Timeline of Events

December 27, 2000 - Johnson & Johnson submits its application for approval to the FDA for the Ortho Evra birth control patch.

November 20, 2001- Ortho Evra receives approval from the Food and Drug Administration (FDA)

April 30, 2002 -  Ortho Evra is made available by prescription.

April 2002 – September 2003 - 9,116 adverse event reports concerning Ortho Evra are submitted to the FDA.  During the same time only 1,237 adverse event reports concerning the leading contraceptive pill are reported to the FDA despite the fact that the pill was used by six times the number of women on the patch.

November 11, 2002 - Time Magazine lists Ortho Evra as one of the “coolest inventions” of 2002.

2004 - almost 10 million prescriptions for Ortho Evra were written in 2004 with sales amounting to $411 million.

April 2005 - First Death Publicly linked with Ortho Evra use.  An 18-year-old fashion student in New York collapses on a subway platform and later dies from a blood clot.

May 7, 2004- An eigth grader dies from a blood clot after using Ortho Evra for eight weeks.  At 14 years old, this is the youngest known death attributed to Ortho Evra.

November 10, 2005 -  FDA requires an update to the Ortho Evra label.  The new label includes information that women who use the Ortho Evra patch are exposed to 60% more estrogen than women using a traditional birth control pill.  This increased exposure to estrogen can raise a woman’s risk for developing blood clots.

February 2006 - A study by Drug Safety shows that women using the Ortho Evra patch have twice the risk of developing a blood clot versus women taking a birth control pill.

March 2006 - FDA announces that it will investigate the safety of medicated patches with Ortho Evra as one of its first products of inquiry.

January 2008 - FDA announces that the risks of blood clots are higher for women taking the Ortho Evra patch than birth control pills.