Weight Loss Medication Trends – Panaceas…or Pitfalls?

Societal beauty standards put pressure on individuals to strive for a specific body shape. The influence of these standards has created a population vulnerable to the advertising of products that appear to promise the way to the ideal body shape. As celebrities and social media influencers go public with their use of Ozempic® and Wegovy® for weight loss, flocks of patients from this vulnerable population are running to their doctors asking for what appears to be a “quick fix” for their bodies.

The explosion in prescriptions of these drugs, along with post-marketing discovery of additional potential adverse reactions, has drawn a growing number of lawsuits. These lawsuits currently focus on manufacturers, but, as gatekeepers of these drugs, prescribers are also vulnerable to legal action. To mitigate the risk of being drawn into such lawsuits, providers must ensure that they engage in well documented informed consent discussions with their patients and that their prescribing practices meet current standards of medical care. This means prescribing only for appropriate candidates and engaging in continuous management and monitoring of their patients’ experience with these drugs. 

“Ask Your Doctor if this Medication is Right for You.” 

The catchphrase at the end of most drug advertisements — “Ask your doctor if this medication is right for you” — essentially shifts the onus for any injury arising from the drug to the “doctor.” This shifting of liability is consistent with legal precedent, particularly in states like New York that define prescribers as the “learned intermediary.” After manufacturers meet their obligation to conduct comprehensive testing and provide accurate information on potential adverse reactions, prescribers have a legal responsibility to accurately assess each patient’s personalized risk of experiencing those reactions. The media hype surrounding Ozempic® and Wegovy® suggests that these drugs are indicated as a “quick fix” for weight loss in any patient population. Providers need to educate patients that this is not true. Wegovy® is indicated for use as part of a more comprehensive long-term treatment plan for obesity¹, and Ozempic® is indicated only as a treatment for type 2 diabetes.² Providers have a legal obligation to educate patients on the regulated indications for these drugs and to perform a thorough review of each patient’s unique health history before deciding whether the drug is clinically indicated for the individual patient. While prescribing for nonapproved indications (prescribing off label) is common, failing to ensure that a patient is an appropriate candidate for the drug as prescribed increases the risk of liability if the patient is injured. 

Known Risks — A Moving Target 

As with any treatment, providers must effectively communicate the risks, benefits, and alternatives of the drug before obtaining consent for treatment. Failure to obtain high-quality informed consent can give rise to legal action. Celebrities touting the success of these drugs do not necessarily disclose side effects. It is up to providers to educate their patients about all risks and potential side effects of these medications and discuss alternatives as well. 

Of course, providers must inform patients of known risks, but what is “known” can become the subject of debate. Some providers are questioning whether to continue prescribing these drugs in the wake of lawsuits alleging that the manufacturers failed to warn of serious side effects. Safety information included in the manufacturer’s product insert may be the best evidence of known risks, but post marketing studies and adverse event reporting may show a trend that is not reflected in the FDA approved labeling.

The Ozempic® lawsuits, which focus on gastrointestinal conditions, demonstrate that “known risks” can be a moving target. The initial package insert for Ozempic® did not warn of some gastrointestinal conditions at issue in the lawsuits, but the label was subsequently changed following post-marketing reports and trials that correlated Ozempic® with issues such as stomach paralysis.³ In fact, there have been six safety-related Ozempic® labeling changes approved by the FDA since the product was approved for marketing.⁴ Wegovy® has had three such changes.⁵ These post marketing, safety-related label changes highlight the importance of keeping up to date with the latest clinical prescribing information and monitoring the results of post-marketing studies and adverse event reports. 

Even if the correlation between an adverse event and use of the drug has not reached the level necessary to prompt a change to the drug label, providers who prescribe this medication should stay up to date on post-marketing research and adverse event reports and use their clinical judgment to determine whether enough evidence of correlation exists to warrant informing the patient of such risks or prescribing the drug at all. If a label change is relevant to a particular patient, it will be important to update the informed consent discussion and assess whether, based on the patient’s individual history, the medication remains an appropriate clinical modality to treat the patient’s condition. 

Mitigating the Risks of Off-Label Use 

Ozempic® and Wegovy® are both being prescribed for weight loss, but only Wegovy® has FDA approval for such use, and even that approval has parameters. Off-label prescribing may be the standard of care for certain medications, but providers should be particularly diligent documenting patient interactions and clinical decision making when prescribing drugs for off-label use. Off-label prescribing — prescribing for a nonapproved indication, dosages outside an approved range, or for a different clinical population — is not per se evidence of a deviation from the standard of care, but this practice will highlight the issue of clinical judgment in any malpractice action. 

