MEDICAL-LEGAL
NOTICE:
I will repost this information.
It keeps coming up in the Lyme
community.
Who can you sue for damages?
If you have been misdiagnosed due
to the Dearborn standard in the last 2
years you can sue Yale. Yale owns
the only scientifically valid (according
to the FDA's rules on the validation of
a bioanalytical method, and according to
Alan Barbour and Yale themselves, re
specificity)
antibody
method to diagnose Lyme, but they
did not deploy that method to validate
their other patented product, LYMErix.
Yale staff/owners of the Flagellin did
not refute the
falsified Dearborn case definition
when they knew it was false because they
intended a monopoly on the nations'
blood supply post-LYMErix, in cahoots
with Imugen and Corixa. (See
L2
Diagnostics being funded by the Yale
Endowment Fund, making that fund
liable for damages attack by Lyme and
LYMErix victims.)
TECHNICAL BASIS FOR SUING OVER LYME MISDIAGNOSIS DUE TO NEGATIVE ELISA OR WHEN A PHYSICIAN USES THE DEARBORN CASE DEFINITION; THIS IS CDC OFFICER PAUL MEAD MAKING IT CLEAR THAT A POSITIVE TEST IS NOT A DEFINING DEFINITION OR "STANDARD OF CARE" - YOU CAN SUE FOR MALPRACTICE AND NEGLIGENCE:
"Lyme Disease Case Definition and Clinical Diagnoses"
"A clinical diagnosis is made for the purpose of treating an individual patient and should consider the many details associated with that patient's illness. Surveillance case definitions are created for the purpose of standardization, not patient care; they exist so that health officials can reasonably compare the number and distribution of "cases" over space and time. Whereas physicians appropriately err on the side of over-diagnosis, thereby assuring they don't miss a case, surveillance case definitions appropriately err on the side of specificity, thereby assuring that they do not inadvertently capture illnesses due to other conditions."
http://www.hhs.gov/asl/testify/t040129.html
TECHNICALITIES RELATED TO MEAD'S STATEMENT:
This statement by CDC's Paul Mead is not entirely correct in that the SPECIFIC flagellin method alone (see CRYMEDISEASE_CHP1.htm) or each antibody band being as accurate for diagnosis as its assigned percent specificity (like, OspA is 100% specific to Lyme, therefore if you have band 31 alone, you can be 100% sure you have Lyme) is the correct FDA usage of the term "Specificity." The Dearborn method does not increase specificity, rather, it narrows the disease definition to the HLA-linked hypersensitivity response as discussed by CDC staff in their 1992 European patents with SmithKline. In other words, the fraudulent, Dearborn case definition only detects Lyme arthritis, and Lyme arthritis alone was okay for the CDC in terms of surveillance. CDC does not care if the Dearborn case definition only detects 15% of all cases. They then can extrapolate 15% accuracy of Dearborn times 10-12 times underreported (see Yale's Robert Schoen in 1998 giving the FDA those statistics) to the actual number of Lyme cases per year. In other words, multiply the reported number of cases times 73 (100/15 = 6.67 and 11 times underreported).
Mead says the case definition increases the specificity, but it does not because A) Lyme and LYMErix are immunosuppressive - don't tend to produce antibodies (compare with Tuberculosis and TB vaccines outcomes)-, and B) narrowing the disease definition to only the HLA-linked cases is not the correct usage of the FDA's terms, especially specificity. Each analyte (each antibody band) has its own specificity. One does not multiply specificities. Note that Yale said their ONE band, 31, was 100% specific for Lyme prevention (LYMErix). If it is specific enough to prevent Lyme, it is specific enough to detect Lyme.
If you wanted to detect a case of Lyme, we know that nearly all Lyme infected people will produce band 41 (flagellin). Therefore, if you wanted to detect Lyme, you would try to make that band even more specific, or not cross react or detect flagellins from other organisms. Yale solved this problem in 1991 and patented it. Other people/researchers pursued the same approach and came to the same conclusion. It is logical.
Yale is furious because they did
not win their monopoly on the national
blood supply and national testing for
all vector borne diseases as well as
human-bioweapons susceptibilities [which
at the time they thought was due to HLA
differences, but later we learn it was
more due to TLRs and the sequence in
which a person acquired their various
infections or exposures (vaccines
included)] because ActionLyme in 1999
led a national campaign to get adverse
events reported to the FDA through the
VAERS, upon the recommendation of the
Lyme Disease Foundation (Hartford, CT)
and Dennis Parenti (SmithKline, Phila,
PA) in a telephone conversation with
yours truly after we learned LYMErix
victims has the same "multisystem
disease" outcomes as Lyme victims.
A year later, the FDA granted us a
hearing (Jan 31, 2001) and the FDA heard
what Yale, Corixa and Imugen already
knew, since they discussed it in their
1995 RICO patent, 6, 045, 804.
"Additional uncertainty may arise if the vaccines are not
completely protective; vaccinated patients with multisystem complaints
characteristic of later presentations of Lyme disease may be difficult to
distinguish from patients with vaccine failure."
"The present invention provides
a method useful to detect a B. burgdorferi infection in a subject. The method
provided by the invention is particularly useful to discriminate B.
burgdorferi infection from OspA vaccination, although it is sufficiently
sensitive and specific to use in any general Lyme disease screening or
diagnostic application. Thus, the method of the invention is particularly
appropriate for large scale screening or diagnostic applications where only
part of the subject population has been vaccinated or where the vaccination
status of the population is unknown. "
We have other reasons to believe Yale knew LYMErix made people sick, not to mention learning directly from the LYMErix victims. Yale's Robert Schoen gave instructions to blow off people who had the expected "multisystem" LYMErix adverse events in a 1998 book where he also instructs people to send the blood to his own little RICO lab with Corixa and Imugen (mo OspA or B in the standard, like the Dearborn case definition, as if they were made for each other, which they were).
