A federal multidistrict litigation (MDL) has been established for all Nexium bone fracture lawsuits, centralizing all complaints filed in U.S. District Courts throughout the country before Judge Dale S. Fischer in the Central District of California.
Following oral arguments late last month, the U.S. Judicial Panel on Multidistrict Litigation (JPML) issed an order (PDF) on December 6, consolidating all product liability lawsuits filed on behalf of users of Nexium who allege they suffered a fracture or other bone problems after using the blockbuster heartburn medication.
Nexium is one of the most widely used drugs in the United States, approved for treatment of acid reflux and other stomach disorders. It is part of a class of medications known as proton pump inhibitors (PPIs), which also includes Prevacid, Protonix, and Prilosec. However, Nexium is the most popular of the class, with more than $6 billion in annual sales.
There are currently at least 39 Nexium injury lawsuits pending in 19 different U.S. District Courts, which involve hundreds of formers users who suffered a broken bone, osteoporosis or other problems that were allegedly caused by the manufacturer’s failure to adequately warn about the potential risk of Nexium side effects.
The FDA first warned that there may be an increased risk of bone fractures from Nexium and other PPI medications in 2010. That warning was updated by the FDA in 2011, indicating that the risk of broken bones from Nexium appears to be linked to high doses of the medication used over long periods of time. Over-the-counter versions of the drug did not appear to be affected, according to federal drug regulators.
Centralizing the Nexium litigation before one judge is designed to reduce duplicative discovery in a large number of cases, eliminate conflicting rulings from different judges and to serve the convenience of the parties, witnesses and the courts.
AstraZeneca opposed consolidation, arguing that the cases would likely involve other drugs as well. In addition, the pharmaceutical company also argued that many of the cases had progressed to the point where they would not benefit from being part of an MDL. The JPML disagreed, saying that the MDL would only allow in cases involving Nexium and that the common facts and allegations contained in the complaints justify centralizing the litigation.
“All the actions before the Panel assert claims against AstraZeneca arising from ingestion of the drug Nexium,” wrote Judge John G. Heyburn, II, in the JPML transfer order. “Specifically, the actions share allegations relating to the safety of Nexium and the adequacy of AstraZeneca’s warnings concerning the possible adverse side effects of using Nexium – in particular, the potential that Nexium may cause bone-related injuries such as osteoporosis, bone deterioration or loss and broken bones.”
AstraZeneca Also Faces Nexium Antitrust Claims
On the same day the JPML established the Nexium bone fracture MDL, a separate order (PDF) was issued creating another Nexium MDL in the U.S. District Court for the District of Massachusetts, involving antitrust lawsuits. That litigation will be centralized before U.S. District Judge William G. Young.
At least six different trust funds have filed Nexium class action lawsuits against AstraZeneca, alleging that the company paid off generic competitors to keep their cheaper versions of Nexium off the market.