Drug & Device News

A federal district court has found that a woman who has a condition that could be a precursor to osteoporosis but who does not yet have a full-blown case of the disease has no case against a pharmaceuticals manufacturer for damage allegedly done to her when she used its birth-control product. In Colville v. Pharmacia & Upjohn Co. LLC, — F.Supp.2d —-, 2008 WL 2721194 (N.D.Fla. 7/10/08), the 35-year-old plaintiff produced evidence that she had developed osteopenia (loss of bone mineral density). She alleged that the condition was brought on by her use of the injectable birth-control drug known as Depo-Provera, and that the fact that she had osteopenia was a sign that she would probably eventually develop osteoporosis as well. She brought suit against Depo-Provera's manufacturers, who moved for summary judgment. The U.S. District Court for the Northern District of Florida granted the defendants' motion, in part because the plaintiff could not prove that she had suffered an injury, although considering her age and lack of family history for the condition, it was highly probable that her osteopenia was caused by her Depo-Provera use. Significant to the court, however, was the fact that neither plaintiff's nor defendants' experts testified that osteopenia is an actual injury; instead, it is a slow process in the bone that could lead to the injury of osteoporosis. In fact, two experts had stated it was even possible, now that plaintiff was no longer using the birth-control method, that her bones could re-strengthen themselves and her risks of future osteoporosis injury could decrease. As plaintiff failed to allege injury, the court felt compelled to dismiss the case.

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