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Ortho Evra Contraceptive Patch Side Effects

A class action lawsuit is currently being investigated against Ortho-McNeil Pharmaceutical, Inc., makers of the Ortho Evra birth control patch, to determine whether it failed to disclose that the side effects and risks of blood clots, stroke or heart attacks are greater for women using the patch (almost 10 million prescriptions written in 2004 alone) than for women using birth control pills. In January, 2008 the FDA warned that women who use Ortho Evra are more likely to suffer blood clots than women who use birth control pills.

ARTICLES AND INTERVIEWS

Ortho Evra Patch Victim thankful to be Alive
Ortho Evra Patch Victim thankful to be Alive Newport News, VA: Lacrecia had 12 days leave from the army and she was scheduled to visit her husband in Germany. But they had an argument and she visited her mum in Virginia instead. That argument likely saved her life. "My doctor said I wouldn't be alive today if I got on that plane," says Lacrecia, "and I can only blame it on the Ortho Evra Patch". Lacrecia was about to board a plane with blood clots in both lungs, caused by Ortho Evra birth control. [ Read More ]
Mother warns daughter Never to Use the Ortho Evra Patch
Mother warns daughter Never to Use the Ortho Evra Patch Chandler, AZ: Tania used the Ortho Evra birth control patch for 9 months without incident—the only complaint she had was "unusual bleeding" but her doctor said that was normal. But then her knee started to hurt and during the next few months, Tania saw 3 doctors, none of whom made the link between the Ortho Evra patch and deep vein thrombosis (DVT). [ Read More ]
Doctor Blamed Ortho Evra Patch for Aneurysm
Doctor Blamed Ortho Evra Patch for Aneurysm Queensbury, NY: Brenda S. started using the Ortho Evra patch in March 2005 and she had an aneurysm in January 2007. Now she wants to know how the manufacturer--Johnson and Johnson subsidiary Ortho McNeil-- can say that Ortho Evra's benefits outweigh the dangers? "Why would anything be marketed that could possibly be a risk to someone's health, or even kill them," says Brenda, "and where is the FDA? [ Read More ]
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IN THE NEWS

MAY-14-08: A lawsuit filed against Johnson and Johnson alleges the company's Ortho Evra birth control patch causes blood clots, heart attacks and strokes. Thirty thousand people are involved in the lawsuit. [KFDA: ORTHO EVRA DANGEROUS] MAY-08-08: Public Citizen’s Health Research Group is urging the FDA to pull Ortho Evra from shelves as studies have linked the birth control patch to an increased risk of life threatening blood clots. [MSNBC: PULL THE PATCH] JAN-18-08: The FDA has approved additional changes to the Ortho Evra Contraceptive Transdermal Patch label to include warnings that patch users are at higher risk of developing venous thromboembolism (VTE), than women using birth control pills. VTE can lead to pulmonary embolism. [FDA: ORTHO EVRA LABEL CHANGES]
MAY-15-07: At least one ob-gyn group has decided to stop prescribing Ortho Evra because of the risk of deep vein thrombosis. Other doctors will still prescribe it, but will recommend other options because of the health risks. [VOLUNTEER TV: ORTHO EVRA RISK] FEB-26-07: Last year's study has shown that Ortho Evra contraceptive does increase risk of blood clots more than birth-control pills. [CONSUMER REPORTS: ORTHO EVRA BLOOD CLOTS] FEB-09-07: Lawsuit names 46 plaintiffs, most of them young women in their teens and 20s, who suffered blood clots, stroke and death after using the Ortho Evra patch. [BUSINESS JOURNAL: ORTHO EVRA DEATH RISK]

[FREE CASE EVALUATION]IN YOUR OWN WORDS

I was on the patch for about 9 months and now had a DVT in January 2008.
I am on Coumadin.
I was in the hospital for 3 days.
I had thrombosis and a vena cava filter inserted and removed.
I am having trouble standing, walking, kneeling and sitting for long periods of time.
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First Ortho Evra Patch Deaths Reported

July 17th, 2005, the Associated Press International (API) reported that they were aware of at least a dozen women, most in their late teens and twenties who died in 2004 due to blood clots that are believed to be related to the use of the Ortho Evra Patch. According to 16,000 federal drug reports filed with the FDA, dozens more women survived strokes and other blood-clot related side effects In fact, API found 23 different fatalities associated with the patch, but the primary cause of death in each case was not always clear.

ortho evra patch risks Some people suspect that there are many more deaths related to Ortho Evra but that aren't reported as such because coroners or doctors are not considering the effect of birth control in the fatal or near-fatal event, so they are not reporting all cases to the government.

These cases are incredible tragedies for the victims and their families. In one case, a 25 year old woman had a stroke and was placed in the Intensive Care Unit, where her condition was so fragile that her family was unable to speak or touch her in any way because even the slightest amount of stimulation could create a fatal level of pressure on her brain.

After the death of this beloved sister, daughter and wife, the coroner stated that her headaches and stroke may have been side effects of the high hormone levels in Ortho-Evra. In March 2004, a young woman from New York died after being on the patch six weeks. A 17-year-old St. Louis girl using Ortho-Evra died from a pulmonary embolism which is a deadly blood clot.

Young women are typically at low risk for blood clots and strokes, but with the use of Ortho Evra, these young women are having strokes, heart attacks and even dying at increased rates.

Ortho Evra Warning Signs

It is alleged that the FDA and the drug maker saw warning signs of problems with the Ortho-Evra patch before it was approved for the general market. Both entities maintain that the medication is as safe as any other pill-form birth control. However, a study with 800,000 women in 2004 showed that using the birth control patch increased the risk of dying or suffering a blood clot three times more than regular birth control pills.

Unaware of the risks, doctors prescribe medications with little thought. It's an unfortunate reality that many doctors are incentivized to prescribe brand name medications; they are legally paid what is essentially the equivalent of sales commissions or receive other incentives such as lunches, parties, clip boards, note pads, and more. These financial incentives bring up a plethora of ethical and liability issues.
 

Ortho Changes Label

In November 2005, Ortho McNeil, the makers of Ortho Evra , revised the birth control warning label to include additional risks and side effects:

"Most side effects of the Patch are not serious and those that are, occur infrequently. Serious risks, which can be life threatening, include blood clots, stroke and heart attacks and are increased if you smoke cigarettes."

Women using the Ortho Evra Patch are "exposed to about 60% more estrogen if they use ORTHO EVRA than if they use a typical birth control pill containing 35 micrograms of estrogen. In general, increased estrogen exposure increases the risk of side effects."

ortho evra label

These changes to the label do little to warn women and their doctors of the potential risk of dying while using the Ortho Evra birth control patch.

Ortho Evra was the first contraceptive patch approved in 2002 by the FDA for Ortho-McNeil Pharmaceuticals under the giant company Johnson and Johnson. Ortho Evra and other birth control methods for these pharmaceutical companies generates over $1 billion in annual sales.


Ortho Evra Patch Legal Help

If you have or a loved on has suffered from blood clots, heart attack or stroke, while using Ortho Evra, you may qualify for damages or remedies that may be awarded in an Ortho Evra class action or lawsuit. Please click the link below to submit your complaint to an Ortho Evra lawyer for a free case evaluation.
Please click here for a free evaluation of your case
Hissey Kientz, LLP - Michael Hissey and Robert Kientz
will work hard to win the settlement that you deserve.


Posted on Oct-22-04
Updated on Oct-5-08

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