Transcript Additional Legal Issues (cont`d) - The American Health Lawyers

Fungal Meningitis Outbreak
in 2012
Marion Kainer MD MPH FRACP - TN Department of Health
Sandy Bledsoe - Assistant Vice Chancellor, Risk & Insurance
Management, Vanderbilt University
Julia Morris - Deputy General Counsel, Vanderbilt University
January 24, 2013
AHLA Issues Affecting Academic Medical
Centers and Other Teaching Institutions
The First Fungal Meningitis
Outbreak Case
• Late summer/early fall: middle aged
man presented with meningitis
– History of epidural steroid injections
– No immunosuppression
– Otherwise healthy
• Initially improved with standard therapy
Vanderbilt University
Vanderbilt University Medical Center
Fungal Meningitis Outbreak
• Condition deteriorated – antifungal therapy
begun
• CSF grew Aspergillus fumigatus
• Tennessee DOH notified
• Death on day 22 of hospitalization
Vanderbilt University
Vanderbilt University Medical Center
Timeline of
Major Events
Date
Major Events
Day 1:
Tuesday,
Sept 18
• Dr. Marion Kainer receives an email from Dr. April 1 case of
Pettit, Infectious Diseases Physician, Vanderbilt
Aspergillus
University Medical Center, about patient with
meningitis
meningitis caused by a fungus, Aspergillus
fumigatus, who had a recent epidural injection at a
pain clinic.
• Dr. Kainer and Dr. Pettit discuss the case.
• Dr. Kainer speaks with Ms. Candace Smith,
infection preventionist (IP) at St Thomas Hospital
(STH), which is organizationally affiliated with the
St Thomas Outpatient Neurosurgical Center
(STONC) where the patient received the injection.
Vanderbilt University
Case Count
as Known at
That Time
Vanderbilt University Medical Center
Date
Major Events
Case Count
as Known at
That Time
Day 3:
• IP from STH contacts Dr. Kainer and confirms that
Thursday,
index case had an epidural steroid injection (ESI)
Sept 20
at STONC. Facility Manager of STONC is on
vacation, so IP at STH continues to help in
investigation.
• Dr. Kainer contacts Dr. Perz at the Division of
Healthcare Quality Promotion (DHQP), Centers for
Disease Control and Prevention (CDC).
• STH reports two additional patients with
meningitis with high levels of white blood cells but
no known cause. Both had undergone ESIs at
STONC.
Vanderbilt University
1 case of
Aspergillus
meningitis
2 cases of
meningitis,
unknown
cause, both
seeming to be
improving
No national
reports of
Aspergillus
meningitis
Vanderbilt University Medical Center
Date
Major Events
Case Count
as Known at
That Time
Day 4:
Friday,
Sept 21
• Visit to STONC by TDH staff for careful review of
all procedures and the physical environment: no
evidence observed of environmental conditions that
would have led to fungal contamination of
procedures.
• TDH contacts CDC and describes findings of site
visit. TDH asks CDC to help with laboratory
testing of patients with meningitis.
• Another patient with meningitis and stroke with a
history of ESI at STONC is identified, while
VUMC also reports yet another patient.
• TDH sent out Health Alert using our TN Health
Alert Network (THAN).
1 case of
Aspergillus
meningitis
Vanderbilt University
2 cases of
meningitis,
unknown cause,
both seeming to
be improving
1 case of stroke
and meningitis,
unknown cause
1 case of stroke;
no spinal tap
done
Vanderbilt University Medical Center
Date
Major Events
Case Count
as Known at
That Time
Day 6:
Sunday,
Sept 23
• IP at STH contacts Dr. Kainer about one new
patient and one patient readmitted with meningitis;
both had ESI at SONC
Day 7:
Monday,
Sept 24
• Facility manager from STONC has returned from
vacation and provides additional information on
the facility practices. TDH staff arrange to begin
collecting data on patients.
• Dr. Kainer contacts State epidemiologist at
Massachusetts Department of Health.
1 case
Aspergillus
meningitis
4 cases of
meningitis
unknown cause
1 case of stroke,
but no spinal
tap done
Vanderbilt University
Vanderbilt University Medical Center
Date
Major Events
Case Count
as Known at
That Time
Day 8:
Tuesday,
Sept 25
• 2 new cases of meningitis reported to TDH. Both
had ESI using MPA from NECC at STONC.
