Lawsuit Filed Over Femur Fracture From Fosamax and Boniva Use

An Alabama woman is suing the makers of Fosamax and Boniva, alleging that the osteoporosis drugs caused her to suffer femur fractures and other bone problems. 

The complaint was filed by Ruth R. Plato and her husband, Reynold, in the U.S. District Court for the Southern District of Alabama in late January, naming Merck, GlaxoSmithKline and Roche as defendants.

According to the femur fracture lawsuit, Plato took Fosamax and Boniva for years believing they would help prevent osteoporosis. Instead she says they caused her to suffer low trauma femur fractures and bone brittleness.

Fosamax and Boniva are two different medications that are part of the same class of drugs, known as bisphosphonates, which are designed to prevent loss of bone made and treat postmenopausal osteoporosis.  However, long-term use of bisphosphonate medications have been linked to an increased risk of atypical femur fractures, which often occur with little or no trauma at all.

The complaint alleges that the drug makers failed to conduct proper post-marketing surveillance about the risk of femur fractures from Fosamax, Boniva and other oral bisphosphonate medications.

In October 2010, the FDA required new warnings about the risk of bone fractures from Fosamax and other bisphosphonate medications. As a result, consumers are now warned that they should seek immediate medical attention if they experience new groin pain or thigh pain while taking the drug, which can occur weeks or months before a complete thigh bone fracture may occur.

Merck currently faces a number of Fosamax femur fracture lawsuits, which have been centralized in federal court for pretrial proceedings as part of an MDL, or multidistrict litigation, in the U.S. District Court for the District of New Jersey.

Plato’s case is likely to be transferred to that MDL, as the U.S. Judicial Panel on Multidistrict Litigation indicated earlier this month that lawsuits involving the use of both Fosamax and Boniva, or Fosamax and Reclast, another bisphosphonate, will be consolidated with complaints filed by individuals who were only taking Fosamax.

Fosamax (alendronate sodium) is the most commonly used bisphosphonate medication in the United States, which was introduced by Merck in 1995.  The medication generated over $3 billion in annual sales before it became available as a generic in 2008.

Boniva (ibandronate sodium), which is manufactured by Roche, was approved in 2005 as a once-monthly treatment of postmenopausal osteoporosis, generating sales of approximately $975 million in 2010.