United States: Boxed Warnings And Adequacy As A Matter Of Law

Last Updated: July 11 2017
Article by James Beck

One of the (many) things that made last year's decision in Barron v. Abbott Laboratories, Inc., ___ S.W.3d ___, 2016 WL 6596091 (Mo. App. Nov. 8, 2016), so hideous that it weighed in at #3 of our worst decisions of the year was that, virtually without discussion, it held that an FDA-approved black box warning was not only inadequate but so poor as to be worthy of punitive damages. Id. at *7. Fortunately the Missouri Supreme Court granted a transfer (on January 5, 2017, according to Westlaw) and (we hope) will restore sanity on at least some of the issues in Barron. However, the mere fact that a boxed warning – the strongest FDCA warning there is – could be utterly disregarded as in Barron got us thinking.

How have courts treated boxed warnings in other inadequate warning cases?

Initially, we're not dealing in this post with claims that, in order to be adequate, a defendant's labeling should have included a boxed warning. We've dealt with that kind of claim elsewhere, and our position is that, since the FDA must pre-approve all boxed warnings, all "should have added" claims are preempted. This post deals with prescription medical products that already have boxed warnings. Preemption becomes an issue in existing black box cases only if the plaintiff claims that the black box should have been changed – since (as discussed in the posts linked to previously) changes to black box warnings require prior FDA approval.

Looking back through our posts, we see we've described one decision, Hain v. Johnson & Johnson, No. ATL-L-8568-11 MT, slip op. (N.J. Super. L.D. June 20, 2013), reaching such a result. Hain recognized that "[a] 'black box' warning is the strongest warning required by the FDA." Id. at 6 (citing 21 C.F.R. §201.57(c)(1). Regardless of what might be the case with other, similar products:

[B]y mandating each manufacturer include the strongest type of warning possible to warn of [the risk at issue], the FDA ensured each prescriber's attention would be focused on the risk. . . . [A] boxed warning required by the FDA existed in the package insert at the time [plaintiff] ingested [the drug]. Courts have previously held prescription warning labels containing a boxed warning, mandated by the FDA, are adequate as a matter of law.

Id. at 7.

In In re Chantix (Varenicline) Products Liability Litigation, 881 F. Supp.2d 1333 (N.D. Ala. 2012), the primary authority cited in Hain, the court determined that under the law of any state in the country, an on-point black box warning was adequate as a matter of law. Such a warning was "the highest level warning possible, prominently displayed at the beginning of a drug's official prescribing information." 881 F. Supp.2d at 1339. There could be no doubt that such a warning "was sufficient to alert to the possibility of the harm actually suffered." Id. at 1340. Plaintiff's quibbles about when the drug should be used failed because they sought to tell physicians how to practice medicine. "[T]he decision as to use [of] a medication as a first-line treatment is uniquely up to the prescribing medical professional and based on a decision concerning his or her individual patient. Id.

Unlike the majority of cases reviewed by this court, the plaintiffs seek to pursue their failure to warn claims post the 2009 black box warning, not for failing to warn of possible complications from [the drug], but for failing to tell physicians when to prescribe it. . . . [Even] the plaintiffs recognize that a black box warning is "the most serious warning in the FDA's arsenal". . . . For the foregoing reasons, the court finds the 2009 black box warning adequate as a matter of law.

Id. at 1342-43 (citation omitted). Accord In re Chantix (Varenicline) Products Liability Litigation, 889 F. Supp.2d 1272, 1304 (N.D. Ala. 2012) ("the court finds that [the] black box warning is adequate as a matter of law").

Similarly, in Christison v. Biogen Idec, Inc., 199 F. Supp.3d 1315 (D. Utah 2016), the court held that a boxed warning of a usually fatal condition was adequate to warn physicians of that risk as a matter of law:

[I]t is undisputed that as a condition of [the drug's] re-approval . . . the FDA required that the prescribing information contain a "black box" warning about [the risk] which is the strongest warning required or permitted by FDA. The black box warning, as the most serious warning available, can be reasonably expected to catch the attention of the consumer. . . . [T]he intensity of the warning matched the magnitude of the risk. The black box warning . . . was not qualified or minimized in any way because the magnitude of the risk − death or severe disability − was of the highest possible degree.

Id. at 1343-44 (footnotes omitted). Accord Amos v. Biogen Idec, Inc., ___ F. Supp.3d ___, 2017 WL 1316968, at *5 (W.D.N.Y. April 10, 2017) (adequacy as a matter of law; the drug's "label contained this information in a black box warning, the strongest warning available"); Gentile v. Biogen Idec, Inc., 33 Mass. L. Rptr. 607, 2016 WL 4168942, at *6 (Mass. Super. July 28, 2016) ("[t]he black box warning in effect when [the prescriber] first prescribed [the drug] to [plaintiff's decedent] explicitly warned against the precise risk . . . that [she] ultimately suffered, and fully disclosed the serious consequences of that disease").

In Aaron v. Wyeth, 2010 WL 653984 (W.D. Pa. Feb. 19, 2010), the product's black box warning "advised physicians of the specific risks at issue in the instant case," thus the court found "no evidence that [defendant] breached its duty to exercise reasonable care to inform [the prescriber] and others similarly situated of the risks associated with" taking the drug in question, even though the prescriber testified that he did not remember the warning correctly. Id. at *10. In Whiteside v. Johnson & Johnson, 2015 WL 11120989 (Mag. N.D. Tex. Mar. 13, 2015), adopted, 2015 WL 11120990 (N.D. Tex. July 8, 2015), the court dismissed the action with prejudice when the plaintiff abandoned ship in the face of the defendant's summary judgment motion. The court noted that the "Plaintiff's prescription postdat[ing] . . . Defendants' addition of an adequate 'black box' warning about the risks associated with the drug in question . . . would be fatal to Plaintiff's claims." Id. at *1 n.1. See also Holland v. Hoffman-La Roche, Inc., 2007 WL 4042757, at *2-3 (N.D. Tex. Nov. 15, 2007) (black box warning held adequate as a matter of law; Texas presumption unrebutted); Clark v. Hoffman-La Roche, Inc., 2006 WL 1374516, at *7 (N.J. Super. May 2, 2006) (boxed warning "satisfied [defendant's] burden under either New Jersey or Utah law to provide an adequate warning with respect to the risks" at issue); cf. In re Actos (Pioglitazone) Products Liability Litigation, 2014 WL 4364832, at *34 (W.D. La. Sept. 2, 2014) (characterizing post-prescription boxed warning as "hav[ing] full and adequate warnings").

In a couple hours of looking we found more than a half-dozen cases where boxed warnings were held adequate as a matter of law. Thus any court "unaware of any court holding that such a [boxed] warning is per se adequate as a matter of law," Hutchens v. Abbott Laboratories, Inc., 2016 WL 5661582, at *6 (N.D. Ohio Sept. 30, 2016), either didn't look very hard, or wasn't willing to accept what it found.

In our view, the bottom line with boxed warnings is: one, the presence of a boxed warning concerning the relevant risk of a prescription medical product demonstrates that the risk is adequately warned about and sufficiently emphasized, making the warning adequate as a matter of law; and in any event two, since the FDA controls the content of black box warnings, any allegations that existing boxed warnings are inadequate are necessarily preempted.

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

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