NELSON v. BIOGENIC IDEC, INC. et al
Filing
140
OPINION re 121 MOTION for Leave to File Fourth Amended Complaint filed by ANDREW NELSON. Signed by Magistrate Judge Mark Falk on 6/7/2016. (seb)
NOT FOR PUBLICATION
UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY
Civil Action No. 12-7317 (JMV)
ANDREW NELSON,
Plaintiff,
v.
BIOGEN IDEC, INC. and ELAN
PHARMACEUTICALS, LLC,
OPINION
Defendants.
FALK, U.S.M.J.
Plaintiff, Andrew Nelson, filed the original Complaint in this matter on November
28, 2012, alleging that he sustained serious injuries stemming from his use of Defendant’s
FDA-approved drug Tysabri®, which was prescribed to him for the treatment of multiple
sclerosis. Following motion practice, Plaintiff’s remaining claim is one for failure to
warn under the New Jersey Products Liability Act, N.J.S.A. 2A:58C-2.
Plaintiff has moved for leave to file a fourth amended complaint. [ECF No. 121.]
The motion is opposed. For the reasons stated below, the motion is GRANTED.
I.
Background
Plaintiff suffers from multiple sclerosis (MS). He was prescribed Defendant’s
drug Tysabri to help treat his MS. One of the possible side effects of Tysabri is an
increased risk of contracting a devastating neurological disease known as progressive
multifocal leukoencephalopathy (“PML”). Plaintiff developed PML, which severely
disabled him. The proposed amended complaint focuses on a test known as a JC Virus
antibody assy, which can help predict whether a person taking Tysabri would develop
PML. In overly simplified terms, Plaintiff alleges that Defendants’ activities and
negligence in connection with the development of the JC Virus Antibody test makes
Defendants liable for Plaintiff’s injuries. Basically, Plaintiff claims had Defendants met
their obligations and developed the test earlier, it would have enabled him to decide not to
take Tysabri or discontinue its use prior to developing PML. Once again, the above
description is a summary oversimplification of complex scientific issues.
There are a number of nearly identical cases around the country between Tysabri
Plaintiffs and Defendants. The same lawyers and certain experts are involved in all of the
cases. On May 11, 2016, in a case pending in the District of Utah, Magistrate Judge
Dustin B. Pead denied a very similar motion to amend.1 On May 20, 2016, Plaintiff’s
counsel (in both cases) submitted a letter stating that Plaintiff is appealing the Magistrate
Judge’s Opinion in Utah as “clearly erroneous and contrary to law.”
1
Christison v. Biogen Idec, Inc., et al., No. 11-cv-1140-DN-DBP. Plaintiff
Christison died, allegedly from PML.
2
II.
Plaintiff’s Motion to Amend2
Plaintiff seeks leave to amend his Complaint to bring a common law claim of
negligent undertaking. Plaintiff’s claim is based on the allegation that Defendants were
negligent in failing to promptly follow up and offer the JC Virus antibody assay,
notwithstanding their alleged undertaking to do so as early as 2006. The proposed
amendment is allegedly based on information in a Biological Materials Licensing
Agreement (MLA) by which Biogen received the JCV antibody assay and samples which
would enable the test to be used effectively.
Plaintiff’s motion comes after the deadline for amending pleadings contained in
the Court’s Scheduling Order. The reason offered for the late amendment is “newly
produced evidence”—the License Agreement between Defendant Biogen and the
National Institute of Health, which was first produced by Defendant on September 28,
2015, following the deposition of Plaintiff’s expert. (Pl.’s Br. 1.)
The License Agreement with NIH, dated October 19, 2006, licensed to Biogen the
use of “serologic assays for the detection and differentiation of antibodies directed against
JC or BK viruses.” Plaintiff claims that Defendants knew that the JC Virus causes PML,
and that the License Agreement proves that, in 2006, Biogen had technology to test the
blood for JC Virus antibodies. Yet, instead of moving expeditiously, Plaintiff claims that
Defendants made a financially-motivated decision to develop their own version of the
2
Aspects of this Opinion are drawn from the parties’ briefs, declarations, and
letters. Many of the submissions contain cross-reference and citation to documents in the
Christison lawsuit pending in the District of Utah.
