The fourth Fosamax trial in the United States is set to begin this week in New Jersey state court, involving a lawsuit filed by a Florida woman who alleges that she developed jaw necrosis from the popular osteoporosis drug.
Jury selection began on Wednesday in the Superior Court for Atlantic County, New Jersey, in a Fosamax lawsuit filed by 75 year-old Carolyn Hester, who was diagnosed with a painful and debilitating jawbone disease, known as osteonecrosis of the jaw (ONJ), after being prescribed Fosamax in 1999.
The trial will be the fourth lawsuit over Fosamax jaw problems to reach a jury in the United States, with the other three occurring in federal court.
Fosamax (alendronate sodium) is a member of a class of drugs known as bisphosphonates, which have been associated with decay of the jawbone when taken long-term or at high doses. With a very long half-life of 10 years, lawsuits over Fosamax allege that dose accumulation over time increases the risk of jaw necrosis, which causes portions of the jaw bone to die and may result in the need for surgery to remove portions of the jaw.
Approved by the FDA in October 1995, Fosamax has been used by more than 20 million people and generated annual sales of more than $3 billion a year for Merck before the medication became available as a generic.
There are more than 1,000 Fosamax lawsuits pending in state and federal courts across the country against Merck, including about 400 that have been centralized for “mass tort” treatment in New Jersey state court before Judge Carol E. Higbee in Atlantic County.
The New Jersey Fosamax trial will be the first case heard by a jury at the state court level. The previous three trials took place in federal court, where hundreds of lawsuits have been consolidated as part of a multidistrict litigation (MDL) in the U.S. District Court for the Southern District of New York before Judge John F. Keenan.
These early trials, known as Fosamax bellwether lawsuits, are used as test cases to help the parties measure how juries are likely to respond to evidence, witness testimony and arguments that will be presented throughout other cases in the Fosamax litigation. The cases are selected so that the results may help the parties reach a potential Fosamax settlement agreement without having individual trials in hundreds of different courts.
The first bellwether trial, involving a lawsuit brought by Shirley Boles, ended in a mistrial in September 2009, after jurors failed to come to an agreement about whether Fosamax caused ONJ suffered by the plaintiff. Boles’ case was later retried and resulted in an $8 million verdict that Keenan ruled was excessive. Boles has elected to have another trial rather than accepting Keenan’s reduced award of $1.5 million.
In a press release issued by Merck officials this week, the drug maker indicated that they intend to argue that Hester’s jaw problems were not from Fosamax, but were a result of other causes, including a history of dental treatments and steroid medications.
In addition to jaw necrosis lawsuits, Merck also faces a growing number of Fosamax femur fracture lawsuits that have been filed by individuals who have suffered a fractured femur after a low-impact or no-impact fall. In October, the FDA issued an alert to warn doctors and consumers about a potential link between Fosamax and femur fractures, requiring new information to be added to the warning label for Fosamax and other similar medications.