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

The clinical trails were held in Australia with 40 women testing a number of skin spray formulations to the forearm once a day over 14 days. The formulations contained the proprietary new generation progestin Nestorone combined with either ethinyl estradiol or estradiol as the estrogen. The amount of each of these hormones in the blood was measured once a day and every four hours on day 14.

These were the first trials to test the performance of daily sprays over an extended period of time. Earlier trials tested only single doses of Nestorone MDTS formulations. Trial results showed that formulations containing Nestorone and ethinyl estradiol successfully delivered therapeutic amounts of both hormones across the skin into the blood. All spray formulations were well tolerated with no serious adverse events recorded, according to the drug maker.

The next step is expected to be a Phase 2 dose-ranging clinical trial before conducting Phase 3 global registration trials.

SOURCE: Ortho Evra and Blood Clots › Contraceptive spray touted as safer alternative to pills, patches

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

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