Christison v. Biogen Idec et al
Filing
186
MEMORANDUM DECISION denying 169 Motion for Leave to Amend Complaint. Signed by Magistrate Judge Dustin B. Pead on 5/11/16 (alt)
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF UTAH, CENTRAL DIVISION
KENNETH CHRISTISON, individually and as
surviving spouse of Annalee Christison,
deceased, and as personal representative of the
estate of Annalee Christison, deceased,
Plaintiff,
MEMORANDUM DECISION
Case No. 2:11-cv-01140-DN-DBP
District Judge David Nuffer
v.
BIOGEN IDEC,
Magistrate Judge Dustin B. Pead
ELAN PHARMACEUTICALS, LLC,
Defendants.
I.
INTRODUCTION
This matter was referred to the Court under 28 U.S.C. § 636(b)(1)(A). (ECF No. 117.) On
December 15, 2015, Plaintiff Kenneth Christison (“Plaintiff”) filed his motion for leave to
amend his First Amended Complaint (“Complaint”). (ECF No. 169.) For the reasons set forth
below, the Court DENIES Plaintiff’s motion to amend.
II.
MOTION TO AMEND
a. Parties’ arguments
Plaintiff claims that a Public Health Service Biological Materials Licensing Agreement
(“Licensing Agreement”) between Defendant Biogen Idec Inc. and the National Institute of
Health (“NIH”), which Defendants produced on September 28, 2015, supports a new claim for
negligent undertaking. (ECF No. 169.) Plaintiff’s proposed amended complaint alleges that
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Defendants failed to adequately develop a test, called a JC Virus antibody assay, which could
help determine whether patients taking Defendants’ drug Tysabri® were at risk of developing
progressive multifocal leukoencephalopathy (“PML”). Plaintiff asserts that the Licensing
Agreement demonstrates that Defendants had access to a JC Virus antibody assay in October
2006. Defendants did not make a JC Virus antibody assay commercially available until January
2012. Plaintiff asserts that the delay in commercializing the JC Virus antibody assay was the
result of actionable negligence on Defendants’ part.
Defendants argue that Plaintiff must meet the good cause standard set forth in Federal Rule
of Civil Procedure 16 because Plaintiff’s motion to amend was filed after the deadline for filing
amended pleadings. Defendants argue that Plaintiff cannot show good cause here because he
knew by at least January 2015 that Defendants received the JC Virus antibody assay from the
NIH. (ECF No. 171.) Notwithstanding that knowledge, Plaintiff did not seek his amendment
until December 2015. Further, Defendants argue that the negligent undertaking claim is futile for
a number of reasons.
b. Legal standard
“After a scheduling order deadline, a party seeking leave to amend must demonstrate (1)
good cause for seeking modification under Fed.R.Civ.P. 16(b)(4) and (2) satisfaction of the Rule
15(a) standard.” Birch v. Polaris Indus., Inc., 812 F.3d 1238, 1247 (10th Cir. 2015) (quoting
Gorsuch, Ltd., B.C. v. Wells Fargo Nat. Bank Ass’n, 771 F.3d 1230 (10th Cir. 2014)). Once the
deadline for an amendment has passed, a party may amend its pleading under Rule 15 only with
his opponent’s written consent or with the court’s leave, which should be “freely” given when
justice so requires. Birch at 1247 (quoting Fed. R. Civ. P. 15(a)(2)). “Under Rule 16(b)(4), a
scheduling order ‘may be modified only for good cause and with the judge’s consent.’” Id.
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In practice, the Rule 16(b)(4) standard requires the movant to show the scheduling
deadlines cannot be met despite the movant's diligent efforts. Rule 16’s good
cause requirement may be satisfied, for example, if a plaintiff learns new
information through discovery or if the underlying law has changed. If the
plaintiff knew of the underlying conduct but simply failed to raise tort claims,
however, the claims are barred.
Id. (alterations omitted).
c. Plaintiff has not demonstrated good cause to amend the scheduling order
Plaintiff’s motion to amend is untimely. Plaintiff does not address Rule 16’s good cause
requirement. Instead, Plaintiff argues the motion is “[t]imely [g]iven [t]he [c]ircumstances.”
(ECF No. 174 at 3.) This statement is incorrect. The deadline for amending pleadings in this case
was May 29, 2014. (ECF No. 121.) Plaintiff did not file this motion until December 15, 2015.
Thus, the motion is untimely and Plaintiff must establish good cause under Rule 16.
