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© 2015 ROBINS KAPLAN LLP
Methadone and Opiate Addiction:
Is the cure as bad as the disease?
PHIL SIEFF AND PAT STONEKING
© 2015 ROBINS KAPLAN LLP 2
IN MINNESOTA
 We have 15 methadone clinics – mostly concentrated in the
metro area
– A majority of them are for-profit
 Approximately 3,000 Minnesota Health Care Plan enrollees
become chronic opioid users.
 From 2007 to 2012, there were about 2,000 new
methadone patients enrolling each year
 On average, only about 6% of methadone patients
complete the program.
© 2015 ROBINS KAPLAN LLP 3
THREE TYPES OF CASES TO LOOK FOR
 Direct claims between a patient and the clinic
– Medical malpractice in pain management
– Medical malpractice in methadone maintenance treatment
 Diversion
 Injuries to innocent people
© 2015 ROBINS KAPLAN LLP 4
Key term:
Opiate / Opioid
© 2015 ROBINS KAPLAN LLP 5
Key term:
Methadone Maintenance
Treatment (MMT)
© 2015 ROBINS KAPLAN LLP 6
Key term:
Diversion
© 2015 ROBINS KAPLAN LLP 7
Key term:
Take-home
© 2015 ROBINS KAPLAN LLP 8
KEY RULES: FEDERAL REGS FOR MMT
 42 C.F.R. §8.12 – Federal opioid treatment standards
 Set minimum standards
 Set limitations on dosage increases
 Set requirements for take-home doses
 Meant to minimize risk of diversion
– Individual counseling a necessary part of MMT
 Standard of care is higher than what the regulations
describe
© 2015 ROBINS KAPLAN LLP 9
INHERENT DIFFICULTIES WITH METHADONE
 Difficult to ever know a person’s fatal dose
– Lethal dose for non-addict is 25 mg.
– Federal regulations allow initial dose for new MMT patients of 30
mg.
 Pain-relieving effects vanish while drug is still in the body
– “New opiate users take longer to clear methadone from their
bodies, placing them at greater risk of overdose.” -Karch, Toxicology and
pathology of deaths related to methadone: retrospective review.
© 2015 ROBINS KAPLAN LLP 10
Medical Malpractice:
Methadone Pain Management
© 2015 ROBINS KAPLAN LLP 11
PAIN MANAGEMENT: WHERE DO MEDICAL
CLINICS GO WRONG?
 Three dangerous traps: Toombs, Methadone Treatment for Pain States (2005):
© 2015 ROBINS KAPLAN LLP 12
WHERE DO MEDICAL CLINICS GO WRONG? -
TRAP #1:
 “Metabolism of and response to methadone varies with
each patient.”
– Example: Due to provider’s inexperience/oversight, the patient
immediately receives lethal dose of methadone.
© 2015 ROBINS KAPLAN LLP 13
WHERE DO MEDICAL CLINICS GO WRONG? -
TRAP #2:
 “Transition to methadone and dosage titration should be
completed slowly and with frequent monitoring.”
– Example: The patient reports that the methadone is working well
but that it is starting to wear off. Doctor authorizes big jump in
dosage without seeing the patient causing nearly instant overdose.
© 2015 ROBINS KAPLAN LLP 14
WHERE DO MEDICAL CLINICS GO WRONG? -
TRAP #3:
 “After starting methadone therapy or increasing the dosage,
systemic toxicity may not become apparent for several
days.”
– Example: The patient overdoses because he takes methadone pills
“as-needed” for pain.
© 2015 ROBINS KAPLAN LLP 15
Medical Malpractice:
Methadone Maintenance
Treatment
© 2015 ROBINS KAPLAN LLP 16
INHERENT DIFFICULTIES WITH MMT
 Methadone treatment requires individualized attention
 It takes a long time to establish stability
– Slow ramp-up of doses under supervision
– Watch cravings
– Stop increases when cravings are gone
 It is difficult for patients to comply early on in treatment
– Constant state of withdrawal
© 2015 ROBINS KAPLAN LLP 17
MMT: WHERE DO METHADONE CLINICS GO
WRONG?
