Product Liability -- 2020



In re: Genentech, Inc. Herceptin (Trastuzumab) Marketing and Sales Practices Litigation   (10th Circuit)

Preemption of state law claims for biologic medication regulated by the FDA

The NAM filed an amicus brief in the 10th Circuit in support of a drug manufacturer in an appeal that implicates how biologic medications are sold and dosed. The defendant manufacturer, Genentech, is a biotechnology company dedicated to developing medicines for people with serious and life-threatening diseases. One of those medications is Herceptin, which treats breast cancer. Herceptin is approved as a biologic drug, which is subject to a similar FDA approval process and labeling requirements as other prescription drugs. A series of lawsuits filed under Oklahoma and other state laws by cancer centers allege that Herceptin’s labeling misrepresents the amount of Herceptin in a vial. The FDA, however, has approved the quantity indicated on the label. Federal regulations and the FDA’s approval permits a variance between the amount stated on the label and the contents of the vial. The district court granted the defendant’s motion for summary judgment on preemption grounds, finding the state law claims were preempted by the federal Food and Drug Act. On appeal to the 10th Circuit, the NAM filed an amicus brief that explains how the FDA utilizes its expert judgment to specifically approve and regulate the sale and dispensing of biologic drugs, and how allowing states to impose conflicting requirements would harm public health and increase the costs of treatment. Unfortunately, on May 29, 2020, the court reversed the district court's ruling and remanded the case for further proceedings.


Related Documents:
NAM brief  (October 11, 2019)