Mismanaged Methadone Treatment - A Prescription for Personal Injury - Professional Liability for Legalized Drug Dealing by Substance Abuse Treatment Centers in New Hampshire

by

Kevin F. Dugan and Holly B. Haines

I.Introduction
Drug use and abuse is increasing in New Hampshire and nationwide.  When left untreated, substance abusers become addicted - - both physically and psychologically dependent on the effects of the drugs they abuse.  Addiction is a disease that can be treated, however, if an appropriate combination of medication and behavioral therapy tailored to a patient’s individual needs is implemented.  Opiate addiction is one of the most common treatable addictions in our state.  It occurs not only in people addicted to heroin or other illegal drugs, but also in people involved in chronic pain management programs. In an effort to treat opiate addiction, many for-profit companies have established substance abuse treatment centers in New Hampshire with a focus on outpatient methadone treatment.  Unfortunately, instead of treating the diseases and addictions of their patients, these treatment centers are merely treating the opiate and fostering a new, cheaper, addiction to and dependence upon methadone.  

As a practical matter, these programs take the opiate addict’s cash, give the addict methadone and send the addict home.  The only time that methadone is generally denied to an opiate addict is if the addict cannot afford to pay for his or her dose.  Meanwhile, opiate addicts engaged in these methadone treatment programs continue to use other drugs due to their untreated addictions to those substances and continue to drive to and from their daily methadone dosing.  Allowing addicts to foster their addictions and drive impaired by the effects of methadone and other drugs is a prescription for personal injury for both the addict and the general public.  
 
Opiate addiction, like diabetes or any other chronic relapsing disease, cannot just be prophylactically treated with medication.  To be successfully treated, addictions require not only medication but also behavioral, psychological and lifestyle changes made available through comprehensive treatment programs for patients.  As such, substance abuse treatment centers and outpatient methadone treatment programs have a duty to provide these comprehensive treatment services to their patients.  When they fail to do so and a patient or member of the general public is harmed by that failure, the substance abuse treatment program must be held professionally liable for the injuries sustained.  Substance abuse treatment centers and outpatient methadone treatment programs cannot be allowed to exist as legalized drug dealers in our state.  Nor can they be allowed to turn a blind eye to their patients after dispensing their methadone dose.  When these treatment centers dispense drugs to addicts, known to be impaired, and allow those addicts to drive from the treatment center, they should be held liable for any injury sustained or caused by the addict while driving.       

II.Methadone and Opioid Treatment Programs (OTPs)

Methadone is a narcotic.  It is classified by the DEA as a Schedule II controlled
substance due to its high potential for abuse and severe physical and psychological dependence.   Narcotics are drugs that cause impairment and are associated with side effects such as drowsiness, inability to concentrate, and respiratory depression. As the dose of methadone is increased, the toxic effects become more pronounced. Unlike many drugs of impairment, there is no apparent loss of motor coordination or slurred speech as occurs with many depressants.   Because methadone alone can cause impairment, in 2006 the FDA warned physicians and health care providers prescribing this drug to have a heightened awareness of the symptoms of impairment in their patients to prevent death, narcotic overdose and serious cardiac arrhythmias from occurring.

Methadone is indicated for the treatment of opiate addiction and has been used in that capacity since the 1960s.  In fact, it is the most widely used medication for the treatment of opioid addiction.   Methadone suppresses withdrawal symptoms, reduces cravings for opioid drugs and blocks the euphoric effects of opioids for 24-36 hours.   When used as prescribed and appropriately monitored, methadone is an effective tool in the treatment of opiate addiction.  When prescribed improperly, in concert with other drugs and/or alcohol and without medical monitoring, however, methadone can be fatal.  “Patients who are prescribed methadone need to be monitored by a physician well trained in the pharamacodynamic and pharmacokinetic properties of the drug.”   

Methadone deaths are increasing nationwide.   Some of these deaths are due to diversion of methadone from narcotic treatment centers to the illegal market by patients.   Some of these deaths, however, are the result of patients using legitimately prescribed methadone when they have been improperly counseled or monitored by their physician for the dangers of taking the drug in combination with other drugs or medications.   Most general practitioners and health care providers lack the training necessary to adequately assess and monitor the patients to whom they are prescribing methadone.  

