Carcinogenic Impurities in Valsartan Lead to Legal Action
On July 13th, 2018, the Food and Drug Administration (FDA) announced that several pharmaceutical companies were voluntarily recalling certain batches of valsartan-containing blood pressure medication after it was found that they may contain carcinogenic impurities. Now, two individuals have filed a lawsuit in New York federal court and are seeking other individuals who have been negatively impacted by tainted valsartan medications. Here, the litigation and pharmaceutical liability attorneys at The Law Offices of Peter Angelos explain what led to the recall and what victims can do if they have been affected.
What is Valsartan?
Valsartan is an antihypertensive drug that is typically prescribed to treat high blood pressure and heart failure. It can also lower the risk of death after an individual experiences a heart attack. According to the FDA, an estimated three to 3.7 million people have been taking valsartan medications each year for the past three years.
What Types of Carcinogenic Impurities Were Found in Some Batches of Valsartan-Containing Drugs?
The FDA announced that certain batches of valsartan medications were contaminated with a substance known as N-nitrosodimethylamine, or NDMA. According to the US Environmental Protection Agency (EPA), it was an industrial by-product or waste product in several industrial processes, including the creation of rocket fuel and the treatment of wastewater, but is now primarily used for research purposes. The EPA has identified NDMA as a known carcinogenic in lab animals, and a likely carcinogenic in humans—meaning it may cause cancer—specifically of the liver, kidneys or lungs. High levels of NDMA exposure can also lead to liver damage or disease and reduced platelet counts. The National Library of Medicine has reports of at least two individuals who were killed by deliberate NDMA poisoning.
Symptoms of NDMA over-exposure include headache, fever, nausea, jaundice, enlarged liver, dizziness and reduced function of the kidneys, liver and lungs. If you believe you have been exposed to toxic levels of NDMA, you should seek medical attention immediately.
Which Pharmaceutical Companies Have Recalled Their Valsartan Medication?
As of August 2018, 11 U.S. pharmaceutical companies have recalled batches of valsartan medications. The FDA is continuing to investigate if any other companies’ medications have been tainted. Zhejiang Huahai Pharmaceuticals in Linhai, China was responsible for manufacturing valsartan medications for 10 of the 11 U.S. pharmaceutical companies. The company claims that NDMA was introduced when they changed their manufacturing process. According to the FDA, NDMA would have been present in the recalled drugs for up to four years prior to the recall. The 11th pharmaceutical company involved in the recall had valsartan drugs manufactured by Hetero Labs in India. U.S. manufacturers implicated in the recall include:
- Bryant Ranch Prepack Inc.,
- J. Harkins Company Inc.,
- Proficient Rx,
- NuCare Pharmaceuticals Inc.,
- Northwind Pharmaceuticals,
- Torrent Pharmaceuticals Ltd.,
- Lake Erie Medical, doing business as Quality Care Products LLC,
- Major Pharmaceuticals (Teva Pharmaceuticals USA),
- Solco Healthcare (Prinson Pharmaceuticals),
- Actavis (Teva Pharmaceuticals Industries Ltd.), and
- Camber Pharmaceuticals Inc.
Three lots of valsartan drugs made by Torrent Pharmaceuticals, Ltd. were also found to contain an additional impurity, N-Nitrosodiethylamine, or NDEA, which is also a probable human carcinogenic. The FDA has said it will continue to test all batches of valsartan drugs contaminated with NDMA for NDEA.
What are the Details of the Current Valsartan Lawsuit?
Elizabeth Duffy and John Duffy, both of whom were prescribed valsartan medication for hypertension, have filed a lawsuit against four companies who distributed or manufactured valsartan medications. The lawsuit accuses them of negligence, fraud and manufacturing a defective product and claims injuries that include the purchase price of the medication as well as non-specific injuries from ingesting NDMA. The lawsuit does not claim that either individual developed cancer due to their use of the contaminated valsartan medication.
What Can Those Impacted by the Recall Do?
A list of recalled valsartan drugs has been provided by the FDA here. The FDA has said that individuals who believe their valsartan medication may have been impacted by the recall should speak with their doctor before making changes to their medication routine. Patients should continue taking valsartan medication, even if they fear it may be contaminated, until their doctor can prescribe an alternative medication.
If you or a loved one has been prescribed a valsartan medication that has been recalled due to NDMA or NDEA contamination, you may be entitled to compensation. To learn more about your legal options, contact the dedicated victim advocates at The Law Offices of Peter Angelos today.