On July 8, 2003, the decedent experienced difficulty breathing and collapsed in her home. Paramedics arrived and found the woman in acute respiratory distress. She was taken to the emergency room at St. John Macomb Hospital in Michigan, where emergency room doctors noted she was cyanotic (blue lips and skin) and in severe respiratory distress. The decedent did not respond to CPR and other life-saving measures and was pronounced dead that evening. An autopsy revealed the cause of death as an acute pulmonary embolism.

On November 10, 2005, Ortho McNeil, in conjunction with the FDA, issued a warning about the increased risks of blood clots associated with Ortho Evra. In the new warning, Ortho-McNeil admitted for the first time that women who use the patch will be exposed to up to 60% more estrogen than they would be exposed to if they were taking a birth control pill with 35 micrograms of estrogen. The patch is only intended to deliver 20 micrograms of estrogen. The FDA's announcement on this warning can be found at www.fda.gov/bbs/topics/news/2005/NEW01262.html . It is widely understood that increased exposure to estrogen greatly increases the risk of blood clots, which can cause serious injury or death.

Pulmonary embolism is a sudden blockage in a lung artery, usually due to a blood clot that traveled to the lung from the leg, but clots can also form in the pelvic vein. Pulmonary thromboembolism can be fatal or may result in pulmonary arterial obstruction, pulmonary obstruction, pulmonary infarction, chronic pulmonary hypertension, dyspenea and tachypnea. Symptoms may include shortness of breath, difficulty breathing, anxiety, chest pain, fainting and convulsions. Treatment may include long term use of anticoagulant medications and/or surgery. Recent reports have indicated that the risk of developing blood clots, pulmonary thromboembolism, heart attack and stroke may be significantly higher with the Ortho Evra patch than with oral contraceptive use.

It is alleged that Ortho-McNeil was aware of the increased medical risks associated with Ortho Evra before the drug was approved and that, once approved, the company failed to adequately warn patients about these risks. Evidence shows that the risk of blood clots, heart attack and stroke associated with Ortho Evra is significantly higher than with oral contraceptive pills. The incidence of embolisms and thrombotic injuries in Phase III trials of Ortho Evra was reportedly six times greater than the incidence of such events in oral contraceptives using the hormone levonorgestrel. The FDA has logged 9,116 reports of adverse reactions to the patch in a 17-month period, whereas Ortho Tri-Cyclen, a birth control pill, only generated 1,237 adverse reports in a six-year period. During a 12-month period, 44 serious injuries or deaths have been associated with Ortho Evra, whereas only 17 such reports were linked to the birth control pill during a similar time period. The pattern is further magnified when usage rates are considered: Ortho Tri-Cyclen has six times the number of users as Ortho Evra.

Ortho Evra is an adhesive, transdermal birth control patch that users are instructed to apply to their upper torso, upper outer arm, buttock or abdomen. The patch is intended to release 150 mcg of norelgestromin and 20 mcg of ethinyl estradiol into the bloodstream per 24 hours. It is replaced once a week for three weeks, and no patch is worn during the fourth week during menstruation. The regimen is then repeated. Ortho Evra was approved by the FDA in November 2001, and over 4 million women have used Ortho Evra since its approval. Ortho Evra continues to be marketed aggressively to both consumers and physicians.

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On November 10, 2005, Johnson & Johnson issued a warning about its Ortho Evra birth control patch causing a higher incidence of blood clots than oral contraceptives. A Pulmonary Embolism is a blood clot that passes from the legs to the lungs.

The AP reported that, based upon FDA records it obtained through a Freedom of Information Act, women using Ortho Evra in 2004 were three (3) times more likely then women using birth control pills to die or develop nonfatal blood clots. The Associated Press learned that of the 23 cases in which death was the outcome, doctors reviewing the cases found 17 that appeared to be blood-clot-related, including 12 in 2004.

Additionally, in The October 12, 1996, issue of the Lancet contains three articles and a letter reporting that current users of postmenopausal hormone replacement therapy (HRT) drugs (Prempro, Premarin, and Premphase) may have a twofold or higher increased risk of deep vein thrombosis (DVT) in the legs and may lead to Pulmonary embolism (PE).

Patients who take or have taken Vioxx are at an increased risk of developing pulmonary embolism (PE). Vioxx promotes the formation of blood clots, which can later cause a pulmonary embolism (PE). Merck & Co. removed its blockbuster arthritis drug Vioxx from the market worldwide because new data from a clinical trial found an increased risk of heart attack and stroke.

Merck decided to remove the drug from the market on September 30, 2004, after data from the trial showed an increased risk of heart attack, stroke, blood clots and other cardiovascular complications.

A pulmonary embolism (PE) is a blood clot in the lung. It usually comes from smaller vessels in the leg, pelvis, arms, or heart. When a clot forms in the legs or arms, it is referred to as a deep venous thrombosis (DVT).

The clot passes through the vessels of the lung continuing to reach smaller vessels until it becomes wedged in a vessel that is too small to allow it to continue anymore. The clot gets wedged and prevents any further blood from traveling to that section of the lung.

There are numerous factors that may make someone more likely to develop a blood clot that can sooner or later break loose and travel to the lung:

1) Immobilization: A stroke, broken bone, or spinal cord injury can result in confinement to bed so that clot formation can occur in either the arms or legs.

2) Travel: Prolonged travel, such as sitting in an airplane or a long car trip, allows the blood to sit in the legs and increases the risk of clot formation.

3) Trauma or injury (especially to the legs).

4) Obesity.

5) Heart disease (such as an irregular heartbeat).

6) Burns.

7) Previous history of blood clot in the legs (DVT) or Pulmonary embolism.

Conditions that increase clotting of the blood

1) Pregnancy
2) Cancer
3) Certain protein and enzyme deficiencies
4) Hormone Replacement Therapy (HRT) drugs

If you or a loved one has taken HRT drugs; COX-II Inhibitors, or the Ortho Evra Patch and were diagnosed with a Pulmonary Embolism (PE), please fill out the form at the right for a free case evaluation by a qualified defective drug attorney.