Valsartan Lawsuits

People who took valsartan blood pressure drugs contaminated with cancer-causing chemicals are suing the companies that made and distributed the tainted medications. Lawsuits claiming consumer losses, as well as personal injuries, have been combined in a mass litigation in a New Jersey federal court.

Valsartan pills
Valsartan Lawsuit Facts
  1. Injuries Liver cancer, kidney cancer, colorectal cancer, stomach or gastric cancer, bladder cancer, pancreatic cancer and liver injuries that require hospitalization
  2. Manufacturers Zhejiang Huahai Pharmaceutical Co., Ltd., Hetero Labs, Ltd. and several other companies
  3. Top Settlement None yet

Valsartan lawsuits claim contamination with toxic chemicals, including N-nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA), caused health problems while others demand compensation for the tainted medicine they bought. Although it is not a typical valsartan side effect, cancer has developed in people and animals exposed to NDMA.

About 3 million Americans take valsartan-containing medications each year. A large-scale recall of certain generic valsartan blood pressure medications that began in July 2018 led lawyers to investigate claims and file lawsuits on behalf of people who took tainted medication.

Status of Lawsuits

In February 2019, a federal panel combined 10 valsartan lawsuits from around the United States into a mass litigation in New Jersey federal court. The panel identified at least 30 other related lawsuits that could join the litigation. Lawsuits named 20 valsartan manufacturers and other companies as defendants.

As of July  2019, there were 88 lawsuits in the litigation. No trial dates have been set, and there have been no settlements or verdicts.

The first 10 cases combined in the mass litigation were consumer class action lawsuits seeking reimbursement for people who had purchased tainted valsartan for as long as six years. But the federal panel also identified 17 individual personal injury lawsuits that claimed the tainted valsartan caused cancer or liver damage. It opened the litigation to personal injury cases as well.

Valsartan is a widely used blood pressure medicine. An estimated 1.5 million people may have taken tainted valsartan in 2018. Recalls of the tainted lots of the medicine rolled out over several months and affected hundreds of batches of valsartan and related blood pressure medicine. The recalls were so extensive they led to shortages of the generic drug.

Because it is so widely used, there is the potential for thousands of valsartan lawsuits to be filed before any of the cases go to trial. Bloomberg reported in April 2019, that an attorney handling valsartan lawsuits told judges attending a conference in New Jersey that he expected “approximately 2,000” personal injury lawsuits over the drugs within two years.

Are All Batches of Valsartan Part of the Litigation?

Not all batches of valsartan were contaminated.

Diovan, the brand-name version of valsartan, was not affected. After the recall, Novartis — the original drugmaker and patent holder of Diovan — issued a statement regarding a separate recall for Sandoz valsartan outside of the United States. The company assured U.S. patients that “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.”

On July 13, 2018, the FDA announced that some companies were issuing valsartan recalls because manufacturers found NDMA in the medications.

Conveyor belt with valsartan medicine
Certain batches of valsartan medications were manufactured with NDMA.

The agency expanded the recall in August 2018 to include 11 U.S. pharmaceutical companies. It said it would continue to investigate.

The European Medicines Agency suspects the NDMA contamination stemmed from manufacturing changes made at Zhejiang Huahai Pharmaceutical’s plant in China, which supplies nearly half of all valsartan to the United States.

In September 2018, the FDA announced that Zhejiang Huahai had found another toxic chemical in the recalled medications — a cancer-causing chemical called N-nitrosodiethylamine (NDEA).

A total of 1,114 lots of angiotensin II receptor blockers, including valsartan, losartan and irbesartan, had been recalled as of June 11, 2019, according to the FDA.

Manufacturers in Lawsuits

Because valsartan is a generic medication, named for the active pharmaceutical ingredient (API), different companies are part of the supply chain: manufacturers, distributors and repackagers.

Zhejiang Huahai Pharmaceutical Co. Ltd. in China and India-based Hetero Labs were among the first companies identified to have manufactured the contaminated valsartan that made its way to the U.S. market. According to lawyers, these two API manufacturers are the main defendants in this litigation. Because the two companies supply several manufacturers, distributors, and repackagers, each may have varying levels of liability.

Companies involved in valsartan lawsuits include:
  • Zhejiang Huahai Pharmaceutical Co. Ltd.
  • Hetero Labs Ltd.
  • Prinston Pharmaceutical Inc.
  • Teva Pharmaceutical Industries Inc.
  • Teva Pharmaceuticals USA Inc.
  • Torrent Pharmaceuticals
  • Solco Healthcare, U.S. LLC
  • Actavis LLC
  • Major Pharmaceuticals
  • Camber Pharmaceuticals Inc.
  • A-S Medication Solutions LLC
  • NuCare Pharmaceuticals Inc.
  • H.J. Harkins Company Inc. (Pharma Pac)
  • Bryant Ranch Prepack Inc.
  • Northwind Pharmaceuticals
  • AvKARE Inc.
  • RemedyRepack Inc.
  • Preferred Pharmaceuticals

In addition to the drugmakers, Walgreens and Throggs Neck Pharmacy have been implicated in complaints.

