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]...
