First federal trial of Merck & Co's Fosamax declared a 'mistrial'

US drug major Merck & Co says that a mistrial was declared by US District Court Judge John Keenan in Bole versus US drug major Merck, the first Fosamax (alendronate) case to go to trial. This case was the Plaintiffs' Steering Committee's first choice to take to trial. The Boles case was tried in New York federal court and involved a Florida woman who blamed her dental and jaw problems on the osteoporosis drug Fosamax. After several days of deliberations by an eight person jury, Judge Keenan declared a mistrial because the jury did not reach a unanimous verdict.

Fosamax had peak sales of $3.2 billion in 2005, but these have plummeted on the entry of generic competition, particularly after that happened in the USA in early 2008. Global sales for the first six months of 2009 totaled just $539 million. Merck faces law suits by roughly 1,500 plaintiffs who allege Fosamax caused the same painful jaw condition that Ms 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

'The plaintiff failed to prove her case before this jury," said Paul Strain of Venable LLP, outside counsel for Merck. "The jury notes included one presented to Judge Keenan on September  9 signed by seven of the eight jurors, including the jury foreperson, stating that the seven jurors 'agree that there is no evidence of proof that Fosamax caused Ms Boles injury," he added.

At trial, Merck said it presented evidence that it acted responsibly and that Fosamax was not the cause of Shirley Boles' dental and jaw problems. 'Unfortunately, Ms Boles had medical problems that cause people to develop jaw problems, regardless of whether they were taking Fosamax,' said Mr Strain. 'She had significant periodontal disease and a history of smoking up to a pack of cigarettes a day, which can result in poor wound healing. The plaintiff would have experienced dental and jaw-related problems whether she took Fosamax or not.'

'We will be prepared to defend this case again if a retrial is scheduled,' said Bruce Kuhlik, executive vice president and general counsel of Merck. 'We continue to believe that the company provided appropriate and timely information about Fosamax to consumers and to the medical, scientific and regulatory communities.'