A Case of Good Gatekeeping · Sep 7, 12:00 PM

On June 1, 2007, United States District Judge for the Northern District of California Phyllis J. Hamilton filed a 31-page order in the product liability case, Redfoot v. B.F. Ascher & Company et al. (C-05-2045-PJH). In this case, the plaintiff alleged that Ayr Saline Nasal Mist was the cause of her son’s autism, and that the manufacturers and distributors of Ayr negligently and recklessly failed to disclose known dangers of their product.

The court was not convinced.

Below, I offer some some background, a summary of the case, excerpts from case documents, and commentary. I have posted the full text of Judge Hamilton’s decision and key documents on this website, linked from a docket sheet and the text of this report. Links from the docket sheet to procedural documents (such as notices of appearance by attorneys, notices of service, scheduling orders and the like) lead to the website of the United States Court for the Northern District of California; these are available for a fee to individuals with a PACER account.

The Plaintiff’s Allegations

The child at the center of the lawsuit was born on January 1, 2000. In 2002, he was diagnosed with Pervasive Developmental Disorder-Not Otherwise Specified; at the age of three and a half, his diagnosis changed to Autistic Disorder.

In the spring of 2003, the parents learned that certain vaccines and other health-care products contained trace amounts of the mercury-based antimicrobial thimerosal, and that some people believed that thimerosal in medical products could cause neurological damage resulting in autism. Their son had received a routine series of vaccinations in infancy, some of them containing trace amounts of thimerosal; and from the age of two months to three years, his parents treated his recurring nasal congestion with frequent doses of Ayr Saline Nasal Mist, which contained 0.00025% thimerosal.

On December 10, 2003, the parents filed Petition 1:03-vv-02801-UNJ in the United States Court of Federal Claims under the Vaccine Injury Compensation Program, alleging that their son was injured by thimerosal in his vaccines. This pending petition is one of approximately 4,750 incorporated into the ongoing Omnibus Autism Proceeding.

On April 1, 2005, the mother filed a civil suit against B.F. Ascher & Company and Kolmar Laboratories Inc., manufacturers and distributors of Ayr. She alleged that absorption of mercury from thimerosal contained in Ayr had made her son autistic; that Ayr was inherently defective because it contained thimerosal; that the defendants had negligently failed to warn her of and deliberately concealed its alleged dangers; and that by adding thimerosal to their product, the defendants had violated a “federal ban on thimerosal products.”

“Defendants were actually aware of the mercury content and of the dangers to human life from the mercury containing thimerosal and thimerosal containing Ayr Saline Nasal Mist and the use thereof. Defendants, through their employees and/or agents, acted recklessly and/or intentionally… They knew or should have known that the thimerosal, which they sold and supplied, was unreasonably dangerous in normal use… The conduct of defendants was and is vile, base, willful, malicious, fraudulent, oppressive, outrageous, and Defendants’ acts were committed in conscious disregard and indifference to the safety and health of users of its products.”
(First Amended Complaint for Damages)

The plaintiff requested an unspecified amount of compensatory and punitive damages. (Although her VICP petition alleged that her son was harmed not by nasal spray but by thimerosal in his vaccines, her suit against Ascher did not reference the vaccine petition or reiterate its allegations; these were mentioned in a motion later filed by the defendants.)

In an expert report dated December 14, 2006, Dr. Mark Geier presented his opinions on “the capability of mercury in thimerosal to cause neurological damage.” He reviewed the history of the use of mercury; the development of thimerosal and its use in medicine; mass environmental mercury poisonings; animal and in vitro studies with mercury and thimerosal, including studies by Thomas Burbacher, David Baskin and Richard Deth; and Bernard et al’s essay asserting a similarity between symptoms of mercury and those of autism. After a review of his own epidemiological studies, discussion follows of studies conducted by Amy Holmes, Jeffrey Bradstreet, James Adams, Jill James, Janet Kern, Robert Nataf, and himself, all purporting to determine autistic children’s “body burden of metals,” impairments in metals excretion, predisposition to oxidative stress, and genetic and hormonal susceptibility to toxicity.

