Valsartan is an active ingredient used in many generic drugs, especially to treat hypertension and heart failure. However, some generic valsartan products contain impurities, such as N-nitrosodimethylamine (NDMA), which FDA has determined can lead to a higher risk of some forms of cancer and liver damage.
Valsartan is the generic name of Diovan, built by Novartis into a pharmaceutical brand selling $6 billion per year. The company Zhejiang Huahai Pharmaceutical in China has made most of the global supply of valsartan since 2012. Valsartan is an angiotensin II receptor antagonist. This means it prevents the action of a hormone that causes our blood vessels to constrict.
Zhejiang Huahai Pharmaceutical provided many of these generic drugs containing NDMA to US pharmaceutical companies, such as Solco Healthcare, Major Pharmaceuticals, and Teva Pharmaceuticals Industries Ltd. These companies processed and distributed several generic hypertension and heart failure drugs to the American market such as valsartan.
If you have taken valsartan for a hypertension or heart condition and developed cancer or liver damage, you could be eligible to file a valsartan blood pressure medication lawsuit.
The Problems With N-nitrosodimethylamine (NMDA)
NDMA is an organic chemical compound that has been identified as a probable human carcinogen, according to the International Agency for Research on Cancer (IARC). NMDA can be found in many products, such as lubricants, softeners and even rocket fuel. It can be produced via chemical reactions that happen in manufacturing.
Animal studies have confirmed that NDMA is a carcinogen that can cause cancer to form on the kidney, liver and respiratory tract. Many serious cancers are associated with NDMA, including liver, gastric, colorectal, kidney, lung and nasal cancer.
Wave of Lawsuits Over Drugs Contaminated with NDMA
Bloomberg reported this year that dozens of lawsuits have been filed against several drug manufacturers over valsartan being contaminated with NDMA. An attorney involved in efforts to combine approximately 50 lawsuits, including 27 who say they got cancer from using tainted drugs, said he expects a major increase in valsartan lawsuits. It is believed there could be as many as 2,000 valsartan personal injury lawsuits in the next two years. (Bloomberg.com)
The surge in lawsuits is possible because of the number of people who take blood pressure drugs. The National Center for Health Statistics shows that ⅓ of US adults have high blood pressure. Of these people, ¾ probably take a drug to treat hypertension or a heart condition. Valsartan-containing drugs that are supplied by the affected manufacturer comprise almost 44% of the market share of valsartan-containing drugs, according to FDA. The drug agency also reports that physicians have prescribed valsartan-based drugs to at least 3.7 million patients through 2018.
FDA Issues Valsartan Recall
In July 2018, FDA issued a recall of several drugs that contained valsartan to treat high blood pressure. This recall was announced because of the higher risk of certain cancers related to NDMA. However, not all drugs that contain valsartan were named in the FDA recall.
The following valsartan drugs were named in the FDA recall:
- Major Pharmaceuticals
- Solco Healthcare
- Teva Pharmaceuticals Industries
- Solco Healthcare
- Teva Pharmaceuticals Industries valsartan and HCTZ drugs
According to FDA in 2018, the agency carefully assessed the above drugs containing valsartan and found the valsartan sold by those companies did not meet FDA safety standards. FDA also noted the presence of NDMA in the drugs was a surprise, and was thought to be caused by changes in ways the active ingredient was manufactured.
FDA also conducted further testing on some of the valsartan drugs and determined there was a second carcinogen in some of the drugs. For example, Torrent Pharmaceuticals used valsartan from ZHP in China to produce drugs that had both carcinogens in them.
A Danish study in 2018 showed that exposure to NDMA can lead to cancer of the liver, stomach, colon, rectum and pancreas. (Bmj.com)
US Valsartan Blood Pressure Medication Lawsuits
Some patients were given contaminated valsartan and have sued the drug companies for damages. Generally, patients in these blood pressure medication lawsuits allege the drugs are unsafe or defective. Patients are trying to get their money back, compensation for their injuries and suffering, and potentially punitive damages to punish the companies for improperly selling dangerous drugs that contain NDMA, which can cause cancer.
For instance, two patients in a product liability lawsuit took contaminated valsartan. They are suing Prinston Pharmaceutical, Walgreens, and Throggs Neck Pharmacy. These are the manufacturers, distributors, and retailers who sold them the allegedly defective drugs. Their lawsuit alleges:
- Patients were misled by the drug company, retailer and distributor and would not have purchased the drugs if they knew they had been contaminated.
- Tainted valsartan drugs are of no value because they have been contaminated with a carcinogen and should not be consumed by humans.
- Patients who took the tainted drugs should be compensated for their injuries from taking a toxic substance.
- Warranties were breached by all three companies above, including express warranty and implied warranty of merchantability.
- All companies lied about the safety of the drug.
- Companies used false advertising.
- Companies engaged in fraud.
- All companies were negligent.
- Patients endured battery from physical harm.
Attorneys in some of the lawsuits filed have alleged that the amount of NDMA contained in tainted valsartan is far above safe levels. FDA has said it is ‘reasonably safe’ to consume up to .096 micrograms of NDMA per day. FDA test results in 2018 found NDMA levels in some valsartan drugs to range from .3 to 17 micrograms. This means the tainted pills may have contained between 3.1 and 177 times the safe level of NDMA, according to FDA standards.
Valsartan Lawsuit Settlements & Payouts
No valsartan cases have been settled or decided at this time. The amount of compensation you could received for your alleged injuries is unknown. Generally, defective drug lawsuits seek compensation for the following:
- Cost of the drugs and any out of pocket medical costs.
- Cost of cancer treatments or other treatments, such as side effect management, follow up appointments and ongoing care.
- Loss of wages due to illness, including time off work, unemployment and possible future lost income.
- Pain and suffering from cancer or other conditions caused by the drug.
- Emotional distress and mental anguish.
- Punitive damages to punish the drug manufacturer for reckless conduct.
How to Qualify for a Valsartan Blood Pressure Medication Lawsuit
First, understand that not all valsartan drugs are tainted or contaminated. To qualify for a lawsuit, you will need to show you took a contaminated valsartan drug and suffered digestive tract cancer or liver damage.
The easiest way to prove you took a contaminated valsartan drug is to examine your pharmacy records to get the lot number of the drug you took. Then, compare that lot number against the lot numbers on the FDA website to see if your lot was subject to an FDA recall. (FDA.gov)
After you confirm that you took a contaminated drug, you need to have a diagnosis of digestive tract cancer or liver damage from your doctor. Contact your physician to obtain a copy of the relevant medical records. Or, talk to a personal injury attorney who can help you with this process.
Contact a Valsartan Personal Injury Attorney for Help
If you or a loved one took contaminated valsartan has been diagnosed with cancer, you could be entitled to compensation for your medical costs, pain and suffering, and loss of income. Our attorneys have assisted many victims of dangerous drugs, and offer years of experience in this specialized area of personal injury law. Please contact us today for a complimentary legal review.
- Valsartan Recall – Tainted Heart Drugs Face Lawsuits Over Cancer. (2019). Retrieved from https://www.bloomberg.com/news/articles/2019-04-24/valsartan-recall-tainted-heart-drugs-face-lawsuits-over-cancer
- Use of N-nitrosodimethylamine (NDMA) contaminated valsartan products and risk of cancer: Danish nationwide cohort study. (2018). Retrieved from https://www.bmj.com/content/362/bmj.k3851
- Search List of Recalled Angiotensin II Receptor Blockers (ARBs) including Valsartan, Losartan and Irbesartan. (n.d.). Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/search-list-recalled-angiotensin-ii-receptor-blockers-arbs-including-valsartan-losartan-and