|Image courtesy of NIH|
Did Merck know about increased fracture risk in Fosamax patients years before the osteoporosis treatment hit the market? A plaintiff's lawyer in the latest lawsuit claims Merck ($MRK) was warned about the potential for spontaneous fractures 5 years before Fosamax made its debut.
"This company should have warned of the problems that they saw coming," attorney Paul Pennock said on the opening day of the trial in a New Jersey federal court (as quoted by Bloomberg). "The company should have warned of the problems they learned actually were happening."
Merck faces 3,300 lawsuits alleging that the bone drug caused serious femur fractures. Pennock represents Fosamax user Bernadette Glynn, who used the drug for 7 years. She claims that Fosamax weakened her femur, causing a fracture when she bent over to pick something up, Bloomberg reports. Hers is the second fracture suit to hit court; the first ended in a mistrial last month.
Merck says doctors and patients were appropriately warned about Fosamax's risks. The company says Glynn didn't simply bend over to pick something up but tripped over a chain saw and broke her leg.
A 2010 study flagged a potential risk of femur fractures in patients using Fosamax and similar bone drugs. FDA reviewed the data and added warnings to the drugs' labels, cautioning doctors about their long-term use. An FDA advisory panel also looked at the drugs' risks--including the leg-fracture data--in 2011; the expert advisers favored warnings and perhaps restrictions on long-term use. At the time, FDA had been reviewing bisphosphonate safety for almost four years. Last year, the FDA weighed in with a New England Journal of Medicine review stating that the bone drugs deliver limited--if any--benefit after three to 5 years of use.
This round of Fosamax liability suits joins more than 1000 other cases linking the bone drug to osteonecrosis of the jaw. A bellwether trial recently ended with a $285,000 jury verdict against Merck. Of 7 similar lawsuits that have been tried, Merck has prevailed in 5.
- read the Bloomberg coverage