Johnson & Johnson sued over birth control patch

The complaint filed in US District Court in the Eastern District of Texas, Marshall Division, says the package insert that came with Ortho Evra was misleading and in direct conflict with Johnson & Johnson's own data. According to the prosecuting law offices, the insert suggests the risk of blood clots among Ortho Evra users is equivalent to that of women using oral contraceptives.

Johnson & Johnson has been conducting trials to determine the safety of the contraceptive patch.

The first results of these studies conducted to evaluate the risk of experiencing serious side effects from using Ortho Evra were released in May 2006. The objective of the first study was to evaluate the combined risk of heart attack, stroke and thrombosis in first-time users of Ortho Evra compared with first-time users of oral contraceptives.

According to J&J, results of the study show that the risk of non-fatal thrombosis for the contraceptive patch was similar to the risk for oral contraceptives containing 35 micrograms ethinyl estradiol and norgestimate. The evaluation of the other study objectives, including the risk of heart attack and stroke is ongoing, but the company says that currently available data do not show an increase in the risk of the combined endpoint of heart attack and stroke with the use of Ortho Evra.

The interim report of the second study, which was conducted by i3 Drug Safety, an Ingenix company, will be published at a later date. The FDA was consulted on the design of both studies.