What to Expect When Filing a Suit for Valsartan Injuries

If your medication was included in the valsartan recall, make sure you keep your medication bottle and pills for evidence and testing.

Next, contact an experienced product-liability attorney. Valsartan litigation can be complicated, especially since some defendants are located in China and India. There are also multiple defendants. An experienced attorney will know how to file the proper paperwork and make sure your case runs smoothly.

Valartan Lawsuit Tip
Lawyers taking valsartan cases urge people who want to file a claim to keep their bottle of recalled medication. It may be valuable evidence in their lawsuit.

Attorneys who specialize in product liability have experts on hand who can review the research. They may even test your valsartan pills for NDMA contamination.

The lawyer will be able to evaluate your case and tell you what to expect. Once you enter into an agreement, the attorney can prepare and file your valsartan lawsuit.

Suffering from liver damage or cancer after taking valsartan? Review Your Legal Options

Injuries Eligible for a Lawsuit

Only certain injuries can be linked to contaminated valsartan.

A Danish study showed that NDMA exposure can cause cancers of the gastrointestinal tract and supplementary digestive organs, including the stomach, colon, rectum, liver and pancreas. Researchers stated, “NDMA is suspected to have both localised and systemic carcinogenic effects due to the induction of DNA-damaging metabolites in the gastrointestinal tract and liver.”

Thus, people diagnosed with liver, kidney, colorectal, stomach, bladder or pancreatic cancer have a viable case if they’d started taking valsartan at least one year before their cancer diagnosis.

Additionally, people injured by valsartan — including the above cancer diagnoses or liver injury with at least 3 days of hospitalization — must have been taking the drug, either alone or in combination with another drug, for at least 30 days between 2014 and present.

If you are not sure if you qualify, you should speak to an attorney.

Time Limits to File a Case

Because states enforce statutes of limitations on lawsuits, it is important to contact an attorney as soon as possible. Some lawsuits include a provision to suspend the statute of limitations.

For example, in court documents filed by Eric J. Erwin in the District of New Jersey Trenton Vicinage, the factual allegations — or the story of the case — state that the plaintiffs could not have filed a complaint earlier because the manufacturers had concealed the NDMA contamination until the FDA announced the recall in 2018. Therefore, the complaint states, “any applicable statute of limitations affecting the rights of Plaintiff and other Class Members has been tolled [paused].”

Only an attorney can properly determine your time limit to file.

Complaints Filed on Behalf of People Who Took Tainted Valsartan

The first lawsuits filed were class actions filed on behalf of people who bought and took contaminated valsartan.

A New York man and woman filed what they propose to be a valsartan class-action lawsuit in the federal Southern District of New York on Aug. 16, 2018. Elizabeth and John Duffy named Solco Healthcare, Prinston Pharmaceutical Inc., Walgreens and Throggs Neck Pharmacy as defendants in their complaint.

The second complaint, which was filed by Eric J. Erwin on August 31, 2018 in the District of New Jersey Trenton Vicinage names Prinston Pharmaceutical, Solco Healthcare, Huahai US Inc., Teva Pharmaceutical and Teva USA.

Then on Sept. 11, 2018, James Jones filed another class action complaint in the Eastern District of Missouri Eastern Division. He named Zhejiang Huahai Pharmaceutical Co. Ltd., Prinston Pharmaceutical, Inc., Solco Healthcare U.S. LLC and Huahai US Inc. in his complaint.

Class Action Claim
The Adulterated Valsartan was unreasonably dangerous because it was adulterated and contaminated by NDMA, a carcinogen.
Source: Jones v Zhejiang Huahai Pharmaceutical Co. Ltd. et al. Class Action Complaint

A fourth complaint was filed on Sept. 26, 2018, by Dominic Stimma, Margoth Strand and Jynona Gail Lee against Torrent Pharma Inc., Hetero USA, Camber Pharmaceuticals, Kroger, Quality Food Centers and CVS. The complaint was filed in the U.S. District Court of New Jersey.

Please seek the advice of a medical professional before making health care decisions.

