Monday, June 12, 2006

Birth Control Patch Death/Injury Settlements

The scariest part about this is that the manufacturer of this product AND the FDA saw problems and approved it anyway. How many women could have avoided blood clots, strokes, or death if the drug manufacturer and the FDA had really done its job? It makes you wonder what they really care about. Do drug companies really care about you as a woman or a man? According the articles below, after it was approved deaths were reported in 2004, 2005, and 2006. The drug company did not do anything about it right away. Hmmmm...

"Documents have surfaced in litigation that show Ortho-McNeil has been analyzing the FDA's death and injury reports on women using the Ortho Evra birth-control patch, and has charts that show a higher rate of blood clots and deaths in women on the patch when compared to women who take birth-control pills.In addition, according to a November 11, 2005, article by the Associated Press, an internal company memo shows that in 2003, the company refused to fund a study comparing the Ortho patch to the company's Ortho-Cyclen pill because there was "too high a chance that study may not produce a positive result for Evra" and a "risk that Ortho Evra may be the same or worse than Ortho-Cyclen."
"It is alleged that the FDA and the drug maker saw warning signs of problems with the Ortho-Evra patch before it was approved for the general market. Both entities maintain that the medication is as safe as any other pill-form birth control. However, a study with 800,000 women in 2004 showed that using the birth control patch increased the risk of dying or suffering a blood clot three times more than regular birth control pills. Unaware of the risks, doctors prescribe medications with little thought. It?s an unfortunate reality that many doctors are incentivized to prescribe brand name medications; they are legally paid what is essentially the equivalent of sales commissions or receive other incentives such as lunches, parties, clip boards, note pads, and more. These financial incentives bring up a plethora of ethical and liability issues. "
"If you have or a loved on has suffered from blood clots, heart attack or stroke, while using Ortho Evra, you may qualify for damages or remedies that may be awarded in an Ortho Evra class action or lawsuit."

The 2 links for articles above contain additional links, for more info. The second article has a news timeline, with links to news articles from the LA Times, the New York Post, CNN, Washington Times, Boston Globe, etc. etc. Go see for yourself

If I were a young woman I would question every drug prescribed to me and research it thoroughly. Don't just accept what your family physician tells you. What if they don't know all the negative side effects or risks? You have to take care of yourself. Why gamble on increased risk of blood clots, stroke, death, or decreased fertility just for convenience. Even taking these kinds of contraceptives for prescribed medical condtions such as acne or painful periods could be not worth the risk. There could be nutritional deficiencies involved or other causes.

Articles like these prove to me that drug manufacturers have to be greatly concerned about their profit margin. Why else push a drug on the market with known serious risks?

*steps down off soap box and quietly walks away*


Sandy Hatcher-Wallace said...

Thanks Alipurr...each and every person needs to know the side effects of each drug they are taking and weigh the risks. There are too many medications out there that haven't been tested long enough or that test results have been withdrawn, like this birthcontrol patch that you have posted about.

From what I have heard of Class Action Suits is that only the lawyers win the settlement money...none goes to the general public or injured parties.

I may take issue with the statement of doctors being bought or bribed...I don't think note pads or free lunches are going to sway a doctor into using a particular drug if they don't think it's suitable for their patients. Doctors have to much to risk on prescribing a questionable drug...they will go with the safer drugs. If they can be bribed...they don't need to be in practice.

Anonymous said...

I'm with my wife on this one. Taken as a whole, the medical industry (health care facilities/professionals, pharmaceuticals, equipment manufacturers, and insurance companies) is the single largest industry in the United States. The FDA and our PAC-loving politicians are motivated more by money than by an interest in your good health. The FDA is a corrupt, power-mad joint arm of the US government and the medical industry. I have been collecting news articles and other data substantiating this view since 1991. In 1994, I wrote a short, pedestrian-targeted paper that introduces the subject. Glancing at it now, I can see it wants considerable revision from a stylistic point (not the clearest piece I've ever written, sorry) and the evidence against the FDA has been accumulating at an ever-increasing rate since 1994. Nevertheless, it presents information concerning the activities and motivations of the FDA that remains relevant. If you're interested, I've posted it at

Note that the paper exposes some political leanings, but such are the facts in this case. I'm fully aware and convinced that in other matters, Republicans are every bit as self-serving and corrupt as the Dems detailed here, so don't get your backs up. I will also remind you that -- in order to keep the peace -- I usually sit quietly while some of you bash the current administration relentlessly, so you can return the favor this one time. :)

Regarding the question of "bribes:" It is an admitted and common practice for drug manufacturers to provide "rebates," "kickbacks," and other incentives to doctors who prescribe particular drugs for first-time users, doctors who persuade patients to switch from competing drugs, pharmacists who indicate name-brand drugs over their generic counterparts (laws have been passed to punish this practice), insurance companies who add particular drugs to their "approved lists," etc. States were even warned by the Bush administration last year not to funnel Social Security recipients into a particular drug plan in order to prevent states from artificially ballooning the "incentives" received by their treasuries from insurance companies. Lawsuits have been successfully argued in regard to these practices, exposing plenty of internal evidence in the process. It's been going on for decades, and continues to thrive. Some of it is legal under current law; some is undoubtedly not. Though calling them "bribes" may be a matter of perspective, the practice of providing these "incentives" -- which far outweigh notepads and pens -- is indisputable. Not even the practioners deny it.

Lastly, I'm reminded of a recent time when my wife and I expressed concern about a particular drug additive to our daughters' pediatrician. The doctor responded with a comment in the vein of "I'm sure if it were dangerous, the FDA wouldn't allow it on the market." My jaw hit the floor. Assuming she actually believed her own words, I don't think I've ever encountered such extreme naivety, considering her medical training and exposure to FDA activities. It's a sad, sad world.

Anonymous said...

Sorry, failed to link the article: Treachery in the FDA.

doubleknot said...

I took a perfectly good medication that worked for me for years - then they moved the manufaturing out of the country - now the FDA has pulled it and it can no longer be bought here - I just wonder what effect the medication that was made elsewhere had on me before they stopped it. I am on a different one now and it isn't as good but at least it is something and made in the States.

Alipurr said...

this story was not about insurance companies

Anonymous said...

Oh, I'm sorry....

Anonymous said...

Not only did the FDA push the drug through, but Planned Parenthood is endorsing it!!! I found some useful info at