ACI's Medical Professional Liability Insurance Forum is the premier event on benchmarking coverage, underwriting, and claims strategies. No other event can match the practical and detailed analysis of the entire MPL Insurance landscape, including the impact of litigation, regulatory action, and market conditions in today's tumultuous environment.

1. #ACIInsurance
ACI’s National Advanced Forum on Medical Professional Liability
Cathleen Kelly Rebar
Partner
Stewart Bernstiel Rebar & Smith
NEW CLAIMS TRENDS RELATED TO THE U.S. PAIN CRISIS:
Taking a Look at the Recent Prescription Drug Abuse Epidemic and Its Potential Impact on the Tide of Med Mal Insurance Claims
John M. Foley
Manager, Claims
Markel
Victoria L. Vance
Health Care Chair
Tucker Ellis LLP
October 30-31, 2014
Tweeting about this conference?

2. #ACIInsurance
The Dilemma
Standard for treatment = Adequate pain control is a fundamental right of every patient.
So what’s the problem?
Balancing treatment for pain control without feeding addition.
Risk = too little or too much pain medication.
Either spectrum can lead to litigation.

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The Problem
The prescription drug epidemic.
The number of prescription drug related deaths has increased every year for the past 15 years.
Prescription pain killers have similar addictive properties to heroin.

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The Cost
Over half a trillion dollars are spent on expenses associated with medical, economic, social and the criminal impact caused by misuse of pain medication.
Immeasurable indirect costs including drug related crimes, doctor shopping, loss of productivity and wages, increasing unemployment, and law enforcement expenses fighting the war.

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Two Spectrums for Exposure
Under Prescribing /failing to properly manage the pain
Over Prescribing /illegitimate prescribing

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The Penalty
All four domains of the law have seen litigation for pain management errors:
Administrative
Civil
Criminal
Constitutional
Most common is administrative/licensing

7. #ACIInsurance
The way things were . . .
Opiophobia
Belief of public, prescribers and medical boards that opioid analgesics were reserved for only the sickest and terminally ill.
Prior to 1999 there are no records of any physician ever being disciplined for under- prescribing/failing to adequately manage patient’s pain.
However, the records are plentiful concerning actions for over-prescribing.

8. #ACIInsurance
To Prescribe or Not to Prescribe . . .

9. #ACIInsurance
Over-Prescribing
Hoover v. Agency for Healthcare Administration
Florida medical licensing board brought action against Katherine Hoover, M.D. for prescription of opiates to manage pain of noncancer patients. Sanctions were issued, and then overturned.
There are hundreds of Dr. Hoovers and examples just like this.

10. #ACIInsurance
Over-Prescribing/Criminal
1994 – Kansas Attorney General
Brought on charges of attempted murder against Stanley Naramore, M.D., a small-town physician . He was convicted.
Two patients who were terminally ill and within days of death were allegedly overprescribed pain medication designed to “ease the patient’s comfort.”
The evidence indicated that the doses would have resulted in respiratory failure almost immediately. Dr. Naramore came off the case. Patient was transferred and died two days later of her disease.
Significantly, the verdict was overturned on appeal as against the weight of the evidence because the burden of proof was beyond a reasonable doubt.

11. #ACIInsurance
Typical Criminal Over-Prescribing
Physician targets = physicians servicing a large group of noncancer patients for treatment of chronic pain.
William Hurwitz, M.D. serviced patients with “chronic pain” from 36 states. He was convicted on 50 counts of drug trafficking, later reduced to 16 counts on appeal. He served 57 months in prison.
Critical issue – Dr. Hurwitz knew or should have known in the exercise of sound clinical judgment that he was prescribing to addicts.

12. #ACIInsurance
Common Liability Themes
Consider alternative non-opioid therapies
Warn patients, get proper informed consent
Properly titrate initial and ongoing doses
Get adequate substance abuse and mental health history
Recognize signs of patient addiction, dependence, abuse
Consider drug-to-drug interactions

13. #ACIInsurance
Common Liability Themes
Failure to (cont.):
Monitor patient for signs and symptoms of prescribed therapy vs. abuse
Coordinate care with other prescribers
Refer patient to specialists (Pain Mgmt., Addiction, Psych)
Train and Supervise clinic/office staff
Document, document, document!

14. #ACIInsurance
Liabilities to Third Parties
Additional theory = physician liability for harm to third persons.
Massachusetts, Utah, New Hampshire and Georgia have all found liability for a prescribing physician for resulting harm to third persons. Duty was owed to people foreseeably put at risk by doctors’ failure to warn about the effects of a provided treatment.
Connecticut has held the opposite.

15. #ACIInsurance
New theories of Liability/ Over-Prescribing
Drug Manufacturer Liability:
Two California counties and the city of Chicago sued 5 of the largest drug manufacturers for causing the nation’s drug epidemic through a “campaign of deception” aimed at boosting sales of prescription pain meds like OxyContin.
The litigation is based on violations of the states’ false advertising, unfair business practices and public nuisance laws.
In the complaints, the counties cite the epidemic of prescription pain killer abuse and the ties to increased deaths and overdoses from those and other drugs.
One focus of the suit is the misleading claims by manufacturers to prescribers that the benefits of these drugs outweigh the risks.

