In September 2005, a federal lawsuit filed in New Jersey on behalf of a 37-year-old woman who suffered a pulmonary embolism after using the patch for seven months, laid out the facts as to what J&J knew and when and exactly what the FDA knew and when as well.
The public filing of the information contained in this lawsuit, and more of the same that soon followed, no doubt contributed greatly to J&J's desire to quickly and quietly settle as many cases possible as soon as they were filed.
Lydia Lilly, a Georgia woman, claimed J&J marketed the Ortho Evra patch for financial gain while failing to warn consumers and doctors about the company's known risks of blood clots and other injuries.
According to the complaint, before the patch was approved on November 20, 2001, the only studies specifically conducted to examine the effect of the patch on humans were Phase III clinical trials funded and conducted by the drug makers.
As it turns out, the incidence of embolisms and thrombotic injuries in those trials was about six times greater with the patch than the incidence of similar adverse events in women who used a widely prescribed class of oral contraceptives.
Yet the package insert that accompanied the Ortho patch when it was placed on the market stated, "the contraceptive patch is expected to be associated with similar risks" to those of other hormonal contraceptives.
The package insert also stated "there is no epidemiological data available to determine whether safety and efficacy with the transdermal route of administration would be different than the oral route."
And as far as what the FDA knew first-hand, according to the lawsuit's complaint, during a 17-month period between April 2002 and September 2003, the FDA logged 9,116 reports of adverse events due to of the patch.
A number significant, the lawsuit states, because over the 6-year time period between November 1997 and September 2003, there were only 1,237 adverse event reports from women taking the leading oral contraceptive. The number is also highly significant because almost six times more women when used the pill.
In addition, according to the complaint, around the time J&J introduced the Ortho Evra patch to the market, the patent for its oral contraceptive, Ortho Tri-Cyclen, was about to expire, creating pressure to make up for lost revenue by getting the patch on the market.
More news of J&J's intentional suppression of the facts related to the dangers of the patch hit the airwaves on November 2, 2005, when CBS News broke the story that the company's own records revealed during litigation showed that between April 2002 and December 2004, the company had received some 500 reports of serious problems associated with the patch.
The records also showed that during the same time frame, the company had only received 61 adverse event reports for women on birth control pills.
In addition, CBC reported that there were four times as many strokes in women using the patch even though there were three times as many women taking the pill.
Overall, CBS said, the evidence indicated that in medically confirmed cases the risk of blood clots was 14 times higher with women using the patch.
On November 11, 2005, the Associated Press dropped another bomb by reporting that J&J knew about the higher death and injury rates of women on the patch all the long and had in fact, had refused to conduct additional testing on the patch because it was afraid of the results.
AP reported that documents "released to attorneys as a result of that litigation show Ortho McNeil has been analyzing the FDA's death and injury reports, creating its own charts that document a higher rate of blood clots and deaths in association with the patch than with the pill."
No woman should put these poisons on their skin or ingest birthcontrol pills. I started the pills in 1976 and within several months was having 4-5 migraines a week.It was seven years before the damage was corrected and the migraines ceased though I had ceased the pills immediately. Fortunately, I read that week I stopped that they had never been sufficiently tested by endocrinoligists!! I stopped IMMEDIATELY. Profits the game, not your health.Never had headaches in my life, I was 36 then.I learned of other horrors from women who took the pills. Women must take control of their bodies and listen to intuition. Nature did not intend these artificial methods or poisons to enter our bodies and disrupt natural rhythms. Let men take the burden for a while and not have women making it so easy for them to have unlimited and undisciplined sexual relations. Many other less harmful methods. That this company continues to foster the patch onto women, whose primary goal always is to please their man, is evil and cruel knowing of their subsequent threat to life.
Boycott, ban these patches!!! Most everything marketed on TV is suspect. Learn the natural way to good health, keep manufactuted poisons out of your bodies except where it is a matter of life and death. Drugs are crippling the people of this nation. Read Kevin Trudeau's book "Natural Cures THEY don't want you to know about."
by
Starchild (0 articles, 0 quicklinks, 0 diaries, 12 comments)
on Thursday, September 21, 2006 at 8:37:02 AM
THIS IS NOT NEWS! It is a blatant advertisement by a lawfirm
This is not a "news" article, nor it it an op-ed -- it is a blatant advertisement for Lawyers and Settlements.com! How irresponsible for opednews.com to accept and post such a submission. Is there no editorial board that reviews submissions???
PALEEZE!
by
Janet (0 articles, 0 quicklinks, 0 diaries, 2 comments)
on Friday, September 22, 2006 at 1:04:51 PM
Then could you please direct readers to a mainstream media sources that has published the information I have found during my investigation and included in this report?
I am not a shill for attorneys and I could care less about waht attorneys make. I am a shill for anyone who has been harmed by the gigantic pharmaceutical industry and who don't have a chance of getting one thin dime going up against a drug company alone.
If the mainstream media would do its job instead of trading its soul to the highest bidder under the guise of "advertising dollars," also known as bribes, to keep its mouth shut about the harm these drug companies do to the average Americans, reporters like myself would not have to find other forums to get the word out.
Evelyn Pringle
by
Evelyn Pringle (186 articles, 0 quicklinks, 0 diaries, 10 comments)
on Friday, September 22, 2006 at 1:40:06 PM
THIS IS NOT NEWS! It is a blatant advertisement by a lawfirm
It is NOT that the subject matter is not news -- indeed it is. But to use that lead (500 Ortho-Evra Birth Control Patch Victims Sue Johnson & Johnson) and to end with a link to the law firm...hey, wait a minute -- all of your "artilces" end with that link to lawyersandsettlements.com/...are you on their payroll?!?!?
by
Janet (0 articles, 0 quicklinks, 0 diaries, 2 comments)
on Friday, September 22, 2006 at 2:34:37 PM
I get offered a topic and if I want to investigate it and submit a report, I take the job. My investigation is all my own and not a word of my work is edited by anyone.
The headline you mention is straight out of the company's latest SEC filing and I think it is highly newsworthy. Furthermore, if there are 500 more young women out there that have been injured by this patch, that this company knew caused this problem, I hope they sue the company as well.
As far as caring if people know that I get paid by the online marketing firm listed at the bottom of the article, I obviously am not trying to hide the identity of the firm that commissioned me to write the report and I really don't care who knows.
Again, if you can direct readers to a mainstream media source that will alert the public to all of the information that I dug up and included in my report, please do so I can move on to another topic.
Cheers,
Evie
by
Evelyn Pringle (186 articles, 0 quicklinks, 0 diaries, 10 comments)
on Friday, September 22, 2006 at 3:57:10 PM
