Valsartan lawsuits claim that batches of the blood pressure medication contaminated with a toxic chemical called N-nitrosodimethylamine (NDMA) caused them to develop cancer and liver damage. Although it is not a typical valsartan side effect, cancer has developed in people and animals exposed to NDMA.
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.
About 3 million Americans take valsartan-containing medications each year.
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.
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).
Manufacturers in Lawsuits
The lawsuits so far include about twenty valsartan manufacturers. 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 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.
- 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.
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.
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
While lawyers have yet to file individual cases, some people have filed lawsuits hoping to start valsartan class-action lawsuits.
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.
The latest complaint was filed on September 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.