On April 24, 2020, the FDA issued a Drug Safety Communication about the known side effects of hydroxychloroquine and chloroquine – the antimalarial drugs being used to treat Covid-19. These side effects include serious and potentially life-threatening heart rhythm problems reported with Covid-19 patients, creating controversy with the “off-label” use of these drugs. Medical providers are being told to mitigate these risks by closely screening and supervising their patients, as indicated in the Emergency Use Authorization the FDA issued for the drugs’ off-label use to treat Covid-19. But since these drugs have not yet been proven safe or effective for treating Covid-19, concerns exist regarding the risk of liability for malpractice resulting from off-label use.
The decision of whether to use a drug for off-label use is considered a matter of medical judgment, not of regulatory approval.[1] Off-label use is not a violation of federal law or FDA regulations because the FDA regulates the marketing and distribution of drugs in the United States, not the practice of medicine, which is the exclusive realm of individual states.[2] The FDA does, however, provide guidance that “[i]f medical providers use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product’s use and effects.”[3]
Although we do not yet know exactly how malpractice claims surrounding the off-label use of hydroxychloroquine and chloroquine could look in Ohio, past cases involving off-label drug use in Ohio highlight the importance of informed consent under these circumstances. For instance, in 2018, the Tenth District Court of Appeals upheld a verdict against a provider who prescribed Lamictal, an anti-epileptic drug, for off-label use to treat pediatric bipolar disorder. The jury found the provider negligent for failing to disclose to the patient and his family the material risks and benefits of Lamictal to treat pediatric bipolar disorder. At trial, the evidence showed that the doctor never discussed the serious side effects, also known as the “black box” warning, with the patient’s mother. In weighing the expert testimony presented at trial, the jury determined that had such discussion occurred, a reasonable person in the same or similar circumstance would have decided against using the drug to treat pediatric bipolar disorder if the risks and dangers were disclosed prior to the therapy.[4]
Informed consent in Ohio does not require that the physician fully inform the patient of all potential risks. But if the physician does not disclose any of the risks, then this failure can constitute a breach of the standard of care.[5] Therefore, not only should medical providers be mitigating risks by closely monitoring their patients as the FDA suggests, but providers should also be disclosing to the patient the material risks and dangers inherently and potentially involved with the use of hydroxychloroquine and chloroquine to treat Covid-19 in order to mitigate the risk of potential malpractice claims.
[1] Klein v. Biscup, 109 Ohio App.3d 855, 864, 673 N.E.2d 225, 231 (8th Dist. 1996).
[2] Planned Parenthood of Cincinnati Region v. Strickland, 531 F.3d 406, 408 (6th Cir.2008), certified question answered sub nom. Cordray v. Planned Parenthood Cincinnati Region, 122 Ohio St.3d 361, 2009-Ohio-2972, 911 N.E.2d 871 (2009).
[3] https://www.fda.gov/regulatory-information/search-fda-guidance-documents/label-and-investigational-use-marketed-drugs-biologics-and-medical-devices.
[4] R.T. v. Knobeloch, 10th Dist. No. 16AP-809, 2018-Ohio-1596, 111 N.E.3d 588, appeal not allowed, 153 Ohio St.3d 1467, 2018-Ohio-3450, 106 N.E.3d 65 (2018).
[5] Id. at ¶24.
