Following on the heals of a Supreme Court decision agreeing with Medtronic’s claim that once a device is deemed safe by the FDA it preempts any lawsuits filed against them claiming injury, Johnson & Johnson is insisting the same for its controversial birth control patch Ortho Evra. In recent lawsuits filed against Johnson & Johnson evidence has been found that internal company documents and emails hid evidence that the patch delivered much more estrogen than birth control pills, potentially increasing the risk of blood clots and strokes. Now Johnson & Johnson is arguing in court that it cannot be sued by women injured by the Ortho Evra patch because the FDA had approved it. More than 3,000 women and their families have sued Johnson & Johnson after suffering heart attacks, strokes and, in 40 cases, death. From 2002 to 2006, the FDA received reports of at least 50 deaths associated with the Ortho Evra patch. The FDA did not inform the public of the potential risks until November 2005, six years after Johnson &Johnson’s own study showed the high estrogen distribution.
Plaintiff’s lawyer Janet Abaray of Burg, Simpson, Eldredge, Hersh, & Jardine, said that Johnson & Johnson took advantage of an agency overwhelmed by its many responsibilities. “Johnson & Johnson knew that FDA does not have the funding or the manpower to police drug companies,” Ms. Abaray said. A series of independent appraisals have concluded that the FDA is poorly organized, scientifically deficient and short of money. In February, FDA commissioner, Andrew C. von Eschenbach, acknowledged that the agency faces a crisis and may not be “adequate to regulate the food and drugs of the 21st century.” David Vladeck, a professor at Georgetown Law School said that the FDA does not test experimental medicines and in fact relies on the drug makers to be honest while reporting the results of their tests. When the pharmaceutical and medical device companies fail to follow FDA rules they are rarely penalized by officials. The Ortho Evra case suggests that Johnson & Johnson, like other drug makers, is not always quick to tell the FDA about potential problems with its medicines. The Supreme Court is to rule on a case next term that could make preemption a legal standard for drug cases.