We have a long, 50-state survey post entitled " Don't Forget About A Prescribing Physician's Failure To Read Warnings," about a subject as to which we feel strongly enough that we keep it updated on an ongoing basis. Its proposition is simple, and powerful: Under the learned intermediary rule, it is impossible to prove causation from purportedly inadequate drug or device labeling when the prescribing doctor to whom the material is directed did not read it. That fact pattern happens quite often. Physicians are smart and busy people. Their familiarity with product risks usually comes from their training and their professional education. Equally often, they are intimately familiar with the risks of the products they prescribe or use, and thus don't bother reading what our clients' FDA-approved labeling has to say.
So, if an allegedly inadequate labeling is never read, it can't cause anything.
Well, how about physician testimony that almost, but not quite, establishes a prescribing physician's failure to read? The fact pattern we address today is: Instead of denying that s/he ever read the product labels in questions, a prescriber will sometimes testify that s/he doesn't "remember"/"recall" reading it. Do the same causation principles apply?
The answer is, usually yes. See Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986) ("the plain language of Rule 56(c) mandates the entry of summary judgment . . . against a party who fails to make a showing sufficient to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial").
As long as the plaintiff retains the usual burden of proving causation, this kind of "don't recall" testimony means that the plaintiff has more work to do to establish causation, and if the plaintiff doesn't do that work, then the plaintiff loses, just as when the prescriber affirmatively denies having read the label. That's the bottom line from what appears to be the leading case on this fact pattern, Pustejovsky v. PLIVA, Inc., 623 F.3d 271 (5th Cir. 2010) (applying Texas law). In Pustejovsky, the plaintiff's prescribing physician "did not recall ever reading the package insert for the drug or consulting the Physician's Desk Reference" concerning it. Id. at 277. While such testimony - unlike an explicit "I never read" statement - is not necessarily fatal to the plaintiff, neither does it satisfy the plaintiff's burden of proving causation. The prescriber's "lack of memory, of course, does not preclude the possibility that she had read these materials, but neither can it sustain [plaintiff's] burden." Id. What defeated the plaintiff's claim in Pustejovsky was her failure to adduce any other evidence, which meant the causation element was speculative:
Lacking any evidence that [the prescriber] was aware of [defendant's] warnings, [plaintiff] instead speculates about other ways an adequate warning might have reached [the prescriber] and altered her decision. She suggests, for example, that a modification to [the] warning label might have come up in conversations with other physicians or been discussed at a continuing-education seminar. Certainly, these scenarios are possible. Ultimately, however, without any summary-judgment evidence to support them, they remain nothing more than possibilities.
Id. (emphasis added). One "can imagine any number of scenarios," but without affirmative evidence, none of those castles in the clouds can satisfy a plaintiff's burden of proof. "Unsubstantiated assertions and unsupported speculation are not sufficient to defeat a motion for summary judgment." Id. (citation and quotation marks omitted). Summary judgment affirmed.
Lewis v. Johnson & Johnson, 601 F. Appx. 205 (4th Cir. 2015) (applying Texas law), is a more recent application of Pustejovsky. On appeal from summary judgment granted in the Pelvic Mesh MDL, the court affirmed for lack of causation evidence under Texas law.
[Plaintiff] presented no evidence that [her surgeon] relied on the warning in [defendant's] patient brochure in deciding to prescribe the [product]. [The surgeon] testified that she did not recall whether she had a [product] patient brochure at the time of [plaintiff's] surgery. . . . [The surgeon] further stated that she would not have verified the accuracy of the information in the brochure. None of this testimony establishes that [the surgeon] considered the patient brochure warning, let alone relied on it.
Id. at 208. Following Pustejovsky, Lewis held that the plaintiff "did not offer sufficient evidence to create a dispute as to material fact regarding whether a different warning would have changed [her surgeon's] decision to prescribe the [the product]." Id. at 209.
In a recent case controlled by Pustejovsky the relevant testimony of the plaintiff's surgeon was that while she "sometimes [did] read through" product labeling, she did "not recall for this case or at the time regarding this device." Castillo v. Boston Scientific Corp., 2020 WL 2771193, at *7 (W.D. Tex. May 28, 2020) (citations and quotation marks omitted). Following Pustejovsky, summary judgment was granted in Castillo. Plaintiff "has not established that a proper warning would have changed [the surgeon's] decision" because "[h]ypothetical situations . . . do not suffice." Id. at *8. "While it remains possible that [the surgeon] did review the [warnings] . . ., [plaintiff] has not presented the evidence that [the surgeon] did in fact do so." Id. See also Robles v. C.R. Bard, Inc., 2015 WL 11120857, at *2 (N.D. Tex. March 23, 2015) (also following Pustejovsky and granting summary judgment based on prescriber testimony "that he does not recall whether or not he read the instructions"; with no other evidence plaintiff "cannot establish causation").
