Unfortunately, an important point about vaccine safety has been lost in the misplaced public debate over Rep. Bachmann’s statement. The pundits and professorial bioethicists have rallied with zeal to the defense of HPV vaccines, along with Gov. Rick Perry who signed a law mandating the vaccine for teenage girls, without acknowledging serious questions about the vaccine’s safety. There have been thousands of adverse event reports regarding Gardasil® over the four years since the Advisory Committee on Immunization Practice of the CDC recommended[5] the vaccine for girls age 9 and up.[6]  As of June 22, 2011 there have been a total 68 VAERS reports of death among those who have received Gardasil®.[7] Pundits have failed to note that there was concern at the outset regarding the CDC’s recommendation favoring the vaccine, because of concerns about safety, which have never been adequately evaluated.  Even one of the scientists who helped develop the vaccine, Diane Harper, then of Dartmouth University, issued some startling caveats about the safety of the HPV vaccine due to concerns about adverse events associated with the vaccine.[8]

Rep. Bachmann referred to an HPV vaccine causing “mental retardation”, a very unlikely event since HPV vaccines are recommended for girls 9 years of age and older. “Mental retardation” is not a condition that is likely to occur in an individual who has reached an advanced age without previous evidence of cognitive or learning problems. Rather, it is likely that cognitive deficits afflict some individuals who have been injured by the Gardasil vaccine, and these have been documented. [9]

Interestingly, the pundits and professors displayed considerable zeal in claiming that vaccines are safe, expressing outrage and doubt about a claim that a vaccine could cause “mental retardation” or even other types of serious cognitive injuries in children. These comments relate, no doubt, to claims that vaccines have caused “autism” in children, a controversy that has been raging for at least a decade. The claim has reportedly been “debunked by science” as it was explained by a media commentator.[10]

In our recent law review article, Unanswered Questions from the Vaccine Injury Compensation Program: A Review of Compensated Cases of Vaccine-Induced Brain Injury, we uncovered many cases where children with “autism” and other cognitive disorder were compensated for vaccine injury. We questioned the dismissal of the claim that vaccines can cause autism and pointed to documented and verified instances that contravened the evidence that claimed to “debunk” the association.[11]

On reviewing the most recent controversy, we conducted a preliminary examination of the legal literature reporting whether vaccines can cause “mental retardation”, something which pundits rebutting Rep. Bachmann seem very sure about. We easily found clear examples of reported cases in the legal literature showing that there has existed credible evidence, going back 50 years, that vaccines have had a causal relationship with “mental retardation”. While the legal process employs standards that are different from a focused scientific inquiry, the cases we found provide support for the claim— based on the evidence provided by medical doctors— that vaccines have, indeed, caused “mental retardation.” 

In presenting what we have found, we acknowledge that our data raises more questions than it resolves. But this is precisely the point. “Science” cannot point to studies showing that vaccines are completely safe. To the contrary, credible information supported by medical experts, shows that vaccines can cause serious neurological injuries such as, or similar to, “mental retardation.” To date, “Science” has not revealed the precise mechanism by which such injuries occur. A recent Institute of Medicine review of specific issues related to the safety of selected vaccines reported that, for most questions regarding vaccine safety, scientific investigation is incomplete and inconclusive.[12]

We have cited four cases below, selected from many that are easily located, that clearly show the connection between vaccine injury and "mental retardation". Notably, the decisions finding that vaccine injury caused "mental retardation" are supported by expert medical testimony.

Contrary to concerted recent claims in the media, it has long been understood that vaccine injury can result in permanent neurological damage. To the specific point regarding “mental retardation” and vaccines raised by Rep. Bachmann, the evidence dates back 50 years.

Case 1 from the Vaccine Injury Compensation Program (“VICP”)

In the early 1960’s physicians at the Mayo clinic diagnosed a little boy with retardation in mental and motor development, visual impairment, and infantile spasms or myoclonic jerks with atypical hypsarrhythmia. They recommended treatment that was completed in 1962. After the treatment, the boy’s seizures ceased. After a second treatment the boy suffered a permanent spastic diplegia rendering him fully dependent on his parents. The parents brought a lawsuit years later when their son was in his 30’s.

The Chief Special Master presiding over the case determined that the evidence showed actual causation. In particular, the Chief Special Master relied on evidence showing the vaccine, Quadrigen's, propensity to cause myoclonic seizures, encephalopathies, and other neurological insults in infants. The Court of Federal Claims adopted the Chief Special Master's recommended compensation award.

A panel of the U.S. Court of Appeals determined that the claimants produced sufficient evidence to show actual causation. In addition, the appeals court panel pointed out that the reviewing judges in the lower courts determined that there was insufficient evidence that the child’s injury was caused by factors unrelated to the vaccine.

Grant v. Sec'y of Dept. of Health & Human Services, 956 F.2d 1144, 1146 (Fed. Cir. 1992)

Case 2 from the VICP

In this case, the Court of Federal Claims reported the following in connection with a claim regarding seizures associated with vaccine injury:

Many experts in vaccine cases have testified that mental retardation and other neurological deficits are likely to accompany intractable seizure disorders in young children, although not in every case. The outcome of convulsive status epilepticus (SE) is variable, however, a series of studies by renowned epileptologist, Jean Aicardi, found a high incidence of mental deficits following SE. Studies by Fujiwara, et al., found similar results and a high incidence of motor damage as well. In the Aicardi series, seizures occurring after SE were mainly of a type “usually associated with brain damage.” Aicardi concluded: ‘Convulsive seizure may end in death or may leave severe mental and/or neurological sequelae that appear to result, at least in part, from the convulsive activity itself, irrespective of its causes.” According to Aicardi, poor prognosis in some types of seizure disorders is often associated with early age of onset. (Internal citations omitted).

