Presentation for Alabama Presentation for Alabama Hospital AssociationHospital Association

ObjectivesObjectives

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 FDA/ Office of Criminal InvestigationsInvestigations

• OCI was established in 1992.OCI was established in 1992.

• The Office of Criminal Investigations The Office of Criminal Investigations currently operates out of 29 offices currently operates out of 29 offices throughout the United States.throughout the United States.

• There are approximately 180 Special There are approximately 180 Special Agents hired from other traditional Agents hired from other traditional law enforcement agencies. law enforcement agencies.

Office of Criminal Office of Criminal InvestigationsInvestigations• OCI is the criminal investigative arm of the OCI is the criminal investigative arm of the

FDA. FDA. • OCI is a traditional Federal Criminal OCI is a traditional Federal Criminal

Investigative Agency.Investigative Agency.• OCI does not conduct inspections or conduct OCI does not conduct inspections or conduct

typical regulatory functions. typical regulatory functions. • FDA Investigators (Consumer Safety Officers) FDA Investigators (Consumer Safety Officers)

and Inspectors conduct regulatory inspections; and Inspectors conduct regulatory inspections; OCI Special Agents have full federal law OCI Special Agents have full federal law enforcement authority, conduct criminal enforcement authority, conduct criminal investigations and present cases to the U.S. investigations and present cases to the U.S. Attorney’s Office for federal prosecution. Attorney’s Office for federal prosecution.

Boston

New York

Metro Washington

OCI Headquarters

Atlanta

MiamiAustin

Kansas City

Chicago

Los Angeles

San Francisco

OCI Field and Resident OfficesOCI Field and Resident Offices

..

Houston

San Juan

Nashville

Buffalo

Headquarters

Field Offices

Resident Offices

Domicile Offices

New Orleans

Seattle

Denver

Phoenix

Minneapolis

DallasTampa

Philadelphia

San Antonio

Norfolk

Syracuse

Cincinnati

BirminghamRaleigh

Detroit

General Areas ofGeneral Areas of EnforcementEnforcement

Manufacturing and Distribution of counterfeit and unapproved drugsManufacturing and Distribution of counterfeit and unapproved drugs

Illicit prescription drug diversion (DEA vs. FDA/OCI)Illicit prescription drug diversion (DEA vs. FDA/OCI)

Product substitution crimesProduct substitution crimes

Product TamperingProduct Tampering

Schemes involving fraudulent health treatmentsSchemes involving fraudulent health treatments

New drug application fraudNew drug application fraud

Frauds involving FDA regulated productsFrauds involving FDA regulated products

Fraud associated with clinical investigationsFraud associated with clinical investigations

OCI

FederalLaw Enforcement

Agencies

U.S.Attorney’s

State/LocalLaw Enforcement

Agencies

U.S. IntelligenceCommunity

PrivateIndustry

FDA

ForeignLaw Enforcement

Agencies

Federal/StateHealth

Authorities

Federal Anti-Tampering ActFederal 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 ActFederal 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 ActFederal Anti-Tampering ActDefinition 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 ActFederal Anti-Tampering ActAdditional 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.

PenaltiesPenalties

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 Signs of Tampering/Drug DiversionDiversion• Tampering often referred to as “substitution.”Tampering often referred to as “substitution.”• Missing drugs – controlled & non-controlledMissing drugs – controlled & non-controlled• Incorrect counts (reconciliation), or not!Incorrect counts (reconciliation), or not!• Apparent false record reportingApparent false record reporting• Suspicious behavior by staff memberSuspicious behavior by staff member• Multiple unjustified or cancelled accesses to automated Multiple unjustified or cancelled accesses to automated

medicine dispensing (Pyxis) machinesmedicine dispensing (Pyxis) machines• Visual signs of compromised drug packaging/needles/vials Visual signs of compromised drug packaging/needles/vials

etc.etc.• Exaggerated claims by staff regarding wasting or loss of Exaggerated claims by staff regarding wasting or loss of

drug product.drug product.• Records reflect the over-prescribing or the inadequate Records reflect the over-prescribing or the inadequate

prescribing of drugs to patients.prescribing of drugs to patients.• Increase in patient complaints of pain after receiving pain Increase in patient complaints of pain after receiving pain

medication.medication.

