only on the adequacy of the label but also proximate
cause. Opp. at 20-21. In other words, Dr. Major’s testimony is that Biogen could have developed
the JC Virus antibody assay earlier, not that the label was inadequate when Plaintiff was receiving
Tysabri infusions. Id.
Yet, Dr. Major admitted that he has never prescribed medication to a patient; he is not a
medical doctor. See Ex. 12 to Marino Cert. at 142:20-21. Nor has he “counseled patients with
respect to the risks and benefits of a particular MS medication.” Id. at 143:24-25, 144:1-3. Dr.
Major also acknowledged, “I am not familiar with the requirements for labeling for prescription
drugs” as far as the use of assays. See Id. at 212:24-25, 213:1. He also said that he did not know
the relevant requirements “to approve or clear an assay to be used with the prescription of a drug,”
and that he was not an expert in MS as compared to “neurologists who see and treat patients.” Id.
at 120:22-25, 121:2, 142:14-17. In fact, Dr. Major declared that he was
on the labeling” of Tysabri. Id.
at
“not going to comment
466:23-24.
By contrast, one of Plaintiff s prescribing physicians, Dr. Citak, testified that he was aware
22
of the PML risk in prescribing Tysabri and that, as a result, he was “more conservative” in
prescribing the drug than before it was taken off the market. See Ex. 10 to Marino Cert at 85:1223. Dr. Citak also discussed the risk of PML with Plaintiff before treating Plaintiff with Tysabri.
Id. at 84:22-25, 85:1-6. Dr. Zabad, another prescribing physician, said that she understood that
there is a risk of PML with Tysabri, and that “[lit is something that we discuss with the patient all
the time.” See Ex. 11 to Marino Cert. at 51:24, 52:1-3. Dr. Zabad also explained: “[I]f I feel it’s
a reasonable option and it’s within the prescription evidence, I will give [the patient] the choice.”
Id. at 66:9-11. Neither Dr. Citak nor Dr. Zabad stated that they would have made a different
prescribing decision for Plaintiff had the JC Virus assay been available to them.8 But Dr. Citak
stated that he would have ordered a test. See Ex. 10 to Marino Cert. at 138:10-16, 146:23-25,
147: 1-17.
The Court agrees with the conclusions reached by the Gentile and Christison courts
concerning Dr. Major’s proposed testimony and proximate cause. New Jersey law does not lead
to a different result. Because Dr. Major is not a neurologist who treats MS, he is not qualified to
opine as to the adequacy of the warning of the Tysabri label at any point in time. Dr. Major also
frankly admits that he is not familiar with the labeling requirements or regulations for prescription
medication. In contrast, Plaintiffs prescribing physicians explain that they knew the risks of
prescribing Tysabri to Plaintiff, and, afier discussing the risk directly with Plaintiff and obtaining
his informed consent, they made the decision to administer Tysabri. As to Plaintiffs theory that
Dr. Major will establish that Biogen could have developed its JC Virus antibody assay earlier,
Plaintiff fails to support this theory with any controlling or persuasive authority. In sum, there is
Dr. Zabad did test Plaintiff for “JC V{irus] DNA” three times in 2009; all of the tests were
negative. Defendants’ SOMF at ¶74.
8
23
not genuine issue of material fact that precludes summary judgment. Defendants are entitled to
summary judgment because Plaintiff does not have the necessary expert testimony to challenge
the adequacy of the Tysabri label or create a genuine issue as to probable cause.
c. Preemption
Defendants further argue that Plaintiffs NJPLA claim is preempted by federal law and that
Elan is entitled to judgment as a matter of law because it could not effect changes to Tysabri’s
label. The Court agrees.
The Supremacy Clause of the Constitution provides that federal law “shall be the supreme
Law of the Land.” U.S. Const. art. VI, ci. 2. States are free to legislate as they see fit, “subject
only to limitations imposed by the Supremacy Clause.” Tafflin v. Levitt, 492 U.S. 455, 458 (1990).
Federal law “preempts” state law in three situations: “(1) when a federal statute includes ‘an
express provision for preemption’; (2) ‘[w]hen Congress intends federal law to “occupy the field”
in an area of law; and (3) when a state and federal statue are in conflict.” In re Foxomax
(Alendronate Sodium) Products Lictbility Litigation (No. ii), 751 F.3d 150, 158-159 (internal
citations omitted). The third scenario, “conflict preemption,” includes two types: impossibility
preemption and obstacle preemption. Id. at 159. Impossibility preemption occurs when it is not
possible to comply with both federal and state law.
Id.
Here, Defendants argue conflict
preemption under the impossibility theory.
Drug manufacturers must seek FDA approval “to market a new drug,” showing that “it is
safe and effective and that the proposed label is accurate and adequate.” PLIVA, Inc. v. Mensing,
564 U.S. 604, 612 (2011). Not only must a manufacturer use the label approved by the FDA, but
“[g]enerally speaking, a manufacturer may only change a drug label after the FDA approves a
supplemental application.”
Wyeth v. Levine, 555 U.S. 555, 568 (2009).
