Thursday, June 04, 2015

Catholic Medical Center v. Civil No. 14-cv-180-JL Opinion No. 2015 DNH 110 Fireman’s Fund Insurance Company Creutzfeldt Jakob Disease TSE Prion tainted medical instruments

UNITED STATES DISTRICT COURT DISTRICT OF NEW HAMPSHIRE

 

Catholic Medical Center v. Civil No. 14-cv-180-JL Opinion No. 2015 DNH 110 Fireman’s Fund Insurance Company

 

OPINION AND ORDER

 

The possible contamination of surgical instruments after exposure to a communicable neurological disease--and whether those instruments constitute “premises” under the terms of an insurance policy--led to a coverage dispute that culminated in this litigation. Plaintiff Catholic Medical Center (“CMC”) seeks a declaratory judgment that defendant Fireman’s Fund Insurance Company (“Fireman’s Fund”) wrongfully denied coverage for certain losses after a CMC neurosurgical patient was diagnosed several months after surgery, necessitating the destruction of the potentially contaminated instruments and causing temporary suspension of CMC’s neurosurgery program. The parties have filed cross-motions for summary judgment. Having reviewed the insurance policy at issue and the undisputed factual record, and having held oral argument, the court finds that CMC’s claims are not covered. Fireman’s Fund’s motion is therefore granted; CMC’s is denied.

 

I. Summary Judgment

 

Summary judgment is properly granted when the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law. See Fed. R. Civ. P. 56(a). The court “views all facts and draws all reasonable inferences in the light most favorable to the non-moving” parties. Estrada v. Rhode Island, 594 F.3d 56, 62 (1st Cir. 2010). On cross-motions for summary judgment, “the court must consider each motion separately, drawing inferences against each movant in turn.” Merchants Ins. Co. of N.H., Inc. v. U.S. Fid. & Guar. Co., 143 F.3d 5, 7 (1st Cir. 1998) (quotation marks omitted). This rule is largely academic here since, as previously noted, the material facts are undisputed.

 

II. Factual Background

 

On May 24, 2013, CMC personnel performed neurosurgery on a patient. Several months after the surgery, CMC learned that the patient was experiencing symptoms consistent with Cruetzfeldt- Jakob Disease (“CJD”), a communicable, incurable and fatal neurological disease. A lab test in mid-August 2013 established that the patient likely had CJD. The patient died soon after and post-mortem analysis confirmed the CJD diagnosis. CMC also determined that eight patients had undergone neurosurgery at CMC

 

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since May 24, 2013. CMC had two sets of neurosurgery instruments, so it was possible that some, none, or all of these eight patients underwent surgery with the same instruments used on the CJD patient, potentially exposing them to the disease. CMC reported the incident to the New Hampshire Department of Health and Human Services (“New Hampshire HHS”), as required by law because CJD is a communicable disease. Representatives from New Hampshire HHS met daily with CMC personnel to formulate a response. Since it could not be determined which of the two surgical kits was used on the original patient, New Hampshire HHS advised CMC that both kits had to be decontaminated, a process that will result in the destruction of the instruments. 1

 

Although DHHS had the authority to issue a formal order requiring CMC to take steps in response to the CJD incident, it did not do so because CMC had already taken the required steps or agreed to do so without resistance.

 

Aside from quarantining the affected instruments and issuing various notifications to the public and the eight post-incident surgical patients, CMC undertook no other action, such as additional decontamination, evacuation or operating room closure. CMC was, however, forced to suspend its neurosurgery program from CMC is maintaining the instruments in quarantine until all 1 potential legal claims resulting from the CJD incident are resolved. The instruments will be incinerated thereafter.

 

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August 16, 2013 until February 24, 2014, when it completed its purchase of new instruments.

