What better way to finish off 2007 than to look at a most amusing judicial ruling on the admissibility of some of the favorite "expert" witnesses trotted out to try to demonstrate a link between mercury in vaccines and autism. It was issued on December 21 in the case of Blackwell v. Sigma Aldrich, Inc. et al. (Circuit Court for Baltimore City, Case No. 24-C-04-004829). As you might expect, this is a case in which the plaintiffs claimed that their son's autism was caused by thimerosal-containing vaccines.
Kathleen Seidel, as usual, has the details, but I can't resist grabbing a few tidbits about everybody's favorite (American) antivaccination pseudoscientists Drs. Mark Geier and Boyd Haley, among others:
"Dr. Geier is not qualified by his knowledge, skill, experience, training or education to render the opinions he proffers in this case... [T]his Court does not find that there exists a sufficient factual basis to support [Dr. Geier's] proffered testimony...""[Dr. Haley's] lack of expertise in genetics, epidemiology and child neurology make it impossible for him to supply the necessary factual basis to support his testimony."
"Dr. Deth is neither an epidemiologist, a neurologist nor a geneticist... [I]n light of his expressed reliance on Dr. Geier's studies, this Court finds that he lacks a sufficient factual basis to support his testimony."
"Dr. Geier's epidemiological studies purporting to show an association between thimerosal-containing vaccines and autism were not conducted in accordance with generally accepted epidemiological methods."
"...Dr. Geier's methodology of differential diagnosis is fundamentally flawed, because he improperly "rules in" thimerosal as a potential cause of autism, and he cannot rule out the high likelihood that autism in any given individual was caused purely by genetic factors that do not require an environmental trigger."
"[T]he plaintiffs... have failed in their burden of proving that the bases of the expert witnesses' testimony are generally accepted as reliable within the relevant scientific field... [and] have failed to show that the methodologies underlying their expert witness' opinions are generally accepted to be reliable in the relevant scientific community."
You know, this restores a bit of my faith in the American judicial system.
If you doubt that the luminaries of the mercury militia movement are die-hard antivaccination loons, there's copious evidence to support that contention here. For example, here's Boyd Haley on the CDC:
On cross-examination, he acknowledged that he conducted only studies of hair, and did not measure urinary, fecal excretion or blood. He accused the IOM committee of dishonesty and asserted that the CDC are bureaucrats that should be charged with criminal activity. He further stated that he had no respect for the science that was reported, and that the goal of the CDC was to find that thimerosal was not toxic. Therefore, he concluded that the goal was not to find the truth about the connection between thimerosal and vaccines.
Whenever I hear rants about the "criminal" CDC (or FDA or FTC, or whatever), I know I'm in the presence of some most excellent crank rhetoric. But here's a great one on Mark Geier:
Although not at all binding of this Court, it is noteworthy that many courts have strongly criticized Dr. Geier's testimony as a purported expert witness in cases involving alleged vaccine injuries. Dr. Geier has never been qualified to testify as an expert in a thimerosal case. One of those cases involved Rhogam, an immunoglobulin preserved with thimerosal (Doe 2 v. Ortho-Clinical Diagnostics, Inc. (M.D.N.C. 2006)). Another of those cases involved a thimerosal-containing over-the-counter nasal spray (Redfoot v. B.F. Ascher & Co. (N.D. Cal. June 1, 2007)). In those proceedings, Dr. Geier's causation testimony failed to satisfy the Daubert standard, and Dr. Geier's credentials were found to be inadequate and his qualifications to not be aligned with the subject matter of his intended testimony.
That one's going to leave a mark.
Yes, 2007 was a bad year for the mercury militia and the "vaccines cause autism" crowd in both the scientific and legal realms. It started right from New Years' Day 2007 with the revelation that Andrew Wakefield had accepted large sums of cash from lawyers interested in suing vaccine manufacturers. It didn't take long after that to see a serious case of sour grapes from David Kirby over the continuing failure of autism rates to fall in California after the removal of thimerosal from vaccines, shortly after which during a debate with Arthur Allen over whether mercury in vaccines causes autism he backpedaled so furiously, going so far as to start invoking mercury due to pollution wafting over to California from China (grasping at straws) or even mercury from the fillings of corpses being cremated (hilariously grasping at straws--I couldn't make stuff like this up). It continued with the Supreme Commander of the Mercury Militia, the man who was so wedded to the idea that mercury in vaccines is the cause of autism that he formed Generation Rescue, which until recently said on its website "that childhood neurological disorders such as autism, Asperger's, ADHD/ADD, speech delay, sensory integration disorder, and many other developmental delays are all misdiagnoses for mercury poisoning" joining David Kirby in starting to back away from the "mercury in vaccines causes autism" dogma and invoking vague "causes" such as "overload of heavy metals, live viruses, and bacteria." So desperate was the mercury militia to blame vaccines for autism that Generation Rescue commissioned a truly execrable telephone survey disguised as a legitimate scientific study that was so full of holes that it didn't prove anything, although, amusingly enough, it could very well have been interpreted that in some groups vaccination is protective against autism.
