Valsartan & Angiotensin II Receptor Blockers (ARBs) Lawsuits

Individuals began filing lawsuits in 2018 after the FDA recalled more than 1150 lots of ARB medications (mainly Valsartan) from more than 25 manufacturers. Since July, 2018 the FDA has issued more than 45 statements and updates concerning the presence of probable cancer-causing contaminants, nitrosamines, in angiotensin II receptor blockers (ARBs). These contaminants include N- Nitrosodimethylamine (NDMA), N-nitrosodiethylamine (NDEA), and N-Methylnitrosobutyric (NMBA).

In February of 2019, 10 consumer class action lawsuits were combined into a New Jersey mass litigation lawsuit in federal court. After the initial motion, the judicial panel was made aware of 30 more cases, including 17 individual personal injury cases. At the time of the mass litigation, the panel stated that it “intended to include personal injury potential tag-along actions in this MDL through the conditional transfer order process”. As of July, 2019, 88 cases are pending in the New Jersey Mass Litigation. (2)

Supplier, Manufacturing, and Distributing Defendants

  • Zhejiang Huahai Pharmaceutical Co. Ltd. (ZHP) and its U.S. affiliates Prinston Pharmaceutical Inc.
  • Solco Healthcare U.S., LLC
  • Huahai U.S., Inc
  • Walgreens Co.
  • Throggs Neck Pharmacy
  • Mylan Laboratories Ltd., Mylan Pharmaceuticals Inc., Mylan N.V., and Mylan Inc
  • Teva Pharmaceuticals USA, Inc., and Teva Pharmaceutical Industries Ltd.
  • Hetero USA Inc.
  • Connecticut CVS Pharmacy LLC
  • Torrent Pharma, Inc.
  • Camber Pharmaceuticals, Inc.
  • The Harvard DrugGroup d/b/a Major Pharmaceuticals
  • Wal-Mart Stores, Inc.
  • The Kroger Co.
  • Quality Food Centers, Inc.

First Lawsuits

  • August, 2018- John & Elizabeth Duff- New York
  • August, 2018- Eric J Erwin- New Jersey
  • September, 2018- James Jones- Missouri
  • September, 2018- Dominic Stimma, Margoth Strand, & Jynona Gail Lee- New Jersey

Health Studies

According to the CDC tox profile for N-Methylnitrosobutyric (NMBA), poisoning in humans can cause liver damage and death. The CDC also found that “when rats, mice, hamsters, and other animals ate food, drank water, or breathed air containing lower levels of NDMA for periods more than several weeks, liver cancer and lung cancer as well non-cancerous liver damage occurred”. (3)

According to a Danish nationwide cohort study reported in the British Medical Journal (BMJ), increased risk for colorectal and ovarian cancers was seen in users of valsartan that was contaminated with N-Nitrosodimethylamine (NDMA). However, the study also concluded that “the results do not imply a markedly increased short term overall cancer risk”. Additionally, the study reported that “longer follow-up studies are needed to assess long term cancer risk”. (6)

After a preliminary evaluation in 2018, the European Medical Agency (EMA) estimated “that there could be one extra case of cancer for every 5,000 patients taking the affected medicines at the highest valsartan dose (320 mg) every day for 7 years. This was based on average levels of this impurity detected in the active substance from Zhejiang Huahai Pharmaceuticals (60 parts per million)”. (4)

In May of 2019, the FDA published the following estimated risks of the contaminated valsartan products:

The FDA NDMA ESTIMATED RISK:

FDA estimated that if 8,000 people took the highest valsartan dose (320 mg) containing NDMA from the recalled batches daily for four years, there may be one additional case of cancer over the lifetimes of the 8,000 people. (7)

NDEA ESTIMATED RISK:

FDA scientists estimate that if 18,000 people took valsartan at the highest dose (320 mg) containing NDEA from recalled batches daily for four years, there may be one additional case of cancer over the lifetime of these 18,000 people. NDEA has a marginally lower cancer risk estimate than NDMA because NDEA levels were lower than levels of NDMA in drug samples. (7)

Legal References

1. https://www.jpml.uscourts.gov/sites/jpml/files/MDL-2875-Initial_Transfer-01-19.pdf

2. https://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_Actions_Pending-July-16-2019.pdf

3. https://www.atsdr.cdc.gov/toxprofiles/tp141-c1.pdf

4. https://www.ema.europa.eu/en/news/update-review-recalled-valsartan-medicines-preliminary-assessment-possible-risk-patients

5. https://www.ema.europa.eu/en/documents/press-release/update-review-valsartan-medicines-following-detection-impurity-active-substance_en.pdf

6. https://www.bmj.com/content/362/bmj.k3851

7. https://www.fda.gov/drugs/drug-safety-and-availability/laboratory-analysis-valsartan-products

8. https://jc6kx1c9izw3wansr3nmip8k-wpengine.netdna-ssl.com/wp-content/uploads/2018-8-16-valsartan-class-action.pdf

9. https://jc6kx1c9izw3wansr3nmip8k-wpengine.netdna-ssl.com/wp-content/uploads/2018-08-31-Complaint.pdf

10. https://jnswire.s3.amazonaws.com/jns-media/07/76/897777/zhejiang.pdf

11. https://jc6kx1c9izw3wansr3nmip8k-wpengine.netdna-ssl.com/wp-content/uploads/2018-9-26-valsartan-class-action.pdf