Ortho-McNeil, makers of the controversial and potentially dangerous Ortho Evra birth-control patch, continues to deal with significant legal challenges.

New York firm Parker & Waichman, LLP, announced it had filed suit in the Superior Court of New Jersey on behalf of a 26-year-old woman who had suffered pulmonary emboli and will be forced to remain on a regimen of anticoagulent medication. The new suit marks the 100th filed by the firm in cases related to the patch.

Last week, 43 women brought a suit against Ortho-McNeil, a subsidiary of Johnson & Johnson, and San Francisco-based distributor McKesson Corp., alleging that use of the Ortho Evra patch has led to blood clots and other serious health problems. In a separate complaint, plaintiffs want to hold the company responsible for the death of an otherwise healthy 25-year-old woman, Kelly Bracken of Maryland, who suffered fatal blood clots in her lungs and legs after using Ortho Evra. Roughly 400 women have now filed suit against the pharmaceutical company in complaints related to the safety of the patch.

A study in September of this year found that women who use the patch face twice the risk of dangerous blood clots than women who take contraceptive pills. Plaintiffs in the suits, as well as some watchdog groups and medical professionals, claim that Ortho-McNeil failed to undertake a comprehensive investigation of the safety of the drug and may have withheld or downplayed potentially damaging information about its side effects during the FDA approval process.

Ortho Evra was approved by the FDA in 2001. According to Parker & Waichman, Evidence shows that the risk of blood clots, heart attack, and stroke associated with Ortho Evra is significantly higher than with oral contraceptive pills. As of November 2005, the FDA had 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 were 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.



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