As the year continued, we were treated to even more signs of the failure of the hypothesis that mercury causes autism, the Autism Omnibus proceedings, for which the first test case was so embarrassing for the entire concept that the very fact that the proceedings weren't stopped right there is strong evidence that the government is not only being fair to vaccine litigants, but is bending over backwards to make it as easy as possible for them to prove their cases. It's like the judges spotted them two touchdowns in a football game.
And they're still failing to make their case.
As we approached the end of the year, the ridiculousness of the entire antivaccination movement became almost surreal. We were treated to the spectacle of an ex-Playboy Playmate declaring that her son "is her science" to Oprah and going on and on about "toxins" in vaccines that she clearly has no clue about, while claiming that she's "cured" her son of autism. Meanwhile, the latest large study failed to find any link between mercury in vaccines or vaccines in general and neurodevelopmental disorders. Then, just when I thought the year couldn't get any more surreal, The Donald himself decided to bring the stupid home by pontificating out of his toupee that his theory (and, he assures us, he's studied the issue) is that mercury causes autism.
We can only hope that 2008 brings more of the same.
I like to view all of this strangeness as evidence for the desperation of antivaccinationists. Against their will, deep down, they're slowly being forced to realize that they are wrong and that neither vaccines nor thimerosal in vaccines causes autism. It's a case of wishful thinking finally smacking into cold, hard, scientific reality. Unfortunately, they're so invested in the concept that they simply can't let it go. Perhaps 2008 will be the year that sanity finally starts to prevail when it comes to the pseudoscientific claims that mercury in vaccines (or vaccines in general) cause autism.
A guy can dream, can't he?
Orac, thanks very much for the link. Here's a passage from the opinion that cracked me up:
"Dr. Geier testified that he was qualified as an expert in a thimerosal case captioned as Easter v. Aventis Pasteur. He testified that the judge in the Easter proceeding qualified him as an expert, purportedly stating in open court that defense counsel should use his time wisely by not challenging Dr. Geier's qualifications because he has so many publications. Despite this Court's review of the transcript of the Daubert hearing in Easter and the opinion of that Court on the Daubert motion, this Court could unearth nothing to support Dr. Geier's statements pertaining to the Easter Court qualifying him as an expert in that proceeding."
This has been my experience -- all you have to do is a little fact-checking, and the whole house of cards falls down.
Happy New Year!
This makes me smile - almost as much as the Kitzmiller ruling a few years back. Perhaps we're seeing a new trend: courts relying on actual science?? Here's to 2008 - may we see that trend continue.
Dr Deth? Is he a chelationist? With a name like that, no wonder he had to turn to quackery.
Freddy - Kethleen has pwned Dr Deth (rhymes with 'teeth') previously. In fact, so sure of his ground was this pontificating windbag that in March 2006 in an exchange of views with Kathleen he said:
"However, I would like to make a virtual wager that within the next 18-24 months scientific evidence will make the thimerosal-autism link a near certainty."
So far we're on month 21 of 24.....and counting....luckily for Deth, Kathleen took pity on him and refused to accept his wager.
In my previous comment I elected to use the German pronunciation of Kathleen. Ahem.
Now, if only we could get our government to rely on science -- heck, on facts of any sort.
"You know, this restores a bit of my faith in the American judicial system."
Maybe. While Drs. Geier and Haley are not being accepted as experts, and while Dr. Geier's opinions are being regarded with great skepticism, the Vaccine Court is still authorizing payment to him as an "expert" (although not nearly as much as he's been seeking). It is somewhat disheartening that in view of all the times that Dr. Geier's assertions have been rejected (going back to at least 1990), he still manages to be proffered as an "expert" and is still paid for his opinions. See,
Dr. Mark Geier & Dr. Boyd Haley - opinion that thimerosal causes autism excluded:
Redfoot v. B.F. Ascher & Co., Case No. C 05-2045 PJH, 2007 U.S. Dist. LEXIS 40002 (N.D. Cal., June 1, 2007). See also John And Jane Doe 2, v. Ortho-Clinical Diagnostics, Inc., Case No. 1:03CV00669, 440 F. Supp. 2d 465 (M.D. N.C. 2006).
