But several months after the event, on September 23, 2004, Ms Kennedy's father and grandmother were interviewed by ABC News and said the young woman had experienced symptoms but did connect them to the patch or take them seriously. "She was complaining about her head was hurting - she felt pain in her leg and she had felt dizzy," her father recalled.
"She was complaining about pains in her leg or in her shoulder," he said. "She thought it was from her exercising."
Roberta Alloway, Ms Kennedy's grandmother, said the drug company should be warning people about the lethal side effects of the patch. "They need to really let people know that my granddaughter and other people have died from this patch," she told ABC news.
"I can't bring her back," she said. "But I want something to bring attention to these young women."
Notwithstanding the high statistics of death and serious injuries revealed by the New York Post based on the FDA's own database, it would take nearly 20 more months for the FDA to force J&J to add a warning to the label of the Ortho patch to alert women about the risk of blood clots, strokes, and heart attacks.
On November 11, 2005, the day after the waning was announced, Dr Sanjay Gupta, CNN's senior medical correspondent, predicted on CNN that the warnings would probably, at a minimum, "mean a complete redesign of the patch so it doesn't deliver as much estrogen and doesn't put women at greater risk for blood clots."
"Or," he stated, "it could mean the demise of the patch altogether."
Unfortunately, neither occurred and as a result, thousands more young women have died or been injured needlessly.
According to J&J at the time, the injuries and deaths with women on the patch were "consistent with the health risks" of the birth control pill, which "kills 0.3 to 1.9 women in every 100,000 users ages 15 to 29."
However, that assertion was proven to be a bold-faced lie on the part of Johnson & Johnson, by FDA reports obtained by the Associated Press under the FOIA, that showed that in 2004, when 800,000 women were using the patch, the risk of a woman dying or suffering a survivable clot while on the patch was three times higher than women using birth control pills.
In fact, the records show that back in 2000, the FDA scientist in charge of reviewing the pre-approval clinical trials submitted on the patch, warned FDA officials that blood clots could be a problem if the device was approved.
While reviewing the trials, the scientist discovered that two of the 3,300 women using the Ortho Evra patch had been treated for blood clots that had traveled to their lungs. J&J argued that one of the two women should not be counted because she had underwent surgery, but the FDA reviewer, using capital letters to emphasize the point, disputed that argument stating:
"THE REVIEWER DOES NOT AGREE WITH THE SPONSOR'S ABOVE CONCLUSIONS. The two cases of pulmonary embolus, a serious and potentially fatal condition, must be counted as two cases..." "The incidence rates quoted by the sponsor may be misleading."
The reviewer also said "the label should clearly reflect this reviewer's safety concern about a potential increased risk."
The official specifically said the professional product labeling and information written for women using Ortho-Evra "should reflect the possible increased risk of venous thromboembolism (VTE) associated with this new transdermal combination hormonal contraceptive containing the new molecular entity progestin norelgestromin (17d-norgestimate)."
In addition, he expressed concern about the fact that 211 women out of 3,088 had gained 10 or more pounds during the trials and noted that the effectiveness of Ortho-Evra was reduced in women weighing more than 198 pounds.
"She was complaining about pains in her leg or in her shoulder," he said. "She thought it was from her exercising."
Roberta Alloway, Ms Kennedy's grandmother, said the drug company should be warning people about the lethal side effects of the patch. "They need to really let people know that my granddaughter and other people have died from this patch," she told ABC news.
"I can't bring her back," she said. "But I want something to bring attention to these young women."
On November 11, 2005, the day after the waning was announced, Dr Sanjay Gupta, CNN's senior medical correspondent, predicted on CNN that the warnings would probably, at a minimum, "mean a complete redesign of the patch so it doesn't deliver as much estrogen and doesn't put women at greater risk for blood clots."
"Or," he stated, "it could mean the demise of the patch altogether."
Unfortunately, neither occurred and as a result, thousands more young women have died or been injured needlessly.
According to J&J at the time, the injuries and deaths with women on the patch were "consistent with the health risks" of the birth control pill, which "kills 0.3 to 1.9 women in every 100,000 users ages 15 to 29."
However, that assertion was proven to be a bold-faced lie on the part of Johnson & Johnson, by FDA reports obtained by the Associated Press under the FOIA, that showed that in 2004, when 800,000 women were using the patch, the risk of a woman dying or suffering a survivable clot while on the patch was three times higher than women using birth control pills.
In fact, the records show that back in 2000, the FDA scientist in charge of reviewing the pre-approval clinical trials submitted on the patch, warned FDA officials that blood clots could be a problem if the device was approved.
While reviewing the trials, the scientist discovered that two of the 3,300 women using the Ortho Evra patch had been treated for blood clots that had traveled to their lungs. J&J argued that one of the two women should not be counted because she had underwent surgery, but the FDA reviewer, using capital letters to emphasize the point, disputed that argument stating:
"THE REVIEWER DOES NOT AGREE WITH THE SPONSOR'S ABOVE CONCLUSIONS. The two cases of pulmonary embolus, a serious and potentially fatal condition, must be counted as two cases..." "The incidence rates quoted by the sponsor may be misleading."
The reviewer also said "the label should clearly reflect this reviewer's safety concern about a potential increased risk."
The official specifically said the professional product labeling and information written for women using Ortho-Evra "should reflect the possible increased risk of venous thromboembolism (VTE) associated with this new transdermal combination hormonal contraceptive containing the new molecular entity progestin norelgestromin (17d-norgestimate)."
In addition, he expressed concern about the fact that 211 women out of 3,088 had gained 10 or more pounds during the trials and noted that the effectiveness of Ortho-Evra was reduced in women weighing more than 198 pounds.
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