Signs of Tampering/Drug Signs of Tampering/Drug DiversionDiversionSuspect is acting suspicious and may be doing theSuspect is acting suspicious and may be doing thefollowing:following:

– Taking a great deal of time off or always on-duty or in the Taking a great deal of time off or always on-duty or in the hospital when not on-dutyhospital when not on-duty

– Extended unexplained absencesExtended unexplained absences– Extended restroom breaksExtended restroom breaks– Mood swingsMood swings– Personal life issuesPersonal life issues– Coming in early, staying lateComing in early, staying late– Always where they shouldn’t be or not where they should Always where they shouldn’t be or not where they should

bebe– Dealing with patients who require pain medicationsDealing with patients who require pain medications– Nervousness, nausea, change in behaviorNervousness, nausea, change in behavior

If you suspect tamperingIf you suspect tampering

• Call FDA/OCI immediatelyCall FDA/OCI immediately– Even if only a mere suspicion – let us do our Even if only a mere suspicion – let us do our

job and reduce your liabilityjob and reduce your liability– Don’t wait until someone gets hurtDon’t wait until someone gets hurt– Collect and segregate evidence – chain of Collect and segregate evidence – chain of

custody – but don’t talk to suspect and don’t custody – but don’t talk to suspect and don’t conduct a full investigationconduct a full investigation

• Press/Discovery IssuesPress/Discovery Issues– Why it is better to be a part of the solution Why it is better to be a part of the solution

instead of being part of the probleminstead of being part of the problem

Course of Action by FDA/OCICourse of Action by FDA/OCI

• Arrange for interview of Arrange for interview of MedExec/Hospital Staff or delegate MedExec/Hospital Staff or delegate (away from suspect)(away from suspect)

• Obtain documents and evidenceObtain documents and evidence• Initiate investigationInitiate investigation

– SurveillanceSurveillance– InterviewsInterviews– Cameras (non-private areas)Cameras (non-private areas)– Subpoenas directed towards suspectSubpoenas directed towards suspect

ReviewReview1. 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 ActivityConcealing 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 Preventative Measures to avoid tampering/drug diversiontampering/drug diversion• Create Rules/policies and procedures that deter Create Rules/policies and procedures that deter

such activity.such activity.• Incorporate a “check and balance” system.Incorporate a “check and balance” system.• Always have at least two qualified individuals Always have at least two qualified individuals

responsible for accountability of the drugs.responsible for accountability of the drugs.• Require documentation - Require documentation - ReviewReview documentation. documentation.• Random Audits of both paperwork and physical Random Audits of both paperwork and physical

inventory.inventory.• Random drug testing-Don’t wait for incident to Random drug testing-Don’t wait for incident to

occur. (Make sure testing facility will provide you occur. (Make sure testing facility will provide you with what you expect.) Conduct the “right” tests.with what you expect.) Conduct the “right” tests.

• Play “devil’s advocate” – look for risks, then Play “devil’s advocate” – look for risks, then eliminate them.eliminate them.

• Pay attention to your employees and their Pay attention to your employees and their behavior.behavior.

Drug DiversionDrug 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. 98-U.S. v Nancy L. Moyer (No. 98-1981/8th Circuit, 1999)1981/8th Circuit, 1999)

FACTSFACTS

• Moyer, a medical doctor, was charged Moyer, a medical doctor, was charged with product tampering with product tampering (18 USC (18 USC 1365(a)) 1365(a)) after an investigation after an investigation determined that she had been inserting determined that she had been inserting a needle-syringe into a morphine a needle-syringe into a morphine delivery device in a hospital, removing delivery device in a hospital, removing morphine and replacing it with saline. morphine and replacing it with saline. Moyer was subsequently found guilty Moyer was subsequently found guilty and appealed her conviction on several and appealed her conviction on several grounds.grounds.

U.S. v Nancy L. Moyer (No. 98-U.S. v Nancy L. Moyer (No. 98-1981/8th Circuit, 1999)1981/8th Circuit, 1999)

IssuesIssues• Moyer argued that the government was required to Moyer argued that the government was required to

prove that Moyer performed a malicious act when prove that Moyer performed a malicious act when tampering with a consumer product beyond merely tampering with a consumer product beyond merely tampering with the product.tampering with the product.

• Moyer argued that her actions did not constitute a Moyer argued that her actions did not constitute a reckless disregard of exposing others to the possibility of reckless disregard of exposing others to the possibility of death or bodily injury and that she did not act with death or bodily injury and that she did not act with extreme indifference to such risk.extreme indifference to such risk.

