A biopharmaceutical company has sued companies in its supply chain, alleging they were negligent or vicariously liable for obtaining from China a raw material, contaminated with beef broth and avian products, for use in the creation of a bacterial master cell bank for the production of a biologic drug that will be used in patients with acute spinal cord injury. Bioaxone Biosciences, Inc. v. Nordion (US), Inc., No. 0:2012cv60739 (U.S. Dist. Ct., S.D. Fla., filed April 26, 2012).
The plaintiff alleges that the defendant knew that the cell bank specifically excluded the use of animal origin products and that source documents for the tainted kanamycin showed it was made in China. The plaintiff also alleges that the certificate of origin for the kanamycin states that it “contained beef extract and chicken feathers and that it was not for human use.” According to the complaint, the defendants did not timely inform the plaintiff that the kananmycin used in the master cell bank contained animal-derived products that created “an unreasonably dangerous foreseeable risk of adventitious agents that cause disease in humans including, but not limited to, the development of BSE [bovine spongiform encephalopathy] in the patients to whom Cethrin would be administered.”
Alleging that it has been unable to use the master cell bank in the development of its biologic drug for clinical trials, the plaintiff seeks damages in excess of $90 million.