Patch (Ortho Evra)

The birth control patch (Ortho Evra) is a sticker that a woman applies to her body weekly. It is considered a “transdermal contraceptive” because the hormones in the patch pass through a woman’s skin and into her bloodstream. Its mechanism to avoid pregnancy is similar to that of the birth control pill, so it too can prevent pregnancies or abort newly conceived babies.[1] With perfect use it is 99 percent effective in preventing pregnancy. However, with typical use it is estimated to have a failure rate of about 8 percent.[2]

When a woman receives the Patch from her doctor, she also receives a patient package insert that outlines many of the potential side effects. The Ortho Evra insert mentions that users of the patch may experience heart attack, stroke, blood clots, gallbladder disease, liver tumors, breast cancer, nausea, headaches, depression, weight gain, loss of scalp hair, and a host of other ailments.[3] It also mentions in passing that the estrogen in the drug will raise a woman’s SHBG levels. As discussed in our article on the birth control pill, this may cause a long-term decrease in a woman’s sex drive.[4]

Occasionally the manufacturer or the company that sells a particular drug will announce new warnings as they discover the need for them. For example, in November 2006 (five years after the patch was approved by the FDA), Johnson & Johnson, the company that sells the Patch, announced that women need to make sure they don’t expose the Patch to heat. This could cause an unexpected surge of estrogen to be released from the product, which could lead to blood clots. If a blood clot reaches the brain, it can cause a stroke; if it reaches the heart, it can lead to heart attack; and if it reaches the lung, it is called a pulmonary embolism.

Since its approval in 2001, the Patch has stirred up enormous controversy. Headlines in 2004 reported that a New York fashion student using the patch suddenly collapsed in the subway and died. The medical examiner’s office revealed that she died of a blood clot, caused by the hormones in Ortho Evra. In November of the same year, an eighth-grade girl from Wisconsin died from a blood clot in her pelvis caused by the Patch.[5] Sadly, the drug company that manufactures the drug knew of these risks but preferred not to look into the matter. In 2003 the company refused to fund a study that would have compared the Patch to a pill it also makes. An internal company memo noted that the study was declined because of concerns there was “too high a chance that study may not produce a positive result for Evra” and there was a “risk that Ortho Evra may be the same or worse than Ortho-Cyclen.”[6] Sure enough, women who use the Patch were later discovered to be more than twice as likely to develop dangerous blood clots as women who take the birth control pill.[7]

Even though the drug company was not interested in publishing the shortcomings of their product, some caring gynecologists took the initiative. One doctor in California sent a note to several thousand women recommending they get off the Patch.[8] Eventually, Johnson & Johnson issued a warning to millions of women that the hormones released by the product may increase their risk of blood clots. This may be due to the fact that users of the Patch are exposed to about 60 percent more estrogen in their blood than women on birth control pills that contain thirty five micrograms of estrogen.[9]

After the label on the drug was changed, the makers of the Patch noted in their annual report to shareholders that, regrettably, the label change and the negative media coverage probably would have a negative impact on sales.[10] The year of this shareholders’ report, a nineteen-year-old named Amanda Bianchi developed a ten-inch blood clot in her brain and suffered two strokes. Her doctors said it was a direct result of using the Patch for three months. She told CNN, “I don’t want any other woman to have to go through what I’m going through.”[11]

In July 2005 the Associated Press reported details of one woman’s death:

“Kathleen Thoren’s family gathered around her in the intensive care unit, unable to speak to their beloved sister, daughter, wife, or even stroke her hands. The slightest stimulation might create a fatal amount of pressure on the twenty-five-year-old woman’s swollen brain, warned the doctors. ‘We were horrified, but we tried to just quietly be with her,’ said her sister Erika Klein. ‘In the end, it didn’t help.’ The mother of three died last fall, just after Thanksgiving, after days of agonizing headaches that the coroner’s report said were brought on by hormones released into her system by Ortho Evra, a birth control patch she had started using a few weeks earlier.”[12]

This woman’s death was not an isolated event. The Associated Press reported in 2005 that it petitioned the FDA for a database containing sixteen thousand reports of adverse reactions to the Patch. Within the reports were twenty-three deaths associated with the Patch, seventeen of them clot-related.[13] However, the FDA admits that it receives reports of only between 1 and 10 percent of serious reactions. So the death toll may be significantly higher. In September 2006 a lawsuit was brought against Johnson & Johnson, pointing out that in a period of thirty-three months, Johnson & Johnson received notice of 27,974 adverse events associated with the Patch.[14]

Reading such information makes one understand why so many people are urging the FDA to take the drug off the market. One attorney pointed out, “The amount of estrogen in the Patch is comparable to a form of contraceptive pill that was banned by the Food and Drug Administration in 1988.”[15] To see a snapshot of the chaos the Patch has caused, all one needs to do is Google the terms “Ortho Evra” and “lawsuit” on the Internet. One will immediately find a litany of lawyers eager to represent injured women. When handling Ortho Evra cases, many attorneys offer their services on a “contingency fee” basis. This means that you don’t pay a dime unless they win your case.