 

CMC notified Fireman’s Fund of a potential claim as soon as it became aware of the CJD incident, and later filed a formal claim for the loss of the surgical instruments and losses occasioned by the suspension of CMC’s neurosurgery program. Fireman’s Fund denied the claim as a non-covered loss, and also denied CMC’s subsequent request to reconsider its position. CMC filed suit in New Hampshire Superior Court in March 2014.

 

Fireman’s Fund timely removed the case to this court.

 

III. The Insurance Policy

 

During the relevant time period, Fireman’s Fund insured CMC pursuant to a Commercial Property policy. As pertinent to this case, the policy includes two endorsements. The first is a Health Care Extension Endorsement, which, in turn, includes Communicable Disease Coverage, which provides, in relevant part:

 

13. Communicable Disease Coverage

 

a. We will pay for the following under Communicable Disease Coverage:

 

(1) Direct Physical loss or damage to Property Insured caused by or resulting from a covered communicable disease event at the premises described in the Declarations.

 

(2) The necessary costs incurred to:

 

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(a) Test, monitor, contain, treat, detoxify, disinfect, and neutralize Property Insured;

 

(b) Cleanup, remove, and dispose of the debris of Property Insured.

 

(c) Replace consumable goods at the premises described in the Declarations which are declared contaminated by the local public health authority.

 

(3) If the Declarations show you have Business Income with Extra Expense Coverage - 190004, we will pay for the actual loss of business income, rental value, or necessary extra expense or expediting expense that you sustain due to the necessary full or partial suspension of operations during the period of restoration. The suspension must be caused by direct physical loss or damage caused by or resulting from a covered communicable disease event at the premises described in the Declarations.

 

(Emphasis in original).

 

The policy also contains a Crisis Management Coverage Extension Endorsement, which obligates Fireman’s Fund to cover certain losses resulting from a “covered crisis event.” The pertinent policy provision defines such an event as: Necessary closure of your covered premises due to any sudden, accidental and unintentional contamination or impairment of the covered premises or other property on the covered premises which results in clear, identifiable, internal or external visible symptoms of bodily injury, illness, or death of any person(s). This includes covered premises contaminated, by communicable disease, Legionnaires’ disease, but does not include premises contaminated by other pollutants or fungi.

 

(Emphasis in original).

 

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As is often the case in insurance policies, the emphasized terms have been assigned particular meanings. “Premises” is defined as “that part of the location you occupy.” The Endorsement defines “communicable disease” as “any disease caused by a biological agent that may be transmitted directly or indirectly from one human or animal to another” and defines “communicable disease event” as an “event in which a public health authority has ordered that the premises described in the Declarations be evacuated, decontaminated, or disinfected due to the outbreak of a communicable disease at such premises.” (emphasis in original). Finally, with respect to the Crisis Management Endorsement, “covered premises” are defined as “that part of the location you occupy which is covered by this policy, including the area within 100 feet thereof.”

 

III. Analysis

 

A. Policy Interpretation

 

The parties agree that New Hampshire law controls this dispute. Therefore, the insurer, Fireman’s Fund, bears the burden of proving that CMC’s claim is not covered. See N.H. Rev. Stat Ann. § 491:22-a (2010); Andrews v. Nationwide Mut. Ins. Co., 124 N.H. 148, 150 (1983) (holding that provisions of New Hampshire’s Declaratory Judgment Act relating to liability insurance apply to first-party insurance claims).

 

