Merck’s Fosamax Didn’t Attack Woman’s Jaw, Jury Told

-Bloomberg

09/02/2009 - Merck & Co. didn’t cause a Florida woman’s “jaw death” with its osteoporosis drug Fosamax, a lawyer for the company told jurors at the close of the first trial of hundreds of claims over the medicine.

Fosamax plaintiffs say Merck, the U.S. drugmaker buying Schering-Plough Corp., misrepresented the drug’s safety and failed to warn doctors and patients that it might hamper blood flow to the jaw, which causes jawbone-tissue death. They also accuse Merck of failing to include an adequate warning about Fosamax’s risks when the label was changed in 2005.

Shirley Boles, 71, of Fort Walton Beach, Florida, said she used the drug from 1997 to 2006 and by September 2003 developed jawbone death, called osteonecrosis of the jaw, or ONJ.

“When you’re grounded in science, as we are in this courtroom, there is no scientific evidence that Fosamax causes ONJ,” Paul Strain, a lawyer for Merck at Venable LLP in Baltimore and Washington, told jurors today in his closing arguments in federal court in New York.

Merck, based in Whitehouse Station, New Jersey, as of June 30 faced about 900 Fosamax cases, including suits with multiple patients, the company said in an Aug. 3 regulatory filing. Merck had a reserve of about $42 million for the litigation, including legal fees, and hadn’t set aside money to pay damages.

Plaintiff’s Arguments

Boles’s attorney, Timothy O’Brien, told jurors today the evidence shows Fosamax caused her injury, which requires her to sleep with a towel near her jaw because puss oozes from it and to refrain from playing with her 18-month-old grandson for fear that he’ll break her jaw.

Boles deserves “a weight of at least $1 million” to “bring the scales of justice back to even,” O’Brien told the jury in discussing damages.

The eight-member panel began its deliberations after lawyers finished their closing arguments.

The trial summations became a battle of the experts, because Boles called experts who said Fosamax causes ONJ and Merck had others who said it doesn’t.

“Fosamax caused Shirley Boles’s ONJ,” said O’Brien of O’Brien, of Levin Papantonio Thomas Mitchell Echsner & Proctor PA in Pensacola, Florida. Strain said Boles’s own experts defined ONJ as exposed bone and the evidence showed she had no exposed bone in October 2003.

U.S. District Judge John Keenan, who’s presiding over the case, ruled that Boles had her injury by October 2003 and couldn’t present evidence about Merck’s behavior after then.

Bone-Turnover Process

O’Brien said Fosamax causes ONJ by oversuppressing the bone-turnover process that creates new bone. Strain told jurors there was “no scientific basis” for that theory.

Strain told jurors the evidence showed Merck didn’t have notice by October 2003 of any problems with the drug, while O’Brien said that, at minimum, it had reports of problems with five patients.

The two sides also disagreed over whether the drug helped Boles.

“When Mrs. Boles was on Fosamax, her bone mineral density was maintained,” Strain told the jury. She went off the drug in 2006 and “she’s now fully osteoporotic,” he said.

O’Brien said the drugmaker told Boles’s doctor that Fosamax was appropriate for her, when it knew the medicine wouldn’t reduce the risk of fractures in women with her bone density, which wasn’t as severe as someone with osteoporosis.

“There is no evidence that this drug works to prevent fractures in women like Shirley Boles,” O’Brien said.

Bellwether Trials

Keenan, with about 700 cases in his Manhattan courtroom, scheduled three so-called bellwether trials that may point the way to out-of-court settlements and show each side the other’s strategy. The judge earlier ruled out the possibility of punitive damages in Boles’s case.

Boles is a retired deputy in the Okaloosa County Sheriff’s Office. Her doctor prescribed Fosamax because of a stress fracture in her foot, she testified at the trial. She eventually developed problems in her mouth.

“I had a lump come up on my jaw,” she testified. “It was like a big lump, and it was throbbing and painful.”

Fosamax, available in pill or liquid form, is part of a group of medicines known as bisphosphonates.

Sales of the drug last year, when it first faced U.S. generic competition, fell by half to $1.55 billion from $3.05 billion in 2007. Sales dropped 44 percent to $261.3 million in this year’s first quarter, Merck reported.

Federal-court trials are scheduled for December and January, according to court papers and Merck’s regulatory filing. A trial is scheduled in Alabama state court later this year, according to Merck.

About 140 other Fosamax cases are before Judge Carol Higbee in state court in Atlantic City, New Jersey, Merck said.

The lawsuits are combined in In Re Fosamax Products Liability Litigation, MDL 1789, U.S. District Court, Southern District of New York ( Manhattan).