Aredia, Zometa Jaw Necrosis Lawsuits Will Proceed, Judges Rule

A federal judge and a New Jersey judge have cleared the way for about 200 Aredia and Zometa jaw necrosis lawsuits against Novartis Corp. to move forward to trial, rejecting the drug maker’s attempts to dismiss the cases. 

The rulings, by U.S. District Judge Todd Campbell in Tennessee and New Jersey Superior Court Judge Jessica Mayer, affect 40 federal cases from Florida and 150 New Jersey lawsuits, respectively. The Aredia lawsuits and Zometa lawsuits were filed by people who say that Novartis’ bone-strengthening drugs caused osteonecrosis of the jaw (ONJ), which involves a painful and disfiguring decay of the jaw bone. The cases are just a small portion of the hundreds of ONJ lawsuits filed against the company, primarily for Zometa.

Novartis attempted to have the cases dismissed, but both judges determined that there is sufficient evidence for plaintiffs’ claims that the drugs’ labeling downplayed health risks to be brought to trial. The requests for summary judgment were denied and the cases can now move forward.

Zometa (zoledronic acid) is a treatment that is used to reduce bone complications associated with multiple myeloma and bone metastases from solid tumors. Although it is used to strengthen bones, it is part of a class of medications known as bisphosphonates, which have been associated with decay of the jawbone. The Zometa jaw necrosis lawsuits allege that Novartis failed to adequately warn about the risk of damage to the jaw.

There are about 600 Aredia and Zometa suits, which have all been consolidated and centralized in U.S. District Court in Nashville as part of a multidistrict litigation, or MDL, for pretrial proceedings. Another 150 lawsuits are being handled by state courts in New Jersey.

In October, Novartis lost the first Zometa trial when a Montana jury awarded $3.2 million to Peggy L. Stevens, 57, who suffered ONJ after using the drug. Stevens took Zometa for three years while she battled lymphoma.

The case was seen by many as a “bellwether” test case for how juries would respond to evidence and witness testimony that will likely be similar to that offered in future lawsuits over Zometa. The Missoula County District Court jury deliberated for only about eight hours before returning the multi-million dollar decision against Novartis.

The Zometa lawsuits are similar to more than 900 Fosamax jaw necrosis lawsuits that are pending against Merck & Co. over their oral bisphosphonate medication. Fosamax is used to reduce the risk of bone fractures associated with osteoporosis, but has also been linked to an increased risk of jaw osteonecrosis.