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Johnson & Johnson spends millions settling Ortho Evra lawsuits

According to Bloomberg News, Johnson & Johnson has spent at least $68.7 million to settle the hundreds of lawsuits filed by women who used the Ortho Evra birth-control patch and suffered blood clots, heart attacks or strokes.

Of 562 complaints reviewed by Bloomberg News, the vast majority of users alleged the patch caused deep-vein thrombosis, or blood clots in the legs, and pulmonary embolisms, or blood clots in the lungs. Some blamed it for heart attacks or strokes. The complaints blamed Ortho Evra for the deaths of 20 women.

One settled case involved Ashley Lewis, a 17-year-old high school junior from St. Louis who died in 2003. She developed a blood clot in her lung after wearing the patch for six months, according to Roger Denton, an attorney for Lewis's family, including her son, who was a one-year-old when she died.

Earlier this year, the NY Times found internal company documents that showed J&J hid evidence that Ortho Evra actually delivered much more estrogen than birth control pills, despite its claims otherwise. So scary. (I was actually a huge NuvaRing fan until I read about women having similar problems, like blood clots, at a higher rate than with the pill.)

Related: One woman recounts her horror story with the patch at Nerve.

Posted by Jessica - October 13, 2008, at 10:16AM | in Health , Law , Reproductive Rights

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28 Comments

I find this new terrifying. Due to a hormonal imbalance I cannot take an form of hormonal birth control. This is something I would have been tempted to use. No matter how much money they pay, it will never bring these women back.

[0+] Author Profile Page MzBitca said:

One of my friends was on the patch and she went through a whole other bunch of hormonal issues while on it, due to the large amount of estrogen. She is glad to be off of it and back on the pill.

This is why I've been using condoms only for at least 15 years. Hormonal BC gave me breast cysts, mood swings, and no periods for 4 years. I don't really get people who say "condoms separated us too much" or whatever. I'd much rather use a sheet of latex than something that screws with my internal chemistry that much any day. And condoms don't cause heart attacks.

I used the patch for a few months but it really screwed up my emotions. I just visited my local Planned Parenthood a few weeks ago to start a new BC (the pill is too inconvenient) and when I explained to the nurse that OrthoEvra made me CRAZY, he stated that it doesn't have any more estrogen than all the other stuff. Um, really? I beg to differ...
I'm on the NuvaRing now and completely, totally in love with it.

Frightening news. I used Nuva-Ring (and like you, Jessica, I was a huge proponent of it to anyone who asked about BC), but I started to have some major problems on it. For starters, because I have a retroverted uterus, it was painful, which my doc assured me was abnormal but was because of my body structure. I also developed cysts repeatedly, but I thought those problems were individual to me and didn't realize they were widespread. As for the patch, I wondered why it wasn't being pushed anymore but had missed the problems with it.

@Bifemme: We're condoms-only, too, and have been for about 2 years. We will be for the immediate future, at least until my partner gets a vasectomy, which he wants to do soon. My docs have really pushed hormonal BC because of my history with depression and because they believe condoms "aren't as good." I don't buy that. I can use them when I need them instead of altering my hormone levels all the time, which for me is a major problem. I'm not all that convinced the BC I took for years isn't part of the problem with depression.

Ugh. I just hope BC methods keep improving.

[0+] Author Profile Page vkh said:

When I first started BC at age 18/19 I had my period for almost an entire month straight, after that it became much more regular. I had very few problems with it. However, after doing some of my own research and reading the book "Cunt" by Inga Muscio it really became apparent how the reproductive health industry really doesn't have the best interests of women, their needs/wants, or physical health in mind. Hormones are serious and subjecting your body to them without anyone really knowing how it's going to impact each person's long and short term health can be extremely dangerous and clearly, is.

At this time I am not currently sexually active with a male partner so I'm not at risk of getting pregnant. However, when the time comes I know that we will be using condoms and spermicide as that will 1. not put my health or his at risk 2. is still very effective at preventing pregnancy and stds if used correctly and 3. shares the reproductive health responsibility with the partner 4. is way cheaper.

I hope everyone does their research when it comes to protecting your own health.

[0+] Author Profile Page Blitzgal said:

These patches are worn for long periods of time, aren't they? I always wondered how that could be safe. It disgusts me how often we hear of drug companies hiding negative results to the detriment of their customers.

This is why why I use a copper IUD: no hormones, nothing to remember to do every day, and more effective than the pill. It's a shame more American women don't know about it.

