A Valsartan lawsuit is a legal claim for money damages brought by a consumer who took the blood pressure medication and was subsequently diagnosed with cancer. The lawsuits allege that many batches of Valsartan from 2012 to 2018 were contaminated with NDMA, a probable human carcinogen. Hundreds of Valsartan products made in China have been recalled. This is the same carcinogen that is currently the subject of Zantac lawsuits.
Shouse Law Group is assisting victims from across the United States to bring lawsuits against more than 20 drug manufacturers. We are seeking to collect financial compensation for serious side effects and complications.
The current litigation is not a class action lawsuit for Valsartan users. It is a mass tort where each individual brings a claim separately. Because of the large number of claims, Valsartan cancer lawsuits have been consolidated into a multi-district litigation based in New Jersey.
It may not be too late to bring a 2023 Valsartan lawsuit. Our law firm is currently accepting cases that meet the following criteria:
- The patient took Valsartan during the period 2014 or later, and
- After at least one year since starting the drug – and after taking it for at least 30 days – the patient was diagnosed with one of the following cancers:
- Liver cancer,
- Kidney cancer,
- Stomach cancer,
- Bowel cancer,
- Intestinal cancer (including colon or rectal cancer),
- Esophageal cancer,
- Pancreatic cancer,
- Bladder cancer,
- Prostate cancer,
- Colorectal cancer,
- Non-Hodgkins lymphoma, or
- Multiple myeloma
Patients who took Valsartan are advised to take the following five steps:
- Check here for FDA updates and to see if their particular medicine is on the recall list,
- Talk to their doctor about an alternative drug or treatment,
- Gather their medical and insurance records,
- Keep any recalled Valsartan pills and bottles they still have as evidence, and
- Talk to a Valsartan lawsuit attorney
There is a limited statute of limitations to file a claim depending on the state. So contact an attorney quickly.
In this article, our Valsartan lawyers will answer the following seven key questions about the current litigation:
- 1. What are the legal grounds for a Valsartan lawsuit?
- 2. What is the link between Valsartan and cancer?
- 3. Has the FDA recalled Valsartan?
- 4. When will the case settle? How big will it be?
- 5. Is the litigation a Valsartan class action lawsuit?
- 6. How does Valsartan work?
- 7. How do I choose a lawyer?
We cite legal authorities and peer-reviewed scientific literature.
1. What are the legal grounds for a Valsartan lawsuit?
Two common claims in the 2023 Valsartan lawsuits are:
- The pills had a manufacturing defect; and
- The pills had improper labeling which failed to warn about the dangers
Plaintiffs do not need to prove that the manufacturers intended to cause harm or even that the manufacturers were negligent.
Instead, manufacturers are held “strictly liable” under products liability for their manufacturing defects and inadequate warning labels. Therefore, the plaintiff just needs to prove that the manufacturer made a major mistake that caused their illness.
1.1 Manufacturing defect
A manufacturing defect occurs when a product that has a safe design becomes unsafe due to poor construction.
Valsartan is an angiotensin ii receptor blocker (arbs) that is safe when it is compounded correctly. However, several hundreds of lots became unsafe when they were contaminated during the manufacturing process in China with possible cancer-causing agents.
In order to win a manufacturing defect product liability claim, the plaintiff would therefore need to prove:
- The drug had a manufacturing defect when it left the manufacturer’s possession; and also
- This defect was a substantial factor in causing the plaintiff’s harm
The FDA (U.S. Food and Drug Administration) has made public which lots of Valsartan contain unacceptable amounts of carcinogens. Consequently, plaintiffs would need to show that the pills they ingested came from those affected lots. Old pill bottles could serve as evidence of this. Prescription records from the pharmacy could also serve as evidence.
In order to prove that the Valsartan caused the plaintiff’s cancer, the plaintiffs’ attorneys could therefore present such evidence as:
- Medical records that show the plaintiff developed cancer after taking Valsartan with NDMA, and
- Expert witness testimony and medical journal articles explaining the link between Valsartan and cancer
1.2 Improper labeling/ failure to warn
All medication including Valsartan carries risk. Therefore, the manufacturers are required to disclose these risks in the form of warning labels and instructions.
