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Nelson v. Biogen Idec, Inc.

United States District Court, D. New Jersey

April 17, 2017


         Not for Publication


          John Michael Vazquez, U.S.D.J.

         The 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).[1] 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 moot.


         The following facts are derived from the FAC. D.E. 142.[2] 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.

         In 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.

         In 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.

         In 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.

         Plaintiff 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.

         Plaintiff 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.

         On May 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.

         On 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.

         Thereafter, 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 this motion.

         II.STANDARD OF ...

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