Dr. Geier’s evaluation of the plaintiff’s son listed diagnoses of Autistic Disorder, Toxic Encephalopathy, Porphyria, Mercury Poisoning by Therapeutic Use of Thimerosal, Testicular Hyperfunction, and chromosomal abnormalities. His narrative account of a December 2005 interview with the mother revealed that she smoked approximately a half-pack of cigarettes per day while pregnant, refrained from eating fish, and had eight amalgam fillings in her teeth. She brought her newborn son home from the hospital with her after an uncomplicated birth; the boy had APGAR scores of 8 and 9. He made a brief reappearance at the hospital to be treated for jaundice. He was immunized according to the routine schedule, and his recurring nasal congestion was treated with Ayr Saline Nasal Mist. Dr. Geier estimated the child’s total “mercury dose” from Ayr to be 700µg. The mother reported that the child’s development progressed well until the age of one year, at which point his physical and language skills declined. Dr. Arthur Krigsman performed a colonoscopy and diagnosed the child with enterocolitis and “inflammation of the gut.” He became variously a patient of Dr. Jeffrey Bradstreet, a Dr. Bhatia, Dr. Lynn Mielke, and was treated at the Pfeiffer Center. The child was put on a gluten- and casein-free diet, and was subsequently administered prednisone, infusions of secretin, the chelator DMSA and methyl B-12 injections. Beginning in March 2005, he was evaluated and treated at the Lovaas Institute.

Dr. Geier classified the four-year old’s “aggressive behaviors” and “fine body hair” under the heading of “Puberty Development.” A physical examination revealed “no gross dysmorphic features.” Dr. Geier diagnosed the child with Autistic Disorder subsequent to a “developmental/psychiatric testing evaluation” consisting of the Autism Treatment Evaluation Checklist (ATEC) and a comparison of the child’s symptoms with diagnostic criteria in the Diagnostic and Statistical Manual of Mental Disorders. A battery of blood and urine tests (standard, nonstandard and investigational) yielded considerable data.

From these data and his examinations, Dr. Geier concluded that:

“The patient’s neurodevelopmental disorder is the apparent result of a toxic encephalopathy… significantly contributed to by mercury exposure from the Thimerosal-containing nasal spray he was administered… If there was thimerosal in the childhood vaccines, there would have been exacerbation from this additional childhood mercury exposure… A[…] has biochemical and genomic markers indicating heightened sensitivity to mercury. A[…] has laboratory tests consistent with increased mercury including elevated fecal mercury levels and elevated urine mercury levels (following provocation with DMSA).”

The Defendants’ Response

The defendants denied the plaintiff’s allegations and requested summary judgment — that is, resolution of the case in their favor. They argued that:

“…[P]laintiffs have no reliable, statistically significant evidence to support their allegation that the Ayr Saline Nasal Mist utilized by plaintiffs is capable of causing autism in the general population, or that the product caused A[…]‘s autism… [T]he scientific evidence offered by plaintiffs is fundamentally flawed, inherently unreliable, and entirely inadmissible. Moreover, the scientific evidence to date which examines the possibility of a causal relationship between thimerosal containing products and autism has concluded that the evidence favors a rejection of a causal relationship… [T]here is no reliable scientific evidence that the nasal spray was harmful to the health of humans. Therefore, plaintiffs cannot establish that defendants were aware of any probable dangerous consequences associated with the product or that defendants willfully and deliberately failed to avoid such consequences.”
(Memorandum in Support of Motion for Summary Judgment)

The defendants further sought to preclude the testimony offered by Mark Geier — the plaintiff’s sole causation expert — as well as by the plaintiff’s “non-retained experts” George Lucier, Boyd Haley, James Bradstreet and Arthur Krigsman. (Dr. Geier was the only one of the five to submit an expert report.) All sought to testify on the same broad range of subjects, including epidemiology, neurology, genetics, toxicology, developmental pediatrics, and alleged conflicts of interest between members of the vaccine industry, researchers, and employees of various governmental and non-governmental organizations.