• Moyer contended that her tampering with the drug Moyer contended that her tampering with the drug delivery device did not constitute any effect upon delivery device did not constitute any effect upon interstate commerce.interstate commerce.

• Moyer argued that she did not act with extreme Moyer argued that she did not act with extreme indifference regarding risks to which her tampering indifference regarding risks to which her tampering exposed her patients to.exposed her patients to.

• Moyer argued that her resulting sentence was too harsh.Moyer argued that her resulting sentence was too harsh.

U.S. v Nancy L. Moyer (No. 98-U.S. v Nancy L. Moyer (No. 98-1981/8th Circuit, 1999)1981/8th Circuit, 1999)

DecisionDecision• The court ruled that there was no requirement for the The court ruled that there was no requirement for the

government to show that Moyer acted maliciously. The government to show that Moyer acted maliciously. The court ruled that the term, "tampering," merely describes court ruled that the term, "tampering," merely describes the physical act of product adulteration.the physical act of product adulteration.

• As a result of Moyer's morphine thefts, her hospital was As a result of Moyer's morphine thefts, her hospital was required to order additional morphine from out-of-state required to order additional morphine from out-of-state manufacturers. This was sufficient to support a finding manufacturers. This was sufficient to support a finding that Moyer's tampering had an effect upon interstate that Moyer's tampering had an effect upon interstate commerce. commerce.

• Testimony by expert witnesses that Moyer's morphine Testimony by expert witnesses that Moyer's morphine thefts placed her patients at risk of increased pain, thefts placed her patients at risk of increased pain, agitation, infection, and air embolism and the defendant, agitation, infection, and air embolism and the defendant, as a physician, was aware at the time of the tampering as a physician, was aware at the time of the tampering that her actions could have created health risks for her that her actions could have created health risks for her patients was sufficient to support a jury's finding that patients was sufficient to support a jury's finding that Moyer acted with reckless disregard of serious health Moyer acted with reckless disregard of serious health risks to which her actions exposed her critically ill risks to which her actions exposed her critically ill patients.patients.

U.S. v Nancy L. Moyer (No. 98-U.S. v Nancy L. Moyer (No. 98-1981/8th Circuit, 1999)1981/8th Circuit, 1999)

Decision (cont)Decision (cont)

• Evidence that Moyer stole morphine from Evidence that Moyer stole morphine from an elderly patient who was dying of lung an elderly patient who was dying of lung disease and who was taking morphine to disease and who was taking morphine to relieve pain through the dying process, relieve pain through the dying process, was sufficient to support a finding that the was sufficient to support a finding that the defendant acted under circumstances defendant acted under circumstances manifesting extreme indifference to the manifesting extreme indifference to the risk of pain and suffering to which her risk of pain and suffering to which her tampering exposed the patients.tampering exposed the patients.

• The court found that Moyer's prison The court found that Moyer's prison sentence was typical of similar product sentence was typical of similar product tampering cases around the country.tampering cases around the country.

U.S. v. Ashton Paul DAIGLEU.S. v. Ashton Paul DAIGLE

U.S. v. Ashton Paul DAIGLEU.S. v. Ashton Paul DAIGLE

Oct 2008 Oct 2008

• Anesthesiologist’s complaintAnesthesiologist’s complaint

• Hospital Pharmacy staff checked vials Hospital Pharmacy staff checked vials in Pyxis machines in 9 Operating in Pyxis machines in 9 Operating RoomsRooms

• Removed 67 suspect Fentanyl vials –Removed 67 suspect Fentanyl vials –

• FDA OCI sent 64 suspect vials to the FDA OCI sent 64 suspect vials to the Forensic Chemistry CenterForensic Chemistry Center

DAIGLE’S ACCESS TO PYXISDAIGLE’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 DAIGLEU.S. v. Ashton Paul DAIGLE

Forensic Chemistry Center AnalysisForensic Chemistry Center Analysis

• 63 of 64 vials contained glue-like residue on 63 of 64 vials contained glue-like residue on metallic crimp tops. 63 were firmly affixed and not metallic crimp tops. 63 were firmly affixed and not able to spin. The one remaining vial’s top fell off.able to spin. The one remaining vial’s top fell off.

