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Merck Starts 2nd Trial on Fosamax Broken-Leg Claims

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Merck & Co. (MRK) is defending a woman’s claim that its osteoporosis drug Fosamax weakened her femur, causing her leg to break when she fell in her driveway. This is the second Fosamax femur fracture injury claim going to trial. The first trial, in state court in Atlantic City, New Jersey, was called off after plaintiff Christina Su suffered a “sudden illness” that was unrelated to her use of Fosamax.

A three-week jury trial started this week before U.S. District Judge Joel Pisano in Trenton, New Jersey. The plaintiff, Bernadette Glynn fell and injured herself in April 2009. Merck claimed that Glynn, 58, tripped over a chainsaw in her garage and that the fracture is typical of women with osteoporosis.

Fosamax and Femur Fracture Allegations

Glynn and her husband, Richard Glynn, residents, New York, sued Merck in September 2011, alleging Fosamax causes “serious and sometimes fatal injuries.” "While the drug increases bone-mass density, the effect doesn’t always correspond to a reduction in fracture risk." The compound can cause bones to become “highly mineralized, homogeneous, brittle.”

Merck, the second-biggest U.S. drugmaker, is alleged in more than 3,300 lawsuits that extended use of bisphosphonates such as Fosamax caused femurs to deteriorate in some patients. According to Merck, it faces another 1,230 cases alleging Fosamax caused similar fractures in jaws.

What is Fosamax?

Fosamax, was approved for sale in the U.S. in 1995, and generated sales of as much $3 billion a year until patent protection lapsed in 2008. The drug is often prescribed for osteoporosis in women and for cancer sufferers worried about fractures from weakened bones.

Femur or Thighbone Fractures

Researchers said in 2010 that Fosamax and other biphosphonates drugs may be linked to increased risks of thighbone fractures. As many as 94 percent of 310 patients who had an uncommon type of fracture to the thigh bone were also taking a bisphosphonate-based drug, according a September 2010 report in the Journal of Bone and Mineral Research. Most had taken the medicine for more than five years, according to the report.

FDA Information

“There is not a scintilla of evidence that Merck knowingly withheld from FDA or misrepresented to FDA any information related to the risk of femur fracture,” Merck said in the filing.

Osteoporosis Diagnoses ‘Skyrocket’

Fosamax and other osteoporosis drugs have become widely over-prescribed and diagnoses of osteoporosis have “skyrocketed” since the assessment method shifted from the use of clinical criteria such as prior bone fracture to testing bone-mass density instead, according to the complaint.

The company has won five of the seven cases decided by juries on the jaw claims. In February, a federal jury in New York ordered Merck to pay $285,000 to a woman who blamed the drug for her jawbone injuries.

The cases are Glynn v. Merck & Co., 3:11-cv-05304, U.S. District Court, District of New Jersey (Trenton); and Su v. Merck & Co., ATL-L-0789-11-MT, Superior Court of New Jersey (Atlantic City).