The defendants warned the court that:

“Lacking reliable epidemiological or scientific evidence of any association between TCVs and autism (or mercury-induced neurotoxicity), plaintiffs’ expert witnesses attempt to Frankenstein together a causation argument by extrapolating from in vitro experiments, animal data, and poorly controlled observational studies, while ignoring valid scientific methods. In doing so, plaintiffs’ experts breach the boundaries of legitimate science by employing improper scientific methodology and relying on unproven or improper studies.”
(Defendants’ Motion to Preclude)

The defendants submitted five expert reports in support of their preclusion motion. Pediatric neurologist Paul G. Fisher of Stanford University noted several pertinent matters evident in the child’s family, medical and developmental history, including matters recorded in Dr. Geier’s notes on his interview with the mother, but not mentioned in his final expert report:

“The child was developmentally delayed… sitting at nine months, walking at thirteen months, running at 24 months, and babbling lasting until 12 to 18 months. The child was macrocephalic from birth onward… (and) noted at four to five months to be hypotonic… (The child) has a number of other risk factors more likely to lead to autism, such as a history of speech and language problems, maternal smoke, or idiopathic cerebral dysgenesis. I will testify that there is no medical probability whatsoever that A[…]‘s developmental difficulties are related to thimerosal exposure from Ayr Saline Nasal Mist…”
(Declaration of Paul G. Fisher)

Dr. Fisher also expressed his concern for the child’s welfare, in view of the multitude of therapies to which he had been subjected with no apparent evidence of medical necessity:

“I am a bit perplexed why the child has received so many other therapies if the mother is convinced the child has suffered a toxic exposure from mercury. It would not be useful at any point to provide chelation therapy to try to remove such and it is unclear to me how therapies such as secretin or other medications would affect the boy’s autism. Chelation therapy is known to be dangerous to children and is not medically indicated for developmental issues. Moreover, I have not seen any confirmatory tests to indicate that (the child) is intolerant of soy, gluten or dairy, and there is no peer-reviewed evidence to indicate that these compounds have a role in autism… I will testify that chelation therapy administered to (A[…]) pose(s) danger to this child for additional harm or death.”
(Declaration of Paul G. Fisher)

In response to the plaintiffs’ claim that the addition of thimerosal to Ayr Saline Nasal Spray constituted a violation of federal law, pharmaceutical chemist and quality control specialist Rhys Bryant asserted that:

“…FDA took action… to remove thimerosal only when used as an active ingredient in first aid antiseptic drug products. FDA did not place a ‘federal ban’ on thimerosal.”
(Declaration of Rhys Bryant)

Toxicologist Philip S. Guzelian of the University of Colorado Health Sciences Center discussed the matter of chemical toxicity:

“Over 400 years ago, the Swiss philosopher and physician Paracelsus (1493-1541) wrote perhaps the most essential tenet in toxicology: All substances are poison, there is none which is not a poison. The right dose differentiates a poison from a remedy.

“In short, because dose determines the nature, intensity and frequency of the adverse effect observed (disease), there will be both acceptably safe doses (and hence exposures) and toxic doses for every chemical. Likewise, without knowing the dose, the threat of toxicity obviously cannot be evaluated properly. Thus, it may be misleading to speak of “toxic chemicals,” because all chemicals have the potential of being toxic. One should instead refer to “toxic exposures” or “toxic doses” of chemicals, including those that individuals receive voluntarily (e.g., drugs).”
(Statement of Philip Guzelian)

Dr. Guzelian also criticized George Lucier’s method for estimating the child’s thimerosal exposure:

“…Review of Dr. Lucier’s method to derive exposure (or dose estimates) is futile inasmuch as he provided no equations, inputs or assumptions. Nevertheless, one immediate conclusion is that his calculation must be in error… It appears that Dr. Lucier’s exposure (or dose) estimates overstate the amount of ethylmercury in the Ayr solution by a factor of ten.”
(Statement of Philip Guzelian)

