Bisphosphonate Mass Litigation Going Strong

Courts of law in the United States and Canada have adopted multiple district litigation (MDL) hearings as a strategy for dispensing justice to complainants seeking compensatory damage claims over Fosamax, media reports say. Intravenous and oral formulations are both included in complaints against bisphosphonate medications.

Biphosphonates, which is a popular class of osteoporosis medication, has been involved in legal controversy for the last few years. Studies have concluded that taking bisphosphonates like Fosamax, Actonel, Aredia or Zometa could lead to higher risks of atypical femur fracture and osteonecrosis of the jaw. Drug companies responsible for producing and marketing bisphosphonates, among which Merck and Co. is the most recognized.

In 2000, the FDA began to receive an increasing number of complaints about occurrences of a rare condition known as osteonecrosis of the jaw. While this complication was originally thought to be linked to intravenous bisphosphonate use, later reports show that oral bisphosphonates such s Fosamax are just as culpable.

Osteonecrosis of the jaw or “dead jaw” syndrome is a disfiguring condition that causes the jaw bone to die. The symptoms of this condition are gum and jaw pain, infection, tissue necrosis, numbness, loss of teeth, and impaired wound healing. On September 24, 2004 an FDA advisory ordered Merck to upgrade their warning list for Fosamax to include osteonecrosis of the jaw, which has since made legal claims of negligence against the company hard to bring to trial. Later in May 13, 2007 hundreds of cases were filed and pending trial against Merck and Fosamax related complaints which alleged that the drug company was responsible for profiting off the misfortune of patients who were mislead into taking the osteoporosis drug.

The first bellwether lawsuit against Merck for osteonecrosis of the jaw resulted in mistrial but regardless has since opened the door for more suits to follow against the bone drug manufacturer. Five more lawsuits were later tried and ended in victory for the pharmaceutical company except one which was appealed and yet to brought to superior court. Most of these subsequent court cases have ruled that Merck was not responsible for causing damages to the plaintiffs for their use of Fosamax related complications and further determined that the cause of osteonecrosis of the jaw is relatively unknown and not necessarily due to taking Fosamax.

Despite the string of victories in favor of Merck in trials involving osteonecrosis of the jaw, lawsuits are continually being brought against the medication company. In recent years, lawsuits alleging that Merck is responsible for patients suffering atypical fractures from taking Fosamax are still awaiting trial. As of 2011, approximately 2,345 cases, which include approximately 2,800 plaintiff groups, had been filed and were pending against Merck in either federal or state court in both Canada and the US.

URL References:

• canada.com/topics/news/national/story.html?id=80c4d7e8-123f-48a5-a914-e1146388d2a8&k=54519
• merck.com/newsroom/news-release-archive/corporate/2012_0418.html