December 10, 2012 — A federal judicial panel has decided to centralize nationwide Nexium bone fracture lawsuits into a Multi-District Litigation (MDL) under Judge Dale S. Fisher in the U.S. District Court for the Central District of California.
The decision overrules the drug manufacturer’s plea against consolidating nearly 40 individual cases and class action lawsuits pending in 19 different District Courts.
AstraZeneca, the manufacturer of Nexium, argued that the cases were not appropriate for an MDL because the types of fractures were so different, many injuries were linked to other drugs, and many of the cases had progressed beyond the point where centralization in an MDL would expedite a resolution.
The Judicial Panel on Multi-District Litigation (JPML) disagreed, saying:
“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.”
The FDA first warned about the increased risk of bone fractures in a Safety Communication published in May 2010. That communication was updated in March 2011 when the FDA determined it was unlikely that short-term, low-dose use of over-the-counter Nexium could increase the risk of bone fractures. However, patients who use high doses of Nexium for more than one year may have a higher risk of bone fractures.
Nexium (esomeprazole) is a medication that treats heartburn, acid reflux, and other conditions that cause the stomach to produce too much acid. It is commonly used to reduce the risk of stomach ulcers and irritation in patients who take NSAID medications for pain or arthritis. It is manufactured by AstraZeneca and was approved by the FDA in October 2006. Nexium belongs to a class of drugs called Proton-Pump Inhibitors (PPIs).
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