Obstetrician and teratologist Patricia Rodier of the University of Rochester described various prenatal exposures linked to autism (these include maternal rubella infection, thalidomide, valproic acid, ethanol, and misoprostol), and commented on the lack of evidence for the thimerosal causation hypothesis:

“It is unscientific and illogical to accord any merit to an hypothesis for which there are no supporting data and many lines of negative data… The plaintiff’s allegation that thimerosal in nasal spray causes autism is based on the earlier hypothesis of a link between vaccines and autism. Since the vaccine hypothesis has been discredited completely, it would be illogical to find any merit in the allegation.”
(Statement of Patricia Rodier)

Infectious disease specialist Peter Katona of UCLA reiterated this conclusion, and also pointed out that thimerosal was removed from Ayr in December 2000.

The Plaintiff’s Rebuttal

In her reply to the motion for summary judgment, the plaintiff discounted the validity of epidemiological studies exonerating thimerosal as a possible cause of autism:

“Although there have been some published epidemiologic studies by researchers with ties to the pharmaceutical companies who manufacture vaccines that purport to refute the association between thimerosal and autism, those studies suffer from significant methodological flaws that impact the validity of their conclusions.”
(Reply to Motion for Summary Judgment)

One page later, she argued that any methodological flaws that might exist in Dr. Geier’s epidemiological studies were insufficient to invalidate his conclusions:

“While there may be some flaws in Dr. Geier’s papers, those imperfections are not enough to render his work invalid as a matter of law. As the court in In re Phenylpropanolamine (PPA) Products Liability Litigation aptly stated, ‘Scientific studies almost invariably contain flaws… When faced with epidemiological evidence, the court must determine whether the flaws compromise the study’s findings…’”
(Reply to Motion for Summary Judgment)

In her reply to the defendants’ preclusion motion, the plaintiff reiterated and defended the qualifications of Geier, Lucier, Haley, Bradstreet and Krigsman; denied the defendants’ assertion that their opinions were formulated for litigation; collectively characterized the U.S. Food and Drug Administration, American Academy of Pediatrics, Institute of Medicine, World Health Organization, U.S. Centers for Disease Control, U.K. Committee on Safety in Medicines and the European Agency for the Evaluation of Medicinal Products as an “alphabet soup of organizations… who have discounted the link between thimerosal and autism without discussing the motivation for or foundations of their conclusions”; and recounted a number of cases in which Dr. Geier’s testimony was admitted by the courts.

The Court’s Decision

In her decision, Judge Hamilton delineated and weighed the arguments forwarded by both plaintiff and defendants on every point. She reviewed the use of thimerosal in biological products, and recent investigations on a posited relationship between thimerosal and autism; discussed legal standards for expert testimony and scientific evidence; devoted twelve pages to an analysis of Dr. Geier’s qualifications and testimony, assertions, research methods, and the references upon which he relies; and also considered the qualifications of George Lucier, Boyd Haley, James Bradstreet and Arthur Krigsman. Legal standards for granting a motion for summary judgment were explored, followed by a discussion of standards for determining causation in toxic tort cases.

Ultimately, Judge Hamilton excluded the testimony of all of the experts put forward by the plaintiffs; granted summary judgment in favor of the defendants; and dismissed the case on its merits.

On thimerosal, autism, and scientific consensus

“(A)fter further research and much debate on the potential for harm from thimerosal-containing vaccines, scientific and medical organizations worldwide have rejected the hypothesis that thimerosal-containing pediatric vaccines cause or contribute to autism. In addition to the IOM and the AAP, these include the FDA, the World Health Organization (“WHO”), the CDC, the U.K. Committee on the Safety of Medicines, and the European Agency for the Evaluation of Medicinal Products.”

On reliable scientific evidence

“Scientific evidence is reliable if it is based on an assertion that is grounded in methods of science — the focus is on principles and methodology, not on conclusions.”

On Mark Geier’s qualifications to testify

“The… plaintiff has not met her burden of showing that Dr. Geier’s testimony is admissible. As an initial matter, the court notes that Dr. Geier is not qualified as a pediatrician, a neurologist, a toxicologist, or an epidemiologist, either by background or training. He is a medical doctor and a geneticist, but has no specialization in any of the relevant medical areas.

