Christison v. Biogen Idec et al
Filing
95
MEMORANDUM DECISION AND ORDER RE 17 Motion to Dismiss, 21 Motion to Dismiss: first, second, third, fifth and seventh causes of action are dismissed with prejudice; fourth cause of action is dismissed without prejudice; sixth cause of action is dismissed as an independent cause of action. Signed by Judge David Nuffer on 12/26/13 (alt)
IN THE UNITED STATES DISTRICT COURT
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 AND
ORDER REGARDING DEFENDANTS'
MOTIONS TO DISMISS
Case No.: 2:11-cv-01140
District Judge David Nuffer
v.
BIOGEN IDEC INC. and ELAN
PHARMACEUTICALS, INC.,
Defendants.
Defendants Biogen Idec Inc. ("Biogen") and Elan Pharmaceuticals, Inc. ("Elan") each
filed motions to dismiss Plaintiff Kenneth Christison's ("Christison") complaint (collectively, the
"Motions"). 1 On October 31, 2013, argument from counsel was heard related to the Motions.
Defendants were represented by Joseph G. Blute of Mintz, Levin, Cohn, Ferris, Glovsky and
Popeo, P.C. and John A. Anderson of Stoel Rives, LLP; Plaintiff was represented by Allen Till
of Blizzard & Nabers, LLP and Karthik Nadesan of Nadesan Beck, P.C. Supplemental
memoranda of points and authorities on the choice of law issue were later submitted by both
Defendants and Plaintiff.
I. FACTUAL BACKGROUND
The Complaint alleges that in May 2004, Defendants sought approval from the Food &
Drug Administration ("FDA") of an immunomodulator, Tysabri®, for the treatment of a
1
Docket nos. 17 and 21, filed by Biogen, and docket nos. 15 and 30 filed by Elan, respectively.
degenerative neurological disease known as multiple sclerosis ("MS"). 2 The FDA approved
Tysabri to treat MS in November of that year. 3 Shortly thereafter, Defendants began to market
and distribute Tysabri in the United States. 4
In February 2005, Defendants removed Tysabri from the market and from use in clinical
trials after Defendants received notice of two adverse event reports relating to patients diagnosed
with Progressive Multifocal Leukoencephalopathy ("PML"). 5 After a safety review was
conducted, the FDA approved the reintroduction of Tysabri monotherapy in treating MS subject
to a prescribing program called Tysabri Outreach: Unified Commitment to Health ("TOUCH"). 6
The TOUCH program requires every Tysabri prescriber, infusion site and MS patient receiving
Tysabri in the United States to enroll in a risk management program that monitors patients for
early indications of PML. 7 The FDA also required Defendants to include a black box warning in
the drug labeling concerning the PML risk.
In 1991, Plaintiff's spouse, Annalee Christison ("Ms. Christison"), was diagnosed with
MS and she was prescribed Tysabri by her treating neurologist in 2007. 8 Ms. Christison
commenced Tysabri infusions pursuant to the TOUCH prescribing program in February 2007. 9
Ms. Christison was treated with Tysabri infusions administered monthly over two years,
2
Compl., at ¶¶ 15, 22, docket no. 33-1.
3
Id. at ¶ 14.
4
Id.
5
Id. at ¶ 23.
6
Id. at ¶ 24.
7
Id.
8
Id. at ¶¶ 36-37.
9
Id. at ¶ 37.
2
terminating in July 2009 when Ms. Christison was diagnosed with PML. 10 Ms. Christison died
as result of PML one week after her diagnosis. 11
II. PROCEDURAL BACKGROUND
The Plaintiff, a Utah resident, filed his Complaint in California state court on his own
behalf and on behalf of the decedent. Biogen Idec removed the case to the United States District
Court for the Northern District of California. Thereafter, the court granted Defendant's Motion
to Transfer pursuant to 28 U.S.C. § 1404(a) and transferred the case to this Court.
