Ortho Evra Lawsuit & News Blog

Users of birth control patch were at higher risk of developing serious blood clots

Sun, 20 Jan 2008 08:54:33 -0500

FDA modified the prescribing information for the Ortho Evra Contraceptive Transdermal (Skin) Patch to include the results of a new epidemiology study that found that users of the birth control patch were at higher risk of developing serious blood clots, also known as venous thromboembolism (VTE), than women using birth control pills. VTE can lead to pulmonary embolism. The label changes are based on a study conducted by the Boston Collaborative Drug Surveillance Program on behalf of Johnson and Johnson. The patch was studied in women aged 15-44. These findings support an earlier study that also said women in this group were at higher risk for VTE.

FDA believes that Ortho Evra is a safe and effective method of contraception when used according to the labeling, which recommends that women with concerns or risk factors for serious blood clots talk with their health care provider about using Ortho Evra versus other contraceptive options.

Read the complete 2008 MedWatch Safety Summary, including a link to the FDA News Release, at: http://www.fda.gov /medwatch/safety/2008/safety08.htm#orthoevrapatch

Birth Control Pill or Blood Clot: What's Your Pleasure? Do You Have a Lawsuit?

Tue, 8 May 2007 08:23:18 -0500

Birth Control Pill or Blood Clot: What's Your Pleasure? Do You Have a Lawsuit? - http://www.notmypill.org

Third generation oral contraceptives like - Desogen, Vilivet, Kariva, Mircette, Ortho-Cept, Reclipsen, and Cyclessa - all contain desogestrel. The ingredient desogestrel almost doubles the risk of life threatening blood clots compared to older forms of birth control.

Desogestrel is used as a female contraceptive. Desogestrel is a progestin or a synthetic form of the naturally occurring female sex hormone, progesterone. In a woman's normal menstrual cycle, an egg matures and is released from the ovaries during ovulation. The ovary then produces progesterone, preventing the release of further eggs and priming the lining of the womb for a possible pregnancy. If pregnancy occurs, progesterone levels in the body remain high, maintaining the womb lining.

If pregnancy does not occur, progesterone levels in the body fall, resulting in a menstrual period. Desogestrel tricks the body processes into thinking that ovulation has already occurred, by maintaining high levels of the synthetic progesterone. This prevents the release of eggs from the ovaries.

It is estimated that American women filled more than 7.5 million prescriptions for third-generation oral contraceptives from November 2005 to October 2006. Hip advertising and exotic, fun brand names like Vilivet, Kariva, Mircette, Reclipsen, and Cyclessa attract women who see the ad and want the sense of freedom that they portray while older forms of oral contraceptives (birth control pills) offer as much security against pregnancy and are safer health-wise without a threat of fatal blood clots and cardiovascular problems. In this case - newer drugs is not better.

Women who use third generation desogestrel oral contraceptives should be strongly advised not to smoke due to the increased risk of cardiovascular side effects. Serious risks reported with the use of oral contraceptives include blood clots, stroke, and heart attacks. Oral contraceptives are contraindicated in women with thrombophlebitis, thromboembolic disorders, breast cancer, hepatic or estrogen-dependent neoplasia, cerebrovascular or coronary artery disease, jaundice, or undiagnosed genital bleeding.

On February 6, 2007, the watchdog consumer group filed a petition with the FDA to ban third generation oral contraceptives that contain desogestrel. Use of any type of birth control pill holds an increased risk of blood clots, third-generation birth control pills double that risk without preventing pregnancy any more effectively than older pills.

The FDA has known since 1995 that these desogestrel birth control pills were more dangerous but has allowed them to stay on the market for 12 years. This speaks volumes as to how the FDA cares about women's health.

If you or your mother or daughter takes third generation birth control pills Desogen, Vilivet, Kariva, Mircette, Ortho-Cept, Reclipsen, and Cyclessa, please ask your doctor how to switch to an older and safer pill. If it's too late and you or a loved one has suffered from a blood clot or other life threatening side effect, it's time to talk to a law firm who can help you file a lawsuit. The FDA, healthcare profession, and pharmaceutical companies are not on your side but we are. Please answer a few questions so we can help you evaluate the facts.

Public Citizen Petitions FDA To Ban Oral Contraceptives Containing Desogestrel

Sun, 1 Apr 2007 06:59:35 -0500

Public Citizen Petitions FDA To Ban Oral Contraceptives Containing Desogestrel in (April 2007): Public Citizen's Health Research Group filed a petition with the Food and Drug Administration (FDA) on February 6, 2007, to ban the sale of all third-generation oral contraceptives (OCs), which double the risk of potentially life-threatening blood clots compared to second-generation birth control pills. A list of these oral contraceptives that contain desogestrel accompanies this article. (http://www.worstpills.org)

Excess Estrogen Causes Blood Clots

Fri, 12 Jan 2007 08:43:27 -0500

The hormones in both HRT and birth control pills can increase the risk for blood clots. If the clots break loose from the legs, they can lodge in the lungs and cause a potentially life-threatening condition. Although most women can take hormones with minimal risk, some may experience heart attacks or strokes because of blood clots. The Ortho Evra birth control patch now comes with a warning that it releases more estrogen into the bloodstream than typical birth control pills. This may increase the risk for blood clots.