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The interpretation of insurance policy language is a question of law for the court to determine. Rivera v. Liberty Mut. Fire Ins. Co., 163 N.H. 603, 606 (2012). “Policy terms are construed objectively; where the terms are clear and unambiguous, [the court] accord[s] the language its natural and ordinary meaning.” Barking Dog, Ltd. v. Citizens Ins. Co. Of Am., 164 N.H. 80, 83 (2012). Where disputed terms are not defined in the policy, the court construes them “in context, and in the light of what a more than casual reading of the policy would reveal to an ordinarily intelligent insured.” Great Am. Dining v. Philadelphia Indem. Ins. Co., 164 NH 612, 625 (2013). If policy terms are clear and unambiguous, the “search for the parties’ intent is limited to the words of the policy.” White v. Vt. Mut. Ins. Co., 167 N.H. 153, 157 (2014). “Ambiguity exists if reasonable disagreement between contracting parties leads to at least two interpretations of the language.” Id. (quoting Colony Ins. Co. v. Dover Indoor Climbing Gym, 158 N.H. 628, 630 (2009)). “If one of the reasonable meanings of the language favors the policyholder, the ambiguity will be construed against the insurer.” Colony, 158 N.H. at 630. However, the court will not “perform amazing feats of linguistic gymnastics to find a purported ambiguity[,]” id. at 630-31, and will “enforce a policy provision that limits the insurance company’s liability when the

 

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policy language is clear and unambiguous.” Merch. Mut. Ins. Co. v. Laighton Homes, Inc., 153 N.H. 485, 487 (2006).2

 

1. Communicable Disease Coverage

 

Fireman’s Fund makes several arguments in support of its position that the policy’s Communicable Disease Coverage does not apply to CMC’s claim. Fireman’s Fund’s overall point, however, is that the CJD incident did not constitute a “communicable disease event,” as that term is defined in the policy. The court agrees.

 

As previously noted, the policy defines a “communicable disease event” as “an event in which a public health authority has ordered that the premises described in the Declarations be evacuated, decontaminated, or disinfected due to the outbreak of communicable disease at such premises” (emphasis in original). Fireman’s Fund specifically contends that: 1) there was no evacuation, decontamination or disinfection of “the premises”; 2) there was no “outbreak” of a communicable disease; 3) no public health authority “ordered” any action; and 4) there was no “direct physical loss or damage to any insured property.” The first point carries the day.

 

While the parties agree as to the law governing policy 2 interpretation, the court is not aware of any case law regarding the policy provisions at issue and the parties supply none.

 

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CMC argues that no policy language would lead a reasonable insured to conclude that coverage to the instruments would only be triggered if the entire premises were disinfected, decontaminated or evacuated. To the contrary, the plain language leads precisely to that conclusion.

 

Restating the relevant provision, the policy defines “premises” as “that part of the location you occupy.” Engrafting that definition onto that of a “communicable disease event” yields “an event in which a public health authority has ordered that that part of the location that [CMC] occup[ies] be evacuated, decontaminated or disinfected . . . .” The parties do not dispute that the only action taken was with respect to the possibly contaminated surgical instruments and that there was no evacuation, decontamination or disinfection of any other part of the hospital.

 

Given this policy language, the existence of a “communicable disease event” serves as an important gateway to coverage. But CMC essentially ignores this step and offers no reasonable explanation as to how surgical instruments can be considered “premises,” a term which connotes a location. Instead, CMC relies on the policy’s coverage for damage to insured property-- such as surgical instruments--at the “premises.” But this proves too much. Covered instruments at the premises are indeed

 

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covered, but only, insofar as relevant here, if lost or damaged as a result of a “communicable disease event,” which requires not just a disease outbreak at the “premises,” but also that those very same “premises,” i.e., “that part of the location that CMC occupies” be, inter alia, decontaminated. This phrase, much like “premises” itself, also connotes a physical location. Reading the two references to “premises” consistently and in context, the court finds that the term refers to the physical structure of the hospital. Cf. Brickley v. Progressive N. Ins. Co., 160 N.H. 625, 629 (2010) (finding ambiguity where terms were defined inconsistently in different parts of insurance policy). Indeed, it would make little sense to read the policy as covering instruments at the premises and to consider the instruments also to be premises.

