Fosamax®/Osteoporosis Medication Lawsuit
Osteoporosis is a major public health threat for an estimated 44 million Americans. Many people diagnosed with osteoporosis and osteopenia take medications known as bisphosphonates.
Since bisphosphonates were first approved for the treatment of osteoporosis in 1995, millions of people, primarily women, have been treated with them. These drugs include Actonel®, Boniva®, Declast®, Fosamax® and Fosamax® +D among others.
These drugs are designed to strengthen bones of those who may be losing bone mass as a result of menopause. The Journal of Oral and Maxillofacial Surgeons published an article linking Fosamax and osteonecrosis of the jaw (ONJ) also known as “dead jaw”. In January 2005 Merck, the manufacturer, received a request for data from the FDA to update the label for Fosamax to include labeling for the jawbone tissue disease.
In January, 2008 the FDA warned that Fosamax had been linked to severe bone, joint and muscle pain and doctors and patients have been advised to be aware of this side effect and to discontinue Fosamax use if it occurs.
On September 14, 2010 the expert Task Force at the American Society of Bone and Mineral Research (ASBMR) released a study that indicates a connection between a risk of femur fractures and bisphosphonates. Recommendations from the study include product label changes alerting patients and healthcare providers of the risk of femur fractures associated with long term use of bisphosphonates. The Food & Drug Administration (FDA) is considering these recommendations and may intervene to force drug companies who manufacture bisphosphoates to change their labels. Another medical study in the Journal of Orthopedic Trauma has linked Fosamax to a rare type of fracture in the femur.
In June 2010, a New York jury ordered Merck to pay $8 million to a former Fosamax user who developed osteonecrosis of the jaw. In September 2010, a study published in the British Medical Journal raised questions about a possible link between use of bisphosphonates and cancer of the esophagus. The FDA reported a year and a half prior to the study that there had been 23 cases of the cancer in Fosamax users in the US between 1995 and 2008. To date, over 1,000 lawsuits have been filed as a result of injuries caused by bisphosphonates.
TWO STUDIES AT 2012 AAOS ANNUAL MEETING ADDRESS BISPHOSPHONATES
The 2012 Annual Meeting of the American association of Orthopedic Surgeons was held in February in San Francisco. Two of the studies presented addressed the use of bisphosphonates and atypical femur fractures. One looked at outcomes in patients who had sustained atypical femur fractures and the other addressed whether discontinuing bisphosphonate treatment decreased the risk of a second fracture on the other femur.
Kenneth A. Egol, M.D. reported on his study, “Outcomes Following Displaced Atypical Fracture of the Femur.” The study found that generally these fractures heal well. One year later 67% of the patients reported being pain-free and 65% reported a return to baseline functional status. The presence of sharp thigh pain that worsens with weight bearing may indicate an impending fracture. Patients experiencing such symptoms should discuss the risks and benefits of preventative surgical treatment.
Ricahrd Dell, M.D. reported on his study, ” Stopping Bisphosphonate Treatment Decreases the Risk of Having a Second Atypical Femur Fracture.” This study indicated that stopping bisphosphonates within the first year of an atypical femur fracture substantially reduces the risk of a second femur fracture. Patients who have sustained an atypical femur fracture should discuss with their doctor discontinuing bisphosphonate treatment or switching to an anabolic anti-osteoporosis medication.
Litigation update: Discovery is progressing and motions are currently being filed addressing expert witness issues.
If you or a loved one have taken these medications and experienced any of the symptoms below or would like more information please call Showard Law Firm.
- osteonecrosis of the jaw “dead jaw”
- severe bone, joint and muscle pain
- fractures of the femur (or thigh bone)
- esophogeal (throat) cancer
See the articles below for further information:
- NY Times | F.D.A. to Review Safety of Popular Bone Drugs
- FDA | Bisphosphonates Information
- FDA | Drug Information Page
Consumer Reports gives a rundown on the benefits and risks of the bisphosphonates (including Fosamax, Fosamax Plus D), some guidelines to help you decide when these drugs might be worthwhile, and some nondrug alternatives that may reduce or even eliminate your need for medication. Read more here.
Trademark Notice: The use of any product, including Boniva®, Fosamax®, Fosamax® + D, Reclast®, or Actonel® is strictly for identification purposes in attorney advertising. They are registered trademarks of the manufacturers. Showard Law Firm is in no way affiliated with the manufacturer of any product referenced on this site.