• Random sample of 20 vials Random sample of 20 vials * ALL 20 contained * ALL 20 contained lessless than 2 mcg/mL of the than 2 mcg/mL of the

labeled 50 mcg/mL of Fentanyllabeled 50 mcg/mL of Fentanyl* 18 had a * 18 had a minimumminimum of 2 punctures on top of 2 punctures on top

& bottom stopper surfaces& bottom stopper surfaces

Fentanyl Vials - EvidenceFentanyl Vials - Evidence

Fentanyl Vials - EvidenceFentanyl Vials - Evidence

Fentanyl Vials - EvidenceFentanyl Vials - Evidence

U.S. v. Ashton Paul DAIGLEU.S. v. Ashton Paul DAIGLE

December 16, 2008December 16, 2008

Indicted on:Indicted on:

108 counts of Tampering with a Consumer Product 108 counts of Tampering with a Consumer Product

18 USC §136518 USC §1365

67 counts of Creating a Counterfeit Controlled 67 counts of Creating a Counterfeit Controlled Substance Substance

21 USC §841(a)(2) and (b)(1)(C)21 USC §841(a)(2) and (b)(1)(C)

4 counts of Adulteration of a Drug 4 counts of Adulteration of a Drug

21 USC §331(b) & §333(a)(2)21 USC §331(b) & §333(a)(2)

U.S. v. Ashton Paul DAIGLEU.S. v. Ashton Paul DAIGLE

DAIGLE’S Proffer/Polygraph:DAIGLE’S Proffer/Polygraph:• Battled drug addiction since he was 11 years oldBattled drug addiction since he was 11 years old• Did not sell, give, trade or transfer drugs to Did not sell, give, trade or transfer drugs to

others – for personal useothers – for personal use• Shot up in restroom and refilled vials with saline Shot up in restroom and refilled vials with saline

at first, then tap water from restroom sinkat first, then tap water from restroom sink• Removed from BCH and used Fentanyl, Morphine, Removed from BCH and used Fentanyl, Morphine,

Versed® (Versed® (MidazolamMidazolam), Sufenta® (), Sufenta® (SufentanilSufentanil) and ) and Nubain® (Nubain® (NalbuphineNalbuphine) for personal use) for personal use

• Stole prescription controlled substances from Stole prescription controlled substances from patients while he worked at Windsor Healthcare patients while he worked at Windsor Healthcare Center prior to his employment at BCHCenter prior to his employment at BCH

U.S. v. Ashton Paul DAIGLEU.S. v. Ashton Paul DAIGLEDaigle Plea Agreement:Daigle Plea Agreement: (June 1, 2009)(June 1, 2009)

• Pled guilty to Pled guilty to * 5 counts of Tampering with a Consumer Product* 5 counts of Tampering with a Consumer Product* 1 count of Creating a Counterfeit Controlled * 1 count of Creating a Counterfeit Controlled SubstanceSubstance

• Government recommends:Government recommends:* 1 full year of blood testing for HIV and Hepatitis* 1 full year of blood testing for HIV and Hepatitis* Surrender of Nursing license* Surrender of Nursing license* Never to work in the healthcare field * Never to work in the healthcare field

or in any medical capacity or in any medical capacity * No less than 54 months prison time & * No less than 54 months prison time & 3 years supervised release thereafter3 years supervised release thereafter

U.S. v. Ashton Paul DAIGLEU.S. v. Ashton Paul DAIGLELessons Learned or to be Learned!Lessons Learned or to be Learned!

• Do not send out evidence to be testedDo not send out evidence to be tested• Call FDA/OCI first – State & Local Police will end up Call FDA/OCI first – State & Local Police will end up

turning it over to us anywayturning it over to us anyway• Addicts are Addicts…Understand you may not Addicts are Addicts…Understand you may not

understand!understand!• Listen to your employees – they are an extension Listen to your employees – they are an extension

of your eyes and ears.of your eyes and ears.• Don’t assume the patients have a tolerance for Don’t assume the patients have a tolerance for

controlled substances.controlled substances.• If an employee should not have access to a If an employee should not have access to a

particular drug – don’t grant him access!particular drug – don’t grant him access!• Review your reports.Review your reports.

U.S. v. Kristen Diane U.S. v. Kristen Diane PARKERPARKER “ “I have a crazy fascination with needles.. I have a crazy fascination with needles..

I just like the way they feel! ;)” I just like the way they feel! ;)”

www.myspace.com

www.myspace.com

U.S. v. Kristen Diane U.S. v. Kristen Diane PARKERPARKER

SUMMARYSUMMARY

• Hospital scrub tech (Parker) was taking Hospital scrub tech (Parker) was taking fentanyl-filled syringes and replacing fentanyl-filled syringes and replacing them with saline-filled syringes – them with saline-filled syringes – syringes she had already syringes she had already used.used.