3
assay, which was eventually released in January 2012. Plaintiffs allege that Defendants
voluntarily assumed the duty to develop and commercialize an antibody assay, and were
negligent in their execution of that duty. (Pl.’s Br. 1-3.)
Defendants counter that Plaintiff’s proposed amendment is untimely and that
Plaintiff has not shown “good cause” to amend the scheduling order and allow the late
claim. (Defs.’ Br. 11-15.) They also claim that the amendment is prejudicial, brought to
avoid summary judgment and prolong the case, and futile for a number of
reasons—including that New Jersey does not recognize a claim for negligent undertaking
on these facts; that a common law claim for negligent undertaking is preempted by
federal law; and that public policy bars the type of negligence claim proposed in this case.
(Defs.’ Br. 15-26.)
III.
Decision
A.
Plaintiff Has Shown Sufficient Good Cause
The legal standard for amending pleadings is extremely liberal. The Amendment
is usually permitted unless the party opposing amendment can show genuine prejudice.
When the request to amend comes after an amendment deadline in a scheduling order, a
higher standard applies requiring a showing of “good cause.”
The deadline to amend pleadings in this case was June 14, 2014. Therefore,
Plaintiff’s motion implicates not only Rule 15, but also Rule 16(b)’s “good cause”
requirement. Dimensional Commc’n Inc. v. Oz Optics, Ltd., 148 Fed. Appx. 82, 85 (3d
4
Cir. 2006).3 Good cause largely depends on the diligence of the moving party. Harrison
Beverage Co. v. Dribeck Importers, Inc., 133 F.R.D. 463, 469 (D.N.J. 1990). The movant
must show that “despite its diligence, it could not reasonably have met the scheduling
order deadline.” Hutchins v. United Parcel Service, No. 01-1462, 2005 WL 1793695, at
*3 (D.N.J. July 26, 2005).
What will constitute “good cause” to warrant modification “necessarily varies with
the circumstances of each case.” 6A Alan Wright et al., Federal Practice & Procedure §
1522.2 at 313 (3d ed. 2010). The Court, therefore, has “great discretion in determining
what kind of showing the moving party must make in order to satisfy the good cause
requirement of Rule 16(b).” Thoman v. Philips Med. Sys., No. 04-3698, 2007 WL
203943, at *10 (D.N.J. Jan. 24, 2007) (citations omitted).
`
Plaintiff claims that “good cause” supporting the amendment is Defendants’ late
production of the NIH-Biogen License Agreement in September 2015. Defendants
counter that the License Agreement does not constitute good cause because Plaintiff was
inferentially aware of the existence of the NIH transfer before the actual License
Agreement was produced. Specifically, Defendants point to the May 2015 report of
Plaintiff’s expert, Dr. Eugene O. Major, which contains a general reference to the
3
Rule 16(b)(4) provides in relevant part: “A schedule may be modified only for
good cause.”
5
existence of a transfer agreement relating to assay technology.4
It is true that Dr. Major’s report refers to a licensing arrangement. However,
it is not a very detailed reference to what is a complicated agreement and the agreement
wasn’t attached to the report. Also, there is a disconnect between what Plaintiff knew and
what one of his experts knew. Indeed, in a declaration submitted with the motion to
amend, Dr. Major explains that he did not disclose to Plaintiff his knowledge relating to
the License Agreement:
[t]here are multiple reasons for the absence of discussion
between myself and the Plaintiff regarding the MLA. First,
although I possessed general knowledge that a transfer
occurred, I had no specific knowledge regarding the terms and
or conditions of the MLA; . . . . Additionally, I abstained from
disclosing any information that I may have possessed about the
MLA or its transfer of materials in an abundance of caution
and respect for ethical and professional standards. As the
Court is aware, the Defendants previously attempted to
disqualify me as an expert witness in this case based on: . . .
[2] Tysabri-related work I performed with Biogen during my
time at NIH. I submitted an affidavit at that time to make clear
my testimony would be based on my general experience and
expertise in virology and the development of ELISA assays
and not about the specific information acquired in the courts of
performing my official duties at the NIH.
