Bundling Up To 300 Plaintiffs on One Lawsuit for Nexium, Prilosec Kidney Problems Proposed in MDL

Plaintiffs involved in the federal litigation over kidney problems from Nexium, Prilosec, Protonix and other proton pump inhibitor (PPI) heartburn drugs are asking the U.S. District Judge presiding over the cases to permit “bundling” of cases involving up to 300 individuals from the same state on one complaint, to conserve resources and allow large numbers of claims to be brought before potential statute of limitations dates that may be approaching.

There are currently about 650 Nexium lawsuits, Prilosec lawsuits, Protonix lawsuits, Prevacid lawsuits and other claims filed against PPI drug manufacturers in the federal court system, each raising similar allegations that long-term use of the medications resulted in chronic kidney disease, renal failure or other kidny problems. However, as lawyers continue to review and file claims, it is ultimately expected that several thousand additional lawsuits will be brought in the coming months.

Given common questions of fact and law raised in the claims, the litigation has been centralized before U.S. District Judge Claire C. Cecchi in the District of New Jersey, for coordinated pretrial proceedings and discovery into common issues.

Earlier this year, Judge Checci approved a streamlined filing procedure for new kidney damage drug cases, where the plaintiffs’ steering committee filed a “Master Complaint” outlining all of the allegations brought against the drug makers. Individual plaintiffs were then permitted to file a “Short Form Complaint”, adopting applicable claims when initiating their case. However, plaintiffs’ attorneys suggest that this process may not be sufficient to handle the coming deluge of claims.

On March 27, Co-Lead Counsel for the plaintiffs filed a proposed case management order (PDF), requesting that Judge Cecchi allow the temporarily bundling of up to 300 plaintiffs living in the same state on one complaint.

This would be a temporary measure that would require the plaintiffs to be severed and re-file within nine months, according to the proposal, and subject those claims to an accelerated schedule for providing evidence of PPI use and a kidney injury. In the meantime, plaintiffs would not incur the expense of filing each case separately and counsel for the drug manufacturers would not need to incur the expense of responding to each complaint.

The proposed order indicates that individual filings would cause needless, large, expenses for both sides.

“Over the past year, Plaintiffs’ counsel have come to better understand that the rampant use of PPIs over the past 30 years has resulted in thousands of potential claims and that obtaining medical and pharmacy records that span decades is an arduous and time-consuming task,” the order states. “This is further complicated by the fact that the medical providers records retention policies tend to expire after seven years. This temporary bundling CMO serves as a tolling mechanism for these cases so they can be adequately vetted.”

In a response (PDF) submitted on April 2, attorneys for AstraZeneca, Takeda Pharmaceuticals, Pfizer, Proctor & Gamble and other defendants involved in the litigation opposed the proposed bundling, arguing that it contradicts previous case management orders and was an unnecessary measure.

“The Proposed Bundling CMO is also improper, as it is an attempt by Plaintiffs to achieve tolling, suspend their Rule 11 obligations, and avoid substantial filing fees, without the consent of Defendants,” the response indicates. “Similar bundling proposals have been rejected by multiple other MDL courts andthis one should be no exception.”

Judge Checci is scheduled to hold a telephone status conference on April 10, and the parties are expected to submit a joint status report and agneda for that conference this week. The next in-person status conference is set for May 1.

Proton Pump Inhibitor Kidney Lawsuits

The proton pump inhibitor 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 regarding the link between the heartburn drugs and kidney problems.

In addition, the manufacturers may soon see additional lawsuits over potential links between the heartburn drugs and stomach cancer, after recent studies suggested that long-term use of Nexium, Prilosec or other PPI drugs may make it more likely to develop the disease.