Ortho Evra Studies Changed, Withheld By Johnson & Johnson to Hide High Estrogen LevelsNov 30, 2007 | Parker Waichman LLP
Ortho Evra Birth Control Patch studies that proved the contraceptive patch exposed women to dangerously high levels of estrogen where either altered or withheld by Johnson & Johnson before the medication was approved by the Food & Drug Administration (FDA), according to court papers file by lawyers for women suing the patch maker in Ohio. Johnson & Johnson is being sued by 2,400 women nationwide who claim the defective Ortho Evra Birth Control Patch caused them to suffer strokes, heart attacks, and blood clots in the legs and lungs.
When Ortho Evra was introduced in 2002, Johnson & Johnson touted the once-weekly patch as a convenient alternative to daily oral contraceptive pills. The drug's original safety label stated that the patch's health risks were similar to those related to oral contraceptives. But in 2005, the FDA warned that women using Ortho Evra were exposed to approximately 60% more estrogen than those who used oral contraceptive pills. High levels of estrogen can greatly increase the risk of developing blood clots, heart attacks, strokes and other serious injuries. As of November 2005, the FDA had received twenty-one reports of life-threatening blood clots and other ailments associated with the use of Ortho Evra. Then a study was published that showed women using Ortho Evra were twice as likely to suffer blood clots as those taking oral birth control pills. That study prompted the FDA to request a change on the Ortho Evra label to include a stronger safety warning.
According to Bloomberg.com, the Ohio filing offers the first detailed look at evidence previously deemed confidential by the judge and may indicate why Johnson &Johnson settled dozens of Ortho Evra cases without allowing any to go to trial. The court papers, which where filed on November 20 in federal court in Toledo, Ohio allege that Johnson & Johnson ``withheld and altered data from the clinical trials which proved that the patch delivered significantly higher levels'' of estrogen than oral contraceptives. "Obviously unaware of the withheld information, the FDA approved Ortho Evra for marketing.''
The Ortho Evra filing details two Ortho Evra studies conducted by Johnson & Johnson. The first, conducted in 1999, was called PHI-014. It measured the amount of ethinyl estradiol, or EE as the estrogen component is called, released into the bloodstream every 24 hours. The company said the study proved the level was 20 micrograms. The actual results showed the patch released 30.4 micrograms when applied to the abdomen and 38.1 micrograms when applied to the buttocks, according to the motion. Johnson & Johnson applied a ``60% correction factor'' to lower the results, the motion said. The Ortho Evra plaintiffs allege that ``Not only was FDA unaware of the use of the 60% correction factor, but even key company employees profess to know nothing about it.'' Johnson & Johnson also left mention of the correction factor out of a journal article published in 2002, leaving doctors in the dark about the true estrogen exposure face by Ortho Evra Birth Control Patch users.
The second study, known as PHI-017, measured the concentration of estrogen from the Ortho Evra patch compared with three forms of the birth control pill, the motion said. The results showed the patch delivered two times more estrogen than one pill and three times more than the other pills. According to the November 20 court filing, ``Over the ensuing six years and to the present date, defendants have never mentioned to the FDA the results of PHI- 017,''. The court papers assert that Johnson & Johnson's failure to provide the FDA with the results of PHI-017 ``was no accident, but instead a very deliberate plan intended to deceive regulators about the high levels of EE delivered by the patch.''