United States District Court, D. New Jersey
Michael Vazquez, U.S.D.J.
present matter comes before the Court on Defendants'
Biogen Idee Inc. ("Biogen") and Elan
Pharmaceuticals, Inc.'s ("Elan") (collectively,
"Defendants") joint objection to the Magistrate
Judge's order granting Plaintiff leave to file a Fourth
Amended Complaint ("FAC") or, in the alternative,
Defendants' joint motion to dismiss the negligent
undertaking claim in the FAC for failure to state a claim
under Rule 12(b)(6). Plaintiff opposes the motions. The
negligent undertaking claim alleges that Biogen acted
negligently in failing to bring to market sooner a medical
test that could have screened Plaintiff for the presence of
an antibody. The motions were decided without oral argument
pursuant to Federal Rule of Civil Procedure 78 and Local
Civil Rule 78.1. The Court has considered the parties'
submissions and grants Defendants' motion to dismiss.
Defendants' appeal of Judge Falk's Order is therefore
BACKGROUND & PROCEDURAL HISTORY
following facts are derived from the FAC. D.E.
In May 2004, Biogen and Elan submitted a Biologies License
Application ("BLA") to the United States Food and
Drug Administration ("FDA") for approval of Tysabri
for treatment of Multiple Sclerosis ("MS").
Id. ¶ 14. Tysabri is the trade name for the
immunosuppressant natalizumab. M ¶ 1. In November 2004,
the FDA approved the drug for treatment of remitting and
relapsing MS. Id. ¶ 15. On or about November
24, 2004, Defendants began to market and distribute Tysabri
in the United States. Id.
February 2005, three months after gaining FDA approval,
Defendants withdrew Tysabri from the market and put all
clinical trials on hold because two patients receiving
Tysabri developed Progressive Multifocal Leukoencephalopathy
("PML"). Id. ¶ 26. PML is an
aggressive brain infection caused by the immunosuppressive
effects of Tysabri. Id. ¶ 18. Specifically, PML
is caused by the JC virus. Id. PML is a typically
fatal brain disease that usually results in death within one
to four months of the onset of the disease. Id.
2006, after no additional cases of PML were reported, the FDA
permitted Tysabri to return to the market, with additional
restrictions. Id. ¶ 26. Nonetheless, MS
patients receiving Tysabri continued to develop PML. See
Id. ¶¶ 32-34. By July 2008, Tysabri had caused
PML in fourteen patients, and by July 2009, the number grew
to more than twenty. Id. ¶¶ 32-33, 36.
2010, Defendants revised the U.S. label for Tysabri to
reflect an increased risk of developing PML with longer
treatment duration. Id. ¶ 42. Then, in 2011,
the FDA issued a drug safety communication stating that
"patients who took an immune system suppressing
medication prior to taking Tysabri have been shown to be at
an increased risk for developing PML." Id.
¶ 48. In January of 2012, the FDA issued another drug
safety communication, which stated that "testing
positive for anti-JC Virus antibodies has been identified as
a risk factor for PML." Id. ¶ 51.
Plaintiff contends that because of this, "Defendants
undoubtedly knew [that] patients whose blood tested positive
for JC virus antibodies would be at a higher risk of
developing PML." Id. ¶ 90.
was diagnosed with MS in October 2002 and commenced Tysabri
infusions in January of 2007. Id. ¶¶
54-55. Plaintiff received monthly Tysabri infusions for the
next three years without any warning of increased risk of
developing PML. Id. ¶ 56. Throughout the time
Plaintiff was receiving treatment, the drug's labeling
contained no warnings regarding risk factors associated with
taking Tysabri. Id. ¶¶ 61-64. In November
2010, Plaintiff was admitted to the hospital with worsening
symptoms and a brain biopsy confirmed a PML diagnosis.
Id. ¶ 65. Nelson was severely debilitated as a
result of the PML and has since undergone steroid treatment
and extensive physical therapy. Id. ¶ 66.
filed his initial Complaint on November 28, 2012, which he
amended shortly thereafter. D.E. 1, 4. The initial and First
Amended Complaint included a negligence claim that was
dismissed pursuant to Rule 12(b)(6) for failure to state a
claim. D.E. 34 at 3. In dismissing Plaintiffs negligence
claim, Judge Linares held that the New Jersey Products
Liability Act ("NJPLA") is the sole remedy for
products liability claims, and under the NJPLA there are only
three available causes of action: manufacturing defect,
failure to warn, and design defect. Id.
22, 2013, Plaintiff filed a Second Amended Complaint,
including two counts under the PLA: (1) design defect; and
(2) failure to warn. D.E. 37. Defendants moved to dismiss the
design defect claim, alleging that federal law preempted it
because Defendants are prohibited from marketing Tysabri with
any design other than that approved by the FDA. D.E. 51.
Plaintiff subsequently withdrew his design defect claim
before the motion to dismiss was decided. Def. Br. at 6.
Plaintiffs Third Amended Complaint, filed on September 20,
2013, asserted a single cause of action pursuant to the PLA -
failure to warn. D.E. 52. The parties then engaged in over
two years of discovery. Id.
September 28, 2015, Plaintiff alleges that Defendants
produced, for the first time, a Biological Materials License
Agreement (the "Agreement") dated October 19, 2006
between the National Institute of Health ("NIH")
and Biogen. D.E. 148-1. The Agreement licensed Biogen to use
NIH's JC virus antibody assay "for the purpose of
developing this assay for commercial use." FAC ¶
92. Since "testing positive for anti-JC [v]irus
antibodies has been identified as a risk factor for PML,
" the assay (if developed) would test for these
antibodies to determine whether a patient faced a greater
risk of contracting PML. Id. ¶¶ 51, 90.
Biogen did not release a JC virus antibody assay until
January 2012, more than five years after it executed the
Agreement. Id. ¶ 92. Plaintiff alleges that the
Agreement demonstrates Defendants' negligence in bringing
the assay to market in a timely manner and forms the basis of
his negligent undertaking claim. Plaintiff further alleges
that in developing its own assay, the Stratify Assay, Biogen
also sought a financial benefit in addition to incurring the
further delay. Id. ¶ 94.
Plaintiff sought leave to amend his Third Amended Complaint,
adding a claim for negligent undertaking. D.E. 121.
Defendants opposed Plaintiff s motion. D.E. 124. On June 7,
2016, Judge Falk granted that motion, finding that although
Plaintiffs negligent undertaking claim is
"enterprising" and "adventurous, " but
not "frivolous on its face." D.E. 140. Judge Falk
further found that the claim was not clearly futile and,
while acknowledging the similarities between a motion to
amend and a motion dismiss, also determined that a motion to
amend does not contemplate the substantive motion practice
associated with a motion to dismiss. Id.
Subsequently, Plaintiff filed the FAC. D.E. 142. Currently
pending before the Court is Defendants' appeal from Judge
Falk's decision, and, in the alternative, their motion to
dismiss the negligent undertaking claim. Plaintiff opposes
II.STANDARD OF ...