Another Lawsuit Against Genentech Over Trastuzumab Drug Volume

An Oklahoma-based non-profit hospital, Comanch County Memorial Hospital, is the latest medical facility to sue pharmaceutical giant Genentech, and the Swiss corporation Roche, which is the parent company. So far, about a dozen lawsuits have been filed against Genentech, accusing the company of shipping less than the labeled claim of the anticancer drug trastuzumab (Herceptin) in each vial.

The multi-dose vial of trastuzumab is shipped as a freeze dried powder, to be reconstituted by the end user prior to administration for breast cancer treatment. However, according to a this most recent lawsuit filed in the US District Court for the Northern District of California, Genentech misrepresented the amount or concentration of trastuzumab in each vial, which resulted in the hospital buying more of this expensive drug, which has a limited shelf life (28 days) once reconstituted in benzyl alcohol as indicated on the label. Any unused drug that is reconstituted in water has to be discarded immediately and cannot be stored.

A targeted therapy, the antibody binds the HER-2 receptor which is often overexpressed in several cancers, especially breast cancer. Initially approved for treatment of HER-2—positive breast cancer in the adjuvant setting, trastuzumab was subsequently approved for use in early stages of breast cancer, as well as advanced gastric and gastroesophageal cancer. And the treatment is not cheap—52 infusions over an entire year cost is the standard treatment, which costs about $70,000. Further, wholesale cost discounts availed by oncology clinics and hospitals have been disappearing as the drug is now available only from specialty distributors. This translates into a significant cost burden on clinics and ultimately, the patient.

In their lawsuit, the hospital explains that after following the company’s directions on reconstitution to achieve a concentration of 21 mg/ml of trastuzumab in the multi-dose vial, the final volume of the solution is less (20.2 ml) than what it should be (20.95 ml). This, the plaintiff claims, could either mean that each vial has less drug or that the concentration of the final solution is not the required 21 mg/ml. Eventually, the shortfall requires hospitals and clinics to purchase additional vials.

Nine other cancer care centers have filed a similar lawsuit against the company earlier this year, and one of the plaintiffs, Tennessee Oncology is pursuing monetary damage to cover the costs of the additional trastuzumab that it was forced to purchase.