(Affidavit of Eugene O. Major at 6; ECF No. 127-1.)
Plaintiff’s expert knew of the License Agreement; but Plaintiff did not. Moreover,
even Plaintiff’s expert swears he “had no specific knowledge regarding the terms and
4
Dr. Major’s report itself was served well after the 2014 Amendment deadline.
6
conditions of the license agreement.” Id. Thus, Plaintiff was unaware of the specifics of
the License Agreement until after the document was produced. It is unfair to claim that
Plaintiff should have sought leave to amend based on the specifics of the License
Agreement without having seen the document. Indeed, it is not inconceivable that
Defendants could have argued that Plaintiff lacked a good faith factual basis for the
Amendment prior to getting the License Agreement.
The parties disagree on Plaintiff’s diligence and just how important the License
Agreement is to pleading the negligent undertaking claim. Nevertheless, good cause is
case dependent and highly discretionary. See Thoman, 2007 WL 203943, at *10 (the
Court has “great discretion in determining what kind of showing the moving party must
make in order to satisfy the good cause requirement of Rule 16(b).”). And it appears
that:
•
Biogen produced the License Agreement in September 2015, long after the
deadline to amend;
•
the License Agreement contains multiple terms that are “both new
information as well as pertinent to the claim for negligent undertaking”;
•
Plaintiff’s knowledge of the License Agreement was minimal and lacking
context (at most) until the Agreement was produced;
•
Plaintiff’s expert has forcefully stated that he did not inform Plaintiff about
the terms of the License Agreement because he himself did not know the
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specifics and because of ethical obligations relating to his prior
employment; and
•
Plaintiff requested the License Agreement from Defendants earlier in
discovery and it was mistakenly represented that it had been produced.
Based on these assertions, the Court is satisfied that Plaintiff has shown sufficient
good cause for seeking to amend after the deadline in the scheduling order.5 More
specifically, Plaintiff has strongly demonstrated that, without the Licensing Agreement,
he could not have met the Scheduling Order deadline. This is especially so in such a
complex scientific realm when pleading a somewhat adventurous claim.
B.
No Undue Prejudice
“Prejudice to the non-moving party is the touchstone for the denial of an
amendment.” Lorenz v. CSX Corp., 1 F.3d 1406,1414 (3d Cir. 1993). Incidental
prejudice is insufficient grounds on which to deny leave to amend. See In re Caterpillar,
Inc. , 67 F. Supp. 3d 663, 668 (D.N.J. 2014). Prejudice is generally evaluated by looking
at whether the amendment would: (1) require the non-moving party to expend significant
additional resources to conduct discovery and prepare for trial; (2) significantly delay the
resolution of the dispute; or (3) prevent the non-moving party from bringing a timely
5
The Court acknowledges that Magistrate Judge Pead denied a similar motion to
amend in the Christison case on May 11, 2016, finding that the plaintiff failed to establish
good cause. The plaintiff is appealing that decision, which remains pending. While the
facts and arguments may be similar, a different conclusion on “good cause” is reached
here, which is largely discretionary.
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action in another forum. See, e.g., Long v. Wilson, 393 F.3d 390, 400 (3d Cir. 2004).
Plaintiff’s proposed amendment is not unduly prejudicial. No new parties are
being brought into the case. Rather, a new legal theory is being added. Importantly, it
does not appear that the amendment will require significant additional discovery.
Plaintiff claims that the amendment arises out of the same subject matter contained in the
original complaint, i.e., testing for the JC Virus antibodies, which has already been the
subject of extensive discovery. By contrast, Defendants claim that significant additional
discovery will be needed, but no specifics are provided. (Defs.’ Br. 15-16.) As best as
the Court can tell, to the extent additional discovery is required, it appears to be limited to
one or two depositions, perhaps including that of Dr. Major. This does not constitute
“undue” prejudice; indeed, any additional discovery could be promptly conducted under
the management of the Magistrate Judge. To the extent there is any delay or prejudice
present, it is insufficient to overcome the liberality associated with the amendment of
pleadings.
