Leslie Niedner

Leslie cannot remember who first raised the question of whether Adrianna was on the birth control patch. But the suggestion sent her searching the Internet for answers. She quickly found dozens of other stories like Adrianna’s – of healthy young women on the Ortho Evra transdermal contraceptive patch who mysteriously suffered sometimes fatal heart attacks, strokes or blood clots.

“Why would they prescribe this?” Leslie asked the Boston Globe. The question is even more painful to ask, knowing that that thousands of lawsuits have mounted against Johnson & Johnson, makers of the Ortho Evra patch, by women who have been injured or died after using the patch. Johnson & Johnson has paid $70 million to settle the lawsuits.

The bad press has dropped sales of the patch by 75 percent, but the drug is still approved for use by the Food and Drug Administration. “It’s needlessly dangerous,” says Sidney Wolfe, director of the Health Research Group at Public Citizen, a consumer advocacy organization in Washington, during an interview with UPI.

The birth control patch was marketed to younger women because the weekly patches provide a more convenient alternative to daily birth control pills. However, those patches have been found to deliver far more estrogen than birth control pills, Those higher estrogen levels can double a woman’s risk of blood clots.

SOURCE: Ortho Evra and Blood Clots › Mother of Ortho Evra user asks why her daughter had to die

Johnson & Johnson

The Ortho Evra patch was originally marketing to young women who were turned off by the notion of taking a once-daily pill for contraception. The patch is replaced after a week. However, the patch was found in some cases to seep too much estrogen into the bloodstream, which can cause serious health problems.

As an emerging pattern of young women suffering from pulmonary embolisms and strokes emerged, health experts began to point fingers at Johnson & Johnson. Despite the settlements in both the U.S. and Canada, the patch is still on the market and doctors are still prescribing it.

Ortho Evra was first approved for marketing and sale in Canada in 2002. Since then, at least 16 cases of blood clots and one heart attack among women who were using the patch have been reported. Two patients died, including a 16-year-old girl, according to Health Canada.

The Canadian lawsuits involve 22 women from Ontario, British Columbia and Quebec; however, anyone else with a valid claim can still come forward and be included in the settlement. The Canadian plaintiffs sought C$400,00 each in compensation and C$20 million in punitive damages.

The lawsuit claims that Johnson & Johnson failed to properly warn patients and doctors that its Ortho Evra contraceptive patch has a higher risk of blood clots, strokes and heart attacks compared to the birth control pill.

An Ontario judge will be asked to end the suit at a hearing March 23.

SOURCE: Ortho Evra and Blood Clots › J&J settles lawsuits with Canadian women harmed by birth control patch

It likely hints at the company’s desire to avoid trials where its actions -or lack thereof – regarding safety problems with the defective Ortho Evra birth control patch could be called into question.

When Ortho Evra was introduced in 2002, Johnson and Johnson touted the once-weekly patch as a convenient alternative to daily oral contraceptive pills. The drug’s original safety label stated that the patch’s health risks were similar to those related to oral contraceptives.

But in 2005, the Food & Drug Administration warned that women using Ortho Evra were exposed to approximately 60 percent more estrogen than those who used oral contraceptive pills. High levels of estrogen can greatly increase the risk of developing blood clots, heart attacks, strokes and other serious injuries. As of November 2005, the FDA had received twenty-one reports of life-threatening blood clots and other ailments associated with the use of Ortho Evra.

Then in 2006, a study was published that showed women using Ortho Evra were twice as likely to suffer blood clots as those taking oral birth control pills. That study prompted the FDA to request a change on the Ortho Evra label to include a stronger safety warning.

Since then, Ortho Evra has been named in well over 2,000 lawsuits, and the suit filed by 14-year-old Alycia Brown’s family is one of them. According to Bloomberg News, Alycia died in May 2004 from two blood clots in her lungs that developed after she had been using the Ortho Evra birth control patch for several weeks.

According to court records obtained by Bloomberg, Johnson & Johnson settled with her family for $1.25 million. The court records said that Johnson & Johnson did not admit that Ortho Evra had caused Alycia’s death, and that the company settled in order to avoid litigation. Neither Johnson & Johnson nor Alycia’s family would comment to Bloomberg, as both sides had signed a confidentiality agreement.

Johnson & Johnson is likely desperate to keep such agreements secret because it has been accused of ignoring warning signs that Ortho Evra was dangerous. There is evidence that such accusations are true, including the testimony of Joe Lippman, a former employee of and a plaintiff in a whistle blower lawsuit against Johnson & Johnson.

Lippman raised concerns over “dangerously high levels of estrogen” that users of the patch were exposed to in the late 1990s. Lippman, who was fired in 2006, claims his concerns were ignored.

October 25th, 2007

SOURCE: Ortho Evra and Blood Clots › Ortho Evra lawsuit settled for $1.25m as J&J tries to avoid public trials