Failure to Warn of the Increased Risk

Prior November 10, 2005, Ortho McNeil, the manufacturer of the Ortho Evra birth control patch, claimed that the risk of developing blood clots was no greater with the Ortho Evra birth control patch that it is with oral contraceptives. Consequently and until recently, the labeling for the Ortho Evra birth control patch, the packaging inserts and the patient information contained no warning of an increased risk of developing blood clots.

The concern that the Ortho Evra birth control patch posed a greater risk of developing blood clots arose even before the FDA had approved the patch. During the pre-marketing clinical trials for the Ortho Evra birth control patch, some of the study participants suffered serious adverse events that Ortho McNeil attributed to causes other than the use of the patch. The FDA medical officer who was responsible for reviewing this pre-marketing clinical data disagreed with Ortho McNeil’s conclusions about the serious adverse events. The FDA medical officer also urged Ortho McNeil to include a warning on the product label disclosing a potentially greater risk for developing blood clots when using the Ortho Evra birth control patch. Despite this disagreement and the urging of a label warning, the Ortho Evra birth control patch was approved for use with no label warning that its use could pose an increased risk of developing blood clots.

In 2005 and using the Freedom of Information Act, the Associated Press (AP) obtained adverse drug reaction reports for the Ortho Evra birth control patch from the FDA. The reports were reviewed by doctors who concluded that in the 23 cases where death was the outcome, 17 appeared to be related to a blood clotting abnormalities. According to the AP,

If you are a woman taking the pill who doesn’t smoke and is under 35, the chance that you are going to have a blood clot that doesn’t kill you is between 1 and 3 in 10,000. Your risk of dying from a blood clot while using the pill is 1 in 200,000. By contrast, with the patch, the rate of nonfatal blood clots was about 12 out of 10,000 users during the clinical trials while the rate of deaths appears to be 3 out of 200,000. ("Birth Control Patch linked to Higher Fatality Rate" July 20, 2005)

On November 10, 2005, the FDA announced that the label for the Ortho Evra birth control patch would be changed to include a warning that the users of the patch are exposed to higher levels of estrogen and are therefore at an increased risk of developing blood clotting abnormalities.

On February 16, 2006, the manufacturer of the Ortho Evra® birth control patch disclosed the results of an unpublished epidemiological study supporting the belief that the use of the Ortho Evra® birth control patch poses a greater risk of developing blood clots than that posed by oral contraceptives. The recent study, funded by the manufacturer of the Ortho Evra® birth control patch, concludes that, when compared to oral contraceptives, the use of the Ortho Evra® birth control patch doubles the risk of developing venous thrombosis (blood clots and deep vein thrombosis). This increased risk is believed to be attributable to the transdermal hormonal delivery system that is unique to the Ortho Evra® birth control patch. The transdermal patch delivers estrogen directly into a woman’s blood stream whereas oral contraceptives provide estrogen through the digestive system. Absorption through the blood stream is greater and more rapid than absorption through the digestive system. 

On February 17, 2006, the FDA held a news conference to assure the public that the FDA is monitoring the results of this and other studies designed to study the risk of blood clots and other thromboembolic injuries (e.g. pulmonary embolism, heart attack, stroke, sudden death) and the use of the Ortho Evra® birth control patch. However, Daniel Shames, M.D., director of the FDA’s Division of Reproductive and Urologic Drug Products, said “At this time we do not plan on taking any specific regulatiry action based on these preliminary results.”


If you or a loved one has suffered a heart attack, stroke, sudden cardiac death, or a pulmonary embolism while using the Ortho Evra Patch and have questions about your legal rights, fill out our free case evaluation form.