The Product Safety & Liability Reporter™ provides updates on significant developments and issues in product safety and liability litigation and regulation, plus analysis from top litigators. Get...
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.
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 email@example.com
To contact the editors responsible for this story: Steven Patrick at firstname.lastname@example.org and
The amended complaint is at http://www.bloomberglaw.com/public/document/NELSON_v_BIOGEN_IDEC_INC_et_al_Docket_No_212cv07317_DNJ_Nov_28_20/1.
The unpublished opinion is at http://www.bloomberglaw.com/public/document/Nelson_v_Biogen_Idec_Inc_No_127317_JMV_2016_BL_182534_DNJ_June_07.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to email@example.com.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to firstname.lastname@example.org.
Put me on standing order
Notify me when new releases are available (no standing order will be created)