Herceptin Class Action Lawsuit

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.

Herceptin is a cancer drug, used for treatment of multiple types of the disease, primarily breast cancer. The FDA issued approval for the drug in 1998.

In 2017, the FDA approved a generic version of Herceptin, called Ogivri.

How Does the Drug Herceptin Work?

Herceptin is an "inhibitor targeted therapy", meaning the drug blocks cancer cell receptors of particular types of breast cancer from receiving chemical signals that influence them to grow further.

The drug has been a useful breast cancer treatment, especially for HER2 positive breast cancer and late stage or metastatic breast cancer.

Possible Side Effects of Herceptin

Herceptin may affect patients in different ways depending on the type of cancer and its stage, similar to other cancer treatment and chemo drugs. Patients taking Herceptin may experience side effects listed on the warning label, including:

• Fatigue

• Joint pain

• Diarrhea

• Injection site reaction

• Upper respiratory tract infection

• Rash

• Muscle pain

• Nausea

Heart Damage and Herceptin

Herceptin possible side effects may also include a significant increase in the risk of heart problems or heart failure, which are included on the warning label.

These heart problems include, but are not limited to:

• Congestive heart failure

• Heart damage

• Cardio toxicity

• Heart muscle damage

Heart problems and Herceptin have only been recently linked in the past few years: a study of a small group of breast cancer patients taking Herceptin were found saw a significant increase in risk of heart problems, heart damage, and heart failure.

Cardio toxicity can be a side effect of cancer and chemotherapy medications like Herceptin. Cardio toxicity resulting from chemotherapy or cancer medication damages the heart muscle and valves, and can potentially lead to severe pain, heart failure, and even death.

Support for Cancer Patients: General Information

Treating cancer is difficult from all angles. Whether you are a patient, family member of a patient, care provider, or in any way affected by a loved one's diagnosis, cancer is a monumentally scary and painful disease to cope with.

As a patient, always listen to your primary doctor and pay as much attention as possible to information regarding your medication and dosage levels.

Do not hesitate to reach out for support and help throughout your diagnosis. Support networks available for cancer patients include:

• The American Cancer Society (programs and support)

• Support Groups at CancerCare

• Cancer Support Community, offering local support group meetings

• Cancer Survivors Network, online support community

If you are taking Herceptin, your healthcare provider may be part of the group involved in the lawsuit against Genentech and Roche.

The potentially negligent actions of a company that provides vital medication for the treatment of cancer must be held under legal scrutiny, both by plaintiffs and by the FDA if necessary.

Even the slightest mistakes in manufacturing processes could mean a significant increase in the risk of injury or death to patients.

Contact our firm for more information regarding this ongoing litigation.