Zometa, a bisphosphonate drug made by Novartis Pharmaceutical, has been associated with a serious side effect called osteonecrosis of the jaw (ONJ) or dead jaw syndrome. Well over 500 lawsuits filed in federal courts by alleged victims of this Zometa side effect have been consolidated in two multidistrict litigations in Tennessee federal court and New Jersey state court. The first of those cases are scheduled to go to trial in March.
Bisphosphonates, sold under the brand names Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa, are commonly used in tablet form to prevent and treat osteoporosis in post-menopausal women. Stronger forms of bisphosphonate drugs are used in the management of advanced cancers that have metastasized to the bone, where the disease often causes bone pain and possibly even fractures. Several cancers can involve or metastasize to the bone, including lung cancer, breast cancer, prostate cancer, multiple myeloma, and others. When bisphosphonates are given in cancer chemotherapy, the drugs are given intravenously in higher doses and usually for longer periods of time.
Zometa lawsuits allege that Novartis failed to adequately warn that the medication can cause ONJ. ONJ is a disorder in which the bone tissue in the jaw fails to heal after minor trauma such as a tooth extraction, causing the bone to be exposed. The exposure can eventually lead to infection and fracture and may require long-term antibiotic therapy or surgery to remove the dying bone tissue. Signs and symptoms of ONJ may include: jaw pain, swelling of the gums, loose teeth, drainage, exposed jaw bone, numbness, or a feeling of heaviness in the jaw.
In October 2009, a Zometa lawsuit filed by a victim of ONJ was brought to trial in Missoula District Court in Montana. Peggy L. Stevens, 57, alleged that she developed ONJ after receiving the drug intravenously for three years as part of her lymphoma treatment. Stevens said her ONJ occurred after she underwent a tooth extraction in 2007. Her lawsuit alleged that Novartis was professionally negligent when it failed to disclose health risks associated with Zometa. Steven’s condition is incurable and will result in lifelong disability, the lawsuit said.
According to an article published in The Missoulian, a jury of six men and six women ultimately awarded Stevens $3.2 million in damages.
Though Steven’s lawsuit was not part of the mass torts pending in New Jersey or Tennessee, her attorney told The Missoulian that the verdict sets a precedent and will influence the other cases.
“The basic facts regarding Novartis’ conduct are the same in every case. In terms of Novartis’ failure to adequately warn doctors, those facts are now fairly well established,” the attorney said.
