PROFESSIONAL LIABILITY CLIENT ALERT: Medical Professionals and Opioid Lawsuits: Protecting Against the Coming Storm
The pharmaceutical industry and medical professionals are facing a crisis over opioid prescriptions – which have been a regular part of medical care and pain management for decades. In 1977, the New England Journal of Medicine published an analysis of opioid medications and associated addiction which found opioid addiction and death to rarely develop from pain management with opioids. Following this publication, the medical industry began to use opioids with greater regularity throughout the 1980’s, 1990’s, and into the present day given their effectiveness in treating patients with both severe short-term and chronic pain.
However, despite the medical value presented by opioids in managing pain, some recent studies have attributed increasing rates of opioid related addiction and opioid related overdose to their use in the medical setting. According to the CDC, over half of the 63,600 drug overdose deaths in 2016 involved an opioid, a figure which has showed a significant increase since the 1990’s. (Understanding the Epidemic, Center for Disease Control and Prevention, https://www.cdc.gov/drugoverdose/epidemic/index.html (2017)). Government entities have been quick to act on these new studies, with the U.S. House of Representatives passing the Overdose Prevention and Patient Safety Act this past week with the hopes of preventing overdoses by increasing communications among physicians offering medical care via opioid prescriptions.
However, not all efforts to address recent opioid studies have been legislative, and government agencies, municipalities, and even consumer have been filing civil suits against pharmaceutical manufacturers relative to their manufacture and sale of synthetic opioids. Lawsuits against manufacturers have primarily come in the form of product liability actions, alleging that prescription opioids were defectively designed or failed to adequately warn of addiction risks. (Rebecca L. Haffajee, Michelle M. Mello, Drug Companies’ Liabiltiy for the Opioid Epidemic, N Engl J Med 2017; 377:2301-2305). The heaviest litigation in this area involves the federal government, states, counties, cities, and Native American tribes claiming restitution relative to costs they allegedly expended in treating, addressing, and preventing opioid addiction and overdose. Id. In December 2017, a judicial panel consolidated 400 of such cases from across the country before Judge Dan Aaron Polster of the Northern District of Ohio with the hope of achieving a rapid resolution of this litigation short of trial; however, progress has been limited and, for the time being, opioid litigation is here to stay. (Jan Hoffman, Can This Judge Solve the Opioid Crisis, The New York Times, https://www.nytimes.com/2018/03/05/health/opioid-crisis-judge-lawsuits.html (March 5, 2018)).
While the litigation to date has focused largely on pharmaceutical companies, it is very likely that this litigation will shift focus toward prescribing physicians, dispensing pharmacists, administering nurses, and their employing hospitals, medical groups, pharmacies, and nursing homes as plaintiffs’ attorneys look for new sources for monetary damages. This process has already begun: in Cook County, Illinois, a recently filed medical malpractice case names various medical centers, prescribing doctors, pharmacies, and pharmacists, attributing their actions to the recent death of musical artist Prince by opioid overdose. See Michael Zimmer v. Trinity Medical Center, Inc., et al., 2018 L 4068. To help medical professionals prepare for the coming storm of opioid litigation, this article examines the legal standards applicable to physicians, pharmacists, nurses, and their employers in Illinois relative to the use of synthetic opioids in patient care so that both insurers and insureds alike can better understand how to limit their risk of liability.
Illinois gives physicians the responsibility to warn patients regarding the risks associated with their medication, putting physicians at significant risk of opioid prescription litigation. Illinois follows the “learned intermediary doctrine” which states that a pharmaceutical company must warn physicians of the risks posed by its medications and that physicians must convey those warnings to patients when deemed necessary according to the physicians’ individual medical judgment. Kirk v. Michael Reese Hosp. & Med. Ctr., 117 Ill. 2d 507, 517, 513 N.E.2d 387, 392 (1987). While this places a duty to warn squarely on the shoulders of physicians, it does not guarantee their liability in opioid litigation.
For decades, pain management has been a routine part of medical care given to patients, whether relative to short-term recovery or long-term management of chronic pain. A medical specialty has even developed around this practice, with board certified physicians from disciplines such as anesthesiology, neurology, physiatrist, and psychology engaging in pain management fellowships specializing in the study and treatment of acute and chronic pain. These physicians often work together in groups or with pharmacologists, palliative care physicians, pharmacists, and nurses in a collective approach to provide their patients with the best pain management care medically possible. Since the 1970’s, opioid medications have been a regular part of pain this management care given their value in relieving significant and chronic pain. As such, in acting within their medical standard of care and striving to provide the best pain management care possible, it is reasonable that physicians would prescribe opioids to treat patients experiencing significant and chronic pain based upon their education, experience, and training regarding opioids.
