Ohio Opioid Verdict Brings Focus To Role Of Pharmacists

Duty to Warn

By Roseann Termini ·Law360® (December 1, 2021, 5:03 PM EST)  

The recent U.S. District Court for the Northern District of Ohio jury verdict in the combined cases In re: National Prescription Opiate Litigation, County of Lake v. Purdue Pharma LP and County of Trumbull v. Purdue Pharma LP, finding pharmacies liable for contributing to the opioid epidemic, has far-reaching consequences.[1]

Undoubtedly, the three chain pharmacies found liable for public nuisance, CVS Health Corp., Walmart Inc. and Walgreens Co., will appeal; however, that does not diminish the effect of the decision on pharmacists’ duty to warn or refuse to fill a prescription.

The initial inquiry involves the role of the various actors in this epidemic. Is it simply the physicians as the learned intermediaries, the pharmaceutical manufacturers who heavily promote the product, the drug distributors and the government? Or are there other players who play a role, such as the pharmacist?

Previously pharmacists were rarely mentioned as contributors to the opioid epidemic. Yet, pharmacists, as well as others mentioned above, play a significant role. A practitioner providing legal counsel to a pharmacist has a duty to advise in this regard.

The jury in the Ohio verdict recognized that the opioid crisis did not simply occur overnight and that pharmacists played a critical role in this epidemic.

The opioid epidemic is such that the pharmacist, as a professional, could red-flag or refuse to fill an opioid drug prescription for the patient. There is a duty of the professional pharmacist to warn — and the jury in the Ohio cases understood that duty. Practitioners also need to advise pharmacists of this critical duty.

Years ago, most courts found pharmacists owed no duty to warn. The consensus among the majority of courts centered on the physician as the conduit for conveying information to the patient and assessing the risks involved with the adverse effects of a prescription drug. The physician, as the learned intermediary between the manufacturer and the patient, was deemed the proper medical professional to warn a patient of possible risks associated with drug consumption.

Traditionally, under the learned intermediary doctrine, the physician had the sole responsibility to monitor and counsel the prescription drug consumption of a patient. Thus, the sole obligation of the pharmacist centered on the accurate dispensing of pharmaceuticals.

Yet, health care today is not the Norman Rockwell picture of yesteryear.

Today, the role of the pharmacist in the health care system has taken on a greater significance. Recent changes in pharmacist education, sophisticated tracking technology, direct-to-consumer advertising and the competitive nature of the pharmaceutical market have altered the scope of liability on the part of pharmacists.

The view has evolved into greater recognition of pharmacists as proactive professionals in the health care field. Advances in technology also expanded the role and capabilities of pharmacists. Computer systems that maintain patient profiles and warn of drug interactions are now commonly utilized within the pharmaceutical market, especially at huge chain drugstores such as Walgreens, Walmart and CVS Health.

The Ohio decision brings into focus when a pharmacist owes a duty to warn.

When Pharmacists Owe a Duty to Warn

The opioid epidemic is one where pharmacists’ actions should be scrutinized.

The primary legal decision supporting pharmacist liability is Hooks SuperX Inc. v. McLaughlin.[2] In that 1994 decision, the Supreme Court of Indiana determined a pharmacist had a duty to refuse to refill prescriptions at an unreasonably faster rate than prescribed, pending direct and explicit directions from the prescribing physician.

Furthermore, the court found that the duty of the pharmacist to provide a standard of care includes the duty to refuse to refill a prescription.

In Hooks, the customer was injured while working and his physician prescribed medication to relieve the pain. The customer became addicted to this medication and was treated for this addiction on numerous occasions. The customer had his prescriptions filled at the same pharmacy for a period of about one-and-a-half years. Although all the prescriptions were valid, the customer had them refilled at a rate considerably faster than the rate prescribed.

The Supreme Court of Indiana considered three factors in concluding a duty exists between a pharmacist and a customer: the relationship between the parties, the foreseeability of harm and public policy.

First, to determine whether there was a relationship between a pharmacist and customer sufficient to constitute a duty, the court focused on what constitutes a relationship. The court found the relationship between a pharmacist and a customer was based on contract principles and was independent of the physician-patient relationship. The Hooks court found the existence of privity of contract between the parties and the expertise of the pharmacist sufficiently close to justify the imposition of a duty.

Second, the Hooks court examined the foreseeability of the harm. The court held it is reasonably foreseeable that consumption of large quantities of addictive substances can give rise to an addiction and that addiction carries foreseeable consequences. Therefore, for the purpose of determining the existence of a duty, the court was satisfied that the addiction was foreseeable from the series of events that occurred.

