Valsartan is a popular drug for high blood pressure and heart failure. Some batches of this drug that were made in China are contaminated with chemicals that can cause cancer or liver damage. The FDA has announced a recall of hundreds of products containing Valsartan as well as recalls of the related drug Amlopidine. Some patients are filing lawsuits. In this article, our personal injury attorneys will address:
- 1. What is Valsartan?
- 2. Contamination with carcinogens
- 3. Legal claims and lawsuits
- 4. Evidence of links to cancer and liver damage
1. What is Valsartan?
Valsartan is the generic component of commonly prescribed drugs used to treat high blood pressure and heart failure. Doctors also sometimes prescribe it to people who have had a heart attack, or to people who have type II diabetes to slow the development of kidney disease. Valsartan is the generic name of the drug Diovan, built by drug company Novartis into a $6 billion a year brand. Drug company Zhejiang Huahai Pharmaceutical Co. (ZHP) of China has manufactured most of the Valsartan in the world since 2012, when the patent expired for the brand-name drug. ZHP sold $50 million worth of Valsartan in 2017.
More than 100 million adults in America have high blood pressure. In 2017 more than 10 billion pills containing Valsartan were sold worldwide. People with high blood pressure typically take one pill daily and heart failure patients take two.
Valsartan is an “angiotensin II receptor antagonist,” which means that it prevents the action of the hormone that causes blood vessels to constrict. Generic drugs are supposed to be of equal quality and safety to their brand-name counterparts. This means Valsartan is supposed to be “bioequivalent” to Diovan.
2. Contamination with carcinogens
In 2018, authorities found that some Valsartan was contaminated with carcinogens, which means substances that cause cancer. This finding led to a worldwide recall of some Valsartan because the contaminated drugs do not meet safety standards.
The US Food and Drug Administration (FDA) announced a recall of hundreds of products that contain Valsartan made in China or India and sold in the US, because the Valsartan was contaminated by carcinogens. These carcinogens are not FDA-approved ingredients for brand-name Diovan or generic Valsartan. Authorities in over 20 countries have recalled contaminated Valsartan. Not all Valsartan has been recalled, and brand-name Diovan has not been recalled.
The first chemical impurity found in some Valsartan is called N-nitrosodimethylamine (NDMA). NDMA is a known carcinogen. The FDA ran further tests on some batches that contained NDMA, and they found a second carcinogen in some of the drugs. Torrent Pharmaceuticals used Valsartan from ZHP of China to make drugs that were contaminated by both carcinogens. The second carcinogen is called N-nitrosodiethylamine (NDEA). NDEA causes cancer in animals and is used to induce liver tumors for research. It is also “reasonably anticipated” to cause cancer in humans.
The US Environmental Protection Agency (EPA) calls NDMA “a probable human carcinogen.” NDMA was used to make liquid rocket fuel, softeners, lubricants, and other industrial products. NDMA causes liver tumors in rats, and some scientists use it to create cancer in rats for research. It can be unintentionally produced through certain chemical reactions. NDMA is a byproduct of some pesticide and rubber tire manufacturing, and fish processing.
Authorities believe that the Valsartan contamination is an unexpected byproduct of changes in how the drug is manufactured. The contamination has apparently been taking place since 2012, when ZHP of China made these changes.
Since the 2018 recall, the FDA has banned imports into the US of any medicines or drug ingredients made by ZHP. Click here for FDA updates about Valsartan, and click here for the list of Valsartan products that the FDA has recalled.
Contaminated Valsartan does not meet safety standards in the US or other countries.
3. Legal claims and lawsuits
Some patients who took contaminated Valsartan are suing the drug companies and pharmacies in class action lawsuits. In general, patients claim that these companies made and sold drugs that were unsafe or defective. Patients want to get their money back, compensation for any injuries or suffering, and any appropriate compensation to punish the drug companies for wrongfully selling dangerous drugs containing unapproved chemicals that can cause cancer.
For example, patients Elizabeth Duffy and John Duffy who took contaminated Valsartan filed a class action lawsuit in New York against Solco Healthcare, Prinston Pharmaceutical, Walgreens, and Throggs Neck Pharmacy, which are Valsartan manufacturers, distributors, and retailers who sold prescriptions to the patients. The lawsuit alleges that:
- Patients were misled and would not have bought the drugs if they knew they were contaminated,
- Valsartan-tainted drugs are worthless because they are contaminated with a carcinogen and are not fit for human consumption,
- Patients should receive money for injuries from consuming high levels of an acutely toxic substance,
- The drug companies, distributors, and pharmacies breached their warranties including express warranty and implied warranty of merchantability,
- The companies lied about the drug's safety,
- The companies engaged in false advertising,
- The companies engaged in fraud,
- Strict liability applies for a manufacturing defect,
- The companies were negligent, and
- Patients suffered battery through physical harm.
