The Ortho-Evra patch came onto the market four years ago amid a glitzy ad campaign featuring sexy models and touting convenience. It was a pitch that appealed to millions of American women, including Philomena Ugochukwu.
But just 12 days after she began wearing the patch, the Texas mother suffered a debilitating stroke and two years later remains almost completely paralyzed.
She was a woman full of life, joy vibrant. She's not somebody who's meant to sit in a wheelchair. She and her family are suing the patch's maker, Ortho McNeil. Theirs is just one of a number of lawsuits facing the company filed on behalf of women who have died or been seriously injured by blood clots allegedly caused by the patch.
Like the pill, the patch uses estrogen to help prevent pregnancy. Although it's long been known, estrogen can increase the risk of blood clots and strokes, Ortho-McNeil and the FDA have always contended the risks are roughly the same for the patch and the pill.
These differences are shocking.
Ray Chester represents the Ugochuckwus. He says Ortho McNeil’s own documents seem to paint a much different picture. The documents, given to Chester as part of the suit, compile unsolicited reports to the company of adverse health effects over a two-and-a-half -ear period.
From April 2002 to December 2004, there were more than 500 serious health problems reported associated with the patch, compared to 61 from the most popular form of the pill. There were four times as many strokes reported in women wearing the patch compared to women on the pill, even though the pill was taken by the equivalent of three times as many women!
Ray Chester, Ugochukwu's attorney, says, “Just looking at the cases they've medically confirmed shows the patch is causing clots at a rate 14 times higher than the pill.”
In a statement to CBS News, Ortho-McNeil said there are limits to the reliability of spontaneous reports like these, but reaffirmed its position that the patch is safe and effective, with risks consistent with other hormonal birth control methods.
The drug maker says it has voluntarily initiated a much larger study with the FDA's input to further characterize the safety of this product.
The company's findings on its new study are expected to be released soon and may provide more answers on the medical front, but on the legal front it's likely to be juries in cases like the Ugochukwus that may have the final say.