AKRON (TDB) -- A federal judge dismissed a lawsuit filed by an Ohio woman who contends pharmaceutical-maker Pfizer Inc. failed to adequately warn her of a dangerous side effect caused by the birth-control drug Depo-Provera. The woman, Jamie Lynn Lorenzi, said she suffered bone mass loss. Unlike birth control pills, Depo-Provera is injected every 11 weeks to prevent pregnancies. It has been on the U.S. market since 1992.
Bone loss is a precursor to osteoporosis, and the package insert that came with the drug from 1992 until 2004 said contraceptive injection was a risk factor for osteoporosis. Lorenzi said in the lawsuit against New York-based Pfizer (2006 revenues $48.4 billion) that she began using Depo-Provera after the birth of a child in 1997. She received the birth-control shots at Planned Parenthood of Mahoning County. She said she chose that form of contraception because she had an infant to care for and it seemed to be the easiest and best choice available at the time.
U.S. District Judge David D. Dowd Jr. dismissed the case, saying the warnings that came with the drug were adequate to detail the risks. He also said there was no proof that the woman's bone density loss was caused by Depo-Provera. The case is Jamie Lynn Lorenzi v. Pfizer Inc., No. 4:06 CV 1985, Northern District of Ohio.
"Any user of this drug who read these warnings would have been informed of the risks relating to bone loss. In fact, plaintiff herself admitted at her deposition that she read the patient labeling and other warnings, even though, at the time of her deposition, she had no independent recollection about what was contained in those labels or warnings. She also acknowledged that she knows (and knew back when she was receiving the drug) that all drugs entail risks."
Dowd also said there was no proof of injury or a link to the drug:
"In the first place, plaintiff is absolutely unable to prove that her low BMD is an injury in any legal sense and, in the second place, even if the Court were to assume plaintiff suffered an injury, she is unable to establish any causal connection between that injury and Depo-Provera."
Dowd noted he relied, in part, upon testimony from Dr. Anthony DeSalvo, Planned Parenthood's medical director, who said the woman's condition was "no more than a statistical indicator, not a disease."
Lorenzi's medical expert, Dr. Angelo Licata of the Cleveland Clinic, also said that osteopenia meant low bone mass, not disease.
"The preferable term used today is low bone density. Osteopenia and 'low bone density' are not diseases. Without other health problems, it does not imply a great deal about future fracture risk."