Ortho Evra Lawsuits Highlight Drug Misrepresentation
In 1996, Johnson & Johnson told the Food & Drug Administration it planned to develop the Ortho Evra patch because it would probably expose women to less estrogen than the standard birth control pills. The company suggested that the women’s body would not break down hormones delivered via the patch as quickly as the pill, so lower doses could be used. The truth was that the patch delivered considerably more estrogen into the bloodstream, a 1999 clinical trial concluded. The study suggested that since up to half of birth control pill’s estrogen is lost in the digestive track, the patch could deliver an amount of estrogen that could be as high as the pill at 76 micrograms. In 1988 the FDA banned birth control pills with more than 50 micrograms of estrogen. The study’s author, who has since retired from Johnson & Johnson, Dr. Larry Abrams, at the time applied a “correction factor” to the 1999 results claiming the patch, delivered 40 percent less estrogen than the trial results showed. According to Dr. Abrams deposition, the adjustment was never part of the study protocol that was filed with the FDA. Clinical trials conducted before the patch was approved showed patients complained of breast soreness and nausea and the side effects seem to be related to high estrogen doses, a company scientist wrote in an e-mail message. The 1999 study and another in 2003 confirmed that the patch delivered more estrogen than the pill. Once the patch was approved, Johnson & Johnson misrepresented it and informed the public it released only 20 micrograms. As the patch was prescribed more and its use rose, reports of side effects increased. By 2004 the death of an 18 year old in New York caused the food and drug officials noticeable concern. In 2005 it announced that it had included a new warning that the patch “exposes women to higher levels of estrogen than most birth control pills.” Since then, an epidemiological study showed women on the patch can have as much as double the risk of blood clots and stroke. Still, lawyers for Johnson & Johnson say that patients should not be allowed to sue the company because the FDA approved the patch and its label.