A similar lawsuit in New Jersey, filed by patient Eric Erwin against Prinston Pharmaceutical Inc., Solco Healthcare, Huahai US Inc., and Teva Pharmaceuticals, also claims that drugmaker ZHP failed to meet FDA standards in other situations in 2007 and 2017. The FDA sent ZHP a warning letter in 2015, stating that ZHP's drug-making facility in China used improper data collection methods, and deviated from good manufacturing practice in other ways too.
Another similar lawsuit, filed in New Jersey by patient Dominic Stimma and others against Torrent Pharma, Hetero USA, Camber Pharmaceuticals, Kroger, Quality Food Centers, CVS, and Wal-Mart, notes that the FDA found violations in 2016 for other situations by two other drug companies involved in making some of the contaminated Valsartan, Camber and Hetero. That lawsuit also alleges that drug company Torrent, which made drugs containing Valsartan sourced from ZHP, failed to recall contaminated Valsartan for a month after the FDA announced that the drugs were contaminated. Some of the Torrent drugs contained both of the carcinogens that authorities found.
In one more example, patient James Jones and his lawyer filed a Valsartan lawsuit in Missouri against Zhejiang Huahai Pharmaceutical, Prinston Pharmaceutical, Solco Healthcare, and Huahai US, alleging:
- Improper merchandising,
- Strict liability,
- Breach of contract,
- Breach of warranties,
- Unjust enrichment,
- And other claims.
No Valsartan cases have been decided or settled yet, so the amount of compensation that may be available is not known. In general, lawsuits like these seek compensation for:
- Costs of the prescriptions and any incidental medical costs,
- Costs of cancer treatment or other necessary treatment, including side effect management, follow-up appointments, and ongoing care,
- Lost income due to illness, such as time off work or unemployment, including potential future income,
- Pain and suffering from the disease,
- Mental anguish and emotional distress,
- Punitive damages to punish the manufacturer for wrongful conduct.
Lawsuits may expand to other drugs that are similar to Valsartan, such as Losartan. The European Medicines Agency, which is like the FDA, is investigating potential contamination in other related drugs. People who developed cancer or had to be hospitalized for liver problems or other problems after taking Valsartan might also file additional lawsuits.
Patients who took Valsartan:
- Can check here for FDA updates and to see if their particular medicine is on the recall list,
- Are advised by the FDA to talk to their doctor about an alternative drug or treatment,
- May want to gather medical or insurance records,
- Should keep any recalled Valsartan they still have for testing, as this could be evidence in a case, and
- Can talk to a Valsartan lawyer.
Drug companies, pharmacies, and others who sold contaminated Valsartan face a growing number of lawsuits. People who took these drugs may have remedies available to them.
4. Evidence of links to cancer and liver damage
The chemical NDMA that contaminated some Valsartan drugs has been shown to cause liver damage and cancer. NDMA is proven to cause cancer in animals, and is expected to cause cancer and other illness in humans. People have poisoned and murdered other people with NDMA.
For example, the US Environmental Protection Agency (EPA) classifies NDMA as a “probable human carcinogen” meaning that it probably causes cancer in humans, and as a “confirmed animal carcinogen” which means scientists have confirmed it causes cancer in animals. The EPA also reports that NDMA exposure may cause liver damage.
The World Health Organization lists NDMA as “probably carcinogenic to humans,” and states that it may be released as a byproduct from municipal wastewater treatment facilities and some industrial manufacturing facilities. Federal regulations list NDMA as a “priority toxic pollutant.” 1
The FDA is part of the US Department of Health and Human Services, which says NDMA is “reasonably anticipated” to cause cancer in humans. Short-term exposure to NDMA can cause liver damage, and long-term exposure can increase the risk of liver, kidney, and lung tumors.
Scientists sometimes use NDMA to cause cancer in rats for research. Animal studies have associated NDMA with the following types of cancer:
- Colorectal cancer
- Gastric cancer
- Liver cancer
- Kidney cancer.
Symptoms of NDMA overexposure include:
- Abdominal cramps
- Enlarged liver
- Reduced function of the liver, kidneys, and lungs, and
A 2018 Danish study showed that NDMA exposure can cause cancer of the liver, stomach, colon, rectum, and pancreas.
People have used NDMA as poison in murders:
- In 1978, a German court convicted a chemistry teacher who attempted to murder his wife by mixing NDMA into her blackberry jam.
- That same year, a court sentenced a man in Omaha, Nebraska, to death for killing a baby and a 24-year-old man by putting NDMA into their lemonade.
- In 2013, a student in China put NDMA into a water cooler and poisoned his roommate, who died 15 days later.
Scientists agree that NDMA is toxic and that it has links to cancer and liver damage.
Call us for help...
If you or a loved one has taken contaminated Valsartan, please contact us at Shouse Law. Contact us today for a free consultation by phone or in-person in our offices.
- 40 CFR §131.36, retrieved October 25, 2018