Ex Birth Control Patch Exec Fired

Thu, 11 Jan 2007 08:45:47 -0500

A former vice president at two Johnson & Johnson subsidiaries claims in a lawsuit he was fired for seeking recalls of numerous faulty products, including the Ortho Evra birth-control patch, which is the subject of at least 1,000 product liability suits.

New Brunswick-based Johnson & Johnson, one of the world's biggest drug and medical product makers, said the ex-executive was fired for inappropriate conduct.

In his civil complaint, he alleges that he was unlawfully terminated on May 15, after working for Johnson & Johnson for 15 years, because he repeatedly complained about product safety problems and urged several be recalled such as the birth control patch or other products not to be launched.

Wrongful Death Lawsuit Filed against Birth Control Patch

Sun, 7 Jan 2007 08:43:56 -0500

The mother of a woman who died in June 2003 after using the Ortho Evra birth control patch recently filed a wrongful-death lawsuit in San Francisco Superior Court alleging that the company knowingly misinformed the public about the drug's risk of severe side effects. The now deceased 26-year-old woman from Tennessee began using Ortho Evra in April 2003 and died of a pulmonary embolism in June 2003. Her mother filed the lawsuit alleging Ortho McNeil misled the public about the drug's risk of side effects, including pulmonary embolism, stroke, deep vein thrombosis, and blood clots (http://www.medicalnewstoday.com/medicalnews.php?newsid=59042&nfid=rssfeeds)

Texas Women File Ortho Evra Birth Control Patch Lawsuits

Wed, 13 Dec 2006 10:22:48 -0500

Three Texas women have filed lawsuits against the makers of the Ortho Evra birth control patch after doctors diagnosed the women with severe blood clots and other life-threatening complications. The lawsuits say the drug's maker, Ortho-McNeil Pharmaceutical Inc., a subsidiary of Johnson & Johnson, should be held responsible for manufacturing and selling a dangerous drug.

The 30-something women, live in Dallas, Euless, and Garland, Texas. All three required hospitalization as a result of their medical problems which include blood clots and pulmonary embolism. Even though none of the women had a history of blood clots before taking Ortho Evra, all three have been told by doctors that they must take blood- thinning drugs to prevent future blood clots. One of the women's doctors has determined that she will be required to take blood thinners for the rest of her life. (Texas Ortho Evra Lawyers file Lawsuits)

Wrongful Death/Mass Action Lawsuits against Birth Control Patch

Wed, 6 Dec 2006 10:25:02 -0500

A wrongful death lawsuit involving a 26-year-old woman and a mass action suit on behalf of 55 women nationwide suffering from blood clots and other serious illnesses were filed December 12, 2006 in California State Court in San Francisco. The women allege their injuries were caused by Ortho Evra, the fastest growing birth control contraceptive in the United States.

The wrongful death suit was filed by the mother of a 26-year-old Hollow Rock, Tennessee woman who died from a pulmonary embolism and blood clots in June 2003. The young woman started taking Ortho Evra in April 2003.

The wrongful death and mass action lawsuits charge that Ortho-McNeil, the world's leading contraceptive manufacturer, knowingly deceived the public about the drug's risk of side effects, which include strokes, blood clots, deep vein thrombosis, and pulmonary embolisms. The suits contend that the defendants failed to properly investigate Ortho Evra's safety and knew of the contraceptive's harmful effects while continuing to market and distribute the drug without accurate warning. (Yahoo Ortho Evra Death Lawsuit Information)

New York Woman Suffers Pulmonary Embolism from Birth Control Patch

Thu, 30 Nov 2006 10:28:42 -0500

At the age of 21, the plaintiff began using the Ortho Evra birth control patch in November of 2003. Within three months, she was hospitalized and diagnosed with a pulmonary embolism. As a direct result of the pulmonary embolism she suffered while using Ortho Evra, the plaintiff is precluded from using any hormone therapy treatment for contraception or menopause. She is also more inclined to experience future medical complications as a result of the injuries she sustained during her use of the Ortho Evra birth control patch. (NY Ortho Evra Lawsuit)

Denver woman files lawsuit against Ortho Evra

Wed, 22 Nov 2006 10:50:38 -0500

Denver woman files lawsuit against Ortho Evra

A lawsuit was filed in Denver on November 16, 2006, against Johnson & Johnson, the makers of the Ortho Evra birth control patch. The lawsuit was filed on behalf of a Colorado woman who suffered a pulmonary embolism and deep vein thrombosis due to her use of the Ortho Evra birth control patch.

The 31-year-old plaintiff began using the Ortho Evra birth control patch in April of 2004. After 9 months of use, she was hospitalized and diagnosed with a pulmonary embolism and a deep vein thrombosis on December 25, 2004. As a direct result of the deep vein thrombosis and bilateral pulmonary emboli she suffered while using Ortho Evra, the plaintiff is precluded from using any hormone therapy treatment for contraception. She is also more likely to experience future medical complications as a result of the injuries sustained during the use of the Ortho Evra birth control patch. (Source: Denver Ortho Evra Lawsuit)