According to Johnson and Johnson's third quarter SEC filing for 2006 , there are over “1,000 claimants who have filed lawsuits or have made claims regarding injuries allegedly due to Ortho Evra.” Ortho Evra, also known as the birth control patch, is a transdermal hormonal contraceptive which is applied weekly to the skin. In addition to being a contraceptive, the patch can act as an abortifacient by preventing implantation of a fertilized egg.

Serious health problems have been associated with Ortho Evra including fatal and non-fatal blood clots, strokes, heart attacks, and even death. From April 2002 to December 2004, over 27,974 adverse effects were reported by users of the Ortho Evra birth control patch. Many of these complaints are serious, and the patch is allegedly responsible for over 23 deaths, including the death of 14 year-old Alycia Brown.

The claims continue to mount – last week a lawsuit was filed on behalf of 40 women against Ortho-McNeil Pharmaceutical Inc, a subsidiary of Johnson & Johnson and the manufacturer of Ortho Evra.. The lawsuit alleges that the Ortho Evra patch was responsible for the serious health problems, including the death of one of those users.

Rather than pull the drug off of the market, it appears Johnson & Johnson finds it cheaper to settle with victims. However, it’s not very surprising, considering that in 2004 Ortho Evra’s sales reached 420 million dollars. With that fact, Johnson & Johnson has plenty of money to spare in order to keep Ortho Evra on the shelves: in 2005 the company sold 1.1 billion dollars worth of hormonal contraceptives. One can speculate that Johnson & Johnson has concluded, despite the settlements, that they will still come out ahead by keeping the patch on the market. The amount they stand to gain from Ortho Evra sales over the next few years will surely offset the settlement payouts.

These claims are being made against the manufacturer of the Ortho Evra birth control patch for several reasons.  Firstly, it is a well known fact in the medical community that hormone-based contraceptives can promote blood clots. Estrogen, one of the hormones in the patch and in many oral contraceptives, is known to promote blood coagulation.

The pill and the patch distribute hormones differently however, which may account for apparent increase in risk associated with the Ortho Evra.

As oral contraceptives are digested they provide the body with a peak and subsequent drop in hormone levels. The patch, on the other hand, distributes the hormones more evenly throughout the night and day, resulting in a more significant exposure. The users of Ortho Evra are exposed to 60 percent more estrogen than those taking typical oral contraceptives.

Fatal and non-fatal blood clots are considered to be an 'acceptable risk' by the FDA, 'big pharma', and medical professionals. So, how many women have been told by their gynecologists that their potential death from a fatal blood clot is an 'acceptable risk' of using hormone based contraceptives?

According to the FDA, two recent studies comparing the patch to similar oral contraceptives provide conflicting outcomes. The studies do not address fatal blood clots associated with Ortho Evra, since the data on which the studies rely is from claims paid by managed care plans.

One study shows a two-fold increase in non-fatal blood clots, while the other only shows a ‘similar’ risk compared with existing oral contraceptive. Thus far, the FDA hasn't recommended either a voluntary recall or involuntary withdrawal of the drug from the market. It appears as though 23 plus deaths aren’t enough for either the FDA or Johnson & Johnson. One has to wonder just how many deaths are?

While a large number of health issues have been associated with the patch, what is largely unknown is the number of underage teens who have experienced 'adverse effects' from Ortho Evra. What is even more uncertain is how many teens use it without the knowledge of their parents and with federal funding provided for by the Title X program. Most states do not have parental notification or consent laws regarding contraception. Some feel this law should change.  However, what could have prevented the death of 14 year-old Alycia Brown, whose mother helped her choose the patch?

The problems associated with Ortho Evra are not new. It is evident that Johnson & Johnson was aware of them prior to the drug ever even reaching the market.  During clinical trials of the patch, two women developed blood clots in the lung, something rare in young women. However, in spite of this danger, Johnson & Johnson decided to market the drug in December of 2000 and submitted it for FDA approval.
In November of 2001, the patch was granted FDA approval WITHOUT a warning about the increased risk of blood clots. Shortly after the patch hit the market in 2002, Ortho-McNeil started to receive reports of serious health issues among users.

Internal documents show that Johnson and Johnson was well aware of the many health problems and complaints associated with the contraceptive patch. In 2003, the company refused to fund further studies since the results might not be what they wanted and would more than likely hurt Ortho Evra sales.  It wasn't until late 2005, when the FDA announced an update on the labeling for Ortho Evra, that Ortho-McNeil acknowledged these serious health problems associated with the patch.

Ortho Evra needs to be removed from the market immediately, either voluntarily or not. It's highly doubtful that Johnson & Johnson, on its own initiative, can be trusted to remove the patch from the market.

It is time for the FDA to step in and request a recall or demand a withdrawal of Ortho Evra from the shelves. A possible reason why this hasn't been happened yet is that the FDA considers blood clots to be 'acceptable risks' of hormonal contraception. If 23 plus deaths and many more cases of serious health problems are considered 'acceptable risks' and of little concern to the FDA, then maybe it's now time for an overhaul of that agency.

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