We’ve been defending the ability of physicians to engage in off-label use ever since the Bone Screw litigation of the 1990s. Buckman Co. v. Plaintiffs Legal Committee, where the United States Supreme Court affirmed that “off-label use is generally accepted” and that under the law, “[p]hysicians may prescribe drugs and devices for off-label uses,” 531 U.S. 341, 351 & n.5 (2001), was one of our Bone Screw cases. Thus, we follow medical malpractice decisions, like Doctors Co. v. Plummer, ___ So.3d___, 2017 WL 242577 (Fla. App. Jan. 20, 2017), which we discussed recently, for what they have to say about off-label use. In malpractice cases, the dark side often attempts to equate “intended uses” listed in FDA-approved drug/device labeling with the medical standard of care. As we mentioned in that post, arguments that FDA-approved product labeling equals the medical standard of care are really attempts to turn off-label use itself into a tort.
The Doctors Co. decision prompted us to look back over our 9+ years of blogging output for where we addressed this issue previously. Surprisingly, there was only one, a 2007 Bexis piece that (even more surprisingly) didn’t cite any caselaw. We also found a 2009 law review article by our erstwhile co-founder, Mark Herrmann, which might have been prompted by the earlier blogpost. But nothing was on the blog itself that could qualify as useful research.
We rectify that today.
As we suspected, the modern rule severely limit the use of FDA-approved labeling as evidence of any medical standard of care in medmal cases. The New Jersey Supreme Court, in Morlino v. Medical Center, 706 A.2d 721 (N.J. 1998), rejected an argument that, because the defendant physician had not disclosed a pregnancy-related risk contained in the package insert (as collected in the Physician’s Desk Reference (“PDR”), that proved malpractice.
[D]rug manufacturers do not design package inserts and PDR entries to establish a standard of medical care. Manufacturers write drug package inserts and PDR warnings for many reasons including compliance with FDA requirements, advertisement, the provision of useful information to physicians, and an attempt to limit the manufacturer’s liability. . . . Those considerations highlight the reasons expert testimony must accompany the introduction of PDR warnings to establish the applicable standard of care in prescribing a drug.
Id. at 729. In Dunn v. Yager, 58 So.3d 1171, 1203 (Miss. 2011), the court affirmed exclusion of an FDA black box warning in a malpractice case, where the warning had not been present at the time of the medical treatment in question.
Another attempt to measure the medical standard of care by drug labeling failed in McCorkle v. Gravois, 152 So.3d 944 (La. App. 2014). Agreeing with Morlino, the McCorkle court:
conclude[d] that in the absence of a specific contraindication or warning in the package insert and PDR, the plaintiffs could not satisfy their burden of establishing the applicable standard of care, nor establish a prima facie case of negligence, by relying upon the package insert and PDR alone, but instead, needed expert testimony.
Id. at 956. Similarly, the court in Chandler v. Simpson, 2000 WL 426441, at *8 (Wash. App. April 18, 2000), refused to allow a warning from a package insert to establish “materiality” for purposes of informed consent. Other cases rejecting evidentiary use of FDA-approved drug/device labeling in medical malpractice cases are: Anderson v. Eli Lilly & Co., 2015 WL 8773795, at *3 (Ohio App. Dec. 15, 2015) (expert testimony required; “that a physician prescribed a medication which arguably was contraindicated . . . does not in and of itself make the treating physician guilty of professional negligence”); Clarke v. Mikhail, 779 S.E.2d 150, 161 (N.C. App. 2015) (a “manufacturer’s recommended titration schedule is a recommendation only, from which medical providers can and do deviate”); Arnold v. Lee, 2006 WL 1410161, at *3 (Iowa App. May 24, 2006) (refusing to admit package insert as evidence of malpractice “[i]n an age where drugs are frequently used for purposes not approved by the FDA”) (in table at 720 N.W.2d 194); cf. Schultz v. AstraZeneca Pharmaceuticals, L.P., 2006 WL 3797932, at *4 (N.D. Cal. Dec. 22, 2006) (“a mere allegation of ‘off-label’ use with nothing more would not be sufficient to state a claim for professional negligence”).
Most jurisdictions will admit package inserts in malpractice cases, but not as conclusive evidence of a violation of the standard of care, and usually only in conjunction with expert testimony. “[T]he majority view [is] that while the information about the drug in the package insert and the PDR is relevant and useful information regarding the prescribing physician’s standard of care, it is not the sole determinant of the standard of care.” Hyman & Armstrong, P.S.C. v. Gunderson, 279 S.W.3d 93, 114 (Ky. 2008). In Spensieri v. Lasky, 723 N.E.2d 544 (N.Y. 1999), the New York Court of Appeals, declared that “[t]he purposes behind [drug labeling] render its content...