While Plaintiff does not explicitly address the good cause requirement, Plaintiff does argue
that the amendment was influenced by newly-discovery information, specifically the Licensing
Agreement. (ECF No. 169.) Newly-discovered information can provide good cause in certain
circumstances. See Pumpco, Inc. v. Schenker Int’l, Inc., 204 F.R.D. 667, 668 (D. Colo. 2001)
(cited with approval in Gorsuch, 771 F.3d 1230). The court concludes the present case does not
present such circumstances.
Plaintiff does not identify any new information in the Licensing Agreement that was
necessary for him to bring the negligent undertaking claim. The Proposed Second Amended
Complaint only mentions the Licensing Agreement in passing: “Then in October 2006, Biogen
acquired a JC virus antibody assay from NIH through a material licensing agreement for the
purpose of developing this assay for commercial use.” (ECF No. 169, Ex. 1.) Plaintiff elsewhere
asserts that there is little new factual information at play: “The only new factual issue is . . . that
Defendants had possession of a JC Virus antibody assay as early as 2006 . . . .” (ECF No. 169 at
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11.) Yet, even this was not a new factual issue. Plaintiff’s own expert’s report, issued in January
2015, indicated that the JC Virus Antibody assay was licensed to Defendants from the NIH in
“approximately 2007.” (ECF No. 171, Ex. 18 (“I am also aware of Material License Agreements
involving the ELISA assay . . . licensed by the Office of Tech Transfer, NIH to . . . BiogenIdec,
Boston, MA 2007.”).) At best, the only information the Licensing Agreement can be said to have
provided was clarification of the date of transfer from sometime in 2007, to October 2006.
Even in his reply, Plaintiff never identifies any specific information he lacked prior to
disclosure of the Licensing Agreement. Plaintiff concludes that he “simply did not have enough
information on which to base an earlier motion for leave to amend.” (ECF No. 174 at 3.) Yet,
Plaintiff never identifies any information in the Licensing Agreement that provided the basis for
his amendment. He vaguely references the “terms or rights of the parties contained” in the
Licensing Agreement, but Plaintiff knew the only terms he mentions in his proposed amended
claim: Defendants obtained a license to the JC Virus Antibody assay. It is clear that Plaintiff
knew this information by January 2015 because his own expert discussed the assignment in his
expert report. (See ECF No. 171, Ex. 18.) The only information that could in any way be
considered new is that Defendants obtained the assay in October 2006, rather than
“approximately 2007.” (Id.) Plaintiff does not suggest he was unable to bring the claim before he
knew the particular month Defendants obtained the assay. While Plaintiff apparently believes
that the Licensing Agreement will strengthen the negligent undertaking claim, he has not shown
that this information provides good cause to justify his tardy motion to amend. Rather, “plaintiff
knew of the underlying conduct but simply failed to raise [his] tort claim[], [thus] the claim[ is]
barred.” Birch, 812 F.3d at 1247.
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d. Plaintiff’s proposed negligent undertaking claim is futile
Additionally, Plaintiff’s claim is futile because he does not allege reliance or that his risk of
harm was increased by the undertaking. As Defendants point out, to state a claim for negligent
undertaking, Plaintiff must allege that Defendants’ undertaking increased Plaintiff’s risk of harm,
or that the harm resulted from Plaintiff’s reliance on the undertaking. See MacGregor v. Walker,
322 P.3d 706, 710 (Utah 2014) (“A mere failure ‘to facilitate the prevention of harm that
occurred through other causes’ is insufficient.”). Plaintiff alleges neither.
Plaintiff does not address this portion of Defendants’ argument in his reply. The court is
unable to independently identify any way in which Defendants’ attempts to develop a JC
antibody assay increased Plaintiff’s risk of harm. Successful development of the assay very well
may have helped Plaintiff, but that is not sufficient to impose a duty on Defendants. Plaintiff
must plead, and ultimately prove, that Defendants’ efforts to develop the assay (their
undertaking) increased Plaintiff’s risk of harm. Plaintiff has not alleged any increased risk of
harm as a result of Defendants’ allegedly negligent undertaking, nor described it in his briefing.
Additionally, Plaintiff does not appear to claim that he relied on the undertaking. Instead, his
briefing suggests he was not aware of the undertaking prior to this litigation. (ECF Nos. 169,
174.) Accordingly, Plaintiff’s proposed negligent undertaking claim is futile.
III.
ORDER
For the reasons analyzed above, the Court DENIES Plaintiff’s motion for leave to amend his
complaint. (ECF No. 169.)
Dated this 11th day of May, 2016.
By the Court:
Dustin B. Pead
United States Magistrate Judge
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