A woman in Idaho who said she developed a blood clot disorder after using the birth control patch Ortho Evra - made by Ortho-McNeil, a subsidiary of Johnson & Johnson - has filed a lawsuit in federal court against the companies, the AP/Houston Chronicle reports.
Katy McKellips Braman said that she began using the patch in 2004 at age 17 and that about one month later, she was diagnosed with deep vein thrombosis - a sometimes fatal condition characterized by leg vein blood clots that can break off and spread to the lungs - the AP/Chronicle reports.
In the lawsuit, Braman says that the patch caused her disorder and that she now must take daily anticlotting medications that prevent her from ever taking medications containing estrogen, such as birth-control pills or treatments for menopause and hormonal imbalances.
The lawsuit also claims that the companies failed to adequately test the patch and that they deceived customers by saying the patch’s risks were equivalent to those associated with other contraceptives.
Braman is asking that the court require the companies to pay compensatory damages and costs of future medical treatments (Boone, AP/Houston Chronicle, 10/17).
FDA in September announced it had updated Ortho Evra’s warning label to include information from two conflicting studies on increased risk of blood clots among patch users (Kaiser Daily Women’s Health Policy Report, 9/21).
Ortho-McNeil spokesperson Julie Keenan said the company could not comment on the pending lawsuit, and officials with Johnson & Johnson did not return calls for comment.
According to company officials, hundreds of lawsuits over the patch have been filed nationwide (AP/Houston Chronicle, 10/17).
Revision date: June 21, 2011
Last revised: by Jorge P. Ribeiro, MD