“In particular, there is no evidence that Dr. Geier has either the training or the background to diagnose autism or to treat autism in any child. Simply having an “interest” in vaccines and the possible connection between thimerosal-containing vaccines and the development of neurodevelopmental disorders in children is not sufficient to qualify an individual as an expert in either pediatrics or neurology, or regarding the various forms of mercury and their neurotoxicity.

“In addition, Dr. Geier’s testimony is not reliable. While his studies have been “peer reviewed,” in the sense that they have been published in scientific journals, they have been severely criticized by the IOM, the AAP, and others. In particular, both the AAP and the IOM have pointed out the problems inherent in studies that rely on the VAERS database.

“It is also true that Dr. Geier has been designated as an expert witness in about 100 cases before the Vaccine Court. However, in some of those cases, particularly the more recent ones, his opinion testimony has been excluded or accorded little or no weight beyond a determination that he was testifying beyond his expertise. See, e.g., Doe v. Ortho, 440 F.Supp. 2d at 471-72.

“Dr. Geier’s report contains his opinions regarding the capability of the mercury in thimerosal to cause neurological damage. However, many of the sources he cites (including a number of his own studies) pre-date the 2004 conclusions by the AAP, the NIH, and the CDC that ingestion of small amounts of thimerosal does not cause autism. In addition, much of the published literature focuses on the effects of exposure to methylmercury, not ethylmercury.

“Dr. Geier has failed to point to a single study that has conclusively established that the amount of thimerosal contained in the Ayr Saline Nasal Mist could cause autism, and has failed to point to a single study that conclusively determined that any amount of mercury could cause the specific neurological disorder of autism. As an example, the Burbacher studies cited by plaintiff involved injecting monkeys with thimerosal in doses that would approximate the U.S. vaccination schedule — not the minuscule amounts present in nasal spray — and there is no evidence supporting a hypothesis that ethylmercury entering the blood system of a child would approximate ethylmercury entering the blood supply of a monkey.

“In short, Dr. Geier’s opinions cannot be used to establish causation because they do not address whether thimerosal in nasal sprays is capable of causing autism. While it is true that Dr. Geier has published more than 50 scientific or medical papers, none was on the subject of thimerosal in nasal spray. All Dr. Geier’s studies have focused on vaccines. Nor can his methodology support a finding that A[…]‘s autism was caused by ingestion of thimerosal in Ayr Saline Nasal Mist. Dr. Geier is not qualified by training or experience to provide an opinion as to the cause of A[…]’ autism, and is not qualified to perform a differential diagnosis of autism. As defendants have persuasively argued, Dr. Geier’s differential diagnosis is faulty because he failed to consider one specific alternative explanation — that the cause of autism is not known today. Moreover, the differential diagnosis he did provide is incomplete, because he did not rule out the unspecified cause of dysgenesis (a brain malformation).”

On Drs. Lucier, Haley, Bradstreet, and Krigsman

“…Drs. Lucier and Haley… submitted no expert reports and are not A[…]‘s treating physicians… (E)ven though they are A[…]‘s treating physicians, it appears that plaintiffs are seeking to have (Drs. Bradstreet and Krigsman) offer true “expert” opinion, about matters as to which they are not percipient witnesses, rather than having them testify about A[…]‘s diagnosis, treatment, or prognosis.

On the burden of proof

“The… plaintiff has not established a genuine issue of fact as to either general or specific causation. In addition, without evidence of a causal connection between Ayr Nasal Saline Mist and A[…]‘s autism, plaintiff cannot maintain the failure-to-warn claim.