24
However, FDA
regulations allow manufacturers to change the labels without FDA approval under the “Changes
Being Effected” (“CBE”) exception. Id. at 614 (citing 21 C.F.R. §314.70(c)(6)(iii)(A)). The
exception allows a manufacturer to “add or strengthen a contraindication, warning, [or]
precaution” without pre-approval from the FDA. Id. Nevertheless, if the manufacturer can show
clear evidence that the FDA would not have approved the labeling change, the CBE exception
does not apply. See Wyeth, 555 U.S. at 571.
Here, the Court agrees with the decisions in Gentile, Christison, and Amos: clear evidence
of impossibility exists. There is clear evidence that FDA would not have approved an earlier
change to the Tysabri label or have earlier approved the JC Virus antibody assay. In September
2010, Biogen proposed adding information to the Tysabri label about the use of the JC Virus
antibody assay, including recommending screening patients before starting infusions.
See
Defendants’ SOMF at ¶132-33. The FDA rejected that proposal because the underlying data was
insufficient. Id.
In November 2010, Biogen proposed making their JC Virus antibody assay
“available to Tysabri prescribers,” which the FDA again rejected because the usefulness of the test
“had not been established.” ld. at ¶f134-35.
Plaintiff argues that the United States Supreme Court severely limited the application of
federal preemption in Wyeth v. Levine, 555 U.S. 555 (2009). However, given the subsequent
decisions inMensing, 564 U.S. at 61$; MutttalFharmacetttical Co., Inc. v. Bartlett, 570 U.S. 472,
486-87 (2013); and In re Fosomax, 751 F.3d at 164-65, the Court disagrees. Plaintiff argues that
the standard of proof for showing that the FDA would not have approved a change, per Wyeth, is
very high, citing Aaron v. Wyeth, 2010 WL 653984 (W.D. Pa. Feb. 19, 2010); Reckis v. Johnson
& Johnson, 471 Mass. 272 (2015); and forst v. SmithKline Beecham Corp., 639 F.Supp.2d 948
(E.D. Wis. 2009). See Opp. at 33. However, as Plaintiff admits, Opp. at 35, all three have different
25
“fact patterns” than the one at bar and none are from this jurisdiction.
“Clear evidence” is necessary to rebut the CBE exception, meaning that the drug
manufacturer must present clear evidence that the FDA would have rejected the manufacturer’s
proposed changes to the label. See Wyeth, 555 U.S. at 571. Plaintiff argues that if Defendants had
pressed their position in the September 2010 meeting with the FDA, something “might have” been
added to the label (although Plaintiff does not indicate what that “something” might have been or
how it would have changed the outcome here). Opp. at 40. Not only is this not the appropriate
standard, it is clear from the record that the FDA would not have permitted a label change. In
September 2010, Biogen disclosed all pertinent information to the FDA (including the number of
PML cases), but the FDA nevertheless affirmatively stated that the label could not be amended.
The FDA determined that the sample size was too small and inconclusive to warrant a label change.
Defendants’ SOMF at ¶129.
Plaintiff also relies on In re fosomax, 852 F.3d 286 (3d Cir. 2017), arguing that the “clear
evidence” standard is always a question of fact for the jury. Opp. at 36-3 7. However, the Third
Circuit in fosomax, while acknowledging that issue would normally be one for the jury, also stated
that “[w]hen there is no issue of genuine material fact—that is, when no reasonably jury applying
the clear evidence standard of proof could conclude that the FDA would have approved a label
change—the manufacturer will be entitled to judgment as a matter of law.” In re fosornax, 252
F.3d at 282. In fact, the Amos court considered the Third Circuit’s decision in Fosomax and still
granted summary judgment for Defendants. See Amos, 249 F.Supp. 3d at 699. Indeed, the Third
Circuit in fosomax found that the state law claims were preempted as a matter of law. $52 f.3d
at 165.
Plaintiff further attempts to distinguish the Gentile and Amos because, in those cases, the
26
Plaintiff has also failed to show that Elan had the power to change the label. Opp. at 4344. Plaintiff merely cites to several cases that are not on point. Id. Because Elan was not the
United States license holder, it could not effect change to the label. Plaintiff has shown no facts
or law to the contrary. Thus, summary judgment is also appropriate for Elan on this ground.
IV.
Conclusion
For the reasons stated above, Defendants’ motion for summary judgment is GRANTED
and their Daitbert motion is DENIED as moot. To be clear, both Defendants are entitled to
summary judgment for the following, distinct reasons: (1) the Tysabri warnings were adequate as
a matter of law; (2) Plaintiff does not have the necessary expert evidence to challenge the adequacy
of the warnings (which, relatedly, also means that Plaintiff cannot establish proximate cause); and
(3) federal preemption. Elan is also entitled to summary judgment for the separate reason that it
is not the holder of the necessary license. An appropriate Order accompanies this Opinion.
Dated: April 25, 201$
JoIm Michael Vazque%3’S.
.j.
patients were diagnosed with PML before Defendants approached the FDA in 2010 to discuss a
labeling change. See Opp at 39-40. The Court disagrees. Here, it is uncontroverted that
Defendants approached the FDA before Plaintiff was diagnosed, and the FDA nevertheless
rejected Biogen’s proposal to change the label. Soon after the FDA rejected the proposal,
Plaintiff was diagnosed with PML. The FDA’s actual rejection is clear evidence; indeed, it is
difficult to conceive of stronger evidence in Defendants’ favor.
27
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