In a decision that could have implications for biosimilar drug manufacturers whose products are used for off-label uses, on October 30, 2015, Texas judge Michael Mery threw out strict liability, implied warranty, and negligence claims brought by plaintiff Robert Burt against Genentech Inc. and Genetech USA, Inc. The complaint alleged that Genentech was at fault for failing to take additional steps to curb off-label uses of its cancer drug, Avastin. The plaintiff’s doctor had allegedly injected him with Avastin to treat an eye disorder, causing an infection which ultimately resulted in the loss of his eye. Avastin is a humanized antibody (an antibody from a non-human species that has been modified to be more similar to those made naturally by humans).
Burt had alleged that Genentech had been selling its drug to ophthalmologists for off-label activities knowing that those activities were dangerous. But Genentech responded that it does not promote any off-label uses of its product. The court granted Genentech’s motion to dismiss Burt’s design defect claims, holding that they “have no basis in law.”
The case is Robert Burt v. Genentech Inc. et al., case number 2015-CI-05771, in the Bexar County District Court of Texas.
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