Federal Rule of Evidence 407, dealing with the inadmissibility of subsequent remedial measures, isn’t all that complicated – as Federal Rules go.  It’s only 73 words long:

When measures are taken that would have made an earlier injury or harm less likely to occur, evidence of the subsequent measures is not admissible to prove:

  • negligence;
  • culpable conduct;
  • a defect in a product or its design; or
  • a need for a warning or instruction.

But the court may admit this evidence for another purpose, such as impeachment or − if disputed − proving ownership, control, or the feasibility of precautionary measures.

It would have been even shorter, if certain courts hadn’t insisted on reading a strict liability exception into Rule 407 that simply wasn’t there.  Thus Rule 407 was amended in 1997:

to provide that evidence of subsequent remedial measures may not be used to prove “a defect in a product or its design, or that a warning or instruction should have accompanied a product.”  This amendment adopts the view of a majority of the circuits that have interpreted Rule 407 to apply to products liability actions.

F.R. Evid. 407, Committee Notes to 1997 amendments.

Trouble is, courts still can’t keep their hands off of Rule 407’s very simple language – if the claimed injury was “earlier” than the “measure” the defendant had “taken,” and there is no other “purpose” for the evidence at issue, it’s excluded.

Back in 2010, we examined one restrictive judicial gloss on Rule 407 – a “policy” based exception that the rule somehow doesn’t apply to government-mandated measures.  That caveat was made up out of whole cloth, since the language of Rule 407 draws no such distinction, nor is any caveat mentioned in any committee note.  Fortunately, that 2010 decision has been a pro-plaintiff anomaly, and FDA required label changes, recalls, etc. continue to be subject to Rule 407-based exclusion.  See, e.g., Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F.3d 281, 292 (6th Cir. 2015) (“we will not consider evidence of a subsequent improvement to a drug label as evidence of prior failure to warn, even in cases such as this in which the FDA mandated the change in labeling”) (citing Rule 407).  Bexis collects those cases in §11.01[2][a] nn.101-106 of his book.

Having two strikes against them hasn’t stopped the other side from trying to conjure up other Rule 407 exceptions, however.  Our present beef is with a couple of decisions purporting to engraft a causation/intent requirement onto Rule 407 – even though the current rule nowhere discusses causation.  Thus in Godelia v. Zoll Services, LLC, 2019 WL 3883682, at *1-2 (S.D. Fla. Aug. 16, 2019), the court inexplicably held that that a post-injury corporate audit report wasn’t excludable under Rule 407 because it was not prompted by the incident that injured the plaintiff:

The record does not reflect that Defendant retained [the outside auditor] to conduct the audit to make the harm suffered by [plaintiff] less likely to occur or to remedy any issues Defendant had with corrective and preventative action for [the claimed defect]. . . .  Defendant believed that there was a communication issue with the FDA.  In response to this belief, Defendant retained [the auditor] − not to remedy [plaintiff’s claimed] defects or regulatory failures. . . .  Accordingly, this analysis and Audit Report are not subsequent remedial measures and are admissible.

Id. at *2 (footnote omitted).  See In re Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Products Liability Litigation, 518 F. Supp.3d 1028, 1036-37 (S.D. Ohio 2021) (relying on “policy” of Rule 407 against “deterrence” to avoid exclusion of a subsequent remedial measure “not trigger[ed]” by “Plaintiff’s injury”).

The interpretation of Rule 407 in those cases goes beyond mere judicial gloss.  Rather, it flies in the face of the most recent (2011) amendments to Rule 407.  Before 2011, Rule 407 used to at least mention causation − the first clause provided that “[w]hen, after an injury or harm allegedly caused by an event, measures are taken. . . .” (Emphasis added).  The 2011 amendments eliminated even that oblique reference, substituting the current language focusing solely on result:  “When measures are taken that would have made an earlier injury or harm less likely to occur. . . .”  Further, since the 2011 amendments omitting causation altogether were not intended to have substantive effect, see Committee Notes to 2011 Amendments (“stylistic only”), the Rule’s current lack of any reference to causation is further indication that Rule 407 was never intended to require any cause-and-effect relationship between a particular plaintiff’s injury and a defendant’s subsequent remedial measure.

Fortunately, most courts have not narrowed Rule 407 on this extratextual basis.  Rather, they take a broad view, excluding evidence of any subsequent remedial measure that, if taken previously, would have made the injury or harm generally less likely to occur, without reference to any particular plaintiff.

[Plaintiffs] seek to sidestep Federal Rule of Evidence 407 by insisting that the change was not a subsequent “remedial” measure because, according to the affidavit of a [defense witness], the change was not prompted by safety concerns.  But [defendant’s] motive for making the change is irrelevant.  All the rule requires is that the measure “would have made the injury or harm less likely to occur.”

