JPML Approves Proton Pump Inhibitor MDL 2757 Assigned to US District Court New Jersey, Judge Claire C. Cecchi on August 2, 2017
The Judicial Panel on Multidistrict Litigation (JPML) has entered an order consolidating the Proton Pump Inhibitor (PPI) MDL 2757 (Nexium, Prevacid, et al) on August 2, 2017 see JPML Consolidation Order of August 2, 2017, assigning PPI MDL 2757 to Judge Claire C. Cecchi, US District Court of New Jersey based on the July 27, 2017 consolidation hearings at the Los Angeles Federal Courthouse. The case is In Re: Proton-Pump Inhibitor Products Liability Litigation [No. II], MDL Docket No. 2757, JPML, where the case filings have significantly increased since the initial JPML hearing on January 26, 2017 in Miami when U.S. District Judge Sarah Vance said at one point during the oral arguments “It just seems to me to be nightmarishly complex” as the primary defense counsel raised concern over the generic makers and related defense issues with so many co-defendants. The JPML ultimately denied the MDL 10 days later to the view that consolidation would be to cumbersome, however due to the large numbers of new suits and the refiling of a Motion to Consolidate, the July 27th Los Angeles hearings have had a different outcome.
The drugs at issue include Prilosec, Nexium, Protonix and Dexilant as well as potential the numerous generic manufacturers. The hearing order lists over 163 cases in 28 federal district courts and a decision will likely come in mid-August. Nevertheless, the judges may try to come up with ways to split up the cases into structures that might be simpler and more efficient or combine all parties. Ideas included single-product or single-defendant MDLs, separating out prescription-only users, or separating out patients who had only used products made and sold by AstraZeneca, which its attorney said is currently named in 100 cases.
In their May 31 motion, Motion to Consolidate Re: PPI Hearing Los Angeles July 27, 2017, the moving plaintiffs seek centralization before U.S. Judge David R. Herndon of the Southern District of Illinois.
The plaintiffs allege that PPIs cause kidney injuries including acute interstitial nephritis, chronic kidney disease and end-stage renal disease. Concerns that these drugs have harmful side effects for users’ kidneys were brought to the U.S. Food and Drug Administration by consumer advocacy group Public Citizen in 2011, and the agency required warnings about risks of acute interstitial nephritis on labels in 2014, according to the patients’ MDL brief.
More recent research led to stronger findings of a connection, including a scientific study published in January 2016 that said PPI use was independently linked to a 20 to 50 percent higher risk of chronic kidney disease. Plaintiffs have also brought allegations of renal failure being caused by the drugs. To date, more than 5,000 PPI cases are under investigation by Plaintiff’s counsel, and more could be added to that number as awareness of the association between PPI use and kidney damage continues to increase. While the drug class first received FDA approval in 1989, serious side effects prompted the FDA in 2014 to require all PPIs to display a warning label that called out the connection to acute interstitial nephritis. The Plaintiff’s brief also mentions several studies that have made a correlation between PPI use and kidney damage during the past 25 years, including a 1992 study by the University of Arizona Health Sciences Center, a 2006 study conducted at the Yale School of Medicine and a 2016 study from John Hopkins published in the Journal of the American Medical Association (JAMA).
The plaintiffs note that in January, the JPML denied centralization of PPI cases, but say later significant developments “warrant a second look at consolidation.”
The defendants are AstraZeneca Pharmaceuticals LP, Proctor & Gamble Co., McKesson Corp., Takeda Pharmaceuticals USA Inc., Novartis Pharmaceuticals Corp., Pfizer Inc. and Pfizer subsidiary Wyeth. The defendants’ responses are due June 27.