Fosamax Lawsuit Underway

In the latest Fosamax legal news, the opening statements were recently made in the Secrecst v. Merck trial. Both the plaintiffs and defendants will be paying close attention to this case in an attempt to glean insight as to how each sides attorneys intends to swing the jury's opinion.

According to court documents, the plaintiff Linda Secrest is alleging that she contracted a painful and debilitating disease known as osteonecrosis of the jaw (ONJ) as a direct result of her taking the osteoporosis drug Fosamax. Unfortunately for the defendant Merck, the Secrest case is only one of more than a thousand claims that have been filed against the manufacturer of Fosamax, Merck & Co. That said, the Secrest case is only the fifth case of its kind against Merck to be taken to trial, the previous four cases regarding allegations of osteonecrosis of the jaw brought on by Fosamax resulted in Merck's successful defense in all but one of the trials.

The plaintiff's attorney's directly spoke to the jurors in their opening statements of the trial made on September 8, 2011. The legal team asserted several arguments: their belief that Fosamax can cause the onset of ONJ, that Merck was fully aware Fosamax had the potential to cause ONJ, that Merck neglected to look further into Fosmax's ability to cause ONJ, and that Merck grossly overstated how well Fosamax worked. More to the point, the plaintiff's attorneys directly indicated that their client's injuries were avoidable and unable to heal.

The defense's attorneys sought to rebuff the plaintiff's allegations that Fosamax caused her debilitating condition by indicating that a long history of dental and oral complications were the cause for the severe injuries to her jaw. The defense counsel went on to assert that Fosamax is not a defective drug and that the drug's manufacturer Merck thoroughly investigated osteonecrosis as related to the drug, and was unable to find any conclusive evidence.

Merck Makes Preparations to Defend Fosamax Femur Fracture Lawsuits

In addition to the ONJ related trials, Merck is having to defend itself in another Fosamax related multidistrict litigation (MDL). The MDL was created late in May of 2011 in order to address an ever growing volume of lawsuits that alleged Fosamax caused the breakage of thigh bones after only a slight impact or no impact at all. This latest MDL currently contains several hundred claims, though most legal experts agree that they expect that number to increase greatly over the next few months. The first Fosamax femur trial is expected to begin in April 2012.

Fosamax Class Action

In addition to the several hundred arbitration lawsuits (better known as "individual" lawsuits), there are two class action lawsuits on the books as having been initiated against drug manufacturer Merck & Co. in relation to Fosamax and its links to a medical condition known as osteonecrosis of the jaw (ONJ) - an extremely painful and most often disfiguring condition that currently has no cure without a cure.

Litigation Timeline

2006: A class action lawsuit was in April of 2006 at the U.S. District Court located in Fort Meyers, Florida. The suit was filed againgst drug company Merck and alleges that Fosamax was the cause of osteonecrosis of the jaw developing in some of the patients taking the drug.

2007: An additional class action suit was filed claiming that Merck Frosst Canada had failed to properly notify and warn consumers that one of the company's medications were associated with a higher risk of contracting osteonecrosis of the jaw. Additionally, this same class action names New Jersey parent company, Merck & Co., as one of the defendents

Merck disclosed that the company has earmarked $48 million for a defense fund to fight the cases against them that allege Fosamax causes osteonecrosis of the jaw. The vast majority of these cases were filed in federal courts.

2008: The U.S. District Court for the Southern District of New York deferred multiple cases to the state courts in Floriday, California and Illinois in July of 2008. Additionally, the Court attributed the fees and costs of the removing the cases from federal court to Merck.

2010: The Manhattan based federal district court scheduled the Boles v Merck retrial for the 7th of June, 2010. Attorneys for the plaintiff have stated their intent to sequester a Merck witness in order to establish that Merck had been notified by FDA to change the labeling for Fosamax labeling in 2007.

On January 29th, a federal judge Manhattan decided not to throwout a lawsuit that alleges Fosamax was the cause for jaw damage suffered by an Indiana woman.

The aformentioned cases all allege that Merck & Co. did not properly research and study Fosamax, nor did they warn about the dangers of ONJ and associated jaw problems. To date, there are close to 900 civil lawsuits that have been filed against Merck & Co. in relation to Fosamax

FDA Warns Fosamax May Cause Bone Fractures

Fosamax and its class of osteoporosis drugs increases the chances of a bone fracture, according to a warning to doctors and patients released by the Food and Drug Administration (FDA) on Wednesday. The FDA has asked for a change in how the Warnings and Precautions section is labeled on all bisphosphonate products. Bisphosphonates are a class of drugs primarily used to treat the symptoms of osteoporosis, a bone disease that weakens the bone's density and can make it more likely to break. According to the FDA, this class of drugs must now be accompanied by a medication guide that alerts people taking the drug of its risks.

The FDA warning comes as the result of a rare type of bone fracture repeatedly occurring in patients receiving these drugs. Currently, many doctors believe that the risk of bone fracture are rare and more closely associated with patients who have long-term bisphosphonate use. "There is a dull aching thigh or groin pain that occurs weeks or months before the fracture occurs," Dr. Sandra Kweder, deputy director, Office of New Drugs in the FDA's Center for Drug Evaluation and Research. "It is predominantly in patients who have taken bisphosphonates for five years or more."

The changes to be made on the warning labels are will only occur on bisphosphonates that have been approved for osteoporosis treatment. These drugs include: Actonel, Actonel with Calcium, Atelvia, Boniva, Fosamax, Fosamax Plus D and all of their respective generic versions. Included in the changes of warning labels are the injectable osteoporosis drugs like Boniva and Reclast Reclast. Bisphosphonates that are labeled for use in the treatment of other diseases will not be affected.

The FDA first began studying the side-effects of bisphosphonate use and the frequency of the bone and femur fractures in March. The FDA was also made aware of and reviewed a report issued by the American Society for Bone Mineral Research Task Force. The report made a strong recommendation to add additional labeling, in addition to adding a system that would identify and track patients with femur and bone breaks.