• Conference call with TDH, CDC, Massachusetts
Department of Health and Board of Registration in
Pharmacy (MABRP) and NECC. NECC stated no
adverse events reported, no new suppliers of
ingredients or changes in procedures.
• STONC starts contacting potentially exposed
patients.
• A new patient who had an ESI at STONC was
admitted to STH.
1 case
Aspergillus
meningitis
Vanderbilt University
6 cases of
meningitis
unknown cause
1 case of stroke,
but no spinal
tap done
1 case other
neurologic
problems/abnor
mal spinal tap
(unknown
cause)
Vanderbilt University Medical Center
Date
Day 9:
Wed,
Sept 26
Day 10:
Thurs,
Sept 27
Major Events
Case Count
as Known at
That Time
Timeline of Major Events
• NECC issues voluntary
recall for 3 lots of
(cont’d)
preservative free MPA and provides distribution
list of consignees to MABORP and FDA.
• TDH and CDC draft an Epi-X Alert.
• TDH staff complete first round of epidemiologic
studies; preliminary findings supports that MPA is
likely source.
• TDH asks STONC to contact all patients who had
procedures since July 30.
• Analysis of the NECC distribution list shows two
other clinics in TN received MPA.
• North Carolina (NC) reports a patient with
meningitis exposed to MPA from NECC.
Vanderbilt University
Vanderbilt University Medical Center
Date
Major Events
Day 11:
Fri,
Sept 28
• Still not absolutely clear that MPA from NECC is
only possible source of contamination.
• CDC notifies all State Health Departments of
situation and urges them to contact clinics who do
ESIs.
• CDC issues another national Epi-X alert indicating
that this now is a multi-state outbreak and
requesting reports of meningitis.
Day 13:
Sunday,
Sept 30
• TDH and STONC staff continue to abstract data on
patients who had procedures since July 1
Day 14:
Monday,
Oct 1
• TDH holds its first press conference and initiates a
daily scheduled press briefing.
Vanderbilt University
Case Count
as Known at
That Time
11 cases,
2 deaths
Vanderbilt University Medical Center
Date
Major Events
Day 15:
Wed
Oct 3
18 cases,
• CDC issues interim guidance on diagnostics and
2 deaths
clinical management using input from an expert
fungal clinical panel convened by CDC.
• For the first time since the initial report, a tissue
biopsy from a case patient shows a fungus.
However, the fungus looks different than
Aspergillus. More tests must be done to identify it.
• TDH analysis of STONC patients suggests that one
particular lot of the 3 NECC MPA lots present at
STONC is the most likely to make patients sick:
Lot 06292012.
Vanderbilt University
Case Count
as Known at
That Time
Vanderbilt University Medical Center
Date
Major Events
Day 16:
Thurs,
Oct 4
• A final identification of fungus causing illness still 25 cases,
3 deaths
not made, but specimen from another patient who
died shows fungus that is not Aspergillus.
• FDA announces fungus was seen on microscopic
examination of an unopened vial of MPA from
Lot 08102012.
• This now is very strong evidence that MPA is the
cause of the outbreak.
• TDH alerts TN healthcare facilities using THAN to
cease use of all medications and products from
NECC.
Vanderbilt University
Case Count
as Known at
That Time
Vanderbilt University Medical Center
Date
Major Events
Case Count
as Known at
That Time
Day 17:
Friday,
Oct 5
TDH opens state health operations center to assist in
case tracking, active surveillance, mobilizes regional
health operations centers and uses public health
nurses to contact hard to reach patients.
29 cases,
3 deaths
Day 18:
Sat,
Oct 6
NECC announces voluntary recall of all NECC
products.
FDA issues Medwatch alert asking providers to stop
using any NECC products.
29 cases,
3 deaths
Day 24:
Fri,
Oct 12
MMWR (CDC publication) is published on clinical
presentation of cases.
50 cases,
6 deaths
Vanderbilt University
Vanderbilt University Medical Center
Date
Major Events
Case Count
as Known at
That Time
Day 26:
Sunday,
Oct 14
FDA call with States and CDC on concerns about
sterility of any product from NECC.
53 cases,
6 deaths
Day 27:
Monday,
Oct 15
• FDA issues Medwatch alert.
