Update on Fosamax Lawsuits

February 21, 2013

575021_x-rayed.jpgWith seven trials already concluded, more than 4,000 Fosamax lawsuits are currently pending in state and federal courts. Fosamax lawyers at Pintas & Mullins report that, in the latest verdict, Merck & Co was ordered to pay $285,000 to a plaintiff who argued that the manufacturer failed to warn her about the serious health risks associated with the drug.

This most recent trial took place in U.S. District Court in Manhattan. The plaintiff argued that Merck & Co failed to warn her of Fosamax's risk of bone jaw degradation, and that the company sold her a defective product. The eight-person jury granted her the $285,000 for her injuries, which included development of a bone disease and delayed healing, although the jury rejected her claim that Fosamax was a defective drug.

This trial was part of Fosamax's preliminary "bellwether" litigation. For widespread mass lawsuits involving plaintiffs with similar claims and injuries, (such as for Mirena and Depuy Hip Replacements) judges often order bellwethers to analyze the claims and determine how the other cases will play out. So far in these initial Fosamax bellwether cases Merck has lost two trials.

The plaintiff in this case suffered severe dental and jaw bone injuries, which at least 975 other plaintiffs are alleging as well. Osteonecrosis of the jaw is a known side effect of Fosamax, and develops when the jaw bone does not heal after minor surgery, causing the bone tissue to die. Each year, about 1 in every 1,000 women taking Fosamax will develop the condition. The drug was originally intended to treat osteoporosis, particularly in postmenopausal women.

Fosamax was approved in 1995, and since then, reports of increased bone fractures and developments of osteonecrosis have become more and more frequent. More than a decade after its approval, the FDA sent a letter to Merck requesting the company make significant changes to its safety labels. In the letter, the FDA cites a 2010 report by the American Society for Bone and Mineral Research, which found that the risk of bone fractures increased with higher durations of bisphosphonate exposure. Bisphosphonate is the main ingredient in Fosamax.

The FDA requested Merck add information to the indications and usage section of the Fosamax label. Among the changes included indicating that patients should be re-evaluated on a regular basis to see if they need to continue the drug. It also included detailing the extent of the increased risk of atypical, low trauma, and low-energy femur fractures. These fractures are especially dangerous because they most often occur with minimum impact to the femur, such as when patients are merely walking or standing up.

Patients at risk for a femur fracture may experience dull, aching pain in the thigh or groin a few weeks or months before the fracture occurs. To date, nearly 850 plaintiffs are alleging Fosamax directly caused severe femur injuries such as those outlined in the FDA letter.

The first lawsuit Merck lost in these bellwether trials was in 2010, also in Manhattan. The plaintiff in this case argued that she developed ostenecrosis of the jaw after taking Fosamax. Patients with osteonecrosis may require long-term antibiotic therapy and additional surgery to remove the dead bone tissue. Symptoms of the condition include pain, swelling, numbness, and infection of the jaw. The plaintiff was awarded $8 million by a jury, which the judge later reduced to $1.5 million.

From 1995 to 2008, Fosamax had annual sales of about $3 billion. Some doctors even started prescribing Fosamax to patients without osteoporosis as a preventative measure, subjecting those people to unnecessary risks. If you or someone you love was seriously injured by Fosamax, you may be entitled to compensation. Fosamax lawyers at Pintas & Mullins are currently accepting claims against Merck & Co.