What’s the problem?
Manufactured by the China-based major pharmaceuticals company Zhejiang Huahai, valsartan containing medications have been found to contain N-nitrosodimethylamine (NDMA), a chemical health authorities consider a probable human carcinogen (cancer-causing substance), according to an FDA recall announcement.
Which Valsartan Medications were Recalled?
The agency originally recalled select batches of valsartan, and has since expanded the action to include blood pressure medicine made by other companies, as well as some tablets with valsartan and hydrochlorothiazide (HCTZ).
Zhejiang Huahai has issued at least 3 major recalls for batches of valsartan products, along with Health Canada and the European Medicines Agency (EMA) conducting their own personal recalls.
In the U.S., the Food and Drug Administration has recalled valsartan-containing products from the following companies:
- A-S Medication Solutions (labeled as Solco Healthcare)
- Bryant Ranch Prepack
- HJ Harkins Company
- Northwind Pharmaceuticals
- Prinston Pharmaceutical Inc. (labeled as Solco Healthcare)
- Teva Pharmaceuticals Industries Ltd. (some labeled as Actavis, some as Major Pharmaceuticals)
- A-S Medication Solutions
- Northwind Pharmaceuticals
- Prinston Pharmaceutical (labeled as Solco Healthcare)
- Proficient Rx
- Remedy Repack
- Teva Pharmaceuticals (some labeled as ACtavis)
In September 2018, the FDA announced that Zhejiang Huahai had found another toxic chemical in generic valsartan — a cancer-causing chemical called N-nitrosodiethylamine (NDEA).
A total of 1,114 lots of angiotensin II receptor blockers, including batches of valsartan, losartan and irbesartan, had been recalled as of June 11, 2019, according to the FDA.
FDA advises consumers who are taking a medication with valsartan to compare their prescription bottle to the agency’s list to determine whether their drugs have been recalled.
Patients can also contact their pharmacist, who may be able to provide valsartan from a pharmaceutical company not involved in the recall.
Patients taking these medications should continue using them until their doctor or pharmacist has a replacement drug or treatment, FDA says.
Valsartan Side Effects
Our lawyers are investigating potential lawsuits for people who were diagnosed with the following serious side effects after taking valsartan:
- Stomach cancer
- Small intestine cancer
- Gastric cancer
- Colorectal cancer
- Esophageal cancer
- Prostate cancer (patient must be under the age of 65 at time of diagnosis)
- Liver damage
- Liver cancer
- Liver tumors
- Blood cancer / Leukemia
- Bladder cancer
- Pancreatic cancer
- Multiple Myeloma
- Non-Hodgkin Lymphoma
- Heart failure
- Congestive heart failure
Other Side Effects
Other, less severe side effects of valsartan may include:
- Flu symptoms
- Upper respiratory infection
- Cold symptoms (cough, runny or stuffy nose, sneezing, sore throat)
- Stomach pain
- Blurred vision
- Itching or skin rash
- Back pain
- Joint pain
What is Generic Valsartan?
Valsartan is the active ingredient in Diovan, a prescription angiotensin II receptor blocker medication used to treat high blood pressure (hypertension), heart failure, and post heart attack. Valsartan was approved by the Food and Drug Administration on August 3, 2005.
Diovan is available as tablets for oral administration in strengths of 40, 80, 160 or 320 mg of valsartan. Usual beginning dose is a total of 80 mg per day, but this may vary. For children with pediatric hypertension (ages 6–16), the dose is weight based at 1.3 mg per Kg weight not to exceed 40 mg per day.
How Does it Work?
Valsartan pills can relax blood vessels by blocking the receptor for angiotensin II, the hormone that can constrict blood vessels and thereby raise pressure. It takes effect after about 2 hours, peaks at 6 hours, and wears off by 24 hours.
Unlike Losartan, valsartan does not decrease levels of serum uric acid – which can cause gout at high doses. However, it poses a lower risk for minor side effects – such as coughing – than Lisinopril.
Valsartan can be taken with food or on its own. It should be stored at room temperature. Patients should 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.
What is N Nitrosodimethylamine (NDMA)?
All of the valsartan recalls were issued over concerns of potential contamination with N-nitrosodimethylamine (NDMA), according to the U.S. Environmental Protection Agency (EPA). NDMA is a semi-volatile organic chemical that belongs to the N-ni-trosamines family of potent carcinogens.
