Appeals Court Ruling Renews 5,000 Lawsuits Alleging Fosamax Caused Thighbone Fractures. A recent appeals court ruling revives roughly 5,000 lawsuits alleging that Merck’s osteoporosis drug Fosamax caused femur fractures. Previously, a Fosamax femur fracture multidistrict litigation (MDL) had been dismissed. However, the U.S. Court of Appeals for the Third Circuit has overturned this decision. Plaintiffs in the litigation allege that Merck failed to warn patients and physicians about the risk of femur fractures with Fosamax.
Parker Waichman LLP is a national personal injury law firm that represents numerous clients in drug injury lawsuits. The firm continues to offer free legal consultations to anyone with questions about filing a Fosamax femur fracture lawsuit.
In June 2014, U.S. District Judge Joel Pisano granted summary judgment to Merck. The judge made the decision based on application of a 2009 ruling, in which the Supreme Court determined that state lawsuits alleging failure-to-warn are pre-empted when there is clear evidence that the U.S. Food and Drug Administration (FDA) would not have approved the label update cited by plaintiffs. Judge Pisano ruled that the Fosamax lawsuit was pre-empted, because the FDA rejected the language of Merck’s proposed label update in 2009.
Due to this decision, all alleged Fosamax femur fractures occurring before September 2010 were dismissed. This resulted in roughly 20 lawsuits remaining, according to Reuters.
However, Third Circuit Judges Julio Fuentes, Michael Chagares and L. Felipe Restrepo disagreed, finding that the Fosamax lawsuits are not pre-empted under this ruling. Judge Fuentes wrote that a jury could determine that regulators would have approved “a properly-worded warning” for the osteoporosis drug, “or at the very least, to conclude that the odds of FDA rejection were less than highly probable.”
Additionally, Judge Fuentes said a jury could conclude that, if Fosamax contained a warning for Femur fractures, some doctors would not prescribe it.
Fosamax Femur Fracture Lawsuit Background
Fosamax is part of a class of drugs known as bisphosphonates; it was approved by the FDA in 1995 to treat osteoporosis. Post-menopausal women and men over the age of 70 have a higher risk of developing osteoporosis, a condition that causes bone loss.
In October 2010, the FDA announced that the warning label on Fosamax and other bisphosphonate drugs would be updated to include a risk of atypical femur fractures. These thigh breaks are known as subtrochanteric and diaphyseal femur fractures.
“Atypical subtrochanteric femur fractures are fractures in the bone just below the hip joint. Diaphyseal femur fractures occur in the long part of the thigh bone,” the FDA said in a Drug Safety Communication. “These fractures are very uncommon and appear to account for less than 1% of all hip and femur fractures overall. Although it is not clear if bisphosphonates are the cause, these unusual femur fractures have been predominantly reported in patients taking bisphosphonates.” The agency said that femur fractures may be related to using Fosamax and other bisphosphonates long-term.
The label update affected bisphosphonate drugs approved to treat osteoporosis, including Fosamax, Fosamax Plus D, Actonel, Actonel with Calcium, Boniva, Atelvia, Reclast and generics.
Previously, the FDA announced an ongoing safety review of bisphosphonates and atypical femur fractures in March 2010.
In 2012, the FDA published a review of bisphosphonates in the New England Journal of Medicine (NEJM). The agency found little, if any, benefit to using bisphosphonates after three to five years. Researchers analyzed data from 2,342 post-menopausal women in the trials.
That same year, the journal Archives of Internal Medicine published a study on femur fractures associated with bisphosphonate use. Researchers noted that “Current evidence suggests that there is an association between bisphosphonate therapy and atypical femoral fractures, but the extent of this risk remains unclear.”
The authors of the study analyzed data from 477 patients between 1999 and 2010. Classic femur fractures were reported in 438 patients while 39 had atypical fractures. Among the patients with atypical femur fractures, 32 (82 percent) were taking bisphosphonates. Comparatively, 28 (6.4 percent) of patients were on bisphosphonate therapy in the classic fractures group. Researchers concluded that “Atypical femoral fractures were associated with bisphosphonate use; longer duration of treatment resulted in augmented risk. The incidence of atypical fractures increased over a 12-year period, but the absolute number of such fractures is very small.”
Parker Waichman notes that Merck has been hit with Fosamax lawsuits alleging necrosis of the jawbone. Roughly 1,200 lawsuits were settled in 2013 for $27 million.
Merck lost its patent for Fosamax in 2008; generic versions of the drug are now on the market. Before this occurred, the drug generated over $3 billion in sales each year.