In recognition of the inherent problems with such a dangerous drug, the U.S. Department of Health and Human Services Substance Abuse and Mental Health Services Administration (SAMHSA) with the Center for Substance Abuse Treatment (CSAT) have established a regulatory system based on an accreditation model for the use of methadone and other narcotic drugs in maintenance treatment and detoxification of opioid addicts.  SAMHSA has administrative and oversight responsibility for all opioid treatment programs (OTP) and must certify all programs before opioid treatment can be provided.  OTPs must be certified by SAMHSA before they can dispense methadone.  To become certified, the programs must meet Federal Regulatory standards under 42 C.F.R. part 8, which includes accreditation by an approved accreditation body such as JCAHO (Joint Commission on Accreditation of Healthcare Organizations) or CARF (Commission on Accreditation of Rehabilitation Facilities).  
 
In addition to federal regulatory compliance, OTPs must comply with all State statutes and regulations applicable to the dispensing and management of methadone.  In New Hampshire, methadone treatment programs are required to comply with heightened state regulations in their operations, including the New Hampshire Controlled Drug Act, to adhere to treatment requirements for methadone maintenance and detoxification programs.    

Under federal and state regulations, OTPs are supposed to provide certain core services such as medical care and psychological services, treatment for drugs other than heroin, and treatment for addiction to alcohol or other illicit drugs.  OTPs may provide additional ancillary services such as educational, vocational, financial, legal, housing, transportation and childcare assistance.  The accreditation requirements assess administrative organization, clinical and facility management, risk management and quality assurance, professional credentials, patient admission criteria, patient medical and psychosocial assessment, therapeutic dosing, treatment planning, evaluation and continuous clinical assessment, testing for illicit drug use and polypharmacy abuse, unsupervised approved use, withdrawal and discharge, management of concurrent alcohol and polysubstance abuse, patient rights, concurrent services, record keeping and documentation, community relations and education, and diversion control.

III.The Problem - Legalized Drug Dealing

In the face of all of these regulations, accreditation, and certification requirements, one would think that substance abuse treatment programs would engage in strict compliance and provide well-trained medical professionals for their patients in an effort to treat their addictions.  Unfortunately, the reality is that these treatment centers are placing their profits over the people they are treating and they have an incentive to get their patients addicted to methadone to continue the profit stream indefinitely into the future.  Many OTPs in New Hampshire superficially comply with accreditation standards to maintain certification to dispense methadone, without ever addressing the needs of the patients they are treating and ignoring the realities of the populations and cultures from which their patients come.  

In order to be eligible for admission to an OTP, a patient must have a formal medical or psychiatric diagnosis of opioid dependence under DSM-IV 304.00.  While this should require a formal medical examination and assessment before a medical diagnosis is made, OTPs that superficially comply will make the diagnosis with a positive drug test for opiates and a patient’s own report that he or she is an opiate addict.  Once a patient is admitted to the program, he or she is able to get a daily dose of methadone indefinitely, merely by showing up and paying for it.  Drug dealers who are familiar with the culture of these programs know the script to tell the admissions personnel and also know that if they pop a few pills they can get a positive drug test granting them admission to the program.  Once they are in the program, they can pay for their daily dose and divert it to the street to make their own profit. Drug addicts know that they can get their daily fix much cheaper at an OTP than on the street and that there is no oversight once they have received their dose.  Drug addicts also know the script to recite to increase their dose and most OTPs willingly increase doses at the request of the addict.  The OTPs know that the higher the methadone dose provided, the more dependent the addict will become and the addict will continue in the program. This is nothing more than legalized drug dealing.
 
