STORY FROM: Drugs & Medical Devices
Summary Judgment Award to Genentech Ends Herceptin MDL
March 22, 2019
TULSA, Okla. — An Oklahoma federal judge has awarded Genentech Inc. summary judgment on claims that it misrepresented the amount of its breast cancer drug Herceptin (trastuzumab) in each vial, bringing the multidistrict litigation to a close.
On March 20, Judge Terence C. Kern of the U.S. District Court for the Northern District of Oklahoma found the plaintiffs’ claims impose an obstacle to the FDA’s “reasonable variations” determination, which recognizes that a reasonable variation in manufacturing and labeling is allowed. The judge further found the claims are preempted by federal law because requiring Genentech to make changes to its manufacturing ...