Tysabri Makers Delayed Making Brain Test, Suit Says

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By Julie A. Steinberg

June 14 — The makers of Tysabri delayed in developing a test that could help predict whether a patient on the multiple sclerosis drug would develop a brain disease, according to an amended complaint ( Nelson v. Biogen, Inc., D.N.J., No. 12-07317, amended complaint 6/13/16 ).

The U.S. District Court for the District of New Jersey recently allowed Andrew Nelson to file a new complaint, raising a “negligent undertaking” claim, even though the 2014 deadline for amending pleadings had passed.

Nelson alleged he developed progressive multifocal leukeoencephalopathy (PML), typically a fatal disease, which severely disabled him. He filed his fourth amended complaint June 13 against Biogen, Inc. and Elan Pharmaceuticals, LLC.

Nelson contended the defendants knew patients whose blood tested positive for JC Virus antibodies would be at a higher risk of developing PML.

Nelson contended that a licensing agreement between Biogen and the National Institutes of Health, produced in September 2015, shows that Biogen acquired NIH technology to test for JC Virus antibodies in 2006.

Instead of moving quickly, the defendants opted for financial reasons to develop their own version of the assay, which wasn't released commercially until 2012, Nelson alleged.

The late production was good cause to allow the amendment, the court said.

Nelson has “strongly demonstrated” that without the licensing agreement, he couldn't have met the pleading deadline, Magistrate Judge Mark Falk said.

Falk acknowledged that Magistrate Judge Dustin B. Pead of the U.S. District Court for the District of Utah recently denied a similar motion to amend. The plaintiff has objected to that ruling.

Seeger Weiss, LLP represents Nelson.

Marino Tortorella & Boyle, PC represents the defendants.

To contact the reporter on this story: Julie A. Steinberg in Washington at jsteinberg@bna.com

To contact the editors responsible for this story: Steven Patrick at spatrick@bna.com and