• Parker had Hepatitis C – exposed Parker had Hepatitis C – exposed approximately 5,000 patients from approximately 5,000 patients from RMC and over 1,200 from ASCRMC and over 1,200 from ASC

• Parker knew she had Hep C Parker knew she had Hep C

U.S. v. Kristen Diane U.S. v. Kristen Diane PARKERPARKER

BACKGROUNDBACKGROUND• March 24, 2009 – Parker stuck a nurse with a March 24, 2009 – Parker stuck a nurse with a

needle that she kept in her front pocket – needle that she kept in her front pocket – counseled, documented & drug tested.counseled, documented & drug tested.

• March 30, 2009 – Negative drug test. Returned to March 30, 2009 – Negative drug test. Returned to work. Specific drug test for Fentanyl not work. Specific drug test for Fentanyl not conducted!! conducted!!

• April 13, 2009 - Employee reported seeing Parker April 13, 2009 - Employee reported seeing Parker place a syringe in her front pocket from an place a syringe in her front pocket from an anesthesia cart.anesthesia cart.

• Parker immediately taken from OR and drug Parker immediately taken from OR and drug tested – this time for Fentanyl. tested – this time for Fentanyl.

• April 22, 2009 – Positive Fentanyl test. Parker April 22, 2009 – Positive Fentanyl test. Parker terminated from RMC.terminated from RMC.

• April 23, 2009 - RMC reported to Denver PD April 23, 2009 - RMC reported to Denver PD potential theft. potential theft.

U.S. v. Kristen Diane U.S. v. Kristen Diane PARKERPARKER

JUNE 30, 2009 INTERVIEWJUNE 30, 2009 INTERVIEW• Denver PD interviewed Parker – she Denver PD interviewed Parker – she

confessed to taking the Fentanyl-filled confessed to taking the Fentanyl-filled syringes off the anesthesia cart, placing a syringes off the anesthesia cart, placing a needle on it, shooting up, refilling with needle on it, shooting up, refilling with saline and placing the contaminated saline and placing the contaminated syringe back onto the anesthesia cart. She syringe back onto the anesthesia cart. She carried a couple previously used syringes carried a couple previously used syringes in her front scrub pocket so she could in her front scrub pocket so she could capitalize on her “opportunity” when capitalize on her “opportunity” when anesthesiologists left the Fentanyl-filled anesthesiologists left the Fentanyl-filled syringes on their carts unattended – even if syringes on their carts unattended – even if for only a few seconds. for only a few seconds.

U.S. v. Kristen Diane U.S. v. Kristen Diane PARKERPARKER

• Parker prowled OR to OR looking Parker prowled OR to OR looking for unattended carts with syringes for unattended carts with syringes placed on top by anesthesiologists placed on top by anesthesiologists when they prepared for upcoming when they prepared for upcoming surgeries.surgeries.

• If asked what she was doing – she If asked what she was doing – she would ask if anyone needed help would ask if anyone needed help preparing for surgery – or she preparing for surgery – or she would claim she was looking for a would claim she was looking for a band-aid or cleaning up.band-aid or cleaning up.

• Claimed it never crossed her mind Claimed it never crossed her mind about contaminating the syringes about contaminating the syringes she used and placed back on the she used and placed back on the anesthesia cart.anesthesia cart.

INTERVIEW

U.S. v. Kristen Diane U.S. v. Kristen Diane PARKERPARKER

• June 2009 - Parker started work at ASC. She June 2009 - Parker started work at ASC. She claimed she was still working at RMC and would claimed she was still working at RMC and would prefer them to NOT contact them for references prefer them to NOT contact them for references – they did not…– they did not…

• Parker claimed to have switched out syringes at Parker claimed to have switched out syringes at RMC 15-20 times and about five times at ASC.RMC 15-20 times and about five times at ASC.

• Parker admitted to sharing needles while Parker admitted to sharing needles while shooting up with heroin while she lived in New shooting up with heroin while she lived in New Jersey a few months before starting work at Jersey a few months before starting work at RMC. She believed that is where she got Hep C.RMC. She believed that is where she got Hep C.

