AZ pays $425m to settle claims heartburn drugs caused harm

AstraZeneca confirmed this morning it has agreed to pay $425 million to settle lawsuits brought in the US that claim its heartburn therapies Nexium and Prilosec caused kidney damage and other harmful effects.

The pharma group said that it continues to believe the claims are without merit, and said the decision to settle should not be taken as a sign that it admits any wrongdoing. Rather, the decision to pay out will “avoid continued costly litigation and allow the company to move forward with its purpose of delivering life-changing medicines to millions of patients around the world.”

There is just one case that remains outstanding in the long-running legal dispute, which has seen thousands of people across the US claim they were injured as a result of taking Nexium (esomeprazole) and Prilosec (omeprazole), which are both based on proton pump inhibitors.

The two products – along with other drugs in the PPI class used to treat conditions like heartburn and gastroesophageal reflux disease (GORD) – are claimed to cause kidney damage, as well as a litany of other harmful effects including stomach cancer, heart attacks, and bone fractures.

The settlement resolves product liability claims that are currently pending in class-action lawsuits in the US District Court for the District of New Jersey, as well as in the Delaware Superior Court and the New Jersey Superior Court, said AZ.

That includes the bellwether case involving James Rieder, who claimed that he developed chronic kidney disease (CKD) as a result of taking Nexium for nearly five years. That trial had been scheduled to begin on 10th October, after several postponements, but was adjourned last month.

The remaining case – in the US District Court for the Middle District of Louisiana – is scheduled to go to trial on 15th April next year, said AZ, adding that it has already made a provision for the costs associated with the litigation in its financial accounting.

Other PPI products that have sparked liability litigation in the US include Pfizer’s Protonix (pantoprazole), Takeda’s Prevacid (lansoprazole) and Dexilant (dexlansoprazole), and Procter & Gamble’s Prilosec OTC (omeprazole).

Most of the cases argue that manufacturers did not do enough to warn patients and healthcare professionals about the possible risks of the drugs, alleging that the companies became aware of them years before issuing warnings.

As of August, there were reported to be around 13,000 lawsuits pending in PPI litigation across the US.