When the patents for drugs expires, competitor companies may create biosimilars or generics. Biosimilars and generics are supposed to be the equal of brand-name drugs. The FDA says, “All generic drugs approved by FDA have the same high quality, strength, purity, and stability as brand-name drugs.” However, the complaint for this class action alleges that Torrent Pharma, Inc. sold contaminated generics to consumers. The medication at issue is losartan and combinations containing losartan.
The Nationwide Class for this action is all persons in the US who bought losartan-containing medications, not for resale, contaminated with NDEA or NMBA. North Carolina, Mississippi, Florida, and New York Subclasses have also been proposed.
The complaint says that losartan is used to treat “high blood pressure, diabetic kidney disease, congestive heart failure, and left ventricular enlargement, among other issues.”
Torrent gets the active pharmaceutical ingredient (API) for its losartan from a laboratory in India. However, in late 2018 and early 2019, certain lots of this API were found to be contaminated with N-Nitrosodiethylamine (NDEA) and N-Methylnitrosobutyric acid (NMBA), substances that can cause liver damage or cancer.
The Food and Drug Administration (FDA) says that NDEA is found in “air pollution, and industrial processes, and has been classified as a probable human carcinogen as per [I]nternational Agency for Research on Cancer (IARC) classification.” The World Health Organization also classifies it as a Group 2A carcinogen (or probable human carcinogen). The complaint says, “NDEA is acutely toxic when consumed orally.”
NMBA is also a nitrosamine contaminant, like NDEA. It is a possible human carcinogen.
On December 20, 2018, Torrent voluntarily recalled two lots of losartan potassium tablets because of trace amounts of NDEA found in the drug’s API. On January 22, 2019, the company expanded its recall to a larger number of lots. Four months after the original recall, on April 18, 2019, Torrent again expanded the recall, to include over a million more bottles of losartan-containing drugs because of the presence of NMBA.
The complaint asks for damages on behalf of consumers who have been exposed to a “potential health hazard or safety risk” in taking the drug. It makes claims for breach of express warranty, breach of implied warranty of merchantability, unjust enrichment, fraud, fraudulent concealment, and conversion. It also claims violations of North Carolina’s Unfair or Deceptive Trade Practices Act, Florida’s Deceptive and Unfair Trade Practices Act, and New York’s General Business Law.