Multidistrict Litigation Over PPIs. On May 31, 2017 an application was filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to create a multidistrict litigation (MDL) in either the District of New Jersey or, alternatively, the Southern District Court of Illinois for the Proton Pump Inhibitor (PPI) cases that allege that taking a PPI as prescribed by a physician or recommended by a healthcare professional, led to kidney injuries.
Alleged injuries include acute interstitial nephritis (AIN), chronic kidney disease (CKD), and renal failure. Renal failure is also known as end-stage renal disease (ESRD).
The JPML creates MDLs to help ensure complex litigations run more efficiently. An MDL is a type of mass tort litigation that centralizes lawsuits that bear common factual allegations in one court before one judge for coordinated (or consolidated) pretrial proceedings. By centralizing the cases into an MDL, the legal process is meant to progress quickly as litigation is streamlined and the need for duplicative discovery is eliminated.
Inconsistent pretrial rulings are also eliminated. Lawsuits in an MDL retain their individuality, which differs from how a class action lawsuit is handled. Plaintiffs in an MDL also share the same basic allegations; however, the severity of injuries may vary between cases. This MDL seeks to consolidate lawsuits that involve seven heartburn and acid reflux disease medications.
some OTC drugs are sold to treat frequent heartburn
Reducing stomach acids helps prevent esophageal, stomach, and duodenum ulcers. Should stomach juices back into the esophagus, a PPI would make the acid less irritating and enable healing in the event of an ulcer. A variety of prescription PPIs are available to treat gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus; some OTC drugs are sold to treat frequent heartburn.
Seven drugs are involved in the lawsuits and are manufactured by five defendant groups. The four prescription drugs are Prilosec (omeprazole), Nexium (esomeprazole), Protonix (pantoprazole), and Dexilant (Dexlansoprazole). The three over-the-counter (OTC) medications are Prilosec OTC, Prevacid 24-Hour (lansoprazole), and Nexium 24-Hour.
Parker Waichman LLP 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 medication. Contact one of our experienced drug injury attorneys today for more information.
Lawsuits began increasing after findings were published associating PPIs to increased risks for kidney disease. Plaintiffs’ injury allegations include that they suffered kidney damage, including acute interstitial nephritis, chronic kidney disease, and renal failure, due to taking a PPI. On May 31, 2017, the plaintiffs in the litigation filed a motion to centralize the PPI kidney injury lawsuits into a federal MDL.
Plaintiffs have asked the JPML to consolidate 172 PPI kidney injury lawsuits to either the United States District Court for New Jersey before Judge Claire C. Cecchi or the United States District Court for the Southern District of Illinois before Judge David R. Herndon. The plaintiffs note that, “In both of these courts, the actions have advanced far ahead of those in any other jurisdiction.”
Court documents indicate that the MDL is seeking consolidation of the lawsuits
Court documents indicate that the MDL is seeking consolidation of the lawsuits over allegations of acute interstitial nephritis, chronic kidney disease, and renal failure/end-stage renal disease associated with taking a PPI either prescribed by a physician or recommended by a healthcare professional.
The PPI lawsuits also allege that the five drug makers involved neglected to advise patients and the medical community about the risks associated with the involved PPI medications and that the plaintiffs been fully informed about risks of PPI kidney injury, they would not have taken the medication.
The plaintiffs noted that a different plaintiff group previously sought an MDL that was denied by the JPML. In this motion, plaintiffs note that there are “significant developments” they believe warrant a second consideration and point out that, when the prior motion for a PPI kidney injury MDL was filed, only 15 cases were involved.
Effective May 2017, the number of cases had significantly increased to 172 lawsuits in 30 federal courts across 21 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 indicate.
Typically, the JPML may create an MDL when two or more civil cases that involve “one or more common questions of fact” are involved and when consolidation would progress “the convenience of parties and witness” and “promote the just and efficient conduct of such actions.” The plaintiffs note that coordination would encourage the convenience of both parties, witnesses, counsel, and the court system.
The plaintiffs state that, because the PPI cases are in the early stages of litigation, transferring the cases into an MDL would not be a significant waste of court resources.
All 172 actions similarly allege that PPI drug makers neglected to sufficiently warn that taking prescription or OTC PPI medications might cause permanent kidney damage.
Many lawsuits also allege negligence, design defect, failure to warn, fraudulent concealment, warranty claims, and loss of consortium. Most lawsuits were filed over prescription Prilosec and Nexium and their corresponding OTC medications. The primary defendant is AstraZeneca, the manufacturer of both Prilosec and Nexium.
Many plaintiffs have taken more than one PPI product for their conditions; therefore, five separate defendant groups have been named. Plaintiffs allege that MDLs have contained multiple defendants previously and, while multiple defendants may add complexity to the litigation, the issue may be managed through staggered or separate discovery and trial schedules.
“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,'” the plaintiffs indicated.
Research Has Tied PPIs to Kidney Disease
Research has long associated PPIs to kidney and other disease. In part, studies have revealed or concluded:
- In April 2016 Medscape reported that PPIs were tied to various side effects, including kidney disease.
- Prior studies have linked PPIs to fractures, dementia, heart disease, and birth defects, among others.
- JAMA Internal Medicine published a study revealing that PPI use was tied to increased risks for chronic kidney disease. For that study, researchers analyzed data from over 10,400 patients and conducted a 12-year follow up with findings replicated in a cohort of over 248,000 patients. The research also tied PPIs to acute kidney injury.
- Research published in April 2015 concluded that, “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.
- A number of studies documented an association between chronic PPI use and hypomagnesemia (electrolyte disturbance), likely the result of decreased intestinal absorption. MedScape noted that some experts believe that poor “magnesium absorption and hypomagnesemia predispose patients to kidney injury.”
- An earlier observational study that appeared in JAMA Internal Medicine and reported by Medscape Medical News found what was described as a significant 35 percent increase in chronic kidney disease risk tied to ever use of a PPI versus no PPI use.
- Research on long-term PPI use been tied to increased bone fracture, pneumonia, and Clostridium difficile.
- Research published in the American Medical Association’s (AMA) journal, JAMA Internal Medicine found that PPI use was tied to 20-50 percent increased risk of developing CKD.