FDA approval and the correlating prescribing guidelines may be used in a malpractice action as evidence of the standard of care. A provider who prescribes outside of those guidelines will need to establish that the rationale for off-label use was personal to the patient and backed by peer reviewed data. 

Disclosing risks during the informed consent discussion becomes more complicated when a drug is prescribed for off-label use. The media hype around Ozempic® suggests that the drug is FDA approved for weight loss. As a result, patients are asking their providers to prescribe Ozempic® for this indication. It may be prudent to inform the patient that Ozempic® is not FDA approved for weight loss but is commonly prescribed for that indication. 

If a provider decides that Ozempic®, rather than a drug approved for weight loss, is right for the patient, the provider should explain to the patient the rationale for off-label use and why an FDA approved medication was not selected. It will be particularly important for the prescriber to document the discussion in the patient’s medical record, especially the patient’s understanding of the provider’s rationale for choosing the nonapproved drug over the approved drug. Documenting the well-reasoned choice and the patient’s consent will go a long way in a legal action to proving that the patient understood the risks of the off-label use and knowingly decided to move forward. 

Patient Management 

All prescribers of Ozempic® and Wegovy® must be in the position to continuously monitor the patient’s overall health to ensure the drugs are working safely and effectively for the patient’s condition. Because these drugs are intended for indefinite use, the patient-provider relationship will need to continue beyond the initial prescribing phase. Failure to properly monitor and manage a patient’s use of these drugs can result in delayed diagnosis of an adverse event, leading to allegations of malpractice. 

Physicians from a number of specialties, such as psychiatry and plastic surgery, are prescribing Ozempic® and Wegovy® for weight loss. While these physicians have prescribing authority, the indications for these drugs may not be within their general scope of practice. The prescribing provider should be in a position to monitor long-term changes in a patient’s overall health and adjust the treatment plan, including the use of the prescribed drug, if necessary. Although patients may not want the “burden” of ongoing and regular medical management, the necessity for such management should be part of the informed consent discussion. Providers should discontinue prescribing either of these drugs for any patient who fails to adhere to the treatment plan, including regularly scheduled appointments. Providers who do not regularly treat obesity but believe Ozempic® or Wegovy® may benefit a patient should consider referring the patient to the appropriate specialty. 

Conclusion 

Many patients are eager to experience the weight loss success from Ozempic® and Wegovy® plugged by celebrities and social media influencers. However, these drugs are not clinically appropriate for weight loss in all populations. It is up to providers to educate their patients that these drugs are not a beauty treatment. Providers must ensure that Ozempic® and Wegovy® are prescribed only for appropriate candidates as part of a more comprehensive continuous and monitored treatment plan. Fulfilling this duty will support not only patient safety but also a strong defense to any claim that a provider’s prescribing practices deviated from standard of care and contributed to a patient’s injury. 

MLMIC policyholders can reach out to our healthcare attorneys for questions about liability issues surrounding weight loss medications or any other healthcare law inquiries by calling (877) 426-9555 Monday-Friday, 8 a.m.-6 p.m. or by email here. 

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This article was originally published on September 24, 2024, in the Q3 2024 issue of MLMIC Insurance Company’s, The Scope. Since then, the FDA has approved several supplements to the product labels discussed in this article. Additionally, a number of weight loss medications have become available on the market such as Zepbound, Mounjaro and other GLP- 1 blockers. Physicians are encouraged to stay up to date with the latest clinical prescribing information and monitor the results of post-marketing studies and adverse event reports.    

This document is for general purposes only and should not be construed as medical, dental or legal advice. This document is not comprehensive and does not cover all possible factual circumstances. Because the facts applicable to your situation may vary, or the laws applicable in your jurisdiction may differ, please contact your attorney or other professional advisors for any questions related to legal, medical, dental or professional obligations, the applicable state or federal laws or other professional questions. 

1. Wegovy® [package insert]. U.S. Food and Drug Administration website: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/ 215256s011lbl.pdf. Revised March 2024. Accessed July 30, 2024. 

2. Ozempic® [package insert]. U.S. Food and Drug Administration website: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/ 209637s020s021lbl.pdf. December 2017. 

3. Ozempic® [package insert]. U.S. Food and Drug Administration website: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209637lbl.pdf. December 2017. 

4. Ozempic® [package insert]. U.S. Food and Drug Administration website: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209637lbl.pdf. December 2017. 

5. Wegovy®. Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER). U.S. Food and Drug Administration website: https://www.access