Lawsuits from around the country over alleged contamination in blood pressure and heart disease drug Valsartan are being transferred to a federal judge in Camden following a consolidation order by the Judicial Panel on Multidistrict Litigation.
The suits were granted mass tort status after an investigation by the Food and Drug Administration found that Valsartan contained trace amounts of N-nitrosodimethylamine, also known as NDMA, a probable human carcinogen. The tainted drugs in question were made in a facility in China and sold as generics in the U.S.
The JPML granted a motion by plaintiffs lawyers on Feb. 14 to transfer Valsartan litigation to the District of New Jersey. Two Valsartan cases from other districts were transferred to New Jersey on Tuesday and three on Wednesday, where they will join five other cases that were previously filed in the state. The JPML order covered 11 cases from California, Illinois, Missouri, New York, Tennessee and New Jersey.
The principal defendants are Zhejiang Huahai Pharmaceutical Co. Ltd. and its U.S. affiliates: Prinston Pharmaceutical Inc., Solco Healthcare U.S. LLC, and Huahai U.S. Inc. Prinston, Solco and Huahai have offices at the same location in Cranbury.
The FDA announced a voluntary recall of several brands of generic drugs containing Valsartan in July based on the discovery of NDMA. While not currently in commercial use in the United States, NDMA was formerly used in the production of liquid rocket fuel, according to a petition for consolidation that was filed with the JPML by lawyers for plaintiff Robert Kruk. The petition said that reports from the Environmental Protection Agency indicate that exposure to NDMA in rats and mice caused tumors in the liver, respiratory tract, kidneys and blood vessels.
Kruk’s petition also cites a report by European Union regulators that the Zhejiang Huahai drug factory in China that produced the recalled Valsartan did not follow an EU code of accepted practices for drug manufacturing.
The Kruk petition asked for the cases to be consolidated before U.S. District Judge Freda Wolfson in the District of New Jersey, but the JPML order sent them to U.S. District Judge Robert Kugler. The JPML order did not mention the request for Wolfson but said Kugler is “an experienced transferee judge with the willingness and ability to manage this litigation.”
The case went to Kugler because he currently is handling one other MDL, while Wolfson has several, said Paul Geske of McGuire Law in Chicago, who represents Kruk.
The JPML order encompasses plaintiffs who are bringing economic claims over the sale of allegedly tainted drugs, people who claim they have been diagnosed with cancer caused by the tainted Valsartan, and suits by third-party payers who paid for the drug.
“This litigation will be massive. It has the potential to be a very, very large MDL,” Geske said. “Our sense is that there are about a million and a half people who take Valsartan-containing drugs every year,” he said.
The scope of the contamination is “unclear at this point,” Geske said. “The FDA investigation that led to a number of suits being filed is still ongoing. I think this has the potential to be one of the largest recalls and one of the largest MDLs in recent memory. At the proceeding before the panel, there were a number of firms there who claimed to represent thousands of plaintiffs who have not yet filed cases.”
The suits bring claims under breach of warranty theories, common-law fraud and state consumer protection laws. Some of the cases bring claims under product liability laws.
The Kruk petition said the 11 cases that were covered by the transfer “represent only a small sample of the cases that will eventually be filed,” and added that government investigations into the scope of the contamination are in their infancy. “It is reasonable to expect that more cases will be filed as the public becomes increasingly aware that a generic drug meant to treat heart disease—the leading cause of death for Americans—has been contaminated with a carcinogen, possibly for years,” the Kruk petition said.
The defendants did not respond to a phone message left by a reporter at their Cranbury office. In December 2018, they issued a statement saying they were “taking every step to ensure that their products remain safe, therapeutically effective, and meet the highest standards. They and their dedicated employees are also cooperating fully with the FDA and regulatory agencies in other countries to address matters relating to the Valsartan recall.”
Seth Goldberg of Duane Morris in Philadelphia, who represented Zhejiang Huahai, Prinston, Solco and Huahai U.S. at the JPML, did not return a call seeking a comment.