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|Suit Claiming Thimerosal-Autism Connection Dismissed, 6/9/2007|
|A federal district court has dismissed a product liability suit against the manufacturer and a distributor of Ayr Saline Nasal Mist, which contains a tiny amount of the mercury-containing preservative thimerosal. The suit was filed by a parent and her autistic son who alleged that the boy's autism was caused by three or four years of daily use of the spray. The expert evidence they offered was from geneticist Mark R. Geier, M.D., Ph.D., whose professional activity is centered around the claim that mercury-containing vaccines are a major cause of autism. In a motion for summary judgment, the defendants argued that the plaintiffs had no reliable evidence to support their allegation the spray was generally capable of causing autism or had caused the boy's autism and that Geier's report should be excluded. The judge agreed. Calling Geier "unreliable," the judge said that Geier's differential diagnosis was faulty because "he failed to consider one specific alternative explanation – that the cause of autism is not known today." The judge also noted: "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."|
BFA and Kolmar now seek an order excluding the testimony of plaintiff’s expert Dr. Mark Geier, as well as the testimony of plaintiff’s “non-retained” experts, Dr. James Bradstreet, Dr. George W. Lucier, Dr. Boyd Haley, and Dr. Arthur Krigsman.
Defendants also seek an order precluding Drs. Haley, Bradstreet, and Krigsman from offering any opinions in the areas of epidemiology, genetics, neurology, or toxicology; precluding Dr. Geier from offering any opinion in the areas of epidemiology, neurology, or toxicology; and precluding Dr. Lucier from offering any opinion in the areas of epidemiology, neurology, or genetics.
a. Dr. Geier
Dr. Geier is a medical doctor, with a Ph.D. in genetics. He specializes in obstetrical genetics, and is board-certified in medical genetics and forensic medicine. He worked as a researcher at the NIH for ten years, and was a professor at Johns Hopkins University. He is president of his own company – Genetic Centers of America – and has been in clinical practice for more than 25 years.
In addition, Dr. Geier has studied vaccines for more than 30 years, and has published numerous scientific/medical papers on vaccine safety, efficacy, contamination, and policy. He has been invited to make presentations to the IOM and other scientific bodies regarding adverse consequences of vaccines.
Dr. Geier is plaintiff’s sole causation expert. In his report, he offers opinions regarding both general and specific causation. First, based on a review of scientific literature and on twelve of his own published studies 9 (plus four studies unpublished as of the date of his report), he asserts that the mercury in thimerosal causes neurological damage, including the development of autistic disorders in children. Second, based on his examination and testing of Alexander, he contends that Alexander suffers from a neurodevelopmental disorder – “the apparent result of a toxic encephalopathy” – and that Alexander presents with “clinical symptoms consistent with a DSMIV criteria autistic disorder;” that the toxic encephalopathy was “significantly contributed to by mercury exposure from the himerosal-containing nasal spray he was administered;” that Alexander has biochemical and genomic markers indicating “heightened sensitivity to mercury;” and that he has laboratory test results consistent with “increased mercury.”
9Geier, D.A. & Geier, M.R. (2003a), “An Assessment of the Impact of Thimerosal on Childhood Neurodevelopmental Disorders,” 6 Pediatr. Rehabil. 97-102 (2003); Geier, M.R. & Geier, D.A. (2003b), “Thimerosal in Childhood Vaccines, Neurodevelopmental Disorders, and Heart Disease in the United States,” 8 J. Am. Phys. Surg. 6-11 (2003); Geier, M.R. & Geier D.A. (2003c), “Neurodevelopmental Disorders after Thimerosal-Containing Vaccines: A Brief Communication,” 228 Exp. Biol. Med. (Maywood) 660-64 (2003); Geier, M.R. & Geier, D.A. (2004a), “A Review of the Vaccine Adverse Event Reporting System Database,” 5 Expert Opin. Pharmacother 691-98 (2004); Geier, D.A. & Geier, M.R. (2004b), “Neurodevelopmental Disorders following Thimerosal-Containing Childhood Immunizations: A Follow-up Analysis,” 23 Int. J. Toxicol. 369-76 (2004); Geier, D.A. & Geier, M.R. (2005(a), “A Two-phased Population Epidemiological Study of the Safety of Thimerosal-Containing Vaccines: A Followup Analysis,” 11 Med. Sci. Monit. CR 160-70 (2005); Geier, M.R. & Geier, D.A. (2005b), “The Potential Importance of Steroids in the Treatment of Autistic Spectrum Disorders and Other Disorders Involving Mercury Toxicity,” 64 Med. Hypotheses 946-54 (2005); Geier, D.A. & Geier, M.R. (2006a), “An Evaluation of the Effects of Thimerosal on Neurodevelopmental Disorders reported following DTP and Hib Vaccines in Comparison to DPTH Vaccine in the United States,” 69 J. Toxicol. Environ. Health A. 1481-95 (2006); Geier, D.A. & Geier, M.R. (2006b), “Early Downward Trends in Neurodevelopmental Disorders Following Removal of Thimerosal-Containing Vaccines.” 11 J. Am. Phys. Surg. 8-13 (2006); Geier, D.A. & Geier, M.R. (2006c), “An Assessment of Downward Trends in Neuro-developmental Disorders in the United States following the Removal of Thimerosal from Childhood Vaccines,” 12 Med. Sci. Monit. CR2310-19 (2006); Geier, D.A. & Geier, M.R. (2006d), “A Prospective Assessment of Porphyrins in Autistic Disorders: A Potential Marker for Heavy Metal Exposure,” 10 Neurotox. Res. 57-64 (2006); Geier, D.A. & Geier, M.R. (2006e), “A Clinical and Laboratory Evaluation of Methionine Cycle-transsulfuration and Androgen Pathway Markers in Children with Autistic Disorders,” 66 Horm. Res. 182-88 (2006).
