Losartan Class Action Lawsuit Seeks Compensation for Buyers of Recalled Drugs

The makers of numerous batches of recalled generic losartan face a class action lawsuit, which says that contaminated versions of the hypertension drug sold in recent years were worthless, due to the presence of cancer-causing impurities.

The complaint (PDF) was filed in the U.S. District Court for the District of New Jersey on May 21, by a number of plaintiffs who seek class action status against generic losartan manufacturers to obtain reimbursements for individuals who bought the recalled drugs, as well as medical monitoring for those who now face a potential risk of developing cancer in the future.

The losartan class action lawsuit names Camber Pharmaceuticals, Hetero USA Inc., and Legacy Pharmaceutical Packaging, LLC, as defendants.

In July 2018, the FDA began an ongoing series of recalls for losartan, valsartan and similar hypertension drugs, which were sold for years laced with traces of N-nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA) or N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). The agency has determined that the chemicals are likely a byproduct of the generic drug manufacturing process, and are all known human carcinogens. The impurities have been linked to reports of liver cancer, kidney cancer, gastric cancer and other digestive tract cancers among individuals who received the tainted valsartan.

The recalled losartan and valsartan ingredients were manufactured primarily by Zhejiang Huahai Pharmaceutical Co. in China and Hetero Labs in India, impacting most of the U.S. supply for the blood pressure drugs.

This lawsuit specifically focuses on the recalled generic losartan tablets. In February, Camber announced a recall of 87 lots of Losartan Tablets, all manufactured by Hetero Labs in India due to the presence of NMBA. This was followed by a recall by Legacy in March, affecting 40 lots of Losartan Tablets also tainted with NMBA.

The complaint notes that the presence of the impurity means that they are not equivalent to the original brand-name drugs they are modeled after, which never had this problem.

“Generic drugs reach the market when the brand-name version of the drug comes off patent, and other competitors are able to seek approval for, market, and sell bioequivalent versions of the brand-name drug. These generic equivalents are supposed to be of equal quality and equal safety,” the lawsuit notes. “Here, the losartan-containing drugs manufactured, distributed, and sold by Camber, Hetero and Legacy are supposed to be equivalent to the brand-name drugs. However, they are not because they suffer from a manufacturing defect which caused their generic losartan to become contaminated with NMBA.”

The losartan lawsuit indicates this makes the drugs unsafe, and effectively worthless, since they were not fit for human consumption. However, plaintiffs and all class members paid for the drugs and consumed them believing they were safe.

The complaint seeks reimbursement for those purchases, and also seeks to have the defendants pay for medical monitoring of anyone who used the recalled drugs, to ensure that any cases of cancer are detected as early as possible for the best potential treatment.

The case joins a growing number of losartan and valsartan class action lawsuits all seeking similar reimbursements and medical monitoring funding.

In addition, there are also a number of individual losartan and valsartan recall lawsuits filed in recent months by individuals who indicate they were left with liver cancer, kidney cancer, bladder cancer, gastric cancer and other injuries following exposure to the impurities.