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Litigation Spotlight: Article #9

Mass Tort of the Month: Valsartan Litigation

Valsartan

In recent months, media exposure surrounding Zantac litigation has spurred wide-reaching familiarity with the chemical compounds N-nitrosodimethylamine (“NDMA”) and N-Nitrosodiethylamine (“NDEA”), among attorneys and plaintiffs. However, Zantac is not the only drug on the American market discovered to be contaminated by NDMA and NDEA.

Similar to Zantac, several batches of the popular blood pressure drug valsartan and many of its generic forms have been shown to contain NDMA and NDEA. Unlike Zantac contamination—due to an inherent defect in the molecular structure of the chemical—valsartan contamination has been linked to a manufacturing defect.

FDA Warnings and Recalls:

Valsartan, losartan, candesartan and irbesartan belong to a class of drugs called antigen II receptor blockers (“ARB”), used to treat high blood pressure and heart failure. Valsartan was initially approved by the FDA in 1996 under the brand name, Diovan. After 2012, when manufacturer Novartis’ patent expired, the drug became widely available due to distribution by more than 30 different companies in a generic form. Since its introduction to the American market, valsartan and its related generics have become increasingly popular with consumers with around three million Americans prescribed the medications each year.

The FDA first disclosed suspicions surrounding the integrity of valsartan drugs in 2016, when it conducted an inspection of Hetero Labs, one of the main manufacturers of the valsartan active pharmaceutical ingredient (“API”). Prior to the December 2016 inspection, the FDA observed (through closed-circuit television) Hetero Quality Assurance technicians destroying and altering records pertaining to commercial batch manufacturing immediately before the FDA’s scheduled onsite regulatory inspection. The FDA also found that equipment at the facility was not cleaned and maintained at appropriate intervals to “prevent contamination that would alter the safety, identity, safety, quality and purity” of the drugs.

Hetero Labs was warned about its quality standards for a second time in 2018. Plaintiffs allege that had the quality control standards been properly managed by the defendants, NDMA contamination in the valsartan products would have been discovered earlier. In addition, plaintiffs allege that evidence of the lab technicians destroying documents is sufficient proof that manufacturers were aware of the NDMA exposure to the valsartan medication.

In July 2018, the FDA announced the voluntary recall of several drugs containing valsartan due to the presence of NDMA. The initial recall involved more than half of the U.S. supply of the valsartan API and at the time, the FDA estimated that batches contaminated with NDMA first entered the U.S. as early as 2014. However, plaintiffs would later allege that defendants were aware of the NDMA contamination as early as 2012. In August 2018, FDA Commissioner Scott Gottlieb, MD issued a statement detailing the FDA’s ongoing investigation into valsartan NDMA contamination. In the statement, Gottlieb described how in June 2018 a manufacturer of valsartan products, Prinston Pharmaceutical Inc. (“Prinston”), contacted the FDA’s Center for Drug Evaluation and Research (CDER) about its products containing valsartan API manufactured by Zhejiang Huahai Pharmaceutical Co., Ltd. (“ZHP”), a manufacturing plant in China. Prinston informed CDER that the production of valsartan products was halted because ZHP had detected an impurity (NDMA) in the API. In September 2018, the FDA issued an updated recall list and placed ZHP on an import alert. The FDA continued to alter its recall list for the next year and in November 2019, Mylan Pharmaceuticals was issued a warning letter indicating that its facility in India was not conforming to the Current Good Manufacturing Practices (“CGMPs”) as outlined by the FDA.

Plaintiff Allegations

Claims in the valsartan litigation arose from contamination of various batches of valsartan, losartan and irbesartan during the manufacturing process with N-nitrosodimethylamine (“NDMA”) and N-Nitrosodiethylamine (“NDEA”). Cases in the valsartan multidistrict litigation all arise from common factual questions emanating from allegations that plaintiffs purchased or used generic formulations of valsartan medications containing NDMA and/or NDEA, that these impurities present a risk of cancer and liver damage and that defendants knew, or should have known, of the impurities as early as 2012.

Specifically, plaintiffs are arguing that for several years, the defendant pharmaceutical companies willfully ignored warning signs regarding the operating standards at the ZHP manufacturing plant in China and Hetero Drug’s laboratories in India and continued to manufacture valsartan products for sale to consumers in the U.S. knowing that the products were likely contaminated by NDMA and other impurities. ZHP and Hetero Labs are the main defendants in the litigation as they supply several manufacturers, distributors and re-packagers of valsartan products. Plaintiffs further claim that the contaminated drugs were introduced to the American market as early as 2012 and presented risks of developing various cancers, particularly gastrointestinal and colorectal cancer.

It is important to note that not all batches of valsartan were contaminated. Notably, Diovan (the original name-brand valsartan medication) was not affected. Shortly after the July 2018 FDA voluntary recall was announced, Novartis issued a statement alleging that the recall did not impact any Novartis or Sandoz valsartan products in the U.S. However, a separate Sandoz recall was issued outside the U.S.

Plaintiffs also asserted that each defendant affirmatively misrepresented and warranted to consumers through their websites, brochures and other marketing or informational materials that their respective valsartan products complied with the FDA’s outlined CGMPs and did not contain (or were not likely to contain) any ingredients besides those identified on the products’ FDA approved labels.

Procedural History:

  • October 2018: the first class action was filed against Solco Healthcare U.S., LLC and Prinston Pharmaceutical Inc. in New Jersey federal court.
  • November 2018: another class action suit was filed in federal court in the District of Massachusetts against Camber Pharmaceuticals, Inc. and Hetero Drugs Ltd.
  • February 14, 2019: the JPML issued a transfer order consolidating five actions into a MDL in the United States District Court for the District of New Jersey under Judge Robert B. Kugler.
  • March 2019: the first case management conference was held designating and approving the parties’ leadership structure and identifying the core discovery to be produced by the defendants.
  • June 2019: three master complaints were filed. The first complaint addressed the claims of individual plaintiffs who alleged they contracted various forms of cancer from consuming defendants’ contaminated valsartan. The second complaint was filed on behalf of all individuals who consumed contaminated generic valsartan-containing drugs since at least January 1, 2012. The third complaint is a nationwide economic class action filed on behalf of all individuals and entities who, since January 1, 2012 to the present, paid any amount of money for a drug containing valsartan.
  • September 2019: U.S. Magistrate Judge Joel Schneider rejected what he called “a hypothetical parade of horribles” and denied the defendants’ request for discovery directed at plaintiffs’ litigation funding.
  • July 17, 2020: Walgreens and other similar pharmacy defendants filed a memo requesting to be removed from the MDL stating that the plaintiffs’ claims run afoul of innocent seller statutes enacted in numerous states, purporting that these statutes explicitly recognize the pharmacies’ unique role in the provision of health care and immunize them from liability in cases like this.

The case is: In re: Valsartan Products Liability Litigation, Case No.: 1:19-md-02875, in the U.S. District Court for the District of New Jersey.

This case is ongoing.

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