Proton Pump Inhibitors have Been Linked to Side Effects, Including Kidney Disease. Medications used to treat heartburn, such as Prevacid (lansoprazole), Nexium (esomeprazole), and Prilosec, (omeprazole) have been reviewed for their potential association with increased risks for kidney disease. The drugs, which are in a class of drugs known as proton pump inhibitors (PPIs), reduce acid production by blocking the stomach wall enzyme that produces acid.
Parker Waichman LLP is pursuing lawsuits on behalf of individuals who have suffered kidney injury due to treatment with PPI medications. The firm also continues to investigate the link between PPIs and kidney disease.
Various Research Ties Proton Pump Inhibitors to Kidney Disease
Acid reduction helps in the prevention of esophageal, stomach, and duodenum ulcers. Should stomach juice back up into the esophagus, the PPI would render the acid less irritating and enable healing in the event of an ulcer, according to a The New York Times January 2016 report.
Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, Aciphex, and Vimovo are available by prescription to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus. Prilosec OTC, Zegerid OTC, and Prevacid 24HR are sold over-the-counter (OTC) for the treatment of frequent heartburn.
PPIs treat conditions that include gastric reflux and peptic ulcers. In an April 2016 Medscape report, the medications have been linked to various side effects, including kidney disease. While studies have long associated PPIs with an array of life-changing health reactions—fractures, dementia, heart disease, and birth defects, among others—recent studies have also suggested a PPI link to kidney disease. JAMA Internal Medicine published a study revealing that PPI use was associated with a higher risk of chronic kidney disease (CKD), according to Medscape. Researchers analyzed data from a total of over 10,400 patients and conducted a 12-year follow up. The findings were replicated in a cohort of over 248,000 patients.
The report also indicated that PPIs are associated with acute kidney injury. In fact, research published in April 2015 compared acute kidney injury in patients who started PPIs within 120 days to those who did not. “These new concerns for CKD, acute kidney injury, and possibly dementia associated with PPIs join a long list of other concerns about side effects from PPIs. Those include decreased calcium absorption and increased fracture risk, decreased iron absorption, pneumonia, and poor magnesium absorption. There have been a number of studies in the last five years that have documented an association between chronic PPI use and hypomagnesemia, most likely due to decreased intestinal absorption. Some experts have speculated that poor magnesium absorption and hypomagnesemia predispose patients to kidney injury,” Medscape also reports.
Studies on the use of PPIs, especially in long-term use, have also tied PPIs to increases in bone fracture, pneumonia, and Clostridium difficile. For over 13 years, researchers followed 10,482 people comparing those who used PPIs to those who took a non-PPI drug in the class known as H2 receptor antagonists, such as Zantac and Pepcid. The research appears in the American Medical Association’s (AMA) journal, JAMA Internal Medicine and concluded that PPI use was associated with a 20-50 percent increased risk of developing CKD. A Johns Hopkins kidney specialist noted that patients using PPIs for a longer period of time should be regularly monitored for their kidney function, according to the January 2016 The New York Times report.
Even more evidence has tied PPI use to increased risks for developing CKD, disease progression, and end-stage renal disease (ESRD), according to an April 2016 Medical Daily report. The review of a national, comprehensive database revealed that, the greater the duration of PPI use, the greater the drugs’ risk.
“The results emphasize the importance of limiting PPI use to only when it is medically necessary, and also limiting the duration of use to the shortest duration possible,” noted senior author Ziyad Al-Aly, MD, from the Veterans Administration (VA) St. Louis Health Care System in Missouri, in a news release. “A lot of patients start taking PPIs for a medical condition and they continue much longer than necessary.” First author Yan Xie, MPH, also from the VA St. Louis Health Care System, and colleagues published their findings online on April 14, 2016 in the Journal of the American Society of Nephrology.
An earlier observational study published by JAMA Internal Medicine and reported by Medscape Medical News revealed what was described as a significant 35 percent increase in chronic kidney disease risk associated with ever use of a PPI versus no PPI use.
PPI Kidney Damage Lawsuits Mount, Plaintiffs Seek MDL
Lawsuits began mounting soon after published findings linked PPI use to an increased risk of kidney disease. The PPI kidney injury claims were filed on behalf of individuals who suffered kidney damage, such as acute interstitial nephritis, chronic kidney disease, and renal failure, allegedly due to taking a PPI. On May 31, 2017, plaintiffs in the litigation filed a motion to centralize PPI kidney injury lawsuits into a federal multidistrict litigation (MDL).
