Out-Of-State Claims Dismissed In Valsartan MDL

Out-Of-State Claims Dismissed In Valsartan MDL

Introduction

On Tuesday, Judge Robert B. Kugler of the U.S. District Court for the District of New Jersey, presiding over the blood pressure drug valsartan lawsuits, said that consumers in the multidistrict litigation (MDL) cannot bring claims under laws of states in which they don't reside in.

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.

According to the order dated January 12, Judge Kugler dismissed several claims in the master complaints stating that the named plaintiffs filed claims under the laws of all 50 states, whereas they represent only 21 states.

The plaintiffs are given a deadline of January 27 to amend their complaints as they brought the claims in states where they neither reside nor were injured, as per the order.

The plaintiffs raised arguments stating that only class representatives need to have standing, and they can file out-of-state claims. Judge Kugler rejected the arguments asserting that the Supreme Court's standing cases have made two principles of law, according to which a plaintiff must demonstrate standing for each claim he seeks to press, and class actions do not change the requirements of standing.

Last month, Judge Kugler rejected the defendants' preemption motion and announced the appointment of Hon. Gregory M. Sleet (retired) and Hon. Lawrence F. Stengel (retired) to work with the parties to resolve lawsuits brought against the recalled versions of the hypertension drug.

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.