Lawyers are nearing a settlement agreement for those who sued Hetero, a manufacturer of valsartan, a generic blood pressure medication tainted with carcinogens.
U.S. District Court Judge Renée M. Bumb, overseeing the valsartan litigation in New Jersey, ordered both sides involved in the lawsuit to finalize details of a settlement in all three plaintiff groups — personal injury, economic loss and medical monitoring — by June 30.
There was some confusion in the legal community after the court posted a settlement order, which made it unclear if the agreement was for all cases in the MDL or just those involving Hetero.
What “the valsartan settlement order doesn’t make clear to an outsider is that the entire valsartan settlement order only applies to a single defendant — Hetero. It is important to understand that Hetero primarily manufactured losartan, which was also recalled for being contaminated with carcinogens,” according to a statement from the lead counsel for the valsartan MDL, Nigh Goldenberg Raso & Vaughn.
“Simply put, the majority of the valsartan litigation is not settling and our valsartan attorneys continue to push forward to the first valsartan trial.”
Hetero Cases Are Less Than 5% of Valsartan Lawsuits
The ongoing valsartan lawsuits target a wide range of players in the drug supply chain, with over a dozen drug manufacturers and distributors named as defendants.
Hetero, an India-based pharmaceutical manufacturing company, is among the many defendants.
“We have announced the Hetero valsartan class action settlements and the Hetero valsartan personal injury settlements, and we are working on getting court approval for the Hetero class action settlements and finalizing the Hetero personal injury settlements,” Daniel Nigh of Nigh Goldenberg Raso & Vaughn, national co-lead counsel for the valsartan MDL lawsuit, told Drugwatch.
“Valsartan cases with the Hetero defendants only make up a small percentage of the overall number of valsartan cases (less than 5%). We are continuing to litigate against the other defendants.”
Bumb also ordered the parties to meet with retired U.S. Magistrate Judge Joel Schneider within 90 days to continue settlement negotiations to “resolve the losartan impasse.” Judge Schneider was integral to the current valsartan settlement negotiations, according to an order dated May 31.
What Is Valsartan?
Valsartan is a medication commonly prescribed to control blood pressure and heart health. It works by relaxing blood vessels in order to improve blood flow and reduce pressure. It was manufactured, safely, by Novartis Pharmaceuticals Corp. under the brand name Diovan.
After the drug went off patent, a number of generic drug manufacturers in China and India began selling valsartan. The U.S. Food & Drug Administration investigated the claims that the drugs made abroad contained toxic carcinogens called NDMA (N-nitrosodimethylamine) and NDEA (N-nitrosodimethylamine). A change in the manufacturing process resulted in the impurities.
In 2018, generic brands of the prescription medicine were recalled worldwide after studies found that the medicine had unacceptable amounts of toxins that could cause cancer. It raised concerns for millions of patients who had unknowingly taken the tainted drugs. Approximately three million Americans take the heart medicine each year.
There are more than 1,200 active lawsuits in the valsartan MDL and no trials have started. A trial that was slated for March was postponed.
“We are hopeful to also have our trial date reset,” Nigh said.