Fosamax is a drug which was intended to provide a solution to a disease called osteoporosis. Osteoporosis makes bones porous and brittle; hence the bones become easily broken. Many younger people suffer from osteopenia – a precursor of osteoporosis and condition where bones lose density. Fosamax was the medication most often prescribed to such patients, with the expectation that they would have to take it for all the remaining days of their life simply to avoid becoming more and more ill. As if that prognosis wasn’t bleak enough, the Fosamax medication was expensive and had many side effects.
Fosamax hardens old bone; it does not make new bone. Recent studies suggest that Fosamax may be linked to a severe bone disease called Osteonecrosis of the Jaw (ONJ). This disease is commonly known as “Jaw Death” or “Dead Jaw.” Other studies have linked Fosamax to certain femur fractures. Fosamax is further believed to cause many other severe side effects.
The Defendants. As a result many law suits have been filed against Merck, the company that developed, produced and marketed Fosamax. These personal injury lawsuits seek compensation for the injuries suffered by those who took the drug.
Some lawsuits may also need to name defendants other than Merck. Merck’s US patent on alendronate expired in 2008, and it did everything possible to stop the US Food and Drug Administration (FDA) from certifying a generic version of the drug. These efforts proved to be all in vain though, and on February 6, 2008, the FDA gave the green flag to the first generic versions of alendronate, which were soon marketed by two pharmaceutical manufacturers in USA. If you took generic versions of Fosamax, be sure to let the lawyers know, so they can consider whether or not to name the generic’s manufacturer as an additional defendant.
Origins of the lawsuits. During the 1990s, the FDA is believed to have received about 140 spontaneous reports through the MedWatch system on Osteonecrosis of the Jaw in cancer patients who were treated with intravenous (IV) bisphopshonates, either IV pamidronate (Aredia) or IV zoledronate (Zometa). At the 2004 Oncologic Drugs Advisory Committee meeting, the number of spontaneous reports had increased. The FDA soon asked the manufacturers to issue warnings on these drugs declaring the possible risks of ONJ.
Other claimants and their doctors started to assert that osteonecrosis of the jaw is a direct result of the use of Fosamax. Merck kept arguing that the reports of ONJ may have been triggered by a tooth extraction or an oral surgery, or by other similar traumatic events. Merck also argued that the underlying cause of osteonecrosis of the jaw is uncertain. But hundreds of cases started piling up against Merck, alleging Fosamax induced osteonecrosis of the jaw. The medical debate was repeated in the courtroom, as these patients filed lawsuits against Merck. The first legal case was set to be tried in late 2008.
The medical opinions. The medical debates over bone density drugs have intensified as these drugs became more and more popular. In 2006, these drugs became the second most profitable class of prescription drugs in the United States, netting $3.2 billion in sales. While Merck and the other manufacturers were no doubt thrilled, others questioned whether these drugs were necessary.
In May 2008, Dr. Nan Fuchs put in her special report, Bone Health News, that after taking Fosamax, a patient (or her doctor) develops a misconception that the bone has become denser. Dr. Fuchs noted that any increased density in the bone is not due to new bone growth. The drug simply prevents the old calcium from leaving the bone in the natural breakdown and replacement process. Therefore, the bone becomes dense, while simultaneously becoming brittle as well. This makes it vulnerable to accidents and traumas.
“I can attest to the fact that there is a safer, far more successful way to deal with bone health –through several natural nutrients,” wrote Dr. Nan Fuchs.
In September 2007, a health letter by Dr. Robert Jay Rowen served a new warning to those people who had been on the drug for some time. A patient came to Dr. Rowen after taking Fosamax for 9 years. She woke up one morning with unbearable pain in her jaw. The result was that she had to go for repeated surgeries, finally replacing part of her jaw with titanium. The patient also had to take antibiotics for infections. Dr. Rowen’s letter raised awareness that even where the drug had been used without noticeable effects for years, the patients were not necessarily immune from ONJ or femur fracture issues.
Hundreds of people have had experiences similar to Dr. Rowen’s patient, and many are presently involved in lawsuits against Merck. These lawsuits focus on the inadequacy of the warnings provided to the users of Fosamax. Merck initially ignored the Food and Drug Administration’s August 2004 request to add a new warning label to the drug. But later, Merck did make some labeling changes. Nonetheless, many plaintiffs in these lawsuits maintain that the label is still inadequate and fails to disclose important facts about the drug’s side effects. If you believe you have been injured by Fosamax, submit a case evaluation form today.