In July 2018, the FDA announced that approximately 1 million Americans have been exposed toa class of generic blood-pressure drugs containing probable human carcinogens. It recalled certain generic forms of the hypertension medications valsartan, irbesartan and losartan that were manufactured in raw-materials facilities in China and India because they contain a class of chemicals called nitrosamines. Most nitrosamines are carcinogenic. The brand-name versions of the medicines, called Diovan, Avapro and Cozaar, are not affected, nor are all generic forms of the medications. Companies whose lots of the drugs have been recalled include Solco Healthcare LLC, Torrent Pharmaceuticals Ltd., Aurobindo Pharma USA, and Teva Pharmaceutical Industries, Ltd. Patients take this class of drugs, known as angiotensin II receptor blockers, or ARBS, for blood pressure and heart failure.
The nitrosamines in question go by the chemical names NDEA and NDMA. They were the result of a manufacturing process used by a raw-material drug supplier in China called Zhejiang Huahai Pharmaceutical Co. The nitrosamines went undetected by global regulators for a time because neither regulators nor industry fully understood how NDMA or NDEA could form during this particular manufacturing process. At least one Zhejiang Huahai facility has been placed on import alert to stop all of its material and finished drugs from legally entering the U.S. Similar impurities have subsequently been found in blood-pressure drugs originating in India. Of the 2 million people worldwide that the FDA estimates have been exposed to the nitrosamines, over half are Americans.
Like with most drug recalls by the FDA, new personal injury lawsuits have followed but may prove difficult to win. The FDA assessed the risk of the exposure to individual patients as being small. FDA scientists estimate there may be only one additional case of cancer among 8,000 people, if those people took the highest daily dose of valsartan constantly for four years. Because many people take different generic drugs and differing dosages, and because not all lots of valsartan, irbesartan and losartan are affected, the risk is less. Furthermore, the chemical impurities occur in trace amounts in water and in some foods.
Since the FDA’s recall, several lawsuits alleging cancer development due to valsartan impurities have been filed across the United States, along with numerous class action claims. On October 22, 2018, a motion was filed to consolidate all federal valsartan impurity lawsuits into the District of New Jersey in front of Judge Freda L. Wolfson. The Judicial Panel on Multidistrict Litigation (JPML) heard arguments to consolidate all claims on January 31, 2018, in Miami, Florida. On February 14, 2019, the JPML decided to consolidate all valsartan cases in the District of New Jersey in front of Judge Robert B. Kugler. The valsartan litigation is now known as MDL 2875 – In Re: Valsartan N-Nitrosodimethylamine (NDMA) Contamination Products Liability Litigation.