Lawsuit Tells How Politics Trump FDA’s “Gold Standard”

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

Jim Dickinson

FDA has long glowed under the banner that its scientific and regulatory standards make it the unchallenged global “gold standard” for all the products for which it is responsible. Gold can’t tarnish—or can it?

In July as treasure seekers and medical device justice seekers 930 miles apart were uncovering far different gold standards we were reminded that FDA’s version may be unattainable hyperbole.

Off the Atlantic coast of Florida divers found Spanish gold coins brilliantly untarnished after 300 years on the seabed, just as a new legal complaint filed in Washington, D.C. federal court revealed tarnish on FDA’s vaunted gold standard for mercury-based dental amalgam. Pure gold like that in old Spanish doubloons is one of the few metals in nature that cannot tarnish. (Perversely, mercury is another!)

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.

Those HHS-coerced responses upheld, without scientific justification, a bitterly contested and scientifically unsound 2009 final rule declaring amalgam safe and placing it in Class II—the far from golden provocation for the three petitions.  

According to the July-filed supplemental complaint, what FDA had intended to say in its 2012 not-final final decision, “based on all of the science it reviewed,” was to ask the dental profession to use mercury amalgams only as a second-line treatment after nontoxic composite material, and to publish a contraindication to their use in pregnant or nursing women and children under age six, and in “those persons with pre-existing kidney or neurological disease” in whom it “may further compromise already impaired renal and neurological systems.”

“HHS made the decision to not release the FDA’s findings and conclusions to the public,” the complaint charges. “Instead, the FDA remained silent for over three years until, after being sued in this lawsuit, it issued its 2015 responses [to the plaintiffs]” that removed the restrictions in FDA’s suppressed 2012 decision.

“However,” the complaint goes on, “during the three-year period between the 2012 response and the 2015 responses, FDA did not review or consider any additional evidence that would have justified the alteration of its findings and opinions on mercury fillings. Therefore, it was arbitrary and capricious for the FDA to reach a contradictory conclusion in 2015 based on the same science it reviewed for its previous decision in 2012.”

If that tarnish on FDA’s scientific glitter were not enough, the complaint says each of the three FDA responses to the petitions in January rejected the plaintiffs’ science-backed, peer-reviewed evidence that mercury amalgam is unsafe—and did so without presenting any scientific evidence to back up its contention that the device is safe.

Indeed, in most of its rejections, FDA airily wrote that there was nothing really new to consider in the plaintiffs’ scientific data, because it came from studies that were too small, had already been rejected for a variety of other reasons in the 2009 final rule, contained insufficient detail, or that FDA simply disagreed with.

This effectively shifted the burden of proof of safety onto the plaintiffs—even though it is FDA’s statutory duty to assure the safety and effectiveness of medical products.

In other words, FDA’s posture toward amalgam is an extra-legal one that it does not allow industry applicants seeking to market new products: a science-defying presumption of safety unless overwhelming proof of unreasonable risk is available. This is the opposite of what FDA requires in its pre-market product reviews.

It has projected this perverse posture in few other cases involving post-market products, not even in its recent refusal to ban laparoscopic power morcellators while adding a (voluntary!) boxed warning and posting a safety communication on its Web site.

The legal principal at issue, seen in other efforts over the years to prod FDA into action when marketed products present new health issues that were unsuspected at the time of market entry, appears to be that the marketers’ property rights in the product are too substantial to be easily brushed aside even for substantiated safety reasons.

One likely reason for FDA’s pro-product, anti-caution behavior through the years might well be the ingrained sensitivity of its political bosses at HHS to the political “clout” of industrial and practitioner interests. In amalgam’s case, this would be both the influence of the largest amalgam distributor, Henry Schein (past patron of former FDA commissioner Margaret Hamburg, a Schein board member), and of the powerful American Dental Association and its many thousands of liability-prone dentists who use amalgam. Hamburg left the agency in April.

Another reason for FDA’s behavior could be management’s instinct to defend its review process and the products it has sent into the marketplace.

