Should valsartan have been recalled sooner?

Valsartan Pills That Injured Some PatientsThe U.S. Food and Drug Administration (FDA) recalled some lots of valsartan in July 2018 because of reported contamination with the carcinogen N-nitrosodimethylamine (NDMA). The recall surprised and frightened many patients who were taking valsartan to treat high blood pressure or congestive heart failure. The recall alerted them to the fact that their possible exposure to NDMA could put them at an increased risk of developing liver problems or cancer.

While the valsartan recall surprised patients, it did not surprise everyone. Twenty-two other countries recalled valsartan before the United States took action, and at least one FDA inspector had concerns long before the FDA recall.

A Former FDA Inspector Comes Forward

In May 2019, a former FDA inspector told NBC News that he knew of potential problems with valsartan more than a year before the recall occurred. Massoud Motamed worked as an FDA inspector for three years and spent much of his FDA career inspecting drug manufacturing facilities overseas.

By the spring of 2017, Dr. Motamed had more than two years of experience with the FDA. In May 2017, he traveled to Linhai, China to inspect the Zhejiang Huahai Pharmaceutical plant. Zhejiang Huahai Pharmaceutical manufactures the main ingredients in the valsartan that was eventually recalled. Dr. Motamed spent four days inspecting the plant and filed an official report with the FDA that included the following information:

  • Facilities and equipment were not properly maintained
  • Testing anomalies were not investigated
  • “Unknown impurities” were dismissed as lab errors without investigation

Dr. Motamed reportedly recommended that the FDA issue a warning letter to Zhejiang Huahai Pharmaceutical. The FDA refused and instead allowed Zhejiang Huahai to fix its problems independently.

The FDA’s recall didn’t come until July 2018—more than one year after Dr. Motamed’s May 2017 visit to Zhejiang Huahai Pharmaceutical. In January 2019, the FDA issued a press release saying, “… our inspections did reveal systemic problems of supervision that could have created the conditions for quality issues to arise.”

There is a concern that what happened with valsartan at the Linhai, China facility could happen to with other medications made in foreign countries. Approximately 85 percent of the facilities that make ingredients found in U.S. medications are outside of the United States. While manufacturing medication overseas is less expensive, there is also less government oversight, which may make it riskier.

You Can Come Forward If Your Hurt by Valsartan​

It is possible that the FDA should have known about the risks and issued a recall of valsartan before July 2018. Either way, it is essential that all valsartan users and their loved ones understand their rights now.

If you develop a liver condition or cancer, or your loved one dies from a liver condition or cancer, after taking valsartan, then you need to know whether the medication that you took was contaminated with NDMA. Your doctor and pharmacist can help you get the necessary information, and an attorney can help you protect your legal rights.

Dozens of lawsuits have already been filed, and many more are expected in the coming months and years. People who took valsartan may not yet be diagnosed with cancer or liver injuries, and their lawsuits may come later.

You took valsartan to improve your health. You were not warned that cancer from NDMA exposure could be a potential side effect. Accordingly, if you do develop cancer after taking a contaminated batch of valsartan, then it is important to contact a mass tort injury lawyer as soon as possible.

Keefe Disability Law is committed to helping every client make a full individualized recovery. We will fight hard for your compensation for medical expenses, lost income, out-of-pocket costs, physical pain, emotional suffering, and other damages. While mass tort cases consolidate some litigation expenses, your recovery will remain unique, and you will remain in control of your case. To learn more, please contact us via this website today for a free, no-obligation consultation.

 

John L. Keefe
Connect with me
Founding Attorney, Massachusetts Social Security Disability Lawyer