Valsartan Class Action Lawsuit Filed Over Cancer Contaminant

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A newly filed class action lawsuit targets companies that distributed or sold valsartan blood pressure medications that were contaminated with NDMA, a chemical believed to cause cancer.

Two New Yorkers filed the lawsuit on behalf of people who bought valsartan that was tainted by NDMA.

NDMA (N-nitrosodimethylamine) is “reasonably anticipated” to cause cancer in humans, according to the U.S. Department of Health and Human Services.

The Environmental Protection Agency classifies NDMA as a probable human carcinogen and says exposure to high levels of NDMA may cause liver damage.

Valsartan products recalled in July and August 2018 contained higher than acceptable NDMA levels. The contamination may have been happening since 2012.

The lawsuit filed in federal court in New York names four companies as defendants. Two distributed the recalled valsartan. The other two are pharmacies that sold it.

The valsartan lawsuit accuses them of negligence, fraud and manufacturing a defective product, among other wrongdoing.

Companies named in valsartan class action are:

  • Solco Healthcare U.S. LLC
  • Prinston Pharmaceutical Inc.
  • Walgreens
  • Throggs Neck Pharmacy

Elizabeth Duffy and John Duffy filed the lawsuit. Both had valsartan prescriptions for high blood pressure. Elizabeth Duffy claims she took contaminated versions of valsartan “for some time.”

How to Join a Valsartan Class Action Lawsuit

The court must first certify the valsartan class action before it moves forward. If that happens, people eligible for it will receive a notification in the mail. People may also join through advertisements posted after the court certifies it.

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To join the class action lawsuit, people must have had the same experience with the companies as outlined in the complaint. People also must have suffered the same injuries as the Duffys.

The lawsuit claims injuries that include the purchase price of the contaminated valsartan. It also mentions non-specific injuries from ingesting NDMA. The lawsuit does not claim either person developed cancer.

People may also opt out of the class action and file their own lawsuits. People who suffer serious valsartan injuries may want to pursue their own lawsuits.

Class actions tend to cover only minor injuries. These are usually injuries that would not make an individual lawsuit worthwhile.

The valsartan class action seeks the full purchase price of the drugs. It also asks for any other payments the law might allow against the four companies named. It does not seek damages that would cover costs associated with cancer.

Valsartan Recall Expanded Quickly

In July 2018, the U.S. Food and Drug Administration announced that three companies voluntarily recalled generic valsartan. By early August, the number of companies announcing valsartan recalls grew to 10.

As of Aug. 20, 2018, 16 companies had announced recalls, according to a list by the FDA.

Most of those companies used the same China-based manufacturer to supply valsartan. Zhejiang Huahai Pharmaceuticals blamed changes to its manufacturing process for the contamination. Those changes took place in 2012.

One company used Hetero Labs Limited in India as its manufacturer.

The FDA continues to track valsartan production. It is testing samples from other valsartan manufacturers for NDMA beyond acceptable levels. The agency also continues to post updates about the recall.

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11 Cited Research Articles

  1. HarrisMartin Publishing. (2018, August 20). Class Action Targets Drug Makers Who Sold NDMA-Contaminated Valsartan Drugs. Retrieved from https://harrismartin.com/article/23760/class-action-targets-drug-makers-who-sold-ndma-contaminated-valsartan-drugs/
  2. U.S. Food and Drug Administration. (2018, August 20, 2018). Products Under the Valsartan Recall. Retrieved from https://www.fda.gov/downloads/Drugs/DrugSafety/UCM615703.pdf
  3. U.S. Dist. Court, Southern District of New York. (2018, August 18). Class Action Complaint and Demand for Jury Trial; Duffy v. Solco Healthcare U.S., LLC, et al. Retrieved from http://www.pacer.gov
  4. CTV News. (2018, July 23). Proposed Class-Action Lawsuit Filed After Blood Pressure Medication Recalled. Retrieved from https://www.ctvnews.ca/health/proposed-class-action-lawsuit-filed-after-blood-pressure-medication-recalled-1.4023577
  5. U.S. Food and Drug Administration. (2018, July 13). FDA Announces Voluntary Recall of Several Medicines Containing Valsartan Following Detection of an Impurity. Retrieved from https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm613532.htm
  6. U.S. Food and Drug Administration. (2018, August 9). FDA updates recalled valsartan-containing product information. Retrieved from https://www.fda.gov/Drugs/DrugSafety/ucm613916.htm?utm_campaign=FDA%20MedWatch%20Recall%20Notice%20-%20Valsartan-Containing%20Product%20by%3A%20Hetero%20Labs&utm_medium=email&utm_source=Eloqua
  7. U.S. Food and Drug Administration. (2018, August 2). FDA updates on valsartan recalls. Retrieved from https://www.fda.gov/Drugs/DrugSafety/ucm613916.htm
  8. U.S. Food and Drug Administration. (2018, July 17). FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity. Retrieved from https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM613532.htm?utm_campaign=07132018_PR_FDA%20announces%20recall%20of%20several%20valsartan%20medicines&utm_medium=email&utm_source=Eloqua
  9. U.S. Food and Drug Administration. (2018, July 18). FDA updates health care professionals and patients on recent valsartan recalls. Retrieved from https://www.fda.gov/drugs/drugsafety/ucm613916.htm
  10. Watts, G. (2019, August. 7). Two more Chinese pharma groups hit by drugs scandal. Retrieved from http://www.atimes.com/article/two-more-chinese-pharma-groups-hit-by-drugs-scandal/
  11. U.S. Environmental Protection Agency. (2000, January). N-Nitrosodimethylamine. Retrieved from https://www.epa.gov/sites/production/files/2016-09/documents/n-nitrosodimethylamine.pdf
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