Defective birth control patch. Ortho Evra manufacturer, Johnson & Johnson, recently settled a lawsuit with the family of a 14-year-old girl killed by the defective birth control patch. The case is just one of many Ortho Evra lawsuits settled by Johnson & Johnson prior to going trial. It likely hints at the company’s desire to avoid trials where its actions –or lack thereof – regarding safety problems with the defective Ortho Evra birth control patch could be called into question.
When Ortho Evra was introduced in 2002, Johnson and Johnson touted the once-weekly patch as a convenient alternative to daily oral contraceptive pills. The drug’s original safety label stated that the patch’s health risks were similar to those related to oral contraceptives. But in 2005, the Food & Drug Administration warned that women using Ortho Evra were exposed to approximately 60 percent more estrogen than those who used oral contraceptive pills. High levels of estrogen can greatly increase the risk of developing blood clots, heart attacks, strokes and other serious injuries. As of November 2005, the FDA had received twenty-one reports of life-threatening blood clots and other ailments associated with the use of Ortho Evra. Then in 2006, a study was published that showed women using Ortho Evra were twice as likely to suffer blood clots as those taking oral birth control pills. That study prompted the FDA to request a change on the Ortho Evra label to include a stronger safety warning.
Ortho Evra has been named in well over 2,000 lawsuits
Since then, Ortho Evra has been named in well over 2,000 lawsuits, and the suit filed by 14-year-old Alycia Brown’s family is one of them. According to Bloomberg News, Alycia died in May 2004 from two blood clots in her lungs that developed after she had been using the Ortho Evra birth control patch for several weeks. According to court records obtained by Bloomberg, Johnson & Johnson settled with her family for $1.25 million. The court records said that Johnson & Johnson did not admit that Ortho Evra had caused Alycia’s death, and that the company settled in order to avoid litigation. Neither Johnson & Johnson nor Alycia’s family would comment to Bloomberg, as both sides had signed a confidentiality agreement.
Johnson & Johnson is likely desperate to keep such agreements secret because it has been accused of ignoring warning signs that Ortho Evra was dangerous. There is evidence that such accusations are true, including the testimony of Joe Lippman, a former employee of and a plaintiff in a whistle blower lawsuit against Johnson & Johnson. Lippman raised concerns over “dangerously high levels of estrogen” that users of the patch were exposed to in the late 1990s. Lippman, who was fired in 2006, claims his concerns were ignored.
unnamed vice president responsible for overseeing the safety of reproductive medicines
Another employee, an unnamed vice president responsible for overseeing the safety of reproductive medicines, had written a letter to Johnson & Johnson CEO William Weldon in 2005 stating that he or she had resigned from the company because of its decision to downplay safety concerns regarding Ortho Evra.
Lengthy and public Ortho Evra trials could bring these and other accusations that Johnson & Johnson knew Ortho Evra was dangerous to the public’s attention. For that reason alone, there are likely to be many more confidential Ortho Evra settlements.