Oral Surgeon Testifies that Fosamax Causes ONJ
On June 10, 2010, the second full day of testimony in the Fosamax trial, Shirley Boles v. Merck, began with the video testimony of Linda Hostelli. Ms. Hostelli is the Vice President of Product Safety and Quality Assurance at Merck. She began by explaining Merck’s procedures for the investigation of potential side effects after a drug is approved and on the market. If seven reports of a particular side effect are received within a six month period, a label review team made up of physicians investigates. To establish that Merck knew or should have known about Fosamax’s alleged osteonecrosis side effects, the plaintiff’s counsel questioned Ms. Hostelli concerning various reports dealing with oral injuries by Fosamax users between the years 1996 and 2001.
The plaintiff’s next witness was Mrs. Boles’ oral surgeon, Dr. Charles Elwell, a former Air Force colonel. On direct examination, Dr. Elwell explained how he came to the conclusion that osteonecrosis was to blame for the deterioration of Mrs. Boles’ jaw bone. He testified that her condition did not respond to therapies that should have worked if her injuries were due to osteomyelitis alone.
On cross examination, the defense counsel pointed out that Dr. Elwell himself, as well as other doctors and dentists who examined Ms. Boles, had previously determined that Mrs. Boles suffered from osteomyelitis, caused by an infection called actinomycosis. Dr. Elwell agreed that Ms. Boles’ injuries were consistent with osteomyelitis, but added that while her jaw problems may have begun with an infection, Fosamax was a co-morbid factor that made it impossible for the jawbone to fight off the infection.