Johnson & Johnson, the maker of the Ortho Evra birth control patch, is looking to the courts to protect it from lawsuits stemming from the defective device. Johnson & Johnson is asserting that Ortho Evra lawsuits should not be allowed to go forward because the contraceptive patch was approved by the Food & Drug Administration (FDA) – even though it is becoming increasingly clear that Johnson & Johnson withheld vital Ortho Evra safety information from the agency for years.
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 FDA warned that women using Ortho Evra were exposed to approximately 60% 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 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.
But court papers filed last November as part of Ortho Evra litigation underway in Ohio show Johnson & Johnson knew about Ortho Evra’s potential problems long before it informed the FDA. Among the evidence detailed in that court filing is an Ortho Evra study Johnson & Johnson conducted called PHI-014. It measured the amount of ethinyl estradiol, or EE as the estrogen component is called, released into the bloodstream every 24 hours. The company said the study proved the level was 20 micrograms. The actual results showed the patch released 30.4 micrograms when applied to the abdomen and 38.1 micrograms when applied to the buttocks, according to the motion. Johnson & Johnson applied a “60% correction factor’’ to lower the results, the motion said. The Ortho Evra plaintiffs allege that “Not only was FDA unaware of the use of the 60% correction factor, but even key company employees profess to know nothing about it.’’ Johnson & Johnson also left mention of the correction factor out of a journal article published in 2002, leaving doctors in the dark about the true estrogen exposure face by Ortho Evra Birth Control Patch users.
Despite such evidence of a cover-up, Johnson & Johnson is trying to convince Judge David A. Katz of Federal District Court for the Northern District of Ohio that patients should not be allowed to sue the company because the FDA approved the patch and its label. According to The New York Times, this legal argument is called pre-emption. After decades of being dismissed by courts, the tactic now appears to be on the verge of success. Earlier this year, the US Supreme Court agreed with Medtronic Inc. that FDA approval of a medical device prevented people from suing in state courts if they sustained an injury from the devce. In his majority opinion, Justice Antonin Scalia wrote that permitting state juries to impose liability on the maker of an approved device “disrupts the federal scheme,” under which the FDA has the responsibility for evaluating the risks and benefits of a new device.
In the fall, the Supreme Court will hear a separate pre-emption case involving Wyeth, another drug company. Many legal experts expect the court to rule in favor of drug companies. This will be unfortunate for patients. As the Ortho Evra case illustrates, drug companies are not always honest in their dealings with the FDA. And unfortunately, the FDA has neither the manpower or the funding to adequately police pharmaceutical companies. In the past, lawsuits against the makers of Vioxx, Rezulin and other medications have proven that drug companies played down the risks of their medicines and failed to disclose clinical trials to the public even as they have aggressively marketed their drugs. Often, lawsuits provide the only vehicle by which such drug company abuses are made public.
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