Nonetheless, modern social concerns regarding opioid addiction will likely result in new forms of opioid litigation against physicians seeking to challenge their medical judgments in hindsight. Under the learned intermediary doctrine, physicians must use their knowledge, training, and experience to make medical judgments regarding patient care. Id. Ultimately, physicians maintain a duty to warn patients of the dangers that their medications pose to them, with that duty being assessed according to the reasonableness of the physicians’ warnings in the circumstances in which they were given.As such, a physician’s defense to an opioid claim will focus on establishing that the prescription of opioids, their dosage, and the associated warnings given by the physician were all reasonable in the circumstances of that particular patient’s care.
To establish a defense to an opioid claim, a physician must be able to offer evidence of the reasonableness of the type and dosage of medication prescribed and the warnings the physician offered with that prescription. To that end, a physician should maintain any materials received from pharmaceutical companies advising of the risks associated with their products and should reference these materials in providing warnings to patients. Additionally, any prescription of opioid medications should be accompanied by both verbal and written warnings as to the addictive propensities of opioids and the potential risks they pose to a patient’s health. When treating chronic pain, patients should be referred to a pain management specialist. Pain management physicians should review all viable pain management methods and their risks with patients before settling on a treatment modality. All of these efforts should be accurately and promptly recorded in a physicians’ medical records system for future reference. Taking the above steps will create a medical record establishing that a physician’s prescription of opioids and accompanying warnings were adequate in the circumstances of a patient’s care.
Generally in Illinois, a pharmacist cannot be held liable for the over-prescription of medications, including opioids. Eldridge v. Eli Lilly & Co., 138 Ill. App. 3d 124, 127, 485 N.E.2d 551, 553 (1985) (finding no duty to warn when a patient died after receiving an abnormally-large opioid refill because the prescription was filled as prescribed). While pharmacists have specialized knowledge regarding medications and their effects, they are not medical doctors and are not in a position to provide medical advice to a patient. Happel v. Wal-Mart Stores, Inc., 199 Ill. 2d 179, 193–94, 766 N.E.2d 1118, 1127–28 (2002) citing Leesley v. West, 165 Ill.App.3d 135, 116 Ill.Dec. 136, 518 N.E.2d 758 (1988). What may be a reasonable medication and dosage for one patient may not be sufficient or appropriate for another patient depending upon that patient’s medical conditions and history. Id. citing Fakhouri v. Taylor, 248 Ill.App.3d 328, 332-333, 187 Ill.Dec. 927, 618 N.E.2d 518 (1993). Requiring a pharmacist to counsel a patient on how to treat a medical condition would require the pharmacist to step into the doctor-patient relationship to offer medical advice outside of his or her specialty. Id. As such, the duty to warn falls on the physician as the learned intermediary between the patient and the pharmaceutical company, and, generally, a pharmacist’s duty is limited to ensuring the correct medication and dosage are dispensed according to what is prescribed.
However, while a pharmacist does not generally have a duty to warn, a pharmacist can create such a duty through his or her voluntary actions. In Happle, a pharmacist accurately filled a patient’s medication as prescribed without giving the patient a warning, and the patient experienced an allergic reaction to the medication. Id. The Illinois Supreme Court recognized that while there would not normally be a duty warn under these circumstances, the pharmacist created a duty to warn because she requested and collected medical information from the patient, including information on her allergies. Id. Because the pharmacist sought medical information from the patient to prevent providing a contraindicated medication, that pharmacist had a duty to warn either the patient or her doctor that the dispensed medication was contraindicated. Id.
In short, a pharmacist’s duty is generally limited to filling a prescription accurately as prescribed; however, a pharmacist can create a duty to warn if he or she oversteps his or her role in filling a medication and attempts to offer medical advice to a patient.  To limit the risk of liability in opioid litigation, pharmacists should limit their practice to accurately filing prescriptions. If a pharmacist notices a problem or issue with a prescription, that pharmacist should immediately contact the prescribing doctor to discuss the issue and confirm the medication prior to filling, and should note that discussion and its contents in the pharmacy’s medical records system. A pharmacist should not solicit medical information from a patient or attempt to offer medical advice to a patient regarding prescribed, regulated, behind-the-counter medications such as opioids. If a patient solicits medical advice from a pharmacist, that pharmacist should refer the patient to his or her medical doctor.
