Ortho Evra Birth Control Patch:  1,000 Claimants and Counting

Youngest victim was 14

By Ruben Obregon

According to Johnson & 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.” [1] 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 death. From April 2002 to December 2004, over 27,974 'adverse effects' were reported by users of Ortho Evra.[2] Many of the complaints are serious, and the patch is alleged to be responsible for over 23 deaths, including the death of 14 year old Alycia Brown.[3]

The claims keep mounting – 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 Ortha Evra.. The lawsuit alleges that the Ortho Evra patch was responsible for the serious health problems, including the death of one user.[4]

"We were saddened for these women and their families but not surprised by the news of these cases," says John David Hart, of the Law Offices of John David Hart in Fort Worth, who represents women who have used the Ortho Evra patch. "All of the women we've met with and all of the research we've done suggest that this is a real problem and that women are being harmed by using this drug."[4]

Rather than pull the drug off of the market, it appears Johnson & Johnson finds it cheaper to settle with victims. It’s not surprising, considering that in 2004 sales of Ortho Evra reached 420 million dollars.[5] 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.[6] 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 eclipse the settlement payouts.

But what is the problem with the patch, and why are so many claims being made?

To begin with, it is well known 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, 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. [7] Ortho Evra exposes users to 60 percent more estrogen than do typical oral contraceptives. [8] (One has to wonder if long term use will increase the breast cancer risk associated with oral contraceptives?)

Fatal and non-fatal blood clots are considered to be an 'acceptable risk' by the FDA, 'big pharma', and medical professionals. One has to wonder how many women have been told by their OB/GYNs 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 results. The studies do not address fatal blood clots associated with Ortho Evra, since the data the studies rely on is from claims paid by managed care plans. (Deaths which occur outside of medical facilities are not billable events, and therefore, not contained within the managed care data.[9])

One study shows a twofold increase in non-fatal blood clots, while the other only shows a ‘similar’ risk compared with existing pills. As of late, the FDA hasn't recommend either a voluntary recall or involuntary withdrawal of the drug from the market. Apparently 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 unkown is number of underage teens who have experienced 'adverse effects' from Ortho Evra. What is even more unclear 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, and it’s time for that to change. Such laws wouldn't have helped prevent the death of 14 year old Alycia Brown, whose mother helped her choose the patch. But they will help to prevent future deaths and serious health complications in teens who seek to use hormone based contraceptives.

The problems associated with Ortho Evra are not new. Johnson & Johnson was aware of them prior to the drug ever reaching the market.[10] During clinical trials of the patch, two women developed blood clots in the lung, something rare in young women. In spite of this danger, Johnson & Johnson decided to market the drug and and so in December of 2000, submitted it for FDA approval.

In November of 2001, the patch was granted FDA approval and did not carry 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 patch. In 2003, the company refused to fund further studies since the results might not be what they wanted and could hurt Ortho Evra sales.[11] It wasn't until late 2005, when the FDA announced an update on the labeling for Otho Evra, that Ortho-McNeil acknowledged these serious health problems associated with the patch.[11]

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's time for the FDA to step in and request a recall or demand a withdrawal of Ortho Evra. 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 time for an overhaul of that agency.
 

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Footnotes

[1] Johnson and Johnson Form 10Q Quarterly report (third quarter), filed 2006-11-08, US Security and Exchange Commission, SEC EDGAR Filing Information. Available at http://www.sec.gov/Archives/edgar/data/200406/000020040606000138/0000200406-06-000138.txt

[2] Johnson & Johnson Sued Over Ortho Evra Damage; Texas Woman Says Drug Caused Life-Threatening Blood Clots, Miscarriage, Law Offices of John David Hart. Available at http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/09-05-2006/0004426923&EDATE=

[3] Parents Blame Ortho Evra Birth Control Patch for Death of their 14-year-old daughter, NewsInferno.com, No 20, 2005. Available at http://www.yourlawyer.com/articles/read/10949

[4] New Ortho Evra Cases Show Problems Continue: Lawsuits filed on behalf of more than 40 women include one death, Law Offices of John David Hart, November 2, 2006. Available at http://sev.prnewswire.com/medical-pharmaceuticals/20061102/NYTH24702112006-1.html

[5] The Top 200 Prescriptions for 2004 by U.S. Sales ($billions), Data furnished by NDCHealth, viewed November 11th, 2006. Available at http://www.rxlist.com/top200_sales_2004.htm

[6] 2005 ANNUAL REPORT TO SHAREHOLDERS, Johnson and Johnson Form 10K, US Security and Exchange Commission, SEC EDGAR Filing Information. Available at http://www.sec.gov/Archives/edgar/data/200406/000095012306003129/y17887exv13.txt

[7] New Prescribing Information Announced for ORTHO EVRA(R) Birth Control Patch, Ortho Women's Health. Available at http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/11-10-2005/0004213709&EDATE

[8] FDA Updates Labeling for Ortho Evra Contraceptive Patch, Food and Drug Administration. Available at http://www.fda.gov/bbs/topics/news/2005/NEW01262.html

[9] Jick S, Kaye J, Russmann S, Jick H, Risk of nonfatal venous thromboembolism in women using a contraceptive transdermal patch and oral contraceptives containing norgestimate and 35micrograms of ethnyl estradiol, Boston Collaborative Drug Surviellance Program, Boston University School of Medicine, Lexington, MA 02421, USA, Contraception journal, issue 73, 2006:223-228. Available at: http://download.journals.elsevierhealth.com/pdfs/journals/0010-7824/PIIS0010782406000084.pdf  (Adobe PDF and site registration required.)

[10] Mendoza M, Birth-control patch may have higher risk, Associated Press, July 16, 2005, Available at http://72.14.203.104/search?q=cache:goIAWW-7feEJ:www.boston.com/yourlife/health/women/articles/2005/07/16/birth_control_patch_may_have_higher_risk%3Fmode%3DPF+Martha+Mendoza,+%E2%80%9CBirth+Control+Patch+May+Have+Higher+Risk&hl=en&gl=us&ct=clnk&cd=3

[11] Warning issued for birth-control patch, Associated Press, Published in USA Today, 11/10/2005. Available at http://www.usatoday.com/news/health/2005-11-10-birth-control-patch_x.htm

ABOUT THE AUTHOR

Ruben Obregon is the the President and co-founder of No Room for Contraception.  He has worked in the pro-family movement for the past 16 years on issues ranging from education to marriage. 
 

(c) 2006 by Ruben Obregon. All rights reserved.