Defendants argue that an analysis of Dr. Geier’s proposed testimony shows that it should be excluded under Rule 702. Defendants contend, first, that Dr. Geier lacks the requisite qualifications; second, that he employed unacceptable methodology; third, that the peer-reviewed literature contradicts Dr. Geier’s conclusions, and that his studies are not generally accepted; fourth, that Dr. Geier’s opinion testimony is not grounded in reliable epidemiological studies; and fifth, that Dr. Geier’s opinions were formulated for litigation, and demonstrate evidence of bias.
Defendants first argue that Dr. Geier is not qualified to provide an opinion regarding whether the mercury in thimerosal-containing nasal sprays causes autism, or regarding whether Alexander has autism or whether the thimerosal in Ayr Saline Nasal Mist caused him to develop autism. A witness can testify on the basis of knowledge, skill, experience, training, or education. Fed. R. Evid. 702. Defendants contend that Dr. Geier is not qualified to testify on the subjects as to which he offers his opinions because, while he is a medical doctor with a Ph.D in genetics, he is not board-certified in pediatrics or pediatric neurology, and is not certified as an epidemiologist, a biostatistician, or a toxicologist.
Plaintiff argues, however, that Dr. Geier is qualified to provide expert testimony regarding thimerosal, mercury, and autism. Plaintiff claims that Dr. Geier has studied vaccines for more than thirty years, and has published more than 50 peer-reviewed scientific/medical papers on vaccine safety, efficacy, contamination, and policy, including more than twelve articles dedicated to the issue of thimerosal, mercury, and neurological disorders, including autism. Plaintiff also asserts that Dr. Geier has been qualified as an expert witness in numerous courts to testify regarding thimerosal in vaccines.
Defendants’ second argument is that Dr. Geier did not employ acceptable methodology in arriving at his opinions. They contend that Dr. Geier’s review of the scientific literature does not establish that Ayr Saline Nasal Mist causes autism, and that Dr. Geier’s own studies have an unknown and indeterminate rate of error.
Defendants first note that Dr. Geier relied on a number of disparate and unconnected studies – including some by plaintiff’s “non-retained experts” Drs. Haley and Lucier – to support his conclusion that the undetermined but small amount of thimerosal received by Alexander could cause autism.
In a case brought in the Middle District of North Carolina, Doe v. Ortho-Clinical Diagnostics, Inc., 440 F.Supp. 2d 465 (M.D.N.C. 2006), the court granted the defendant’s motion to exclude Dr. Geier as an expert on the question whether a thimerosal-containing RH-factor immunoglobulin administered to the mother of a child (once before the birth of her child and once after) caused the child to develop autism. As in the present case, Dr. Geier based his opinion on a review of scientific literature, on his own studies, and on a differential diagnosis of the child.
With regard to the literature review, the court observed that Dr. Geier had “relied on a number of disparate and unconnected studies . . . to reach a piecemeal conclusion with respect to general causation,” and that his methodology “consisted of attempting to connect various individual studies.” Id. at 472-73. The court also found that Dr. Geier’s analysis, “based on his collective review of a motley assortment of diverse literature,” proved to be “overstated.” Id. at 473-74.
As did the Doe court with respect to similar literature, see id. at 472-73 & nn. 6-13, defendants argue Dr. Geier has attempted to cobble together a theory of causation based on disparate studies in which the researchers found, for example, that mercury exposure may destroy neurons;10 that high levels of pre-natal methylmercury may cause developmental defects;11 that methylmercury can be transmitted through a mother’s milk to her child;10 that thimerosal can cross blood-brain and placental barriers at doses of 1000 micrograms of thimerosal;11 that direct and multiple injections of 50,000 micrograms of thimerosal can kill or deform embryonic chickens;12 that a mouse model exposed to thimerosal mimicking a childhood immunization schedule developed symptoms allegedly similar to autism;11 that thimerosal-containing vaccines may cause a novel form of mercury poisoning in some children;12 and that a study of hair of children with autism showed a statistically significant correlation between RhoD (RH-factor) immunoglobulin administration and autism.13 Defendants contend that these disconnected studies do not add up to the opinion Dr. Geier is offering.
As for Dr. Geier’s own studies, defendants argue that Dr. Geier employed a flawed methodology. They note that the IOM, in its 2004 Report, discussed five of Dr. Geier’s studies (including the three studies identified in note 9, above, as Geier 2003a, 2003b, and 2003c) and two reports presented by Dr. Geier to the IOM in 2004. Among other things, the Committee found that Dr. Geier’s studies lacked a complete and transparent description of their methods and underlying data – noting in particular that Dr. Geier had provided no information on specification of regression models, had not provided the frequency distribution of variables, and had not clearly reported calculations of statistics. As a result of these deficiencies, the Committee found the results of the studies to be “improbable,” “uninterpretable,” and “noncontributory with respect to causality.”
In opposition, plaintiff contends that Dr. Geier’s reliable and peer-reviewed epidemiological studies support general causation – i.e., that exposure to thimerosal, generally, is a cause of autism.
In their third argument, defendants contend that Dr. Geier’s studies are not generally accepted in the scientific community, and that the peer-reviewed literature flatly contradicts Dr. Geier’s conclusions. Dr. Geier has published14 a number of articles purporting to find a statistically significant link between thimerosal-containing vaccines and autism. These studies utilize data from the Vaccine Adverse Event Reporting System (“VAERS”) database and/or the Department of Education (“DOE”) database. Dr. Geier has also performed an analysis of Vaccine Safety Datalink (“VSD”) data. Defendants argue that these databases do not contain sufficient or appropriate data to test a hypothesized association between thimerosal-containing vaccines and autism, and that Dr. Geier’s studies are therefore methodologically unsound.
