Johnson & Johnson, the world's largest manufacturer of healthcare products, allegedly misled doctors and regulators for years by withholding and altering medical data about the health risks of their Ortho-Evra birth control patch, according to the lawyers for 7 women that are suiting Johnson & Johnson.
The Ortho-Evra birth control patch was a popular form of birth control as it did not require the user to take a pill on a daily basis at a specific time. The patch was applied to the skin and then left alone until it wore out in roughly a month's time. Unfortunately, the patch released much higher levels of estrogen into the user's bloodstream than other forms of birth control do. This resulted in a higher incidence of strokes and heart attacks for users of the patch than the pill. Johnson & Johnson is now facing lawsuits by roughly 2,400 women who claim that the high levels of estrogen released by the patch cause strokes, heart attacks, and blood clots in the heart and lungs.
Internal documents and pre-trial interviews show that Johnson & Johnson learned of the risks in 1999 and did not inform the FDA while they were seeking approval for the Ortho-Evra birth control patch in 2001. 5 million women have used the patch since it went on the market in 2002. The filings offer the first glimpse at evidence that was deemed confidential by judges. This new data/evidence also gives a hint as to why Johnson & Johnson previously has settled out of court on dozens of other law suits. The FDA warned in 2005 that using the Ortho-Evra patch exposes women to 60% more estrogen than the pill does. In February of 2006, a different study found a two-fold increase in the number of blood clots.