Monday, April 14, 2008

The Ignorant Bliss of Supreme Court Justices

As anyone who has ever taken a high school biology course knows, there are four major blood groups; O, A, B and AB. Millions of woman of all blood groups over the years have taken birth control pills. What most people don't know, including physicians throughout the country, is that women in blood group A are at increased risk of developing blood clots as opposed to their blood group O sisters. There was half a dozen published epidemiological studies performed by highly respected researchers documenting such an effect by the end of 1980. In the early 1980's there was litigation over this issue and the standard industry defense at the time was that the FDA prevented the companies from telling doctors and users about this known risk. In that time frame there were five major producers of the birth control pills. One of them included blood group information in its labeling for a two year time period and was then ordered by the F.D.A. to remove it because the company had failed to adequately document the justification for such a statement. Discovery efforts in civil litigation revealed that the attempt by the company to document the information was done poorly. One expert witness at the time characterized the attempt as failing or incomplete based on a desultory effort to present an adequate scientific picture of the potential for harm to the Agency. Juries hearing this evidence had little trouble in deciding that omitting this critical information was wrong and that such information was critical to the decision a woman needed to make when she decided whether or not to expose her healthy body to the potential risk of harm to avoid conception.

As reported in the New York Times this week, litigation is rampant against the maker of another form of estrogen-based birth control. Johnson & Johnson is being sued by over 3000 women and their families for hiding the fact that its Ortho Evra birth control patch delivered much more estrogen than standard birth control pills, thereby increasing the risk of blood clots and strokes. The company's defense is based on the same contention that the women can’t sue because the patch and its labeling were approved by the Food and Drug Administration. The Times reports " But the disturbing element is that the company seems to have done its best to mislead the F. D.A., as revealed in company documents made public as a result of the lawsuits. The company’s primary study on Ortho Evra, completed in 1999, found that the patch delivered a relatively high amount of estrogen into the bloodstream. A company official dealt with that uncomfortable and unexpected fact by applying a “correction factor” to lower the numbers by 40 percent. He rationalized that the correction was justified because the body metabolizes hormones from pills and patches in different ways. But the company was not eager to acknowledge what it had done. The correction factor was mentioned only once in a 435-page report to the F. D.A. and even then only in a complex mathematical formula. Nor was it mentioned when the study was published in 2002."

The most disheartening aspect of this continued industry subterfuge which has harmed or killed thousands of women is that the Supreme Court is likely to swallow the conclusion that the F.D.A. is the expert on safety evaluation and thus civil litigation for the damage and havoc caused in the damaged users' lives will be preempted as a matter of law. That's a fancy way of saying these cases will be tossed out of court and the drug industry will finally be allowed to count its excessive profits free of ever being held accountable for these practices which are, in fact, violations of the criminal provisions of the Food Drug and Cosmetic Act.

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