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The U.S. District Judge presiding over all federal Nexium lawsuits and Prilosec lawsuits has been asked to intervene in several discovery disputes between the parties, and force the drug makers to turn over long-awaited documents in a timely fashion, which plaintiffs indicate are holding up the litigation.
There are currently about 650 product liability lawsuits pending in the federal court system against the makers of proton pump inhibitors (PPI) drugs, each raising similar allegations that manufacturers of the widely used heartburn medications failed to adequately warn consumers and doctors about the risk of acute kidney injury, chronic kidney disease, renal failure or other complications.
Since August 2017, the cases have been centralized before U.S. District Judge Claire C. Cecchi in the District of New Jersey, as part of a federal MDL, or multidistrict litigation, which is designed to coordinate discovery into common issues, avoid conflicting pretrial schedules and serve the convenience of the parties, witnesses and the judicial system.
Although early discovery has been on-going for six months, plaintiffs’ attorneys indicate that they have encountered unreasonable delays in obtaining certain documents and information from AstraZeneca and Proctor & Gamble.
In a letter (PDF) sent to Judge Cecchi on February 13, the Co-Lead Counsel for Plaintiffs asked the Court to consider scheduling bi-weekly telephone conferences to address ongoing issues and delays with AstraZeneca, which developed and manufactures Nexium and Prilosec.
Although the company was previously ordered to run plaintiffs’ proposed search terms and provide information about how many documents were identified at a status conference on January 12, the letter indicates that the results still have not been received.
The plaintiffs’ indicate that repeated contacts with attorneys for AstraZeneca suggest that the company does not intend to comply with the extent of the order, and that the information should have been available months ago.
“Thus, nearly one month after Your Honor ordered the AstraZeneca Defendants to run Plaintiffs’ proposed search terms and to provide us with data on the results, we have nothing,” the letter states. “Plaintiffs are troubled by the AstraZeneca Defendants’ response, which in our view reflects a pattern of delay.”
Days later, a second letter (PDF) was sent to Judge Cecchi about discovery delays involving Procter & Gamble, which sells Prilosec OTC (Over-the-Counter) products.
Plaintiffs’ leadership counsel noted that over the past six months, the only documents produced by Proctor & Gamble are copies of insurance policies, calling for the Court to intervene and hold a specific hearing related to the discovery delays.
“The PSC (Plaintiffs’ Steering Committee) is concerned that P&G’s document production is moving way too slowly (actually it may not even be moving at all),” according to the letter filed February 16. “The PSC requests that the P&G Defendants be ordered to produce documents and other information on a court-imposed deadline, with specific dates set forth.”
The parties are scheduled to meet with Judge Cecchi for a previously scheduled status conference on February 22, at which time it is expected that the discovery disputes will be addressed.
Proton Pump Inhibitor Kidney Risks
The proton pump inhibitor (PPI) litigation has 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.