Fosamax that caused fractures in both my femurs."Michigan is the only state in the US that has immunity from drug suits. This statute, which is known as the "FDA defense," states that pharmaceutical manufacturers cannot be sued if their medical products are approved by the FDA, unless the company intentionally withheld information or misled the FDA or misrepresented the product in advertising—which is very difficult to establish. Carole is hopeful that two bills will soon be passed that will repeal the statute, but at the same time the statute of limitations may be a problem. Her three femur fractures occurred from 2002 through 2004.
Carole started to have severe bone pain about three years before the first fracture occurred, but she was misdiagnosed with fibromyalgia. "One doctor said that my symptoms didn't make any sense," Carole says. "He said it was my imagination because there was nothing there. Some of these doctors are so arrogant—if your symptoms don't fit a diagnosis they are familiar with, they just write you off—or diagnose fibromyalgia. They weren't familiar with Fosamax side effects in the early years.
"I started taking Fosamax when it was first approved in 1995, and I was on it until 2006," says Carole. "At that time there was so much written about Vioxx and Motrin—I was taking a lot of both drugs, believing that I had fibromyalgia because I was hurting all over, but mainly in my thighs. But there was no correlation between these drugs and femur fractures. I didn't know what was going on, until I saw Diane Sawyer talk about Fosamax on TV.
"I was climbing up a flight of metal stairs outdoors in the rain when I heard the bone snap—my husband even heard it and everyone to Kentucky could have heard me scream. I immediately knew my leg was broken but I couldn't understand why.
"The paramedics arrived and put me on a back board and inserted an IV—I knew I was in trouble when the morphine didn't ease the pain. I had emergency surgery that night: they put a titanium rod in my leg with a screw in my hip and a screw in my knee. They were going to put me in a rehab facility but thankfully I was able to have people come to my house.
"Just as I was recovering, I had more pain in my left leg. I was getting ready for a trip to Ireland with my nurses' group but thought I had better go back to the surgeon before leaving. He took multiple X rays and he saw multiple cracks in my left femur—he said I would likely end up in an Irish hospital so I had to cancel my trip.
"He put a rod in my left femur and a screw in my left knee. I managed with that until three months later—I rolled over in bed and the bone broke in a spiral around the rod. Then I had a third surgery: they put a screw in my left hip and another doctor took the screw out of my right hip because I was having a lot of pain from that.
"I kept having more pain so finally I went to the Mayo Clinic. By this time I wondered about Fosamax but I went online and didn't see a link; neither did anyone at the clinic. Again I was diagnosed with fibromylalgia because they couldn't think of anything else; but I don't have the fatigue that goes with it…
"During those two years I had six surgeries because of these fractures in both legs. I was repeatedly assured it had nothing to do with Fosamax and I needed to stay on it because my bones were breaking. I finally stopped taking Fosamax in April 2006 and the bone pain went away after a few months. That says it all right there! I had a few friends who went on Fosamax but went off it right away because they experienced pain. I wish I had done the same.
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"If I had the chance to meet with the makers of Fosamax, I would ask them when they knew of these horrific side effects and why they didn't educate doctors. Instead they damaged people through advertising and greed. I don't know if they honestly didn't know at first or they just didn't do enough research. And Fosamax has been their golden egg—I was shocked at how much it cost. I am blessed to have insurance, but we all wind up paying eventually.…"