Last week, the judge overseeing the federal Fosamax litigation denied a motion for summary judgment filed by lawyers for Merck & Co. to dismiss a lawsuit filed by a woman who claims she developed osteonecrosis of the jaw after less than three years of continuous use of their osteoporosis drug.
Fosamax (alendronate sodium), which is manufactured by Merck, is a prescription medication used to treat osteoporosis by reducing the risk of fractures. It was approved by the FDA in October 1995 and has been used by nearly 20 million people.
Fosamax is part of a class of drugs known as bisphosphonates, which have been linked to an increased risk of a debilitating jaw bone condition known a osteonecrosis of the jaw (ONJ). While the drug is designed to strengthen bones, prolonged exposure to Fosamax has been linked to the detioration and rotting of the jaw bone.
Over 600 Fosamax lawsuits have been filed by individuals who claim to have suffered osteonecrosis as a result of the use of the osteoporosis drug. The federal court Fosamax litigation has been consolidated for pretrial proceedings in the U.S. District Court for the Southern District of New York, where Judge John F. Keenan is overseeing the cases.
On September 9, 2008, Judge Keenan entered an order that the court will not grant summary judgment at this time for Merck in a case that involves less than three years of continuous use of Fosamax.
“Whether or not Fosamax can cause ONJ in anyone before three years of use remains an open question that should be resolved uniformly on the basis of the scientific evidence generated after a full opportunity for discovery,” said Judge Keenan in the order.
The motion for summary judgment was filed in May by lawyers for Merck in the case of Jo Anne Gladin de la Fuenta, a resident of New Mexico who filed her Fosamax suit in April 2006. Gladin de la Fuenta alleges that she developed osteonecrosis of the jaw less than two years after she started taking Fosamax and a few months after she stopped taking the drug.
Although Merck generally denies that Fosamax can cause osteonecrosis of the jaw, their lawyers argued that Gladin de la Fuenta’s case cannot prevail since she only used Fosamax for 18 to 20 months continuously. In their motion, they relied on testimony from Dr. Robert Marx, an expert used by plaintiffs in the MDL, who has stated that a person is not at significant risk of osteonecrosis within the first three years.
The attorneys for Jo Anne Gladin de la Fuenta argued that it was premature to rule on the motion, as the court had not yet set any schedule for expert discovery. The case is one of 25 cases selected for “early trial / discovery” in the mutidistrict litigation. After fact discovery is complete, three of the 25 cases are to be selected for trial, at which point the parties are supposed to conduct expert discovery.
By denying the motion for summary judgment, the attorneys for Gladin de la Fuenta will have an opportunity to retain an expert, have them review a complete set of her dental and medical records and arrange for her to be examined by the expert for purposes of offering testimony about the viability of a Fosamax lawsuit when the user has not used the osteoporosis drug for three years or less.