Pharma Companies Argue the Proton Pump Litigation Too Complex for an MDL

nexium-b-1Vehemently opposing a motion to create a new MDL for proton-pump inhibitor litigation (PPI), pharmaceutical companies argue that there are too many disparate issues involving drugs, companies and plaintiffs to centralize the cases.

So far, plaintiffs have filed 27 cases in federal court. They requested that the Judicial Panel on Multidistrict Litigation create a new MDL 2757 in Louisiana to consolidate all the cases.

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).

Hodge-podge

But the primary defendant AstraZeneca Pharmaceuticals LP asserts, “Movants seek to create an unwieldy MDL with a hodge-podge of divergent defendants, medications (prescription and OTC), and alleged injuries.  More than 40 companies manufacturing and/or selling nearly 30 different PPIs (brand and generic) spanning nearly three decades may be implicated.”

The three primary drugs are Prilosec, Nexium, and Prevacid. The primary defendants are AstraZeneca, Takeda, and McKesson. But the defense says this is making things too simple.

“More than 40 companies manufacturing and/or selling nearly 30 different PPIs (brand and generic) spanning nearly three decades may be implicated,” AstraZeneca argues.

With so many different products, parties, and alleged injuries, individualized issues will eclipse any purported common ones, and MDL efficiency tools, such as a Master Complaint and bellwether trials, will be, at best, cumbersome and, at worst, unfeasible, and in all likelihood ineffective at efficiently narrowing claims and issues.”

AstraZeneca argues that the injuries cited are common among aging Americans and that the complaints focus on one of the most commonly prescribed classes of medications.

However if the JPMDL does create an MDL, AstraZeneca requested US District Judge Dale S. Fisher of the Central District of California. He presided over Nexium product liability litigation in 2012.

Enzyme Inhibitor

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.

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.


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