 

Finally, CMC invites the court to find ambiguity by citing internal Fireman’s Fund communications showing that there was, at some point in the claims handling process, disagreement among Fireman personnel as to the breadth of the definition of “premises,” with two Fireman’s Fund employees seemingly favoring CMC’s position. The court declines the invitation as it is improper to resort to such extrinsic evidence where, as here, the policy provision is not facially ambiguous. See In re Reid, 143 N.H. 246, 249 (1998) (noting, in context of lease interpretation,

 

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“[w]e will reverse the determination of the fact finder where, although the terms of the agreement are unambiguous, the fact finder has improperly relied on extrinsic evidence in reaching a determination contrary to the unambiguous language of the agreement.”). 3

 

Against this backdrop, the court finds that the Fireman’s Fund’s Communicable Disease Coverage does not cover CMC’s claim.4

 

2. Crisis Management Coverage

 

CMC argues that the Crisis Management Coverage Extension Endorsement covers the losses it sustained when it had to suspend its neurosurgery program in the absence of surgical instruments. Once again, though, the policy language does not support such a conclusion. While CMC is correct that the policy covers various losses caused by “suspension of operations,” such suspension must be the result of a “covered crisis event,” which requires The court also notes that while any such extrinsic evidence 3 is for the purpose of determining the parties intent in the absence of clear policy language, CMC’s putative evidence does not do that. The claims process, incepting long after the policy was drafted, has little to do with the parties’ intent. Indeed, under CMC’s novel theory, unless all of an insurer’s claimshandling personnel agreed with the ultimate decision from the outset of the claim, insureds would be entitled to coverage based on an “ambiguity.” There appears to be no authority for that proposition.

 

The court need not rule on Fireman’s Fund’s other theories: 4 lack of an “outbreak”; lack of a public health authority order; and lack of direct physical loss.

 

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“closure of the covered premises.” CMC argues that coverage of “suspension” is internally inconsistent with the requirement of “closure,” and that the provision is therefore ambiguous. Relatedly, it argues that Fireman’s Fund’s position ignores the “suspension” coverage. The court finds both arguments wanting. The policy is clear that only “a suspension . . . caused by or result[ing] from a ‘covered crisis event’” is covered. Here, again, CMC’s argument ignores the threshold requirement of a “covered crisis event”--defined as requiring closure of the premises--and focuses solely on the resulting damage. Similarly, any inconsistency between coverage for “suspension of operations” and “closure of premises” is irrelevant because only the latter term in contained within the threshold definition of “covered crisis event.” Thus, CMC’s loss is not covered under the Crisis Management Coverage Extension Endorsement.

 

IV. Conclusion

 

Eschewing, as it must, “linguistic gymnastics,” the court finds that, as relevant to CMC’s claims, the Fireman’s Fund policy is not ambiguous and does not cover those claims. Accordingly, Fireman’s Fund’s motion for summary judgment is 5 Document No. 5 15.

 

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granted and CMC’s motion for summary judgment is denied. The 6 clerk shall enter judgment accordingly and close the case.

 

SO ORDERED.

 

____________________________

 

Joseph N. Laplante United States District Judge Dated: June 1, 2015 cc: Donald L. Smith, Esq. Gregory P. Varga, Esq. Raymond T. DeMeo, Esq. Danielle Andrews Long, Esq. Document No.

 


 

Saturday, September 21, 2013

 

CJD CONFIRMED in patient at New Hampshire Department of Health and Human Services (DHHS), Catholic Medical Center (CMC), and the Manchester Health Department (MHD)

 


 

Tuesday, May 26, 2015

 

 Minimise transmission risk of CJD and vCJD in healthcare settings Last updated 15 May 2015

 


 

 Miss Storms, Olympus et al stated ;

 

>>> As duodenoscopes do not contact tissue at high risk associated with CJD, ...snip...end <<<

 

BUT, duodenoscopes DO contact medium to low dose TSE prion infections tissues, if the person being scoped is silently harboring a CJD TSE prion, thus exposing everyone after that to the CJD TSE prion disease. I am very well aware of the old study by Gibbs et al, and those brain electrodes ;

 

Transmission of Creutzfeldt-Jakob disease to a chimpanzee by electrodes contaminated during neurosurgery.

