After their findings were reported, the FDA recommended that patients taking one of the affected Valsartan drugs continue taking the medication until their physician provided an alternative. While it has been confirmed that NDMA and NDEA are likely carcinogens, it has not yet been ascertained how exposure to the different levels of these two carcinogens in Valsartan drugs affected the patients that used it. As you might expect, this is a dangerous legal position for them to be in.

On August 16, 2018, a case was filed in New York against Valsartan manufacturers as well as pharmacies that dispensed these medications. The case, Duffy vs Prinston Pharmaceutical, Inc., et al was later transferred on October 11, 2018, to the United States District Court in New Jersey and given class-action status after a consolidation order was filed by the Judicial Panel on Multidistrict Litigation. The order covers 11 cases from throughout the United States.

The filing states that the plaintiffs are seeking damages from the defendants because a generic version of valsartan, that contained carcinogenic impurities, was developed and then distributed for six years before the impurities were detected. In addition, within the filing, a report is cited from the European Union (EU) which declared that the Zhejiang Huahai drug factory in China which produced the recalled Valsartan did not follow accepted EU code of conduct practices for drug manufacturing.

The plaintiffs listed in this filing each claim they were prescribed valsartan for an extended period of time and each time they refilled the prescription, received information about the medication, including “representations and warranties that the medication was properly manufactured and free from contaminants and defects.”

It is still unknown how many manufacturers have produced contaminated valsartan. Meanwhile, more and more patients are coming forward who claim to have been affected by the carcinogenic impurities in these medications.

Paul Geske of McGuire Law in Chicago, who represented Robert Kruk, lawyer for the plaintiffs, in the JPML filing stated in an interview that, “This litigation will be massive. Our sense is that there are about a million and a half people who take Valsartan-containing drugs every year.”

He went on to say “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.”

Prinston Pharmaceuticals fought back in a statement they released in December 2018. They claimed that several media outlets have significantly misinterpreted and mischaracterized the FDA’s warning letter “disregarding all of the positive, proactive steps which the company has implemented and will continue to implement.” 

The statement went on to say, “Prinston Pharmaceutical, Solco Healthcare, Zhejiang Huahai, and their affiliated companies assure the public, drug prescribers and patients that they are taking every step to ensure that their products remain safe, therapeutically effective, and meets the highest standards.”