Judge declares mistrial in 1st Fosamax trial

[September 12, 2009]  TRENTON, N.J. (AP) -- A federal judge declared a mistrial Friday in the first trial over whether Merck & Co.'s former blockbuster osteoporosis drug, Fosamax, causes painful jaw bone destruction.

Since Monday, jurors in the month-long trial in New York City had been telling the judge via a series of notes that they couldn't reach a verdict, with one holdout juror accusing others of intimidation. Lawyers waiting in the courtroom could hear loud voices coming from the jury room this week. One female juror -- apparently the holdout -- wrote in a note to the judge Wednesday that another juror had thrown a chair and one had threatened to "beat me up."

After just an hour of deliberations Friday, Judge John F. Keenan declared a mistrial in the case of plaintiff Shirley Boles.

The 71-year-old Fort Walton, Fla., woman alleged she developed severe dental and jaw-related problems in September 2003, six years after she began taking Fosamax, including repeated infections that drain through the bottom of her chin, loss of some bone tissue and inability to eat anything but soft food.

Boles' lawyer, Timothy O'Brien, said he expected the case of the retired sheriff's deputy to be retried in the spring, after two other Fosamax cases already scheduled by Keenan.

"Obviously, she would like a resolution, but she feels like she's done something important and she's ready to go again," O'Brien told The Associated Press. He had asked the jury to award damages exceeding $1 million, before deliberations began on Sept. 2.

O'Brien said the judge asked the jury forewoman early Friday afternoon whether jurors were making any progress and could possibly reach a verdict. By then, the five women and three men had deliberated less than 20 hours over five days.

"Absolutely not," the forewoman replied, according to attorneys for both sides.

The day before, the judge had given the jury a day off, to cool down after the alleged chair-throwing incident on Wednesday.

After the mistrial was declared, Paul Strain, the attorney representing Merck, said seven of the jurors had signed a note Wednesday indicating they agreed there was no proof Fosamax caused Boles' injury.

"This demonstrates what we've been saying all along, that is that Fosamax is a good medicine," Strain said.

Merck faces lawsuits by roughly 1,500 plaintiffs who allege Fosamax caused the same painful jaw condition that Boles now has -- osteonecrosis of the jaw, in which bone tissue dies and detaches from the gum. That causes difficulty with chewing or wearing dentures, among other problems.

Strain said that since July 2005, the drug's detailed package insert has stated that both Fosamax and a newer version that combines the drug with Vitamin D "may cause jawbone problems in some people. Jawbone problems may include infection, and delayed healing after teeth are pulled."

Merck attorneys had argued that in Boles' case, other factors were to blame. Their expert doctor testified that since at least the early '90s, Boles had suffered worsening infections in jawbone that eventually moved into the interior of the bone and eroded it. They also said the woman had smoked up to a pack of cigarettes per day, which they said can retard wound healing.

Strain said he requested that the judge permanently dismiss the case.

The trial began Aug. 11 in U.S. District Court for the Southern District of New York in Manhattan.

Fosamax was once Merck's second best-selling drug, and the heavily advertised pill dominated the category of bone-preserving osteoporosis drugs for years.

Fosamax had peak sales of $3.2 billion in 2005, but sales have plummeted as it got generic competition, particularly after that happened in the United States in early 2008. Global sales for the first six months of 2009 totaled only $539 million.

The drug was approved by the Food and Drug Administration in September 1995.

Merck General Counsel Bruce Kuhlik said in a statement that the company's patient studies, conducted both before and after approval, included more than 17,000 people treated with Fosamax. He said the company gave consumers, doctors and regulators "appropriate and timely information" about Fosamax.

Wall Street took little notice of the verdict, with Merck shares, which had been advancing all day, up 50 cents, or 1.6 percent, at $32.46 by late afternoon.

[Associated Press; By LINDA A. JOHNSON]

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