Fosamax Trial Begins
The first of what are expected to be three bellwether cases involving the osteoporosis drug Fosamax began this week in New York. Plaintiffs in about 900 cases claim that Merck & Co. failed to warn that the drug may cause the death of jawbone tissue. Attorneys for the plaintiffs contend that Merck was aware of the potentially severe side effect as early as 1996.
The trial in New York of the first case of the group, filed by Shirley Boles, 71, will be one of three so-called bellwether cases that may point the way to out-of-court settlements.
Merck faced about 900 Fosamax cases as of June 30, including suits with multiple patients, the company said in an Aug. 3 regulatory filing. Whitehouse Station, New Jersey-based Merck, which is buying rival Schering-Plough Corp., had a reserve of about $42 million for the litigation, including lawyers’ fees, it said. It hasn’t set aside any money to pay damages, it said.
There are as many as 1,200 plaintiffs in state and federal cases, Merck says. Timothy O’Brien, a lawyer representing about 400 plaintiffs, said the number is closer to 2,000.
Sales of Fosamax last year, when the drug first faced U.S. generic competition, fell by half to $1.55 billion from $3.05 billion in 2007. Sales fell 44 percent to $261.3 million in this year’s first quarter, Merck reported in April.
On July 29, U.S. District Judge John Keenan said he won’t allow any evidence at the Boles trial about how much money Merck made on Fosamax since jurors might think any award would be “a drop in the bucket” for the company.
He also ruled out the possibility of punitive damages in the case and rejected Merck’s request to find in its favor without a trial.
Keenan last year denied the patients’ request to treat the litigation as a class-action, or group, lawsuit allowing them to ask for court-ordered medical monitoring of all Fosamax users.
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, or ONJ.
The patients claim Merck didn’t sufficiently warn about the drug’s risks when it changed the label in 2005. “They were the only drug company not to use the language that the FDA requested,” O’Brien said, referring to the U.S. Food and Drug Administration.
Bahe Cook Cantley & Nefzger PLC attorneys John Bahe, Shawn Cantley, and Brian Cook represent several plaintiffs from Kentucky in the Fosamax litigation.
