Fosamax and its generic version, Alendronate Sodium, is a bisphosphonate, a class of drug designed to prevent bone loss and aid in the treatment of osteoporosis. Fosamax was approved for use by the FDA in 1995 and several other bisphosphonates and their generics gained approval shortly thereafter, with Actonel joining the market in 1997 and Boniva in 2003.
Evidence suggests, however, that long term use of bisphosphonates can lead to spontaneous atypical femur fractures (AFF) in those taking the drug, leading to excruciating femur breaks, often necessitating a need for surgical repair.
In 2010, the FDA updated safety information on the label of Fosamax and other bisphosphonates warning of the increased risk of AFFs.
In September 2011, the FDA again recommended increasing the cautionary language on the product labels for bisphosphonates, including Fosamax, Actonel, and Boniva.
A Multi District Litigation (MDL) for Fosamax femur fractures was created in 2011 in the United States District Court for the District of New Jersey (2243). In California, the Judicial Counsel Coordinated Proceedings (JCCP) was created in Orange County Superior Court in front of Judge Ronald Bauer (4644).
Partners Steven Skikos and Mark Crawford were both appointed by the judge to serve as Co-Lead Counsel in the California JCCP, and also serve on the Plaintiff’s Executive Committee.