14Defendants do not contest that Dr. Geier’s articles have appeared in numerous journals, but they do claim, based on the statements by one of their experts (Dr. Rodier), that some of the journals in which Dr. Geier’s studies have been published are “weak” journals, not widely read in the scientific community. For example, they assert that Medical Hypotheses is not peer-reviewed for science content, but rather offers a forum for “radical ideas” that “conflict with current theory and practice” (citing from the journal’s website). They also claim that it is not widely read. They contend that Journal of American Physicians and Surgeons is a political journal dealing with the rights of physicians in private practice, and is not indexed in PubMed or in Journal Citations Reports. They claim that the Medical Science Monitor is indexed by PubMed but not by Journal Citation Reports, and is an obscure journal published in Poland. They assert that Journal of the History of Medicine and Allied Science is a history journal, not widely read. They contend that no scientist, by choice, would submit his study for publication in a journal that is not widely read.
|Maryland Medical Board Suspends theLicense of John L. Young, M.D., 19/9/2013|
|From 1980 through April 2011, Young had partnered with Mark A. Geier, M.D., in medical practice.|
In April 2011, the board had summarily suspended Geier's license after concluding that he was inappropriately administering Lupron and chelation therapy to autistic children whom he failed to examine and monitor adequately. In 2012, Geier's license was revoked.
Young obtained a pharmacy dispensing permit so he could take over the care of many of Geier's patients, and he admitted that some prescriptions were based on recommendations made by Geier after he was suspended. Young also obtained licenses in other states in which clinics owned by Geier existed.
3. From 1980 until April 2011, the Respondent had been medical practice partners with Mark R. Geier, M.D.
4. The Board initiated an investigation of the Respondent based upon concerns regarding his practice subsequent to the Board's summary suspension and revocation of Dr. Geier's license to practice medicine in Maryland.
Dr. Mark Geier
Effective April 27, 2011, the Board summarily suspended Dr. Geier having concluded that the public health, safety or welfare imperatively required such emergency action. State Gov't § 10-226(c)(2). The Board suspended Dr. Geier after concluding that his practice of administering Lupron, 2 a powerful antiÂandrogen, and chelation to autistic children whom he failed to examine and monitor adequately raised a substantial likelihood of risk of serious harm to the public health, safety or welfare.
2The trade name of leuprolide acetate. Dr. Geier's Lupron treatment regimen consisted of daily subcutaneous ("SQ") injections of Lupron (typically indicated on prescriptions as "Ieuprolide acetate solution") and bi-weekly intramuscular ("1M") injections of Lupron (typically indicated on prescriptions as "Lupron Pediatric Depot"). When interviewed by Board staff, the Respondent stated that Lupron is a longÂacting form of the medication and leuprolide is the short-acting version.
On May 12, 2011, the Board reaffirmed Dr. Geier's summary suspension, subject to his right to request a full evidentiary hearing before an Administrative Law Judge (UALJ") of the Office of Administrative Hearings (UOAH").
8. By Final Decision and Order dated March 22, 2012, the Board ordered Dr. Geier's Summary Suspension to be upheld pending resolution of charges that Dr. Geier had violated the Maryland Medical Practice Act. In the Final Decision and Order, the Board held:
The ALJ concluded that 'allowing to continue practicing medicine while formal charges are pending raises a substantial likelihood of risk of serious harm to the public health, safety, or welfare.' The Board entirely agrees. For Dr. Geier to practice medicine at this time would constitute a danger to the patient community.
On May 16, 2011, the Board charged Dr. Geier with numerous violations of the Medical Practice Act related, inter alia, to his administration of Lupron and chelation to autistic children in the absence of proper evaluation and monitoring. On March 12, 2012, after a five-day evidentiary hearing, the ALJ concluded that Dr. Geier had violated the standard of quality care as well as other provisions of the Maryland Medical Practice Act.
On August 22, 2012, the Board issued its Final Decision and Order in which Dr. Geier's license to practice medicine in Maryland was revoked.
With regard to Dr. Geier's administration of Lupron to autistic children, the Board held in pertinent part:
The ALJ made findings that Lupron therapy may have been medically beneficial. (citation omitted) These findings are questionable, in the Board's opinion, because Dr. Geier did not even properly evaluate whether the treatment was effective. The ALJ made these findings about the effectiveness of Lupron therapy primarily based on the testimony of the parents, but the testimony was unsupported by any adequate documentation in the medical records. (Footnote omitted) The Board does not believe that this is the appropriate methodology to evaluate the possible effectiveness of Lupron. (Footnote omitted) Nor does the Board adopt the ALJ's findings that determining the Tanner Stage of these patients was irrelevant. (Footnote omitted) ... The evidence of the safety of this treatment was, in the Board's opinion, insufficient to justify the dismissal of this serious concern. However, it is not necessary to make finding on the value of this off-label use of Lupron ... because Dr. Geier in any case egregiously violated basic medical standards in his treatment of these patients by not evaluating them properly ... and failing to evaluate in any realistic medical way whether his intensive and very expensive treatment was effective.
