Ortho Evra Patch
In 2008 “The New York Times” reported that Johnson & Johnson concealed evidence that its Ortho Evra birth control patch delivers a level of estrogen far higher than allowed by the FDA. Introduced in 2002, the patch delivered 60% more estrogen than COCs, increasing the risk of VTE by three times. There have been over 40 known deaths (50 were then reported to FDA) and over 3,000 lawsuits have been filed. Some lawsuits, as of 2008, were settled for $68 million. A 2012 product information site now offers a fair picture of its dangers.
It is alleged that “the company knew that users of the patch were 12 times more likely to suffer stroke and 18 times more likely to have blood clots than Pill takers. Further, NBC revealed, a vice president of research at J&J, Dr. Patrick Caubel, had quit over frustration that the company ignored his data showing elevated levels of complications and mortality associated with the patch.”
A 2001-2010 study in BMJ by O. Lidegaard et al., published in BMJ in 2012, reported that the relative risk of confirmed venous thrombosis in users of Ortho Evra is 7.9 compared to non-users of hormonal contraception and 2.3 compared to users of 2nd generation COCs.
The same Lidegaard study found that users of Merck’s NuvaRing were at a 6.5 greater relative risk for VTE compared to non-users of hormonal contraception and twice that of women using a 2nd generation COCs.
NuvaRing was introduced in 2001 and since then enjoyed global sales of $3 billion. Merck settled some 1,700 U.S. lawsuits for $100 million in early 2014.
Mirena is a progestin-only intrauterine device (IUD). Since 2000, more than 70,000 adverse events have been filed with the FDA involving Mirena IUD problems, including at least 5,000 cases involving women who complained that Mirena moved out of place since 2008, and 1,322 reports where the Mirena IUD punctured the uterus. Over 2,000 lawsuits have been filed nationwide, of which 600 were consolidated in federal Multidistrict litigation in the Southern District of New York. The trial is scheduled for March 2016.
Even if these risks may be called "relatively rare" given the total number of users, every stroke, every heart attack, every death was completely unnecessary. The excess hormones provided no benefit to users beyond what they could have safely enjoyed through the use of the modern methods of natural family planning.
Susan E. Wills is spirituality editor of Aleteia’s English-language edition.