Valsartan Lawsuit

Valsartan Recall

The FDA is alerting healthcare professionals and patients that several lots of a common high blood pressure and heart failure drug containing Valsartan have been recalled in the U.S. because they contain an impurity that poses a potential cancer risk.

Not all products manufactured by these foreign companies and distributed in the U.S. are being recalled.

Patients using high blood pressure medicines should look at the drug name and company on the label of their prescription and compare it to the FDA list or call their doctor/pharmacy to check whether their medicine has been recalled.

Here are the lists of Valsartan drugs that have been recalled, and Valsartan drugs that have not been recalled, by the FDA:

• FDA list of valsartan drugs recalled
• FDA list of valsartan drugs not recalled

The Valsartan recall resulted because of the presence of the potentially cancer-causing impurity, N-nitrosodimethylamine (NDMA).

The FDA believes that the impurity may have been in the Valsartan-containing products for as long as four years.

NDMA is a known environmental contaminant that forms in both industrial and natural processes.

It has been used to make liquid rocket fuel, softeners, and lubricants and can be found naturally in meats, dairy products, and vegetables.

Exposure to high levels of NDMA may cause liver damage in humans, according to the U.S. Environmental Protection Agency.

Test results from the affected valsartan-containing medications found the amount of NDMA exceeds acceptable levels.

The FDA is working with drug manufacturers to determine the full impact of the unsafe impurities and to ensure future valsartan active pharmaceutical ingredients are not at risk of NDMA formation.

We will continue to update this page as we learn of changes due to the ongoing investigation.

NDMA Found in Valsartan Can Increase Risk of Cancer

NDMA has been founded to increase the occurrence of cancer in animal studies and have been labeled as a “probably human carcinogen” in humans by the U.S. Environmental Protection Agency.

A lot is currently unknown about the increased risk of cancer or other serious injuries that may result from this impurity.

Investigations are ongoing. TruLaw will consider investigating this risk.

We believe that even a small increase in the risk of injury/diagnosis is one that should be warned about so patients can make an informed decision about the medications they take.

The list of cancers/serious injuries that are currently being pursued legally further are as follows:

• Liver cancer
• Serious liver injury with hospitalization
• Kidney cancer
• Intestinal cancer (including colon cancer)
• Stomach cancer
• Bladder cancer
• Pancreatic cancer
• Serious kidney injury with hospitalization

TruLaw is aware that there are a number of individuals concerned that their cancer diagnosis or other injuries may be linked to the impurities found in valsartan, and we will continue to investigate these cancers/injuries and update the public as we learn more.

As with any side effects/injuries related to drugs/medical devices, consumers should report these to the FDA.

Have Valsartan Lawsuits Been Filed?

TruLaw is currently speaking to individuals prescribed the contaminated medication and diagnosed with certain cancers or kidney/liver injuries.

Lawsuits have been filed and we believe there will be many more individuals who may need to seek compensation for their injuries.

You can fill out the Valsartan Instant Case Evaluation ℠ to see if you have a case to file.

Valsartan lawsuits allege that Zhejiang Huahai, Hetero Labs, and other defendants supplied, manufactured, distributed and ultimately sold valsartan that was adulterated and defective because it contained the toxic substance NDMA.

Class action lawsuits are seeking the cost of the medication plus medical expenses.

Compensation from a valsartan lawsuit can help injured individuals recover from injuries that may have resulted from their use of the contaminated drug.

Valsartan attorneys are now saying that individual lawsuits filed will be consolidated into a multidistrict litigation (MDL) at the beginning of 2019.

FDA Timeline and Actions

FDA Press Release about voluntary recalls of several drug products containing the active pharmaceutical ingredient (API) Valsartan.

7/18/2018 – FDA clarifies which valsartan-containing products are being recalled.  Includes medications manufactured by Zhejiang Huahai Pharmaceuticals, Linhai, China.

• Teva Pharmaceuticals USA labeled as Major Pharmaceuticals – retail level recall.
• Prinston Pharmaceuticals Inc.  labeled as Solco Healthcare LLC – consumer/user level  recall
• Teva Pharmaceuticals labeled as Actavis LLC – consumer/user level recall

7/24/18 – FDA updates consumers with a list of valsartan-containing products not impacted by the recall

7/27/2018 – FDA explains NDMA and notes that the investigation into the safety of valsartan-containing products continues. Additional repackages of the products made by Teva Pharmaceuticals and Prinston Pharmaceuticals (labeled as A-S Medication Solutions, AvKARE and Remedy Repack) are added to the list of medications containing impurities.

•  Bryant Ranch Prepackaged Inc.
•  H.J. Harkins Company Inc.
•  Lake Erie Medical, doing business as Quality Care Products LLC
•  NuCare Pharmaceuticals Inc.
•  Northwind Pharmaceuticals
•  Proficient Rx

8/2/2018 – FDA updates the ongoing list with more details on products included and not included in the recall

8/9/18 – FDA updates list of recalled medicines to include new manufacturer:

• Hetero Labs Limited, in India (labeled as Camber Pharmaceuticals Inc.)

8/20/18 – FDA updates the ongoing list of recalled medications to include a new manufacturer:

• Torrent Pharmaceuticals Limited

8/22/18 – FDA releases a gas chromatography-mass spectrometers method for manufacturer and regulators to detect and quantify NDMA in valsartan API and finished drugs.

11/8/18 – Sandoz Inc. issues a voluntary nationwide recall for a lot of their high blood pressure medication Losartan Potassium and Hydrochlorothiazide due to contamination of trace amounts of N-Nitrosodiethylamine (NDEA) — a known human carcinogen.  This is the same contamination that was found in certain batches of Valsartan.

1/3/19 – Losartan recall has expanded again to specifically include 30-, 90- and 1000- tablets of 50- milligram tablets, and 90-count bottles of 25-milligram tablets.  Tests again found trace amounts of NDEA above the interim acceptable intake level.

The Losartan recall is specifically for 100 milligram/25 milligram tablets that have the lot number JB8912.

The affected product was distributed nationwide on or after October 8, 2018.