However, none of the contaminated Valsartan pill bottles warned that they may contain carcinogens. Had doctors and patients known of this risk, they likely would have chosen another medication instead.
In sum, failure to warn is a straightforward claim to prove in court. The plaintiffs’ attorneys would show how the pill packaging and instructions omitted important information. The plaintiffs can also testify that they would not have taken the pills but for this misinformation.1
2. What is the link between Valsartan and cancer?
The chemical NDMA that contaminated more than one thousand lots of Valsartan medications has been shown to cause cancer. NDMA is short for N-nitrosodimethylamine. In short, the active ingredient Valsartan is a cancer risk due to NDMA contamination. The affected Valsartan pills often contain 400 times the safe daily threshold of NDMA.
Authorities believe that Valsartan contamination is an unexpected byproduct of changes in how the drug is manufactured. The contamination has apparently been taking place since 2012. This is when ZHP of China started manufacturing the generic drug pills.
ZHP stands for Zhejiang Huahai Pharmaceuticals. ZHP made most of the world’s Valsartan. (Another Chinese manufacturer that made contaminated Valsartan is Zhejiang Tianyu.) Ultimately, more than 30 different companies made generic Valsartan. This contamination has allegedly occurred for years until random testing uncovered the contamination.
The US Environmental Protection Agency (EPA) classifies NDMA as a “probable human carcinogen” (commonly called a B2 carcinogen). This means that it probably causes cancer in humans since it causes cancer in animals. Scientists often use NDMA to cause cancer in rats for research. In the past, people have also 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.
- Also in 1978, 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. He died 15 days later.2
2.1. What is NDMA?
The World Health Organization lists the chemical NDMA as “probably carcinogenic to humans.” Federal regulations list NDMA as a “priority toxic pollutant.” The U.S. National Library of Medicine says NDMA is “reasonably anticipated” to cause cancer in humans. A 2018 Danish study showed that NDMA exposure can cause cancer of the liver, stomach, colon, rectum, and pancreas. Also, the EPA reports that NDMA exposure may cause liver damage.3
NDMA has been used to make antioxidants, softeners for copolymers, additives for lubricants, and other industrial products. This chemical is a byproduct of some pesticide and rubber tire manufacturing. NDMA was required to synthesize UDMH (unsymmetrical dimethylhydrazine), an ingredient of rocket fuel. The WHO also states NDMA is a byproduct of municipal wastewater treatment facilities and some industrial manufacturing facilities. Trace amounts of NDMA – which are not harmful – are sometimes found in bacon.
The FDA ran further tests on Valsartan batches that contained NDMA and also found a second carcinogen in some of the drugs. This 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.
(Another carcinogen that was also found in Losartan is N-Nitroso-N-methyl-4-aminobutyric acid (NMBA).)4
Note that many Valsartan pills were compounded with hydrochlorothiazide (HCTZ), which is a water pill and is safe.
2.2. What kind of cancer does Valsartan cause?
Animal studies have associated NDMA with the following diseases:
- Colorectal cancer,
- Gastric cancer,
- Esophageal cancer,
- Multiple Myeloma,
- Non-Hodgkin’s Lymphoma,
- Prostate cancer,
- Pancreatic cancer, and also
- Liver cancer5
In addition, people overexposed to NDMA in the short-term may exhibit such symptoms as:
- enlarged liver
- liver fibrosis and scarring
- nausea and vomiting
- stomach cramps, and/or also
- impairment of lungs, liver, or kidneys
3. Has the FDA recalled Valsartan?
No. Not all batches of Valsartan have been contaminated. But several drug companies voluntarily recalled their lots of the high blood-pressure medication. And the FDA banned any imports of drugs made by ZHP in China.
3.1. Which Valsartan has been recalled?
The FDA announced the first recall on July 13, 2018. The FDA maintains a list of recalled lots. And it publishes regular updates. As of June 11, 2019, 1,114 lots of angiotensin II receptor blockers have been recalled.
