500 Ortho-Evra Birth Control Patch Victims Sue Johnson & Johnson

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By Evelyn Pringle (about the author) Page 5 of 7 page(s)

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"The risks of using this product are similar to the risks of using birth control pills, including an increased risk of blood clots, heart attack, and stroke. The data is not precise enough to tell whether there is an increased incidence (with the patch)."

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.

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Evelyn Pringle is a columnist for OpEd News and investigative journalist focused on exposing corruption in government and corporate America.

The views expressed in this article are the sole responsibility of the author
and do not necessarily reflect those of this website or its editors.

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