One former executive of the company is even suing them for firing him because he tried to recall the flawed product over safety concerns.[16] The former vice-president of two of Johnson and Johnson’s subsidiaries filed a lawsuit against the company, saying that he was fired partly because he “raised serious health concerns about . . . the Evra patch, which released dangerously high levels of estrogen into patients…[and the company] disregarded [his] concerns and launched the product.”[17] Johnson and Johnson denied the allegation. Yet another V.P. within Johnson & Johnson resigned from his position overseeing the safety of reproductive products, including the patch, because he was “unable to properly exercise this responsibility.”[18]

It’s no surprise that the attorneys are having a field day with the makers of the Patch. In August 2006 Johnson & Johnson told its shareholders, “There are approximately 500 claimants who have filed lawsuits or made claims regarding injuries allegedly due to Ortho Evra.”[19] Three months later, the number of lawsuits had doubled to a thousand.[20] By the end of 2007, it reached approximately 4,000.[21]

Johnson & Johnson mentioned, “The damages claimed are substantial, and . . . the Company is confident of the adequacy of the warnings and instructions.”[22] In other words, when Johnson & Johnson arrives in court, it can tell the women: “We told you this could happen. Didn’t you read the nine pages of prescribing information that came with your drug? You know the one with over nineteen thousand words?”

In its report to shareholders, Johnson and Johnson stated, “However, the Company believes that if any liability results from such cases, it will be substantially covered by existing amounts accrued in the Company’s balance sheet and, where available, by third-party product liability insurance.”[23] What this means is that despite all the money being lost by Johnson & Johnson in legal settlements, it is far more profitable for it to continue selling the Patch.

Even before these lawsuits made headlines, the makers of the patch were quick to minimize the bad press that was on the way. According to internal company emails and a memorandum, Johnson & Johnson investigated the purchase of purchase of more than 100 domain names of “negative URLs.” They were willing to pay up to $10,000 to purchase the domain names that included OrthoEvraKills.com, ThePatchTruth.com, and TheBirthControlPatchKills.com.[24]

Johnson and Johnson has even gone so far as to urge a U.S. District court to allow them to be immune from any liability or injuries caused by the Patch, because the FDA approved it.[25]

Such legal problems do not come as a surprise for those who are familiar with those behind the research of the patch. In 1990s, a scientist named Dr. Andrew Friedman admitted he had been fabricating “80 percent of patient data” that he used in articles he had published in medical journals. He also “alter[ed] files in three studies of hormonal drugs for women.”[26] Because of this, “he was banned for three years from government-funded research for ‘scientific misconduct,’ resigned from his post … and lost his medical license in Massachusetts for a year.”[27] Despite his history of wrongdoing, the makers of the Patch hired him as their senior director of clinical research,[28] and called his reputation in the medical field “excellent,”[29] and he was put in charge of designing and reviewing clinical trials for hormonal birth control.[30]

In 2004, when about a dozen women on the Patch died from blood clots,[31] sales of the patch reached $420 million.[32] If you include its other contraceptives, Johnson & Johnson sold $1.3 billion worth of hormonal birth control in 2004![33] Including all forms of hormonal birth control, the contraceptive market is worth more than $6 billion.[34]

