Litigation against the makers of powerful antacids, know as proton pump inhibitors, is mounting as plaintiffs charge that the key ingredient causes kidney damage and disease.
Daniel Thornburgh, an attorney with Aylstock, Witkin, Kreis & Overholtz, PLLC in Pensacola, FL, said that defendants include AstraZeneca, Pfizer, Procter and Gamble and Takeda. He spoke at the recent Mass Torts Nexus course in Ft. Lauderdale, FL.
The products in question are Nexium, Prevacid and Prilosec — the “purple pill” that is the third most-prescribed drug which produces $6.3 billion in annual sales. Omeprazole is the ingredient that blocks histamines in the stomach lining from creating acid.
Acute interstitial nephritis (AIN)
“You’re not supposed to take proton-pump inhibitors for more than two weeks,” he said. “If you take it more than eight weeks and stop, you will get a bad acid reflux rebound and become dependent on it.” Long term use causes acute interstitial nephritis (AIN), acute kidney injury, chronic kidney disease and kidney failure, according to Thornburgh.
“It’s been known since 2006 that PPIs causes interstitial nephritis, an inflammatory response that swells the kidney. To cure it, you must immediately remove the drug, stop taking it and get rounds of steroids,” he said. There was no warning on the label about interstitial nephritis until 2014.
The litigation is in the emerging stage, with individual lawsuits filed in New York, New Jersey, Kansas and Tennessee. No multidistrict litigation docket has been organized yet.
The product his heavily advertised, with TV commercials featuring Larry the Cable Guy saying. The voiceover says, “One pill, each morning, 24 hours, zero heartburn.”
The drug is prescribed for Gastroesophageal reflux disease (GERD), Dyspepsia, Acid peptic disease, Zollinger-Ellison syndrome, Acid reflux, and Peptic or stomach ulcers.
Federal case in NY
A case filed in US District Court for the Eastern District of New York is George Mullen V. Astrazeneca Pharmaceuticals LP and Astrazeneca LP, Case 1:16-cv-04801-NGG-CLP.
It states that the risk of AIN among PPI users was first raised in 1992. By 2011, the World Health organization adverse drug reaction report included nearly 500 cases of AIN as of July 2011.
Between 2004 and 2007 at least three additional studies confirmed AIN related to PPI usage. More recent studies indicate that those using PPIs such as Nexium are at a three times greater risk than the general population to suffer AIN.
On October 30, 2014, the FDA notified Defendants that the FDA determined that PPIs pose additional risks not previously disclosed. On December 19, 2014, the labeling for PPIs was updated to include a warning about AIN. The new label added a (never-before-included) section about AIN that read, in the relevant part, that AIN “may occur at any point during PPI therapy.”
Among others, the following medical studies support the fact that there is an association between PPIs, including Nexium, and AIN:
- Ruffenach, Stephen J., Mark S. Siskind, and Yeong-Hau H. Lien, Acute interstitial nephritis due to omeprazole. The American journal of medicine 93, no. 4 (1992): 472-473.
- Badov, David, Greg Perry, John Lambert, and John Dowling, Acute interstitial nephritis secondary to omeprazole, Nephrology Dialysis Transplantation 12, no. 11 (1997): 2414-2416, available at http://ndt.oxfordjournals.org/content/12/11/2414.short
- Torpey, Nicholas, Tim Barker, and Calum Ross, Drug-induced tubulointerstitial nephritis secondary to proton pump inhibitors: experience from a single UK renal unit, Nephrology Dialysis Transplantation 19, no. 6 (2004): 1441-1446, available at http://ndt.oxfordjournals.org/content/19/6/1441.short
- Geevasinga, Nimeshan et al., Proton Pump Inhibitors and Acute Interstitial Nephritis, Clinical Gastroenterology and Hepatology , Volume 4 , Issue 5 , 597 – 604, available at http://www.cghjournal.org/article/S1542-3565(05)01092- X/abstract?cc=y=.
- Harmark, Linda, Hans E. Van Der Wiel, Mark C. H. De Groot, and A. C. Van Grootheest, 2007, Proton Pump Inhibitor‐Induced Acute Interstitial Nephritis, British Journal Of Clinical Pharmacology 64 (6): 819-823, available at http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2125.2007.02927.x/full.
- K. Sampathkumar, A. Abraham. 2013, Acute Interstitial Nephritis Due To Proton Pump Inhibitors, Indian Journal Of Nephrology 23 (4): 304, available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3741979/.
“Even the current warning of AIN is far from complete, lacking the necessary force to give patients and theaters the proper information needed to make an informed decision about whether to start a drug regimen with such potential dire consequences,” the complaint states.