Recent federal court filings in the Ortho Evra products liability litigation disclosed that Johnson & Johnson hid data from the FDA about their birth control patches’ side effects and failed to address flaws in the manufacturing process which could increase the risk of serious and potentially fatal problems.
The factual allegations were publicly released as part of the plaintiffs opposition to a motion by Johnson & Johnson to dismiss the claims of women injured by their birth control patch. The allegations include that Johnson & Johnson applied an apparently random correction factor of 60% to tests that measured the level of estrogen in the blood, which resulted in a false reporting of 60% less estrogen to the FDA.
Without litigation, this information might never have been disclosed. Johnson & Johnson’s determination to hide its knowledge of the dangerous properties of its products is also illustrated by the lawsuit brought in December, 2006, by a former vice president at two Johnson & Johnson subsidiaries claiming that he was fired for seeking recalls of numerous faulty products, including the Ortho Evra birth control patch.
In his civil complaint, Dr. Joel S. Lippman alleges he was unlawfully terminated after working for Johnson & Johnson for 15 years because he repeatedly complained about product safety problems and urged several be recalled or not launched.
Hiding adverse test results from the FDA is not limited to Ortho Evra. A review of materials in Vioxx litigation, published in the Journal of the American Medical Association (JAMA), reveals that Merck & Co. frequently paid academic scientists to take credit for research articles prepared by company-hired medical writers, a practice called ghostwriting. The reports also contend Merck tried to minimize deaths in two studies that showed that the now withdrawn Vioxx did not work at treating or preventing Alzheimer’s disease.
The dangers to consumers of federal preemption will hopefully be addressed and avoided should Congress pass and the President sign the Medical Device Safety Act of 2008. This will never happen with the current president, of course, because rendering consumers of medical devices and pharmaceuticals powerless to protect themselves in court when they sustain personal injury or death, and absolving the manufacturers of accountability for doing so, is a primary goal of this administration and its financial backers.
It has unfortunately been quite successful in achieving this goal, often with the blessing of those who do not comprehend that they are themselves the targets of this deprivation of rights.