Despite the enormous profits being made, the litigation fees have pharmaceutical companies concerned. According to The New York Times, “fear of product liability suits has driven most companies out of research directed toward development of new birth control products.”[35].
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[1]. Physicians’ Desk Reference (Montvale, N.J.: Thomson, 2006), 2402.
[2]. Hatcher, et al., Contraceptive Technology, Nineteenth Revised Edition.
[3]. “Ortho Evra (norelgestromin/ethinyl estradiol Transdermal Contraceptive) ,” Ortho McNeil Pharmaceutical, Inc. (September 2006).
[4]. Panzer, et al., “Impact of Oral Contraceptives on Sex Hormone-Binding Globulin and Androgen Levels: A Retrospective Study in Women with Sexual Dysfunction,”Journal of Sexual Medicine 3:1 (January 2006), 104–113.
[5]. “Parents Blame Ortho Evra Birth Control Patch for Death of Their 14-Year-Old Daughter,” NewsInferno.com, November 20, 2005.
[6]. Associated Press, “Warning Issued for Birth-Control Patch,” USA Today, November 11, 2005.
[7]. J. Alexander Cole, et al., “Venous Thromboembolism, Myocardial Infarction, and Stroke Among Transdermal Contraceptive System Users,” Obstetrics & Gynecology 109 (February 2007), 339–346.
[8]. “Warning Issued for Birth-Control Patch.”
[9]. Patient Information Sheet: Norelgestromin/ethinyl estradiol (marketed as Ortho Evra), www.fda.gov (September 20, 2006).
[10]. Johnson & Johnson, “2005 Annual Report,” 31.
[11]. “Women Sue Birth Control Patch Maker,” CNNmoney.com (July 25, 2005).
[12]. Associated Press, “Birth Control Patch Linked to Higher Fatality Rate,” MSNBC (July 17, 2005).
[13]. “Birth Control Patch Linked to Higher Fatality Rate.”
[14]. Evelyn Pringle, “500 Ortho Evra Birth Control Patch Victims Sue Johnson & Johnson,” www.lawyersandsettlements.com (September 17, 2006).
[15]. “Lawsuit Filed Against Johnson & Johnson in Los Angeles Over Ortho Evra Birth Control Patch,” PR Web Press Release Newswire (February 15, 2007).
[16]. Linda A. Johnson, “Johnson & Johnson Exec Claims He Was Fired for Raising Safety Concerns,” Associated Press (December 20, 2006); Joel S. Lippman, M.D. v. Ethicon, Inc and Johnson & Johnson, Superior Court of New Jersey, November 13, 2006.
[17]. Id. at Complaint, p. 6
[18]. May, Jeff, “J&J Faces Thousands of Ortho Lawsuits; Plaintiffs Say Drug Maker Downplayed Patch’s Risk,” Star-
Ledger, September 19, 2007.
[19]. Johnson & Johnson, SEC Filing, Quarterly Report for Period Ending 7/2/2006.
[20]. Johnson & Johnson, SEC Filing, Quarterly Report for Period Ending 10/1/2006.
[21]. Johnson & Johnson, SEC Filing, Annual Report for Period Ending 12/31/2007.
[22]. Johnson & Johnson, SEC Filing, 12/31/2007.
[23]. Johnson & Johnson, SEC Filing, 12/31/2007.
[24]. Brown v. Johnson & Johnson, et al. MID-L-5446-05 MT; Memorandum of Decision on Motion filed March 23, 2007.
[25]. Harris, Gardiner and Berenson, Alex, “Drug Makers Near Old Goal: ALegal Shield,” New York Times, April 6,
2008.
[26]. Edelman, Susan, “Contra-Deception; Doc Faked ‘Sex Patch’ Data in 90’s,” New York Post, May 8, 2005; and
Mendoza, Martha, “Allegations of Fake Research Reach New High,” Associated Press, July 5, 2005.
[27]. Edelman, Susan, “Contra-Deception; Doc Faked ‘Sex Patch’ Data in 90’s,” New York Post, May 8, 2005; and
Mendoza, Martha, “Allegations of Fake Research Reach New High,” Associated Press, July 5, 2005.
[28]. Mendoza, Martha, “Allegations of Fake Research Reach New High,” Associated Press, July 5, 2005.
[29]. Edelman, Susan, “Contra-Deception; Doc Faked ‘Sex Patch’ Data in 90’s,” New York Post, May 8, 2005.
[30]. Mendoza, Martha, “Allegations of Fake Research Reach New High,” Associated Press, July 5, 2005.
[31]. “Warning Issued for Birth-Control Patch.”
[32]. “Top 200 Drugs for 2004 by U.S. Sales,” idrugs.com data from NDCHealth (March 2005).
[33]. Johnson & Johnson, 2004 Annual Report (March 2005), 30–31.
[34]. “Systemic Hormonal Contraceptives: Schering Goes from Strength to Strength,” www.imshealth.com (August 23, 2006).
[35]. Daniel J. Kevles, “The Secret History of Birth Control,” The New York Times, July 22, 2001.