J&J settled state courts cases in Texas, New Jersey, and California and federal courts in North Carolina and Pennsylvania, Mr Chester said.
One settlement involved Philomena Ugochukwu, 40, who had a massive stroke after wearing the patch for 12 days, he said.
The mother of two is now a quadriplegic with brain damage and needs round-the-clock care, Mr Chester told Bloomberg. She was his first Ortho Evra client.
"Johnson & Johnson is going to lose most of these cases," he warned. "The cost to defend them and the public relations hit they would take if they tried the cases," he advised, "has tilted them toward settling."
The early settlement offers are no doubt due in large part to the damning internal documents that have surfaced that show the company was aware of the lethal dangers of the patch but kept right on selling it in pursuit of the almighty dollar.
For instance, on November 11, 2005, the Associated Press 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."
"In addition," the report said, "an internal Ortho McNeil memo shows that the company refused, in 2003, to fund a study comparing its Ortho Evra patch to its Ortho-Cyclen pill 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.'"
According to FDA records obtained in July 2005, by the Associated Press with a freedom of information request, over a 71 month period, there were 1,237 adverse event reports by women taking the pill, but over an 18 month period, there were 9,116 adverse event reports by women using the patch, which means there were over seven times more adverse event reports with the patch.
The AP found that before the patch was approved, the FDA had already noticed that blood clots with the patch were 3 times more common than with the pill. In 2000, FDA doctors reviewing the clinical trials submitted by the company warned that blood clots could be a problem if the patch was approved. In those trials, the doctors found that 2 of the 3,300 women using the patch were treated for blood clots that traveled to their lungs.
The reviewer said "the label should clearly reflect this reviewer's safety concern about a potential increased risk." But it didn't and there were no requirement for follow-up studies other than routine reviews of voluntary reports called in by doctors, consumers, and the drug company.
Experts say the dangers with the patch stem from how it works in that rather than digestion and metabolization of the hormones like with the pill, the patch releases the hormones directly into the blood stream, leaving a significantly high concentration of hormones in the body.
In fact, the FDA advisory in November 2005, said users of Ortho Evra are exposed to about 60% more estrogen in their blood than if they were taking a birth control pill.
According to the complaints in many of the lawsuits filed, beginning on May 1, 2002, the FDA received 44 reports of clot-related injuries or deaths caused by the Ortho patch, but only 17 similar reports during the same time period for J&J's Ortho Tri-Cyclen birth control pill, even though the pill was used by close to six times as many women.
However the statistics are known to be inaccurate because FDA officials acknowledge that as few as 1 to 10% of all serious side effects are ever reported to the agency so the number of clot related adverse events reported would have to be multiplied many times over to get an actual account of the cases.
According to a CBS news report in November 2005, based on documents that had surfaced in litigation, the drug maker's own records show it received some 500 reports of serious problems with the patch between April 2002 and December 2004, while only 61 reports were received on all types of birth control pills.
In addition, there were four times as many strokes in women on the patch compared to women taking the pill even though 3 times as many women were taking the pill.
One settlement involved Philomena Ugochukwu, 40, who had a massive stroke after wearing the patch for 12 days, he said.
The mother of two is now a quadriplegic with brain damage and needs round-the-clock care, Mr Chester told Bloomberg. She was his first Ortho Evra client.
"Johnson & Johnson is going to lose most of these cases," he warned. "The cost to defend them and the public relations hit they would take if they tried the cases," he advised, "has tilted them toward settling."
For instance, on November 11, 2005, the Associated Press 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."
"In addition," the report said, "an internal Ortho McNeil memo shows that the company refused, in 2003, to fund a study comparing its Ortho Evra patch to its Ortho-Cyclen pill 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.'"
According to FDA records obtained in July 2005, by the Associated Press with a freedom of information request, over a 71 month period, there were 1,237 adverse event reports by women taking the pill, but over an 18 month period, there were 9,116 adverse event reports by women using the patch, which means there were over seven times more adverse event reports with the patch.
The AP found that before the patch was approved, the FDA had already noticed that blood clots with the patch were 3 times more common than with the pill. In 2000, FDA doctors reviewing the clinical trials submitted by the company warned that blood clots could be a problem if the patch was approved. In those trials, the doctors found that 2 of the 3,300 women using the patch were treated for blood clots that traveled to their lungs.
The reviewer said "the label should clearly reflect this reviewer's safety concern about a potential increased risk." But it didn't and there were no requirement for follow-up studies other than routine reviews of voluntary reports called in by doctors, consumers, and the drug company.
Experts say the dangers with the patch stem from how it works in that rather than digestion and metabolization of the hormones like with the pill, the patch releases the hormones directly into the blood stream, leaving a significantly high concentration of hormones in the body.
In fact, the FDA advisory in November 2005, said users of Ortho Evra are exposed to about 60% more estrogen in their blood than if they were taking a birth control pill.
According to the complaints in many of the lawsuits filed, beginning on May 1, 2002, the FDA received 44 reports of clot-related injuries or deaths caused by the Ortho patch, but only 17 similar reports during the same time period for J&J's Ortho Tri-Cyclen birth control pill, even though the pill was used by close to six times as many women.
However the statistics are known to be inaccurate because FDA officials acknowledge that as few as 1 to 10% of all serious side effects are ever reported to the agency so the number of clot related adverse events reported would have to be multiplied many times over to get an actual account of the cases.
According to a CBS news report in November 2005, based on documents that had surfaced in litigation, the drug maker's own records show it received some 500 reports of serious problems with the patch between April 2002 and December 2004, while only 61 reports were received on all types of birth control pills.
In addition, there were four times as many strokes in women on the patch compared to women taking the pill even though 3 times as many women were taking the pill.
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