On March 22, 2017, the Third Circuit Court of Appeals in Philadelphia ruled that hundreds of previously dismissed claims against Merck & Co., Inc., can proceed to trial. The appeals court decision reverses a ruling by a lower court that found that the claims were pre-empted by federal law. The plaintiffs are accusing Merck of failing to warn of femur fracture risks when taking Fosamax (alendronate).
Fosamax hit the market in 1995. It is primarily prescribed to postmenopausal women. Fosamax uses include:
- Treat or prevent osteoporosis caused by menopause
- Treat osteoporosis caused by steroid use
- Treat Paget’s disease of the bone
- Increase bone mass in men with osteoporosis
Fosamax can have serious side effects including:
- Femur fracture, more common with long-term use
- Osteonecrosis of the jaw, also called “dead jaw syndrome”
- Esophagus problems including irritation, bleeding ulcers, esophageal erosion and perforation
- Hypocalcemia – low blood calcium
- Musculoskeletal pain
Failure to Warn
In the lawsuits restored by the ruling, plaintiffs claimed that they suffered atypical femur fractures as a result of long-term Fosamax use, and that Merck knew about the risk for more than 10 years before adding it to the warning label.
The warning label was changed in 2011. The lower court dismissed cases of all plaintiffs who were injured before September 14, 2010, because the judge believed that there was “clear evidence” that the FDA would not have approved the warning that plaintiffs say the drug should have carried, and that would pre-empt the claims. Circuit Judge Julio Fuentes of the appeals court disagreed, saying that he found evidence that could lead a jury to conclude that the FDA would possibly have approved it and that some doctors would not have prescribed Fosamax if warned of the fracture risk.
If you have been harmed by Fosamax, please talk to an experienced defective drug attorney right away to learn more about your rights and potential compensation.