Facing a rising tide of lawsuits over its Ortho Evra birth-control patch, Johnson & Johnson has always maintained that the patch is a "safe and needed" form of contraception.
But the hundreds of plaintiffs suing the pharmaceutical company feel otherwise, with most of them claiming that Johnson & Johnson had prior knowledge that the Ortho Evra patch had a higher risk of causing blood clots, stokes and heart attacks than oral contraceptives. Unfortunately for Johnson & Johnson, at least two former employees of the company have backed up those allegations.
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 related to 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. 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.
Since then, the Ortho Evra patch has been the subject of more than 2500 lawsuits. Most of the plaintiffs allege that Johnson & Johnson knew of problems with the patch long before the risks became public. These plaintiffs have quite a bit of ammunition to back up their claims. Two former employees at Johnson & Johnson had long ago expressed concerns that the company purposely chose to downplay the risks associated with the Ortho Evra patch.
One employee is Joe Lippman, himself 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.
The second 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.
The letter was released in August by the New Jersey Superior Court at the request of plaintiffs suing the company over the defective Ortho Evra birth-control patch. Specifically, this employee wrote that of two studies conducted by Johnson & Johnson, the company deliberately emphasized "partial and incomplete" results of the one that was most favorable to the Ortho Evra birth-control patch.
These revelations are not good news for Johnson & Johnson. It is evidence that the company knew women using Ortho Evra were exposed to dangerously high levels of estrogen. Andres Alonso, a partner with Parker Waichman Alonso, LLP, a firm representing more than 600 Ortho Evra plaintiffs, told the Star-Ledger, "They should have warned about that, and they didn't."
Johnson & Johnson has already settled hundreds of Ortho Evra cases, but many more are scheduled to come to trial. One of the first trials is expected to begin in November in Manhattan. That lawsuit, brought by the family of a 19-year-old woman, alleges that her death was a result of the Ortho Evra patch. The case of Zakiya Kennedy, who collapsed and died from a pulmonary embolism while she waited for a New York City Subway, made headlines and was one of the first deaths to be blamed on the defective Ortho Evra birth-control patch.