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New theories of Criminal Liability/Over-Prescribing
Fed-Ex and UPS face criminal charges for delivering controlled substances to internet pharmacies with knowledge the drugs were being dispensed to drug addicts.
Walgreen faced criminal charges for diverting OxyContin from a Florida store.

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What about under-prescribing?
In 1999
Oregon was the first state to discipline a doctor for failing to adequately manage his patients’ pain by under-prescribing to six terminally ill cancer patients. The sanctions were 10 years probation, a formal reprimand and mandatory training. Two years later he was sanctioned for the same conduct.
Prior to 1990
There were no reported civil actions based solely on inadequate pain management through medication.

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Under Prescribing/Groundbreaking
1991 North Carolina –
An SNF was found liable for millions of dollars in compensatory damages and punitive damages after a nurse intentionally withheld pain medications from a patient dying of metastatic prostrate cancer.
2001 California (ten years later) –
A California jury found a physician civilly liable for millions of dollars for failing to manage the pain of a lung cancer patient just days from death. The jury was one vote shy of a punitive damages award. The theory was elder abuse and the standard was gross departure from standard of care.
The California licensing board’s failure to find actionable conduct by the physician was the motivating factor to the family to bring suit.

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The Reality
Two significant issues with prescription pain medication, both creating a double-edged sword for prescribers.

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Duped, Dealer, Dense, Dependent?
Medication over or under prescribing generally due to one of four reasons:
Doctor was duped by Patient
Doctor is intentional diverting drugs (Dealer)
Doctor lacks proper education to recognize legitimate pain need (Dense)
Doctor is drug- dependent himself

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Exposed Classes of Insureds
Pharmacists who fill pain prescriptions without question
Pharmacists who refuse to fill pain prescriptions
Pain management/anesthesiology
Locum tenens – entire spectrum
Physician assistants
Others who “should have known”

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Really Bad Behavior
Patient 1
Rx 247,980 Oxycodone tablets prescribed over a 13 month period;
Patient RX 7,200 30-milligram tablets = 3,600 tablets per day
Average Rx as 250 tablets per day
Patient 2
Lollipop abuse. RX thousands of doses of Actiq over several months
Co-pay = $55, cost to insurance as nearly $16,000
33 lollipops per day to a non-cancer patient
Pharmacy received $163,000 for Rx

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Pharmacist Duty
Quasi-medical duty to verify necessity and propriety of Rx.
Texas v. individual pharmacist for death of 38 year old man from excessive Carisoprodol, Hydrocodone and Xanax Rx.
120 Rx of Hyrodocodone and Carisoprodol filled on 12/1/07
Died on 12/3/07
Basis of the suit was pharmacy owed duty to verify “valid medical purpose.”
Pharmacies have not been held liable to third-parties but Florida and Nevada have come close.

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How can Pharmacists avoid Liability?
Obvious answer = verify that RX is for “valid medical purpose”.
Every action has consequences:
Physician threatened to sue Pharmacy for defamation for refusing to honor Rx he had written patient.
Pharmacy had also advised other pharmacies of his suspicion that the RX were not for a “valid medical purpose”.

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To Write or Not To Write?
Yes or No?
Example 1: 23 y/o unemployed patient is prescribed Oxycontin, Oxycodone and Alprazolam and dies 3 days after the Insured’s physician assistant renewed his prescriptions.
Yes or No?
Example 2: 40 y/o correction officer is prescribed Xanax for anxiety, Trazadone for sleep, and Fentanyl for pain relief by the Insured’s locum tenens family practice physician for a work injury, and dies in his sleep.

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To Write or Not To Write?
Example 1: 23 y/o unemployed patient is prescribed Oxycontin, Oxycodone and Alprazolam and dies 3 days after the Insured physician assistant renewed his prescriptions.
Patient was in an auto accident two years prior, evaluated by orthopedic surgeon for spinal issues, and underwent ineffective epidural steroid injections. Physician’s assistant saw patient at least monthly for over one year, performed drug screens to assure no abuse of non-prescribed substances and ordered follow-up MRI’s.
Yes or No?

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To Write or Not to Write?
Yes or No?
Example 2: 40 y/o correctional officer is prescribed Xanax for anxiety, Trazadone for sleep, and Fentanyl for pain relief by the Insured’s locum tenens family practice physician for a work injury, and dies in his sleep.
Cause of death from Fentanyl intoxication only, no other drugs in system at death. Patient was cutting Fentanyl patches into smaller pieces, which he then froze and chewed/sucked, resulting in lethal dose.

28. #ACIInsurance
Claims Involving Special Populations
Elderly Patients
Both Outpatient and in NH/AL settings
Slower metabolism to clear drugs
Increased risk of drug-to- drug interactions
Impairments of kidney/liver systems
Unsuspected risk of abuse/diversion/addiction

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Claims Involving Special Populations
Pre-Teens/Adolescents
Find Rx drugs at home “must be OK”
High incidence of teens using Rx drug w/o MD script (narcotics, multiple drugs, unknown drugs)
Majority obtain drugs from friends/family
When opioids run out, they turn to heroin (cheaper, readily available)
Result: Heroin addiction skyrocketing!

