Current Opioid Litigation and the Role of Medical Record Reviews

According to the Centers for Disease Control (CDC), from 1999 to 2017, approximately 218,000 people died in the US from overdoses related to prescription opioids.  Deaths were five times higher in 2017 than in 1999.[1]  Further, a study published in 2015 of patients aged 15-64 who received opioids for chronic noncancer pain revealed one in 550 patients died from an opioid-related overdose at a median of 2.6 years from their first prescription.[2]  The CDC estimates that the total costs of prescription opioid misuse in the United States, including healthcare, lost productivity, addiction treatment and criminal justice involvement, is $78.5 billion a year.[3]

Federal Opioid Case

As a result of the impact of this public health crisis, lawsuits have been filed throughout the country.  Many cases have been brought by government bodies against manufacturers, distributers and retail pharmacies.  Of national interest are the cases in multidistrict litigation, MDL 2804 In re: National Prescription Opiate Litigation, which have a trial date for the bellwether cases set for October 2019 in the United States District Court, Northern District of Ohio, presided by Judge Dan Polster.

In the MDL, plaintiffs allege that the manufacturers of prescription opioids grossly misrepresented the risks of long-term use of those drugs for persons with chronic pain, and distributors failed to properly monitor suspicious orders of those prescription drugs–all of which contributed to the current opioid epidemic.[4]  The consolidation includes approximately 1,500 cases filed by government entities, hospitals, Indian tribes, and third party payors.  Defendants include Purdue Pharma, Actavis Phama, Insys Therapeutics, Janssen Pharmaceuticals, AmerisourceBergen, Cardinal Health, McKesson, CVS, Walgreen, Walmart and Rite Aid.

The Use of Medical Records in Opioid Litigation

Individual medical records, which may document examples of patients who received unnecessary prescriptions that resulted in addiction, are not coming into play at this point in the MDL.  The plaintiffs are pursuing all of the costs related to the drug addictions, taking into account costs to the community.  Defendants have argued specific individual examples are needed to demonstrate the events from manufacturer to end use.  In this regard, Judge Polster has ordered that plaintiffs could rely on “aggregate proof” using statistical evidence relating to appropriate versus actual prescriptions in a given population as opposed to individual records.

Unquestionably, medical record documentation will play a key role in other cases, particularly those specifically citing physicians, physician extenders, pharmacists and health care facilities.  As evidenced by the $17.6 million verdict against a doctor and hospital in St. Louis in 2016, which was upheld on appeal in 2017, the stakes can be high.[5][6] In such cases, the review of records typically begins with a comparison to guidelines and standards.

CDC Guidelines for Prescribing Opioids

The CDC released guidelines for primary care physicians prescribing opioids for chronic pain (excluding cancer, palliative and end of life care patients) in March 2016.  The CDC notes that primary care providers account for approximately half of all opioid prescriptions.

The CDC guidelines include 12 recommendations:[7]

  • Opioids are not the first-line therapy, and should only be used when the benefits outweigh the risks;
  • Establish goals for pain and function;
  • Discuss risks and benefits with patients;
  • Use immediate-release opioids, rather than extended-release, when starting;
  • Use the lowest effective dosage;
  • Prescribe shorter durations for acute pain;
  • Frequently evaluate benefits and harms;
  • Use strategies to mitigate risk;
  • Review patients’ Prescription Drug Monitoring Program data;
  • Use urine drug testing before starting opioid therapy;
  • Avoid prescribing concurrent opioid and benzodiazepine treatments; and
  • Offer treatment for opioid use disorder.

State Guidelines for Prescribing Opioids

Many states also have guidelines for prescribing opioids.  For example, the Ohio Revised Code contains administrative rules for management of chronic pain with controlled substances.[8]  The rules outline the following in regard to the physician maintaining a written record of all of the following:

  • Medical history and physical examination of the patient;
  • The diagnosis of chronic pain, including signs, symptoms, and causes;
  • The plan of treatment, the patient’s response, and any modifications, including all of the following:
    • Documentation that other medically reasonable treatments for relief of the patient’s chronic pain have been offered;
    • Periodic assessment and documentation of the patient’s functional status;
    • Periodic assessment and documentation of the patient’s progress toward treatment objectives;
    • Periodic assessment and documentation for indicators of possible addiction, drug abuse, or drug diversion;
    • Notation of any adverse drug effects.
  • The dates on which controlled substances were prescribed, furnished, or administered, the name and address of the patient, and the amounts and dosage forms;
  • A copy of any record or report made by another physician that was used or consulted for the purpose of diagnosing the patient’s chronic pain or treating the patient for chronic pain.
  • A physician shall not prescribe, personally furnish, or administer to a patient a controlled substance without taking into account the potential for abuse, the possibility it may lead to dependence, the possibility the patient will obtain the controlled substance for a nontherapeutic use or distribute it to other persons, and the potential existence of an illicit market. In addition, the physician shall address with the patient the risks associated with protracted treatment, including informing the patient of the potential for dependence, tolerance, and addiction and the clinical or monitoring tools the physician may use if signs of addiction, drug abuse, or drug diversion are present.

As the examples above show, CDC guidelines, state-specific rules, and professional organizations provide extensive resources for the appropriate content of medical record documentation related to opioid use.  Many challenges remain in gathering the complete medical picture on a specific patient, as non-compatible data may be maintained in various systems, including, but not limited to, electronic health records (EHR), pharmacy records (including state specific Prescription Drug Monitoring Programs), billing systems, and paper records.

Sources:
[1] https://www.cdc.gov/drugoverdose/data/prescribing.html
[2]https://www.ncbi.nlm.nih.gov/pubmed/26291716
[3] Florence CS, Zhou C, Luo F, Xu L. The Economic Burden of Prescription Opioid Overdose, Abuse, and Dependence in the United States, 2013. Med Care. 2016;54(10):901-906.
[4] https://www.ohnd.uscourts.gov/mdl-2804
[5] https://molawyersmedia.com/momedlaw/2016/09/20/jury-awards-17-6-million-in-opioid-case/
[6] https://www.courthousenews.com/appeals-court-upholds-15-million-damages-opioid-case/
[7] https://www.cdc.gov/drugoverdose/pdf/pdo_checklist-a.pdf
[8] http://codes.ohio.gov/orc/4731.052

About Excelas

Excelas provides medical record services to organizations nationwide. Our team of credentialed health information managers and medical analysts have the necessary experience and expertise to gather, organize, and analyze complex medical information related to the chain of events in cases involving opioid abuse and overdose.

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