Chlopek v. Federal Insurance Co., 499 F.3d 692, 700 (7th Cir. 2007) (quoting text of Rule 407).  Earlier, in Mills v. Beech Aircraft Corp., 886 F.2d 758, 763 (5th Cir. 1989), the court refused to turn Rule 407 exclusion into a battle over the defendant’s subjective intent, holding instead:

In the present case, as in the vast majority of the cases, it is not known why the changes were made.  Instead of attempting to prove or disprove the reasons for subsequent product changes, we should consider the probative value of such evidence on the point at issue . . . whether the product or design was defective at the time the product was sold. . . .  The introduction of evidence about subsequent changes in the product or its design threatens to confuse the jury by diverting its attention from whether the product was defective at the relevant time to what was done later.

Id. at 763 (citation and quotation marks omitted) (emphasis added).  See Bush v. Michelin Tire Corp., 963 F. Supp. 1436, 1449 (W.D. Ky. 1996) (“The rule’s language does not go to Defendant’s intent in adopting the later measures.  It simply asks whether the later measures could have prevented the earlier accident.”); see also Maiorano v. Home Depot U.S.A., Inc., 2018 WL 2128609, at *3 n.3 (S.D. Cal. May 9, 2018) (quoting and following Chlopek).  Cf. Hassebrock v. Air & Liquid Systems Corp., 2016 WL 4496917, at *6 (W.D. Wash. April 11, 2016) (Rule 407 barred admission of the defendant’s subsequent remedial measures after the date of plaintiff’s last exposure to asbestos, even though that exposure was not from the defendant’s products).

The issue has also come up in a number of state cases applying Rule 407 analogs.  We caution that, in all such cases, the language of the relevant rule might not be identical to Rule 407, but here are a few state high court examples:  Johnson v. State, Dept. of Transportation, 233 P.3d 1133, 1137 (Ariz. 2010) (“Rule 407 requires the exclusion of evidence of subsequent measures to prove a party’s negligence or culpable conduct, even when such measures are taken without specific knowledge of the accident in question”); Martin v. Norfolk Southern Railway Co., 271 S.W.3d 76, 88 (Tenn. 2008) (Rule 407 applied even though action was “carried out pursuant to corporate policy” rather than in response to an accident because “it corrected an allegedly dangerous condition and made the [area] safer”); Webb v. CSX Transportation, Inc., 615 S.E.2d 440, 448 (S.C. 2005) (“narrow interpretation” of Rule 407 “that only measures taken in direct response to the accident qualify for exclusion” rejected because it “ignores the literal language of the rule”); Doe v. Johnston, 476 N.W.2d 28, 34 (Iowa 1991) (Rule 407’s “policy would not be served if evidence of defendants’ changed behavior could be used to prove liability just because defendant was unaware that any injury or accident had occurred”).

Decisions applying Rule 407 in the specific context of prescription medical product liability litigation also apply the rule without detours into whether the plaintiff’s injury somehow caused the defendant to take the remedial measure at issue.  “[A] plaintiff could not avoid the effect of Rule 407 simply by arguing a label change was not prompted by safety concerns.”  Hill v. Novartis Pharmaceuticals Corp., 944 F. Supp.2d 943, 961 (E.D. Cal. 2013).

[T]he court did not hold that the absence of a remedial motive prevented exclusion under Rule 407 . . .[, and] other courts specifically addressing this precise issue have held otherwise.  The Court reaffirms its conclusion at the pretrial conference that subjective intent or motive in taking a remedial measure is not a dispositive prerequisite for exclusion under Rule 407.

In re Mentor Corp. ObTape Transobturator Sling Products Liability Litigation, 2010 WL 2015146, at *1 (M.D. Ga. May 20, 2010).  See Herrera-Nevarez v. Ethicon, Inc., 2017 WL 3381718, at *3 (N.D. Ill. Aug. 6, 2017) (rejecting argument that Rule 407 did not apply because “the change was not made for safety-related or other remedial reasons”); In re Depakote, 87 F. Supp. 3d 916, 925 (S.D. Ill. 2015) (“motives are irrelevant to the Court’s Rule 407 analysis”) (both Chlopek-bound courts).

As this discussion indicates, there hasn’t been a lot of litigation over what caused a defendant to undertake a particular remedial measure in prescription medical product liability litigation.  Like the would-be strict liability and government mandate exceptions before it, this purported exception has no basis in the text of Rule 407, and that should be the end of the inquiry.  We think things should stay that way.  “When the express terms of a statute [here a rule, but the proposition is the same] give us one answer and extratextual considerations suggest another, it’s no contest.  Only the written word is the law, and all persons are entitled to its benefit.”  Bostock v. Clayton County, Georgia, 140 S. Ct. 1731, 1737 (2020).