More Related Content Similar to Methadone Trial Advocacy Seminar 2016 (20) Methadone Trial Advocacy Seminar 20161. © 2015 ROBINS KAPLAN LLP
Methadone and Opiate Addiction:
Is the cure as bad as the disease?
PHIL SIEFF AND PAT STONEKING
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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.
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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
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Key term:
Methadone Maintenance
Treatment (MMT)
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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
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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.
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Medical Malpractice:
Methadone Pain Management
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PAIN MANAGEMENT: WHERE DO MEDICAL
CLINICS GO WRONG?
Three dangerous traps: Toombs, Methadone Treatment for Pain States (2005):
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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.
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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.
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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.
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Medical Malpractice:
Methadone Maintenance
Treatment
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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
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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
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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
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Methadone Treatment:
Injuries to third parties
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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
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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
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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