Nine cancer hospitals in seven different states have launched lawsuits against a drug maker they say is short-changing them on cancer drug Herceptin. San Francisco-based manufacturer Genentech is accused of shipping less medication than claimed on its packaging – which the plaintiffs say is a breach of express warranty.
Herceptin Is One of the More Potent Breast Cancer Drugs
The drug at the heart of the lawsuit is Herceptin (trastuzumab). It is often used in combination with chemotherapy to fight breast and gastric cancers, especially tumors which trigger the HER2 gene. These cancers can be aggressive and grow quickly, so Herceptin is used to help prevent the metastatic spread and recurrence of HER2 cancers. Genentech won FDA approval to sell Herceptin in 2002.
Genentech Accused of Shortchanging Hospital Orders
Herceptin is packaged in freeze-dried vials which must be combined with liquid to create an intravenous fluid. Genentech’s labeling for Herceptin claims the vials are able to produce 20.952 milliliters of fluid. However, in actual practice, the cancer centers claim that the vials only yield 20.2 milliliters.
Herceptin Dose Shaving Could Impact Breast Cancer Patients
The difference of 0.752 mL may seem small to the untrained eye, but for cancer drugs like Herceptin, the correct dosage can be a matter of life and death. The medication shortfall has wide-reaching consequences:
- Over one-and-a-half pounds missing – Since Herceptin doses are based on a person’s weight (milliliters per kilogram), the dosing changes for every 1.66 pounds of patient weight – not a trivial amount.
- Cancer hospitals are paying more – and charging more – The Herceptin shortage is costing hospitals more than their supply projections estimate since they have to make up the 0.752 mL shortfall by using another full vial of the medication.
- Cancer drugs wasted – Because hospitals must use more vials than predicted, the excess Herceptin that is made to reach the desired dosage is then wasted because it can’t be preserved.
- Possible treatment delays – Lastly, treatments and patients’ lives may be affected if a cancer center comes up against a shortfall of its Herceptin supply. Treatment delays can be deadly for cancer patients.
Seven States Sue Genentech Over Herceptin
The states involved in the lawsuits against Genentech include Tennessee, New York, Florida, Oklahoma, Minnesota, Virginia, and the District of Columbia. Since the cases involve multiple suits in multiple states, it’s likely that the cases will all be referred to the US District Court for the Northern District of Oklahoma.
Recent Comments