 

Gibbs CJ Jr, Asher DM, Kobrine A, Amyx HL, Sulima MP, Gajdusek DC.

 

Laboratory of Central Nervous System Studies, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD 20892.

 

Stereotactic multicontact electrodes used to probe the cerebral cortex of a middle aged woman with progressive dementia were previously implicated in the accidental transmission of Creutzfeldt-Jakob disease (CJD) to two younger patients. The diagnoses of CJD have been confirmed for all three cases. More than two years after their last use in humans, after three cleanings and repeated sterilisation in ethanol and formaldehyde vapour, the electrodes were implanted in the cortex of a chimpanzee. Eighteen months later the animal became ill with CJD. This finding serves to re-emphasise the potential danger posed by reuse of instruments contaminated with the agents of spongiform encephalopathies, even after scrupulous attempts to clean them.

 


 

regardless of how many lives endoscopy equipment saves ever year, I strongly, strenuously, urge Olympus to warn their product users, and consumers, that there is NO KNOWN way to date, that will completely clean and decontaminate the endoscopy equipment from the CJD TSE prion disease, and they risk exposure to this agent when exposed to endoscopy equipment. anything less than that would be criminal in my opinion, with the documented science to date. these atypical strains of TSE prion disease are mutating, and as they mutate, they can, and have, become more virulent.

 

with the emergence of atypical strains of TSE prion in animals and humans, we cannot wait to prove a negative, while exposing millions waiting on that negative to come. the science to date, in my opinion, has shown us that this negative has not, and is not coming, thus, exposure, and friendly fire, i.e. iatrogenic, is the key to the 85%+ of all human TSE, i.e. sporadic CJD, and once the science is finally peeled all the way back, biomarkers of some sorts are discovered, and trace back of iatrogenic events are finally able to be documented and traced back to source, I believe that companies like Olympus, that chose to continue to expose millions, regardless of these facts, will be left for much litigation.

 

I strongly urge Olympus et al to state plainly these risk factors of their equipment to the CJD TSE prion like disease, for all to know and see, ASAP. ...

 

thank you, with kind regards, terry

 

Saturday, January 16, 2010

 

*** Evidence For CJD TSE Transmission Via Endoscopes 1-24-3 re-Singeltary to Bramble et al ***

 

Evidence For CJD/TSE Transmission Via Endoscopes

 

From Terry S. Singletary, Sr flounder@wt.net 1-24-3

 

Terry S. Singeltary Sr., P.O. BOX 42, Bacliff, Texas 77518 USA

 


 

Professor Michael Farthing wrote:

 

Louise Send this to Bramble (author) for a comment before we post. Michael

 

snip...

 

Evidence For CJD/TSE Transmission Via Endoscopes

 

From Terry S. Singletary, Sr flounder@wt.net 1-24-3

 

I have researched human/animal TSEs now for over 5 years due to the death of my Mother from the Heidenhain Variant Creutzfeldt Jakob disease, one of six - known - variants of the infamous 'sporadic' CJD.

 

I did a little survey several years ago about CJD and ENDOSCOPY in 2001, and then went there again when another article was released recently. However, they seemed to only be concerned with the vCJD strain and risk from endoscopy equipment.

 

My concerns are if vCJD can be transmitted by blood, and there are now 6 variants of the infamous sporadic CJDs that they are documenting to date, how do they know that none of these 6 variants will not transmit the agent (prion) via blood?...especially since the sporadic CJDs are the only ones documented to date to transmit via the surgical arena and now that the CWD is spreading more and more, who knows about the cattle?

 

I would always read this study and it would bring me back to reality as to how serious/dangerous this agent is in the surgical/medical arena. You might want to read this short abstract from the late, great Dr. Gibbs twice, and let it really sink in. And please remember while reading some of these transmission studies, that most all, if not ALL these agents transmit freely to primates. Humans, of course, are primates.