The Plaintiff's Complaint alleges design defect, failure to warn, strict liability in tort,
negligence, breach of implied warranty, wrongful death, and violation of California Civil Code §
1750. The Plaintiff seeks damages, including punitive damages, of an unspecified amount. The
stated grounds for the claim asserted are (1) that the Defendants acted negligently in their design
and failure to warn of the risks associated with Tysabri, and (2) that Ms. Christison died from
PML as result of the Defendants' negligence and sale of a defective product. With respect to the
warnings claims, Plaintiff alleges that Defendants failed to adequately warn that the PML risk
associated with Tysabri use increases with longer treatment duration.
The Defendants move to dismiss the Complaint on grounds that the Complaint fails to
state a claim under Fed. R. Civ. P. 12(b)(6) as interpreted by Bell Atlantic Corp. v. Twombly 12
and Ashcroft v. Iqbal. 13 Specifically, Defendants argue that Plaintiff's claims based on a design
defect theory and under California Civil Code § 1750 are expressly barred under Utah law.
Similarly, Defendants also argue that punitive damages are expressly barred under Utah law in
cases involving prescription drugs approved by the FDA pursuant to Utah Code Ann. § 78B-810
Id. at ¶¶ 38-39.
11
Id. at ¶ 41.
12
550 U.S. 544 (2007).
13
556 U.S. 662 (2009).
3
203(1). The only exception to this limitation is if the Plaintiff can prove "by clear and
convincing evidence that the drug manufacturer knowingly withheld or misrepresented
information required to be submitted to the Federal Food and Drug Administration under its
regulations, which information was material and relevant to the claimant's harm." 14 Defendants
argue Plaintiff cannot offer any plausible basis for such an argument and that this exception
cannot apply in this case because the application of the exception is preempted by federal law
under Buckman Co. v. Plaintiff's Legal Comm.15 Lastly, Defendants argue that the Plaintiff's
remaining claims for failure to warn, negligence, and breach of warranty are all based on
boilerplate, conclusory assertions that do not meet the minimum federal pleading standards
under Twombly and Iqbal. In particular, Defendants argue (1) that the Plaintiff fails to allege the
specific deficiency in the adequacy of the labeling and the information reasonably scientifically
available to the Defendants at the time the drug was prescribed to Ms. Christison that would
mandate a different warning, and (2) that the Plaintiff fails to allege any facts in support of the
claim that a different warning would have changed the prescribing physician's medical judgment
as to whether to prescribe Tysabri for the treatment of Ms. Christison's multiple sclerosis.
III. ORDER
In order to withstand a motion to dismiss under Bell Atlantic Corp. v. Twombly and
Ashcroft v. Iqbal, a plaintiff must allege enough facts, "taken as true, to state a claim to relief that
is plausible on its face." 16 A plaintiff must "offer specific factual allegations to support each
claim" and while the Court must "accept as true all of the allegations contained in the complaint"
14
Utah Code Ann. § 78B-8-203(2).
15
531 U.S. 341 (2001).
16
Kansas Penn Gaming, LLC v. Collins, 656 F.3d 1210, 1214 (10th Cir. 2011) (internal quotation marks omitted)
(quoting Twombly, 550 U.S. at 570)
4
this requirement is "inapplicable to legal conclusions." 17 A plaintiff's "obligation to provide the
‘grounds' of his ‘entitlement to relief' requires more than labels and conclusions, and a formulaic
recitation of a cause of action's elements will not do." 18 Therefore, "in ruling on a motion to
dismiss, a court should disregard all conclusory statements of law and consider whether the
remaining specific factual allegations, if assumed to be true, plausibly suggest the defendant is
liable." 19
Having reviewed the memoranda in support of and opposition to the motions to dismiss,
including the supplemental memoranda on punitive damages and separate supplemental
memoranda on the choice of law issue, and having considered the oral arguments of counsel,
Plaintiff having stipulated to the dismissal of certain causes of action, and good cause appearing,
IT IS HEREBY ORDERED as follows:
1.