C.
No Clear Futility
The futility analysis on a motion to amend compares to a Rule 12(b)(6) motion.
See In re NAHC, Inc. Sec. Litig., 306 F.3d 1314, 1332 (3d Cir. 2002) (“An amendment
would be futile when ‘the complaint, as amended, would fail to state a claim upon which
relief could be granted.’”). For a complaint to survive dismissal, it “must contain
sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its
9
face.’” Ashcroft v. Iqbal, 556 U.S. 662 (2009) (citing Bell Atl. Corp. v. Twombly, 550
U.S. 544, 570, (2007)). Given the liberal standard for the amendment of pleadings,
“courts place a heavy burden on opponents who wish to declare a proposed amendment
futile.” Pharmaceutical Sales and Consulting Corp. v. J.W.S. Delavau Co., Inc., 106 F.
Supp. 2d 761, 764 (D.N.J. 2000) (citations omitted). Although tracking Rule 12(b)(6),
Rule 15 futility does not contemplate substantive motion practice on the merits of the
claims:
If a proposed amendment is not clearly futile, then denial
of leave to amend is improper. This does not
require the parties to engage in the equivalent of
substantive motion practice upon the proposed new claim
or defense; this does require, however, that the newly
asserted defense appear to be sufficiently well-grounded in
fact or law that it is not a frivolous pursuit.
Harrison Beverage Co. v. Dribeck Importers, Inc., 133 F.R.D. 463, 468 (D.N.J.1990)
(emphases added) (citations omitted); see also 6 Wright, Miller & Kane Federal Practice
and Procedure, §1487 (2d ed. 1990). Effectively, this means that the proposed
amendment must be “frivolous or advance a claim or defense that is legally insufficient
on its face . . . .” Marlowe Patent Holdings, LLC v. Dice Electronics, LLC., 293 F.R.D.
688, 695 (D.N.J. 2013).
Defendants forcefully argue that the proposed amendment is futile for numerous
reasons, including that: New Jersey law does not recognize a negligent undertaking claim
in the circumstances present here; Defendants had no duty to develop a JCV antibody
10
assay; and Plaintiff’s claim is preempted by federal law. Plaintiff has a credible response
to all of these arguments, including that a jury should decide Defendants’ obligations
under the somewhat unique facts presented.
In this Court’s view, the futility arguments made all go beyond the scope of what is
appropriate in the context of a motion to amend. Defendants’ futility arguments are claim
dispositive issues focused on, for example, federal preemption and the obligations
imposed on pharmaceutical companies by the FDA. Deciding such arguments in the
context of a non-dispositive, Rule 15 motion to amend pleadings arguably usurps the
authority of a District Judge deciding a Rule 12(b)(6) motion; stated differently, it is
making an embedded dispositive decision in the context of a facially non-dispositive
motion. The Court does not believe that is the contemplation of Rule 15 motion practice.
The amendment is somewhat sophisticated and presented against a background of
intricate scientific principals and heavy governmental regulation of a pharmaceutical
industry where the rules and practices have been changing over time. It is no doubt an
enterprising claim. However, we cannot conclude that the claim is clearly futile on its
face. Defendants’ claims of futility may ultimately be correct; if so, Plaintiff’s claim will
fall. But that decision requires a more searching analysis than is called for by Rule 15,
where the futility analysis speaks of patent frivolousness on the face of the pleading.
Harrison Beverage Co., 133 F.R.D. at 468. We do not have that here. The proposed
amendment is the subject of some forceful merits-based attack, but not one that is “legally
11
insufficient on its face.” Marlowe Patent Hold., 293 F.R.D. at 695. For purposes of Rule
15 only, the Court is satisfied that Plaintiff’s proposed amendment is not futile.
CONCLUSION
For the reasons stated above, Plaintiff’s motion to amend [ECF No. 121] is
GRANTED. The pleading should be filed within 7 days. Defendants may respond to the
pleading in any manner authorized by the Federal Rules of Civil Procedure.
SO ORDERED.
s/Mark Falk
MARK FALK
United States Magistrate Judge
Dated: June 7, 2016
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