IUD IUD IUD!!! Come on, people! No hormones, no interrupting sex, long term (up to 10 yrs), easily reversible, cheap (they can cost up to $475 dollars, but divide that by 10 years), no daily/weekly/monthly changing or pill-taking, no interactions with other drugs (antibiotics, smoking, etc.), 99% effective, etc.

http://paraguard.com/

I don't work for Paraguard, I swear. I'm just a user and a huuuuuuuge fan. If your gyno won't give you one because you haven't had children (old, outdated, and incorrect research claims they're not safe for women who haven't had kids), go to Planned Parenthood.

By the by, the IUD is the most commonly used method of birth control worldwide - just not in the US, where people would much rather throw a pill at a problem.

Oh, and fuck J&J for not only fucking women over, but being one of the biggest proponents of grotesque and unnecessary animal testing.

[0+] Author Profile Page josiecat said:

I'm on NuvaRing right now and I think I'm going to stick with it, risks and all. I used to be on the pill, but I never remembered to take it on time.

I have to take BC now because I was just recently diagnosed with PCOS, so I don't have the luxury of just using condoms anymore. It sucks, but at least I'm able to restore my body to some sort of normality now.

I grow more and more suspicious of hormonal BC. The pharma industry just doesn't have a good history when it comes to women and especially repro issues.

I went to the women's clinic at my college and asked for a diaphragm and they told me that they not only don't carry them (or cervical caps), no one at the clinic even knew how to fit one. I called Planned Parenthood and they dug up the one person at the clinic who knew how to fit me with one. Then it took them three weeks to order it.

Other than spelling it, a diaphragm is a great bit of BC: it costs $20 plus spermicide, can be put in well in advance of sex, and is 96% effective (if used correctly every time). I can't feel it and neither can my male partners. So that's my BC shout-out. Quit treating me like a relic of the 70s, women's clinic!

I'm on the patch, have never had any problems with it, and love it. I just wish it was available in generic so I didn't have to spend $60 every month to get it.

[0+] Author Profile Page Maeve said:

This isn't the first time I've heard of problems with the patch. I was on Nuva Ring for about two years, but after reading about alternative methods of birth control on a feminist group on Myspace, I decided to get an IUD. I've had my paraguard since July, and I love it! Yeah the cramps are a bit worse and my period is heavier, but I love being hormone free.

Thanks for posting this. I was on the Patch for a full year before a nurse told me what they were finding. I went off immediately -- but this was after a full year of migraines almost weekly and the worst anxiety of my life, during which I'd been to a doctor who told me I was "neurologically normal."
My partner and I have been using condoms for almost 2 years now. I was so encouraged after I went to an ob-gyn and told her we were using condoms, to which her response was, "Well, what's wrong with that?"

[0+] Author Profile Page MachineGhost said:

Zoom in to Table 1 / Typical use on Page 1:

http://www.paragard.com/custom_images/Prescribing-Info.pdf

Pretty shock stats. Especially when withdrawal is more effective than the majority of birth control.

The pill seems overrated given the wide array of side effects from ingesting synthetic hormones (the increased risk of breast cancer is still downplayed by the establishment, though it should taper off somewhat as the pill was reformulated over the years to be relatively lower dose). Does anyone know if there is a birth control pill available composed of bioidentical hormones?

[0+] Author Profile Page LoveFromAlaska said:

The patch gave me heart palpitations.

I went through 2 months of heart test (EKG etc.), doctors couldn't figure it out, I put two-and-two together and took myself off the patch, guess what! Palpitation frequency declined and I'm now completely free of them!

I vote diaphram and condoms.

[0+] Author Profile Page raina said:

Whoa, now. Please remember, it is very important to take medical advise from those who are not medical professionals with a grain of salt.

I work in a women's health clinic and counsel women on birth control use all day long. Of course it is crucial to consider what contraindications individual contraceptive methods may present when considering your personal health history. It is true that the Ortho Evra Patch and the NuvaRing (just like ALL estrogen birth control methods, including pills) present small risks of things like blood clots, and it is especially important to consider these risks if you are a smoker. However, there are many benefits to balance along with the possible risks when considering all birth control methods.

The ring and the patch have proven to be excellent methods for many women, and the fact that you do not need to remember to use them with every sex act (like condoms or diaphragm) or every day (like pills) decreases the chances of human error with normal use and often thus increases statistical efficacy.

The point of all of this is that ONLY YOU AND YOUR HEALTH CARE PROVIDER can choose what method is best for you. Review and consider the risks of each method carefully, but let's not let Feministing turn into a forum for frightening women out of using a method of contraception that may indeed be ideal for them.

P.S. Withdrawal is NOT "more effective than the majority of birth control." Plus, as a woman you have no control over what happens.