“The only evidence provided to support causation is the report and opinion of Dr. Geier. Because the court has found, however, that Dr. Geier’s testimony must be excluded because he is not qualified as a pediatrician, neurologist, toxicologist, or epidemiologist, and because the opinion is not reliable, plaintiff has no evidence of causation. In addition, plaintiff has cited no reliable, peer-reviewed epidemiological studies showing a causal link between the administration of thimerosal-containing nasal spray and the onset of autistic disorder. As defendants assert, multiple reliable epidemiological studies have consistently found no evidence of any association between thimerosal-containing vaccines and autism. Plaintiff presents no reliable scientific evidence either that thimerosal is toxic to humans at the incremental doses delivered by nasal sprays; or that thimerosal is toxic to humans at the doses delivered by thimerosal-containing vaccines; or that there is an identified sub-population of children who are genetically vulnerable to mercury neurotoxicity; or that mercury can cause neurological damage that manifests as autism.”

On the matter of negligence

“Plaintiff… cannot show that A[…]‘s autism was caused by the Ayr Saline Nasal Mist. Plaintiff presents no evidence, other than Dr. Geier’s studies, showing any connection between thimerosal and autism, and no studies at all showing a connection between thimerosal in nasal sprays and autism. As indicated above, in the discussion of defendants’ Daubert motion, Dr. Geier is not qualified by training or experience to express an opinion as to what caused A[…]‘s autism, because he is not qualified in any of the relevant disciplines. Moreover, since there is no evidence that there is any medical consensus as to what causes autism in general, Dr. Geier’s opinions cannot be used to show that A[…]‘s autism was caused by the Ayr Saline Nasal Mist.

“Plaintiff… cannot show injury/causation — thus, there was nothing to conceal or warn about… Moreover, general questions regarding the hazards of mercury (such as those posed to Ascher) are not relevant to the present action. The issue on which plaintiff is required to produce evidence is whether Ayr Saline Nasal Mist, containing 0.00025% thimerosal, was dangerous. Plaintiff has not produced any such evidence…

Conclusion

“In accordance with the foregoing, the court GRANTS defendants’ motion to exclude expert testimony and motion for summary judgment. The trial date is VACATED. The clerk shall close the file.”
(Order Granting Motion for Summary Judgment)

The Emerging Case Law

The decision in Redfoot v. Ascher adds to a growing series of judicial analyses of the hypothesis that autism is caused by thimerosal poisoning; of the legal arguments advanced by those who seek to extract compensatory and punitive damages for harm alleged to have been caused by thimerosal-containing products; and of the qualifications of the insular coterie of “maverick scientists” and entrepreneurs who profess expertise on the subject of autism causation.

In Bothwell v. Abbott (Superior Court for the State of California, County of Los Angeles, Case JCCP 4246, issued May 16, 2003 by Judge Victoria Chaney), the court denied the plaintiffs’ demand for an injunction requiring defendants to change their FDA-approved labels, and found that federal food and drug regulations preempt any state laws that might conflict with them.

In Doe v. Ortho-Clinical Diagnostics (U.S. Court for the Middle District of North Carolina, Case 1:03CV00669, issued July 6, 2006 by Judge James Beaty), the court excluded the testimony of Mark Geier, Boyd Haley and George Lucier, finding that most of the subjects about which they sought to testify were beyond the scope of their training and expertise. “This Court must find more than the ‘hypothesis and speculation,’ engaged in by Dr. Geier in this instance, in order to allow Dr. Geier to rely upon the methodology he used in forming a conclusion based upon his review of the literature presented to the Court. In any event, Dr. Geier’s conclusion in this matter is not supported even by the literature he presented to the Court… Dr. Geier was not specifically qualified to perform a differential diagnosis of a pediatric neurological disorder, and… he did not properly perform the differential diagnosis given his failure to consider within his analysis the high probability that an unknown genetic cause cannot be ruled out as the specific cause of Minor Child Doe’s autism.”

The FDA Response to Citizen Petition by the Coalition on Mercury-Free Drugs (FDA Docket Number CP2004P-0439/CP1, issued September 27, 2006 by Dr. Jeffrey Shuren, M.D., J.D., Assistant Commission for Policy, FDA), includes an extensive examination of the scientific evidence offered in support of the hypothesis that thimerosal causes developmental disabilities. Addressing the petitioners, Shuren concluded that, “the studies and other documents on which you rely do not support your argument that FDA should take action against biologics and other drugs that contain thimerosal. Only a small number of licensed and approved products still contain thimerosal, and the available evidence supports FDA’s conclusion that all currently licensed vaccines and other pharmaceutical drug products containing thimerosal are safe.”

