A MICA Member Asks About Prescribing Depo-Provera

MICA’s Risk Team recently consulted with an ob-gyn who asked:

Considering the recent class action lawsuit against Pfizer, what recommendations do you have about prescribing Depo-Provera?

In response, the MICA Risk Consultant provided guidance and recommendations that we summarize here. In a nutshell:

• • Recently filed products liability lawsuits against the manufacturer of Depo-Provera do not target prescribers.
    
    
  • Prescribing any medication involves the exercise of clinical judgment based on available information.
    
    
  • Prescribers owe a duty of care to patients that includes obtaining informed consent by disclosing the risks and benefits of a particular drug prior to prescribing.
    
    
  • Prescribers should always remain alert to the possibility that patients may file claims alleging lack of informed consent.
    
    
  • Through individual consults, written guidance, and articles such as this one, MICA’s Risk Team can help you reduce liability exposure by optimizing your medication informed consent process.

Plaintiff Attorneys Are Filing Lawsuits Claiming Depo-Provera Caused Meningiomas

Over the last several years, Plaintiff attorneys have filed lawsuits nationwide against the manufacturer of Depo-Provera. In general, these lawsuits allege that the manufacturer defendants failed to warn, instruct, advise, educate, or inform Depo-Provera prescribers and their patients about the risk of intracranial meningioma.

In February 2025, 27 of these cases pending in eight different federal courts across five states were transferred to a Florida federal court for consolidated pretrial proceedings. Because these 27 cases share common factual allegations, coordinating all pretrial activities in one court is more efficient for the court and parties. In all the cases, Plaintiffs and the drug manufacturer dispute:

• • Whether Depo-Provera causes meningioma; and
    
    
  • Whether the manufacturer knew of an alleged risk of meningioma and failed to adequately warn patients and prescribers.

One of the 27 cases transferred to Florida is a lawsuit filed in Nevada in November 2024.¹ In support of her argument that Depo-Provera causes meningioma and the manufacturer failed to adequately warn patients and prescribers, Plaintiff makes the following allegations (which have yet to be proven in court and many of which defendants aggressively dispute):

• • New research suggests a potential link between Depo-Provera use and meningiomas.²

• • Depo-Provera labeling in the European Union has been changed to say that “meningiomas have been reported following long-term administration of progestogens, including medroxyprogesterone acetate.”³

• • Despite research demonstrating the “biological plausibility of the association between progesterone and meningioma” and potential links between Depo-Provera use and meningioma, no such changes have been made to the U.S. labeling.⁴

• • The drug manufacturer continues to promote and market Depo-Provera in the U.S. without providing prescribers and patients with “adequate clinically relevant information and data.”⁵

• • Through “affirmative misrepresentations and omissions,” the manufacturer “actively concealed” from Plaintiff and her physician the “significant risks” associated with Depo-Provera.⁶

• • As a result, Plaintiff and her physicians “were unaware” that Depo-Provera use could expose Plaintiff to meningioma risk.⁷

Prescribing, Clinical Judgment, and the Clinician’s Duty to Inform

Whether to recommend any medication (including Depo-Provera) to a particular patient involves the exercise of clinical judgment. The prescriber, relying on education, training and experience, may consider patient-specific factors such as medical history and current medications, relevant medical literature, product labeling and inserts, FDA warnings, and other available information.

When prescribers recommend Depo-Provera or other medications to patients, they have a legal duty to inform and educate patients about material risks, benefits, and alternatives. Providing understandable, adequate information is an essential part of the medication informed consent discussion because it enables the patient to ask follow-up questions and make an informed decision about whether to use the medication the prescriber is recommending.

Lack of Informed Consent Claims: What They Look Like

Patients who believe they were injured by a certain medication may file a lack of informed consent claim against the prescriber, saying the clinician failed to adequately disclose the medication’s risks. Different states have varying requirements for lack of informed consent claims, but generally a plaintiff/patient must prove:

• • The prescriber owed a duty of care to the patient arising out of the clinician-patient relationship;

• • The prescriber breached the duty/violated the applicable standard of care by failing to adequately disclose substantial or material risks of the medication;

• • The patient would not have suffered injury but for the medication usage; and

• • A reasonable person in the same position as the patient would have refused the medication if the prescriber had adequately disclosed the risks.