 

Regarding claims that:

 

'Well, it has never been documented to transmit to humans."

 

There are two critical factors to think about:

 

A. CJD/TSEs in the USA are NOT reportable in most states and there is NO CJD/TSE questionnaire for most victims and their families, and the one they are now issuing asks absolutely nothing about route and source of the (prion) agent, only how the disease was diagnosed. Furthermore, the elderly are only very rarely autopsied, ie looking for Alzheimer's or 'FAST Alzheimer's' OR prion disease-related factors and phenomena, such as heart failure caused by disease.

 

B. It is unethical and against the law to do transmission studies of TSEs to humans, they are 100% FATAL.

 

I suggest you read these case studies about medical arena CJD transmission very carefully:

 

1: J Neurol Neurosurg Psychiatry 1994 Jun;57(6):757-8

 

Transmission of Creutzfeldt-Jakob disease to a chimpanzee by electrodes contaminated during neurosurgery.

 

Gibbs CJ Jr, Asher DM, Kobrine A, Amyx HL, Sulima MP, Gajdusek DC.

 

Laboratory of Central Nervous System Studies, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD 20892.

 

Stereotactic multicontact electrodes used to probe the cerebral cortex of a middle aged woman with progressive dementia were previously implicated in the accidental transmission of Creutzfeldt-Jakob disease (CJD) to two younger patients. The diagnoses of CJD have been confirmed for all three cases. More than two years after their last use in humans, after three cleanings and repeated sterilisation in ethanol and formaldehyde vapour, the electrodes were implanted in the cortex of a chimpanzee. Eighteen months later the animal became ill with CJD. This finding serves to re-emphasise the potential danger posed by reuse of instruments contaminated with the agents of spongiform encephalopathies, even after scrupulous attempts to clean them.

 


 

Tissue Infectivity and TSEs (brain = high / rectum = medium)

 

snip...see full text ;

 

Evidence For CJD TSE Transmission Via Endoscopes 1-24-3

 

re-Singeltary to Bramble et al

 

Evidence For CJD/TSE Transmission Via Endoscopes

 

From Terry S. Singletary, Sr flounder@wt.net 1-24-3

 


 

Subject: CJD * Olympus Endoscope

 

Date: Sun, 10 Oct 1999 16:41:49 –0500

 

From: "Terry S. Singeltary Sr."

 

Saturday, February 21, 2015

 

Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication

 


 

Wednesday, September 10, 2014

 

Creutzfeldt-Jakob disease (CJD) biannual update (August 2014), with updated guidance on decontamination of gastrointestinal endoscopy equipment

 

Research and analysis

 


 

Blood reference materials from macaques infected with variant Creutzfeldt-Jakob disease agent

 


 

*** O.05: Transmission of prions to primates after extended silent incubation periods: Implications for BSE and scrapie risk assessment in human populations ***

 

Emmanuel Comoy, Jacqueline Mikol, Val erie Durand, Sophie Luccantoni, Evelyne Correia, Nathalie Lescoutra, Capucine Dehen, and Jean-Philippe Deslys Atomic Energy Commission; Fontenay-aux-Roses, France

 

Prion diseases (PD) are the unique neurodegenerative proteinopathies reputed to be transmissible under field conditions since decades. The transmission of Bovine Spongiform Encephalopathy (BSE) to humans evidenced that an animal PD might be zoonotic under appropriate conditions. Contrarily, in the absence of obvious (epidemiological or experimental) elements supporting a transmission or genetic predispositions, PD, like the other proteinopathies, are reputed to occur spontaneously (atpical animal prion strains, sporadic CJD summing 80% of human prion cases). Non-human primate models provided the first evidences supporting the transmissibiity of human prion strains and the zoonotic potential of BSE. Among them, cynomolgus macaques brought major information for BSE risk assessment for human health (Chen, 2014), according to their phylogenetic proximity to humans and extended lifetime. We used this model to assess the zoonotic potential of other animal PD from bovine, ovine and cervid origins even after very long silent incubation periods. We recently observed the direct transmission of a natural classical scrapie isolate to macaque after a 10-year silent incubation period, with features similar to some reported for human cases of sporadic CJD, albeit requiring fourfold longe incubation than BSE. Scrapie, as recently evoked in humanized mice (Cassard, 2014), is the third potentially zoonotic PD (with BSE and L-type BSE), ***thus questioning the origin of human sporadic cases. We will present an updated panorama of our different transmission studies and discuss the implications of such extended incubation periods on risk assessment of animal PD for human health.

