Court Appoints Special Masters For Valsartan Settlement

Court Appoints Special Masters For Valsartan Settlement

Introduction

Last week, U.S. District Judge Robert B. Kugler, overseeing the valsartan multidistrict litigation docket (MDL), along with rejecting defendants' preemption motion, announced the appointment of Special Masters to work with the parties to resolve lawsuits brought against the recalled versions of the hypertension drug

Valsartan belongs to a class of drugs called Angiotensin II Receptor Antagonist and is used to treat high blood pressure (Hypertension), and Congestive heart failure.

Diovan (Valsartan) was manufactured by Novartis International AG and was approved by the FDA on August 14, 2002. Diovan lost its patent in September 2014. The launch of the generic drug had been on hold since patent expiry due to regulatory problems with the FDA. In 2014, a US-based Ohm Laboratories (Ohm), a subsidiary of Ranbaxy Laboratories, was the first to get the approval from FDA for generic Valsartan. Thereafter, many generic versions of Valsartan came into the market via many other pharma companies.

The usage of Diovan had no evidence of any adversity in its entire span, but the FDA did find that the generic versions of Valsartan were causing issues. The most serious issue reported was that it had the presence of an impurity called N-Nitrosodimethylamine (NDMA), which was believed to be formed as a byproduct through a chemical reaction. Not only was this an impurity, but a concern was also raised when it was detected that NDMA is carcinogenic and can lead to cancer in people consuming this drug for the long term.

The letter dated December 18 stated that the court appointed Hon. Gregory M. Sleet (retired) and Hon. Lawrence F. Stengel (retired) as Special Masters for Settlement in the litigation. The counsels involved in the litigation have seven days to raise any objections pursuant to the Code of Judicial Conduct.

Judge Sleet served as Chief Judge of the United States District Court for the District of Delaware and is currently with JAMS, formerly known as Judicial Arbitration and Mediation Services, Inc., in Philadelphia. Judge Stengel served as Chief Judge of the United States District Court for the Eastern District of Pennsylvania and is currently with Saxton & Stump in Lancaster, PA.

Valsartan is used to treat high blood pressure (hypertension) and Congestive heart failure (CHF). In July 2018, the U.S. Food and Drug Administration (FDA) issued a press release indicating that some generic valsartan might contain an impurity known as N-nitrosodimethylamine (NDMA), which is a probable human carcinogen, and announced a massive recall. Several former users of the drug who were diagnosed with cancer filed lawsuits against manufacturers, wholesalers, and pharmacies claiming the pill for their cancer.

Currently, at least 650 cases are pending in the litigation docket, each raising similar allegations that long-term exposure to recalled valsartan drug results in stomach cancer, liver cancer, esophageal cancer, prostate cancer, pancreatic cancer, and other injuries. The lawsuits are consolidated under MDL No. 2875 in the United States District Court, District of New Jersey, presided by Judge Robert B. Kugler, U.S.D.J and Hon. Joel Schneider, U.S.M.J.