Transcript Slide 1

Presentation for Alabama
Hospital Association
Objectives
1. To familiarize Hospital
Association Personnel with
federal criminal violations that
they may encounter.
2. To encourage Hospital
Association Personnel and their
delegates to report these
violations to FDA/OCI (ASAP).
FDA/ Office of Criminal
Investigations
• OCI was established in 1992.
• The Office of Criminal Investigations
currently operates out of 29 offices
throughout the United States.
• There are approximately 180 Special
Agents hired from other traditional law
enforcement agencies.
Office of Criminal Investigations
• OCI is the criminal investigative arm of the FDA.
• OCI is a traditional Federal Criminal Investigative
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Agency.
OCI does not conduct inspections or conduct
typical regulatory functions.
FDA Investigators (Consumer Safety Officers)
and Inspectors conduct regulatory inspections;
OCI Special Agents have full federal law
enforcement authority, conduct criminal
investigations and present cases to the U.S.
Attorney’s Office for federal prosecution.
OCI Field and Resident Offices
Minneapolis
Detroit
Syracuse
Seattle
Boston
Buffalo
New York
Chicago
Philadelphia
San Francisco
Cincinnati
Denver
Kansas City
Nashville
Los Angeles
OCI Headquarters
Metro Washington
Norfolk
Raleigh
Birmingham
Atlanta
Phoenix
Headquarters
Field Offices
Resident Offices
Domicile Offices
Austin
Dallas
San AntonioHouston
New Orleans
Tampa
Miami
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.
San Juan
General Areas of
Enforcement
 Manufacturing and Distribution of counterfeit and unapproved drugs
 Illicit prescription drug diversion (DEA vs. FDA/OCI)
 Product substitution crimes
 Product Tampering
 Schemes involving fraudulent health treatments
 New drug application fraud
 Fraud associated with clinical investigations
 Frauds involving FDA regulated products
U.S.
Intelligence
Community
Federal
Law Enforcement
Agencies
Private
Industry
OCI
Foreign
Law Enforcement
Agencies
U.S.
Attorney’s
FDA
Federal/State
Health
Authorities
State/Local
Law Enforcement
Agencies
Federal Anti-Tampering Act
18 USC 1365(a)-Whoever, with reckless
disregard for the risk that another person will
be placed in danger of death or bodily injury
and under circumstances manifesting extreme
indifference to such risk, tampers with any
consumer product that affects interstate or
foreign commerce, or the labeling of, or
container for, any such product, or attempts to
do so, commits product tampering.
Federal Anti-Tampering Act
1. Food, drugs, medical devices, cosmetics, biologics (such
as blood) are all considered to be consumer products.
2. It is not necessary that death or bodily injury occur.
3. It is not necessary to prove that the suspect intended to
cause death or bodily injury.
4. All that is required is, as a result of the tampering, death
or any bodily injury could have happened.
5. Bodily injury is any physical or mental injury, however
slight, no matter how temporary.
Federal Anti-Tampering Act
Definition of Bodily Injury
(18 USC 1365(h)(4))
• A cut, abrasion, bruise, burn, or disfigurement.
• Physical pain.
• Illness.
• Impairment of the function of a bodily member, organ, or
mental faculty.
• Any other injury to the body, no matter how temporary.
Federal Anti-Tampering Act
Additional charges within the statute
• 18 USC §1365(b) – intent to cause serious injury the
business of any person, taints any consumer product…
• 18 USC §1365(c) – knowingly communicates false
information that a consumer product has been
tainted,…,and if such tainting, had it occurred, would
create a risk of death or bodily jury to another person…
• 18 USC §1365(d) – knowingly threatens and threat may
reasonably be expected to be believed.
• 18 USC §1365(e) – conspiracy – 2 or more persons
tamper or attempt to tamper with a consumer product.
Penalties
1. Level 25 (57-71 months)
2. Enhancement for multiple victims.
3. Enhancement for serious bodily injury or
death.
4. Special Skill or Position of Trust
5. Maximum penalty is life.
Signs of Tampering/Drug Diversion
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Tampering often referred to as “substitution.”
Missing drugs – controlled & non-controlled
Incorrect counts (reconciliation), or not!
Apparent false record reporting
Suspicious behavior by staff member
Multiple unjustified or cancelled accesses to automated medicine
dispensing (Pyxis) machines
Visual signs of compromised drug packaging/needles/vials etc.
Exaggerated claims by staff regarding wasting or loss of drug
product.
Records reflect the over-prescribing or the inadequate prescribing of
drugs to patients.
Increase in patient complaints of pain after receiving pain
medication.
