By Megan Breckenridge, Staff Writer
SULLO & SULLO, LLP
HOUSTON—Millions of women across the country rejoiced in 2002 when a new,
convenient alternative to daily oral contraceptive pills hit the market.
Ortho Evra, a hormone-containing patch, was praised by public health experts and
consumers alike because it eliminates one of the major barriers to perfect birth
control use: Remembering to take a daily pill. The patch can be placed on the arm,
back or abdomen—anywhere it adheres well and won’t be damaged—and
needs only to be changed once a week. Since it’s introduction, over 40 million
prescriptions for Ortho Evra have been written, and TIME Magazine named it one of
the best inventions of 2002.
But in 2005, the Food and Drug Administration (FDA) warned that women using Ortho
Evra were exposed to approximately 60 percent more estrogen than those who use oral
contraceptive pills. It is believed that the difference in exposure is related to
the delivery mechanism of the birth control patch. Hormones in birth control pills
are partially diluted by the digestive system, while those in the patch are absorbed
directly into the patient’s blood stream. The latter causes a higher concentration
of medication, specifically estrogen, to enter a patient’s body, increasing
the risks of pulmonary embolism—a specific type of blood clot—as well
as stroke and heart attack.
The first fatality publicly blamed on Ortho Evra occurred in April 2005, when a
Manhattan fashion student collapsed in a New York City subway station. An autopsy
found that a blood clot had moved into the victim’s lung, which the medical
examiner ruled a side effect of the birth control patch.
By November of 2005, the FDA had received 21 reports of life-threatening blood clots
and other ailments associated with Ortho Evra. But it wasn’t until 2006, when
a study was published that confirmed women using the patch were twice as likely
to suffer from venous thromboembolisms (VTEs) as those taking oral birth control
pills, that the FDA requested that the Ortho Evra label be changed to include a
stronger safety warning.
According to an NBC news report, broadcast September 22, 2010, leaked patient reports
from Johnson & Johnson show that the company knew users of the patch were 12
times more likely to suffer stroke and 18 times more likely to have blood clots
than Pill takers. Further, NBC revealed, a vice president of research at Johnson
& Johnson, Dr. Patrick Caubel, quit over frustration that the company ignored
his data showing elevated levels of complications and mortality associated with
the patch.
Another former vice president, Dr. Joel Lippman, claimed in a lawsuit that he was
fired by Johnson & Johnson because he expressed concerns about the patch’s
dangerously high estrogen levels prior to its coming to market. The company, he
says, "disregarded his concerns and launched the product anyway."
According to NBC, 24 deaths have been attributed to blood clots induced by the patch,
and more than 2,400 women currently have personal injury lawsuits filed against
Johnson & Johnson. To date, the company has spent $68 million to quietly settle
Ortho Evra lawsuits.
Unfortunately, Ortho Evra remains on the market, despite countless calls to have
it pulled. In spite of its risks, the patch is still a big money maker for Johnson
& Johnson, which has earned $1.6 billion on its sales.
- In response to
NBC’s news report, the company issued the following statement:
- Thank you for
your inquiry to Ortho Women’s Health & Urology, Division of Ortho-McNeil-Janssen
Pharmaceuticals, Inc. We believe it is inappropriate to comment on the details around
ongoing litigation and therefore are not providing responses to your individual
questions beyond the statement below:
- ORTHO EVRA has
been a safe and effective birth control option for women and their healthcare providers
since 2002. It addresses a birth control need and provides another choice for women
who, with the counseling of their healthcare provider, do not want or are unable
to take a birth control pill every day. Ortho Women’s Health & Urology
has regularly disclosed scientific data regarding ORTHO EVRA to the FDA, the medical
community and the public in a timely manner, and when used according to the FDA-approved
label, ORTHO EVRA remains a safe and effective method of hormonal birth control.
It also, like all methods of hormonal birth control, has benefits and risks which,
as a prescription medicine, should be the subject of discussion between a woman
and her healthcare provider. These benefits, risks and other important safety information
are contained in the Detailed Patient Labeling, which is part of the ORTHO EVRA®
Prescribing Information, and can be found at
http://www.orthoevra.com/sites/default/files/assets/OrthoEvraPI_0.pdf.
- — Jeff Christensen, spokesperson, Johnson
& Johnson
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