INTERVIEW

U.S. v. Kristen Diane PARKERU.S. v. Kristen Diane PARKER

INTERVIEWINTERVIEW

• Parker denied knowing she had Hep C and Parker denied knowing she had Hep C and then contradicted herself a few times stating then contradicted herself a few times stating she had been informed her first day of work she had been informed her first day of work but did not think it was a big deal.but did not think it was a big deal.

• July 1, 2009 - Denver PD and DEA immediately July 1, 2009 - Denver PD and DEA immediately referred to FDA OCI due to tampering – referred to FDA OCI due to tampering – significantly greater penalties than state significantly greater penalties than state charges.charges.

• July 3, 2009 – we arrested Parker on a criminal July 3, 2009 – we arrested Parker on a criminal complaint. complaint.

U.S. v. Kristen Diane U.S. v. Kristen Diane PARKERPARKER

• July 23, 2009 and August 27, 2009– Parker July 23, 2009 and August 27, 2009– Parker was indicted on:was indicted on:* Tampering with a Consumer Product* Tampering with a Consumer Product 18 USC §1365(a)18 USC §1365(a)* Obtaining a Controlled Substance by * Obtaining a Controlled Substance by

Deceit or SubterfugeDeceit or Subterfuge 21 USC §843(a)(3) and (d)(1)21 USC §843(a)(3) and (d)(1)

• Trial set for September 28, 2009Trial set for September 28, 2009• Parker was denied bond and remains in Parker was denied bond and remains in

jail.jail.

U.S. v. Kristen Diane U.S. v. Kristen Diane PARKERPARKER

• RMC “War Room” & swift actionRMC “War Room” & swift action

• Almost 5,000 were testedAlmost 5,000 were tested

• Center for Disease Control (CDC) Center for Disease Control (CDC) conducted genetic sequencing analysis on conducted genetic sequencing analysis on cases CDPHE identified as probable in cases CDPHE identified as probable in contracting Hep C from Parker.contracting Hep C from Parker.

• Obtained medical releases from 35 highest Obtained medical releases from 35 highest risk patients (genotype 1b, no previous risk patients (genotype 1b, no previous history) history)

U.S. v. Kristen Diane U.S. v. Kristen Diane PARKERPARKER

September 24, 2009September 24, 2009

• CDC Report:CDC Report:

* 16 genetic sequencing analysis completed* 16 genetic sequencing analysis completed

* 16 samples genetically linked, including Parker* 16 samples genetically linked, including Parker

* 97% level of confidence that Parker is source* 97% level of confidence that Parker is source

to other 15 casesto other 15 cases

U.S. v. Kristen Diane U.S. v. Kristen Diane PARKERPARKERSeptember 25, 2009September 25, 2009

• Pled guilty to Pled guilty to * 5 counts of Tampering with a Consumer Product* 5 counts of Tampering with a Consumer Product* 5 counts of Obtaining a Controlled Substance by* 5 counts of Obtaining a Controlled Substance by

Deceit or SubterfugeDeceit or Subterfuge• Government recommends:Government recommends:

* Full cooperation and disclosure* Full cooperation and disclosure* 1 full year of blood testing for HIV* 1 full year of blood testing for HIV* Surrender of any license/certification* Surrender of any license/certification* Ceasing to ever work in the healthcare field * Ceasing to ever work in the healthcare field

or in any medical capacity or in any medical capacity * no less than 240 months prison time & * no less than 240 months prison time & 3 years supervised release thereafter3 years supervised release thereafter

• Sentencing set for January 22, 2010Sentencing set for January 22, 2010

U.S. v. Kristen Diane U.S. v. Kristen Diane PARKERPARKER

Lessons Learned or to be LearnedLessons Learned or to be Learned

• Immediately notify FDA/OCI Immediately notify FDA/OCI andand DEA for theft & tampering DEA for theft & tampering

• Do a good background on employees that will have access Do a good background on employees that will have access to controlled substancesto controlled substances

• Test for Fentanyl in addition to other drug screensTest for Fentanyl in addition to other drug screens

• Identify potential patientsIdentify potential patients

• Assume and prepare for us to get copies of patient files with Assume and prepare for us to get copies of patient files with proper subpoenasproper subpoenas

• Share your information/findings with us – work with us, but Share your information/findings with us – work with us, but not for us or against usnot for us or against us

• Be ready for the onslaught of the press – good and bad (it’s Be ready for the onslaught of the press – good and bad (it’s rarely good….)rarely good….)

Contact InformationContact Information

Special Agent Martha HughesOffice (205) 966-6074

http://www.fda.gov/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