Proton Pump Inhibitor (PPI) Lawsuits

As of October 2024, 12,062 active PPI lawsuits were pending in federal court in the PPI litigation MDL 2789 in New Jersey. A judicial panel first combined the cases into multidistrict litigation, or MDL, in August 2017.

After the October 2023 settlement, our legal partners are no longer taking these cases. Many lawyers have also stopped taking new cases. However, we will provide any updates in this litigation as they become available.

All PPI lawsuits in the MDL claim the acid-reducing drugs caused side effects that damaged kidneys. The main claim in these cases is that manufacturers failed to warn the public of the risk.

Lawsuits involving Prilosec, for example, claim AstraZeneca knew of kidney risks as early as 2004, but the company did not warn patients about the risks for 10 years.

The largest group of cases in the MDL was filed against AstraZeneca, who manufactures Nexium and Prilosec. But others filed lawsuits against Takeda, Pfizer and Protec & Gamble.

People filed more than 18,600 PPI lawsuits against the manufacturers of Nexium, Prilosec, Prevacid, Protonix and Dexilant because they claimed injuries such as kidney disease, kidney injury, kidney failure and acute interstitial nephritis.

The lawsuits argued that manufacturers didn’t do enough to warn patients and medical professionals about the possible risks as the companies became aware of them. Some Prilosec lawsuits alleged that AstraZeneca knew of kidney risks for at least 10 years before warning the public.

In October 2016, PPI users who filed six lawsuits against the drugs’ manufacturers asked a federal judicial panel to consolidate all federal kidney injury cases into a single multidistrict litigation.

At the time, 15 cases asserting similar claims were pending in 12 district courts. By February 2017, the number of related federal lawsuits had more than doubled, reaching 39. Complainants alleged they “suffered and continue to suffer from kidney injuries including but not limited to, acute interstitial nephritis, chronic kidney disease or renal failure known as end-stage renal disease, and acute kidney injuries,” according to the motion.

“Given the widespread use of PPIs and their defective nature, it is likely that additional claimants will be harmed by the medications and additional similar actions will be filed in or removed to federal courts in the future,” Paul J. Pennock said in the plaintiffs’ motion.

The U.S. Judicial Panel on Multidistrict Litigation denied the MDL request in February 2017. In its order denying transfer, the panel said it recognized the lawsuits all arose from plaintiffs’ allegations that taking PPIs may result in various types of kidney injury, but the named defendants varied from action to action and are competitors. AstraZeneca was sued in most of the actions — 37, to be precise — but Proctor & Gamble was sued in only eight, Takeda in four, and Pfizer in two.

The panel also took issue with the variety of kidney injuries alleged and the differences among the drugs, including the different U.S. Food and Drug Administration approval times and the fact some are available over-the-counter while others require a prescription.

However, on Aug. 2, 2017, the judicial panel ordered the cases centralized in the District of New Jersey. Plaintiffs in 24 lawsuits had asked for the MDL the second time. There were 161 lawsuits pending — 60 in the District of New Jersey, which is more than in any other district. The panel also knew of 34 additional cases involving related issues. It assigned U.S. District Judge Claire C. Cecchi to oversee the proceedings.

Hundreds of consumers filed Nexium lawsuits against AstraZeneca, alleging the drug caused bone deterioration, loss of bone density and bone fractures. These Nexium lawsuits claimed the pharmaceutical company was aware of the risk of fractures but did not inform Nexium users.

However, a judge questioned the reliability of the expert testimony and said without it, the plaintiffs could not establish their cases. He ruled in favor of the defendants. After a few appeals, MDL-2404 IN RE: Nexium (Esomeprazole) Products Liability Litigation officially closed on Jan. 4, 2017, according to the U.S. Judicial Panel on Multidistrict Litigation website.

Despite this, some plaintiffs found success in these cases, including a class-action suit from 2014 that forced the FDA to require stricter warnings on the labels of Nexium and other proton pump inhibitors. Also in 2014, Takeda Pharmaceutical Company reached a settlement in Prevacid lawsuits that claimed a link between the drug and bone fractures. But the amount remains undisclosed.

PPI manufacturers also have faced lawsuits over complaints such as misbranding, deceptive advertising and kickbacks. Some of the complaints were brought forth as class-action lawsuits.

AstraZeneca Paid More Than $34 Million to Resolve Nexium Allegations

In 2015, AstraZeneca said it would pay the U.S. government $7.9 million to resolve kickback allegations involving Nexium. The government claimed AstraZeneca worked with another company to boost Nexium sales.

AstraZeneca was the focus of a Nexium class-action lawsuit that claimed the company essentially paid off Teva Pharmaceutical Company to delay its release of a generic version of Nexium. Teva paid a $24 million settlement to the U.S. government, freeing itself from the case. In January 2015, Teva announced that the FDA had approved its generic equivalent of the drug.

Also in 2015, AstraZeneca agreed to pay the U.S. government and several states $26.7 million plus interest to settle claims that the pharmaceutical company underpaid rebates owed under the Medicaid Drug Rebate Program, according to the U.S. Justice Department.

Medco Paid $7.9 Million to DOJ Over Prilosec Kickback Scheme

Medco Health Solutions Inc. agreed to pay the government $7.9 million over allegations it solicited kickbacks from AstraZeneca in the form of reduced prices on Prilosec, Toprol-XL and Plendil.

According to the government, this kickback arrangement between Medco and AstraZeneca violated the federal Anti-Kickback statute. The scheme caused the “submission of false or fraudulent claims for Nexium to the Retiree Drug Subsidy Program.”

“Pharmacy benefit managers that seek or accept kickbacks will be held accountable for their improper conduct,” Special Agent in Charge Nick DiGiulio of the U.S. Department of Health and Human Services-Office of Inspector General said in the DOJ’s 2015 statement.

Pfizer Agreed to Two Protonix Settlements Totaling $839 Million

In 2016, Pfizer agreed to a $784 million Protonix lawsuit settlement with the U.S. government. The government had accused Pfizer’s Wyeth unit of overcharging Medicaid for Protonix.

In 2012, Pfizer agreed to pay $55 million plus interest to resolve allegations by the government that the company misbranded the drug. The government said Pfizer’s sales force promoted the medication to physicians for unapproved uses.

Sales reps were only supposed to market it for specific forms of gastroesophageal reflux disease, or GERD. However, the company trained its salespeople to push it for treatment of all forms of the condition, according to the U.S. Justice Department. It announced the settlement on Dec. 12, 2012.

AstraZeneca Paid $20 Million in Prilosec and Nexium Class Action Lawsuits

In February 2015, AstraZeneca agreed to pay $20 million to consumers in a Prilosec and Nexium class-action lawsuit that lasted for 10 years.

The class action claimed the company spent $260 million on an advertising campaign to mislead consumers into buying more expensive medicine. It accused AstraZeneca of attempting to “evergreen” the medicines. That is, the company tried to keep market share as a patent expired.

According to the lawsuit, AstraZeneca’s patent on Prilosec was about to expire, so the company pushed Nexium to replace it. The two drugs were almost chemically identical, but Nexium was far more expensive than Prilosec. Plaintiffs alleged the company’s marketing campaign tricked consumers into buying the more expensive Nexium rather than Prilosec, even though the drugs have the same effect.

Most lawyers are no longer taking new PPI cases. However, these were questions they might have asked people before taking them as clients or to build a personal injury claim.