Drug manufacturers who recalled generic Valsartan include:
- Camber Pharmaceuticals
- Hetero Labs (based in India)
- Major Pharmaceuticals
- Northwind Pharmaceuticals
- NuCare Pharmaceuticals
- Solco Healthcare
- Prinston Pharmaceuticals – Prinston is a division of ZHP
- Actavis/ Teva Pharmaceuticals Industries
- Torrent Pharmaceuticals
Other pharmaceutical companies involved in the Valsartan lawsuits include Walgreens, Throggs Neck Pharmacy, A-S Medications Solutions, RemedyRepack Inc., Bryant Ranch Prepack Inc., Preferred Pharmaceuticals, Rising Pharmaceuticals, and also H.J. Harkins Company (Pharma Pac).
3.2. Is Valsartan safe now?
Novartis makes brand name Valsartan, called Diovan. (The FDA approved Diovan in 1996. The patent for Diovan expired in 2012.) As of 2023, it is safe and remains on the market. Other names for it are Byvalson, Entresto, and Exforge. The RXCUI number is 69749.6
4. When will the cases settle? How big will it be?
Valsartan lawsuit settlements are still at least a couple of years away. First, a few Valsartan cases will to trial in a district court in 2022 and 2023. The results of these bellwether trials are crucial. They help plaintiffs’ attorneys gauge how to negotiate and how much money they can demand.
In any case, plaintiffs’ attorneys will fight for enough money to cover:
- All medical costs;
- Lost income from being too ill to work;
- Pain and suffering;
- Any other out-of-pocket expenses; and also
- Funeral expenses (if the victim died)
The drug companies can afford big settlements. In 2017, more than 10 billion Valsartan pills sold worldwide.
The main defendants in this litigation include:
- ZHP (based in China) – They create the active pharmaceutical (API) ingredient and also sell it to manufacturers.
- Torrent (based in India) – They are a “finished dose manufacturer”, obtaining the API from places like ZHP.
- Teva (based in Israel) – They are also a “finished dose manufacturer”, obtaining the API from places like ZHP.
- Aurobindo (based in India) – Like ZHP, they make their own API.
- Mylan (based in Pennsylvania) – Like ZHP, they make their own API.
- Hetero (based in India) – Like ZHP, they make their own API.
There is evidence that these companies ran subpar facilities, hid information from the FDA, and failed to test their products for NDMA.
5. Is the litigation a Valsartan class action lawsuit?
No. But all the plaintiffs’ lawsuits consolidate into an MDL. This is short for multi-district litigation.
MDLs are similar to class actions. Plaintiffs join forces to sue the same defendants. And it helps to streamline pretrial proceedings.
But class actions combine everything into one case. MDLs keep each case separate. This gives each plaintiff more bargaining power.
Currently, there is one Valsartan MDL against the pharmaceutical companies:
- In re: Valsartan NDMA Products Liability Litigation. MDL # 19-2875. Federal Court, District of New Jersey. Judges Robert B Kugler and Joel Schneider.
The judges will allow about five cases to reach trial. How these bellwether trial verdicts turn out sets the tone for negotiations. As of February 17, 2021, the MDL contains 700 separate lawsuits.7
6. How does Valsartan work?
The non-proprietary hypertension medication Valsartan blocks the receptor for angiotensin II, the hormone that can constrict blood vessels and thereby raise pressure. It takes effect after about two hours, peaks at six hours, and wears off by 24 hours.
Unlike Losartan, Valsartan does not decrease levels of serum uric acid – which can cause gout at high levels. But it poses a lower risk for adverse events – such as coughing – than Lisinopril.
Valsartan is manufactured in four tablet dosages: 40 mg, 80 mg, 160 mg and also 320 mg. Adults typically take 80 mg or 160 mg daily. Younger patients typically start with 40 mg a day but may increase over time. Heart failure patients are usually started on two 40 mg tablets a day. And heart attack patients usually take half a 40 mg pill twice a day before increasing the dose.
Valsartan can be taken with food or on its own. It should be stored at room temperature. Patients should also try to take it at the same time each day. People who overdose should call 911 right away. OD symptoms include dizziness and a rapid or slow heartbeat. An infusion of saline may help reverse low blood pressure.
