Public Citizen's Sydney Wolfe petitioned the FDA two years ago to pull the patch off the market, but the FDA has yet to make a decision.The FDA told NBC:
It's a complicated issue that takes time to review.In the meantime, girls are still -- literally -- dropping dead from the patch, such as Adrianna Duffy, a college freshman who collapsed in September 2009.
The FDA is running out of excuses for not making a decision about Ortho Evra. The history is a long one, and it reflects badly on J&J:
- The patch has killed more than 40 women.
- J&J has settled thousands of Ortho Evra lawsuits.
- When the brand was launched in 2002, J&J's ads frequently carried no warnings.
- A J&J physician on the brand had a history of faking test results.
- When a patient at New York's Mount Sinai adolescent health center died from an Ortho Evra blood clot, J&J sales reps triples their visits to the staff there, treating them to breakfast and lunch until their concerns went away.
- An FDA staffer reviewing J&J's application to market the drug warned that the blood clot risks were actually twice what J&J's stats said they were.