Taking proton pump inhibitors longer than recommended can be dangerous. Experts now link long-term, regular PPI use to 20-50% increased risk for kidney disease and 96% increased kidney failure risk. PPI therapy helps manage gastroesophageal reflux disease (GERD) symptoms and other conditions related to excessive stomach acid production. Patients who suffer life-threatening side effects, such as stomach cancer or dementia, may seek the compensation and justice they deserve through a PPI lawsuit.

Most claims now pending are against AstraZeneca, manufacturer of Prilosec^® (omeprazole) and Nexium^® (esopremazole). Pfizer, Inc., manufacturer of Protonix, already settled one PPI lawsuit for $55 million in 2012. The U.S. government accused Pfizer of promoting Protonix beyond its sole approval for use in treating GERD-associated erosive esophagitis.

PPI Lawsuit History

The first PPI lawsuit filed against AstraZeneca in 2004 claimed the company spent billions marketing newly patented Nexium (the “little purple pill”), to replace Prilosec. Despite the fact that both medications are nearly chemically identical, AstraZeneca heavily advertised Nexium as the more effective remedy. Ads pushed Nexium to treat acid reflux symptoms over cheaper generic omeprazole or other comparable heartburn remedies. In reality, Alka-Seltzer, TUMS or other popular antacids can effectively treat occasional heartburn symptoms.

Medical experts and chemists believe AstraZeneca simply found a way to purify its original PPI formulation for the prodrug omeprazole into esomeprazole. Esomeprazole is an active drug, which means it can halt excessive stomach acid production before metabolization. Due to this chemical restructuring, the FDA approved Nexium in 2001. Thus, AstraZeneca secured a new and highly profitable patent that cost eight times as much as generic omeprazole. In 2010, the company earned an estimated $5 billion in Nexium sales revenue.

Despite AstraZeneca’s strong marketing push, plaintiffs alleged “there is no evidence that Nexium is superior, at standard doses, to Prilosec and other P.P.I.’s.” Lawyers asked the company to make “restitution and/or disgorgement of all unlawful or illegal profits” earned from Nexium sales. Plaintiffs also asked AstraZeneca to pay all legal costs incurred from filing the PPI lawsuit.

Increased Bone Fracture Risk Alleged in PPI Lawsuit

According to one May 2010 report, PPI patients face increased bone fracture risks. For this reason, the FDA updated warning labels for Aciphex, Nexium, Prevacid, Prilosec, Protonix, Vimovo and Zegerid twice 2011. In April 2011, Ginny Begin of Toledo, OH filed a PPI lawsuit against AstraZeneca. Begin accused AstraZeneca of failing to disclose “serious bone deterioration” risks. The plaintiff says this led to her snapping her fibula in July 2005 and again June 2007. She also says daily Nexium use from 2003 to early 2011 caused additional ankle bone breaks.

The FDA issued yet another warning in May 2011 advising consumers about low serum magnesium level risks with long-term PPI use. The agency advised that “OTC PPIs are only intended for a 14-day course of treatment up to 3 times per year.” In February 2012, the FDA issued another warning about increased risk for developing Clostridium Difficile-Associated Diarrhea (CDAD). CDAD-induced diarrhea is a communicable bacterial infection that doesn’t improve. Common CDAD symptoms include abdominal pain, watery stool and fever.

Massachusetts PPI Lawsuit Settled Out of Court for $20 Million

In April 2013, AstraZeneca paid $20 million to settle a pending class action lawsuit. The Massachusetts settlement covered any person or business “who purchased Nexium directly from AstraZeneca at any time during the period from Aug. 27, 2008 through Dec. 11, 2013,” thus avoiding trial and any admission of wrongdoing. The FDA added a “black box warning” to Nexium, Prilosec and several other PPI drug medications about potential side effects.

Researchers Link Kidney, Cardiovascular Risks to Ongoing PPI Use

New studies unearthed other adverse effects from long-term PPI use in 2015. Researchers found that patients over 66 faced a two-fold risk of acute kidney injury. Yet another study showed a 1.16-fold increase in heart attack risk and double the risk of cardiovascular mortality. However, patients taking H2 blockers for heartburn relief don’t face these cardiovascular risks.

Additional studies from Johns Hopkins University in February as well as the American Society of Nephrology in April 2016 linked long-term PPI use with a 20-50% increased risk of chronic kidney disease (CKD) and a 96% increased risk of kidney failure, respectively. After these troubling studies, 5,000 plaintiffs filed at least 15 pending class-action lawsuits against PPI drug manufacturers Takeda Pharmaceuticals USA, AstraZeneca Pharmaceuticals LP, Pfizer, Inc. and Procter & Gamble. These claims are for kidney damage and other renal injuries associated with long-term PPI therapy, such as acute interstitial nephritis (AIN), acute kidney injury, kidney failure, chronic kidney disease (CKD), kidney transplant surgery, dialysis and even death.

PPI Use In Patients Over 75 Linked to Increased Dementia Risk

A German observational study in February 2016 linked long-term PPI use in patients over 75 to a 44% increased risk for developing dementia. Still, researchers say they found no direct causal link between proton pump inhibitors and dementia cases. However, as studies link more severe complications (like stomach cancer) to these drugs, more patients may file PPI lawsuit claims going forward. Since doctors often over-prescribe PPIs to older patients or for off-label use, consumers should know about these risks.