6.1. Side effects
Possible Valsartan side effects
|High blood pressure|| |
|Heart failure|| |
|Heart attack|| |
Valsartan has a black box warning that the drug can disable or also kill a fetus, so it should not be prescribed to pregnant women.
Valsartan can also have negative interactions with the following drugs:
- NSAIDs (nonsteroidal anti-inflammatory drugs), including aspirin, celecoxib, diclofenac, ibuprofen, indomethacin, meloxicam, and also naproxen,
- Certain diuretics,
- Some diuretics,
- Substitutes for salt, and also
- Truvada and other HIV/AIDS drugs
Valsartan can also be risky for patients with severe CHF (congestive heart failure), hepatic or renal impairment, volume depletion, hereditary angioedema, mitral or aortic valve stenosis, or hyperkalemia (high potassium).
Finally, patients with congestive heart failure or chronic kidney disease are more susceptible to acute renal failure if they take Valsartan. So anyone with heart, liver, kidney, or dehydration problems should consult with their doctor before taking Valsartan.
About three million patients were prescribed Valsartan at the time the recalls began.8
7. How do I choose a lawyer?
In sum, choose a personal injury attorney committed to fighting for the maximum possible settlement and staying in contact with clients.
Steer clear of lawyers who want payment upfront. Reputable attorneys also accept no money unless they win the case.
Therefore, look for attorneys with a track record against Big Pharma. Drug companies hire bullying law firms. They do everything to intimidate victims and delay proceedings.
But experienced plaintiffs’ attorneys stay the course and they have one focus: Recovering the largest financial reward available in a 2023 Valsartan lawsuit.
- See also Chase Purdey, A common blood pressure medicine is being recalled because of a toxic ingredient, Quartz (July 18, 2018). Also see Update on review of recalled valsartan medicines, European Medicines Agency (August 2, 2018).
- See also 40 CFR §131.36.
- Also see Muhammad Junaid Farrukh, Muhammad Haseeb Tariq, Obaidullah Malik, and Tahir Mehmood Khan, Valsartan recall: global regulatory overview and future challenges, Ther Adv Drug Saf. (January 18, 2019).
- See also Public Health Statement, CDC. Many people took Valsartan, irbesartan (Avapro), or candesartan (Atacand) to relax blood vessels and prevent heart attacks. So patients should discuss alternatives with their doctors to keep protecting their heart. Unacceptable amounts of NMBA (N-Nitroso-N-methyl-4-aminobutyric acid) as well as NDEA were found in some losartan and irbesartan products.
- Also see Novartis Pharmaceuticals Corporation (Novartis) Statement on Recall Outside the United States of Sandoz Generic Valsartan and Sandoz Valsartan and Hydrochlorothiazide Film-Coated Tablets, Novartis (July 16, 2018) (“This recall does NOT impact any Novartis or Sandoz valsartan products in the United States or any Novartis Pharma products that contain valsartan, including Diovan”).
- See also Jones v. Zhejiang Huahai Pharmaceutical Co., Ltd., (E.D. Missouri), Case: 4:18-cv-01525-RLW. Also see Stimma, Strand & Lee v. Torrent et al. (N.J., 2018), Case 2:18-cv-14318. See also Duffy & Duffy v. Solco Healthcare et al. (S.D.N.Y., 2018), Case 1:18-cv-07460. Also see Erwin v. Prinston Pharmaceutical et al. (N.J., 2018), Case 3:18-cv-13447. See also the Valsartan MDL Transfer Order, statistics report (July 16, 2019), and statistics report (April 15, 2019). The MDL originally began by combining 10 existing lawsuits and named 20 defendants. It is expected to grow to several thousand.
- See also Delthia Ricks, FDA probes tainted blood pressure drug valsartan; might still be in use, Newsday (September 10, 2018).
