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Ortho Evra Timeline
2003—Ortho-McNeil refuses to fund study comparing the birth control patch with the pill for fear it might not produce positive results.
April 2002–September 2003—FDA logs 9,116 reports of adverse effects related to Ortho Evra. During same time period, only 1,237 such reports are filed by women taking the leading form of the pill (Ortho Tri-Cyclen), although it is used almost six times more than Ortho Evra in 2003.
April 2005—An 18-year-old college student collapses and dies after suffering headache, dizziness and pain in her leg; autopsy reveals blood clot in her lung, and medical examiner determines that it resulted from her use of Ortho Evra.
July 16, 2005—Associated Press article states that women who use the Ortho Evra birth control patch are three times as likely to suffer blood clots as those using the pill. Article indicates that 12 young women died in 2004 from blood clots linked to Ortho Evra.
August 2005—First class action lawsuit is filed against Ortho-McNeil for injuries caused by Ortho Evra birth control patch.
November 10, 2005—FDA notes that Ortho Evra delivers 60% more estrogen than do birth control pills and warns users about risks of blood clots. “Black-box” warning is added to label of Ortho Evra birth control patch.
September 20, 2006—FDA updates Ortho Evra birth control patch warning label after study shows that women using the patch are twice as likely to suffer serious blood clots.
February 2007—The i3 Drug Safety Group finishes its study involving 98,000 women who used transdermal contraception (such as Ortho Evra) and 250,000 who used the pill. The study, published in Obstetrics & Gynecology, confirms that those using the patch are more than twice as likely to suffer blood clots.
January 2008—The FDA warns that women who use the Ortho Evra patch are more likely to suffer serious blood clots than users of birth control pills. Women who experience these blood clots may be at risk of other serious Ortho Evra side effects, including heart attack, stroke or pulmonary embolism.
April 2002–September 2003—FDA logs 9,116 reports of adverse effects related to Ortho Evra. During same time period, only 1,237 such reports are filed by women taking the leading form of the pill (Ortho Tri-Cyclen), although it is used almost six times more than Ortho Evra in 2003.
In April 2006, Ortho Evra was prescribed often despite FDA warnings and many reports of blood clots, stroke and heart attack. Ortho-McNeil saw no reason for a recall.
April 2005—An 18-year-old college student collapses and dies after suffering headache, dizziness and pain in her leg; autopsy reveals blood clot in her lung, and medical examiner determines that it resulted from her use of Ortho Evra.
July 16, 2005—Associated Press article states that women who use the Ortho Evra birth control patch are three times as likely to suffer blood clots as those using the pill. Article indicates that 12 young women died in 2004 from blood clots linked to Ortho Evra.
August 2005—First class action lawsuit is filed against Ortho-McNeil for injuries caused by Ortho Evra birth control patch.
November 10, 2005—FDA notes that Ortho Evra delivers 60% more estrogen than do birth control pills and warns users about risks of blood clots. “Black-box” warning is added to label of Ortho Evra birth control patch.
September 20, 2006—FDA updates Ortho Evra birth control patch warning label after study shows that women using the patch are twice as likely to suffer serious blood clots.
February 2007—The i3 Drug Safety Group finishes its study involving 98,000 women who used transdermal contraception (such as Ortho Evra) and 250,000 who used the pill. The study, published in Obstetrics & Gynecology, confirms that those using the patch are more than twice as likely to suffer blood clots.
January 2008—The FDA warns that women who use the Ortho Evra patch are more likely to suffer serious blood clots than users of birth control pills. Women who experience these blood clots may be at risk of other serious Ortho Evra side effects, including heart attack, stroke or pulmonary embolism.
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