The first lawsuit over injuries stemming from Merck's biophosphonate osteoporosis drug, Fosamax, and its link to osteonecrosis of the jaw, or ONJ, has begun in New York. Product liability lawyers say that between 1,000 and 2,000 lawsuits have been filed against the pharmaceutical giant alleging that the manufacturer misrepresented the drug’s safety and failed to warn doctors and patients about the possibility of jawbone tissue death.

Details of the first case

The first Fosamax (link to ) lawsuit to go to trial involves 71 year old Shirley Boles. According to news reports, the Walton Beach Florida woman used Fosamax from 1997 to 2006 and eventually developed osteonecrosis of the jaw (ONJ). She alleges that Merck had a duty to change the Fosamax label to warn doctors about a connection to the disease as early as the mid-1990s.

While Fosamax attorneys say that as many as 2,000 similar lawsuits have been filed against Merck, the manufacturer denies these allegations, saying that there is no reliable evidence that Fosamax caused ONJ. However, plaintiff lawyers say that they have evidence that Merck actually did know about these issues as early as 1996 and that the company may have also created fake medical journals in order to boost sales of the product.

How the first case may affect others

This first bellwether (test) case will basically set a precedent for the many other Fosamax / ONJ cases to follow. It allows both sides to see how a jury will react to evidence, testimony and whatever else occurs during the trial and make a determination about whether future cases should be tried or whether Merck will decide to settle the cases out of court.

“Three year” controversy

One of the controversial issues in these cases is whether Fosamax patients can contract ONJ by using the drug for less than three years. Part of the confusion stems from the testimony of a Dr. Robert Marx.. The chief of oral surgery at the University of Miami School of Medicine, Marx originally stated that Fosamax could not cause ONJ if taken for less than three years. Even though he has since recanted that statement, Merck is still seeking to dismiss those product liability cases in which patients used the drug for less than that time – based on Marx's first statements.