In a lawsuit against Yale, you will only
need two witnesses: Someone from
the FDA's bioanalytics division, and
either Erol Fikrig or Richard
Flavell, because
those 2 have their names on both the
Flagellin antibody method that detects
94.4% of all Lyme cases with 100%
specificity, and they also own the
patent for LYMErix. The
LYMErix patent was filed after the
Flagellin patent, so they, Yale, knew
how to diagnose Lyme but did not use
this valid method to qualify LYMErix.
If you are being newly introduced
to this crime, it's quite fascinating.
Far better than any crime show you could
watch on TV. One of the Lyme
criminals recently sued the FBI.
We don't know why exactly, but I would
guess it had something to do with Edward
McSweegan taking himself on a junket to
an Israeli bioweapons facility (look for
that link on this homepage).
This is in addition to all the
now-criminal stalking and harassing Lyme
victims, myself, included,
because my kids
have one of the best verified cases of
congenital Lyme in the country.
Not to mention the fact that I am an
analytical chemist and would know about
things like valid analytical methods.
And so of course I blew the whistle on
the entire crime - from Dearborn being
scientifically false (invalid) to the
LYMErix results being falsified to OspA
being immunosuppressive - to the FDA
Vaccine Committee at that 2001 Meeting.
The CDC has said numerous times
and in numerous places that the Dearborn
'case definition" is for surveillance
(tracking Lyme's spread across the
country) and not for diagnosis.
This is how you sue. If someone
said you should have a Lyme test and
they went straight for an ELISA, you
have a malpractice/negligence case.
You can sue whoever misdiagnosed you and
you can sue Yale for the same.
http://www.medicalmalpractice.com/resources/medical-malpractice/medical-malpractice-introduction/medical-negligence.htm
Causation: The Link Between Negligence and Injury. The final step in establishing a medical malpractice claim from an act of medical negligence requires establishing a causal relationship between the negligent medical treatment and the injury to the patient. This is a legal concept known as causation, and is another very difficult aspect to prove in a medical malpractice case.
Establishing causation in a medical malpractice suit, similar to establishing negligence, requires a medical expert witness to show if and how the negligent medical treatment directly caused an injury to the patient. Further, it must be shown that, had the negligence not taken place, the injury would have been avoided.
The experts you will use to
establish injury and negligence will be
the FDA employee and either Fikrig or
Flavell. They all will be forced
to say that the Flagellin method is
valid, and that the Dearborn Method was
not.
At one time, the "L2 Diagnostics"
Lab at Yale was called the "Lyme and
Lupus Clinic" (two-Ls). Nowadays,
Yale does not say that Lyme causes a
Lupus outcome, because that would
contradict their later, Dearborn lie
that Lyme is only an HLA-linked
arthritis or hypersensitivity response
to OspA, the vaccine.
If you think all of this makes no
sense, you would be right. It's
total craziness but not one MD in
America can detect this craziness,
because they're all crazy too, if they
believe the convoluted bullshit coming
out of the now-totally defunded Yale and
UConn U's.
Oh, and if you
are bored with all the other the cartoon
antics of the US Government, you might
find it interesting and a distraction to
know that the German scientist Roland
Martin, recruited to head the NIH's MS
Group because he found an association
between Lyme and MS, went back home to
Germany once he found out that Lyme and
LYMErix cause the reactivation of
Epstein-Barr (and similars) especially
in the brain, but that that disease will
produce no antibodies (and therefore
can't be called MS- MS being known to be
associated with reactivated
Epstein-Barr, as is Lupus).
http://www.ncbi.nlm.nih.gov/pubmed/16783164
In other words, LYMErix caused MS
and Lupus, too, (with or without the
HLA, the non-HLA linked cases now being
called "paraneoplastic neurological
diseases"). And guess who
specializes in
ONLY
Epstein-Barr and Lyme?
I, personally find all the antics of the US Government cartoonish, but as I said, this question of recovering damages keeps coming up in the Lyme community. Yes you can sue. It's very, very easy to make a case and it will only take two witnesses for you to win. There is absolutely no way for Yale staff to weasel out of it.
Whatever data you can find to link the Yale Endowment Fund to Yale's biotech spinoffs would be good. Helpful. Oh, and try not to be in Connecticut when you sue. No set of government employees is better-versed in retaliation. CT lost all its manufacturing jobs long ago so the CT Staties are Transformer-Vultures on steroids and nuclear-fueled. They're so afraid of having to perform real work for a living....
They WILL kill you. And worse. They'll take your children away and give them people known to be physically and sexually violent.
You be careful. They don't grow 'em any stupider than in Connecticut. The New Haven FBI even told me they don't know where or how to hire a chemist to advise them on the FDA's rules on the validation of an analytical method.
They said they don't know any chemists and don't know how to find one.
And you just can't make this shtuff up.
Oh, and the dude who manages Yale's Endowment Fund has cancer. I wonder what he thinks of having funded his own outcome? Boomerang does not rhyme with Lyme but it should.
120914- Kathleen M. Dickson
Former Pfizer Analytical Methods Development and Validation Chemist,
STAD Group, Building 257, Groton, CT, USA
BS Chemistry, 1981, Southern CT State University.