The oldest case we've found holding that "do not recall" physician testimony is insufficient, without more, to establish a prima facie case of warning causation is Oppenheimer v. Sterling Drug, Inc., 219 N.E.2d 54 (Ohio App. 1964), in which the prescribing physician "specifically said-'I don't recall specifically reading the precautions.'" Id. at 58. Oppenheimer held:
His recollection was not clear as to the readings in Physicians' Desk Reference and defendant's literature circulated to physicians and druggists. It can hardly be said that he relied upon anything produced by the defendant or found in the general literature.
Id. at 59. This lack of prescriber reliance was dispositive of plaintiff's warranty claim, which was the only claim at issue in Oppenheimer. Id. (discussing reliance element of warranty).
Sherman v. Pfizer, Inc., 440 P.3d 1016 (Wash. App. 2019), is substantially more recent state appellate authority than Oppenheimer. In Sherman, the plaintiff's prescriber testified that he "did not read package inserts and did not recall ever reading a package insert." Id. at 1023. That testimony was fatal to the plaintiff's inadequate warning claims.
Based on these undisputed facts, . . . Defendants' alleged failure to update the package inserts cannot be the proximate cause of [plaintiff's] condition as a matter of law because even if they had updated the package inserts, [the prescriber] would not have read them.
Id. (citation omitted).
Most recently, in Russell v. Ethicon, Inc., 2020 WL 5993774 (M.D. Pa. Oct. 9, 2020), the implanting surgeon's "admissions that he does not recall reading the [instructions for use] and that he does not use the IFU when consenting patients are fatal to [plaintiff's warning] claim." Id. at *6. This failure to recall did not meet the plaintiff's burden of proof. "Plaintiff argues that the mere fact that [her surgeon] did not remember whether he had read the IFU creates a genuine dispute of material fact. It does not." Id.
[The surgeon's] lack of memory, of course, does not preclude the possibility that he read these materials, but neither can it sustain Plaintiff's] burden. Plaintiff was not foreclosed from pointing to contrary evidence in the record that would suggest that [her surgeon] did read and rely upon [defendant's] inadequate warning, but she has failed to do so. Therefore, even if [defendant's] warning was inadequate, Plaintiff has not provided evidence that the warning was a proximate cause of her injuries. Accordingly, the Court grants summary judgment as to the failure to warn claims.
Id. (quotation marks and footnotes citing Pustejovsky omitted). See Ebert v. C.R. Bard, Inc., ___ F. Supp.3d ___, 2020 WL 2332060, at *7 (E.D. Pa. May 11, 2020) (surgeon could not "recall whether he read [the product label] before implanting the [product]"; "even assuming that the warnings were inadequate, more detailed warnings . . . would have made no difference") (we blogged about Ebert here).
Another recent case along the same lines is Morris v. Biomet, Inc., 2020 WL 5849482, at *10 (D. Md. Sept. 30, 2020), where the plaintiff's surgeon "did not specifically recall whether he read the IFU prior to Plaintiff's surgery" (citation omitted). "Because Plaintiff cannot establish that [her surgeon] would have relied on more adequate warnings, she cannot prove her failure to warn claims." Id.
Similarly, in In re Wright Medical Technology Inc., Conserve Hip Implant Products Liability Litigation, 127 F. Supp.3d 1306 (N.D. Ga. 2015) (applying Utah law), the implanting surgeon testified that he did not "recall" ever reading the product's package insert. Id. at 1360. In the absence of any affirmative evidence of some other way the allegedly inadequate information could have affected the plaintiff's course of treatment, causation was not proven:
The question here is whether the learned intermediary doctrine precludes Plaintiff's failure to warn claim based on the package insert warning. The Court concludes that it does. [Plaintiff's surgeon] was unequivocal in his testimony about how he determined the risks and benefits of devices he implants. He prefers to "educate himself" on the product, and review the studies and what went into a design. He applied that same approach when evaluating the implanted device at issue in this case. [He] did not recall reading the insert included in the packaging.
Id. Thus "the evidence here does not support a failure to warn claim based on the warning provided for the implant at issue in this case." Id.
