New York Times and Reader’s Digest Address Problem of Preemption in Drug Cases, Part I

Well even the mainstream media is really catching on to the problems I discussed last week about preemption. Both the New York Times and Reader’s Digest have just recently printed articles taking on the issue of preemption and how the problems at the FDA make this issue one of significant importance. In the New York Times article, which appeared on the front page of Sunday’s edition, it explains how the issue of preemption may significantly effect ongoing litigation involving the Ortho Evra birth control patch (the Patch). As background, the Patch was touted by its manufacturer, Johnson & Johnson (J&J), as an easy alternative to the Pill. Instead of having to take a pill every day, the Patch was applied weekly. J&J told the FDA that this patch would actually supply less estrogen to women than the Pill, but yet still provide protection from pregnancy. The amount of estrogen that goes into a woman’s body is important because, as addressed in the article, it has been known for a long time that high doses of estrogen raise the risks of blood clots which can lead to heart attacks and strokes.
The New York Times article goes on to explain how a study was done for J&J on the Patch and it found in 1999 that in fact the Patch released significantly more estrogen into the body than the Pill, Moreover, the amount of estrogen being put into the body by the patch was at a dangerous level and beyond the level of estrogen which the FDA had determined 11 years earlier, could not be sold in the Pill. The interesting fact was that the author of this J&J study, who has since retired from J&J, applied what has come to be known as a “correction factor” to this study such that he played with the numbers and showed that the Patch released alot less estrogen into the body than the study actually showed, Apparently when this study was provided to the FDA so it could evaluate the Patch, it only mentioned this “correction factor” ONCE in 435 pages of the report, and that mention was only when discussing a complicated math formula. J&J did what they could to obscure the fact that this “correction factor” was applied to the results so that the levels of estrogen being released into the body looked OK, when in fact they were at dangerous levels.
Ultimately the FDA relied on this study to make its decisions regarding approval of the drug and the warning to place on the drug. J&J had two other studies, one in 1999 and one in 2003 which both showed that the Patch released more estrogen than the Pill, but guess what???? J&J delayed giving this information to the FDA.
J&J has now filed a motion with the Court requesting it find preemption and that the lawsuits regarding this drug not be permitted to continue. The argument goes that the FDA is in the best position to decide issues regarding whether the warnings are good and since the FDA approved the warnings regarding the Patch, a court cannot now say the FDA was wrong. Problem with this argument is that the FDA’s decision is only as good as the information provided to it by the manufacturer when it makes these decisions. The FDA does not do its own testing on these drugs. It relies on the manufacturers to be forthright and provide it with all the information it has learned about the drug…..good AND bad. It appears J&J hid this problematic information from the FDA when it made its decisions about permitting the marketing of the Patch and the warnings that should go with the Patch.
This is one of the main reasons for the problematic nature of preemption, especially in the context of the FDA. The drug manufacturers argue that the FDA should have the last word about warnings on a drug. But this assumes the FDA is provided ALL the necessary information to make the right decisions, and clearly in the case of the Patch, that was not the case.
As mentioned at the beginning of this post, Reader’s Digest published an article recently addressing the problems with the FDA which also relates to this issue of preemption. Stay tuned for part II of this post where I will address this article and how it points out problems at the FDA which impact on this argument of preemption.