A new trial is scheduled to begin next Tuesday for the Fosamax bellwether case that ended in a mistrial last fall, after a jury could not come to a decision about whether side effects from Fosamax, a Merck & Co. osteoporosis medication, caused a woman’s jaw bone to decay.Â
The Fosamax lawsuit involves a claim by 71 year-old Shirley Boles, who claims that she developed osteonecrosis of the jaw in 2003 after using the drug for a number of years. Boles alleges that Merck failed to adequately warn about the risk of the jaw damage from Fosamax, which is associated with death of the bone, often resulting in infection and portions of the jaw bone becoming exposed inside the mouth.
According to a scheduling order issued earlier this month, U.S. District Court Judge John Keenan, who is overseeing the pretrial proceedings for the federal Fosamax litigation, set a retrial date for June 2 in the Boles case. The trial is expected to take about two weeks.
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Fosamax (alendronate sodium), is a member of a class of drugs known as bisphosphonates, and is prescribed for treatment of osteoporosis. Fosamax was approved by FDA in October 1995, and has been used by more than 20 million people. The drug generated over $3 billion in annual sales for Merck before it became available as a generic last year.
Merck faces nearly 1,000 other lawsuits against Fosamax that involve similar allegations that users of the drug suffered jaw decay. All federal cases are consolidated before Judge Keenan in the U.S. District Court for the Southern District of New York as part of an MDL, or multidistrict litigation.
Boles’ case was the first of three Fosamax bellwether cases selected for an early trial to help give the parties an idea of how juries will respond to evidence that may be similar to what will be presented in other cases. Such trials are often useful in gauging the strengths and weaknesses of common claims in complex litigation, and could help lead to an eventual Fosamax settlement.
In September 2009, Judge Keenan declared a mistrial after several days of tense jury deliberations at the conclusion of Boles’ first Fosamax trial. The eight jury members were unable to reach a unanimous verdict in the case, though media reports suggested that most of the jurors were siding with Merck.
Earlier this month, the second Fosamax bellwether trial, involving a claim filed by Louise H. Maley, ended in a defense verdict for Merck after the jury determined that the plaintiff did not suffer osteonecrosis of the jaw from Fosamax. That jury agreed with Merck’s position that multiple medical conditions suffered by Maley could have caused her jaw and dental problems, so they never considered whether the drug maker failed to adequately warn about the risk of Fosamax jaw problems.
A third bellwether Fosamax case in the MDL is expected to go to trial in November.
In addition to the jawbone decay claims, Merck also faces a growing number of lawsuits over Fosamax femur fractures. Although Fosamax is designed to strengthen the bones and reduce the risk of fractures associated with osteoporosis, the drug has been linked to a number of non-impact femur fractures, which are allegedly caused by Fosamax side effects weakening the ability of the bone to repair itself from microdamage.
2 Comments
RitaMay 30, 2010 at 5:11 am
On Sept. 20th 2008 I stood up from my recliner, took two steps and went to the floor because my right femur broke. I had had pain in the right thigh for almost a year prior, but never related it to my femur. I had been taking Fosamax for ten years prior to this fall for ostioperosis. I did not connect the break to Fosamax until recently. I found out many other women on Fosamax experienced simi[Show More]On Sept. 20th 2008 I stood up from my recliner, took two steps and went to the floor because my right femur broke. I had had pain in the right thigh for almost a year prior, but never related it to my femur. I had been taking Fosamax for ten years prior to this fall for ostioperosis. I did not connect the break to Fosamax until recently. I found out many other women on Fosamax experienced similar fractures, with prior thigh pain. I stopped taking Fosamax immediatly. In March of 2003 my cerebral Palsied daughter, Mary Therese Prassa, was being turned in bed by her caregiver and sustained a spiral fracture of her right femur which failed to heal until she had a second surgery and a long metal plate was insereted with screws. Mary Therese was on Fosamax for about five years at that time. She is not ambulatory and uses a geri chair each day for comfort. After the recent news reports of femur fractures connected with Fosamax I feel certain both mine and my daughter's fractures were caused by Fosamax. The ironey of the whole thing is the Fosamax has not improved our bone condition.
GailMay 26, 2010 at 12:14 am
My mother took Fosamax for 6 years but stopped in 2004 when my sister read an article about how Fosamax was possibly linked to problems. Now my mother has an infection and has started to show signs of jawbone decay. She has never been a cancer patient. We have been trying to find a good dental specialist for her to see. She is scared that she will lose her jawbone. This is a woman who has always b[Show More]My mother took Fosamax for 6 years but stopped in 2004 when my sister read an article about how Fosamax was possibly linked to problems. Now my mother has an infection and has started to show signs of jawbone decay. She has never been a cancer patient. We have been trying to find a good dental specialist for her to see. She is scared that she will lose her jawbone. This is a woman who has always been in excellent health and taken very good care of her teeth for over 80 years and now this. All because a Doctor told her it was to prevent a bone loss she didn't even have!