By failing to properly evaluate patients before treating them with an intensive regimen of drug therapy by failing to properly evaluate Â whether his treatment was working Dr. Geier failed to meet the standard of quality care
By failing to document adequately the reasons these treatments were initiated, halted or modified, by failing to maintain clear evidence of informed consent, or even in some cases failing to document even the manner in which the patients were contacted, Dr. Geier failed to keep adequate medical records
The Board revoked Dr. Geier's medical license for reasons including the following:
Dr. Geier has displayed in this case an almost total disregard of basic medical and ethical standards by treating patients without examining or diagnosing them continuing treatment without properly evaluating its effectiveness ... Dr. Geier made little use of those methodologies that distinguish the practice of medicine as a profession. At the same time, he profited greatly from the minimal efforts he made for these patients. In plain words, Dr. Geier exploited these patients under the guise of providing competent medical treatment. Such a use of a medical license is anathema to the Board. The Board has no hesitation in revoking his medical license. (Footnote omitted)
4Some prescriptions written by the Respondent were dispensed from Dr. Geier's home address. The Respondent advised Board staff that he did not practice at that location.
|RhoGAM Autism Suit Dismissed after Judge Bars Testimony of Dr. Mark Geier, 11/7/2006|
|RhoGAM Autism Suit Dismissed after Judge Bars Testimony of Dr. Mark Geier|
Judge Bars Testimony of Dr. Mark Geier
When subjected to extensive cross-examination, Geier could not point to a single study that conclusively determined that any amount of mercury could cause the specific neurological disorder of autism.
Geier's conclusion that the peer-reviewed literature he has relied upon supports his theory that autism can be caused by thimerosal is flatly contradicted by all of the epidemiological studies available at this time.
Geier's testimony was excluded or accorded little or no weight in more than ten of the vaccine cases. In one case, the special master who presided over the case referred to him as "intellectually dishonest." In another case, the special master referred to him as "a professional witness in areas for which he has no training, expertise, and experience."
Plaintiffs John and Jane Doe 2 ("Plaintiffs") have initiated this lawsuit based upon their contention that the thimerosal in Defendant Ortho-Clinical Diagnostics, Inc.'s ("Ortho-Clinical" or "Defendant") biologic product RhoGAM caused their child's autism. This matter is presently before the Court on three motions: Defendant's Motion to Exclude All Testimony that Thimerosal-Containing RhoGAM Causes Autism (Document #63), Defendant's Motion to Exclude Plaintiffs' Expert Suzanne Parisian, M.D. (Document #65), and relatedly, Defendant's Motion for Summary Judgment (Document #94). The Court heard testimony concerning Defendant's motions to exclude witnesses for three days at the end of May 2006. Based upon the testimony at that hearing, the Court will grant Defendant's Motion to Exclude All Testimony that Thimerosal-Containing RhoGAM Causes Autism. More specifically, the focus of the Court's present Memorandum Opinion is the testimony of Plaintiffs' expert witness, Dr. Mark Geier. Dr. Geier was the only expert offered in this case by Plaintiffs who is designated to testify as to both general and specific causation. For the reasons given by the Court herein, Dr. Geier's testimony is specifically being excluded pursuant to Defendant's Motion to Exclude. As such, without Dr. Geier's testimony, Plaintiffs are unable to meet their burden to demonstrate that the thimerosal in Defendant's RhoGAM product caused Plaintiff Minor Child Doe 2' s autism, a result that leads directly to the failure of all of Plaintiffs' claims. Accordingly, for the reasons detailed below, the Court will also grant Defendant's Motion for Summary Judgment.
In order to prove their claims, Plaintiffs designated three experts on the question of whether thimerosal could cause autism: Dr. Mark Geier ("Geier"), Boyd Haley, Ph.D. ("Haley") and George Lucier, Ph.D. ("Lucier"). As a separate matter, Plaintiffs have designated a fourth expert, Dr. Suzanne Parisian, to testify about the FDA regulatory process as it relates to claims regarding negligent failure to warn and inadequate design. The Court conducted a Daubert hearing in this matter that included the testimony of Dr. Geier, as well as testimony from several of Defendant's experts who asserted that Dr. Geier's methodology that supports his proffered opinion on the causal connection, both general and specific causation, as it relates to the autism of Minor Child Doe, was flawed, as well as his conclusions in that regard.3
Footnote 3: At the hearing, Plaintiffs also made available expert reports from their other two experts, Dr. Haley and Dr. Lucier, as to the general causation question. The Court has appropriately taken this information into account, but nevertheless finds that Dr. Haley's report does not state an expert opinion that thimerosal causes autism, rather just that he has a theory, See Def. Apx. Tab 18, Dep. of Boyd Haley, at 190), about how such a thing could happen. At best, he expressed "strong belief" that the cause of "neurodevelopmental disorders in infants" is exposure to an organic-mercury compound such as thimerosal. (See Def. Apx. Tab. 14, Haley Expert Report, p. 5.) Additionally, Plaintiffs proffered the report of Dr. Lucier, who is an expert in methylmercury and not ethylmercury, which is the substance in RhoGAM. Dr. Lucier does not offer an opinion that methylmercury causes autism, but rather that it may cause "developmental disorders." Significantly, the Court notes that neither Dr. Haley nor Dr. Lucier asserts that he is an expert on autism nor are they offered as such. In any event, the Court finds that neither of the proffered reports of Dr. Haley nor Dr. Lucier are sufficiently reliable under Daubert on the general causation issue because neither is relevant to the "task at hand." It would be an unacceptable scientific leap to suggest that they serve as proof, by a preponderance of the evidence, of Plaintiff's claim that the thimerosal in RhoGAM can cause autism. See Dunn v. Sandoz pharma. Corp., 275 F. Supp. 2d 672,684 (M.D.N.C. 2003) ("While hypothesis is essential in the scientific community because it leads to advances in science, speculation in the courtroom cannot aid the fact finder in making a determination of whether liability exists. Ultimately, speculation is unreliable evidence and is inadmissible."). Accordingly, the majority of the Court's opinion is focused only on the testimony of Dr. Geier, Plaintiffs' primary general causation expert and single specific causation expert. Nevertheless, it is the Court's finding that the discussion and analysis herein regarding the relevant scientific literature applies equally to the proffered reports of Drs. Haley and Lucier, which also purport to survey the relevant literature in coming to their respective conclusions.