The U.S. Judicial Panel on Multidistrict Litigation (JPML) creates MDLs to make complex litigation more efficient. An MDL is a type of mass tort that centralizes lawsuits with common factual allegations to one court before one judge for coordinated or consolidated pretrial proceedings. Centralizing cases into an MDL makes the legal process move along faster because it streamlines the litigation process and eliminates the need for duplicate discovery and inconsistent pretrial rulings. Lawsuits in an MDL remain separate, and plaintiffs are treated individually, unlike in a class action lawsuit. Plaintiffs in an MDL share the same basic allegations, although severity of injuries may vary between cases.
This MDL seeks to consolidate lawsuits involving four prescription PPI medications (Prilosec, Nexium, Protonix, and Dexilant) and three over-the-counter products (Prilosec OTC, Prevacid 24-Hour, and Nexium 24 Hour). These medications treat conditions such as heartburn and acid reflux disease by reducing the amount of acid in the stomach.
Plaintiffs are asking the JPML to consolidate 172 PPI kidney injury lawsuits to the U.S. District Court for New Jersey before Judge Claire C. Cecchi. Alternatively, the plaintiffs request the U.S. District Court for the Southern District of Illinois before Judge David R. Herndon. Plaintiffs note that “In both of these courts, the actions have advanced far ahead of those in any other jurisdiction.”
According to court documents, the MDL seeks to consolidate lawsuits alleging acute interstitial nephritis, chronic kidney disease, and renal failure (also known as end-stage renal disease) due to ingesting a PPI prescribed by a physician or recommended by a healthcare professional. PPI lawsuits allege that drug makers failed to warn patients and the medical community about the risks. Plaintiffs allege that, if they were fully informed about the risk of kidney injury, they would not have taken the medication.
The plaintiffs note that a different group of plaintiffs sought an MDL previously, which was denied by the JPML. In the more recent motion, however, plaintiffs note “significant developments” that they believe warrant a second consideration.
Plaintiffs note that, when the first motion for a PPI kidney injury MDL was filed, there were only 15 cases. As of May 2017, the number of cases increased significantly to 172 lawsuits filed in 30 different federal courts across 21 different states. “The scattered nature of the Actions across the country does not serve either the parties’ or judicial efficiency interests, and will inevitably lead to disparate decisions and outcomes,” court documents state.
In general, the JPML may create an MDL when there are two or more civil cases involving “one or more common questions of fact” and consolidation would advance “the convenience of parties and witness” and “promote the just and efficient conduct of such actions.” Plaintiffs argue that coordination would promote the convenience of both parties, witnesses, counsel, and the court system. If an MDL is not established, there could be inconsistent pretrial rulings. Since the PPI cases are in the early stages of litigation, plaintiffs state, transferring them into an MDL would not waste a substantial amount of court resources.
The 172 actions similarly allege that PPI manufacturers failed to adequately warn that taking prescription or over-the-counter PPI medications could cause irreparable harm to the kidneys. Many lawsuits allege negligence, design defect, failure to warn, fraudulent concealment, warranty claims, and loss of consortium. Most lawsuits have been filed over the prescription PPIs Prilosec and Nexium, along with the corresponding over-the-counter products.
The primary defendant in the PPI kidney injury litigation appears to be AstraZeneca, which manufactures Prilosec and Nexium; however, many plaintiffs have taken more than one PPI product for their conditions. Because of this, five different defendant groups have been named. Plaintiffs argue that MDLs have contained multiple defendants in the past and, although this adds complexity to the case, the matter may be managed through staggered or separate discovery and trial schedules. Plaintiffs note that, “As this Panel recently expressed, MDL judges are adept at handling such complexities, and even given the complexity of ‘individualized factual issues in each action … these issues do not … negate the efficiencies to be gained by centralization.'”
Parker Waichman continues to offer free legal consultations to individuals who suffered kidney injuries, including acute interstitial nephritis, chronic kidney disease, and renal failure after taking a PPI product. Contact one of our experienced drug injury attorneys today for more information.
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