- See also Pottegård, A., Use of N-nitrosodimethylamine (NDMA) contaminated valsartan products and risk of cancer: Danish nationwide cohort study, BMJ (September 9, 2018)(“In July 2018, some valsartan products were discovered to have been contaminated with N-nitrosodimethylamine (NDMA). This contamination, which far exceeded regulatory exposure limits, was specific to drug products manufactured by Zhejiang Huahai Pharmaceuticals, a company in Linhai, China, and seems to be related to a change in the manufacturing process that was implemented in 2012. Consequently, medical agencies across Europe as well as the US Food and Drug Administration have withdrawn all affected valsartan products from the market as of July 2018.”)
- Also see Technical Fact Sheet – N-Nitroso-dimethylamine (NDMA) November 2017, Environmental Protection Agency (“NDMA is not currently produced in pure form or commercially used in the United States, except for research purposes. It was formerly used in the production of liquid rocket fuel, antioxidants, additives for lubricants and softeners for copolymers “)
- See also Update on review of valsartan medicines following detection of impurity in active substance, European Medicines Agency (July 17, 2018).
Other FDA links
- See also FDA Updates and Press Announcements on Angiotensin II Receptor Blocker (ARB) Recalls (Valsartan, Losartan, and Irbesartan)
- Also see FDA provides update on its ongoing investigation into ARB drug products; reports on finding of a new nitrosamine impurity in certain lots of losartan and product recall, FDA (March 1, 2019) (NDMA is “of special concern to global regulators because, unlike most impurities in drugs, they have the potential to cause harm at very low levels.”)
- See also FDA Updates and Press Announcements on Angiotensin II Receptor Blocker (ARB) Recalls (Valsartan, Losartan, and Irbesartan).
- Also see FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity, FDA (July 13, 2018).
- See also FDA provides update on its ongoing investigation into valsartan products; and reports on the finding of an additional impurity identified in one firm’s already recalled product, FDA (September 13, 2018).
- Also see Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets, FDA (March 20, 2020) (14 lots recalled).
- See also Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on FDA’s ongoing investigation into valsartan impurities and recalls and an update on FDA’s current findings, FDA (August 30, 2018).
- See also Anna Edney and Margaret Cronin Fisk, Popular Heart Drugs Tainted With Carcinogens Face a Wave of Lawsuits, Bloomberg (April 24, 2019)(“‘My best estimate sitting here today is I expect that we will have approximately 2,000 personal-injury cases on file in the next two years,’ Daniel Nigh, who has filed 12 such lawsuits so far, told judges at a conference in the U.S. District Court in New Jersey last month, according to a transcript.”)
- Also see Edney, A. and Fisk, M.C., Popular Heart Drugs Tainted With Carcinogens Face a Wave of Lawsuits, Bloomberg (April 24, 2019). Other ARB drugs include Olmesartan, Telmisartan, Eprosartan, and Azilsartan.
- See also Jen Christensen, Recall of heart drug valsartan continues to expand, CNN (August 28, 2018).
- Also see Didi Martinez, Brenda Breslauer and Stephanie Gosk, Tainted drugs: Ex-FDA inspector warns of dangers in U.S. meds made in China, India, NBC News (March 10, 2019)(“The valsartan recall came as little surprise to Massoud Motamed, a former inspector with the U.S. Food and Drug Administration (FDA). More than a year before the notices went out, Motamed had tried to sound the alarm on what he flagged as potential systemic problems at two facilities in China and India that produce the active ingredients in generic valsartan and other blood pressure medications.”).
- See also Palmer, E., New Diovan Generic Approved as FDA Attacks Valsartan Shortage, FiercePharma (March 13, 2019).
- Also see Sheila Kaplan, Blood Pressure Medicine Is Recalled, NY Times (July 16, 2018).
- Jacqueline Howard, Valsartan recall: 4 things patients should know, CNN (November 1, 2018)(“The FDA action came after 22 other countries issued recalls involving 2,300 valsartan batches sent to Germany, Norway, Finland, Sweden, Hungary, the Netherlands, Austria, Ireland, Bulgaria, Italy, Spain, Portugal, Belgium, France, Poland, Croatia, Lithuania, Greece, Canada, Bosnia and Herzegovina, Bahrain and Malta.”).