In Sykes v. Glaxo (U.S. Court for the Eastern District of Pennsylvania, Case 06-1111, issued March 28, 2007 by Judge Lawrence F. Stengel), the court ruled that manufacturers cannot be held liable for failure to add to their labeling “unsubstantiated risk information that the FDA has considered and rejected,” and rejected the plaintiffs’ claims of wrongdoing; these claims were unspecific, unsupported by evidence, and contradicted by evidence that that the defendants fully disclosed ingredients of their products throughout the licensing process.

“Test Case #2” in the Omnibus Autism Proceeding is scheduled to be heard before the end of 2007. Names remaining on the OAP plaintiffs’ expert witness list include David Baskin, Richard Deth, Mary Megson, Elizabeth Mumper, James Woods, Boyd Haley, and Mark Geier.

New Citations & Absent Information

Redfoot v. Ascher appears to be the first case in which Dr. Geier’s reports of research on vulnerable human subjects — i.e., autistic children — have been offered as legal evidence of his claimed expertise on autism causation and treatment, and as authorities upon which scientists and the court might rely. A Clinical and Laboratory Evaluation of Methionine Cycle-Transsulfuration and Androgen Pathway Markers in Children with Autistic Disorders, A Prospective Assessment of Porphyrins in Autistic Disorders, and A Clinical Trial of Combined Anti-Androgen and Anti-Heavy Metal Therapy in Autistic Disorders were appended to the Plaintiff’s Response to Defendants’ Motion to Preclude the Testimony of Plaintiff’s Expert Witnesses, and were cited in his expert report. That report also cited, A Case Series of Children With Apparent Mercury Toxic Encephalopathies Manifesting With Clinical Symptoms of Regressive Autistic Disorders, then in-press.

None of these studies discloses whether any research subjects are also plaintiffs in litigation in which Dr. Geier serves as an expert witness.

Inexplicably missing from Dr. Geier’s December 2006 resume is any mention of his role as founder, President and principal researcher of the “Institute for Chronic Illnesses,” which was incorporated in September 2005, is headquartered in his suburban Maryland home, and is identified in his reports as the institutional sponsor of his human subjects research, which commenced in November 2004. Neither is there any mention of his role as President of the in-house Institutional Review Board which reviewed and approved that research after the IRB’s March 2006 registration with the Office of Human Research Protections.

The resume also makes no reference to Dr. Geier’s applications to patent the “Lupron protocol,” or to his relationship as co-applicant with TAP Pharmaceuticals on the World Intellectual Property Organization application.

Opportunism and Opportunity

In his expert report, Dr. Geier claimed that in the “past several years” he has “evaluated and treated several hundred patients with autistic disorders” — barely two years after admitting (in his deposition in the case Easter v. American Home Products) that prior to November 2004 he had no experience in the evaluation and treatment of autistic children. Considering Judge Hamilton’s finding that “there is no evidence that Dr. Geier has either the training or the background to diagnose autism or to treat autism in any child,” the methods by which he has managed to acquire such a generous caseload of disabled patients and such a newfound abundance of blood and data for his studies in such a short period of time are certainly worthy of judicial scrutiny.

With consideration of the first thimerosal test case in the Omnibus Autism Proceeding scheduled for the coming months, with Sykes v. Glaxo under appeal, with dozens of other thimerosal lawsuits wending their way through U.S. courts, and with thimerosal plaintiffs and their allies continuing to petition the FDA to adopt their dubious hypotheses, more opportunities for such scrutiny abound. Here’s hoping that a few members of the bench will rise to the occasion.

Comments


  1. Great investigative reporting. It is criminally negligent that the justice system has allowed these two to continue castrating children. I do hope they appear in court very soon to answer to their crimes.

    Maybe they can share a bunk, just like at home.

