A New Jersey federal judge on Friday tossed out consumers' fraud claims against distributors of generic valsartan blood pressure drugs but waved through allegations against manufacturers themselves.
U.S. District Judge Robert Kugler allowed a variety of fraud allegations to proceed against a suite of valsartan drugmakers that consumers say knowingly sold their products tainted with the probable carcinogen N‐nitrosodimethylamine (NDMA).
The companies include China’s Zhejiang Huahai Pharmaceutical, Prinston Pharmaceutical, Hetero Drugs, Mylan and Aurobindo Pharma, as well as Teva, Arrow Pharm Malta, Actavis Pharma and more, according to the judge's opinion.
The consumers essentially are trying to hold the companies liable for a global recall of drugs containing valsartan, the active ingredient in Novartis' Diovan. They claim the companies' drugs were mislabeled because they didn't note the potential presence of NDMA.
The FDA in 2018 discovered NDMA and a similar agent, N-nitrosodiethylamine (NDEA), could be created in the process of manufacturing the -sartan drugs. Impurities were first discovered at the U.S. drug manufacturer Huahai, which had been using valsartan active ingredient from China’s Zhejiang Huahai Pharmaceutical, which is targeted in the lawsuit.
The findings triggered a global recall spree on hundreds of lots of the ubiquitous blood pressure drugs valsartan, irbesartan and losartan, while the FDA launched an intensive investigation into how the contamination may have occurred and the risks it could pose to U.S. consumers.
"The massive contamination of Valsartan and subsequent concealment and misrepresentation of that contamination is at the very heart of this case," Ruben Honik, an attorney for the consumers, told Law360 last week.
In the lawsuit, the plaintiffs claim the drugmakers would have found the NDMA contamination sooner if they had properly followed FDA guidelines, Kugler explained in his ruling. The consumers “reasonably suggest that the manufacturing defendants either knew of or recklessly disregarded the contamination,” the judge wrote.
Meanwhile, wholesalers Cardinal Health, McKesson and AmerisourceBergen and pharmacies including CVS Health, Walgreens Boots Alliance and Rite Aid are off the hook, Judge Kugler said. Wholesalers couldn’t have reasonably known that they were distributing tainted products, he said.