The second trial over the drug Fosamax resulted in a verdict of $8 million dollars for Shirely Boles. Mrs. Boles, 71, sued Merck for jaw damage (dead jaw) resulting from her use of the osteoporosis drug Fosamax for 9 years.
Merck’s Fosamax (drug: Alendronate) is used to treat two bone disorders, osteoporosis in postmenopausal women and PagetÃ¢â‚¬â„¢s disease. Osteoporosis causes a decrease in bone mass volume and reduction in bone strength leading to fracture of spine, wrist and hip. In PagetÃ¢â‚¬â„¢s disease, healthy bone is deteriorated to poor quality bone resulting in many bone disorders. Ã‚Â Fosamax was the first of a class of drugs called bisphosphonates which gave women an alternative to traditional treatments for osteoporosis (estrogen (female sex hormone) and calcitonin).
The lawsuits claim that Fosamax causes osteonecrosis of the jaw. Ã‚Â Osteonecrosis is death of jawbone tissue due to poor blood supply to the jaw area. As on March 31 2010, close to 1,039 including approximately 1,417 plaintiff groups had been filed and were pending against Merck in either state or federal courts.
Merck states that they are responsible for the patient safety and hence enough patient safety data was collected from clinical trials and post marketing trials of Fosamax. These updates, Merck argued, were regularly provided to medical, scientific and regulatory communities and also sent to consumers.
Mrs. Boles’ alleged that she suffered from dead jaw and complications following two tooth extractions in June 2002. She was admitted to the hospital to treat her Fosamax related osteonecrosis. Ã‚Â Her treating doctor testified that Boles was unable to eat food and was Ã¢â‚¬Å“wasting awayÃ¢â‚¬Â. Doctors also indicated that she cannot orally consume the food and hence she will have to perform a surgery to remove a large section of her dead jaw bone and reconstruct her face. Ã‚Â Mrs. Boles’ used Fosamax from 1997 to 2006.
Merck has indicated that the company would appeal the juryÃ¢â‚¬â„¢s decision as the compensation for damages were excessive and unjustified.