Lawsuit Over Valsartan Recall Filed Against Mylan

The number of class action lawsuits filed over recent valsartan recalls continues to grow, as more and more consumers seek reimbursement and for manufacturers to provide future medical monitoring, after discovering they took pills for years that may have been tainted with cancer-causing chemicals. 

In a complaint (PDF) filed last week by Joseph Cacaccio in the U.S. District Court for the Eastern District of New York, Mylan Pharmaceuticals and Rite Aid Corporation join a number of other generic drug manufacturers and distributors now facing claims over recalled valsartan pills.

Cacaccio seeks class action status to pursue damages for himself and other consumers who took generic valsartan manufactured by Mylan for the treatment of hypertension, believing it was therapeutically equivalent to the name-brand drug Diovan. However, the drugs were allegedly contaminated with the chemical by-product N-Nitrosodiethylamine (NDEA), which is a known human carcinogen.

The lawsuit was brought just days after Mylan announced that it was recalling all of its valsartan products which had not yet expired, following the confirmation that trace amounts of NDEA were in the active pharmaceutical ingredients.

Although a number of other generic drug makers discovered problems that valsartan ingredients were contaminated in July 2018, Mylan first announced a recall on November 20, limiting the action to certain lots. However, last week, that action was expanded.

Cacaccio claims that Mylan knew or should have known that it’s generic valsartan pills were contaminated, but delayed recalling the drugs, causing consumers to continue to be exposed to carcinogens for several months longer than necessary.

“Mylan…failed to promptly recall its valsartan-containing medications for over four months after the initial recall was announced, and over three months after labs in India were implicated,” the lawsuits states. “The Mylan Defendants failed to do so despite knowing that their valsartan-containing medication were also likely contaminated. It took the Mylan Defendants another two weeks to recall all non-expired lots of the medication due to the presence of NDEA.”

The lawsuit notes that Mylan profited from this delay, as Cacaccio and other consumers switched to Mylan products following the initial valsartan recalls issued by other drug makers, believing their products to be safe.

The first valsartan problems surfaced on July 5, after European regulators announced that batches of the active ingredient supplied by Zhejiang Huahai Pharmaceuticals tested positive for NDMA.

The FDA followed with its own recall announcement on July 13, indicating that the agency had launched an investigation to determine the scope of the contamination and the potential risk to consumers, providing a list of generic valsartan pills believed to be safe at that time.

The recalls issued by a number of different generic drug makers have led to a valsartan shortage and a spike in prices for products that are not tainted, with the cost of 160 milligram and 80 milligram tablets of generic valsartan more than doubling in September 2018.

Cacaccio is one of a growing number of valsartan recall class action lawsuits have been filed nationwide, seeking damages for the cost of the recalled drugs and medical monitoring. For those diagnosed with liver cancer, kidney cancer, pancreatic cancer, stomach cancer and other cancers, individual cases are being reviewed by valsartan lawyers.