In this case, much, but not all, of Dr. Geier's proposed testimony is not based upon his own research, but instead upon a review of the relevant literature. Where proffered expert testimony is not based on independent research, but instead on such a literature review, the party proffering such testimony must "come forward with other objective, verifiable evidence that the testimony is based on 'scientifically valid principles.' One means of showing this is by proof that the research and analysis supporting the proffered conclusions have been subjected to normal scientific scrutiny through peer review and publication." Daubert II, 43 F.3d at 1318. Thus, the research Dr. Geier relied upon must itself be able to meet the Daubert test. The fact that a journal is peer-reviewed is a significant consideration. Id.
In addition to a consideration of the Daubert analysis, the Court notes that it must also distinguish in this case between Dr. Geier's proffered testimony as to both "general causation" and "specific causation." See. e.g., Dunn v. Sandoz Pharma. Corp., 275 F. Supp. 2d 672, 676 (M.D.N.C. 2003) (citing Reference Manual on Scientific Evidence 444 (2d ed. 2000)). On the one hand, "(g)eneral causation 'is established by demonstrating. . . that exposure to a substance can cause a particular disease.''' Id. "Specific, 'or individual causation, however(,) is established by demonstrating that a given exposure is the cause' of a particular individual's disease." Id. Where a "plaintiff is not able to establish general causation, it is unnecessary to consider whether the plaintiff can establish specific causation." Id.; see also Raynor v. Merrell pharma., 104 F .3d 1371, 1376 (D.C. Cir. 1997).
With these legal standards in mind, it was the Court's undertaking to determine whether Plaintiffs' evidence satisfied their burden of proof to show that their experts used proper scientific methodology in reaching their ultimate conclusion that Minor Child Doe's autism was caused by the thimerosal in Defendant's product RhoGAM. At the close of Plaintiffs' presentation at the Daubert hearing, Plaintiffs argued that their evidence would support such a conclusion. In response to Plaintiffs' position, Defendant challenged Plaintiffs' proffer by way of a cross examination of Plaintiffs' expert Dr. Geier and by offering its own experts to demonstrate that Plaintiffs' experts used unsound methodology or otherwise failed to follow sound protocol. Having closely considered the evidence and arguments both by Plaintiffs and Defendant, the Court has made a number of findings with respect to the testimony by Plaintiffs' primary expert Dr. Geier. These findings form the basis of the Court's ultimate conclusion that Plaintiffs have not met their burden under the Daubert analysis.
III. ANALYSIS OF DAUBERT AS APPLIED TO DR. MARK GEIER
As initial background information with respect to the qualifications of Dr. Geier, the Court notes that he is the president of his own company, The Genetic Centers of America. He is a medical doctor who specializes in obstetrical genetics with a Ph.D. as well in genetics. He is board certified in medical genetics and forensic medicine. However, it is significant to the Court that he is not board certified in pediatrics or in pediatric neurology, nor is he certified as an epidemiologist or biostatistician. Dr. Geier did serve as a researcher at the National Institutes of Health for 10 years and worked as a professor at John Hopkins University. While he has published more than 50 peer-reviewed medical papers, none of these prior publications were on the specific issue at hand, that is, whether RhoGAM with thimerosal causes autism. The Court has taken into account, as well, the fact that Dr. Geier has testified as an expert witness in about one hundred cases before the National Vaccine Injury Compensation Program of the United States Court of Federal Claims. It is noteworthy that in more than ten of these cases, particularly in some of the more recent cases, Dr. Geier's opinion testimony has either been excluded or accorded little or no weight based upon a determination that he was testifying beyond his expertise.5 In this case, subject to the Court's Daubert analysis, Dr. Geier's testimony is being offered by Plaintiffs for presentation at trial to support Dr. Geier's ultimate conclusion that the thimerosal in RhoGAM caused Minor Child Doe's autism. However, appropriately under Daubert, the Court's focus, principally, is on the acceptability of the methodology by which Dr. Geier reached his ultimate conclusion. The specific methodology at issue here is Dr. Geier's method of using (1) a review of the relevant literature and his own studies as related to the incidence of autism, so as to support a general causation theory, and furthermore, (2) his use of a differential diagnosis of Minor Child Doe, so as to establish specific causation with respect to Minor Child Doe's own condition. The Court will address each of these areas in turn.