Signs of Tampering/Drug Diversion
Suspect is acting suspicious and may be doing the
following:
– Taking a great deal of time off or always on-duty or in the
hospital when not on-duty
– Extended unexplained absences
– Extended restroom breaks
– Mood swings
– Personal life issues
– Coming in early, staying late
– Always where they shouldn’t be or not where they should be
– Dealing with patients who require pain medications
– Nervousness, nausea, change in behavior
If you suspect tampering
• Call FDA/OCI immediately
– Even if only a mere suspicion – let us do our job and
reduce your liability
– Don’t wait until someone gets hurt
– Collect and segregate evidence – chain of custody –
but don’t talk to suspect and don’t conduct a full
investigation
• Press/Discovery Issues
– Why it is better to be a part of the solution instead of
being part of the problem
Course of Action by FDA/OCI
• Arrange for interview of MedExec/Hospital
Staff or delegate (away from suspect)
• Obtain documents and evidence
• Initiate investigation
– Surveillance
– Interviews
– Cameras (non-private areas)
– Subpoenas directed towards suspect
Review
1. Not every drug theft is a tampering case. Not every tampering
case is going to get prosecuted.
2. Must be an adulteration of the product, its container, or its
labeling.
3. As a result of the tampering, there must be the risk of death or
any bodily injury – just the risk!
4. Take custody of any suspected tampered drug products –
minimize handling and maintain chain of custody. Check
remaining sources – or ask us to check as soon as possible.
5. Engage OCI as soon as possible. This is a Federal crime – not a
state or local police department matter.
Concealing Unlawful Activity
1. Telling patients or staff to not tell anyone.
2. Destroying or altering documents to conceal
the activity or minimize liability.
3. Lying to any regulatory or law enforcement
agency.
4. Withholding information/documents pertinent
to the investigation.
Preventative Measures to avoid
tampering/drug diversion
• Create Rules/policies and procedures that deter such
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activity.
Incorporate a “check and balance” system.
Always have at least two qualified individuals responsible
for accountability of the drugs.
Require documentation - Review documentation.
Random Audits of both paperwork and physical
inventory.
Random drug testing-Don’t wait for incident to occur.
(Make sure testing facility will provide you with what you
expect.) Conduct the “right” tests.
Play “devil’s advocate” – look for risks, then eliminate
them.
Pay attention to your employees and their behavior.
Drug Diversion
• Theft of commercial quantities of drugs for
profit.
* Controlled vs. non-controlled.
* Drugs are resold at a profit to a third
party distributor.
• Diverted for personal use
* Discuss need to determine if tampering
was an issue. If simple theft, then
discuss DEA’S involvement
U.S. v Nancy L. Moyer (No. 981981/8th Circuit, 1999)
FACTS
• Moyer, a medical doctor, was charged
with product tampering (18 USC
1365(a)) after an investigation
determined that she had been inserting a
needle-syringe into a morphine delivery
device in a hospital, removing morphine
and replacing it with saline. Moyer was
subsequently found guilty and appealed
her conviction on several grounds.
U.S. v Nancy L. Moyer (No. 981981/8th Circuit, 1999)
Issues
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Moyer argued that the government was required to
prove that Moyer performed a malicious act when
tampering with a consumer product beyond merely
tampering with the product.
Moyer argued that her actions did not constitute a
reckless disregard of exposing others to the possibility
of death or bodily injury and that she did not act with
extreme indifference to such risk.
Moyer contended that her tampering with the drug
delivery device did not constitute any effect upon
interstate commerce.
Moyer argued that she did not act with extreme
indifference regarding risks to which her tampering
exposed her patients to.
Moyer argued that her resulting sentence was too
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U.S. v Nancy L. Moyer (No. 981981/8th Circuit, 1999)
Decision
The court ruled that there was no requirement for the
government to show that Moyer acted maliciously. The court
ruled that the term, "tampering," merely describes the physical
act of product adulteration.
As a result of Moyer's morphine thefts, her hospital was required
to order additional morphine from out-of-state manufacturers.
This was sufficient to support a finding that Moyer's tampering
had an effect upon interstate commerce.
Testimony by expert witnesses that Moyer's morphine thefts
placed her patients at risk of increased pain, agitation, infection,
and air embolism and the defendant, as a physician, was aware
at the time of the tampering that her actions could have created
health risks for her patients was sufficient to support a jury's
finding that Moyer acted with reckless disregard of serious health
risks to which her actions exposed her critically ill patients.
U.S. v Nancy L. Moyer (No. 981981/8th Circuit, 1999)
Decision (cont)
• Evidence that Moyer stole morphine from an
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elderly patient who was dying of lung disease
and who was taking morphine to relieve pain
through the dying process, was sufficient to
support a finding that the defendant acted under
circumstances manifesting extreme indifference
to the risk of pain and suffering to which her
tampering exposed the patients.