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Claims Involving Special Populations
“Soccer Moms”
Increase in death from prescription painkiller ODs (1999 – 2009): ● Men 265% ● Women 400%
Under-recognized; growing problem for women
Women (25-54 yo): more likely to go to ED for Rx painkiller misuse/abuse
Women (45-54 yo): highest risk of dying from Rx painkiller OD

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Claims Involving Special Populations
“Soccer Moms”/Women are more likely to:
have chronic pain
be prescribed painkillers
be given higher doses
use them for longer periods of time
become dependent more quickly
engage in doctor shopping

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Claims Involving Special Settings “Methadone Prescriptions”
Historically – a safe and effective treatment for addiction
Recently – low cost generic drug provides long-lasting pain relief
Reality – 6-fold increase in methadone OD deaths 1999 - 2009

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Claims Involving Special Settings Methadone Risk Profile
Narrow therapeutic range
Prescribe within the recommended ranges; take care when titrating
Can accumulate in body leading to respiratory depression
Can disrupt cardiac rhythm
Other meds can potentiate the effects of methadone

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Claims Involving Special Settings Drug Treatment Centers
Many use outdated treatment methods; not evidence-based
Personnel lack qualifications and training
Too many offer only revolving door, celebrity, “get fixed quick” approach
Reality:
Patients need multi-faceted, continuous, individualized treatment programs

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Claims Involving Special Settings: Drug Treatment Centers
Liability Claims:
Self-destructive behavior
Assaults (by staff; by patients)
Infections, falls, injuries
Exceptional withdrawal symptoms
Failure to recognize/diagnose/address underlying medical problems

36. #ACIInsurance
Claims Involving Special Settings Drug Treatment Centers
Look For:
Licensed addiction counselors
Individualized treatment programs
Able to address underlying medical, psychological, social, and legal problems
Offer medical and support services
Offer validated treatment methods:
Community Reinforcement And Family Training (CRAFT)

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State Government Response
Prescription Drug Monitoring Programs (PDMPs)
Prescribing Guidelines—80 mg. Morphine Equivalency Dosing (MED) threshold; “press pause” to re-evaluate risks/benefits of LT opioid therapy
Pain Clinic (“Pill Mill”) crackdown
In office physician dispensing limits
Medicaid & BWC “lock-in” programs to limit who can prescribe and who can dispense to the patient

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Federal Government Response: FDA
New! April 16, 2014-class-wide labeling changes for all extended-release and long-acting (ER/LA)opioids
Restricted Indication for Use: severe, round-the- clock pain; reserved for patients who have failed non-opioid alternatives
NOT indicated for PRN pain relief
Black Box Warning: chronic maternal use during pregnancy can cause Neonatal Opioid Withdrawl Syndrome (NOWS)

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Federal Government Response: FDA
REMS—drug sponsor (manufacturer) to provide:
Educational programs for safe prescribing for clinicians;
Medication Guides and Drug counseling documents for patients

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Medicare (CMS)
“Protecting the Integrity of Medicare Act of 2014” discussion draft bill
§17 Programs to Prevent Prescription Drug Abuse Under Medicare Part D
High-risk beneficiaries can be “locked in” to one physician and one pharmacy for opioids and high- risk drugs
States can share information across state lines
Medicare Drug Integrity Contractors (MEDICs) will monitor prescribers and beneficiaries for frequently abused drugs

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Risk Management - Best Practices: Care of Patients
Obtain a thorough and accurate H&P
Use validated screening tools to identify at- risk patients
Recognize the “Red Flags” for abuse
Refill practices: require office visits and regular exams to justify refills
Perform Urine Drug Screens (UDS) at outset of care, when meds are adjusted, and on a random basis

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Risk Management - Best Practices: Care of Patients
Utilize tracking and monitoring databases (PDMD)
Include Psychologists and Behavioral Health Specialists as adjuncts to Rx therapy
Give clear instructions for use
Avoid risky drug combinations (i.e., Opioids and Benzodiazepines)
Female Patients: Discuss R/B/A for Rx painkillers, especially during pregnancy

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Risk Management - Best Practices: Documentation
Thoroughly document all encounters and rationale for prescribing decisions
“Informed Consent”: signed, reviewed, specific
Use Patient Opioid Contracts to set ground rules for treatment, and provide basis for termination
Provide Education materials to patient and family

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Risk Management - Best Practices: Training & Education
Understand the link between substance abuse and mental health
Take CME courses for Opioid Prescribing (AMA Module Series)
Review all new product labeling and educational materials
Talk to pharmacists, colleagues, consultants on complex cases

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QUESTIONS?
Cathleen Kelly Rebar
Partner
STEWART BERNSTIEL REBAR & SMITH
CRebar@SBRSLaw.com
John M. Foley
Manager, Claims
MARKEL CORPORATION
JFoley@MarkelCorp.com
Victoria L. Vance
Health Care Chair
TUCKER ELLIS LLP
Victoria.Vance@TuckerEllis.com