However, petitioners in the Vaccine Court cases have been awarded expert fees for Dr. Geier's work as an "expert":
Jeffries v. Sec., Dept. of HHS, Case No. 99-670V, 2006 U.S. Claims LEXIS 411 (US Ct. of Fed. Cl., Dec. 15, 2006): at pages 35-35:
"4. Dr. Mark R. Geier
Petitioner's Position
Petitioner requests $29,330.50 as compensation Dr. Geier's total fees and costs. See P. App. at 23. In support of this request, petitioner has filed a one-page invoice describing the 117.20 hours of work performed by Dr. Geier at an hourly rate of $250.00, and a $30.50 parking fee. See id. at 24-31.
Petitioner states that Dr. Geier has provided "extensive" work, reports, and research for this case, on which he based his testimony at hearing, which was "relevant to the instant case." P. Reply R. Opp. at 18. Petitioner further asserts that the hours billed by Dr. Geier for preparing his own personal medical literature are proper since "work accepted for publication in peer-reviewed journals have [sic] an even higher standard of citation and documentary support than a typical expert report, and therefore potentially a greater asset to the Court for review." Id. In responding to the Court's request for an explanation as to why Dr. Geier billed petitioner for these hours, petitioner asserts that Dr. Geier spent the 13 hours in question reviewing charts and tables included in his own publications in order to determine whether said material was relevant to petitioner's case. See P. Resp. R. Reply at 8. Petitioner also states that the articles in question had already been published at the time of Dr. Geier's review. Therefore, Dr. Geier could not have been writing the articles. See id."
At page 41:
"The undersigned awards Dr. Geier $3,520.00 for his testimony at the hearing. This amount includes 1.6 hours of trial testimony 11 and 15 hours for preparation billed at $200.00/hour, and 2 hours of travel time billed at half his hourly rate. 12
FOOTNOTES:
11 The April 14, 2003 hearing began at 9:53 a.m. and ended at 6:27 p.m. There was a 15-minute break and an 8-minute break. Therefore, the approximate total time at trial for the first day was 8 hours. The hearing transcript consists of 301 pages, and Dr. Geier's testimony spans 59 pages. Fifty-nine pages is approximately 20% of 8 hours, or 1.6 hours. None of petitioner's experts testified on the second day of trial.
12 Dr. Geier resides in suburban Washington, DC, and it is reasonable to estimate that he spent a total of 2 hours traveling to and from the hearing location.
The Court awards petitioner a total of $8,520.00 for Dr. Geier's expert fee and costs."
[The court also awarded petitioner $1,000 which he had previously paid Dr. Geier]
Schrum v. Sec., Dept. of HHS, Case No. 04-210V, 2007 U.S. Claims LEXIS 188 (US Ct. of Fed. Cl., May 31, 2007), at page 14:
"The remaining articles, while informative, are not difficult to locate or review. In fact, a simple internet search of PAN and/or vasculitis and hepatitis B provides the same articles that petitioner filed in just a few minutes. It is therefore difficult for the undersigned to understand why Dr. Geier spent 13.5 hours searching for and reviewing seven articles, none of which was longer than six pages. Dr. Geier has taken 13.5 hours to do a literature search that would likely have taken Dr. Bellanti or an associate attorney of petitioner's counsel much less time.
For the reasons stated above, the undersigned finds 13.5 hours to be excessive. Dr. Geier will be compensated for only those hours that are reasonable. Based on the undersigned's experience with the Vaccine Program, Dr. Geier will be awarded compensation for five hours of his time which is a reasonable, indeed generous, number of hours for a literature search and review of articles.
Therefore, the undersigned awards Dr. Geier a total of six hours for reviewing case documents and doing a literature research at a rate of $ 175 per hour. Instead of the $5,000 requested for Dr. Geier's services, petitioner shall receive $1,050."
