Zometa Lawsuit Over Jaw Necrosis Heading to Jury

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A Montana jury is expected to hear closing arguments today in the first Zometa lawsuit to go to trial, involving allegations that the bone strengthening cancer drug caused a woman to develop debilitating jaw problems.

The case was brought by Peggy Stevens against Novartis Pharmaceuticals Corp., alleging that Zometa side effects caused the decay and deterioration of her jawbone, a condition known as osteonecrosis of the jaw. The lawsuit is the first of more than 500 similar cases involving the drug to be submitted to a jury.

The outcome of the Zometa trial in Missoula County District Court in Montana could be a bellwether, indicating how juries will respond to similar evidence that will be presented in other trials throughout the country, most of which are consolidated in federal court in Tennessee or New Jersey state court.

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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 lawsuits allege that Novartis failed to adequately warn about the risk of jaw necrosis.

The cases are similar to more than 900 Fosamax lawsuits that are pending against Merck & Co. over their oral bisphosphonate medication, which is used to reduce the risk of bone fractures associated with osteoporosis. The first Fosamax trial resulted in a mistrial last month in New York after jurors failed to come to a unanimous decision. The next Fosamax case is scheduled for January 2010.

Stevens’ Zometa trial began on October 13, and closing arguments were scheduled to begin today according to a report in The Missoulian. In the case, Stevens alleged that she developed osteonecrosis of the jaw after taking Zometa intravenously for three years as part of a battle with lymphoma. She claims that after she had a tooth pulled, she developed the disease, which commonly results in jaw pain, loosening of the teeth, exposed bone in the mouth and jaw infections.

Tags: Bisphosphonates, Fosamax, Jaw Necrosis, Merck, Montana, Osteonecrosis of the Jaw, Zometa
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4 Comments

Cathy
My mother had ONJ, it was stage 3 ONJ, her teeth fell out of her jaw, with painful secondary infections, a horrible decaying odor, and exposed jaw bone, she suffered more from her ONJ than she ever did from her metastatic breast cancer, I mean that truthfully. She deserved a warning about this side effect! Especially given the fact that she did have a history of periodontal disease, she was more suseptable. Patients need to get their teeth checked, cleaned and any extractions needed done befor starting this drug. The very first dose can do this to you b/c the half-life of the drug is so long.
bob
No worries Robert, the result of this trial would only mean strong warnings and not the pulling of zometa from the market. Even then, there are a reasonable number of other bisphosphonates available as well that might be used, though zometa is one of the most potent…
Richard
Robert, Bisphosphonates should NOT be taken off the market. When prescribed properly bisphosphonates are highly effective in controlling/preventing bone lesions in Myeloma patients. Bisphosphonate manufacturers must provide more information to doctors and patients about osteonecrosis of the jaw (ONJ). ONJ can be reduced, or possible prevented, by the appropriate use of bisphosphonates. No one has all the answers, but the Mayo Clinic has studied ONJ and it gave a “Consensus Statement for the Use of Bisphosphonates in Multiple Myeloma”. See: http://www.mayoclinicproceedings.com/content/81/8/1047.full This report and the following letter to the Editor of the Mayo Clinic Proceedings give a sensible approach to the use of Bisphosphonate in the Myeloma bone disease. http://www.mayoclinicproceedings.com/content/82/4/516.full.pdf+html
Robert
I am a multiple myeloma patient. What are the rest of us going to do if this multiple myeloma cancer- bone strenghing drug, is taken off the market.

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