Merck, a large pharmaceutical company, developed, marketed, and started selling Fosamax, generic drug alendronate, in the 1990s. The drug is supposed to build bone density and was first approved by the U.S. Food and Drug Administration (FDA) in 1995 for use in treating osteoporosis, in preventing osteoporosis in postmenopausal women, and to treat a rare bone disease called Paget’s disease.
While Fosamax is supposed to increase bone density and prevent the complications caused by bone loss in people at risk for osteoporosis, in some patients the opposite happened. Many women who took this drug reported a weakening of the femur that led to fractures, and even death of bone tissue in the jaw, a painful condition. Lawsuits have been filed, and some have already been settled, accusing Merck of failure to warn and selling a drug that causes harm and carries serious risks.
Why Women Are Suing over Fosamax
Fosamax lawsuits have numbered in the hundreds, started by women who suffered from serious and painful conditions they claim were a direct result of using this drug. Most cases have focused on a condition called osteonecrosis, bone death, which has caused women serious pain and loss of bone in the jaw. Some women have also experienced fractures in the femur bone, and painful damage to the esophagus and have sued Merck over these conditions.
The women who have started lawsuits did so because they believe that Merck did not warn them about the risks of taking Fosamax. They feel wronged by the fact that they took a drug that was supposed to counteract bone loss, and instead ended up with bone death, fractures, or both. The complications from the drug in some women have caused pain, permanent damage, and a need for a lot of invasive and expensive medical treatment. These women want justice and financial compensation for their suffering.
Fosamax is Merck’s brand name drug for treating and preventing osteoporosis. As we age, we lose bone density naturally, but in some people, especially postmenopausal women, this bone loss becomes extreme. Osteoporosis causes bones to become weak and brittle and can lead to painful fractures and breaks and decreases mobility and quality of life. Medications that can prevent or treat this can make a big difference in a patient’s life.
Unfortunately, Fosamax has not proven to improve life for all patients. There are side effects like gas, vomiting, ulcers, dizziness, headaches, and swelling in the joints. There is also the potential for serious musculoskeletal pain, serious enough to warrant a special warning from the FDA in 2008. The pain becomes debilitating in some people.
Pushing Fosamax on Women
One of the biggest controversies over Fosamax is its use in the treatment of osteopenia. This is the normal, age-related bones loss that before Fosamax was not treated in most people. Some people have accused Merck of pushing Fosamax for the treatment of something that really never needed to be treated, thus exposing more women to the side effects and serious complications associated with the drug.
Merck actively pushed to get more bone density scanners in doctors’ offices by creating something called the Bone Measurement Institute. Under the guise of helping catch bone loss earlier, Merck made a case for prescribing Fosamax to more women. Now, doctors and other experts are questioning whether treating osteopenia, this minimal, natural bone loss, is necessary at all. Some say Merck pushed for it to make more sales of Fosamax, an important point to make in lawsuits against the company.
In 1997 the FDA issued a warning letter to Merck about its advertising and marketing messages. The letter warned the company that it was being dishonest in certain marketing materials. The FDA accused Merck of downplaying risks associated with taking Fosamax and overstated the benefits while also making outright lies and false statements about the drug. In lawsuits against Merck, these instances of unethical marketing help make the case in favor of the plaintiffs.
In addition to some of the uncomfortable and even painful side effects of Fosamax, this drug has been found to cause serious complications in some women. Some of these run contrary to what the drug is supposed to be treating. In some women hoping to prevent bone loss and resulting bone fractures, Fosamax actually caused them to suffer serious and painful femur fractures.
This particular complication was discovered to be most common in women taking the drug over a longer period of time. When the evidence came to light, from adverse event reports and research data, the FDA required that Merck include a warning on the drug label. Unfortunately many patients suffered painful fractures before the warning went into effect.
Esophageal Bleeding and Cancer
Fosamax has also been found to increase the risk of damage to the esophagus and even esophageal cancer. The esophagus is the tube that runs from the mouth to the stomach and some patients have experienced esophageal ulcers, bleeding, inflammation, and pain. This kind of damage causes chest pains, heartburn, and trouble swallowing.
Even more serious, one study found that taking Fosamax over the long term can increase the risk of developing cancer of the esophagus. The risk is as much as doubled and the type of cancer is both rare and potentially fatal.
While esophageal damage and femur fractures are serious, the complication that has caused the most uproar and led to most of the Fosamax lawsuits is osteonecrosis of the jaw. Osteonecrosis is the death of living bone tissue. Women taking Fosamax expected to have their bones get stronger, not die. What some of the unfortunate patients taking the drug experienced was pain and serious damage to the jaw bone.
The osteonecrosis of the jaw is most often seen in patients who had dental work done. Trauma to the jaw, such as from having a tooth pulled, resulted in poor healing and bone tissue death for some patients. These women experienced pain, swelling, exposed bone in the mouth, and in some cases serious infections. Osteonecrosis has to be treated or it gets progressively worse. For some women the ordeal ended with permanent disfiguration in the face.
Fosamax Lawsuits and Settlements
There are many reasons why women might sue Merck over Fosamax, from esophageal damage to painful leg fractures, to disfiguring osteonecrosis. Merck has proven to use unscrupulous methods to sell more of this drug including pushing it on women who may not have needed it and using unethical marketing techniques that downplayed the serious risks of using the drug.
Thousands of lawsuits have been filed over Fosamax, and while a court denied a class action suit, hundreds of the cases were consolidated into one multidistrict legislation case. The case was brought in New York where eventually Merck agreed to settle and pay $27.7 million to the plaintiffs who suffered from osteonecrosis of the jaw. The settlement resolved only a portion of the thousands of outstanding cases against Fosamax.
There have also been individual suits that resulted in settlements from Merck. In one case a woman in Florida who suffered from osteonecrosis won a jury-awarded settlement of $8 million, although the judge cut that amount to $1.5 million. In spite of these cases and settlements, Merck has denied any wrongdoing and continues to claim Fosamax is safe and effective.