Michelle Llamas, Senior Content Writer
Written By Michelle Llamas Senior Writer

Michelle Llamas has been writing articles and producing podcasts about drugs, medical devices and the FDA for seven years. She specializes in fluoroquinolone antibiotics and products that affect women’s health such as Essure birth control, transvaginal mesh and talcum powder. Michelle collaborates with experts, including board-certified doctors, patients and advocates, to provide trusted health information to the public. Some of her qualifications include:

  • American Medical Writers Association (AMWA) Engage Committee and Membership Committee member
  • Centers for Disease Control and Prevention (CDC) Health Literacy certificates
  • Original works published or cited in The Lancet, British Journal of Clinical Pharmacology and the Journal for Palliative Medicine
Edited By
Kevin Connolly
Kevin Connolly Managing Editor

15 Cited Research Articles

  1. Duffy & Duffy v. Solco Healthcare et al. (2018, August 16). Class Action Complaint and Demand for Jury Trial. Case 1:18-cv-07460. Retrieved from https://jc6kx1c9izw3wansr3nmip8k-wpengine.netdna-ssl.com/wp-content/uploads/2018-8-16-valsartan-class-action.pdf
  2. Edney, A. and Fisk, M.C. (2019, April 24). Popular Heart Drugs Tainted With Carcinogens Face a Wave of Lawsuits. Bloomberg. Retrieved from https://www.bloomberg.com/news/articles/2019-04-24/valsartan-recall-tainted-heart-drugs-face-lawsuits-over-cancer
  3. Erwin v. Prinston Pharmaceutical et al. (2018, August 31). Jury Trial Demanded Complaint-Class Action. Case 3:18-cv-13447. Retrieved from https://jc6kx1c9izw3wansr3nmip8k-wpengine.netdna-ssl.com/wp-content/uploads/2018-08-31-Complaint.pdf
  4. European Medicines Agency. (2018, August 2). Update on review of recalled valsartan medicines. Retrieved from https://www.ema.europa.eu/en/news/update-review-recalled-valsartan-medicines-preliminary-assessment-possible-risk-patients
  5. European Medicines Agency. (2018, July 17). Update on review of valsartan medicines following detection of impurity in active substance. Retrieved from https://www.ema.europa.eu/en/documents/press-release/update-review-valsartan-medicines-following-detection-impurity-active-substance_en.pdf
  6. Novartis. (n.d.) Novartis Pharmaceuticals Corporation (Novartis) Statement on Recall Outside the United States of Sandoz Generic Valsartan and Sandoz Valsartan and Hydrochlorothiazide Film-Coated Tablets. Retrieved from https://www.pharma.us.novartis.com/news/statements#ui-id-1=1
  7. Pottegård, A. (2018, September 9). Use of N-nitrosodimethylamine (NDMA) contaminated valsartan products and risk of cancer: Danish nationwide cohort study. Retrieved from https://www.bmj.com/content/362/bmj.k3851
  8. Stimma, Strand & Lee v. Torrent et al. (2018, September 26). Class Action Complaint and Demand for Jury Trial. Case 2:18-cv-14318. Retrieved from https://jc6kx1c9izw3wansr3nmip8k-wpengine.netdna-ssl.com/wp-content/uploads/2018-9-26-valsartan-class-action.pdf
  9. United States District Court For The Eastern District Of Missouri Eastern Division. (2018, September 11). Class Action Complaint. Case No.: 4:18-cv-01525-RLW. Retrieved from https://jnswire.s3.amazonaws.com/jns-media/07/76/897777/zhejiang.pdf
  10. U.S. Food and Drug Administration. (2018, September 13). 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 products. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-provides-update-its-ongoing-investigation-valsartan-products-and-reports-finding-additional
  11. U.S. Food and Drug Administration. (2018, August 30.) 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. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-statement-agencys-list-known-nitrosamine-free-valsartan-and-arb-class-medicines-part-agencys
  12. U.S. Food and Drug Administration. (2019, March 13). Search List of Recalled Angiotensin II Receptor Blockers (ARBS) Including Valsartan, Losartan and Irbesartan. Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/search-list-recalled-angiotensin-ii-receptor-blockers-arbs-including-valsartan-losartan-and
  13. U.S. Judicial Panel on Multidistrict Litigation. (2019, February 14). In re: Valsartan N-Nitrosodimethylamine (NDMA) Contamination Products Liability Litigation, MDL No. 2875; Transfer Order. Retrieved from https://www.jpml.uscourts.gov/sites/jpml/files/MDL-2875-Initial_Transfer-01-19.pdf
  14. Palmer, E. (2019, March 13). New Diovan Generic Approved as FDA Attacks Valsartan Shortage. FiercePharma. Retrieved from https://www.fiercepharma.com/manufacturing/new-diovan-generic-approved-as-fda-attacks-valsartan-shortage
  15. U.S. Judicial Panel on Multidistrict Litigation. (2019, April 15). MDL Statistics Report. Retrieved from https://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-April-15-U.S. Judicial Panel on Multidistrict Litigation. (2019, July 16). MDL Statistics Report. Retrieved from https://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_Actions_Pending-July-16-2019.pdf
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