It's Fosamax trial time again. Amid litigation over the bone drug's risks of jawbone injury, Merck ($MRK) is in court to fight claims that Fosamax caused patients' femur fractures. Once again, the drugmaker faces charges that it ignored the drug's safety risks, leaving patients in the dark.
The latest case involves 67-year-old Christina Su, who suffered a femur fracture after using Fosamax to prevent osteoporosis, Bloomberg reports. Su's attorney, Karen Menzies, said Merck researchers ignored data indicating that long-term Fosamax use put women at risk of "atypical femur fractures." Menzies cited a 2006 email flagging "brittle bones" in Singaporean women using Fosamax.
In 2010, a published study flagged a potential link between bisphosphonate drugs, including Fosamax and several rival products, and atypical femur fractures. The FDA had already been reviewing data on the fractures, and in 2010 added warnings to the drugs' labels, cautioning doctors to take care with their long-term use.
The agency stopped short of positively linking bisphosphonates to the fractures, however. FDA said the fractures mostly occurred in women taking the drugs, but no causal link had been established. An advisory panel came to similar conclusions in 2011.
Merck's attorney said the company had properly warned of Fosamax's risks, and contended that the company will show that Su suffered the same kind of fracture as women who didn't use Fosamax.
Last month, a jury ordered Merck to pay $285,000 to a woman who'd suffered jawbone death after using Fosamax. It was one of two losses for Merck in that batch of Fosamax lawsuits; the company prevailed in 5 others. Merck faces more than 3,000 lawsuits claiming Fosamax caused femur fractures, Bloomberg says. It faces at least 900 more claims of jawbone injury.
- see the Bloomberg story