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Ortho Evra Maker Johnson & Johnson Allegedly Altered Birth Control Patch Data to Hide Risks

Filed November 30th, 2007 amy

Johnson & Johnson faces lawsuits of nearly 2,500 women who claim the company withheld and altered data that its Ortho Evra birth control patch could cause strokes, heart attacks, and blood clots in the legs and lungs at a higher risk than oral contraceptives.

These lawsuits are uncovering evidence that the company knew of the risks in 1999 and misled the FDA when seeking approval for the patch in 2001.  This detailed look at the evidence, previously deemed confidential by the judge, finally became a matter of public record through a motion filed in Toledo federal court, where about 1,500 Ortho Evra lawsuits are pending, last Tuesday.  This evidence may explain why Johnson & Johnson settled so many of its cases in an effort not to go to trial.

Per a Bloomberg news report,”The filing details a clinical trial in 1999, known internally as 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. A company pharmacologist, Dr. Larry Abrams, applied a “60% correction factor” to lower the results, the motion said.”

It wasn’t until 2005 that the FDA stated that Ortho Evra patch users are exposed to around 60% more estrogen than those on the pill.  By then, the FDA had 21 reports of life-threatening blood clots and other related ailments from Ortho Evra patch users.  Those suing include a14 year old girl who suffered deep vein thrombosis and the husband of a 25 woman who died of a heart attack after using the patch for only a month.

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