Because this matter was transferred from the United States District Court for the
District of Northern California to this district, pursuant to 28 U.S.C. §1404(a), this Court must
apply California's choice of law rules. 20 California courts apply a "governmental interest"
analysis to resolve choice of law questions. 21 This analysis looks at the competing interests of
the states whose laws are potentially applicable to the claim. The court applies the law of the
state whose interests would be most significantly impaired if not chosen to apply to the dispute. 22
Utah law governs the substantive issues in the case. Accordingly, Utah's substantive law
rules shall governs any and all state law claims asserted in the complaint or any subsequently
17
Id. at 1214.
18
Twombly, 550 U.S. at 555.
19
Kansas Penn Gaming, 656 F.3d at 1214.
20
Van Dusen v. Barrack, 376 U.S. 612, 635-37 (1964); Trierweiler v. Croxton & Trench Holding Corp., 90 F.3d
1523, 1532 (10th Cir. 1996).
21
McCann v. Foster Wheeler, LLC, 48 Cal. 4th 68, 83 (Cal. Feb. 18, 2010).
22
Id.
5
filed amended complaint. Utah's substantive law has been applied in reaching the rulings set
forth herein except to the extent Plaintiff's counsel has stipulated to the dismissal of any cause of
action under any state's laws or where federal pleadings standards apply.
2.
For purposes of this motion only, Elan's motion to dismiss is denied to the extent
it seeks to have Elan treated separately from Biogen. All rulings contained herein apply equally
to Elan and Biogen.
3.
Plaintiff's first cause of action for "Design Defect" is dismissed with prejudice
based on the Utah Supreme Court's holding in Grundberg v. Upjohn 23 and based on the
stipulation of Plaintiff's counsel. 24
4.
Plaintiff's second cause of action for "Strict Liability - Failure to Warn" is
dismissed with prejudice based on the stipulation of Plaintiff's counsel. 25
5.
Plaintiff's third cause of action for "Strict Liability In Tort" is dismissed with
prejudice based upon the stipulation of Plaintiff's counsel to dismiss. 26
6.
Plaintiff's fourth cause of action for "Negligence" is dismissed without prejudice.
Plaintiff is granted leave to amend to restate this cause of action by asserting specific facts about
the existence of information that made the labeling of Tysabri® inadequate at times material to
Plaintiff's decedent's ingestion of the drug, together with specific facts alleging that a change in
warnings would have had an impact on the prescribing physician's decision to prescribe
Tysabri® to Plaintiff's decedent.
23
813 P.2d 89 (Utah 1991).
24
Plaintiff's Opposition to Defendant Biogen Idec, Inc.'s Motion to Dismiss at 13, docket no. 33, filed January 30,
2012.
25
Reporter's Transcript of Proceedings at 7:25-8:3, docket no. 76, filed November 4. 2013.
26
Id. at 8:6-15
6
7.
Plaintiff's fifth cause of action for "Breach of Implied Warranty" is dismissed with
prejudice based on the stipulation of Plaintiff's counsel. 27
8.
Plaintiff's sixth cause of action for "Wrongful Death" is dismissed as an
independent cause of action. Plaintiff may restate the fact of Plaintiff's decedent's alleged
wrongful death as a predicate to Plaintiff's re-pleaded claim for negligence.
9.
Plaintiff's seventh cause of action for "Violation of Civil Code §1750" is
dismissed with prejudice based on the stipulation of Plaintiff's counsel. 28
10.
Plaintiff's prayer for "Punitive Damages" under any cause of action is dismissed
without prejudice based on Plaintiff's failure to plead that FDA itself has found that Defendants
knowingly withheld or misrepresented information required to be submitted to FDA under its
regulations in connection with Tysabri®. Plaintiff is not in this order granted leave to amend to
pray for punitive damages under his remaining theory of negligence. However, Plaintiff may file
a motion to amend to pray for an award of punitive damages if Plaintiff can allege that FDA
itself has found that Defendants knowingly withheld or misrepresented information required to
be submitted to FDA under its regulations in connection with Tysabri®.
Dated December 26, 2013.
BY THE COURT:
___________________________________
David Nuffer
United States District Judge
27
Id. at 25:25-26:15.
28
Id. at 8:21-9:5.
7
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