Footnote 5: See. e.g., Piscopo v. Sec'y of HHS, 66 Fed. Cl. 49, 55 (May 26, 2005) (approving Dr. Geier's exclusion under Daubert because his training is in genetics and obstetrics, which is "largely irrelevant to the expertise needed to establish a causal relationship between the Hepatitis B vaccine and the petitioner's autoimmune disorder"); Weiss v. Sec'y of HHS, No. 03-190V, 2003 WL 22853059 (Fed. Cl. Oct. 9, 2003) (finding Dr. Geier is a "professional witness in areas for which he has no training, expertise, and experience"); Thompson v. Sec'y of HHS, No. 99-436V, 2003 WL 21439672 (Fed. Cl. May 23, 2003) (finding Dr. Geier was not qualified because his causation theory was filed with "speculation that is directly contrary to the conclusions reached in well-respected and numerous epidemiologic and medical studies ranging over two decades"); Bruesewitz v. Sec'y of HHS, No. 95-0266V, 2002 WL 31965744 (Fed. Cl. Dec. 20, 2002) (finding Dr. Geier unqualified to diagnose neurological diseases); Rai v. Sec'y of HHS, No. 96-294V, 2001 WL 963984 (Fed. Cl. July 31, 2001) (finding Dr. Geier "wholly unqualified to testify concerning the two major issues in this case (encephalopathy and infantile spasms) . . . because he is neither board certified nor has formal training in pediatrics and pediatric neurology"); Haim v. Sec'y of HHS, No. 90-1031V, 1993 WL 346392 (Fed. Cl. Aug. 27, 1993) (finding that Dr. Geier's testimony did not reach "the level of evidentiary reliability that Daubert requires because it is not based upon scientific validity, valid methodology, peer review or testing, and more than minimal support within the scientific community"); Marascalco v. Sec'y of HHS, No. 90-1571 V, 1993 WL 277095 (Fed. Cl. July 9,1993) (finding Dr. Geier's testimony "intellectually dishonest" and that his affidavit was "nothing more than an egregious example of blatant, result-oriented testimony").
Plaintiffs point to a number of cases in which Dr. Geier was apparently able to give his opinion as to causation in vaccine cases. However, the Court finds that the majority of cases cited in Plaintiffs' Response concern testimony by Dr. Geier on vaccine issues prior to 1995. Plaintiffs, however, do not assert that any of these cases or any previous testimony by Dr. Geier concern or even address the issue of whether thimerosal in RhoGAM causes autism.
A. Dr. Geier's Review of Literature Concerning Whether RhoGAM Causes Autism
In examining Dr. Geier's methodology, the Court notes that, in fact, a literature review can be an appropriate part of a method of determining general causation. See. e.g. Benedi v. McNeil-P.P.C.. Inc., 66 F.3d 1378, 1384 (4th Cir. 1995) (allowing an expert opinion based upon patient history, examination, lab and pathology data, and a study of the peer-reviewed literature). However, a literature review must still be performed appropriately. As revealed by his testimony at the Daubert hearing, Dr. Geier, however, relied upon a number of disparate and unconnected studies, including the findings of Dr. Haley and Dr. Lucier, to reach a piecemeal conclusion with respect to general causation that the small amount of thimerosal received in this case by the mother of Minor Child Doe during the course of her pregnancy and shortly after the child's birth, could cause autism. Dr. Geier's methodology consisted of attempting to connect various individual studies that had developed the existence of certain findings such as the following: (1) mercury exposure could destroy neurons6; (2) high levels of methylmercury exposure may cause developmental defects in children (Faroe Islanders study7and Iraq study8); (3) mercury can be transmitted through a mother's milk to her suckling child (Iraq study); (4) thimerosal can cross the blood-brain and placental barriers9 (this study considered doses of 1,000 micrograms of thimerosal, whereas the product RhoGAM has only about 10 micrograms of thimerosal); (5) direct and multiple (6x) injections of 50 milligrams of thimerosal can kill or deform embryonic chickens10; (6) topical use of thimerosal as an antimicrobial by pregnant women may have caused birth defects11(7) a mouse model exposed to thimerosal in a way mimicking a childhood immunization schedule developed physical, psychological, and pathological symptoms similar to autism12; and (8) a hair study of children with autism showed a statistically significant correlation between Rho D immunoglobulin administration and autism (Holmes study).13 Thus, on its face, all these study results, when pieced together, would seem to support Plaintiffs' general causation theory, as offered by Dr. Geier, that RhoGAM could cause autism.
Footnote 15: The Court notes that Dr. Geier also exhibited some bias against health agencies that have criticized his methodology on other issues to such an extent that he has publicly accused the Centers for Disease Control ("CDC"), the World Health Organization, the American Academy of Pediatrics, and the National Academy of Sciences of deceiving the American public as to the dangers of mercury and specifically called the CDC a "rogue organization." (Def. Apx. Tab 15, Transcript of Videotape Deposition of Dr. Mark R. Geier in Civil Action No. 5:03-CV- 141, E.D. Tex. 2004.)
|Dr. Mark Geier Severely Criticized, 11/7/2012|
|Dr. Mark Geier Severely Criticized|
Dr. Mark Geier Severely Criticized
Mark R. Geier, M.D., Ph.D., is president of Genetic Centers of America. He has been a consultant and expert witness in many cases presented to the National Vaccine Injury Compensation Program and in civil litigation. In publications and testimony, he suggests that the thimerosal in vaccines is a cause of autism. His son David A. Geier is president of MedCon, a medical–legal consulting firm that helps vaccine injury claimants to try to obtain funds from both the National Vaccine Injury Compensation Program and through civil litigation.
In 2003, a special master who presided over a case of alleged vaccine injury issued a report that severely criticized Dr. Geier's analysis of a case. The ruling is especially noteworthy because the special master referred to him as "a professional witness in areas for which he has no training, expertise, and experience" and listed nine other cases in which Geier's expert testimony was given "no weight."
In 2004, Geier was ordered to stop a research project because of alleged improprieties in data collection .
In 2011, t he Maryland State Board of Physicians summarily suspended Geier's medical license. The emergency suspension order stated that he misrepresented his credentials, operated an institutional review board that did not meet state and federal regulations, and rendered substandard care to nine autistic patients. In six of the patients, the board charged, he inappropriately diagnosed precocious puberty (a rare condition) and administered Lupron, a drug that reduces the body's production of the male hormone testosteroneand is used to castrate sex offenders. In three of the patients, he administered inappropriate chelation therapy. The emergency order was subsequently upheld and the nine other states in which he was licensed suspended his license pending resolution of the Maryland charges. In 2012, Maryland charged him with violating its emergency suspension order.
