United States: FDA-Approved Labeling ≠ Medical Standard Of Care

Last Updated: February 23 2017
Article by James Beck

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 ill-suited to serve as prima facie evidence of a standard of care," and consequently "reject[ed] the contention that the PDR constitutes prima facie evidence of a standard of care." "[A]dmission of the PDR alone in place of expert testimony would result in a standard of care established by drug manufacturers instead of the medical profession." Id. at 548.

In Richardson v. Miller, 44 S.W.3d 1 (Tenn. App. 2000), the court distilled (mostly from Spensieri) four reasons for restricting the use of manufacturer/FDA labeling in medical malpractice cases relating to the standard of care:

  • First, permitting the labeling or the PDR reference alone to establish a physician's standard of care would be inconsistent with [state statutory law] because it would permit the drug manufacturer, rather than the medical profession, to establish the standard of care.
  • Second, the FDA-required labeling and parallel PDR reference may not be easily understood by the jury without expert assistance because these materials are written for the medical profession, not the general public.
  • Third, the drug manufacturer and the FDA do not intend to establish the standard of care when they prepare a drug's labeling or PDR reference. These materials are intended to comply with the FDA's regulations, to provide advertising and promotional material, and to limit the manufacturer's liability.
  • Finally, the labeling and PDR reference cannot be cross-examined.

Id. at 16-17 (citations omitted).

Other cases allowing use of manufacturer labeling in a role subsidiary to expert testimony in medical malpractice/informed consent litigation against physicians include: Ngo v. Queen's Medical Center, 358 P.3d 26, 41 (Haw. 2015) ("information contained in a manufacturer's insert cannot, on its own, satisfy a plaintiff's burden of production in an informed consent case, [but] can constitute evidence that the jury or fact finder may consider along with the requisite expert testimony"); Bissett v. Renna, 710 A.2d 404, 407 (N.H. 1998) ("the PDR, by itself, is insufficient to establish the standard of care required of the defendant"); Craft v. Peebles, 893 P.2d 138 (Haw. 1995) ("manufacturer's package inserts do not, by themselves, set the standard of care which is applicable to a physician on the issue of informed consent"); Bowman v. Songer, 820 P.2d 1110, 1114 (Colo. 1991) ("manufacturer's instructions . . . may be admissible evidence on the standard of care, when supported by expert testimony"); Ramon v. Farr, 770 P.2d 131, 135-36 (Utah 1989) ("the better rule is that manufacturers' inserts and parallel P.D.R. entries do not by themselves set the standard of care, even as a prima facie matter" but are "some evidence that the finder of fact may consider along with expert testimony on the standard of care"); Garvey v. O'Donoghue, 530 A.2d 1141, 1146 (D.C. 1987) ("[w]hen the package insert or the PDR is offered in conjunction with expert testimony . . . that combination may be sufficient to establish the standard of care"); Thompson v. Carter, 518 So.2d 609, 613 (Miss. 1987) ("the package insert in the instant case should not be taken as conclusive evidence of the physician's standard of care, nor should a departure from the directions contained in the package insert be considered to establish a prima facie case of negligence"; but is admissible as proof "of the proper method of use"); Nolan v. Dillon, 276 A.2d 36, 49 (Md. 1971) ("[t]he package insert . . . does not standing alone establish a standard of care, but rather, prima facie proof of proper use"); Crouch v. Most, 432 P.2d 250, 252 (N.M. 1967) ("directions in the brochure are, at best, only proof of a proper method of use"); Doctors Co., ___ So.3d at ___, 2017 WL 242577, at *6 ("a prescription drug package insert may have some significance in identifying a doctor's standard of care" but "cannot be used as 'stand-alone proof'"); Grayson v. State, 838 P.2d 546, 548-49 (Okla. App. 1992) ("declin[ing] to hold that departure from the drug manufacturer's recommendations found on the package insert is prima facie evidence of negligence"; they may only "be considered along with all other evidence," and "do[] not relieve the plaintiff of the burden of proving, through expert testimony, the standard of medical care") (emphasis original); Gaston v. Hunter, 588 P.2d 326, 345 n.18 (Ariz. App. 1978) ("manufacturer's instructions are at least some evidence of the appropriate standard of care in the administration of a drug"); Rodriguez v. Jackson, 574 P.2d 481, 486 (Ariz. App. 1977) ("the package insert is admissible into evidence, [but] does not establish conclusive evidence of the standard or accepted practice in the use of the drug by physicians and surgeons"); Salgo v. Leland Stanford, Jr. University Board of Trustees, 317 P.2d 170, 180 (Cal. App. 1957) (package inserts "while admissible, . . . cannot establish as a matter of law the standard of care required of a physician in the use of the drug"); Bay v. Abel, 2004 WL 5453008 (Okla. Dist. April 21, 2004) ("non-approval by the FDA with regard to the [device] and technique utilized by [the physician] does not, per se, demonstrate or prove professional malpractice").

Some courts, in mostly older decisions, allow package inserts, without more, to stand as "prima facie" evidence of the medical standard of care. Mueller v. Mueller, 221 N.W.2d 39, 42-43 (S.D. 1974); Ohligschlager v. Proctor Community Hospital, 303 N.E.2d 392, 386 (Ill. 1973); Mulder v. Parke Davis & Co., 181 N.W.2d 882, 887 (Minn. 1970); Julien v. Barker, 272 P.2d 718, 724 (Idaho 1954); Haught v. Maceluch, 681 F.2d 291, 303 n.12 (5th Cir. 1982) (applying Texas law). Interestingly, this approach tended to exculpate manufacturers from liability for off-label use, while imposing such liability on physicians:

The drug manufacturers are being held accountable in courts of law for injuries caused by these drugs only when these recommendations are followed. The busy doctor has no alternative but to prescribe these drugs according to the recommendations of the drug manufacturers.

Mueller, 221 N.W.2d at 42-43 (emphasis added).

Finally, that a prescription medical product has been prescribed off-label has been held not to undermine a statutory presumption that the product's FDA approved labeling was adequate:

The decision of [plaintiff's] physicians to prescribe [the drug] off-label, and the fact that the FDA had not yet approved [it] for the particular indication for which it was prescribed to [plaintiff], does not rebut the statutory presumption of adequacy to which the [drug's] labeling is entitled. . . . The FDA's decision not to include a risk . . . warning on the [drug's] label was deliberate and informed. Plaintiffs cannot use the fact that [the drug] was prescribed off-label to rebut the statutory presumption of adequacy.

Bailey v. Wyeth, Inc., 37 A.3d 549, 576 (N.J. Super. Law. Div. 2008) (product liability action; "[f]ollowing the accepted medical standard of care, physicians frequently prescribe drugs for off-label or unapproved uses"), aff'd, 28 A.3d 1245 (N.J. Super. App. Div. 2011). Accord Seavey v. Globus Medical, Inc., 2014 WL 1876957, at *7-8 (D.N.J. March 11, 2014) (applying same statutory presumption as Bailey to off-label use of §510k medical device).

This article is presented for informational purposes only and is not intended to constitute legal advice.

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