 Shortcuts to increase volume of patients
 Lack of medical attention
 Standardized treatment
 Ignore signs of diversion
 Improperly allowing take-homes
© 2015 ROBINS KAPLAN LLP 18
POTENTIAL ISSUES TO IDENTIFY WHEN MMT
IS INVOLVED
 Length of time the patient was in the program
 Amount of time at the same dose
 Socioeconomic factors
– Review counseling notes
 Potential diversion indicators
© 2015 ROBINS KAPLAN LLP 19
Methadone Treatment:
Injuries to third parties
© 2015 ROBINS KAPLAN LLP 20
HOW DOES METHADONE HURT THIRD
PARTIES?
 Unsecured methadone taken by a family member or child.
– Regulations discuss ensuring patient’s security of doses at home
 Impaired methadone user at the wheel
 Case often hinges on underlying medical malpractice to the
patient
© 2015 ROBINS KAPLAN LLP 21
LEGAL BARRIERS IN THIRD-PARTY
METHADONE CLAIMS
 Culpability of Addict
 Addict’s cooperation
 Obtaining medical records
– HIPAA Privacy Rule: 45 C.F.R. § 164.512 (e): Judicial and
Administrative proceedings
• Records can be produced subject to protective order and after
procedures are followed
© 2015 ROBINS KAPLAN LLP 22
LEGAL BARRIERS IN THIRD-PARTY
METHADONE CLAIMS
 Duty to third-party
– Lingren et al v. Pinnacle
– Special Relationship
• Lundgren v. Fultz
 Causation
 Insurance coverage
– Read the policy and expect a coverage dispute
– May claim no liability to third-parties
– May claim type of damage not covered
© 2015 ROBINS KAPLAN LLP 23

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Methadone Trial Advocacy Seminar 2016

  • 1. © 2015 ROBINS KAPLAN LLP Methadone and Opiate Addiction: Is the cure as bad as the disease? PHIL SIEFF AND PAT STONEKING
  • 2. © 2015 ROBINS KAPLAN LLP 2 IN MINNESOTA  We have 15 methadone clinics – mostly concentrated in the metro area – A majority of them are for-profit  Approximately 3,000 Minnesota Health Care Plan enrollees become chronic opioid users.  From 2007 to 2012, there were about 2,000 new methadone patients enrolling each year  On average, only about 6% of methadone patients complete the program.
  • 3. © 2015 ROBINS KAPLAN LLP 3 THREE TYPES OF CASES TO LOOK FOR  Direct claims between a patient and the clinic – Medical malpractice in pain management – Medical malpractice in methadone maintenance treatment  Diversion  Injuries to innocent people
  • 4. © 2015 ROBINS KAPLAN LLP 4 Key term: Opiate / Opioid
  • 5. © 2015 ROBINS KAPLAN LLP 5 Key term: Methadone Maintenance Treatment (MMT)
  • 6. © 2015 ROBINS KAPLAN LLP 6 Key term: Diversion
  • 7. © 2015 ROBINS KAPLAN LLP 7 Key term: Take-home
  • 8. © 2015 ROBINS KAPLAN LLP 8 KEY RULES: FEDERAL REGS FOR MMT  42 C.F.R. §8.12 – Federal opioid treatment standards  Set minimum standards  Set limitations on dosage increases  Set requirements for take-home doses  Meant to minimize risk of diversion – Individual counseling a necessary part of MMT  Standard of care is higher than what the regulations describe
  • 9. © 2015 ROBINS KAPLAN LLP 9 INHERENT DIFFICULTIES WITH METHADONE  Difficult to ever know a person’s fatal dose – Lethal dose for non-addict is 25 mg. – Federal regulations allow initial dose for new MMT patients of 30 mg.  Pain-relieving effects vanish while drug is still in the body – “New opiate users take longer to clear methadone from their bodies, placing them at greater risk of overdose.” -Karch, Toxicology and pathology of deaths related to methadone: retrospective review.
