Lawsuits Allege Serious Blood Clots Conditions Such As Pulmonary Embolism, With One Young Woman Dying From Using Ortho Evra
In early November 2006 two new California Ortho Evra lawsuits were filed in San Francisco Superior Court, Bracken-Hodge v. Ortho-McNeil (Case No. 06-457523) and Abel v. Ortho-McNeil (Case No. 06-4575240), according to an Associated Press article published by the Washington Post.
This November 1, 2006 article in the Post informs us that the first case concerns "25-year-old Kelly Bracken of Elk Ridge, Md., died of severe blood clots in her lungs and legs after she started wearing the skin patch," while the second case combines the personal injury claims of 43 women who suffered from various serious side effects caused by blood clots related to the women's use of the Ortho Evra birth control patch.
In September 2006 the FDA warned doctors and patients that women had an increased risk of developing blood clots in their legs -- called deep vein thrombosis or DVT -- and their lungs -- pulmonary embolism -- if they used the Ortho Evra birth-control patch instead of the traditional oral contraceptive pill. Ortho Evra, which was approved by the FDA in 2001, is unique in that is a birth control patch that transfers the hormones estrogen and progestin through a woman's skin directly into the bloodstream.
The Post article tells us that the two companies named as defendants in the two new California Ortho Evra lawsuits filed in November 2006 are the drug's manufacturer, Ortho-McNeil Pharmaceutical Co., a subsidiary of Johnson & Johnson (J&J), and San Francisco-based distributor McKesson Corp.
In September 2006 the Ortho Evra package insert, or label, was updated by J&J to make doctors and patients aware of the results of two conflicting studies: one study that Ortho Evra doubled the risk of serious blood clots compared to the pill, while a second study found no difference in risk between the patch and the pill.
(Posted by: Tom Lamb)