Case details
Drug marketer failed to warn of side effect, patient alleged
SUMMARY
$2162000
Amount
Verdict-Plaintiff
Result type
Not present
Ruling
KEYWORDS
face, jaw, nose
FACTS
In 1999, plaintiff Adriann Georges, 48, learned that her breast cancer, which was previously diagnosed in 1989, had metastasized to Stage IV cancer. As a result, her treating oncologist prescribed Aredia, a bisphosphonate drug marketed and distributed by Novartis Pharmaceuticals Corp. Bisphosphonates are a class of drugs that prevent the loss of bone mass, and are given to strengthen the bone and reduce the chance a cancer victim has of sustaining a fracture of the skeleton, a well-recognized complication when cancer has metastasized to the bone. However, in 2000, Georges was diagnosed with osteomyelitis, but which was actually osteonecrosis, of the jaw. In 2002, Georges’ treating oncologist switched her prescription to Zometa, another bisphosphonate marketed and distributed by Novartis. Zometa had the same effect as Aredia, but was considerably more powerful. In September 2003, Novartis changed a subsection of Zometa’s label, during the post-marketing experience, to include a statement about how cases of osteonecrosis, primarily of the jaw, have been reported since market introduction. However, Georges noted that this was not in the warning section of the label. Novartis then informed oncologists and oral surgeons, in September 2004, that there were certain jaw issues that could occur. As a result, when Georges’ physician became aware of Georges’ jaw problems and the bisphosphonate correlation in late 2004, Georges temporarily stopped taking Zometa. However, her oncologist urged her to go back on Zometa for two or three more sessions, which she did, but in March 2005, Georges stopped taking Zometa all together after pieces of her jaw bone extruded from her mandible. Overall, Georges received the bisphosphonate drugs, which were administered intravenously, every three to four weeks, resulting in 70 infusions between 1999 and 2005. Georges sued Novartis Pharmaceuticals Corp. and Novartis’ predecessor, Geneva Pharmaceuticals Inc. Georges alleged that the defendants failed to timely warn of the correlation between osteonecrosis and their bisphosphonate medication, intentionally concealed this finding, and breached the implied warranty. Geneva was ultimately determined to be not a party in the case and Georges dismissed the implied warranty claim early in the case. Thus, the matter continued against Novartis only. At trial, plaintiff’s counsel provided evidence of an animal study from 1981, during which it was allegedly indicated that bisphosphonates started bone destruction in the jaw. Counsel also provided evidence that about five clinical trial cases revealed individuals with symptoms consistent with osteonecrosis of the jaw. In addition, counsel presented evidence that when different oral surgeons began identifying osteonecrosis in bisphosphonate patients in 2002 and 2003, Novartis developed a program to downplay any relationship between bisphosphonates and osteonecrosis of the jaw. Plaintiff’s counsel noted that Novartis alleged that there were other well-documented causes of osteonecrosis of the jaw, such as chemotherapy, steroids and periodontal disease, but plaintiff’s counsel argued that there was actually little, if any, scientific support of this and for nearly three years, Novartis discouraged the dissemination of information about the disease. Novartis claimed that both Aredia and Zometa were effective in reducing skeletal complications, including fractures, spinal cord compressions that can cause paralysis, and hypercalcemia, and that both drugs extended the lives of individuals that received them. It also claimed that prior to 2002, there was no information that osteonecrosis of the jaw was a possible consequence of bisphosphonate therapy. Novartis’ counsel contended that Novartis never had any valid scientific information that osteonecrosis of the jaw was a consequence of the bisphosphonates, and that it reacted promptly and appropriately to the first reports from oral and maxillofacial surgeons about what was described as a “new disease,” which it could not have anticipated. Counsel also contended that due to the believed benefits of bisphosphonate therapy, Georges admitted that she would still have taken the medication, even if she was warned about osteonecrosis of the jaw before the therapy. Thus, Novartis’ counsel argued that Georges could not show that an earlier or different warning would have affected her injury. In addition, counsel argued that Georges’ treating oncologist thought the medication was substantial benefit to Georges and would continue to prescribe it, even though the physician was aware of the possible risk of osteonecrosis of the jaw., In 2000, Georges was diagnosed with osteomyelitis of the jaw, but it was later determined to actually be osteonecrosis. As a result, she underwent multiple jaw procedures, including extractions and debridements, but her condition progressed to the point where pieces of her jaw bone extruded from her mandible in March 2005. Georges, who was 62 at the time of trial, claimed that although she has had some improvement due to the years of care provided by the treating oral and maxillofacial surgeon, she still has problems associated with osteonecrosis of the jaw, such as the extrusion of small pieces of bone, infections and drainage. She claimed that as a result, she continues to undergo multiple jaw procedures, such as additional extractions and debridements.
COURT
United States District Court, Central District, Los Angeles, CA
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