• TDH works with the Tennessee Hospital
Association (THA) to identify and notify patients
who received NECC products.
53 cases,
6 deaths
Day 29:
Wed,
Oct 17
TDH identifies that patients who received older vials
are much more likely to get sick.
61 cases,
8 deaths
Vanderbilt University
Vanderbilt University Medical Center
Date
Major Events
Case Count
as Known at
That Time
Day 30:
Thurs,
Oct 18
• TDH works with CDC experts to develop
mathematical model used for decision analysis by
CDC about what to do for high risk patients.
• For the first time, CDC and FDA confirm
presence of Exserohilum rostratum in unopened
vials from Lot 0810210@51
63 cases,
8 deaths
Day 35:
Tuesday,
Oct 23
MA Board of Registration in Pharmacy issues report
initial preliminary findings.
70 cases,
9 deaths
Day 38:
Friday,
Oct 26
FDA releases copy of FDA form 483. All 50 vials of
MPA tested showed contamination (likely fungal).
74 cases,
10 deaths
Vanderbilt University
Vanderbilt University Medical Center
Date
Major Events
Case Count
as Known at
That Time
Day 48:
Tuesday,
Nov 6
The New England Journal of Medicine publishes an
article written by TDH and CDC investigators on this
outbreak.
78 cases,
13 deaths
Day 51:
Friday,
Nov 9
TDH invited to provide testimony to the Senate HELP 81 cases,
13 deaths
committee.
Vanderbilt University
Vanderbilt University Medical Center
Lessons Learned
Lessons Learned
• Compounding and/or repackaging of
medications must be performed safely.
• Recent investments in public health
infrastructure through cooperative
agreements from the CDC have
supported building public health capacity
at the TDH.
Vanderbilt University
Vanderbilt University Medical Center
Lessons Learned (cont’d)
• Relationships with Federal partners were
critical in the response to this outbreak.
– CDC provided invaluable assistance
throughout the outbreak including
weeknights and weekends
– FDA provided valuable information on local
inspection findings, as well as laboratory
testing of products
Vanderbilt University
Vanderbilt University Medical Center
Lessons Learned (cont’d)
• Relationships and Infrastructure
Vanderbilt University
Vanderbilt University Medical Center
Conclusion
This has been a devastating outbreak for
patients, their families and friends,
healthcare providers and clinics. In
Tennessee we still have many patients
hospitalized and suffering from
complications and others who are exposed
and frightened that they may become
infected.
Vanderbilt University
Vanderbilt University Medical Center
Conclusion
Sustained commitment to funding for
emergency preparedness and reduction of
healthcare associated infections through
cooperative agreements from the CDC has
supported our productive relationships
with our partners and healthcare providers
across the state.
Vanderbilt University
Vanderbilt University Medical Center
Conclusion
These pre-existing relationships allowed us
to respond quickly because we trusted each
other. We all need to work together to do
our best to prevent such a tragedy from
occurring again and to ensure that we have
the public health capacity to detect and
rapidly respond to any future outbreaks.
Vanderbilt University
Vanderbilt University Medical Center
Legal and Risk Management
Considerations
• Searching for product in our facility and
affiliates
– NECC
– Ameridose
• Potential medical malpractice claims
• Case Study Publication
– Communication with family
– Manuscript review
Vanderbilt University
Vanderbilt University Medical Center
Legal and Risk Management
Considerations
• Patient notification
– Obligations vs. proactive management
• Compounding issues
– Initial
– Ongoing
• Insurance coverage limits – how much is
appropriate?
Vanderbilt University
Vanderbilt University Medical Center
Additional Legal Issues
• HIPAA issues
– Public Health Exception
– Review prior to NEJM case study
publication
• Privacy Issues
• Balancing Possible liability vs publication/1st
Amendment considerations
– Press inquiries – local and national
Vanderbilt University
Vanderbilt University Medical Center
Additional Legal Issues (cont’d)
• Relationships with Third Parties
–
–
–
–
Pharmacies
Partnerships
Holding out to public
Branding, reputational risk
Vanderbilt University
Vanderbilt University Medical Center
Vanderbilt University
Vanderbilt University Medical Center
Additional Legal Issues (cont’d)
• Regulatory Issues with Compounding
Pharmacies, in-house compounding
• Duty of Due Diligence for Purchasing
from Compounding Pharmacies – a new
standard?