In addition to physicians and pharmacists, nurses must also be cognizant of potential legal issues when administering medications – including opioids – to their patients. Although there is no finite rule for nurses to follow in order to adhere to the standard of care in all instances of medication administration, a review of relevant Illinois law provides a number of guiding principles. First, if a nurse accurately carries out a physician’s orders, it is unlikely that he or she will be found to have breached the standard of care. See Simpkins v. HSHS Medical Group, Inc. 2017 IL App. (5th) 160578 at ¶ 20 (expert opined that nurse breached standard of care by failing to follow doctor’s orders in administering treatment). However, when it comes to administering medications to patients, simply executing a physician’s orders may not always be sufficient. Specifically, “giving medication to patients is the responsibility of the nurse who is assigned to a patient, and a nurse who actually administers a drug is required to know the reason for giving it, be aware of its risks and side-effects, and know whether it is contraindicated for that particular individual.” See Schroeder v. Northwest Community Hospital, 862 N.E.2d 1011, 1015 (Ill. App. Ct. 1st Dist. 2006).
Nurses find themselves in the unique position of having to carry out a physician’s orders while also remaining cognizant of the impact those orders may have relative to a patient’s complete medical history, plan of care, and medication list. Multiple physician practice groups may simultaneously prescribe medications without communicating with one another, and orders entered into electronic records systems are sometimes outdated, conflicting, or duplicative - creating confusion for nurses administering medications. Some orders also give nurses discretion as to the amount or timing of medication administration, making nurses directly responsible not only for administering medications but also judging when to administer those medications. These issues could foster potential liability for nurses administering opioids, as nurses act as the last line of care in the administration of opioids in hospital and nursing home settings.
In order to ensure compliance with the standard of care when administering opioids to a patient, nurses should remain aware of the reason for giving the opioid, the potential side effects of the opioid, and whether the opioid is contraindicated for the specific patient. If, after evaluating the aforementioned factors, a nurse feels he or she should not administer the given medication, it is important that they communicate these feelings to the prescribing physician and also chart the substance of the discussion with the physician. See, e.g., Gulino v. Zurawski, 43 N.E.3d 1102, 1118 (Ill. App. Ct. 1st Dist. 2015) (where a nurse does not comply with a doctor’s orders, the standard of care requires the nurse to communicate the circumstances causing the noncompliance with the doctor and “get further direction”). Therefore, in order to comply with the standard of care in administering opioids, nurses should accurately carry out the physician’s orders while also remaining privy to the side effects of the opioid and potential contraindication of the opioid for the specific patient. If, after considering these factors, a nurse feels that he or she should not administer the opioid to the patient, they should communicate this feeling to the physician and chart the substance of their conversation with the physician as well as the ultimate, collaborative decision regarding the medication.
IV. Hospitals, Medical Groups, Pharmacies, and Nursing Homes
Illinois recognizes vicarious liability for hospitals, medical groups, pharmacies, and nursing homes based upon the negligence and misconduct of their employed medical professionals. As such, the above issues faced by doctors, pharmacists, and nurses in the current opioid litigation crisis will also be faced by their employer hospitals, medical groups, pharmacies, and nursing homes. These entities should venture to ensure that their staff follow the above precautions to minimize the risk of opioid litigation. In ensuring staff compliance, medical entities should strive to train staff on appropriate conduct relative to standards of care, necessary safeguards, and the operation of medical equipment, such as diffusion equipment used to administer opioids.
However, in addition to vicarious liability, medical entities face additional risks because they carry layered liability for employed professionals specializing in medicine, pharmacy, and nursing. First, multiple layers of care necessitate communication within and among each layer of care. A failure of communication within or among any layer can have disastrous consequences, especially in the context of prescribing, dispersing, and administering opioids. Medical entities must train their staff to recognize the need for communication with other teams of staff members and with medical teams outside the staff that may have an impact on care. As part of this effort, medical professionals must review and be cognizant of medical orders in the file, ensuring that they are not duplicating or contradict standing medical orders. Also, medical staff must communicate both up-and-down the layers of medical care, with nurses and pharmacists reporting issues up to physicians whenever discovered.
Second, this layering of professional responsibility could increase the risk of liability if employed medical professionals do not work together and seek to blame one another for an opioid related injury. It is essential that medical entities provide, encourage, and coordinate open channels of communication among staff members at all levels and specialties of patient care to ensure the highest quality of care. Staff communication and record keeping regarding the circumstances of opioid prescription, dispensing, and administration in patient care are a must for any medical entity defending itself in opioid litigation.
Pharmaceutical companies may currently be the primary target of opioid litigation, but physicians, pharmacists, nurses, and their employers still face substantial risk of litigation – risk which will only grow as plaintiffs’ attorneys seek out new forms of personal injury litigation from which to profit. While medical professionals cannot stem the tide of this litigation, they can help to protect themselves from liability by taking the precautions outlined above.
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