Ortho-Evra Patch Was Lethal
April 20th 2006
Documents have surfaced in litigation that show Ortho-McNeil has been
analyzing the FDA's death and injury reports on women using the Ortho
Evra birth-control patch, and has charts that show a higher rate of
blood clots and deaths in women on the patch when compared to women who
take birth-control pills.
In addition, according to a November 11, 2005, article by the Associated
Press, an internal company memo shows that in 2003, the company refused
to fund a study comparing the Ortho patch to the company's Ortho-Cyclen
pill because there was "too high a chance that study may not produce a
positive result for Evra" and a "risk that Ortho Evra may be the same or
worse than Ortho-Cyclen."
A number of doctors and health-care providers no longer prescribe the
patch, saying they do not want to take any chances. In Memphis, TN,
obstetrician and gynecologist, Henry Sullivant, told the Wall Street
Journal, that he has stopped writing new prescriptions and suggests that
his roughly 2 dozen users try other forms of birth control, such as the
pill or vaginal ring.
Pennsylvania State University, which provides health services for 42,000
students, is also no longer issuing prescriptions, and according to the
Journal, is considering contacting all students who have been given
prescriptions, even if they are no longer at the university.
Since obtaining FDA approval in 2002, the Ortho patch has become a very
popular product. In 2004, according to the industry monitoring firm, IMS
Health, doctors wrote more than 9.4 million prescriptions for the patch
and sales topping $411 million. That is 21% more than the top-selling
brand of birth-control pill, IMS Health says.
The patch is about the size of a matchbook and the biggest draw is that
it eliminates the need to remember to take a pill every day. The patch
is applied to the lower abdomen, buttocks, upper arm or upper body and
worn for 7 days, and then replaced with another patch for 3 weeks,
followed by a week without a patch.
The system delivers hormones through the skin into the bloodstream and
contains progestin and estrogen, the same hormones found in
birth-control pills. Although the estrogen levels are similar in the
pill and the patch, before entering the blood stream the hormones in the
pill are processed through the digestive tract, while hormones in the
patch go straight to the bloodstream.
Both products work the same by: (1) preventing ovulation; an egg is not
released by the ovaries for fertilization; (2) thickening cervical mucus
so sperm are less likely to enter the uterus; and (3) causing changes in
the endometrium to reduce egg implantation.
In the case of adverse reactions, blood clots usually form in the legs,
and become serious problems if they travel to the heart, lungs or brain.
Symptoms include pain in the calf, shortness of breath, chest pain, or
coughing up blood.
When the patch was up for approval in 2000, it is now known that doctors
warned the FDA that clots could be a problem if the patch was approved.
When conducting the review of more than 3000 women, doctors discovered
that two women had been treated for clots in the lungs. Ortho argued
that one case should not be counted as an adverse event because the
woman had undergone surgery. However, in report, a reviewing doctor
argued against that claim in capital letters.
“THE REVIEWER DOES NOT AGREE WITH THE SPONSOR’S ABOVE CONCLUSIONS," he
"The two cases of pulmonary embolus, a serious and potentially fatal
condition, must be counted as two cases ...,” the report said. “The
incidence rates quoted by the sponsor may be misleading.”
The doctor also said, “the label should clearly reflect this reviewer’s
safety concern about a potential increased risk.”
In addition, the reviewer expressed concern that 211 women had gained 10
or more pounds during the trial and said the effectiveness of the patch
was reduced in women weighing over 198 pounds.
And although the report said it would be important to continue to study
problems with the patch once it was approved, there were no requirements
for follow-up studies other than the routine review of reports filed by
consumers, doctors and manufacturers.
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
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
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
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
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.
In another case, twenty-five-year-old, Sasha Webber, a Baychester, NY
mother of two, died of a heart attack in March 2004, after 6 weeks on
In many instances it is difficult to determine with any degree of
certainty that a specific product did in fact cause a death or an
injury. Such is not the case with the Ortho patch, experts say, because
the injuries and deaths are occurring in young women of child-bearing
age, who in most cases have no prior history of health problems.
For information for injured parties go to Lawyers and Settlements
By Evelyn Pringle
Evelyn Pringle is a columnist for Independent Media TV and an
investigative journalist focused on exposing corruption in government.
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