© 2015 ROBINS KAPLAN LLP

Methadone and Opiate Addict ion: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