The court found that Moyer's prison sentence
was typical of similar product tampering cases
around the country.
U.S. v. Ashton Paul DAIGLE
U.S. v. Ashton Paul DAIGLE
Oct 2008
• Anesthesiologist’s complaint
• Hospital Pharmacy staff checked vials in
Pyxis machines in 9 Operating Rooms
• Removed 67 suspect Fentanyl vials –
• FDA OCI sent 64 suspect vials to the
Forensic Chemistry Center
DAIGLE’S ACCESS TO PYXIS
DATE
ACCESS WORK SCHEDULE
09/24/08
2
10:50a - 7:38p
09/25/08
2
10:50a - 7:42p
09/26/08
2
10:53a - 7:34p
09/29/08
3
10:55a - 7:29p
09/30/08
1
11:23a - 7:30p
10/02/08
1
10:55a - 7:27p
10/03/08
3
10:55a - 5:31p
10/05/08
1
absent
10/06/08
2
11:33a-7:39p
10/07/08
3
10:52a - 7:32p
10/08/08
8
10:54a - 7:37p
10/09/08
2
10:56a - 1:30p
10/10/08
5
7:34p - unknown
10/12/08
3
absent
10/13/08
11
10:58a - 7:30p
10/14/08
3
10:58a - 4:39p
10/15/08
13
10:54a - 7:32p
10/16/08
25
11:00a - 7:25p
10/17/08
14
10:59a - 7:29p
10/23/08
4
10:58a - 7:23p
• Pyxis accessed 108 times in 8 Operating
rooms over 20 days
• As much as 25 times in one day
• Used “Cancelled/Remove” access code
U.S. v. Ashton Paul DAIGLE
Forensic Chemistry Center Analysis
• 63 of 64 vials contained glue-like residue on metallic
crimp tops. 63 were firmly affixed and not able to spin.
The one remaining vial’s top fell off.
• Random sample of 20 vials
* ALL 20 contained less than 2 mcg/mL of the
labeled 50 mcg/mL of Fentanyl
* 18 had a minimum of 2 punctures on top
& bottom stopper surfaces
Fentanyl Vials - Evidence
Fentanyl Vials - Evidence
Fentanyl Vials - Evidence
U.S. v. Ashton Paul DAIGLE
December 16, 2008
Indicted on:
108 counts of Tampering with a Consumer Product
18 USC §1365
67 counts of Creating a Counterfeit Controlled Substance
21 USC §841(a)(2) and (b)(1)(C)
4 counts of Adulteration of a Drug
21 USC §331(b) & §333(a)(2)
U.S. v. Ashton Paul DAIGLE
DAIGLE’S Proffer/Polygraph:
• Battled drug addiction since he was 11 years old
• Did not sell, give, trade or transfer drugs to others – for
personal use
• Shot up in restroom and refilled vials with saline at first,
then tap water from restroom sink
• Removed from BCH and used Fentanyl, Morphine,
Versed® (Midazolam), Sufenta® (Sufentanil) and Nubain®
(Nalbuphine) for personal use
• Stole prescription controlled substances from patients
while he worked at Windsor Healthcare Center prior to
his employment at BCH
U.S. v. Ashton Paul DAIGLE
Daigle Plea Agreement:
• Pled guilty to
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(June 1, 2009)
* 5 counts of Tampering with a Consumer Product
* 1 count of Creating a Counterfeit Controlled Substance
Government recommends:
* 1 full year of blood testing for HIV and Hepatitis
* Surrender of Nursing license
* Never to work in the healthcare field
or in any medical capacity
* No less than 54 months prison time &
3 years supervised release thereafter
U.S. v. Ashton Paul DAIGLE
Lessons Learned or to be Learned!
• Do not send out evidence to be tested
• Call FDA/OCI first – State & Local Police will end up
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turning it over to us anyway
Addicts are Addicts…Understand you may not
understand!
Listen to your employees – they are an extension of your
eyes and ears.
Don’t assume the patients have a tolerance for controlled
substances.
If an employee should not have access to a particular
drug – don’t grant him access!
Review your reports.
U.S. v. Kristen Diane PARKER
“I have a crazy fascination with needles..
I just like the way they feel! ;)”
www.myspace.com
www.myspace.com
U.S. v. Kristen Diane PARKER
SUMMARY
• Hospital scrub tech (Parker) was taking
fentanyl-filled syringes and replacing them
with saline-filled syringes – syringes she had
already used.
