As the FDA and other drug agencies work to limit damage from a massive recall of blood pressure drugs, litigation stemming from the mess is just getting started.
Lawsuits have started to pile up alleging that tainted versions of valsartan harmed patients. But one lawyer involved says he expects thousands of personal injury lawsuits over the impurities—which turned up in versions of valsartan and its rival meds irbesartan and losartan—in the next two years.
At a status conference last month, attorney Daniel Nigh told judges he expects some 2,000 lawsuits claiming injuries from the adulterated drugs, all within the next two years, Bloomberg reports. So far, since the FDA initiated the first valsartan recall last year, plaintiffs have filed dozens of suits, the news service reports.
The sartan drug fiasco began last year when a U.S. drug manufacturer told the FDA it had discovered the impurity N-nitrosodimethylamine (NDMA) in a valsartan active pharmaceutical ingredient made by China’s Zhejiang Huahai Pharmaceutical. After investigating, the agency found NDMA and a similar chemical, NDEA, had contaminated certain valsartan APIs for years. The agency said the two contaminants, both considered probable carcinogens, can form through a specific and commonly used manufacturing process.
The findings set off recalls around the world for blood pressure meds valsartan, irbesartan and losartan. The FDA kicked off a probe into the cause of the regulatory slip-up and its associated dangers to consumers.
In January, the FDA said "overall, the risk to individual patients remains very small," but acknowledged it was still concerned about the episode.
So far, plaintiffs have sued 40 companies, alleging they were harmed by the tainted drugs, Bloomberg reports. Defendants include Zhejiang, generics giants Teva and Mylan and numerous India-based generic drug makers.
In a letter to the judge overseeing the litigation, defense attorneys wrote that NDMA and NDEA are “organic chemicals that are the by-product of several biological and industrial processes.” They appear in air, water, soil, beer, cheese and other substances, the attorneys say, and don’t harm patients if they appear in drugs at trace levels.
The defendants contend there’s “no evidence that the trace amount” of NDMA and NDEA found in drugs can cause cancer.