Third, the Hooks court analyzed the three public policy considerations present: preventing intentional and unintentional drug abuse, not jeopardizing the physician-patient relationship and avoiding unnecessary health costs. The court determined that the public policy of Indiana requires the imposition of a duty on the pharmacist.

The court examined the Indiana Pharmacy Code, which provides immunity for a pharmacist who refuses to fill a prescription: “The pharmacist is immune from criminal prosecution or civil liability if he, in good faith, refuses to honor a prescription because, in his professional judgment, the honoring of the prescription would … [a]id or abet an addiction of habit.”

Although the statute does not create a duty on the part of the pharmacist, the Hooks court found the statute demonstrates the state’s significant interest in preventing drug addiction. The Hooks court concluded that establishing this duty for pharmacists would not interfere with the physician-patient relationship.

The principles enunciated in Hooks similarly apply to the current opioid litigation. All the factors detailed in Hooks — relationship between the parties, foreseeability of harm and public policy for determining the imposition of a duty — indicate this obligation should be utilized in the opioid crisis.

Understandably, what is required in each case is a question of fact depending upon the circumstances of each case. These elements relied on by the Hooks court — relationship, foreseeability and public policy — all evidenced the recognition of an independent duty on the part of the pharmacist separate from that of the physician. Those elements undoubtedly are relevant to the opioid epidemic.

Final Commentary for Practitioners

The crisis our nation struggles with today did not materialize overnight. The opioid epidemic is complex and there is no simple, quick-fix solution. Decades of questionable practices in the pharmaceutical and medical communities, coupled with government decisions, barriers to treatment, and lack of public and medical awareness around addiction created this enormous problem.

The pharmacist plays a serious role in the crisis. The pharmacist is the final point of patient contact. The pharmacist most certainly can refuse to fill the prescription and/or contact the prescribing physician.

Regarding many of the opioid lawsuits, including the recent Ohio decision, there should have been a red-flag system in place. Alternatively, if there was a system to flag these prescriptions, it was disregarded. There is no excuse for filling the abnormally high volume of prescriptions.

Finally, today the pharmacist is more than a pill counter and is obligated to uphold the tenets of the Oath of a Pharmacist, which, in part, is as follows:

I promise to devote myself to a lifetime of service to others through the profession of pharmacy. In fulfilling this vow:

  • I will consider the welfare of humanity and relief of suffering my primary concerns.
  • I will apply my knowledge, experience, and skills to the best of my ability to assure optimal outcomes for my patients.
  • I will hold myself and my colleagues to the highest principles of our profession’s moral, ethical and legal conduct.

The recent Ohio verdict demonstrates that the days when the sole duty of a pharmacist consisted of accurately filling and dispensing prescription drugs are no longer — and it is incumbent that pharmacists be aware of this.

Roseann B. Termini is teaches at Widener University’s Delaware Law School. She is the author of “Food and Drug Law: Federal Regulation of Drugs, Biologics, Medical Devices, Food, Dietary Supplements, Personal Care, Veterinary and Tobacco Products.”

The opinions expressed are those of the author(s) and do not necessarily reflect the views of the organization, or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.

[1] In re: National Prescription Opiate Litigation, case number 1:17-md-02804, County of Lake v. Purdue Pharma LP et al., case number 1:18-op-45032, and County of Trumbull v. Purdue Pharma LP et al., case number 1:18-op-45079, in the U.S. District Court for the Northern District of Ohio.

[2] Hooks SuperX v. McLaughlin , 642 N.E.2d 514 (Ind. 1994). 

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Attached Documents


Government Agencies

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Power Morcellators, Informed Consent, Laparoscopic Surgery, and Protocols …


Power Morcellator

Laparoscopic Uterine Power Morcellation: Immediately in Effect Guidance Document: Product Labeling for Laparoscopic Power Morcellators; Guidance for Industry and Food and Drug Administration Staff http://www.gpo.gov/fdsys/pkg/FR-2014-11-25/html/2014-27857.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm

 Paying the Price of Not Being Fully Informed… Update 

Recently, the topic of laparoscopic hysterectomy or myomectomy for the treatment of fibroids and a procedure known as morcellation has become very controversial. What may seem like an everyday simple surgical procedure has become for some women the unwanted end result of invasive cancer.

The issues are quite complex. The purpose of this blog is to simply point out a few concepts to consider in the decision making process of whether a woman should undergo a full traditional surgical procedure or a  laparoscopic procedure. What may seem like a simple choice could potentially become a nightmare with a life changing outcome.

