Johnson & Johnson, which makes the Ortho Evra (norelgestromin/ethinyl estradiol) Transdermal System, has been the focus of hundreds of lawsuits filed over the past two years by women who suffered blood clots and other serious side effects from heightened estrogen levels caused by the birth control patches. Some reports include fatalities. J&J has already settled several of the lawsuits, and the company has told plaintiffs attorneys it is ready to settle remaining ones.

The new labeling on the Ortho Evra packaing includes
- CONTRAINDICATIONS – The term “significant hypertension” was replaced with actual blood pressure values.
- WARNINGS – Under “Elevated Blood Pressure,” providing more complete guidance to health care providers regarding use in women with hypertension.
- ADVERSE REACTIONS – Under “Clinical Trial Experience, Postmarketing Experience,” editorial revisions to provide for use of MedDRA terminology and a more user-friendly format.

The Ortho Evra patch was approved by the FDA in 2001. In 2008, J&J updated its labeling on the birth control patch after testing revealed women between the ages of 15 and 44 on the patch are at higher risk for pulmonary embolism. Serious side effects related to Ortho Evra include heart attack or stroke; blood clots in the legs, lungs (pulmonary embolism), or eyes, or in the deep veins of the legs; chest pain, breast cancer or cancer of the lining of the uterus, cervix or vagina; liver tumor (benign or cancerous); severe high blood pressure; and diabetes with complications of the kidneys, eyes, nerves or blood vessels.

SOURCE: Ortho Evra and Blood Clots › New warnings, adverse reactions added to Ortho Evra

However, students may want to weigh their contraception options more closely. Johnson & Johnson, the makers of the Ortho Evra contraceptive patch has been riddled with lawsuits claiming the patches cause serious side effects in young women, such as blood clots and even death. The patches reportedly can leak too much estrogen into the bloodstream causing the serious health problems.

According to reports, several lawsuits against the company have already ended with confidential settlements and Johnson & Johnson has already told plaintiffs attorneys that it is ready to work out settlements with the others it faces.

The Ortho Evra patch was originally marketed to women seeking an alternative to the once-daily birth control pill. However, since its debut there has been an emerging pattern of young women suffering from pulmonary embolisms and strokes.

Johnson & Johnson no longer actively markets the patch, but it is still available and has yet to be pulled from the market despite petitions by consumer group Public Citizen to the FDA to remove the product. The group also claims removal of the patch would have an environmental benefit, as the discarded patches could leak contaminants into the environment after they are disposed of by consumers.

SOURCE: Ortho Evra and Blood Clots › TCU students urged to heed contraception patch warnings

Currently there is litigation pending throughout the United States, including in Chicago, relating to the use of the Ortho Evra patch. Plaintiffs have filed claims after suffering from blood clots, pulmonary embolisms and in some cases death. The side effects of the patch can be very serious and even deadly.

If you or someone you know developed blood clots while being on the Ortho Evra patch, contact an attorney immediately to learn your legal rights. You may be able to file a claim against the manufacturer for the injuries suffered.

January 31st, 2008 by Gary MaCallister with injuryboard.com

SOURCE: Ortho Evra and Blood Clots › Ortho Evra birth control patch label change

The confidential agreement involved Alycia Brown, a resident of LaCrosse, Wisconsin, who suffered two blood clots in her lungs on May 7, 2004, after using the patch for several weeks. J&J, the world’s largest maker of health-care products, faces lawsuits by 2,400 of the 5 million women who used the patch.

Most claim they suffered strokes or clots in their legs or lungs. The company settled dozens of cases before trial without releasing financial details. The Brown agreement offers the first glimpse into how much money the company paid to resolve a case and avoid a trial that might air details of the company’s safety concerns about the drug before it came to market in 2001.

“Johnson & Johnson is finally starting to realize that the value of these cases and the toll they’ve taken on people is quite considerable,” said New York attorney Hunter Shkolnik, whose firm has filed Ortho Evra lawsuits. “They initially took the position that their conduct cannot be defended and there was low value to these cases.”

The Brown agreement, dated April 21 and entered in federal court in Ohio, was in the file of another Ortho Evra case in state court in Manhattan and made available to Bloomberg News by a court clerk. The 12-page document states that the company denied that Ortho Evra caused Brown’s death, and it acknowledged the uncertainty of litigation as a reason for settling.

Confidentiality Order

Company spokeswoman Gloria Vanderham said the company could not discuss the case because of a confidentiality order. She said the company does not discuss how many cases it settled.
“The company is defending against these claims, except where settlement is deemed appropriate,” said Vanderham, a spokeswoman for Ortho Women’s Health & Urology unit, a division of Ortho-McNeil Pharmaceutical Inc., a J&J subsidiary. “Settlement is not an admission of fault or that the company caused the event.”

The Brown agreement was in the file of a lawsuit by survivors of Zakiya Kennedy, who was 18 when she died on April 2, 2004, after using the patch. Court records show that a confidential settlement was reached in that case on Oct. 11.

Her case was scheduled for Nov. 19 and would have been the first to go to trial. The next scheduled trial involves the death of Ashley Lewis, who was 17 when she died in late 2003. It is slated for state court in St. Louis on Feb. 11.

Brown attorney Janet Abaray and Kennedy lawyer Gary Douglas declined to comment.

Warning Signs

Those suing J&J claim the company failed to heed warning signs about the patch, which delivers the hormones progestin and estrogen through the skin into the bloodstream. The plaintiffs claim the company, based in New Brunswick, New Jersey, knew that the patch, which went on the market in 2002, caused more blood clots and deaths than the birth-control pill.

The Food and Drug Administration warned in November 2005 that the patch may cause clots and expose women to 60 percent more estrogen than oral contraceptives. In February 2006, another study found a twofold increase in the risk of clots compared with women who took the pill.

Johnson & Johnson does not detail any reserves for Ortho Evra cases. It said in an Aug. 8 regulatory filing that it faces numerous product liability cases and believes any liability “will be substantially covered by existing amounts accrued in the company’s balance sheet and, where available, by third-party liability insurance.”

October 24th, 2007

SOURCE: Ortho Evra and Blood Clots › J&J pays $1.25m to settle lawuit over death of 14-year-old