We’ve blogged several times about the nearly unanimously accepted proposition that FDA regulatory status – that is, the bare fact that a drug or medical device is used off-label – is not a medical risk, benefit, or alternative about which physicians must tell patients under the law of informed consent. Bexis in particular is emphatic on this point because he played a big part in creating that law in the Bone Screw litigation.
Recently, in a case we didn’t blog about – because we didn’t want to tip off the other side – a Maryland intermediate appellate decision had gone the other way. We’re now pleased to inform everyone, however, that the Maryland Court of Appeals (that state’s highest court) has reversed that bad decision on precisely the grounds we hoped it would (yes, Bexis was in touch with the appellant physician’s counsel in that case). Here’s the money quote:
Information pertaining to an “off-label” use provides the patient with no information about the treatment itself. As the Pennsylvania court recognized inSouthard [a case Bexis briefed], “‘[t]he mere fact that the FDA has not cleared a product for a particular use does not mean that the product is not in fact suitable for that purpose; it simply means that the FDA has not cleared it.’” Southard, 781 A.2d at 107. Because it provides no information regarding the medical treatment, it cannot, therefore, be considered material information to an informed consent discussion. We note, finally, with respect to this issue, that the FDA-approval status does not provide any information regarding the materiality of the risks of the administration of [the drug]; it does not inform the fact-finder of the likelihood or severity of any risk.
Shannon v. Fusco, 2014 Md. Lexis 275 (Md. April 24, 2014) (citation and footnote omitted) (emphasis added).