In Jane Doe/03 v. Sec., Dept., HHS, 2007 U.S. Claims LEXIS 265 (US Ct. of Fed. Cl., July 31, 2007), the Special Master refused to recuse himself, although had stated that he found Dr. Grier's articles unscientific and unpersuasive. It states at pages 7 - 11:
"I then noted two problem areas in petitioner's case: the destruction of some of the medical records for the time period around onset of petitioner's symptoms, and Dr. Alper's citation of articles principally authored by Dr. Mark Geier. 7 I suggested that, in view of the criticisms leveled at Dr. Geier and his research, petitioner would be better served if her expert could opine favorably at the hearing without relying on the cited articles. I indicated that there was no need to file these articles because I had already read them. I did not prohibit petitioner from filing any article. To place my remarks in context, Dr. Alper's report discussed several other articles and referenced ten other articles supporting his view of vaccine causation and I expressed no other opinion on Dr. Alper's report.
FOOTNOTES:
7 Petitioner's Exhibit 21, the article listed on the references page of Dr. Alper's report, has been severely criticized. Respondent's Exhibits ["Res. Ex."] H, I, and J, filed with respondent's brief on the motion to reassign, are representative of the criticisms I have previously seen leveled at this article and its authors' use of VAERS data to support their opinions regarding vaccine causation of various illnesses.
I did not offer any opinion on whether petitioner can establish vaccine causation of her condition, only that I found that the articles authored by Dr. Geier unpersuasive and not scientifically sound, based on my prior reading of the articles and critiques of them. I am also aware that Dr. Geier is trained as a geneticist and obstetrician, not an immunologist, epidemiologist, or rheumatologist, and that my fellow special masters 8 and several other judges 9 have opined unfavorably on his qualifications and testimony as an expert.
FOOTNOTES:
8 Thompson v. Sec'y, HHS, No. 99-436V, 2003 U.S. Claims LEXIS 161 at *58, 2003 WL 21439672 at *19 (Fed. Cl. Spec. Mstr. May 23, 2003)(special master found Dr. Geier unqualified to testify about infantile spasms and found his testimony filled with speculation); Haim v. Sec'y, HHS, No. 90-1031V, 1993 U.S. Claims LEXIS 145 at *46, 1993 WL 346392 at *15 (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. Sec'y, HHS, No. 90-1571V, 1993 U.S. Claims LEXIS 96 at *16, 1993 WL 277095 at *5 (Fed. Cl. Spec. Mstr. July 9, 1993) (where the special master described Dr. Geier's testimony as intellectually dishonest); Aldridge v. Sec'y, HHS, No. 90-2475V, 1992 U.S. Cl. Ct. LEXIS 284 at *37, 1992 WL 153770 at *9 (Cl. Ct. Spec. Mstr. June 11, 1992)(special master found Dr. Geier's reliance on statement from two outdated medical textbooks which was not included in the current edition to be disingenuous. "Were Dr. Geier an attorney, he would fall below the ethical standards for representation."); Ormechea v. Sec'y, HHS, No. 90-1683V, 1992 U.S. Cl. Ct. LEXIS 274 at *20, 1992 WL 151816 at *7 (Cl. Ct. Spec. Mstr. June 10, 1992) ("Because Dr. Geier has made a profession of testifying in matters to which his professional background [obstetrics and genetics] is unrelated, his testimony is of limited value to the court."); Daly v. Sec'y, HHS, No. 90-590V, 1991 U.S. Cl. Ct. LEXIS 368 at *21, 1991 WL 154573 at *7 (Cl. Ct. Spec. Mstr. July 26, 1991) ("[T]his 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.").
9 Piscopo v. Sec'y, HHS, 66 Fed. Cl. 49 (2005) (special master did not abuse his discretion in determining that Dr. Geier did not have the education, training or experience to proffer a reliable opinion on the cause of petitioner's autoimmune disorder); Graham v. Wyeth Laboratories, 906 F.2d 1399, 1418 (10th Cir. 1990) (Dr. Geier's calculation error was of sufficient magnitude so as to warrant a new trial); Doe v. Ortho-Clinical Diagnostics, 440 F. Supp. 2d 465, 474 (M.D.N.C. 2006) (excluding Dr. Geier's testimony as based on "hypothesis and speculation."); Redfoot v. B.F. Ascher & Co., 2007 U.S. Dist. LEXIS 40002 (N.D. Ca 2007) (excluding Dr. Geier as an expert, finding his testimony "not reliable.") Pease v. American Cyanamid Co., 795 F. Supp. 755, 760-61 (D. Md 1992) (in granting summary judgment, trial judge noted inconsistencies in Dr. Geier's opinion); Jones v. Lederle Laboratories, American Cyanamid Co., 785 F. Supp. 1123, 1126 (E.D. NY 1992) ("the court was unimpressed with the qualifications, veracity, and bona fides" of Dr. Geier); and Militrano v. Lederle Laboratories, American Cyanamid Co., SCt NY, 3 Misc. 3d, 523, 537-38, 769 N.Y.S.2d 839 (2003) (characterizing Dr. Geier's affidavit as "conclusory and scattershot" and "undermined by many of the materials submitted in support of it")."
