The FDA has issued a warning regarding the elevated risk of blood clots in a woman's legs and lungs from the Ortho Evra birth control patch.
The FDA claims the warning was issued based on the results of a single study that found women using the patch doubled their risk of blood clots compared to those taking the pill.
However, earlier reports have put the risk of these potentially fatal clots as actually being as much as three times higher than the risk from taking the pill. In 2004 alone, a dozen deaths were linked to the patch and many more to strokes and clots.
Johnson & Johnson is facing 500 claimants in lawsuits related to deaths and injuries caused by the patch. Legal analysts believe that these 500 claims are only the beginning, since thousands of women may have suffered from blood clots, heart attacks and strokes, but could be as yet unaware of the cause.
Johnson & Johnson is attempting to settle as many of the cases out of court as possible in an attempt to reduce media coverage of the problem, which so far has not been widely reported.
If the cases go to court, Johnson & Johnson is likely to lose many of them, as the victims are almost always young women with no prior history of heart trouble, so the birth control patch can be easily pinpointed as the cause of the problem.
In 2005, there were more than 9.4 million prescriptions written for the Ortho Evra patch.