Weighing the Risks: Physicians’ Duty to Warn in Prescribing GLP-1 Medications

 Anthony Abeln, Esq., Morrison Mahoney

As pharmaceutical advertisements flood the media, patients are increasingly requesting specific drugs from their healthcare providers. This trend places a greater responsibility on prescribing practitioners to manage patient expectations. But what exactly is the provider’s duty to inform patients about risks and interactions, especially when drug manufacturers are directly marketing to consumers? Does this responsibility change when medications are prescribed from a compounding pharmacy?

Like providing informed consent when a patient considers undergoing a procedure, a physician has a duty to educate patients about the material risks, benefits, and alternatives of medications. Providers often grapple with what information they must disclose. Using their clinical judgment, they balance the severity of potential harm, the likelihood of occurrence, and the relevance to the patient. A classic example of weighing and balancing these circumstances by the provider is when an antibiotic has a remote risk of hearing loss—is there a different obligation to report that risk to a professional opera singer where the significance may be tremendous?

These questions are particularly pertinent with medications like Ozempic capturing public attention, and the resulting drug shortages from higher demand. As demand exceeds supply and practitioners turn toward compounding providers, additional challenges arise.

Understanding the “Learned Intermediary Doctrine” and Its Impact on Medication Prescriptions

Courts recognize the “learned intermediary” doctrine, which places the primary responsibility of advising patients about medication risks on the prescribing doctor. As such, it becomes the physician’s responsibility to pass on to patients that information which enables the patient to use the medication safely. The rationale behind the doctrine is that the prescribing physician, acting between the manufacturer and the patient as the product consumer, is in the best position to relay to the patient the warnings of the pharmaceutical manufacturer. Physicians, using their independent clinical judgment, are generally better suited to determine the appropriateness of a treatment for a particular patient.

This doctrine has been upheld in numerous lawsuits against drug companies, shielding manufacturers from liability for prescriptions of drugs like Accutane, Cialis, and Amiodarone. It also extends protections to pharmacies, although jurisdictions vary. While pharmacies must exercise reasonable care in dispensing medications, the primary responsibility for warning patients lies with the prescribing physician. The pharmacy’s role is typically limited to ensuring the correct medication is dispensed.

As one court explained, the learned intermediary doctrine coexists between pharmacy and manufacturer. The provider remains at the center.

How will “Learned Intermediary” Doctrine Impact New Ozempic Lawsuits?

The “learned intermediary” doctrine will be significant in the emerging litigation concerning Ozempic. Recently, a group of lawsuits has been filed regarding the use of Ozempic—currently, the number is relatively small, with fewer than 100 cases.

The first lawsuit involved a woman who began receiving Ozempic injections in the spring of 2022. According to the plaintiff, within two years, she was suffering from severe stomach paralysis (gastroparesis). Switching to another GLP-1 medication, Mounjaro, did not alleviate her symptoms.

The plaintiff alleged that Novo Nordisk, the manufacturer of Ozempic, did not adequately warn about the increased risk of gastroparesis. The drug manufacturer has publicly acknowledged that gastrointestinal side effects can occur with the use of its drug but has downplayed their severity, characterizing them as mild to moderate and of short duration. In its public commentary, Novo Nordisk emphasized that these effects are listed on the drug’s warning label. However, this litigation has the potential to expand as more patients may claim additional adverse outcomes. For example, recent research suggests a higher risk of nonarteritic anterior ischemic optic neuropathy with the use of semaglutides.

Although early in the litigation, one of Novo Nordisk’s defenses will likely rely on the “learned intermediary” doctrine—arguing that physicians were provided sufficient warnings of potential gastrointestinal issues and that it was the physicians’ duty to pass on these warnings to their patients. If the manufacturer claims that the warning was proper, the question then returns to the provider: Did the provider have enough information to warn patients about the risks associated with gastroparesis, and did they do so?

This challenge becomes even more complicated when compounded medications, rather than FDA-approved drugs, are prescribed.

Who is Responsible When Regulated Compounding is Used to Fulfill Demand?

When specialized or personalized drugs are needed, or when popular drugs are unavailable, the FDA allows for compounding to fill the gap. This highly regulated process enables physicians to obtain legal and certified versions of GLP-1 from compounding pharmacies that follow best practices and are appropriately licensed. During shortages, compounders can create “essentially a copy” of an approved medication, adhering to all federal and state regulations and dispensing medications only with a valid prescription.

As of 2023, the FDA listed Ozempic and Wegovy as experiencing a “Drug Shortage,” allowing regulated compounding to fill the gap. However, compounded medications are not FDA-approved and do not undergo the same premarket review for safety, efficacy, and quality. This makes determining their appropriateness more challenging and places greater liability on the prescribing physician.

In October 2023, the FDA alerted the Federation of State Medical Boards about adverse reports related to semaglutide salts in some compounded medications. The FDA noted that there are no FDA-approved products containing semaglutide salts and that their safety or efficacy profiles are unknown.

Using this example, is the physician a “learned intermediary” with respect to a compounding pharmacy? While more complex, the answer is generally yes. If the adverse event is something the physician should have known about, either from the state of medical literature or pharmaceutical labeling, the compounding pharmacy may not be deemed to have a duty to warn.

Where the physician’s heightened duty comes into play is when there is a direct relationship between the provider’s office and the compounding pharmacy. The physician should ensure that the compounded medication is appropriate and safe for the patient, given the lack of FDA approval and the potential for variability in compounded formulations.

Have Questions? We’re Here to Help!

If you have questions about the insurance risks of GLP-1s, compounded medications, or need assistance with insurance submissions, our team is ready to provide guidance and expertise.

For underwriting support contact Kyle Laudadio at [email protected]

For claims insights contact Roseanne DeBellis at [email protected]