After receiving petitioners' expert Dr. Mark Robin Geier's two affidavits, the undersigned issues this preliminary ruling. The evidence in the medical records contemporaneous with the events at issue in this case show that Christopher Weiss did not have an acute encephalopathy on January 25, 2000, which was the 15th day after he received MMR vaccine on January 10, 2000. The records state that he had had fever on the night of the 24th, cried a lot, had a temperature of 101°, or otherwise less than100.2°, and was teething. On physical examination, Christopher was alert and in no acute distress. His temperature was 100.7° and he had several new teeth. His left tympanic membrane was red with excessive fluid. The doctor diagnosed Christopher with left otitis media. He had several tiny white spots at the bottom of his jaw (gingiva) and was prescribed Amoxicillin.
Dr. Geier, who is a geneticist and an obstetrician, is not qualified to give a neurological diagnosis.
Footnote: It is doubtful that Dr. Geier fulfills the American Medical Association (AMA) guidelines for expert witnesses: H.265-994 Expert Witness Testimony: (3)(a) "Existing policy regarding the competency of expert witnesses ... (BOT Rep. SS A-89) is reaffirmed, as follows: The AMA believes that the minimum statutory requirements for qualification as an expert witness should reflect the following: (i) that the witness be required to have comparable education, training, and occupational experience in the same field as the defendant; (ii) that the occupational experience include active medical practice or teaching experience in the same field as the defendant; and (iii) that the active medical practice or teaching experience must have been within five years of the date of the occurrence giving rise to the claim." American Medical Association, Policy Compendium (1999). In addition, the AMA "Code of Medical Ethics" states at 9.07 Medical Testimony: "Medical experts should have recent and substantive experience in the area in which they testify and should limit testimony to their sphere of medical expertise .... The medical witness must not become an advocate or a partisan in the legal proceeding." AMA Council on Ethical and Judicial Affairs, "Code of Medical Ethics" (2002-2003 edition). Dr. Geier's expertise, training, and experience is in genetics and obstetrics. He is however a professional witness in areas for which he has no training, expertise, and experience. Petitioners must seriously consider whether they want to proceed with a witness whose opinion on neurological diagnosis is unacceptable to the undersigned. When we reach the end of this case and the question of expert fees arises, there will be serious doubt whether Dr. Geier should be compensated for his time devoted to diagnosing an acute encephalopathy where none exists, and discussing (in his first supplemental affidavit) the MMR reactions of acute encephalopathy and encephalitis when neither is relevant in this case because Christopher, who was alert and in no acute distress on the 15th day after his MMR vaccination (when Dr. Geier opines his acute encephalopathy began on the 14th day, less than 24 hours earlier), could not possibly have had a Table acute encephalopathy or encephalitis. Moreover, three days later, he was also alert and in no acute distress. He was, however, miserable on January 25th with left otitis media, a fever, and new teeth, and on January 28th with a blister on his tongue and very red gums (with three new teeth).
In other vaccine cases, Dr. Geier's testimony has similarly been accorded no weight: Thompson v. Secretary of HHS, No. 99-0436,2003 WL 221439672 (Fed. Cl. Spec. Mstr. May 23, 2003); Bruesewitz v. Secretary of HHS, No. 95-0266,2002 WL 3 1965744 (Fed. Cl. Spec. Mstr. Dec. 20,2002); Raj v. Secretary of HHS, No. 96-0294V, 2001 WL 963984, * 12 (Fed. Cl. Spec. Mstr. July 3 1,2001); Haim v. Secretary of HHS, No. 90-1 03 lV, 1993 WL 346392 (Fed. Cl. Spec. Mstr. Aug. 27, 1993) ("Dr Geier's testimony is not reliable, or grounded in scientific methodology and procedure. His testimony is merely subjective belief and unsupported speculation."); Marascalco v. Secretary of HHS, No. 90-1571V, 1993 WL 277095 (Fed. Cl. Spec. Mstr. July 9, 1993) (where the special master described Dr. Geier's testimony as intellectually dishonest); Einspahr v. Secretary of HHS, No. 90-923V, 1992 WL 336396 (Cl. Ct. Spec. Mstr. Oct. 28, 19921, a, 17 F.3d 1444 (Fed. Cir. 1994); Aldridge v . Secretary of HHS, No. 90-2475V, 1992 WL 153770 (Cl. Ct. Spec. Mstr. June 11,1992); Ormechea v. Secretary of HHS, No. 90-1 683V, 1992 WL 15 18 16 (Cl. Ct. Spec. Mstr. June 10, 1992) ("Because Dr. Geier has made a profession of testifying in matters to which his professional background (obstetrics, genetics) is unrelated, his testimony is of limited value to the court."); Daly v. Secretary of HHS, No. 90-590V, 1991 WL 15473 (Cl. Ct. Spec. Mstr. July 26, 1991) ("The court is inclined not to allow Dr. Geier to testify before it on issues of Table injuries. Dr. Geier clearly lacks the expertise to evaluate the symptomatology of the Table injuries and render an opinion thereon.").
|Maryland Medical Board Suspends Dr. Mark Geier's License, 15/10/2012|
|Maryland Medical Board Suspends Dr. Mark Geier's License|
Dr. Mark Geier's License
The Maryland State Board of Physicians has summarily suspended the license of Mark R. Geier, M.D. The emergency suspension order (shown below) states that he misrepresented his credentials, operated an institutional review board that did not meet state and federal regulations, and rendered substandard care to nine autistic patients. In six of the patients, the board charges, he inappropriately diagnosed precocious puberty (a rare condition) and administered Lupron, a drug that reduces the body's production of the male hormone testosteroneand is used to castrate sex offenders. In three of the patients, he administered inappropriate chelation therapy. The emergency order was subsequently upheld and the nine other states in which Geier was licensed suspended his license pending resolution of the Maryland charges. In 2012, Maryland charged him with violating its emergency suspension order.
