Merck and Co. was unable to stop doctors from giving expert testimony during the New Jersey-based trial, now under way, regarding osteoporosis drug Fosamax for allegedly causing atypical femur fractures.
The federal judge ruled, however, that while the plaintiff’s treating physicians can testify, they may not discuss general causation; rather, they must focus on the specifics regarding the care and treatment they chose for her, according to a Law360 report.
Specifically, Merck had claimed that four of the eight doctors called as expert witnesses by plaintiff Bernadette Glynn were unqualified to testify on any alleged link between Fosamax and femoral fractures – a bid, however, that was rejected by U.S. District Judge Joel A. Pisano.
This trial, considered a bellwether for subsequent Fosamax trials, began in New Jersey federal court on Tuesday.
Merck began working on getting the doctors’ testimony thrown out back in January, claiming that Glynn was attempting to rebut a consensus that had been established between the U.S. Food and Drug Administration (FDA) and the scientific community regarding any connections between bisphosphonates, such as Fosamax, and an atypical femur fracture, reported Law360.
This is one of over 3,300 pending cases alleging that Merck’s Fosamax caused so-called atypical femur fractures. The plaintiff, Glynn, 59, took Fosamax for more than six years before suffering a femur fracture while bending over to pick something up. These atypical femur fractures are often the result of traumatic events, such as high falls, car accidents, or skiing mishaps. Glynn alleges that use of Fosamax alone makes patients susceptible to these kinds of injuries.
The U.S. Food and Drug Administration (FDA) approved Fosamax in 1995 to treat and prevent postmenopausal osteoporosis and to treat other bone loss-related issues, including weakened bones following some cancer treatments. In 2010, the FDA updated the safety information on Fosamax to warn of the risk of atypical femur fractures. The agency published a review in the New England Journal of Medicine in 2012 suggesting there is little benefit from taking bisphosphonates, the class of drugs that includes Fosamax, for longer than five years.
Plaintiffs’ counsel Paul Pennock, in his opening statement at the trial, alleged that Merck violated federal regulations by not warning doctors and patients of the problems associated with Fosamax.
“Doing so is not optional—warning Fosamax users of the risks is their obligation.” Pennock told the jurors that Merck’s own documents would show that. some five years prior to FDA approval, “the company was concerned about femur fractures, yet never warned about these dangers.”
Merck objected to the four doctors for various reasons. It claimed that one, an orthopedist, is not an epidemiologist and had revealed during his deposition that he “lacks an understanding of basic epidemiological terms and concepts,” noted the Law360 article.
Judge Pisano rebutted this claim, however, and ruled that the doctor’s academic background and professional experience were enough to qualify him as an expert witness, reported Law360.