Today, more than ever, noninvasive surgery has become the “protocol” for many procedures. Yet, should it? The simple answer is that it depends on many factors. The single most important factor should be the patient and obtaining a valid informed consent. A valid informed consent should be videotaped. The patient must receive a “Plain English” explanation of the risks and benefits of such procedures.

It might sound “high tech” to use such a device approved by the United States Food and Drug Administration (FDA)  and the costs in terms of insurance might be beneficial to the to the insurer and insured. According to FDA: “Laparoscopic power morcellators are medical devices used during different types of laparoscopic (minimally invasive) surgeries. These can include certain procedures to treat uterine fibroids, such as removing the uterus (hysterectomy) or removing the uterine fibroids (myomectomy). Morcellation refers to the division of tissue into smaller pieces or fragments and is often used during laparoscopic surgeries to facilitate the removal of tissue through small incision sites.”  MedWatch

Yet, the question remains at what cost?

An excellent example is the removal of fibroids and morcellation without the benefit of a biopsy prior to the morcellation. What this means is if the fibroids are cancerous, the “morcellation procedure” spreads the cancer throughout the patient’s body. How? Power morcellators use extended, tube-shaped blades to cut uterine tissue into little pieces. This permits the surgeon who performs a laparoscopic or minimally invasive hysterectomy, to remove the tissue through a small incision.

Does it all come down to dollars and lack of informed conformed? Apparently so, as the practice continues and is sanctioned in protocols. According to physician Amy Reed: Morcellation is done in at least 11% of the nearly 500,000 hysterectomies are performed each year. See: http://www.usatoday.com/story/news/nation/2014/02/18/hysterectomy-laparoscopic-morcellation-amy-reed/5347093/

Benefit: Easier removal of the uterus and speedier recovery time rather than traditional abdominal surgery which could result in a large scar.

Major Risk: Undiagnosed cancer may be present and the morcellation process spreads the cancer.

FDA Warning, Guidance and Alerts, FDA Medical Device Advisory Committee Recommendations and Lawsuits 

Laparoscopic Uterine Power Morcellation: Immediately in Effect Guidance Document: Product Labeling for Laparoscopic Power Morcellators; Guidance for Industry and Food and Drug Administration Staff http://www.gpo.gov/fdsys/pkg/FR-2014-11-25/html/2014-27857.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm

FDA had  issued an alert in April 2014 to discourage the use of power morcellation. Specifically, FDA set forth: “laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival. For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”

The Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee was convened by FDA on July 10 and 11, 2014. The committee discussed the “safety of laparoscopic power morcellator devices as it pertains to their potential to disseminate and upstage a confined, but undetected (occult) uterine malignancy during laparoscopic hysterectomy or myomectomy.” According to FDA the purpose of the committee meetings was to  “seek expert scientific and clinical opinion on the risks and benefits of these types of devices when used for these procedures, based on available scientific data.” The committee will make recommendations regarding the appropriate use, premarket testing, labeling, and other risk mitigations (including the use of containment bags) for these devices.

http://www.fda.gov/newsEvents/Newsroom/PressAnnouncements/ucm393689.htm  Quantitative Assessment of the Prevalence of Unsuspected Uterine Sarcoma in Women Undergoing Treatment of Uterine Fibroids Summary and Key Findings April 17, 2014 http://www.fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/UCM393589.pdf

See also: “New Cancer Risk Seen From Surgical Tool” in the Wall St. J. (July 23, 2014).

Lawsuits: Yes, lawsuits have been instituted. Yet, are lawsuits the solution? Here are suggestions to prevent what has occurred to date.


  • Medical Device companies who manufacture the device(s) used in these types of procedures should redesign the product and until that is done conduct a field correction recall of the medical device(s) in question. Ethicon Inc., a unit of Johnson & Johnson,  suspended the sales of several of its power morcellators and in July 2014 issued a market withdrawal.
  • Hospitals should consider a revised protocol and some hospitals have already temporarily banned morcellation until the risk can be more fully evaluated.
  • Physicians should offer “informed” options to the patient.
  • Informed consent should be just that- a plain language explanation of the benefits and risks of consenting to this type of procedure.

Stay tuned for more on this critical health medical-legal issue as the FDA Advisory Committee will issue recommendations pertaining to  appropriate use, premarket testing, labeling, and other risk mitigations such as containment bags) for these devices.

This blog was written by Roseann B. Termini, Esq. with insight and review by Desencia E. Thomas, M.D.