Contamination in Generic Drug Results in Class Action Lawsuit

Case Title: In re: Valsartan Products Liability Litigation, MDL No. 2875 (D.N.J.)

High blood pressure, or hypertension, is a common medical condition affecting approximately 103 million Americans. Valsartan is a generic drug version of the brand name drug Diovan, which was originally developed and sold by Novartis to treat hypertension. Valsartan is also combined with the drug hydrochlorothiazide to form the generic version of Exforge and Exforge HCT. Diovan was originally approved by the Food and Drug Administration (FDA) in 1998, and the first generic versions were approved in 2005. It is estimated that 1.5 million people took generic Valsartan in 2018.

Generic drugs are a large and growing segment of the pharmaceutical market. In 2015, it was estimated that generic drugs accounted for 88% of all prescription drug sales. Generic drugs are required to be bioequivalent to brand-name drugs. That means they may not be chemically identical, but they should act in the body in the same way as the brand name drug. This also indicates that the drug should not have harmful, potentially lethal side effects. Many generic manufacturers are large companies with their labs and manufacturing facilities overseas, frequently headquartered in China and India. These overseas manufacturers are difficult for the FDA to inspect in the same manner they inspect facilities in the United States. This has led to many challenges in the pharmaceutical drug chain in general.

In order to begin manufacturing, generic drug manufacturers must have an approved Abbreviated New Drug Application on file with the FDA. After this rigorous process, they may make changes by filing change requests that the company may classify as major or minor amendments. In approximately 2011, several generic producers of Valsartan changed their manufacturing process to be able to have a larger yield of the product at a lower price. They labeled this change as a minor amendment, even though the process change involved using a solvent that caused the drugs to be contaminated with NDMA, NDEA, and other contaminants. These substances, known as nitrosamines, are largely carcinogenic or cancer-causing. Other manufacturers instituted a process change that involved re-using solvent in their production of Valsartan, contaminating the drug. According to the FDA, these generic drugs were contaminated at levels that were hundreds of times higher than the limits they allow.

FDA Drug Recall

The generic drug manufacturers knew of the contamination as early as 2011, but it was not discovered by the FDA until 2018. At that time, the FDA instituted one of the largest drug recalls in the agency’s history. The recall was so widespread and far-reaching that doctors had to deal with shortages of generic drugs that were not contaminated and were appropriate for therapeutic use.

Positive Results for Our Clients

In 2019, dozens of lawsuits for personal injury and economic loss were consolidated in multi-district litigation in the federal district of New Jersey under the Honorable Judge Robert Kugler. The class-action plaintiffs are seeking compensation for economic damages and potential personal injury due to purchasing Valsartan that was, essentially, adulterated and contaminated.

John R. Davis was appointed to the Plaintiffs’ Executive Committee in the Valsartan Products Liability Litigation, MDL No. 2875 in the District of New Jersey. His leadership on this committee recognizes his contributions and experience in class action and economic loss litigation.

John R. Davis‘ practice is focused on complex litigation, with an emphasis on consumer fraud, healthcare fraud, antitrust, environmental, and insurance matters. He has spent the majority of his career either working for or litigating cases in the U.S. Federal Courts.