Prevacid Lawsuit Alleges Heartburn Medication Caused Kidney Injury and Kidney Disease. Takeda Pharmaceuticals is facing a new lawsuit alleging that its popular heartburn drug Prevacid caused kidney injuries. The product liability lawsuit, filed in Arizona federal court, joins other similar cases alleging that Takeda failed to warn patients or their physicians about the risk of kidney injury with Prevacid, a proton pump inhibitor (PPI). PPI kidney injury lawsuits have been mounting after two studies were published linking the drugs to a possible increased risk of kidney injury.
Parker Waichman LLP has spent decades representing clients in drug injury lawsuits. The firm continues to offer free legal consultations to individuals with questions about filing a PPI side effects lawsuit.
PPIs, which include drugs such as Prevacid, Prilosec and Nexium, are a class of medications that reduce acid secretions by the stomach. They are used to treat conditions such as heartburn or acid reflux.
According to the complaint, the plaintiff took Prevacid from May 2005 through May 2012. The lawsuit states that he now suffers from renal disease, allegedly due to Prevacid side effects. The plaintiff alleges that Takeda failed to warn patients and the medical community about the risk of kidney injury associated with Prevacid.
Other PPI kidney injury lawsuits are being filed. For example, court records show that one plaintiff suffered acute kidney injury after taking both Nexium and Prevacid in 2006. He alleges that his kidney injuries result from PPI use and that drug makers failed to disclose the risks.
Plaintiffs alleging kidney injuries from PPIs have asked the U.S. Judicial Panel on Multidistrict Litigation (JPML) to establish a federal multidistrict litigation (MDL), where similar lawsuits are consolidated to one court before one judge to streamline legal proceedings and eliminate duplicate discovery. In late January of 2017, Law360 reported that over 100 PPI kidney damage lawsuits had been filed. Comparatively, there were only 15 cases in October 2016. Reportedly, some 5,000 possible lawsuits are being investigated.
The JPML has commented on the “complex” nature of the PPI litigation, since it involves many different products including both prescription and over-the-counter medications. “It just seems to me to be nightmarishly complex,” said U.S. District Judge Sarah Vance at an oral argument, according to Law360.
AstraZeneca manufactures Nexium and Prilosec, while Pfizer and Procter & Gamble market Nexium and Prilosec. The pharmaceutical giants are fighting consolidation.
PPI Kidney Injury Background
In 2011, consumer advocacy group Public Citizen petitioned the U.S. Food and Drug Administration (FDA) to address additional risks associated with the use of PPIs. Regulators updated the label in 2014 to warn about the risk of various adverse events. Among other things, the label was updated to include information about acute interstitial nephritis.
Studies have suggested that PPIs may be associated with an increased risk of kidney damage. In January 2016, a study published in JAMA Internal Medicine found that PPI use was associated with an increased risk of chronic kidney disease. “Proton pump inhibitor use is associated with a higher risk of incident CKD,” the authors wrote. “Future research should evaluate whether limiting PPI use reduces the incidence of CKD.”
The findings are only correlational, meaning researchers are unable to draw conclusions about cause-and-effect. However, the authors note that PPIs are often overused. “We note that our study is observational and does not provide evidence of causality. However, a causal relationship between PPI use and CKD could have a considerable public health effect given the widespread extent of use,” researchers wrote. “More than 15 million Americans used prescription PPIs in 2013, costing more than $10 billion. Study findings suggest that up to 70% of these prescriptions are without indication and that 25% of long-term PPI users could discontinue therapy without developing symptoms. Indeed, there are already calls for the reduction of unnecessary use of PPIs.”
In 2016, another study was published linking PPI use to a possible increased risk of kidney damage. The American Society of Nephrology published a study showing that PPIs were associated with a 28 percent increased risk of chronic kidney disease. Researchers analyzed data from two groups: 170,000 new PPI users and 20,000 new users of H2 receptor blockers, another class of heartburn medication. Only a small number of people developed end-stage renal failure, although it was linked to a 96 percent increased risk in the study.