The chemical is not currently produced in pure form or commercially used in the U.S., except for research purposes. It was formerly used in production of liquid rocket fuel, antioxidants, additives for lubricants and softeners for copolymers, according to the EPA.
Are Valsartan Lawsuits Being Filed?
A panel of federal judges in Feb. 2019 ordered that a multi district litigation (MDL) for 10 Valsartan lawsuits be created in New Jersey federal court. The panel identified at least 30 other related lawsuits that could join the litigation. The complaints named at least 20 valsartan drug companies and other companies as defendants in the litigation.
As of July 2019, there were 88 lawsuits pending in the MDL. No trial dates have been set, and there have been no settlements or verdicts.
The first 10 cases in the litigation were class action lawsuits seeking reimbursement for people who had purchased contaminated valsartan products for up to 6 years. The panel also identified at least 17 individual personal injury lawsuits alleging the tainted valsartan caused cancer or liver damage. This opened the MDL to personal injury cases as well.
Because the medication is so widely used, there is the potential for thousands of valsartan lawsuits to be filed before any of the cases go to trial.
Which Injuries are Eligible for a Valsartan Lawsuit?
If you were diagnosed with liver damage, kidney cancer, colorectal cancer, stomach cancer, bladder cancer or pancreatic cancer, you may qualify to file a lawsuit if you started taking valsartan at least 1 year prior to the 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.
How Long Do I Have to File a Claim?
Because states enforce statutes of limitations on lawsuits, it is important to contact an attorney as soon as possible. Failing to do so could bar your ability to collect compensation for your injuries.
Some lawsuits include a provision to suspend the statute of limitations. Only an attorney can properly determine your time limit to file.
What To Do if You've Been Injured by Valsartan
If your prescription drug was included in the valsartan recall, make sure you keep your pill bottles and pills for evidence.
Next, you should contact the experienced Valsartan Lawyers at Schmidt & Clark, LLP. Valsartan litigation can be complicated, as many of the drug companies are located overseas in China and India. An experienced attorney will know how to file the proper paperwork and make sure your case runs smoothly.
Attorneys who specialize in defective drug lawsuits have experts on hand who can review the evidence. They may even test your valsartan pills for potential n nitrosodimethylamine 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.
Questions a Valsartan Lawyer may ask a potential client include:
Was your valsartan part of the recall?
In July 2018, the U.S. Food and Drug Administration recalled several lots of valsartan after they were found to have been contaminated with NDMA. To find out if your drug was part of the recall, locate the name of the drug’s manufacturer and the lot number on the pill bottle or on the warning label that comes with it and then search the FDA’s recall list.
What have you been diagnosed with?
Plaintiffs filing valsartan lawsuits have typically been diagnosed with liver cancer, kidney cancer, intestinal cancer or stomach cancer. Your attorney will be able to confirm your diagnosis by reviewing your medical records.
When did you first experience side effects?
All U.S. states have a specific statute of limitations on valsartan lawsuits that indicates how long you have to file a claim from the time you started experiencing serious side effects. Your attorney can help you determine whether you’re eligible to file a suit.
How have these side effects affected your daily life?
A cancer diagnosis will have a major effect on your daily life. Let your attorney know what kind of toll the disease has had on you physically, mentally and emotionally as well as what you’ve done to combat the condition.
What treatments are you undergoing?
There are many ways to treat cancer, including surgery, chemotherapy and radiation. Your attorney will want to know about the cancer treatment plan you’ve chosen, as well as how effective it’s been for you.
Valsartan Lawsuit Examples
The first lawsuits filed were class actions filed on behalf of people who bought and took contaminated valsartan.
- August 16, 2018 - A New York man and woman filed the first valsartan class action lawsuit in the federal Southern District of New York. Plaintiffs Elizabeth and John Duffy named Solco Healthcare, Prinston Pharmaceutical Inc., Walgreens and Throggs Neck Pharmacy as defendants in the suit.
- August 31, 2018 - The second class action was filed by Eric J. Erwin in the District of New Jersey. The complaint names Prinston Pharmaceutical, Solco Healthcare, Huahai US Inc., Teva Pharmaceutical and Teva USA as defendants.
- September 11, 2018 - Plaintiff 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., and Huahai US Inc. in his complaint.
- September 26, 2018 - Valsartan lawsuit filed 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.
Do I Have a Valsartan Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in valsartan lawsuits. We are handling individual personal injury litigation nationwide from valsartan patients and currently accepting new valsartan cases in all 50 states.
Again, if you or a loved one got cancer after taking valsartan, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.