Merck & Co. lost a legal bid to dismiss 24 lawsuits claiming its osteoporosis drug Fosamax causes ‘jaw death’ in patients who took the medicine for fewer than three years.
U.S. District Judge John Keenan in New York, in a ruling released today refused to dismiss the lawsuits, saying that whether there is a three- year threshold is a “genuine issue of fact for trial.” The plaintiffs claim Fosamax causes osteonecrosis of the jaw, or ONJ.
“This simply reflects what’s been known in the science for a while now, that there is no magic window where a patient can be automatically said to be safe from developing ONJ after beginning Fosamax,” Tim O’Brien, one of the plaintiffs’ lawyers, said of Keenan’s ruling.
The ruling comes in cases separate from one on trial before Keenan in Manhattan federal court. Jurors in that case are deliberating on whether Fosamax caused a Florida woman’s ONJ.
Keenan ruled that a plaintiffs’ expert, Robert Marx, can’t testify on the three-year issue because he previously said Fosamax doesn’t cause ONJ in patients who take the drug for less than that period. The judge said testimony by two other plaintiffs’ experts could be admitted because they never opined on the time limit.
“Judge Keenan did not rule that Fosamax causes jaw injury,” according to Casey Stavropoulos, a Merck spokeswoman. “He only ruled that plaintiffs may attempt to prove that Fosamax causes jaw injury in future cases. The court also ruled appropriately in prohibiting a large part of future testimony by plaintiffs expert Dr. Marx.”
Marx is chief of oral surgery at the University of Miami School of Medicine in Florida.
Marx began to change his mind on the three-year threshold in early 2008, according to Keenan’s ruling.
“On balance, the court finds that the” plaintiffs “failed to show that Dr. Marx’s new opinion on the three-year issue is sufficiently reliable to be admitted,” Keenan wrote.
Merck, based in Whitehouse Station, New Jersey, faced about 900 Fosamax cases as of June 30, including lawsuits with multiple patients, the company said in an Aug. 3 regulatory filing.
There are as many as 1,200 plaintiffs in state and federal cases, Merck said. O’Brien, who represents about 400 plaintiffs, said the number is closer to 2,000. Plaintiffs in the 24 cases covered by today’s ruling submitted a profile form disclosing Fosamax use for fewer than three years, according to Keenan.
Last month, the company estimated that about 25 percent of the Fosamax plaintiffs took the drug for fewer than three years. O’Brien said at that time it could be as many as 40 percent.
A federal jury started deliberating Sept. 2 in the case of Shirley Boles, 71, of Fort Walton Beach, Florida. Boles’s is the first of three so-called bellwether cases that may point the way to out-of-court settlements. Boles took Fosamax for more than three years.
The federal lawsuits are combined in In Re Fosamax Products Liability Litigation, MDL 1789, U.S. District Court, Southern District of New York (Manhattan).
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