After taking proton-pump inhibitors (PPIs), the most serious side effects reported included kidney disease, kidney injury, kidney failure, acute interstitial nephritis, and bone fracture. The most frequently reported side effects are stomach pain, nausea, and diarrhea.

Proton-Pump Inhibitor Products Liability Litigation

In multidistrict litigation (MDL) 2789, pending before Judge Claire C. Cecchi, the deadline for each individual plaintiff listed to respond to the Orders to Show Cause was extended to June 30, 2022. The deadline for Defendants to oppose each plaintiff’s response was extended to August 16, 2022.

Lawsuits Filed

More than 15,000 PPI lawsuits have been filed against the manufacturers AstraZeneca, Takeda, and Pfizer, who failed to warn of the dangers of PPIs adequately. The lawsuits included Nexium, Prilosec, Prevacid, Protonix, Dexilant, and other PPI brands.

The lawsuits argue that manufacturers did not do enough to warn patients and medical professionals about the possible risks associated with PPIs when the companies became aware of them. By mid-2019, it had become the second-largest mass litigation in the United States.

All cases in the MDL claim that the drugs, used to control stomach acid, caused serious adverse effects that damaged kidneys; however, the manufacturers did not warn patients about the risks for 10 years.

Kidney Injury Lawsuits

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 MDL.

On August 2, 2017, the judicial panel ordered the cases centralized in the District of New Jersey.

  • Harry Mason from Madison County, Illinois, filed the first federal kidney disease lawsuit against AstraZeneca in the U.S. District Court, Southern District of Illinois, in May 2016. He claimed that the pharmaceutical company had received complaints about Nexium’s link to kidney injury as early as 2004 but continued to market the drug aggressively without adjusting its warning label. Harry Mason began taking the medication in 2006, which led to chronic kidney disease and kidney failure. He was able to survive only after undergoing a kidney transplant.

Bone Fracture Lawsuits

  • In 2011, Ginny Begin of Toledo, Ohio, filed a lawsuit against AstraZeneca, claiming that the pharmaceutical company was aware of the risk of fractures associated with PPIs but did not inform Nexium users of this. Ginny Begin had been taking the drug on a daily basis when she broke a bone in her leg during everyday activities. Two years later, the same bone broke—along with two others—as she was descending a staircase.
  • In 2011, more than 30 Texans filed a lawsuit against the manufacturer of Nexium over bone fractures as adverse effects of the drug. The lead plaintiff, then-49-year-old Natalie Stempfer, said that she fractured a bone in the middle of her foot while walking in the mall. Her doctors had never seen that type of fracture before.
  • According to court documents, the only male injured in the case—then-9-year-old Cole Williams—fractured his right hand after taking Nexium for a year and a half.

Misbranding, Deceptive Advertising, and Kickbacks

  • In 2016, Pfizer agreed to a $784-million settlement with the U.S. government. In 2012, Pfizer agreed to pay $55 million plus interest to resolve allegations by the government that the company misbranded the drug.
  • In February 2015, AstraZeneca agreed to pay $20 million to consumers in a Prilosec and Nexium class action lawsuit that had lasted for 10 years. The class action claimed that the company spent $260 million on an advertising campaign to mislead consumers into buying the more expensive medicine.