To friends of mercury free dentistry:

A heads up to you:  tomorrow (12/28/07) lawyer Bob Reeves and I are filing a lawsuit against FDA for failing to classify mercury fillings and other violations of law.  The eleven plaintiffs include Consumers for Dental Choice and three other nonprofit groups, Moms Against Mercury, the CT Coalition for Environmental Justice, and Oregonians for Life, plus Michael Bender, Senator Karen Johnson, dentists Andy Landerman and Corrie Crowe, dental assistant Karen Palmer, and consumer victims Linda Brocato and Anita Vazquez Tibau.
 
In June FDA promised me, in writing – as we were on the verge of suing them -- that they would initiate an advanced notice of proposed rulemaking, the first step toward classifying mercury amalgam.  That promise has disappeared into the FDA’s quicksand.  As much political science as I’ve had, and as many years in politics as well, I remain amazed how much the bureaucracy runs FDA’s policies, and how either impotent or disinterested are the people at the top.  For the third time (in 2002, in 2006, and in 2007), a specific promise for a specific action by a high-ranking FDA official has been sabotaged by the mercury amalgam protectors in the bureaucracy.  But those at the top are to blame too, for presiding over but not actually running this agency. 
 
To stop this pattern of FDA officials avoiding legal accountability by hiding behind each other, we named as defendants the entire chain of command on mercury fillings regulation: six layers of bureaucracy from the Commissioner to the Director of the Dental Devices Branch.  Each has acted to protect mercury fillings on behalf of the pro-mercury side of the dental profession; each has acted to conceal the mercury from American consumers, even from pregnant women and parents of young children.
 
Charlie
 
 
Charles G. Brown, National Counsel            
Consumers for Dental Choice   

At the end of that 30 days (in June 2007), the FDA Commissioner’s office phoned and said with enthusiasm, “You will like our plan,” promising details the next day.  The next day, FDA counsel phoned me and said FDA intended to begin the classifying process, by issuing an Advanced Notice of Proposed Rulemaking (ANPR).  I asked the lawyer to put that promise in writing, which she did.  I then immediately contacted two reporters (from FDA Week and the Bureau of Nat. Affairs Medical Devices Reporter), both of whom called FDA’s press office, which confirmed the agency would issue such an Advanced Notice of Proposed Rulemaking, by the end of the calendar year at the latest. 

Month after month, we waited.  No ANPR issued.  In November, FDA witness Norris Alderson, FDA’s lead scientist (his degree is in veterinary medicine), appeared before Congress and stonewalled, repeatedly misleading Congress and refusing even to commit to doing an Environmental Assessment (legally required).  Over the past 15 years, FDA repeatedly promises (to courts, to Congress, to petitioners) to classify mercury fillings -- then doesn’t.  Fool me once, shame on you; fool me repeatedly, shame on me.  So I guess the shame is on me for, in my naiveté, actually believing FDA when the agency lawyers make a written promise.

FDA lied to us and to the American people -- again.  Accordingly, on the last workday of the calendar year (Fri. Dec. 28, 2007), my co-counsel Bob Reeves and I, with substantial assistance from lawyer Johann Wehrle, sued.  The lawsuit is at www.toxicteeth.org/Complaint_Dec282007.pdf

The malfeasance at FDA -- this sequence of illegal actions to shield dentists’ pocketbooks instead of showing any concern with children’s health, unborn children’s lives, or the environment -- extends deep into the agency.  Accordingly, we sued six individuals at FDA (not just the Commissioner), going several layers deep into the agency.  We are going to stop these autocratic bureaucrats from hiding behind each other.

Charlie Brown

16 January 2008