Ortho Evra Maker Paid $68.7 Million to Settle LawsuitsOct 13, 2008 | Parker Waichman LLP
Ortho Evra maker Johnson & Johnson has spent just over $68 million so far to settle hundreds of lawsuit. The defective birth control patch has been linked to a variety of health ailment, including blood clots, heart attacks and strokes Johnson & Johnson has been named in more than 4,000 state and federal lawsuits that claim the company hid or altered data about the risks of high levels of estrogen released by Ortho Evra.
When Ortho Evra was introduced in 2002, Johnson & 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 of oral contraceptives. But in 2005, the Food & Drug Administration (FDA) warned that women using Ortho Evra were exposed to approximately 60 percent more estrogen than those who use oral contraceptive pills. It is believed that the difference in exposure is related to the delivery mechanism of the birth control patch. Hormones in birth control pills are partially diluted by the digestive system. However, hormones in Ortho Evra are absorbed directly into the blood stream, which causes a higher concentration of the medication to enter a patient’s body. 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 a type of blood clot called venous thromboembolisms (VTEs) — a clot that can travel to the lungs and cause a fatal pulmonary embolism - 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. Just this past January, the FDA asked that the Ortho Evra label be changed again to include information on yet another study that indicated the patch doubles the risk of developing VTEs compared to the Pill.
As Ortho Evra lawsuits have made their way through the courts, evidence has been presented that Johnson & Johnson knew long before the FDA or the public that the patch put users at risk for developing blood clots. In Ohio, lawyers have filed papers detailing two separate Ortho Evra studies that showed the patch was dangerous, but where altered or suppressed by Johnson & Johnson. Last August, the New Jersey Supreme Court released a letter written to Johnson & Johnson CEO William Weldon in 2005 by an unnamed former vice president stating that he or she had resigned from the company because of its decision to downplay safety concerns regarding Ortho Evra. Joe Lippman, another former Johnson & Johnson employee who was fired in 2006, has testified that in the late 1990s, he raised concerns over “dangerously high levels of estrogen” that users of the patch were exposed to, but was ignored.
According to Bloomberg.com, Johnson & Johnson has so far spent $68.7 million to settle Ortho Evra claims. The settlements are confidential, and their financial details haven't been released to investors. Bloomberg.com's $68.7 million estimate is based on the size of a so-called common benefit fund that finances a group of lawyers who gather evidence available for use by all attorneys involved in Ortho Evra cases. Participants pay 3 percent of their settlements to the fund. According to a court filing by one of the lead plaintiff attorneys on the Ortho Evra cases, the fund had been paid $2.06 million as of March 31. The document, dated April 17, states that "Several hundred individual cases" had been settled as of March 31. According to Bloomberg.com, a large number of others have been settled since then.
Of the 562 complaints reviewed by Bloomberg News, the vast majority of Ortho Evra lawsuits alleged the patch caused blood clots in the legs or lungs. Some blamed it for heart attacks or strokes. The complaints also blamed Ortho Evra for the death of 20 women.