FDA’s shifting of the burden of proof to the amalgam plaintiffs is the July supplemental complaint’s first courthouse “claim for relief.” It appends seven examples of the agency rejecting, without presenting contradictory scientific substantiation, all of the plaintiffs’ scientific evidence that mercury vapor emitted from amalgam can cause hearing loss, Multiple Sclerosis, harm to developing fetuses and infants under age six, harm to people with genetic polymorphisms, ALS (amyotrophic lateral sclerosis, or Lou Gehrig’s Disease), and harm to the kidneys.

In another claim for relief, the complaint faults FDA for departing in the 2009 final rule, without legal basis, from its original position prior to 1978 that mercury amalgams are implants and therefore presumptively in Class III where device safety and effectiveness must be scientifically demonstrated.

Other claims fault the agency for denying that dental patients are entitled to information about amalgam’s potential risks and alternatives before undergoing treatment, and fault FDA for not providing a legally required Environmental Impact Assessment of amalgam in its 2009 rulemaking.

Among the complaint’s requests for judicial relief are:

  1. Enjoining the enforcement of FDA’s 2009 final rule, including FDA’s supportive 2015 responses;
  2. Enjoining the use of mercury fillings in the protected subpopulations;
  3. Requiring FDA to instruct the dental profession to minimize the use of mercury fillings in favor of alternative restorative materials, which should be used as the first line of restorative care, as asserted by FDA in its suppressed 2012 response;
  4. Mandating that FDA provide and/or require appropriate warnings be submitted to patients, and parents of minor patients, explaining the potential harms and risks associated with mercury fillings, including the availability of alternative, nontoxic restorative devices;
  5. Directing FDA to amend its “Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy”; and
  6. Requiring FDA to classify dental mercury fillings as implants and to designate such fillings as Class III devices, thereby forcing the manufacturers to affirmatively prove their safety and efficacy.

Also in July, as over a million dollars in real Spanish gold was being brought from Florida’s seabed and FDA’s false gold was being exposed in federal court, broader and deeper questions were surfacing.

How can such flawed science prevail through six successive White House administrations? And beyond that, is it any wonder that so many Americans seem to be fed up with Washington?

Enhance your medtech knowledge by attending MEDevice San Diego, September 1–2, 2015, in San Diego.

Jim Dickinson is MD+DI's contributing editor. 

[Image courtesy of PONSULAK/FREEDIGITALPHOTOS.NET]

Time to Reboot Device Regulations for Patient Safety

Medical device manufacturers, please join together with patients to bring FDA regulations for medical and dental devices into the 21st Century. There is great promise in Precision Medicine, but a huge gap to fill first regarding basic disclosure and Precision Devices. Here is a new petition for Medical and Dental Device Safety Urgent Reform (MEDDSURGE): http://www.petition2congress.com/18325/medical-dental-device-safety-urge...

Why is this needed? Unlike for prescription drugs, OTCs, personal care and food products, there is NO information required to go to the patient or parent about device materials. Patients can experience harm from devices ranging from dental amalgam fillings to Essure, Mesh, joints, implants, stents and more. We are all genetic snowflakes. Basket studies are needed. Reactions vary based on gene types that impact how well we clear materials that are not natural to the human body. There is NO pretesting to determine if you will have a reaction in advance as is recommended for hair color (although a one-time test is available). Peer reviewed research links autoimmune, neurological and other illnesses with devices.

For dental fillings, there is NO right of written informed consent. FDA warnings for dental amalgam (called silver fillings, but 50% mercury) are required only from manufacturer to dentist, NOT to patients. There is a flawed MedWatch reporting system for dental device reactions (no mention, no examples given, request for manufacturer, model/serial number not available, and for date of incident vs period of exposure). Dental information does not go into patients' Electronic Medical Records so it is hard for doctors to connect illnesses. Dental insurance does not cover the higher cost of replacing amalgam fillings when medically indicated. Patients face high costs and lost income.

Make Medical and Dental Device Safety Urgent Reform (MEDDSURGE) job one. Refocus CDC and National Institutes of Health (NIH) funding on Chronic Diseases. Provide treatment for patients with device illnesses. Ask the Surgeon General to take emergency action. Put patient safety first. These reforms will save money, improve health outcomes, lower healthcare costs, and protect manufacturers from costly post-market recalls.

Thank you. Laura Henze Russell, Principal, Precision Research & Communications. For more information, contact laurarussell2@comcast.net.