I was surprised to read, on Planned Parenthood's website, how effective withdrawal is. I'm also surprised that men are willing, even eager, to use this method, because it sounds awful to me. But I've known people who've had it work for years. I think you do need to be in a relationship where an "oops" wouldn't be the end of the world, though. I've certainly never had the courage to rely on it except as a secondary method.

[0+] Author Profile Page penny rose said:

Prior to my husband getting a vasectomy, we used condoms as a form of birth control. After my last child, I decided to try the patch and it caused swelling and pain on the area I placed it. We went back to condoms, but you would be surprised how many of my friends thought it was weird that we used condoms as a married couple!

[0+] Author Profile Page GrowingViolet said:

Seconding raina here, and also note: no court judgment or medical review found that the manufacturer failed to make information about the risks available, or that the contraception was unsafe. Rather, they settled to avoid publicity and the expense of a lawsuit - which, given that the device is still on the market, the manufacturer almost certainly would have won. This kind of thing happens all the time in the U.S. civil litigation system with high-value defendants. They'll spend more money defending a safe product (legal fees, lost revenues, information campaigns) than in paying off people who either made an informed decision and got unlucky, had careless/negligent doctors (who should be liable), or provided inaccurate/incomplete medical histories to their doctors. That's not to say that the patch doesn't have risks, contraindications, and potential disadvantages. It does. But the fact that the plaintiff's lawyers took a settlement (rather than pressing a suit, which would likely net a several hundred million dollar payment) is in this kind of case pretty good evidence that they didn't think the preponderance of evidence could possibly support their claim.

As for the efficacy of HBC: The perfect use success rate for withdrawal is usually given around 4% per woman-year, while the TYPICAL (real-world) use is usually about 25%. Combined oral contraceptives, which fail more often than the patch/Depo-Provera/Implanon, have a perfect use success rate of 99.5% per woman-year and a perfect use one of 91%. (These are WHO figures, IIRC; a quick Google should back them up.) Thus, perfect use of withdrawal is only one-eighth as effective as perfect-use hormonal contraception, and with typical use withdrawal still fails at least three times more often. That's not to say that withdrawal doesn't work for some couples, just that the overall pregnancy risk is much higher than for any other recognized method apart from diaphragms and cervical caps.

[0+] Author Profile Page GrowingViolet said:

Seconding raina here, and also note: no court judgment or medical review found that the manufacturer failed to make information about the risks available, or that the contraception was unsafe. Rather, they settled to avoid publicity and the expense of a lawsuit - which, given that the device is still on the market, the manufacturer almost certainly would have won. This kind of thing happens all the time in the U.S. civil litigation system with high-value defendants. They'll spend more money defending a safe product (legal fees, lost revenues, information campaigns) than in paying off people who either made an informed decision and got unlucky, had careless/negligent doctors (who should be liable), or provided inaccurate/incomplete medical histories to their doctors. That's not to say that the patch doesn't have risks, contraindications, and potential disadvantages. It does. But the fact that the plaintiff's lawyers took a settlement (rather than pressing a suit, which would likely net a several hundred million dollar payment) is in this kind of case pretty good evidence that they didn't think the preponderance of evidence could possibly support their claim.

As for the efficacy of HBC: The perfect use success rate for withdrawal is usually given around 4% per woman-year, while the TYPICAL (real-world) use is usually about 25%. Combined oral contraceptives, which fail more often than the patch/Depo-Provera/Implanon, have a perfect use success rate of 99.5% per woman-year and a perfect use one of 91%. (These are WHO figures, IIRC; a quick Google should back them up.) Thus, perfect use of withdrawal is only one-eighth as effective as perfect-use hormonal contraception, and with typical use withdrawal still fails at least three times more often. That's not to say that withdrawal doesn't work for some couples, just that the overall pregnancy risk is much higher than for any other recognized method apart from diaphragms and cervical caps.

[0+] Author Profile Page GrowingViolet said:

Seconding raina here, and also note: no court judgment or medical review found that the manufacturer failed to make information about the risks available, or that the contraception was unsafe. Rather, they settled to avoid publicity and the expense of a lawsuit - which, given that the device is still on the market, the manufacturer almost certainly would have won. This kind of thing happens all the time in the U.S. civil litigation system with high-value defendants. They'll spend more money defending a safe product (legal fees, lost revenues, information campaigns) than in paying off people who either made an informed decision and got unlucky, had careless/negligent doctors (who should be liable), or provided inaccurate/incomplete medical histories to their doctors. That's not to say that the patch doesn't have risks, contraindications, and potential disadvantages. It does. But the fact that the plaintiff's lawyers took a settlement (rather than pressing a suit, which would likely net a several hundred million dollar payment) is in this kind of case pretty good evidence that they didn't think the preponderance of evidence could possibly support their claim.

