Valsartan Lawsuit Centralization on JPML’s January Agenda

Published on December 17, 2018 by Laurie Villanueva

The U.S. Judicial Panel on Multidistrict Litigation (JPML) will convene its next Hearing Session on January 31, 2019, in Miami Florida.

At that time, the Panel will hear Oral Arguments on a proposal to centralize all federally-filed lawsuits stemming from the recent valsartan recall in a single U.S. District Court for coordinated pre-trial proceedings.

Valsartan Contaminated with Cancer-Causing Chemical

Valsartan is the generic name for a blood pressure and heart medication called Diovan.  The U.S. Food & Drug Administration (FDA) approved Diovan in 1996, while the first generic versions were cleared for sale in 2012.

In June, Zhejiang Huahai Pharmaceutical Co. of China informed regulators around the world that it had detected an impurity – N-Nitrosodimethylamine (NDMA) – in its valsartan API (active pharmaceutical ingredient).

The U.S. Environmental Protection Agency has classified NDMA as a probable human carcinogen, as animal studies suggest exposure may cause tumors involving the liver, respiratory tract, kidney and blood vessels.  At high levels, exposure can cause liver damage in humans.

So far, tests have only detected low levels of NDMA in recalled valsartan. As such, the FDA’s scientists estimate that if 8,000 people took the highest valsartan dose (320 mg) from the recalled batches daily for the full four years, there might be one additional case of cancer over the lifetimes of those 8,000 people.

It’s likely that the NDMA contamination occurred when Zhejiang Huahai Pharmaceutical modified its production methods in 2014. Thus, tainted valsartan may have been in circulation for the past four years.

Valsartan Recall and Other FDA Actions

Since June, multiple generic drug makers in the United States and 21 other countries have announced valsartan recalls.

Patients with recalled valsartan in their possession should continue using the medication until they obtain a replacement. According to the FDA, ceasing treatment entirely could lead to serious adverse health consequences.

Moreover, the recall does not include all generic valsartan products. Patients should contact their pharmacy to determine if their medication has been recalled or refer to the FDA’s website.

What Centralization Means for Valsartan Lawsuits

According to a Hearing Session Order issued by the JPML on December 13th, there are currently 11 valsartan lawsuits pending in federal courts around the country.  The docket include class action consumer complaints, as well as individual personal injury lawsuit.

Plaintiffs proposed consolidating  federally-filed valsartan lawsuits in October, asserting that the litigation would eventually come to include hundreds of similar claims. Among other things, their motion contends centralized pretrial proceedings will promote judicial efficiency and preserve the resources of the courts, parties, and witnesses involved in the valsartan litigation.

If the JPML consolidates the federal valsartan litigation, the 11 pending claims would be transferred to a single U.S. District court for coordinated discovery and motions practice. Any valsartan lawsuits filed in the future would also be eligible for transfer.

In most multidistrict litigations, a small group of representative cases are selected for bellwether trials to test the strength of plaintiffs’ claims. While there is no guarantee, the bellwether trial process sometimes provides a path towards a global settlement that ultimately resolves all cases pending in the proceeding.

If a case cannot be resolved to multidistrict litigation process, it will be remanded to the original court of filing for trial.

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