According to the suit, she died from an acute pulmonary embolism after using the Ortho Evra birth control patch from November 26, 2002 to July 8, 2003. The suit was filed on July 13, 2006 in the United States District Court for the Eastern District of Michigan.
On July 8, 2003, the young woman experienced difficulty breathing and collapsed in her home. When the paramedics arrived they found the woman in acute respiratory distress. She was taken to the emergency room at St. John Macomb Hospital in Michigan. After failure to respond to CPR and other life-saving measures she was pronounced dead that evening. An autopsy revealed the cause of death as an acute pulmonary embolism.
Pulmonary embolism is a sudden blockage in a lung artery, usually due to a blood clot that has travelled to the lung from the leg, but clots can also form in the pelvic vein. Recent reports have indicated that the risk of developing blood clots, pulmonary embolism, heart attack and stroke may be significantly higher with the Ortho Evra patch than with oral contraceptive use. In fact, the patch has been linked to the deaths of at least seventeen young American women over the past two years
The FDA has logged 9,116 reports of adverse reactions to the patch in a 17-month period. While Ortho Tri-Cyclen - a birth control pill - had only 1,237 adverse reactions reported over six years. During a 12-month period, 44 serious injuries or deaths have been associated with Ortho Evra, whereas only 17 such reports were linked to the birth control pill during a similar time period. These statistics are even more damning when you consider the fact that Ortho Tri-Cyclen has six times the number of users of Ortho Evra.
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Would these 4 million women have been so quick to toss out their pills and put on the patch if they had known what Ortho-McNeil did? It is alleged that the drug company was aware of the increased medical risks associated with Ortho Evra before the drug was approved and that, once approved, the company failed to adequately warn patients about these risks. This is a horrific charge and if found guilty, Ortho-McNeil will face severe repercussions.