In In re Cook Medical, Inc. IVC Filters Marketing, Sales Practices & Products Liability Litigation, 2018 WL 6415585 (S.D. Ind. Dec. 5, 2018) (applying Georgia law), the "[p]laintiff fail[ed] to raise a genuine issue of material fact on the proximate causation element of . . . failure to warn claims." Id. at *4. This result was required because the implanting surgeon "could not recall whether he read the [product] IFU. If he could not recall reading [it], he could not have relied upon the warnings and other information set forth in it." Id. at *3 n.2 (citation omitted).
In In re Mentor Corp. ObTape Transobturator Sling Products Liability Litigation, 2015 WL 5468712 (M.D. Ga. Sept. 16, 2015), the court, applying Arkansas law, granted summary judgment against warning claims where the implanting surgeon "does not recall reading the . . . product information data sheet, and he does not recall speaking with a [sales] representative about [the product]." Id. at *1. Not only did this testimony fail to establish causation, it also rebutted the Arkansas heeding presumption:
[Plaintiff] did not point to any evidence that [her surgeon] would have taken a different approach had [defendant] provided additional warnings. [Plaintiff] argues that the Court should presume that [the surgeon] would have read and heeded adequate warnings in the product insert data sheet. But it is undisputed that [the surgeon] did not recall reading the . . . product insert data sheet. . . . Given this evidence ? and the lack of any evidence that [the surgeon] would have altered his treatment . . . had the [product] warnings been different - [plaintiff's] failure to warn claim fails.
Id. at *2 (citation omitted). See In re C.R. Bard, Inc., 2013 WL 5591948, at *6 (S.D.W. Va. June 4, 2013) (implanter remembered neither the product's instructions for use nor reviewing same; summary judgment granted for lack of evidence that the surgeon "would have altered his conduct if adequate warnings were given") (applying Mississippi law).
In California, the plaintiff in Latiolais v. Merck & Co., 2007 WL 5861354 (C.D. Cal. Feb. 6, 2007), aff'd, 302 F. Appx. 756 (9th Cir. 2008), lost where the prescriber's "do not recall" testimony was paired with a statement of non-reliance.
[The prescriber] could not recall receiving any information from [defendant] concerning [the drug] that affected his decision to prescribe it to Decedent. [He] stated that he saw sales representatives from drug companies only "rarely" and could not recall any interaction with [defendant's] representative. . . . He could not recall being influenced by any information from [defendant] or any other source concerning [the drug, and] stated that he could not recall if he ever read the package insert regarding [the drug], but, most importantly, stated conclusively that the inserts played no role in his decision to prescribe [the drug] to Decedent.
Id. at *2 (citations omitted). This do not recall "minus" (as opposed to the "plus" discussed in Pustejovsky) evidence completely failed to establish causation. Id. at *3 (the prescriber "could not recall if he ever read the package insert, or warnings, regarding [the drug]. Further, [he] stated he could not recall being influenced in this regard by any information from [defendant]").
Earlier, Harris v. McNeil Pharmaceutical, 2000 WL 33339657 (D.N.D. Sept. 5, 2000), reached a similar conclusion. The facts were unfortunate - the plaintiff was a physician who was also a drug addict and who "self-prescribed" the drug in question. Id. at *1-2. He answered "no" to whether he "recall[ed] . . . reviewing any information about the drug having a potential for abuse or dependence." Id. at *2. Plaintiff therefore lost his case for "lack of causation." Id. at *5.
[Plaintiff] testified that he does not recall reading the package insert. . . . He does not recall reading anything about the mechanism of action . . . or a discussion of the drug having a potential for abuse or dependence, until after he recognized he was addicted. Nor does [plaintiff] recall reading the package insert portion which [discussed drug dependency], or that portion which [discusses prior opioid use]. . . .
Proximate cause is such an element [essential to plaintiff's case]. It is this court's opinion that [plaintiff's] failure to review the contents of the package insert pertaining to precautions and dependency potential accompanying the [drug] provided to him is fatal to his claims under all theories of liability.
Id. at *4 (citation and footnote omitted).
Finally, what is the kind of additional evidence that, when added to prescriber "do not recall" testimony, can satisfy a plaintiff's burden of proof? We're not going to do the other side's research for them, but In re Taxotere (Docetaxel) Products Liability Litigation, 2020 WL 4228387 (E.D. La. July 23, 2020), is illustrative. While the prescriber "could not recall reading the [product's] label," the plaintiff adduced evidence that the prescriber "stays informed of drug labels through several third-party sites." Id. at *1-2. That was enough to create a fact question.
Thus, while "not recall reading" testimony is obviously not as definitive as "did not read" testimony, it often can and should be dispositive, given the usual burden of proof, unless the plaintiff can develop some other affirmative testimony that establishes a causal link to purportedly inadequate labeling information.
This article is presented for informational purposes only and is not intended to constitute legal advice.