Practice Area: Fosamax
Fosamax® (alendronate), a prescription drug manufactured by Merck, is used to treat osteoporosis, a disease in which bones become increasingly fragile. Drugs like Fosamax, called bisphosphonates, are prescribed to increase bone density, but recent evidence indicates it may have the opposite effect and destroy bone. A 2004 FDA analysis linked bisphosphonates to osteonecrosis of the jaw (ONJ). ONJ is an irreversible condition in which the jawbone dies and is unable to regenerate,
Fosamax is the most commonly dispensed bisphosphonate in the United States: 22 million prescriptions were written in 2004. Bisphosphonates, once taken, remain in the bones indefinitely.
Symptoms of ONJ include the following:
- Loose teeth
- Jaw pain
- Exposed bone
- Severe mouth infections
- Swelling in the mouth
- Mouth ulcers and sores
Fosamax Lawsuit Progress
The drug manufacturer Merck & Co. is currently facing 900 lawsuits over allegations that their osteoporosis drug Fosamax is the cause of jaw necrosis. The trial began on August 11 in a case that could strongly affect all of the others.
The trial, which was filed by Shirley Boles, 71, will take place in New York. The case is one of three bellwether cases that could lead to out-of-court settlements being made.
As of June 30, Merck is facing close to 900 Fosamax lawsuits filed by what may be as many as 2,000 plaintiffs.
The plaintiffs in the Fosamax lawsuits are alleging that Merck failed to warn both patients and doctors that the drug may inhibit blood flow to the jaw area, which in turn lead to jawbone-tissue necrosis, commonly referred to as osteonecrosis of the jaw, or ONJ.
The plaintiffs are further alleging that Merck misrepresented the drug's safety when it refused to use the language requested by the FDA when it changed its label in 2005.
Merck is currently disputing the claims, and says that there is no direct evidence that Fosamax causes osteonecrosis.
How Much Did Merck Know?
"Merck had notice through adverse reports starting in 1996", Boles attorney recently stated in an interview. Since then, the company has had "thousands of reports" regarding jawbone-tissue loss, he elaborated.
A major issue that is being raised in the Fosamax lawsuit is over whether Fosamax can cause ONJ if it's taken for a period of less than three years. The judge presiding over the case has put off a decision regarding what expert testimony he will allow on the subject for now; the issue isn't relevant to the Boles' case since she took the drug for longer than three years.
The federal-court Fosamax trials are currently slated for December and January. An additional state court trial is scheduled later this year in Alabama.
If you or a loved one have been injured by Fosamax and are experiencing complications, contact us for a free consultation and case evaluation by our drug recall attorneys.
Osteonecrosis of the Jaw
Osteonecrosis of the jaw ( ONJ ) also known as dead jaw, or jaw necrosis is a condition in which the bone tissue in the jaw doesn't heal after a minor trauma like a tooth extraction, and causes the bone to be exposed. The exposure of the bone can eventually lead to fractures and infection which may require long-term antibiotic therapy or even surgery to remove the dying or dead bone tissue.
Osteonecrosis is a bone disease that is usually associated with the large joints of the body such as the ankles, knees, hips, and shoulders. ONJ has been associated with the temporary or even permanent loss of blood to the bone tissue, this leads to the death of the tissue and the collapse of the bone. There are an estimated 10,000 to 20,000 new cases of osteonecrosis being diagnosed each year in the United States alone, most of these cases occur as a result of some kind of bone injury such as dislocation or a fracture.
Patients taking Fosamax are at a higher risk of developing severe osteonecrosis and having to suffer the extreme pain associated with the death of the jawbone tissue. The severe pain commonly associated with ONJ is thought to be very similar to the exterme pain often suffered by arthritics. Common symptoms of osteonecrosis of the jaw may include pain in the jaw / maxillofacial region, numbness or altered sensation in the jaw area, loosening of teeth, infections of soft tissue, and the eventual exposure of bone within the oral cavities.
Users of Fosamax that are displaying any of these osteonecrosis of the jaw symptoms should consult with their doctor as soon as possible. Untreated cases of osteonecrosis of the jaw can potentially lead to the death of bone tissue and irreversible joint collapse within the jaw.
Experts have said that prevention and early treatment of individuals using Fosamax or other bisphosphonates is extremely important in preserving the jaw bone. Individuals using Fosomax or other bisphosphonates should avoid tooth extractions and other major dental work while taking the drug.
Osteomyelitis of the Jaw
Osteomyelitis of the jaw occurs when there is an imflamation of the marrow-filled central cavity along with the cellular inbetween the trabeculae bone, as well as the muscles around it.
Most cases of reported osteonecrosis of the jaw related to Fosamax have occurred after dental work, however several cases have reportedly occured without any prior dental work. Anyone currently taking Fosamax may be at risk of developing osteonecrosis. If you or a loved one have been injured by Fosamax side effects you may be entitled to compensation. For more information about your legal rights contact our Fosamax injury attorneys.
