The Lawyer Who Became Dupont's Worst Nightmare

"Rob Bilott was a corporate defense attorney for eight years. Then he took on an environmental suit that would upend his entire career — and expose a brazen, decades-long history of chemical pollution."

By NATHANIEL RICH, New York Times, Jan. 6, 2016

Another in-depth report in the tradition of Steven Brill's brilliant account of America's Most Admired Lawbreaker, Nathaniel Rich paints a riveting portrait and account of corporate attorney Rob Bilott taking the case of a cattle farmer who called about his cows mysteriously dying. Years of digging let to discovery of the cause: wide scale poisoning from PFOA-tainted water from DuPont's landfill from Teflon production. Long after DuPont learned of PFOA's health hazards, they buried the data and denied the links - and the responsibility. Federal, state and local regulators repeatedly sided with DuPont's claims of safety over citizens' and scientists' claims of harm. Perfluorooctanoic acid (PFOA) is now recognized by EPA as a health risk. 

"STATES OF UNCERTAINTY

No one knows for certain how much PFOA is safe to drink. Rob Bilott’s lawsuit against DuPont in West Virginia included anyone whose drinking water had levels above 0.05 parts per billion. But last June, based on a comprehensive review of previous health studies, Philippe Grandjean of the Harvard School of Public Health and Richard Clapp of the University of Massachusetts-Lowell named an ‘‘approximate’’ safe level of 0.001 p.p.b. Soon thereafter, the nonprofit Environmental Working Group analyzed two years of E.P.A. survey data to find that this threshold had been exceeded — in some cases by factors of 100 or more — in 94 water systems across 27 states."

A series of lawsuits have begun against DuPont for PFOA poisoning. The article states that there are 60,000 unregulated chemicals in the United States. 

Read it here: The Lawyer Who Became DuPont's Worst Nightmare

FDA Regulatory "Oversight" of Dental Amalgam - A Timeline -

FDA Regulatory "Oversight" of Dental Amalgam
- Timeline -

2011-2019: Eight Years of  Denial and Delay

• 2011-2014: James S. Woods et. al. publish four retractions of their findings of amalgam safety in children, finding neurobehavioral deficits in boys with four gene types.
• 2011: At FDA regional public hearings around the country, many dental professionals and patients testified of harm and many diseases caused by mercury in dental amalgam. 
• 2012: HHS quashed a planned FDA Safety Communication in an election year. The FDA called for reducing the use of amalgam, recognizing the risk of occupational exposure for dental personnel, and avoiding its use in susceptible sub-populations: Pregnant and nursing women; Parents and guardians of infants and children under age 6; People with mercury allergy or sensitivity; People with neurological disease; and People with kidney disease.[1] 
• 2014: FDA and HHS were sued for failure to respond to multiple petitions for reconsideration.
• 2015: FDA response to lawsuit is to take no action. McClatchy DC, Medscape and MD+DI Device Talk all report on HHS cover-up. FDA and HHS are sued for third time.

2006-2010: Five Years of Wrong Action

•       2006: FDA issued a White Paper concluding dental amalgam was safe. However, the FDA’s Dental Products Panel rejected the FDA’s position 13-7. The FDA did not act.
•       2008: a number of organizations and plaintiffs sued the FDA for its failure to classify amalgam. The FDA settled the lawsuit, published a website warning, and agreed to issue a final rule within a year. FDA Commissioner Hamburg came in after a six year board seat on dental products distributor Henry Schein; the website warning was removed. 

Federal judge Ellen Huvelle told the FDA that, "the probability of harm is enormous," and called the agency's 32-year foot-dragging, "government at its worst."[2]

• 2009: FDA classified dental amalgam as Class II, with warning labels only to dentists.
• 2010: After strong objections, FDA reconvened a Dental Products Panel. FDA did not take a vote. Dentists, patients and an expert risk assessment testified of risk and harm.

1976-2005: Thirty Years of Inaction

• 1976: Congress passed legislation to add medical, dental and radiological devices to the Food and Drug Administration (FDA).  Certain materials were ‘grandfathered’ as generally recognized as safe (GRAS) initially, including cigarettes, asbestos, and dental amalgam, but were to be reviewed and classified. The FDA declined to classify dental amalgam for three decades. The FDA also declined to exempt it from classification.
• 1987: FDA developed a new definition for an element to add to the periodic table, “dental mercury.” The FDA ruled “dental mercury” to be Class I – generally recognized as safe.
• 2002: FDA announced a proposal to reclassify dental amalgam as Class II with special controls related to dentists. Then it was put on the back burner again.

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[1] http://iaomt.org/wp-content/uploads/FDA-2012-safety-communication-mercury.pdf

[2] http://mpp.cclearn.org/wp-content/uploads/2008/08/transcript051508momsvfda.pdf

MD+DI DeviceTalk: Lawsuit Tells How Politics Trump FDA's 'Gold Standard' on Mercury Fillings

MD+DI: Lawsuit Tells How Politics Trump FDA’s “Gold Standard”

Jim Dickinson August 3, 2015

FDA tarnishes its reputation as the regulatory "gold standard" with its stance on mercury-based dental amalgam.

..."Copiously documented with legal, regulatory, and scientific exhibits, the 28-page Washington complaint supplements a 16-month-old lawsuit that FDA has been trying to ignore from the International Academy of Oral and Medical Toxicology and other mercury-opposed plaintiffs who, on other fronts, are winning as the archaic amalgam market in U.S. dentistry dwindles in favor of non-mercury composite resin alternatives.

The darkest tarnish on FDA’s illusory gold glitter could be the new complaint’s discovery that after the agency in 2012 dutifully sent to its political bosses at HHS a scientifically-based final decision restricting mercury amalgam’s use in dentistry, FDA mysteriously reversed course.

That final decision remained a secret, internal document until by a process unexplained in the complaint, it came into the hands of the plaintiffs’ lawyers, enabling them to compare what FDA had decided to tell the world about amalgam and what it was diverted from above to say instead. It did this last January in deceptive responses to three petitions from plaintiffs for a ban on amalgam."...

Medscape: Did HHS Cancel Proposed FDA Limits on Mercury Fillings?

Robert Lowes  July 29, 2015

"In January 2012, the US Food and Drug Administration (FDA) appeared ready to prohibit the use of mercury-based dental fillings, or dental amalgam, in pregnant women, nursing mothers, children aged less than 6 years, and other groups considered sensitive to the metal's neurotoxic vapors.

The agency also was ready to advise dentists that "alternative materials would best be offered as the first line of restorative care minimizing the use of dental amalgam," according to a draft FDA safety communication dated "January XX, 2012."

The proposed FDA guidance, stemming more from cautious uncertainty than clear evidence on dental amalgam's effects on health, would have represented a sea change in the government's regulation of the controversial filling material.

However, as part of the US Department of Health & Human Services (HHS), the FDA needed a green light from higher-ups to issue this guidance. The green light never came.

"We were unable to obtain clearance from HHS," an FDA official told an attorney in February 2012 in a lawsuit seeking to either ban or limit the use of dental amalgam. "We are still working on securing that clearance. When or even if it will happen I cannot say."...