Contact the expert birth control patch attorneys at Phillips and Associates to have your Ortho Evra® patch case evaluated.
The following Ortho Evra® timeline is being provided for you by Phillips and Associates, the right choice in birth control patch attorneys. The timeline outlines events as they have unfolded. As you will see below, it took about four years for the Ortho Evra® patch product labeling to reflect the elevated risks of blood clots, even though the issue was raised before the contraceptive patch’s approval. Our firm’s birth control patch attorneys believe this is unacceptable and want you to see the evidence yourself.
The R.W. Johnson Pharmaceutical Research Institute (PRI), the pharmaceutical branch of Johnson & Johnson, submits an application to the U.S. Food and Drug Administration (FDA) for approval of its new Ortho Evra® birth control patch.
The FDA medical officer reviewing the Ortho Evra® clinical trials notes in an official report that he is concerned with two women who suffered from blood clots in the lungs during the clinical trials. He notes that the birth control patch’s labeling should reflect the possible increased risk of blood clots.
The FDA grants approval to market the first ever skin patch approved for birth control. The announcement listed that two percent of the women in the clinical trials withdrew from the study due to skin irritation and that the birth control patch was less effective in women who weighed more than 198 pounds. No other risks were mentioned.
Ortho-McNeil Pharmaceutical, Inc. offers the Ortho Evra® patch as an alternative to the birth control pill. The contraceptive patch is heavily marketed towards younger women.
TIME Magazine lists the Ortho Evra® birth control patch as one of the “coolest inventions” of 2002, furthering the product’s appeal.
Ortho-McNeil Pharmaceutical’s records show 500 separate incidents of serious health problems associated with the birth control patch reported directly to the company.
Records indicate that more than 9.9 million prescriptions for the Ortho Evra® birth control patch were written in 2004. Sales reached $411 million.
Zakiya Kennedy, an 18-year-old fashion student, collapses on a subway platform in New York. She later dies from a blood clot. Officials for the FDA consider Kennedy’s death to be the first linked to the Ortho Evra® birth control patch.
Eighth-grader Alycia Brown dies of a blood clot in her lower pelvis after using the Ortho Evra® patch for about eight weeks. Only 14 years old, Brown becomes the product’s youngest known fatality.
One of the first lawsuits concerning the Ortho Evra® birth control patch is filed by attorneys on behalf of a 30-year-old woman. Her premature death was caused by blood clots thought to be linked to her use of the birth control patch.
The Associated Press (AP) releases an investigative report that links the Ortho Evra® patch with an increased risk of blood clots and death. The news story also notes that Ortho-McNeil Pharmaceutical had been analyzing the FDA’s death and injury reports. It further cited a memo in which the manufacturer refused to fund a study in 2003 comparing the birth control patch with the pill because there was “too high a chance” that it “may not produce a positive result.”
A true scope of problems with the birth control patch is revealed when attorneys produce documentation that the FDA logged 9,116 reports of adverse effects related to Ortho Evra® patch use between April 2002 and September 2003. During the same time period, only 1,237 negative reports were filed by women taking the leading oral contraceptive, even though the oral contraceptive was almost six times more popular than the birth control patch in 2003.
After much debate, Ortho-McNeil Pharmaceutical acknowledges the increased risk of blood clots, stroke, and death for the birth control patch users. The new warnings are placed on Ortho Evra® labeling.
A study by i3 Drug Safety concludes that women who use the Ortho Evra® birth control patch are twice as likely to develop blood clots as women taking birth control pills. The FDA states that the results are only preliminary and do not require immediate action other than advising women to discuss the risk with their doctors.
The FDA announces that it will conduct an exhaustive review of the safety of medicated patches. The Ortho Evra® birth control patch will be one of the first patches reviewed.
As shown by the timeline above, the early warning signs of Ortho Evra® patch side effects were discounted until it was too late. Our birth control patch attorneys want to help you receive fair compensation for suffering that may have been avoided. If you or someone you love has been adversely affected by the Ortho Evra® birth control patch, contact the attorneys at Phillips and Associates to have your case evaluated.