Multiple healthcare agencies, cancer centers, and a hospital filed complaints against Roche and Genentech in 2016 for delivering vials of the drug Herceptin to their facilities that, when mixed with a liquid, failed to produce the correct concentration or dosage of the drug.
Genentech is a South San Francisco, California based biotech company. Roche Holding AG is based in Switzerland.
Why did Healthcare Providers take Legal Action?
Doctors said the the volume indicated on the label did not equal the amount rendered when preparing the drugs for treatment, which forced them to have to purchase more.
Herceptin’s active ingredient, trastuzumab, is refined by scientists and frozen for shipping. When the cancer drug are delivered to healthcare facilities, its concentration per dose is supposed to remain within the FDA-approved range.
Two of these plaintiffs wanted to form a class action lawsuit against Genentech.
What is the Status of the Lawsuit?
The original complaints were consolidated and transferred to the U.S. District Court of Northern Oklahoma.
Genentech quickly moved for a summary judgment, contending that the plaintiffs’ state law claims are preempted by federal law, which the court accepted.
Group of Lawsuits Reinstated in 2020
In May 2020, the Federal Appeals Court for the 10th Circuit reversed this decision, reinstating the suit.
Through this decision, the circuit court will allow for further discovery regarding the consistent manufacturing process of the drug, whether medication was truly mis-labeled, if the company is failing to provide warning on incorrect dosages, and if mistakes have been left unchanged.
The “Genentech, Inc., Herceptin (Trastuzumab) Marketing and Sales Practices Litigation” (MDL 2700) docket is still pending, with 14 plaintiffs involved according to the Judicial Panel on Multidistrict Litigation.