Lurtz v. Sec'y of Dept. of Health & Human Services, 90-1703 V, 1998 WL 321926 (Fed. Cl. June 4, 1998)

Case 3 from the VICP

In Case 3, a child met developmental milestones for a period after his initial seizures that an expert found consistent with vaccine causation. Initial seizures, which were relatively brief, had little impact on his neurological development, but subsequent seizures, which “became intractable and uncontrolled by medication,” caused much more significant cognitive deficits. The Court cited Case 2 above, Lurtz, that noted that “[m]any experts in vaccine cases have testified that mental retardation and other neurological deficits are likely to accompany intractable seizure disorders in young children”). The special master explicitly rejected the government's contention that evidence of brain injury from the DPT vaccine will manifest itself immediately. Instead, the special master credited the testimony of the claimant's expert who explained that:

In cases of severe seizure disorders, the initial MRI is more commonly negative than it is positive, regardless of the cause of the disorder. In vaccine injury, both MRI's and CT scans will be normal initially. Over the years, one might expect to observe cerebral atrophy, but one would not observe it right away. Customarily, one will observe no immediate markers to identify a DPT injury other than its clinical course.... If the condition continues, pathology can be later identified ... but would not indicate what caused the injuries.

Andreu ex rel. Andreu v. Sec'y of Dept. of Health & Human Services, 569 F.3d 1367, 1381-82 (Fed. Cir. 2009)

Case 4 from the VICP

In this case parents brought a claim for damages for the vaccine-related injury of their son. They alleged that as a result of the administration of a DPT vaccine he suffered a hypotonic-hyporesponsive collapse and encephalopathy and residual seizure disorder. The parents further maintain that the injuries resulted in permanent disabilities involving significant developmental delay, moderate autistic characteristics, and mental retardation.

The court found that the claimants were entitled to compensation, concluding that the DPT was the presumed cause.

Sorenson v. HHS, 1990 WL 290491 (Cl.Ct.)

In offering these examples of support for the proposition that vaccines can and have caused “mental retardation” along with neurological deficits and other cognitive problems, we are mindful of the difference between “causation” in law and “causality” in science.  In particular, we are mindful of the standards applicable in the Vaccine Injury Compensation Program. But these are the sources of data available to us as citizens, doctors, lawyers, and, perhaps most importantly, parents, while we strive to make responsible decisions regarding the health of our children. It is the absence of understanding by scientists of the nature and cause of vaccine injury, something that indisputably occurs, that has required us to employ other than absolute scientific standards in order to make judgments regarding safety. It is the absence of science— something which must be resolved— that was one factor motivating Congress to establish the VICP so that justice would be available to victims of vaccine injury.[13]

We also observe, as we have done in the case of “autism” that imprecise definitions often confuse understanding. There is no doubt that the emerging data show that the HPV vaccine, in keeping with most vaccines, has caused various forms of brain injury or “encephalopathy”.[14] “Mental Retardation”[15] has a generalized definition and manifests in multiple ways and to varying degrees, all relating to deficits in cognitive ability and intellectual functioning. The term is in disfavor among those who work in the disabilities field, with the phrase “intellectual disability” being more favored. This highlights the moving target presented by debates over the question of whether vaccines cause “mental retardation”.[16] The shifting of terminology also highlights some of the unresolvable confusion inherent in any discussion of the issue. This “definitional ambiguity” creates a linguistic imprecision which should not be laid at the doorstep of anyone, such as Michele Bachmann, who publicly suggests that vaccines can cause “mental retardation.”

As the matter currently stands, the confusion in the discussion itself leaves parents to make the call over the safety of an invasive medical intervention like vaccination, in the absence of clear-cut evidence of safety. If the benefit outweighs the risk, as public health vaccine advocates repeatedly proclaim, the safety risk can be openly and freely weighed by parents, without the need for media talking heads and bioethicists to gloss over a complicated medical issue.

For a narrative account and photographs of a teenage girl injured by the HPV vaccine, read Amy Pingel’s chapter in Vaccine Epidemic, edited by Louise Kuo Habakus and Mary Holland, describing and illustrating the profound injuries, including neurological and cognitive ones, sustained by Amy’s daughter Zeda.  Amy Pingel states that had she been fully informed of the risks of the HPV vaccine, she would never have permitted her daughter to be vaccinated.

We offer the foregoing information, therefore, in the interest of avoiding simplistic assertion or condemnation, and to counter overzealous punditry that advances misleading assurances regarding vaccine safety. Ignorance of the precise cause of vaccine injury does not justify grandstanding proclamations, whether by campaign advocates or bioethicists, when their claims are grounded in profound ignorance. “Absence of proof is not proof of absence.”[17] While Michele Bachmann could have been more accurate in her choice of words, she is not nearly so wrong as the media pundits and bioethicists would have us believe. There is significant evidence that she is correct in raising questions – and that her critics are ill-informed in their effort to stifle those questions.

/s/ Robert J. Krakow, Esq. and the Coauthors of “Unanswered Questions”, Mary Holland, Esq., Louis Conte, and Lisa Colin, Esq.