In July 2005, the Associated Press conducted an investigation that tracked adverse reactions in women using the patch since it came on the market. In response to a FOIA request, the FDA provided the AP with a database that contained roughly 16,000 adverse reaction reports.
The FDA's Adverse Event Reporting System (AERS) is a computerized database designed to handle the agency's post-marketing safety surveillance program for approved drugs. AERS receives reports from manufacturers as required by law, and health care providers and consumers send reports voluntarily through the MedWatch program. The reports then become part of the AERS database.
Since the FDA estimates that it only receives reports on between 1% and 10% of the adverse events that actually occur, the death and injury rate for products is known to be significantly higher that indicated in the database.
Within the group of 16,000 adverse reaction reports, the AP determined that there were 23 deaths. Doctors who reviewed the 23 deaths said about 17 appeared to be clot-related.
According to the AP, about a dozen women, mostly in their late teens and early 20s, died from clots in 2004, and dozens more experienced strokes and other clot-related problems.
In November 2005, the FDA warned that women using the patch were found to have as much as 60% more estrogen in their blood steam than women on the pill, putting them at a higher risk for potentially fatal side effects.
Greater exposure to estrogen, the FDA said, may increase the risk of blood clots. Experts say that clots are a known risk with hormonal birth control because estrogen promotes blood coagulation.
On November 10, 2005, the FDA revised the labeling for the Ortho patch to include a new, bolded warning to alert health care providers that the amount of estrogen delivered through the patch produces a higher level of estrogen exposure than birth control pills.
Johnson and Johnson has consistently denied knowledge of any problems with the patch. However, according to a story by CBS News, documents have surfaced in a lawsuit that show the company's own records reveal that it received some 500 reports of serious problems associated with the patch between April 2002 and December 2004.
Apparently, Johnson and Johnson has decided its time to spring into damage control. On April 9, 2006, the New York Post reported that women "who suffered life-threatening blood clots and strokes on the Ortho-Evra birth-control patch are receiving cash settlements from the manufacturer, which allegedly failed to warn customers about the known risks, The Post has learned."
"Ortho-McNeil Pharmaceutical of Raritan, N.J., a subsidiary of Johnson & Johnson," the Post said, "has settled a dozen lawsuits for millions of dollars in the last few months, and more than 100 other suits are pending."
The settled cases include a lawsuit filed by Philomena Ugochukwa, a 37-year-old woman, who remains totally paralyzed after suffering a massive stroke and brain damage while wearing the patch for less than 2 weeks.
The other 11 plaintiffs who settled out of court include women between the ages 18 to 47, who suffered blood clots in the lung, leg, and brain.
One case involved 18-year-old Zakiya Kennedy, who died after collapsing in a subway station, in which the medical examiner determined the death was caused by a clot brought on by use of the Evra patch
More lawsuits are being filed all across the country.
In November 2005, a federal lawsuit was filed in Madison, Wisconsin, by the parents of the youngest patch victim, Alycia Brown, a 14-year-old eighth-grader, who died on May 7, 2004, after using the patch for 8 weeks, when blood clots developed in her lower pelvis. The medical examiner listed the patch as a likely contributing factor in her death.
The FDA's Adverse Event Reporting System (AERS) is a computerized database designed to handle the agency's post-marketing safety surveillance program for approved drugs. AERS receives reports from manufacturers as required by law, and health care providers and consumers send reports voluntarily through the MedWatch program. The reports then become part of the AERS database.
Since the FDA estimates that it only receives reports on between 1% and 10% of the adverse events that actually occur, the death and injury rate for products is known to be significantly higher that indicated in the database.
Within the group of 16,000 adverse reaction reports, the AP determined that there were 23 deaths. Doctors who reviewed the 23 deaths said about 17 appeared to be clot-related.
In November 2005, the FDA warned that women using the patch were found to have as much as 60% more estrogen in their blood steam than women on the pill, putting them at a higher risk for potentially fatal side effects.
Greater exposure to estrogen, the FDA said, may increase the risk of blood clots. Experts say that clots are a known risk with hormonal birth control because estrogen promotes blood coagulation.
On November 10, 2005, the FDA revised the labeling for the Ortho patch to include a new, bolded warning to alert health care providers that the amount of estrogen delivered through the patch produces a higher level of estrogen exposure than birth control pills.
Johnson and Johnson has consistently denied knowledge of any problems with the patch. However, according to a story by CBS News, documents have surfaced in a lawsuit that show the company's own records reveal that it received some 500 reports of serious problems associated with the patch between April 2002 and December 2004.
Apparently, Johnson and Johnson has decided its time to spring into damage control. On April 9, 2006, the New York Post reported that women "who suffered life-threatening blood clots and strokes on the Ortho-Evra birth-control patch are receiving cash settlements from the manufacturer, which allegedly failed to warn customers about the known risks, The Post has learned."
"Ortho-McNeil Pharmaceutical of Raritan, N.J., a subsidiary of Johnson & Johnson," the Post said, "has settled a dozen lawsuits for millions of dollars in the last few months, and more than 100 other suits are pending."
The settled cases include a lawsuit filed by Philomena Ugochukwa, a 37-year-old woman, who remains totally paralyzed after suffering a massive stroke and brain damage while wearing the patch for less than 2 weeks.
The other 11 plaintiffs who settled out of court include women between the ages 18 to 47, who suffered blood clots in the lung, leg, and brain.
One case involved 18-year-old Zakiya Kennedy, who died after collapsing in a subway station, in which the medical examiner determined the death was caused by a clot brought on by use of the Evra patch
More lawsuits are being filed all across the country.
In November 2005, a federal lawsuit was filed in Madison, Wisconsin, by the parents of the youngest patch victim, Alycia Brown, a 14-year-old eighth-grader, who died on May 7, 2004, after using the patch for 8 weeks, when blood clots developed in her lower pelvis. The medical examiner listed the patch as a likely contributing factor in her death.
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