In order to maintain accreditation, OTPs must regularly perform drug screens of their patients.  The problem is, while OTPs perform regular urinalyses on their patients, they do not impose consequences for positive drug screens.  Many patients will consistently test positive for cocaine, marijuana, benzodiazepines, or other drugs but they are never kicked out of the program.  Nor do they ever receive treatment for their continued drug use and abuse. As long as the patient continues to show up and pay for his or her dose, the OTP will continue to provide it despite ongoing evidence of illicit drug use and polypharmacy abuse.

Finally, OTPs are not monitoring their patients for impairment.  Methadone alone can cause impairment.  When used in concert with other illegal or controlled substances, impairment is even more likely.  OTPs often use their baseline assessment of a patient when they receive the first dose as the gauge for whether or not a patient is impaired in the future.  The problem is, most patients truly suffering from addiction who come to an OTP for treatment are impaired on arrival, so they are never seen in a sober state by these OTPs and the baseline for the patient is impairment.  Thus, these patients come to the clinic impaired, receive a dose of a narcotic which increases their impairment, and then they are allowed to leave the clinic and drive home.

SAMHSA recognizes that the failure of OTPs to recognize and treat patient impairment is the greatest risk factor for claims to be filed against OTPs for personal injury and death caused by an OTP patient.    This is because impaired patients present potential dangers themselves and others if they do not restrict their activities to those that can be done safely and without risk of harm to others.  “Identifying impairment in a patient is typically grounds to support the refusal to medicate.  Suspicion of impairment can and [] should trigger a set of preemptive actions aimed at avoiding and minimizing the risk of potential harm.”   Notably, SAMHSA has identified the following risk factors for injury and death:

•During induction, patient impairment is common and should be anticipated.
•Loss associated with patient impairment is more probable in patients whose urinalysis indicates continued poly-substance use.
•For patients who drive long distances to and from the OTP, loss becomes even more probable.
•Loss associated with automobile accidents often involves third parties and can be severe.

The major risk factor for methadone injury or death is poly-substance abuse.

IV.The Law - Professional Liability for Legalized Drug Dealing
 
In the Petition of Juli George, the New Hampshire Supreme Court recently found that a substance abuse treatment center dispensing methadone to patients is a medical provider subject to the provisions of the medical injury statute, RSA ch. 507-E, and the medical injury screening panel statute, RSA ch. 519-B.   In the George case, the plaintiff was injured when she was struck by a driver impaired by methadone who fell asleep at the wheel after receiving her dose of methadone at a substance abuse treatment center.  While the Supreme Court declined to address the merits of the plaintiff’s third-party liability claim, the George Court clearly recognized that these OTPs are medical care providers subject to the medical malpractice and professional liability laws in New Hampshire.

We recently filed suit in two cases against OTPs, one on behalf of a patient and one on behalf of a third-party, both plaintiffs who were catastrophically injured because the OTP allowed its patients to drive while impaired.  In each case, the patient of the treatment center sought comprehensive treatment for his or her addictions, but received only a new, stronger addiction to methadone.  In each case, the patient was impaired by and addicted to substances in addition to Heroin when they sought treatment.  In each case, the patient consistently tested positive for drugs and poly-substance abuse in addition to methadone for a period of more than one year and continued to receive his or her dose as long as he or she continued to pay. In each case, the patient was known to be driving to and from the OTP to get his or her dose and was known to have positive drug screens indicative of impairment by other drugs when receiving treatment.  Finally, in each case, the patient was able to get dose increases at his or her request.  Neither of these patients were warned about driving while under the influence of methadone.  Neither of these patients were told not to drive while under the influence of methadone and other drugs such as marijuana and benzodiazepines.  Finally, neither of these patients were ever reprimanded for their continued poly-substance abuse because they were never provided with any actual treatment for their addictions.  Notably, these two cases and the case of Juli George arise out of three different clinics in three different regions of New Hampshire, which means this problem is happening statewide and drivers impaired by methadone and other drugs are on the roadways throughout our state due to the legalized drug dealing of these centers.