Geier practiced under the name ASD Centers LLC," a chain of clinics that offered "a new combined genetic, biochemical, heavy metal, and hormonal evaluation/treatment for patients diagnosed with autism spectrum disorder (ASD)." The advertising also claimed that evaluations of more than 600 ASD patients had revealed that most had symptoms and laboratory results consistent with high levels of male hormones. Several experts have denounced Geier's use of Lupron to treat autistic children.
MARK R. GEIER, M.D.
The Maryland State Board of Physicians (the "Board") hereby SUMMARILY SUSPENDS the license of Mark R. Geier, M.D., (the "Respondent") (D.O.B. 05/03/1948), license number 024250, to practice medicine in the State of Maryland. The Board takes such action pursuant to its authority under Md. State Govt Code Ann. § 10-226(c)(2009 Repl. Vol.) concluding that the public health, safety or welfare imperatively requires emergency action.
The ASD Centers, LLC nationwide network, announces a new combined genetic, biochemical, heavy metal, and hormonal evaluationltreatment for patients diagnosed with an autism spectrum disorder (ASD). ASD Centers, LLC founder and medical director, Mark Geier, MD, PhD, FABMG,2 FACE3 has provided innovative genetic services for over 28 years, and is a leader in researching and helping to treat patients diagnosed with an ASD. The ASD Centers, LLC is excited to now offer innovative evaluatio/ltreatment protocols, which have successfully helped over 500 patients diagnosed with ASD.
5. In or around 2006, the Respondent established the Institute of Chronic Illness ("lei") of which he is President. His son, an unlicensed individual,4 is the "Founder and Vice-President" of the ICI. Both the Respondent and his son are members of the Institutional Review Board ("IRB") of ICI. The mission of an IRB is to protect the rights and welfare of human research subjects. One of the patients whose care was reviewed, Patient I, was enrolled in the "Geier Experimental Protocol" for the Treatment of Regressive Autism." The Consent Form states that the ICI IRB approved the study. As set forth in Section VIII below, the IRB fails to meet federal and State regulatory criteria.
8. In 2004, the National Academy of Science's Institute of Medicine ("IOM") 9 published a report entitled, "Immunization Safety Review - Vaccines and Autism." ("I0M Report") The IOM Report rejected a causal relationship between vaccines containing thimerosal, a preservative containing mercury, and autism.'? The report specifically rejected the Respondent's and his son's studies that reported findings of such an association concluding, "the studies by Geier and Geier ... have serious methodological flaws and their analytic methods were nontransparent making their results uninterpretable, and therefore noncontributory with respect to causality."11
14The Respondent is aware of the age component of the precocious puberty diagnosis. In a 2007 Patent Application, his definition of precocious puberty included the age criterion. United States Patent Application 20070254314, Inventors: Mark .R. Geier & , Methods of treating autism and autism spectrum disorders, ¶0107 (Nov. 1, 2007)
29The Respondent has reported that "ercury toxicity and M.R. Geier, A prospective study of mercury toxicity biomarkers in autistic spectrum disorders. J. Toxicolol. Environ Health A., 20 (2007)..
72. An undated form entitled, "Geier Clinical Study Protocol" (the "Protocol") states that "absent any significant adverse reactions", IM Lupron would be administered monthly with daily SQ injections. The Respondent failed to describe the possible adverse reactions of Lupron therapy. The Protocol required patients to undergo monthly laboratory testing for: androgen levels (DHEA, DHEA-S, androstenedione and testosterone), glutathione levels, liver, kidney and thyroid function, as well as monthly CBC studies.
149. On July 29, 2006, Patient I's mother signed a "Consent for Enrollment in the Geier Experimental Protocol for the Treatment of Regressive Autism." The Consent reads in pertinent part:
1. I request that my child be enrolled in the Geier Experimental Protocol for the treatment of regressive autism. The Institutional Review Board (lRB) of the Institute for Chronic Illnesses (Office for Human Research Protection, US Department of Health and Human Services IRB number: IRB00005375) has approved this study protocol.
162. The IRB noted in Patient I's "Consent for Enrollment in the Geier Experimental Protocol for the Treatment of Regressive Autism" (IRB00005375) was registered with OHRP; however, it is not linked to any OHRP assurance—the mechanism whereby the IRB commits to adhering to the ethical requirements of the Common Rule.
|Warning Letter re: Dr. Mark Geier, 9/5/2011|
|Warning Letter re: Dr. Mark Geier|
My office in the National Immunization Program has oversight responsibility for IRB issues related to research sponsored by the National Immunization Program. This letter is to inform you that my office has received reports from the technical monitors that accompanied Dr. Mark Geier and Mr. David Geier on their October 2003 and January 2004 visits to the Centers for Disease Control and Prevention (CDC) Research Data Center) in Hyattsville, Maryland. These investigators were approved by your Institutional Review Board to conduct analyses in our RDC. These reports describe potential breaches in confidentiality and execution of analyses that were not approved in advance. Below is a synopsis of the key issues on these two topics.
|Warning Letter re: Dr. Mark Geier, 15/4/2005|
|Warning Letter re: Dr. Mark Geier|
Mark Geier, MD
Dear Dr. Geier:
Submission of a response from you to the attached letter, which the Centers for Disease Control and Prevention recently sent to the IRB notifying it of reports received from the technical monitors who accompanied you on visits to the CDC Research Data Center (RDC)
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|Mark Geier, MD|