 

===============

 

***thus questioning the origin of human sporadic cases...TSS

 

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P.164: Blood transmission of prion infectivity in the squirrel monkey: The Baxter study

 

Paul Brown1, Diane Ritchie2, James Ironside2, Christian Abee3, Thomas Kreil4, and Susan Gibson5 1NIH (retired); Bethesda, MD USA; 2University of Edinburgh; Edinburgh, UK; 3University of Texas; Bastrop, TX USA; 4Baxter Bioscience; Vienna, Austria; 5University of South Alabama; Mobile, AL USA

 

Five vCJD disease transmissions and an estimated 1 in 2000 ‘silent’ infections in UK residents emphasize the continued need for information about disease risk in humans. A large study of blood component infectivity in a non-human primate model has now been completed and analyzed. Among 1 GSS, 4 sCJD, and 3 vCJD cases, only GSS leukocytes transmitted disease within a 5–6 year surveillance period. A transmission study in recipients of multiple whole blood transfusions during the incubation and clinical stages of sCJD and vCJD in ic-infected donor animals was uniformly negative. These results, together with other laboratory studies in rodents and nonhuman primates and epidemiological observations in humans, ***suggest that blood donations from cases of GSS (and perhaps other familial forms of TSE) carry more risk than from vCJD cases, and that little or no risk is associated with sCJD. The issue of decades-long incubation periods in ‘silent’ vCJD carriers remains open.

 

=============

 

***suggest that blood donations from cases of GSS (and perhaps other familial forms of TSE) carry more risk than from vCJD cases, and that little or no risk is associated with sCJD...see;

 

============= P.23: An improved test for the detection of Creutzfeldt-Jakob Disease from human CSF using new RT-QuIC conditions

 

Bradley R Groveman1, Christina D Orr u1, Andrew G Hughson1, Gianluigi Zanusso2, Maurizio Pocchiari3, Michael B Coulthart4, and Byron Caughey1 1Laboratory of Persistent Viral Diseases; Rocky Mountain Laboratories; NIAID; NIH; Hamilton, MT USA; 2Department of Neurological and Movement Sciences; University of Verona; Verona, Italy; 3Department of Cell Biology and Neurosciences; Istituto Superiore di Sanit a; Rome, Italy; 4Canadian CJD Surveillance System; Public Health Agency of Canada; Ottawa, ON Canada

 

Neurodegenerative protein misfolding diseases are difficult to diagnose early and accurately. This is particularly worrisome with human prion diseases, such as Creutzfeldt- Jakob disease (CJD), because prions are transmissible, deadly, and unusually resistant to decontamination. Real-time quaking-induced conversion (RT-QuIC) assays allow highly sensitive and specific testing for CJD using human cerebrospinal fluid (CSF) or nasal brushings and are being widely implemented as important diagnostic tools. However, such laboratory analyses have required 2.5 to 5 d to complete. Furthermore, CSF testing using previously evaluated RT-QuIC conditions still yields false negative results in 11 to 23% of CJD cases. We have now developed an improved RT-QuIC assay which can identify positive CSF samples within 4 to 14 h with better analytical and diagnostic sensitivity. Analysis of CSF samples from 11 CJD patients demonstrated that while 7 were RT-QuIC positive using previous conditions, an additional 3 samples were positive using the new assay. In these and subsequent analyses, a total of 46 of 48 CSF samples from sporadic CJD patients gave positive RT-QuIC responses, while all 39 non-CJD patients were negative, giving 95.8% diagnostic sensitivity and 100% specificity. This diagnostic sensitivity was significantly better than that obtained using the previous conditions. We continue to expand the testing of CJD-positive and -negative CSF samples to further establish the diagnostic utility of this new assay for various human prion diseases. So far, our improved RT-QuIC assay appears to allow for much faster, more accurate and practical antemortem testing for CJD using CSF samples.