Duty to the Patient

Addiction is a disease that must be treated.  To be successfully treated, addictions require not only medication but also behavioral, psychological and lifestyle changes made available through comprehensive treatment programs for patients, tailored to the patient’s individual needs.  As such, substance abuse treatment centers and outpatient methadone treatment programs have a duty to provide these comprehensive treatment services to their patients who come to them seeking treatment for their addictions.  Under federal and state regulations, these treatment centers have a duty to provide certain core services such as medical care and psychological services, treatment for drugs other than heroin, and treatment for addiction to alcohol or other illicit drugs.  Furthermore, when dispensing methadone as part of the treatment to an opiate addict, these centers have a duty to have medical staff trained in the pharamacodynamic and pharmacokinetic properties of the drug.  The centers also must have staff trained to recognize and address impairment of the patient to prevent administration of another narcotic, methadone, from being given to an already impaired patient.  

One of the hallmarks of addiction is denial of impairment, so the providers at these treatment programs have a heightened duty to detect impairment to prevent the patient from harming him or herself and others. These centers cannot be allowed to ignore evidence of impairment of their patients.  Willful ignorance is not a defense. When a treatment center knows or should know that a patient is impaired, it has a duty to take reasonable action by not dispensing the methadone dose and by  preventing that patient from driving.  When a patient is harmed by a center’s failure to treat his or her addiction or by a the center dispensing methadone to that patient when he or she is already impaired, the patient is entitled to compensation for his or her injuries.

Duty to Third Parties

Whether an OTP owes a duty of care to reasonably foreseeable non-patient third-parties has yet to be determined by the New Hampshire Supreme Court.  In fact, the Supreme Court expressly declined to answer this question in the Petition of Juli George.  The New Hampshire Supreme Court has recognized, however, that a professional person acting in the course of his or her employment may own a duty of care to third parties in certain circumstances.   New Hampshire does impose third-person liability on medical providers when they know of a specific risk of harm by their patient to an identifiable third-party and the medical provider fails to take reasonable action to prevent that harm from occurring.   The difficulty in extending this rule of liability arises when the third-party is not readily identifiable because he or she is a member of the general public.  In those cases, our Supreme Court has indicated that the existence of a duty to third-parties must be based “upon a balancing of the societal interests involved, the severity of the risk, the burden [placed] upon the defendant, the likelihood of occurrence and the relationship between the parties.”  

We submit that the liability of an OTP for providing methadone to an impaired patient is no different than the liability imposed on a liquor licensee who provides alcoholic beverages to an intoxicated patron.   In each case, the defendant is engaged in a highly regulated profession and the societal risks are high.  Drivers impaired by methadone and other illegal drugs are no less of a risk to public safety than drivers impaired by alcohol.  OTPs have a duty to inform their patients of all side effects and potential drug interactions when they prescribe and administer methadone to their patients.  Before administering methadone the OTP also has a duty to ensure that the patient is not otherwise impaired and the methadone is not contraindicated.  Finally, if an OTP gives treatment of any kind that may impair a patient’s driving abilities, the OTP has a duty to ensure that the patient does not drive until he or she is able.

We have written in the past about Medical Provider Liability to Non-Patient Third Parties for Negligent Medical Care and Prescribing Practices.   All of the principles addressed in that article are applicable to OTPs as medical providers to opiate addicts and should be incorporated here by reference.
 
Injuries and deaths caused by patients impaired by methadone are a problem nationwide.  Many other States already impose third-party liability on OTPs when they negligently dispense methadone to an impaired patient and allow him or her to drive, causing injury or death to a third party. One of the leading cases is Taylor v. Smith, where the Alabama Supreme Court imposed liability on an OTP for administering methadone to an outpatient who consistently failed drug screens for other illegal drugs and who was known to be a daily user of marijuana and benzodiazepines during her methadone treatment.  The patient left the clinic for her daily 90 minute drive home and caused an accident with a third-party.  The Taylor Court found that the physician’s knowledge of the patient’s known, continuing, drug abuse along with the knowledge that the patient would get behind the wheel made the accident entirely foreseeable.   The Court also found that the societal costs of the accidents caused by impaired drivers outweighed the need to treat patients with methadone, especially those receiving methadone while continuing to use illegal drugs.   

