DentalOsteonecrosis of the jaw, generally associated with tooth extraction and/or local infection, often with delayed healing, has been reported in patients taking bisphosphonates. Most reported cases of bisphosphonate-associated osteonecrosis have been in cancer patients treated with intravenous bisphosphonates, but some have occurred in patients with postmenopausal osteoporosis.Known risk factors for osteonecrosis include a diagnosis of cancer, concomitant therapies (e.g., chemotherapy, radiotherapy, corticosteroids), poor oral hygiene, and co-morbid disorders (e.g., pre-existing dental disease, anemia, coagulopathy, infection).Patients who develop osteonecrosis of the jaw (ONJ) while on bisphosphonate therapy should receive care by an oral surgeon. Dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk forONJ. Clinical judgment of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.
Plaintiff does not provide the Court any scientific literature or studies that would support Dr. Rose’s theory of causation. Through the course of this multi-district litigation, other experts have opined based on scientifically valid methodologies that Fosamax can cause ONJ. However, nowhere in its opposition to Defendant’s motion for summary judgment, or in the exhibits attached thereto, does Plaintiff provide the Court information regarding Dr. Rose’s theory — that a patient’s ONJ would heal soon after she stopped taking Fosamax only if in fact the injury was caused by the drug.55 The Court observed in its ruling on the parties’ Daubert motions that the Plaintiffs’ Steering Committee and its experts “did not defend the reliability” of a similar theory — that a “drug holiday” before dental surgery reduces the risk of developing ONJ. In re Fosamax Prods. Liab. Litig., No. 06 MD 1789, 2009 WL 2222910, at *31 (S.D.N.Y. July 27, 2009). The Court therefore granted Merck’s motion to preclude testimony that “cessation of Fosamax treatment is appropriate before major dental surgery.” Id.