Valsartan Lawsuit Status: January to March 2019
March 28, 2019
Author: Daniel Gala
Even as the dubious one-year anniversary of the first valsartan recalls in mid-2018 approaches, the United States Food and Drug Administration (FDA) continues to issue new recalls of valsartan and other angiotensin II receptor blockers (ARBs), including losartan and irbesartan, due to contamination with possible human carcinogens. With new recalls and valsartan-related lawsuits announced seemingly every week, it can be tough to get a handle on all the latest developments. Here’s an overview of major valsartan recall news for the first part of 2019.
Valsartan Recalls Continue
New and expanded recalls of valsartan and other ARBs continued throughout the first part of 2019, with the FDA issuing in those three months alone about ten additional updates regarding the ARB recalls, about a third of which dealt directly with recalls of additional lots of valsartan and valsartan-containing combination drugs.
January to March 2019 Updates to FDA Valsartan Recalls:
January 2, 2019 – The FDA announced AurobindoPharma USA’s voluntary recall of “two lots of valsartan tablets, 26 lots of amlodipine and valsartan combination tablets, and 52 lots of valsartan and hydrocholorothiazide (HCTZ) combination tablets due to the amount of N-Nitrosodiethylamine (NDEA) in the valsartan active pharmaceutical ingredient.”
March 1, 2019 – The FDA announced that AurobindoPharma USA was expanding its recall of valsartan and valsartan/amlodipine combination drugs to include 38 additional lots of the medication. The recalls were again due to contamination with the probable human carcinogen NDEA.
March 22, 2019 – The FDA announced a further update to the list of valsartan lots under recall to “incorporate additional repackagers of Aurobindo’s valsartan-containing medicine.”
Source:
Valsartan Products Liability Litigation – Panel Orders Creation of Valsartan MDL
As one might expect, patients have begun suing the makers and sellers of contaminated valsartan for exposing them to probable human carcinogens, and the first part of 2019 saw the establishment of multidistrict litigation (MDL) to centralize federal products liability claims over valsartan contamination.
On February 14, 2019, the Judicial Panel on Multidistrict Litigation (JPML) issued a transfer order consolidating valsartan products liability lawsuits from at least half a dozen different districts in the District of New Jersey. Named defendants in the consolidated cases included Prinston Pharmaceutical, Zhejiang Huahai Pharmaceutical, Torrent Pharma, and Solco Healthcare US. The MDL contained 40 cases at the time of the transfer order and is likely to grow rapidly.
On February 25, 2019, the Honorable Robert B. Kugler issued the first case management order for the valsartan MDL, scheduling the initial case management conference for March 27 and laying out its agenda, which, at this early stage, covers almost exclusively procedural matters.
Sources:
