Valsartan Recall…A Case for Product Liability
Valsartan impurities put millions of patients at risk of serious drug injuries. The FDA’s July 2018 recall of valsartan affects several major pharmaceutical manufacturers and distributors in the US.
Valsartan, is an FDA-approved medication used to treat high blood pressure & heart failure, and to reduce the risk of fatality after a heart attack. Valsartan works by loosening constricted blood vessels so that blood can flow more freely. Valsartan is used on its own or as valsartan HCTZ. In July 2018, the FDA initiated a voluntary recall of several pharmaceuticals containing valsartan manufactured in China due an impurity that can cause serious health issues for patients.
The Valsartan Recall
The volunteer recall initiated by the FDA in July includes valsartan manufactured by the Chinese company, Zhejiang Huahai Pharmaceuticals. In 2012 Zhejiang Huahai Pharmaceuticals changed its manufacturing method in a manner that caused the production of an impurity, known as N-nitrosodimethylamine (NDMA), as a byproduct. NDMA is a substance linked to higher risk for cancer among other health issues, including liver damage. Aside from recall in the US, valsartan has been recalled in 22 other countries.
Not all of the valsartan products on the market in the United States were produced by Zhejiang Huahai Pharmaceuticals. The recall only affects those manufacturers and distributors that incorporated the contaminated batches of valsartan into their final product. The manufacturers, distributors and labels affected by the recall include:
- Solco Healthcare
- Teva Pharmaceuticals Industries Inc.
- Prinston Pharmaceuticals Inc.
- A-S Medication Solutions LLC
- NuCare Pharmaceuticals Inc.
- H.J. Harkins Co., Inc.
- Lake Erie Medical, doing business as Quality Care Products LLC
- Proficient Rx
- Northwind Pharmaceuticals
- Bryant Ranch Prepack Inc.
Click here for the FDA’s complete list of products and lot numbers affected.
NDMA can be a dangerous substance and is used as an additive for lubricants and as a softener for copolymers. It was also used in making rocket fuels. . The EPA classifies NDMA as a B2 (probable human) carcinogen. If you have been taking a recalled valsartan product and you experience the following symptoms, you may be a victim of NDMA poisoning:
- abdominal cramps
Long term exposure of the NDMA contaminated valsartan products can cause liver damage and cancer of the liver, kidney, and lungs.
What to do if you suspect NDMA poisoning
- Contact your doctor right away. It’s important to note that health care professionals recommend you do not stop taking your medication without consulting your doctor. According to Dr. Victoria Shin, a cardiologist with Torrance Memorial Medical Center in Torrance, California, it is not recommended to stop your medication without the supervision of your doctor due to the “risk of elevated and uncontrolled blood pressure which can potentially have severe health consequences. Over the short term, the risk of stopping your medication could exceed the risk of continuing to take a recalled product.”
- Look at the drug name and manufacturer on the label of your medication bottle to find out if your medication has been recalled. If you are still unsure, contact the pharmacy that dispensed the medicine to you or your doctor. If your medication has been recalled, contact your doctor and follow the recall instructions posted on the FDA website by the company that manufactured or distributed your medication.
Legal liability against a manufacturer or distributor of a valsartan product is likely to be based on Texas’ product liability laws. A lawsuit might allege, for example, that the manufacturer was negligent due to failure to exercise appropriate quality control over raw materials that it received from China.
Texas personal injury law allows an victims injured by drugs to recover losses arising from a negligent act including:
- Past, present and future medical expenses
- Compensation for both physical and emotional pain and suffering
- Lost earnings, especially if you spent a long time in the hospital
- Other economic losses
If you or a loved one has taken a valsartan product contaminated by NDMA and have been diagnosed with liver damage, tumors, or cancer, contact a Dallas valsartan drug injury attorney at Rasansky Law Firm for a free evaluation of your potential product liability case. At Rasansky Law Firm, we work on contingency – No Fees unless you win your case.