This is too much fun - thank you, Kathleen (and Orac) - from the court docs:
Booyah!
And Kev Leitch, I remember Deth's exchange with Kathleen and being surprised that he delved into this muck. IMHO, seems as though his funding on dopamine D4 receptors hit a low point and there was something to potentially be gained with an oxidative stress/methylation hypothesis of neural injury that somehow involved mercury. It's a real shame because Deth's previous publication record in mechanistic neuropharmacology (unrelated to autism) was actually quite strong relative to other 'experts' in this case.
Good to see some courts doing some things right.
Happy New Year! Down with the Quacks!
Elissa said:
The Daubert case (that gives its name to the Daubert hearing regarding admissibility of scientific evidence, including expert testimony) was decided in 1993. And you mentioned the Kitzmiller case, which is 2 years old (and which relied in part on a Supreme Court "creation science" case from 1987). What would you cite as examples of courts relying on quackery, that make reliance on science a "new trend"?
How long before the losing plaintiffs in these cases sue their lawyers for malpractice? Trotting out the same "experts" time and time again, only to have them shot down in flames each and every time isn't "good lawyering". It is a waste of the court's time, it is a waste of the defendants time, and is a waste of the plaintiff's legal fees.
Jud:
Elissa's comment isn't erroneous. In Blackwell v. Sigma Aldrich, the court applied a version of the Frye test, not Daubert.
For recent examples of questionable science being allowed as expert testimony, check "Dr. Eckhardt Johanning". Compare, Cameron v. Merisel Properties, Inc., NO. COA07-54, 652 S.E.2d 660 (N.C. App. 2007) (Johanning testified that exposure to toxic mold caused plaintiff's "irreversible bilateral vestibular dysfunction". Judgment awarding damages to plaintiff affirmed) and Brandt v. Rokeby Realty Co., No. 97C-10-132-RFS , 2006 Del. Super. LEXIS 280 (Mar. 17, 2006) (Applying Daubert. Johanning allowed to testify that plaintiff's diverse symptoms caused by exposure to toxic mold), with, MacGregor v. Born, Docket Number: 03-1439 , 21 Mass. L. Rep. 353, 2006 Mass. Super. LEXIS 394 (Aug. 17, 2006) (Applying version of Frye test, modified by Daubert. Johanning's opinion that autism caused by exposure to toxic mold excluded), and Jazairi v. Royal Oaks Apt. Assocs., L.P., No. 06-15389 Non-Argument Calendar , 217 Fed. Appx. 895, 2007 U.S. App. LEXIS 3501, (11th Cir., Feb. 13, 2007) (Review of application of Daubert standards. Affirming District Court's exclusion of Johanning's opinion that exposure to mold caused plaintiff's health problems, and affirming dismissal of suit. Johanning's opinion relied only on temporal proximity of mold exposure and plaintiff's symptoms).
Dr. Johanning's record is not nearly as well established as that of Dr. Mark Geier. Dr. Johanning, however, appears to have made a career of opining that exposure to "black mold" or "toxic mold" causes a wide variety of health problems well beyond allergies and upper respiratory problems recognized as associated with mold exposure (e.g., like autism), and operates a clinic to provide treatment for such problems. While it appears that most of the time his "expert opinions" are excluded, he has been allowed to testify in a number of cases, in courts applying both Frye and Daubert standards.
While Daubert standards can be more rigorous than Frye, whether it is rigorously applied depends more on whether the presiding judge is willing to delve into the issues and educate him/herself. If the judge does that, it doesn't appear to matter whether Daubert or Frye is applied.
There is hope yet....
OT...Hi, Kev. Nice to see you at least commenting. I miss your blog.
Happy new year to Orac, all the other SB'ers and the commenters. (OK, I'm a day late, but it's been busy...) Hey, Orac, how about the snow back in MI? Wanna go home and have a snowball fight? :)