As for the efficacy of HBC: The perfect use success rate for withdrawal is usually given around 4% per woman-year, while the TYPICAL (real-world) use is usually about 25%. Combined oral contraceptives, which fail more often than the patch/Depo-Provera/Implanon, have a perfect use success rate of 99.5% per woman-year and a perfect use one of 91%. (These are WHO figures, IIRC; a quick Google should back them up.) Thus, perfect use of withdrawal is only one-eighth as effective as perfect-use hormonal contraception, and with typical use withdrawal still fails at least three times more often. That's not to say that withdrawal doesn't work for some couples, just that the overall pregnancy risk is much higher than for any other recognized method apart from diaphragms and cervical caps.

[0+] Author Profile Page GrowingViolet said:

Argh! Sorry for the multiple post.

[0+] Author Profile Page LoveFromAlaska said:

I do agree that in an ideal world "me and my doctor" would be able to figure out what is best. But unfortunately THREE doctors were unable to figure out the cause of heart palpitations.

I am on a personal mission to let every doctor I encounter know my story. I'm also very happy feministing posted this because I wish I had known the pros and cons and controvery for I feel I would have recognized the problem sooner.

[0+] Author Profile Page doctorjess said:

a quick medical perspective on the issue . . . make an informed decision about your birth control and your personal risks. it's important to realize that 5 in 100,000 women not on birth control will develop blood clots. for women using hormonal contraception the risk is 15-30 per 100,000. but note, in women who are PREGNANT, the risk is 60 per 100,000.

which is to say "twice the risk of a rare event is still a rare event."

also, it's important to know that some women are at more risk than others, for example, if you are a smoker or have had previously blood clots.

finally, when choosing a birth control method, it's important to know yourself and how honestly reliable you can be remembering to take your pill at the same exact time every day or in the heated moment of passion . . . condoms may not be a great solution for you and the pill might not be the best either. or maybe you and your partner are completely reliable. ask yourself what would an unintended pregnancy mean for you . . . and make an informed decision about your birth control choice.

as for J&J, down with big pharma!

[0+] Author Profile Page doctorjess said:

a quick medical perspective on the issue . . . make an informed decision about your birth control and your personal risks. it's important to realize that 5 in 100,000 women not on birth control will develop blood clots. for women using hormonal contraception the risk is 15-30 per 100,000. but note, in women who are PREGNANT, the risk is 60 per 100,000.

which is to say "twice the risk of a rare event is still a rare event."

also, it's important to know that some women are at more risk than others, for example, if you are a smoker or have had previously blood clots.

finally, when choosing a birth control method, it's important to know yourself and how honestly reliable you can be remembering to take your pill at the same exact time every day or in the heated moment of passion . . . condoms may not be a great solution for you and the pill might not be the best either. or maybe you and your partner are completely reliable. ask yourself what would an unintended pregnancy mean for you . . . and make an informed decision about your birth control choice.

At my last physical my doctor told me that they are phasing out the copper IUD, and suggested I consider the hormonal one. My body can't handle hormones for several reasons, and I can't find anything to back his claim up. Have any Paragard users heard about this?

I thought the patch was taken off of the market a few years back. Just before my doctors decided I shouldn't be on hormones they wouldn't give me the patch b/c of the risks of blood clots and such. I was actually surprised to hear it is on the market again. Of course, I was on Tricare, so maybe that had something to do w/ it.

Thanks, Feministing for this info!

[0+] Author Profile Page wonderwoman said:

I am a nurse, have worked in women's health clinics for five years doing patient education and counseling, and currently am in graduate school to become a women's health NP and certified nurse-midwife.

I don't know anything about Johnson & Johnson intentionally trying to cover up information about the higher estrogen levels created by the Ortho-Evra patch compared to lower-dose birth control pills.

However, I don't think it's accurate or appropriate to portray the patch as this dangerous, scary thing that no woman should use. What is now known and the company acknowledges is that the patch exposes women to about 60% more estrogen than a typical low-dose pill. This approximately doubles the risk of women having vascular complications like DVT or MI. But, as other commenters have noted, even with double the risk, it is still an extremely rare event. And with either the pill or the patch, your risk of a DVT or MI is *still lower than if you were pregnant*.

There is also no truth to the claim that the copper IUD, Paragard, is being "phased out." It is made by a differen company than the Mirena IUD that contains hormones. The Mirena, incidentally, contains the hormone progestin, and not estrogen. As it is estrogen that is associated with the risks of blood clots and heart attacks, you don't need to be worried that the Mirena IUD would increase your risk.

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