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The U.S. District Judge presiding over all federal kidney injury lawsuits involving a popular class of heartburn drugs, known as proton pump inhibitors (PPI), will hold a “science day” this week to hear presentations on medical and scientific issues that will come up during the litigation.
There are currently more than 2,300 Nexium lawsuits, Prilosec lawsuits, Prevacid lawsuits, Protonix lawsuits and other PPI claims pending before U.S. District Judge Claire C. Cecchi in the District of New Jersey, who is presiding over coordinated discovery and pretrial proceedings as part of a federal multidistrict litigation (MDL).
Each of the complaints raise similar allegations that the drug manufacturers failed to warn about the risk that users developed an acute kidney injury, chronic kidney disease, renal failure or other complications following use of the heartburn and acid reflux drugs.
In a case management order (PDF) issued on May 4, Judge Checchi outlined the structure for the “science day”, which will be held on May 16, 2018.
Given the early stage of the litigation and discovery in the cases, the parties agreed to several “ground rules” to avoid duplication in presentations, which are designed to educate the Court on the basic issues in a non-adversarial manner.
The presentations will be limited to background information on diseases treated by the drugs; background on the targeted heartburn drugs and other acid suppressors; injuries alleged by plaintiffs; and medical literature on the link between the heartburn drugs and kidney injuries.
Up to two experts will be presented per side, but they will not be questioned by the opposing counsel or other experts. The experts will give lecture-style presentations, and the conference will be closed to the public. None of the presentations will be admissible, discoverable or used for any purpose other than to educate the Court.
In complex pharmaceutical litigation, where large numbers of claims are being presented involving similar injuries associated with the same types of drugs, it is common for the Court to schedule such scientific presentations prior to ruling on discovery disputes, admissibility of evidence and other issues.
Proton Pump Inhibitor Kidney Risks
The proton pump inhibitor (PPI) litigation rapidly emerged following the publication of several studies in recent years, which suggest that users may face certain kidney risks that are not disclosed on the warning labels for the popular heartburn drugs, which are used by millions of Americans on a daily basis.
In December 2014, the FDA required new warnings for the first time about a form of kidney damage associated with proton pump inhibitors, known as acute interstitial nephritis (AIN), which involves a sudden inflammation of the kidneys, which can lead to more severe problems.
More recent studies have highlighted the potential link between Nexium and kidney problems, suggesting that the popular drugs make also cause users to experience acute kidney injury, chronic kidney disease and end-stage kidney failure, often resulting in the need for dialysis treatment or a kidney transplant.
Last year, a study published in the medical journal JAMA Internal Medicine also found an increased risk of chronic kidney disease with the heartburn medications, indicating that users of Nexium, Prilosec and other PPI may be 50% more likely when compared to non-users.
These findings were supported by another study published in April 2016, in which researchers with the Department of Veterans Affairs found that users of Nexium, Prilosec or other PPIs may be 96% more likely to develop kidney failure and 28% more likely to develop chronic kidney disease after five years of use.
As part of the MDL proceedings, it is expected that Judge Cecchi will eventually establish a “bellwether” program, where small groups of cases against each drug maker will be prepared for early trial dates. While the outcomes of such trials are not binding on other plaintiffs, they are designed to help gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation.