PROFESSIONAL LIABILITY CLIENT ALERT: Opioid Litigation - The Practitioner's Guide to Managing the FDA's 2019 Roadmap


On February 26, 2019, FDA Commissioner Scott Gottlieb released a press announcement detailing the FDA’s efforts in combating the opioid crisis. The FDA holds a guarded belief that the opioid crisis is improving but that significant changes to FDA rules and regulations are still needed to resolve the epidemic. While Gottlieb’s statement  considered the FDA’s efforts to curb illicit opioid proliferation, it also discussed the FDA’s plans for new regulations for medical professionals meant to further reduce and limit the use opioids in the U.S. The press announcement included a roadmap for the FDA’s 2019 regulatory plans  which could have substantial implications for medical professionals defending against opioid litigation. This Article analyzes some of the FDA’s proposed changes that could have the greatest impact on opioid litigation and how medical practitioners can prepare for opioid litigation in Illinois in the wake of these regulatory changes. (For more on how medical professionals can prepare for and protect against future opioid litigation and liability, please see Medical Professionals and Opioid Lawsuits: Protecting Against the Coming Storm.)

I. “Rationalizing” Opioid Prescriptions.

The FDA’s plan for professionals focuses on “rationalizing” the process of prescribing opioids. According to the FDA, “rationalizing” prescription opioids involves reducing the number of opioid prescriptions written by physicians, physician’s assistants, and nurse practitioners through ensuring such medications are “for a dose and duration of use that comports closely with the clinical circumstance and the medical need of the patient.” While directly targeting the actions of prescribers, “rationalizing” can also affect other professionals, such as nurses and pharmacists who may find themselves in the position of monitoring the volume of opioid medication prescribed to a particular patient. The FDA seeks to achieve its goal of “rationalizing” through drafting new “evidence-based guidelines” based upon its own data collection processes and its work with organizations such as National Academies of Science, Engineering, and Medicine.

These guidelines have not been published and their exact extent and effect is not currently known; however, the FDA did provide an example of how it intends to effectuate this “rationalizing” process through opioid packaging. In 2019, the FDA will begin requiring “unit of dose” packaging for opioids – essentially blister packs containing a few days of medications for treatment of an acute injury or recovery.  The FDA believes that limiting opioid medications doses to quantities that will only last a few days will limit opioid abuse by preventing over prescription. It supports this assertion through un-cited, FDA collected data which purportedly shows that “a day or two for medication is sufficient, [and] could reduce the overall amount of dispensed drugs available for misuse, abuse, and diversion.”

However,  the FDA’s concept of “rationalization” is founded upon the misbelief that pain management medicine is entirely routine, ordinary, and predictable. As practicing medical professionals can attest, each patient has a variable tolerance for pain and pain medication. This is true of acute injury and recovery patients, who often have orders for opioids prescriptions “PRN” within certain limits due to a lack of historical pain management data establishing how a particular patient will respond to pain management regimen. Moreover, chronic pain management patients often have debilitating pain that requires routine prescription opioids which necessitate large volume, longer-term prescriptions. As such, medical professional face serious risk in litigation through the FDA’s proposed changes, as the pain management needs of their patients may conflict with the FDA’s broader goal of finding ways to reduce opioid prescription volume.

As the FDA’s “rationalization” of prescription opioids takes greater effect, plaintiff lawyers will begin to argue that medical professional defendants over prescribed relative to the guidelines, ignoring the patient-specific nature of pain management in favor of the more regimented structure of the guidelines that are likely to be issued by the FDA. It will be up to medical practitioners to establish that their actions were not only medically reasonable, but reasonable within the confines of the FDA’s guidelines. The key to this defense will be understanding the guidelines and using effective documentation and communication to prove that the appropriate guidelines were followed or that the guidelines did not apply in a particular clinical situation, due to patient-specific circumstances.

Once the guidelines are drafted and effective, medical practitioners should ensure that they understand and follow the applicable guidelines, or clearly document the basis for any decision to intentionally deviate from the guidelines—including explaining the need for opioid medications and why the dose and frequency of the prescription is justified in the context of the patient’s care.. This will require understanding the full extent and limits of the guidelines. This process can be facilitated by an employing medical group, hospital, nursing home, pharmacy, or other entity through continuing education programs. Moreover, treating professionals must communicate with one another about what opioids are being prescribed, who has the responsibility for prescribing them, and how and by whom they are being administered. A working understanding of guidelines together with strong documentation and communication throughout the care team will ensure that the guidelines are being followed appropriately for each patient’s particular circumstance.

II. Risk Evaluation and Mitigation Strategies

In 2018, the FDA required the pharmaceutical industry to develop Risk Evaluation and Mitigation Strategies (“REM’s”) for opioid prescriptions. These REM’s place additional requirements on medical professionals prescribing and administering opioid medications, including requirement for attending continuing professional education programs and limitations on when, where, and under what circumstances certain opioid medications may be used. The FDA’s statement describes a 2019 goal of re-working some of its opioid REM’s to make them more robust, especially relative to medications such as fentanyl.   

Much like with the new guidelines, changes to the REM’s could be used by plaintiffs’ lawyers to argue that a medical care professional over prescribed, over issued, or over administered opioid medications based upon the failure to follow a specific REM. Again, the best means to defend against these arguments is to be aware of and understand the REM’s, to document the process of following the REM’s or the reason for deviating from them, and to communicate openly among medical professionals within the care team. Under current FDA regulations, many opioid manufacturers are required to offer continuing education programs to medical professionals before those professionals may prescribe, issue, or administer opioids, which provides professionals with a clear educational source and authority for understanding REM’s. Documentation and communication are essential to proving when, where, and how the REM’s were followed during litigation filed years after care.

III. New Products

The FDA’s statement also touted new product development within the pharmaceutical industry as a possible tool in combating the opioid crisis. The statement discusses the FDA’s strong encouragement for manufacturers to develop an over-the-counter version of Naloxne, detailing its efforts to streamline the process by developing a model drug facts label. The FDA also reported on the development of non-addictive or less-addictive opioid alternatives for pain management and the development of new medicines and medical devices that could aid in treatment of those with opioid addictions.

It will be essential for medical professionals to stay abreast of scientific and technological developments relative to opioid alternatives and other products for the treatment of opioid abuse. The more that these products enter the market, the more likely that plaintiff lawyers will use them as a tool in litigation – arguing that a medical professional (particularly prescribers) should have known of alternative medications and used them to prevent the risk of injury and addiction. Remaining vigilant and aware of updates to opioid alternative and addiction treatment products will allow a medical prescriber to provide the most up-to-date treatment modalities possible relative to pain management and treatment of addiction. Understanding new medications can help providers to explain why a novel medication or treatment tool was or was not appropriate for a particular patient’s care.  Documentation and communication will again be essential to a medical provider’s defense.

IV. Planning Ahead

While the FDA’s 2019 goals contain some concerning changes to opioid regulations and guidelines, the goal of medical professionals in protecting against litigation remains the same. Medical professionals must understand FDA guidelines on opioids that are relevant to their practice area and must incorporate these guidelines into their clinical decision-making and their charting. Pain management is an incredibly patient-specific area of medical practice, and it should be every medical professional’s goal to specifically chart the details and justifications of a patient’s pain management regimen. This will ensure the best quality of care and provide evidence that appropriate care was provided should litigation ever develop.

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