    — Tom    Sep 7, 12:56 PM    #

  2. Another good slapdown.

    I don’t even understand at this point why a plaintiff would want to support their case with Geier & Geier’s work.

    — Joseph    Sep 7, 04:33 PM    #

  3. That was some very interesting reading Kathleen. Thanks for putting it all together in one place and for clipping the highlights.

    — notmercury    Sep 7, 04:42 PM    #

  4. Bravo!
    But what happens to the children after the court cases. Do they continue to suffer “treatment” from the discredited doctors whose testimony was rejected?

    — mike stanton    Sep 7, 06:42 PM    #

  5. I'm sure that in many cases the answer is Yes. People don't readily abandon their heroes, or their convictions, even if their heroes have failed them and even if the bases for their convictions have been shown to be false.

    — Kathleen Seidel    Sep 7, 06:49 PM    #

  6. You must submit a version of this to a legal journal. More people need to know about it.

    — isles    Sep 7, 08:57 PM    #

  7. That’s the puzzle – hundreds apparently, of autistic kids being castrated and chelated, either of which should be classified as child endangerment and nobody is doing anything. Why not?

    I’ve thought that Geier, while lacking expertise in many areas seems to be a master in finding the gaps in oversight and accountability.

    Isles has it right – this needs to go to a legal journal. If child protection services can’t or won’t do anything, perhaps some civic minded legal eagles can step up to the plate.

    — Alyric    Sep 8, 08:31 AM    #

  8. I could almost feel sorry for Geier, dismissed by so many courts as being “unqualified” and “unreliable”. Ordinary people might hang up their shingles and hang their heads in shame, but not him, not as long as there’s a buck to be made from frantic parents desperate to “cure” their children, and also receive a large settlement in the bargain!

    I’m always amazed at how thoroughly you research and reference any topic you write about. Here’s hoping it reaches the right people.

    — Clay    Sep 8, 04:55 PM    #

  9. I salute you, Kathleen, and hope that your work is recognized on wider scale someday soon. Thank you.

    — Bink    Sep 8, 06:49 PM    #

  10. Amazing work, as usual. I have to wonder if these guys are hearing reality nipping at their well-heeled heels. On the other hand, the judge gave them a major dose of reality with a stinging slap right across their collective kisser.

    — Bartholomew Cubbins    Sep 8, 07:03 PM    #

  11. Hello Everyone! I’m one of those idiot parents who believes all the quack doctors. And guess what? Eighteen months of IV chelation has changed my son’s life. (And, no, he’s not dead.) Oh wait, I guess kids just sometimes lose their autism naturally…

    — Dad    Sep 10, 01:24 PM    #

  12. Edited for reality: “Eighteen months” “has changed my son’s life.”

    — Bartholomew Cubbins    Sep 10, 08:24 PM    #

  13. ‘Dad’ said: “Oh wait, I guess kids just sometimes lose their autism naturally…”
    No, they don’t. However, as BC pointed out, 18 months is a long time for a child to develop and progress naturally—without quack remedies.
    You should see my son, who is truly amazing and has never been chelated… I would not have imagined how far he would come in just a few short years.
    Great post Kathleen, as usual.

    — Soapy    Sep 11, 10:13 PM    #

  14. The reality, BC, is that my son’s receptive and expressive language skills improved only slightly during the 18 month period prior to chelation.

    — Dad    Sep 13, 12:38 PM    #

  15. Ironic title, “gatekeeping”...
    Nine months have changed my son’s life. Clay chelation and bio-available vitamins & minerals cleaned then restored his system, and he’s back to where he was before he severely regressed after a flu shot. We are now gaining ground so furiously, I’m Googleing “Aspergers” for orientation and finding this “neurodiversity”.
    Really, people?
    Mercury will restrict functional organization of effective connectivity do to the shrinking of the Corpus callosum that’s limitedly protected by children’s immature blood-brain barrier. Promote selective myelination with specific tasks to regain lost time. Don’t kid yourselves.

    — Norcal Mom    Sep 27, 02:54 PM    #