In a Florida case, Cheeks v. Dorsey, an OTP patient killed the appellant’s fiancé and her daughter in an accident, after receiving his methadone dose and while he was impaired by other drugs.  The Florida Appellate Court found that the OTP breached its duty to the third-party appellants by its willful blindness because the patient was known to routinely abuse prescription and nonprescription drugs, yet the OTP failed to test the patient for drugs that could adversely interact with methadone.  Specifically, the Court held that the defendant had a duty to a non-patient third party because the defendant’s conduct foreseeably and substantially caused the injury that occurred.

[T]his case presents a situation in which the variables are, or should be, known to the doctor or health care provider at the time the drug is administered .... When one administers a drug which, when combined with other drugs or alcohol, may severely impair the patient, the doctor’s failure to take the proper precautions (e.g., verify whether the patient is already under the influence of another drug) is an affirmative act which creates the risk that unidentifiable third parties might be injured.  Under these circumstances, there is, most certainly, a duty to unidentifiable third parties who may be injured as a result.

In other non-methadone cases, a duty to non-patient third-parties has been upheld when the physician knew or should have known that adverse reactions to a prescription drug could affect a patient’s ability to drive.  In those cases, the risk of harm to non-patient, third-parties was reasonably foreseeable and the physician’s duty was extended to the general public.  In Wilschinsky v. Medina,  the physician administered certain drugs to his patient in his office.  Like methadone, these drugs were known to impair judgment and physical abilities, thereby adversely affecting the patient’s ability to drive.  Shortly after receiving the medication, the patient was involved in a serious motor vehicle accident that caused the plaintiff’s injuries.  The New Mexico Supreme Court held that a duty was owed to the non-patient third-party plaintiff who was foreseeably harmed when the physician recently administered powerful drugs which had known side effects of drowsiness and impaired judgment.  

Similarly, in Joy v. Eastern Maine Medical Center, a patient operated his motor vehicle after receiving an eye patch from the defendant medical center.  No one warned him that he should not drive while wearing the eye patch, and he caused a collision with the plaintiff.  The Maine Supreme Judicial Court held that the physician owed a duty to the third-party plaintiff because the physician knew or should have known that the eye patch would affect the patient’s ability to drive.  “[W]hen a doctor knows, or reasonably should know that his patient’s ability to drive has been affected, he has a duty to the [] public as well as to the patient to warn his patient of that fact.”

In all of these cases, the bottom line is that when a medical provider treats a patient who has a foreseeable risk of causing an accident, the medical provider has a duty to take all reasonable precautions to prevent that accident from occurring and to prevent that patient from causing injury to himself or others.

V.Conclusion

New Hampshire cannot allow these for-profit methadone treatment programs to place their profits over the people they are treating or the public that they serve.  Opiate addiction is a treatable disease and addicts seeking treatment to overcome their addictions should receive appropriate comprehensive medical care that will enable them to do so. OTPs have a duty to their patients to treat their addictions and they have a duty to the public to prevent their patients from driving while impaired.  Methadone is a dangerous, highly addictive drug that cannot just be blindly dispensed to patients who are known to succumb to the effects of addiction, who are known to be impaired by other substances, and who are known to be driving.  If it is, its prescription will be for personal injury and death.  

ENDNOTES
 .  See http://www.justice.gov/dea/pubs/abuse/1 csa.htm.
 .  See http://www.justice.gov/dea/pubs/abuse/4 narc.htm.
 . See http://www.fda.gov/cder/drug/advisory/methadone.htm.
 . See Eric C. Strain, M.D. and Maxine L. Stritzer, Ph.D., Methadone Treatment for Opioid Dependence, 1 (1999).
 .  See Methadone Diversion, Abuse, and Misuse: Deaths Increasing at an Alarming Rate, U.S. Department of Justice National Drug Intelligence Center Publication No. 2007-Q0317-001, at 3. (November 2007).
 .  See id.
 . See id. at 2.
 . See id. at 1.
 . See id. at 5.
 .  See id. at 7.
 . See id.