 

===========

 

P.159: Improvements of nasal brushing procedure for Creutzfeldt-Jakob disease diagnosis

 

Matilde Bongianni1, Christina Orr u2, Giovanni Tonoli3, Bradley Groveman2, Giorgo Triva4, Santina Castriciano4, Luca Sacchetto1, Andrew Hughson2, Annachiara Cagnin5, Stefano Capaldi1, Sergio Ferrari1, Michele Fiorini1, Salvatore Monaco1, Maurizio Pocchiari6, Byron Caughey2, and Gianluigi Zanusso1 1University of Verona; Verona, Italy; 2Rocky Montain Laboratories; Hamilton, MT USA; 3Ospedale “Santa Maria della Misericordia”; Rovigo, Italy; 4Copan Italia S.P.A.; Brescia, Italy; 5University of Padua; Padua, Italy; 6Istituto Superiore di Sanit a; Rome, Italy

 

Introduction. We previously identified prion seeding activity in olfactory mucosa (OM) of CJD patients using nasal brushings coupled with Real Time Quaking induced Conversion (RT-QuIC) with 100% specificity and >97% sensitivity. OM samples were collected using a sterile disposable Cyto-brush (Kito-Brush, Kaltek) which might provoke a mild discomfort for patients. Therefore, we aimed to use a more gentle tool for OM samplings such as short nylon fiber Flocked swabs (Copan technologies).

 

Materials and Methods. We collected OM and CSF samples in 43 CJD patients. To ensure efficient OM sample collection, each patient underwent to two OM samplings using flocked swabs one in each nostril and a final with Cytobrush. OM samples were processed and analyzed by RT-QuIC, as previously described.

 

Results. Using Cyto-brushes 32 out of 35 OM samples were positive by RT-QuIC analysis, while flocked swabs in 40 out of 43 OM samples. In contrast, CSF samples were positive in 33 out of 43. Two OM samples resulted negative for both Cyto-brush and Flocked swab. Neither OM sampling technique or CSF produced false positives.

 

***Conclusion. This study demonstrates that OM brushing following RT-QuIC ssay is 95% sensitive and 100% specific in CJD diagnosis while CSF resulted 77% sensitive. OM collection using flocked swabs is preferred and provides same sensitivity as cyto-brush. These data recommend four separate samplings possibly from both nostrils to maximize the sensitivity, using three Flocked swabs and lastly a brush.

 

============

 

 snip...see ; Saturday, May 30, 2015

 

PRION 2015 ORAL AND POSTER CONGRESSIONAL ABSTRACTS

 


 

Wednesday, December 11, 2013

 

*** Detection of Infectivity in Blood of Persons with Variant and Sporadic Creutzfeldt-Jakob Disease ***

 


 

THE BAXTER STUDY...SEE MORE HERE ;

 


 

Tuesday, April 21, 2015

 

Transmissible Spongiform Encephalopathy Advisory Committee TSEAC MEETING SCHEDULED FOR June 1, 2015

 


 

Saturday, April 18, 2015

 

*** vCJD TEXAS CDC Emerging Infectious Diseases May 2015 Baylor College of Medicine Neuroscience 2014 case of human form of “mad cow disease” highlights need for continued surveillance

 


 

Saturday, May 09, 2015

 

*** Psychiatric Symptoms in Patients With Sporadic Creutzfeldt-Jakob Disease ***

 


 


 


 

TSS

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