  • 10. © 2015 ROBINS KAPLAN LLP 10 Medical Malpractice: Methadone Pain Management
  • 11. © 2015 ROBINS KAPLAN LLP 11 PAIN MANAGEMENT: WHERE DO MEDICAL CLINICS GO WRONG?  Three dangerous traps: Toombs, Methadone Treatment for Pain States (2005):
  • 12. © 2015 ROBINS KAPLAN LLP 12 WHERE DO MEDICAL CLINICS GO WRONG? - TRAP #1:  “Metabolism of and response to methadone varies with each patient.” – Example: Due to provider’s inexperience/oversight, the patient immediately receives lethal dose of methadone.
  • 13. © 2015 ROBINS KAPLAN LLP 13 WHERE DO MEDICAL CLINICS GO WRONG? - TRAP #2:  “Transition to methadone and dosage titration should be completed slowly and with frequent monitoring.” – Example: The patient reports that the methadone is working well but that it is starting to wear off. Doctor authorizes big jump in dosage without seeing the patient causing nearly instant overdose.
  • 14. © 2015 ROBINS KAPLAN LLP 14 WHERE DO MEDICAL CLINICS GO WRONG? - TRAP #3:  “After starting methadone therapy or increasing the dosage, systemic toxicity may not become apparent for several days.” – Example: The patient overdoses because he takes methadone pills “as-needed” for pain.
  • 15. © 2015 ROBINS KAPLAN LLP 15 Medical Malpractice: Methadone Maintenance Treatment
  • 16. © 2015 ROBINS KAPLAN LLP 16 INHERENT DIFFICULTIES WITH MMT  Methadone treatment requires individualized attention  It takes a long time to establish stability – Slow ramp-up of doses under supervision – Watch cravings – Stop increases when cravings are gone  It is difficult for patients to comply early on in treatment – Constant state of withdrawal
  • 17. © 2015 ROBINS KAPLAN LLP 17 MMT: WHERE DO METHADONE CLINICS GO WRONG?  Shortcuts to increase volume of patients  Lack of medical attention  Standardized treatment  Ignore signs of diversion  Improperly allowing take-homes
  • 18. © 2015 ROBINS KAPLAN LLP 18 POTENTIAL ISSUES TO IDENTIFY WHEN MMT IS INVOLVED  Length of time the patient was in the program  Amount of time at the same dose  Socioeconomic factors – Review counseling notes  Potential diversion indicators
  • 19. © 2015 ROBINS KAPLAN LLP 19 Methadone Treatment: Injuries to third parties
  • 20. © 2015 ROBINS KAPLAN LLP 20 HOW DOES METHADONE HURT THIRD PARTIES?  Unsecured methadone taken by a family member or child. – Regulations discuss ensuring patient’s security of doses at home  Impaired methadone user at the wheel  Case often hinges on underlying medical malpractice to the patient
  • 21. © 2015 ROBINS KAPLAN LLP 21 LEGAL BARRIERS IN THIRD-PARTY METHADONE CLAIMS  Culpability of Addict  Addict’s cooperation  Obtaining medical records – HIPAA Privacy Rule: 45 C.F.R. § 164.512 (e): Judicial and Administrative proceedings • Records can be produced subject to protective order and after procedures are followed
  • 22. © 2015 ROBINS KAPLAN LLP 22 LEGAL BARRIERS IN THIRD-PARTY METHADONE CLAIMS  Duty to third-party – Lingren et al v. Pinnacle – Special Relationship • Lundgren v. Fultz  Causation  Insurance coverage – Read the policy and expect a coverage dispute – May claim no liability to third-parties – May claim type of damage not covered
  • 23. © 2015 ROBINS KAPLAN LLP 23