By Damian D. Capozzola, Esq., and Jamie Terrence, RN
Capozzola is an attorney in The Law Offices of Damian D. Capozzola in Los Angeles. Terrence is president and founder of Healthcare Risk Services and the former director of risk management services for the California Hospital Medical Center in Los Angeles.
News: When FDA warnings provide clear indications, expert testimony is not always necessary to establish the standard of care physicians owe to patients, according to a recent appellate court ruling. This decision highlights the importance of comprehensive patient information and adherence to FDA guidelines.
A patient alleged his physician failed to inform him about the risks of the antibiotic Cipro, resulting in permanent pain and injury to him after a urological procedure. The case hinged on a state statute that requires expert testimony in medical malpractice claims. The patient argued expert testimony was unnecessary for his lack of informed consent claim, given the explicit FDA warnings about Cipro, as well as his medical history. The trial court disagreed and dismissed his lawsuit, but an appeals court reversed, ruling the absence of expert testimony does not always lead to dismissal when FDA warnings provide clear indications. This case could lower the standard a patient must satisfy to bring medical negligence claims by not requiring an expert opinion of negligence in some cases.
Background: A patient underwent a urological procedure in 2018, after which his physician prescribed him the antibiotic drug, Cipro. In Cipro’s package insert, the FDA warned the drug can cause “disabling and potentially irreversible serious adverse reactions,” and instructed physicians to use caution “when prescribing Cipro to elderly patients, especially those on corticosteroids,” to inform patients of this potential adverse reaction, and to give instructions “to discontinue Cipro use and contact their healthcare provider if any symptoms of tendinitis or tendon rupture occur.” The patient was 66 years old and had been taking corticosteroids for about 40 years. He experienced permanent pain and injury after taking Cipro.
The patient filed a medical negligence claim against the physician and his practice based on negligent prescription of the drug and failure to inform of the risks of taking the drug. The patient alleged the physician failed to inform him about the potential risks associated with Cipro, which resulted in his injuries. He claimed had the physician offered adequate information or prescribed a reasonable alternative, he would have requested a different antibiotic.
The patient filed his claim without an expert opinion affidavit that is required under Arizona law. In the trial court, the patient claimed he did not need an expert because the FDA warnings provided sufficient evidence to establish the standard of care and liability a layperson could understand. The physician countered the patient’s lack of informed consent claim fell within the scope of medical malpractice, as confirmed by several previous court decisions, and as a result, expert testimony was necessary to determine the standard of care in informing patients about potential risks associated with prescribed medications.
The trial court required the patient to provide a preliminary expert opinion affidavit, which he was unable to obtain. The court granted the physician’s motion to dismiss the case with prejudice.
But the state appeals court reversed this dismissal, ruling expert testimony was not essential in this case. The appeals court held the relevant state statute did not automatically require expert testimony when clear and explicit FDA warnings existed, and there was no rule requiring that expert testimony always exists to define the standard of care. The court emphasized patients and laypersons could evaluate whether the failure to warn constituted negligence based on FDA guidelines.
What this means for you: The appeals court’s decision holds significant implications for the medical community, particularly regarding their duty to provide informed consent and disclose potential risks to patients. It reinforces the importance of comprehensive communication practices and staying up to date on FDA guidelines and warnings for prescribed medications. The appeals court’s ruling that not all medical negligence claims require an expert opinion affidavit may open the door to additional lawsuits for plaintiffs who otherwise would be unable to locate an expert willing to submit an affidavit, as was the case here.
This decision is a reminder that providers must diligently inform patients about the potential risks associated with prescribed medications, especially when specific warnings are outlined in FDA guidelines or package inserts. Failure to disclose such risks can expose providers to liability for medical negligence. It also is a reminder providers bear the responsibility of ensuring patients are fully informed about the potential risks of their prescribed medications.
The court’s ruling also clarifies the interpretation of a statute in the context of lack of informed consent claims. While expert testimony typically is required to establish the standard of care in medical malpractice cases, this decision outlines exceptions when clear and explicit warnings from authoritative sources, such as the FDA, exist. Although the court only focused on the FDA’s disclosures, it did not foreclose warning from other sources as well. Providers and hospitals should know the absence of expert testimony on medical customs or practices does not automatically lead to dismissal under the statute when FDA warnings explicitly outline the duty to inform patients about specific risks associated with prescribed medications.
This decision also highlights the necessity of staying informed about FDA guidelines and package insert warnings for the medications they prescribe. It is crucial to regularly review and understand the potential adverse effects and risks, especially when new information or warnings are issued. By proactively staying updated, providers can fulfill their duty to provide comprehensive patient information and ensure the highest standard of care.
Anyone who listens to a TV commercial for a drug probably will not want to take that medication. While watching a “patient” with the targeted ailment skip through the tulips, a quiet voice is rapidly stating the wonderful drug also brings a multitude of side effects, all of which can lead to death. Drug companies do this to prevent lawsuits if patients viewing the commercials request the drug from their providers. Physicians are similarly obligated to their patients, hopefully for the sake of patient safety (although avoiding litigation would be a side benefit).
Cipro is a powerful antibiotic. It often is used for certain infections caused by bacteria resistant to gentler antibiotics. Most physicians now rely on pharmacists to offer counseling on new medications and provide warning labels on the side of medication containers.
These steps can be helpful to patient, but do not remove the responsibility and the legal requirements of informed consent. The provider prescribing the treatments, including medications, is obligated to inform the patient of the risks and benefits of whatever the patient is receiving. This includes available alternatives, as well as recovery times and consequences of refusing the prescribed interventions. To do this for every patient and for every drug prescribed is not often practical — and frequently overlooked. This is a risk most physicians accept for common medications. However, high-risk drugs and drugs prescribed to high-risk patients require the extra time to keep patients safe. FDA warnings are published and distributed to prescribing physicians. It is not a patient’s responsibility to research these warnings. It is the physician’s responsibility to know if a drug is contraindicated for a patient with a specific medical condition. If the physician believes the drug should be prescribed, the patient must be informed of this, of what signs and symptoms to note, and when to stop the medication and seek medical attention. This conversation must be documented in the patient’s medical records along with the physician’s confirmation the patient understood.
Effective communication between providers and patients is vital for fostering trust, promoting patient autonomy, and mitigating legal risks. Providers should prioritize open and honest discussions with their patients, allowing them to make informed decisions about their healthcare and mitigate their own legal risk. This includes providing patients with clear explanations of potential risks and side effects of medications.
Moreover, the court’s decision highlights the role of patients in evaluating whether the failure to warn constitutes negligence. With the assistance of FDA warnings and other explicit information about the adverse effects of medications, laypersons can assess whether a physician’s alleged failure to provide adequate information about risks of a medication meets the standards of care. This recognition of patient autonomy and agency signifies the evolving dynamics between healthcare providers and patients, moving toward a more patient-centered approach.
REFERENCE
• Decided May 23, 2023, in the Arizona Court Of Appeals, Case No. 1 CA-CV 21-0701.
This case reinforces the importance of comprehensive communication practices and staying up to date on FDA guidelines and warnings for prescribed medications. The ruling could open the door to additional lawsuits for plaintiffs who otherwise would be unable to locate an expert willing to submit an affidavit.
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