By the time this issue is received, the first Fosamax trial should have began in a New York court. The trial was scheduled to start on August 11th. Merck & Co., the drug maker, faces a tremendous number of lawsuits over claims that its osteoporosis drug Fosamax causes the death of jawbone tissue. The outcome in the New York case may affect the others. This case, filed by Shirley Boles, 71, is being called one of three bellwether cases that is being watched closely.
As of June 30th, Merck faced about 900 Fosamax cases, including suits with multiple patients. Merck, which has bought rival Schering-Plough Corp., has set up a reserve of about $42 million for the litigation. There are as many as 2,000 plaintiffs in the state and federal Fosamax cases.
The judge, who will preside over the Boles’ case, has ruled out the possibility of punitive damages in the case, but he rejected Merck’s motion to find in its favor without a trial. Last year, the Plaintiffs’ request to treat the litigation as a class-action lawsuit, which would have allowed the Plaintiff to ask for court-ordered medical monitoring of all Fosamax users, was denied. The Fosamax Plaintiffs claim Merck misrepresented the drug’s safety and failed to warn doctors and patients that it might hamper blood flow to the jaw, causing jawbone-tissue death and leading to partial removal in some patients. Jawbone tissue death is called osteonecrosis of the jaw, (ONJ). The Plaintiffs claim Merck didn’t sufficiently warn about the drug’s risks when it changed the label in 2005.
Fosamax, available in pill or liquid form, is part of a group of medicines known as bisphosphonates. The only cases of jaw necrosis have been found in the drugs’ users and cancer patients receiving chemotherapy, according to Mahyar Etminan, a pharmacy expert for the Plaintiffs.
Ms. Boles used Fosamax from 1997 to 2006 and eventually developed osteonecrosis. Merck had a duty to change the Fosamax label to warn doctors about a connection to the disease as early as the mid-1990s. But, the drug manufacturer failed to do so. Merck had notice of the problems through adverse reports starting in 1996. The company has thousands of reports of jawbone loss related to Fosamax. Patients with dental problems are most vulnerable to developing ONJ by using Fosamax. Those are the people who are the most at risk.
In the Boles’ case, oral maxillofacial experts, but not an epidemiologist, will be allowed to testify that Fosamax causes osteonecrosis of the jaw. Merck’s lawyers had sought to exclude testimony on general causation by four Plaintiffs’ experts: three oral maxillofacial experts and an epidemiologist. The court held that the testimony of the oral maxillofacial experts was admissible, but granted Merck’s motion to exclude the testimony of the epidemiologist on general causation. The judge wrote:
In forming their opinions on general causation, [the oral maxillofacial experts] rely upon their clinical experience in treating ONJ, understanding of the physiology of the jaws and the pharmacology of bisphosphonates, and review of the available scientific literature and evidence. Their theory on the mechanism of causation is generally accepted as biologically plausible. In addition, they formed their opinions independently of litigation, have published them in leading peer-reviewed journals, and frequently are cited by others in the field.
But the judge ruled that the Plaintiffs’ steering committee did not show that the epidemiologist reached his general causation opinion in this case by applying the same level of intellectual rigor that characterizes his work as an epidemiologist in the field.
Federal court trials are scheduled for December and January. We have a case set for trial in Alabama state court starting on October 21st. About 700 of the lawsuits have been consolidated before one judge in a New York federal court for discovery purposes only. About 140 cases are before Judge Carol Higbee in state court in Atlantic City, New Jersey. The New York suits are combined in In Re Fosamax Products Liability Litigation, MDL 1789, U.S. District Court, Southern District of New York (Manhattan). The firm of Levin Papantonio Thomas Mitchell Echsner & Proctor PA in Pensacola, Florida, represents Ms. Boles in her case.
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