Vanderbilt University
Vanderbilt University Medical Center
Vanderbilt University
Vanderbilt University Medical Center
Additional Legal Issues (cont’d)
• FDA Oversight / State Law
Vanderbilt University
Vanderbilt University Medical Center
Vanderbilt University
Selected Pharmacy Sterile Compounding Misadventures
Year
State
Description
1990
Nebraska
4 patients died of a bacterial infection from non-sterile cardioplegia solution compounded in a hospital
1990
Pennsylvania
2 patients lost their vision after becoming infected by Pseuomonas aeruginosa found in indomethacin eye
drops compounded in a drug store even though commercial non-steroidal drops were available at the time
1998
California
11 children became septic – 10 tested positive for Enterobacter cloacae blood-stream infections associated
with contaminated prefilled saline syringes
2001
California
11 patients contracted Serratia marcescens infections following the injection of betamethasone compounded
at a community pharmacy
2001
Missouri
4 children contracted Enterobacter cloacae infections from IV ranitidine
compounded in a hospital pharmacy
2002
North Carolina
South Carolina
5 patients developed Exophiala infections from contaminated injectable methylPREDNISolone prepared by a
compounding pharmacy; one patient died
2002
Michigan
Pharmacy preparing injectable methylPREDNISolone and baclofen recalled the products because of
contamination with Penicillium mold, Methylobacterium, and/or Mycobacterium chelonae
2003
Missouri
Bacteria contamination with Burkholderia cepacia found in at least 2 batches of a compounded inhalant
solution used by 19,000 patients with chronic lung diseases
2004
Texas, New
York,
Michigan,
Missouri
36 patients developed Pseudomonas bloodstream infections after receiving heparin/saline flushes from
multiple lots of preloaded syringes
2005
New Jersey,
California
Up to 25 patients contracted Serratia marcescens infections due to contaminated magnesium sulfate minibags prepared by a compounding pharmacy
2005
Minnesota
2 patients were blinded after receiving a compounded trypan blue ophthalmic injection contaminated with
Pseudomonas aeruginosa and Burkholderia cepacia
Vanderbilt University
Vanderbilt University Medical Center
Selected Pharmacy Sterile Compounding Misadventures
Year
State
Description
2005
California
Sterile talc vials with unwashed stoppers were not sterility tested before distribution from a compounding
pharmacy
2005
Maryland
10 patients died after exposure to cardioplegia solution from 2 lots contaminated with gram-negative rods
2006
Nevada
1 baby died from a 1,000-fold zinc overdose (mcg and mg zinc sulfate confused) compounded in a hospital
pharmacy
2006
Ohio
1 child died after a compounding error led to administration of chemotherapy in 23.4% sodium chloride
injection instead of 0.9% sodium chloride
2007
Washington,
Oregon
2, possibly 3, patients died after receiving an IV colchicine product compounded at a concentration higher
than standard (4 mg/ml. vs. 0.5 mg/ml) in a compounding pharmacy
2009
Florida
21 horses died after receiving a compounded vitamin supplement containing vitamin B, potassium,
magnesium, and selenium (product not approved in the US)
2010
Illinois
1 child died after receiving more than 60 times the amount of sodium chloride prescribed due to a
compounding error in a hospital pharmacy
2011
California,
Florida,
Tennessee
16 patients being treated for wet macular degeneration developed severe eye infections due to contamination
of AVASTIN (bevacizumab) during compounding; one patient lost vision, another patient developed a brain
infection
2011
Alabama
9 patients among 19 died when parenteral nutrition solutions were contaminated with Serratia marcescens
during compounding using non-sterile components to prepare amino acids in a compounding pharmacy
2012
California
9 patients developed fungal endophthalmitis after use of the compounded product Brilliant Blue-G (BBG) or
receiving injections of triamcinolone-containing products dispensed from the same compounding pharmacy
2012
Nationwide
More than 200 patients contracted fungal meningitis after receiving methlyPREDNISolone acetate injection
prepared by a compounding pharmacy that was contaminated with Exserohilum (a brown-black mold) and
Aspergillus species
Vanderbilt University
Vanderbilt University Medical Center
Additional Legal Issues (cont’d)
• Informed Consent
– Duty to inform patients drugs obtained from
compounding pharmacy?
• Plethora of Plaintiff Attorney
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