Often, one of the most hotly debated issues in these cases is the disclosure necessary to meet the standard of care. At trial, plaintiff and defense standard of care experts in the same specialty as the prescriber-defendant will offer opinions on what information, at minimum, the prescriber was required to provide the patient to obtain “informed consent.” The prescriber defendant will also testify and explain how he/she met the standard of care. Sometimes, if the court permits, jurors may consider other evidence that bears on the standard of care. This may include pertinent FDA warnings or package labeling/inserts that plaintiff contends the clinician should have discussed with the patient.

Reducing Lack of Informed Consent Liability Exposure When Prescribing Depo-Provera

As discussed above, Depo-Provera lawsuits and class actions are currently making news headlines. In general, these lawsuits target the drug manufacturer and involve product liability claims.

Nevertheless, whether prescribing Depo-Provera or another medication, physicians and advanced practice providers should always remain alert to the possibility of medication lack of informed consent claims. MICA’s Risk Team offers the following recommendations for reducing liability exposure to these types of claims:

• • Stay current with guidance and recommendations published by the American College of Obstetricians and Gynecologists (ACOG) concerning Depo-Provera. Incorporate the guidance into your informed consent discussions and practice workflows. Plaintiff attorneys and their expert witnesses often argue that guidance from specialty-specific professional organizations like ACOG set the standard of care.

• • Incorporate into your informed consent discussions the “Counseling” recommendations from ACOG’s Committee Opinion Number 602 (June 2014): Depot Medroxyprogesterone Acetate and Bone Effects.

• • When deciding how to talk to patients about recent studies focused on Depo-Provera and meningioma, consider ACOG’s Guide for Ob-Gyns for Patient Counseling on Birth Control Injection and Meningioma (Nov. 20, 2024).

• • Modify medication informed consent discussions as necessary when the FDA issues warnings or manufacturers make significant changes to product labeling/inserts. Although the FDA issued a warning in 2004 about Depo-Provera and bone density risk (discussed in ACOG 2014 Committee Opinion), as of April 2025 the FDA has not issued any warnings linking Depo-Provera use to meningiomas.

• • Consider developing written, medication-specific policies that standardize the substance of informed consent discussions for all prescribers in the practice. These policies should also require prescribers to thoroughly document medication informed consent discussions.

• • Consider developing a written prescribing policy that standardizes the type of clinical data prescribers should collect and consider prior to prescribing. For example, prescribers should carefully document a medical history that includes information on whether a patient has ever been diagnosed with meningioma.

• • While not a substitute for a detailed chart note, practices may consider asking patients to sign informed consent forms about the contraceptive discussion. Such forms should restate/summarize the information provided by the prescriber about risks, benefits, and alternatives. Patients would then be asked to sign and acknowledge they received the information, understood the information, and had the opportunity to ask questions which were answered.

Additional Resources

• • For more information on lack of informed consent claims generally in Arizona, read MICA’s Medical Malpractice Claim: Lack of Informed Consent in Arizona.

• • To learn more about lack of informed consent claims in Utah, read MICA’s Medical Malpractice Claim: Lack of Informed Consent in Utah.

• • For information on lack of informed consent in Nevada, read MICA’s Medical Malpractice Claim: Lack of Informed Consent in Nevada.

• • Prescribers seeking to reduce the risk of prescribing and other medication-related errors can consult MICA’s Medication Errors and Medical Malpractice Guide

 

^{[1] Stephens-Smith v. Pfizer, Inc. et al; No. 2:24-cv-02123 (D. Nev. filed Nov. 24, 2024).}

^{[2] Id. at paras. 104-108  (citing Roland N, Neumann A, Hoisnard L, Duranteau L, Froelich S, Zureik M et al. Use of progestogens and the risk of intracranial meningioma: national case-control study BMJ 2024; 384 :e078078 doi:10.1136/bmj-2023-078078; Abou-Al-Shaar, Hussam & Wrigley, Rachel & Patel, Aneek & Mallela, Arka & Zenonos, Georgios & Gardner, Paul. (2023). Skull Base Meningiomas as Part of a Novel Meningioma Syndrome Associated with Chronic Depot Medroxyprogesterone Acetate Use. Journal of Neurological Surgery Part B: Skull Base. 84. 10.1055/s-0043-1762201.).}

^{[3] Id. at para. 118.}

^{[4] Id. at para. 117.}

^{[5] Id. at paras. 117 & 177.}

^{[6] Id. at para. 137.}

^{[7] Id. at para. 138.}