Litigation concerning jaw injuries from osteoporosis drug Fosamax have finally settled, with plaintiffs receiving a total of $27.7 million. This settlement resolves the drawn-out multidistrict litigation (MDL) over bone death, or osteonecrosis, in Fosamax patients’ jaws. Our Fosamax attorneys point out that this settlement does not resolve claims concerning femur fractures caused by the same drug.
Merck initially created Fosamax in 1995 to help prevent and treat osteoporosis, specifically in post-menopausal women and Paget’s disease patients. These patients have an imbalanced bone-rebuilding cycle, characterized by decreasing bone mass and strength. Osteoporosis affects about 25 million Americans, of which 80% are women.
In thousands of patients, particularly those taking the drug for several years at a time, Fosamax actually had the opposite effect. In the cohort of plaintiffs who will receive the $27.7 million, the drug caused their jaw bones to deteriorate and, in severe cases, die completely. These jaw death cases were consolidated in the MDL in 2006, and bellwether trials began in shortly after.
After a series of bellwether trials – which involve hand-picked cases to allow both plaintiffs and defendants to predict outcomes – the MDL judge ordered hundreds of Fosamax cases to be sent back to state courts for trial. Merck lost two of the bellwethers, the first in the amount of $285,000. In second loss, a jury decided Merck should pay $1.5 million for Fosamax’s defective design. Four other bellwethers that resulted in Merck wins are scheduled for appeal.
Sending hundreds of cases back to their home courts would have been incredibly costly for Merck, undoubtedly influencing its decision to settle. A judge threatened a similar order against Merck during its mass litigation over the painkiller Vioxx, which ultimately resulted in a $4.85 billion settlement.
How Does Fosamax Cause Bone Loss, Fracture, and Deterioration?
In its clinical trials, women taking Fosamax were followed for two years. The most common side effect reported in these women was musculoskeletal pain, which should have alerted researchers to the potential of bone deterioration. The clinical trials were conducted by scientists on Merck’s payroll, however, so no further investigation was launched.
According to the Mayo Clinic, Fosamax can prevent the jaw bone from healing after minor injury, such as getting a tooth pulled. In 2006, two medical journals published articles associating Fosamax with jawbone deterioration, one in the New England Journal of Medicine and the other in Hematology. Both authors cited older age, prior history of dental procedures, and duration of Fosamax exposure as risk factors for jawbone death.
Similarly, the active ingredient in Fosamax, bisphosphonate, when taken for long periods of time, may slow the development of new collagen, which is critical to the bone rebuilding process. Other theories suggest that the rebuilding process is slower in those on bisphosphonates, which causes microdamage to accumulate over time, making bones more susceptible to fractures.
The femur (thigh) is one of the largest and strongest bones in the body,
and when a fracture occurs, 90% of the time it is caused by major trauma
such as a car accident. What makes these Fosamax femur fractures so unusual
is that they occur in low-impact, atypical situations, when the patient
is doing little more than simply walking.
About two-third of women who suffered a Fosamax femur fracture were on the medication for over seven years, with the average prescribing time being 5.4 years. There remains over 4,000 lawsuits concerning Fosamax femur fractures, however, which Merck still faces in federal court in a separate MDL.
Fosamax attorneys at Pintas & Mullins Law Firm are currently investigating cases of Fosamax femur fractures. We have been fighting against Big Pharma for over two decades, and accept injured clients from across the country. Our legal consultations are always free and confidential.