Six plaintiffs who suffered kidney damage have filed a motion for the Judicial Panel on Multidistrict Litigation (JPML) to create a new MDL 2757 in Louisiana to consolidate dozens of lawsuits nationwide filed against manufacturers of proton pump inhibitor (PPI) heartburn medicines.
The cases are among 15 actions filed in federal court in California, Illinois, Kansas, Louisiana, Missouri, New Jersey, New York, Ohio, Tennessee, and West Virginia.
They allege that as a result of ingesting a PPI for gastric acid-related conditions, they have been diagnosed with kidney injuries including acute interstitial nephritis (AIN), chronic kidney disease (CKD), and renal failure, also known as end-stage renal disease (ESRD).
5,000 potential cases
Plaintiffs’ counsel have more than 5,000 Proton-Pump Inhibitor cases under investigation, with nearly 100 PPI cases will be filed in the coming weeks, according to plaintiff’s attorney Paul J. Pennock of Weitz & Luxenberg, P.C. in New York, NY.
Defendants include Takeda Pharmaceuticals USA, AstraZeneca Pharmaceuticals LP, Pfizer, Inc., and The Procter & Gamble Company. The products in question include Nexium, Prilosec, Protonix, Prevacid and Dexilant.
PPIs are a group of drugs containing Omeprazole that are intended to act as hydrogen potassium ATPase (“H+/K+ ATPase”) enzyme inhibitor to block the production of gastric acid. The FDA approved PPIs in 1989 and on Oct. 31, 2014 required PPIs to carry a warning label:
Acute interstitial nephritis has been observed in patients taking PPIs including [Brand]. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Discontinue [Brand] if acute interstitial nephritis develops.
The plaintiff’s brief cites several studied supporting their arguments:
- In October 1992, researchers from the University of Arizona Health Sciences Center led by Stephen Ruffenach published the first article associating PPI usage with kidney injuries in The American Journal of Medicine.
- In 2006, researchers at the Yale School of Medicine conducted a case series published in the International Society of Nephrology’s Kidney International finding that PPI use, by way of AIN, left most patients “with some level of chronic kidney disease.”
- On August 23, 2011, Public Citizen, a consumer advocacy group, filed a petition with the FDA to add black box warnings and other safety information about several risks associated with PPIs including AIN.
- In January 2016, a study published in the Journal of the American Medical Association found that PPI use was independently associated with a 20 – 50% higher risk of CKD.
Initial symptoms can be non-specific, such as fatigue, nausea and weakness. However, failure to treat interstitial nephritis (AIN) can lead to kidney death, dialysis, a kidney transplant or death.
The plaintiffs recommended the MDL be created in the federal Middle District of Louisiana in Baton Rouge before Chief Judge Brian A. Jackson, Judge Shelly D. Dick, Judge John W. deGravelles or Senior Judge James Joseph Brady. Alternatively, they would accepts venues including the District of New Jersey, Southern District of Illinois, the District of Kansas or the Western District of Louisiana.