• Parker had Hepatitis C – exposed
approximately 5,000 patients from RMC and
over 1,200 from ASC
• Parker knew she had Hep C
U.S. v. Kristen Diane PARKER
BACKGROUND
• March 24, 2009 – Parker stuck a nurse with a needle that
she kept in her front pocket – counseled, documented &
drug tested.
• March 30, 2009 – Negative drug test. Returned to work.
Specific drug test for Fentanyl not conducted!!
• April 13, 2009 - Employee reported seeing Parker place a
syringe in her front pocket from an anesthesia cart.
• Parker immediately taken from OR and drug tested – this
time for Fentanyl.
• April 22, 2009 – Positive Fentanyl test. Parker
terminated from RMC.
• April 23, 2009 - RMC reported to Denver PD potential
theft.
U.S. v. Kristen Diane PARKER
JUNE 30, 2009 INTERVIEW
• Denver PD interviewed Parker – she confessed to
taking the Fentanyl-filled syringes off the
anesthesia cart, placing a needle on it, shooting
up, refilling with saline and placing the
contaminated syringe back onto the anesthesia
cart. She carried a couple previously used
syringes in her front scrub pocket so she could
capitalize on her “opportunity” when
anesthesiologists left the Fentanyl-filled syringes
on their carts unattended – even if for only a few
seconds.
U.S. v. Kristen Diane PARKER
INTERVIEW
• Parker prowled OR to OR looking for
unattended carts with syringes placed
on top by anesthesiologists when they
prepared for upcoming surgeries.
• If asked what she was doing – she
would ask if anyone needed help
preparing for surgery – or she would
claim she was looking for a band-aid or
cleaning up.
• Claimed it never crossed her mind
about contaminating the syringes she
used and placed back on the
anesthesia cart.
U.S. v. Kristen Diane PARKER
INTERVIEW
• June 2009 - Parker started work at ASC. She
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claimed she was still working at RMC and would
prefer them to NOT contact them for references
– they did not…
Parker claimed to have switched out syringes at
RMC 15-20 times and about five times at ASC.
Parker admitted to sharing needles while
shooting up with heroin while she lived in New
Jersey a few months before starting work at
RMC. She believed that is where she got Hep C.
U.S. v. Kristen Diane PARKER
INTERVIEW
• Parker denied knowing she had Hep C and then
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contradicted herself a few times stating she had
been informed her first day of work but did not
think it was a big deal.
July 1, 2009 - Denver PD and DEA immediately
referred to FDA OCI due to tampering –
significantly greater penalties than state charges.
July 3, 2009 – we arrested Parker on a criminal
complaint.
U.S. v. Kristen Diane PARKER
• July 23, 2009 and August 27, 2009– Parker was
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indicted on:
* Tampering with a Consumer Product
18 USC §1365(a)
* Obtaining a Controlled Substance by
Deceit or Subterfuge
21 USC §843(a)(3) and (d)(1)
Trial set for September 28, 2009
Parker was denied bond and remains in jail.
U.S. v. Kristen Diane PARKER
• RMC “War Room” & swift action
• Almost 5,000 were tested
• Center for Disease Control (CDC) conducted
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genetic sequencing analysis on cases CDPHE
identified as probable in contracting Hep C from
Parker.
Obtained medical releases from 35 highest risk
patients (genotype 1b, no previous history)
U.S. v. Kristen Diane PARKER
September 24, 2009
• CDC Report:
* 16 genetic sequencing analysis completed
* 16 samples genetically linked, including Parker
* 97% level of confidence that Parker is source
to other 15 cases
U.S. v. Kristen Diane PARKER
September 25, 2009
• Pled guilty to
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* 5 counts of Tampering with a Consumer Product
* 5 counts of Obtaining a Controlled Substance by
Deceit or Subterfuge
Government recommends:
* Full cooperation and disclosure
* 1 full year of blood testing for HIV
* Surrender of any license/certification
* Ceasing to ever work in the healthcare field
or in any medical capacity
* no less than 240 months prison time &
3 years supervised release thereafter
Sentencing set for January 22, 2010
U.S. v. Kristen Diane PARKER
Lessons Learned or to be Learned
• Immediately notify FDA/OCI and DEA for theft & tampering
• Do a good background on employees that will have access to
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controlled substances
Test for Fentanyl in addition to other drug screens
Identify potential patients
Assume and prepare for us to get copies of patient files with proper
subpoenas
Share your information/findings with us – work with us, but not for
us or against us
Be ready for the onslaught of the press – good and bad (it’s rarely
good….)
Contact Information
Special Agent Martha Hughes
Office (205) 966-6074
http://www.fda.gov/
Report a Problem
•Drugs, Medical Devices…(MedWatch)
•To Report an Emergency
•To Report a Non-Emergency
•Report Suspected Criminal Activity
•For Industry: Reportable Food Registry