Drug Companies Find Shelter In Overwhelmed FDA

    Probably in the next year and in furtherance of Chief Justice Roberts's expressed desire that the Supreme Court function to insulate corporate America from accountability, responsibility and liability, drug companies will find themselves immune from any lawsuit arising from harm, damage and injuries caused by their products based on FDA approval and the preemptive shelter the Supreme Court will rule it provides.
    For decades FDA officials have acknowledged that product liability lawsuits against pharmaceutical companies could aid the agency's oversight of safety issues.  Within the last decade suits over Zyprexa, the withdrawn pain pill Vioxx, the withdrawn diabetes medicine Rezulin, the withdrawn heartburn medicine Propulsid, and several antidepressants have illustrated how private liability suits provide absolute necessary help to the FDA's mission to protect the public.  After all and who's kidding who, through politics the big pharmaceutical companies know the FDA can be had but actually having to pay money and accept responsibility can eventually cause a change in corporate behavior.
    The case of the Ortho Evra patch from Johnson & Johnson is a good example.  The company began development of the product in 1996.  Part of the aim was to provide a birth control product likely to expose women to less estrogen, which in high doses is known to raise the risk for blood clots that can cause heart attacks.  But in 1999 a clinical trial indicated the patch delivered excessive estrogen into the bloodstream.  That problem was solved by creation of ...... a "correction factor" that was not part of the study protocol plan filed with the FDA and was not mentioned when a study based on the trial was published in 2002.  Two other studies, another conducted in 1999 and one in 2003, also indicated that the patch delivered excessive estrogen into the bloodstream.  Clinical trials also indicated other side effects caused by the patch.  Nonetheless, the FDA approved the patch and it was marketed as releasing a level of estrogen into the bloodstream that the company now acknowledges was inaccurate.  By November 2005, the FDA, after mounting evidence of the patch's side effects and the death of an 18 year old woman, was moved to issue a warning that the patch, as shown by the company's studies prior to the patch's FDA approval, exposed women to higher levels of estrogen. 
    Over 3000 women and their families have sued Johnson & Johnson over heart attacks, strokes and, in 40 cases, death, they claim were caused by the patch.  The lawsuits have uncovered internal company e-mails showing that the company's researchers had found that the patch delivered excessive estrogen than was publicly reported.  These lawsuits will be dismissed because of the FDA approval, which it looks like occurred because the company succeeded in snookering the agency.

Robert L. Abell
www.RobertAbellLaw.com