Johnson & Johnson Sued Over Ortho Evra Patch

Johnson & Johnson misled doctors and regulators for years by altering and withholding medical data about the health risks of its Ortho Evra birth-control patch, lawyers for women suing the company claim in court papers.

J&J faces lawsuits by 2,400 women who claim the patch releases high levels of estrogen that cause strokes, heart attacks, and blood clots. Internal documents and pre-trial interviews with J&J scientists show the company learned the risk in 1999 and misled the Food and Drug Administration when seeking approval in 2001 to market the device, the filings state.

The company "withheld and altered data from the clinical trials which proved that the patch delivered significantly higher levels" of estrogen than oral contraceptives, according to a motion filed by patch users November 20 in federal court in Toledo, Ohio. "Obviously unaware of the withheld information, the FDA approved Ortho Evra for marketing."