Photo of Bexis

Speaking of iffy propositions, we’re reminded of the hypothetical, hindsight-oriented questions that plaintiffs so often ask prescribing physicians:  “What if you had known X?”  “Would you have liked to know X?”  “Wouldn’t you have wanted to know Y?”  The (usually) unspoken premise of these questions is the more knowledge is always better than less – no matter how questionable propositions “X” and/or “Y” might be.

This, we like the Texas Supreme Court’s response to such arguments in Centocor, Inc. v. Hamilton, 372 S.W.3d 140 (Tex. 2012) (which we also discussed here).

Moreover, [plaintiffs] failed to show that the warning’s alleged inadequacies . . . would have changed [the] prescribing physicians’ decision to prescribe [the drug] in light of her complicated medical history and serious ailments. . . .  [The prescriber] stated that he would want to know if [defendant] was aware of more cases of patients contracting [condition]. . . .  Even if the additional reports . . . constituted valid and reliable evidence of an elevated risk of [the condition] beyond that of a “rare” . . . side effect, the fact that [the prescriber] would have considered such information, if included in the package insert, does not prove that the presence of such information would have changed his decision to prescribe [the drug] to [plaintiff] − a critical element of [these] claims.

Id. at 172.  So much for speculative hindsight.  “Want to know” prescriber testimony, alone, is not a valid basis for establishing the warning causation element in a learned intermediary rule case.

Similarly, in Gaghan v. Hoffman-La Roche Inc., 2014 WL 37983386 (N.J. Super. App. Div. Aug. 4, 2014) (applying California law), the court ordered entry of judgment n.o.v. where all the plaintiff had was the prescriber’s affirmative answers to “would you want to know about” questions.  Plaintiff “could not get [the prescriber] to testify that he would have warned [plaintiff] . . .  if the [defendant’s]warnings had been as plaintiffs’ evidence and argument would have required.”  Id. at *16. Then,

On cross-examination, [the prescriber]testified that the stronger warnings would not have dissuaded him from recommending and prescribing [the drug] because the side effects were rare, the drug was highly effective, and a patient . . . who had tried other medications would benefit greatly by its use.

Id. at *17.  That did it.  “Want to know” was not enough.  “[E]ven if California law did focus on the decision of the patient rather than the decision of the doctor, there was insufficient evidence in the record from which the jury could rationally conclude that stronger warnings would have altered [the prescriber’s] treatment . . . .  [Plaintiff] did not establish that stronger warnings would have changed [the prescriber’s] conduct.”  Id.

Essentially the same thing happened in Sager v. Hoffman-La Roche, Inc., 2012 WL 3166630 (N.J. Super. App. Div. Aug. 7, 2012), another New Jersey litigation tourist case involving the same drug, but this time under Florida law.  “Want to know” prescriber testimony was not enough to establish causation under the learned intermediary rule:

[The prescriber], who continued to prescribe [the drug] to other patients . . ., testified that if she saw [plaintiff] . . . in the same condition, she still would have strongly considered prescribing [the drug]. . . .  [The prescriber] did note that she would have wanted to know if [defendant] had found a causal relationship . . . and that if the drug was a probable or highly likely cause of [the condition], she would have informed a patient of the relationship.  Even so, her testimony was unambiguous when asked about whether, if the product warning had been stronger, she would have made the same prescribing decision as to [plaintiff].

Id. at *17.  Under Florida law, “the inescapable conclusion is that the trial proofs failed in this case to establish proximate causation.”  Id. at *18.

In Hanson v. Boston Scientific Corp., 2016 WL 1448868, at *5 (S.D.W. Va. April 12, 2016) (applying Wisconsin law), the court held that, regardless of the learned intermediary rule, unstated implanter testimony that “at most” her “risk/benefit analysis would have been impacted” led to summary judgment in a vaginal mesh case.  Such threadbare testimony “requires a reasonable juror to speculate, based only on mere possibility, that [the implanting surgeon] would have altered her decision to prescribe the product simply because she would have considered an additional factor in her risk/benefit calculus.”  Id. at *5 (emphasis original).

Similarly abstract implanter testimony that allegedly omitted information would be a “cause for concern” likewise failed in another mesh case, Hoffman v. Boston Scientific Corp., 2015 WL 5842785, at *5 (S.D.W. Va. Oct. 6, 2015) (applying Utah law).  Such testimony:

D[id] not show that . . . the implanting physician, would have altered his decision to prescribe the product had he known of additional warnings. . . .  [Plaintiff’s] evidence is insufficient.  Indeed, such evidence requires a reasonable juror to speculate, based only on mere possibility, that [the implanter]  would have altered his decision to prescribe the product simply because of “cause for concern.”  Accordingly, a reasonable juror cannot infer that allegedly inadequate warnings proximately caused [plaintiff’s] injuries.

Id. (citations omitted) (emphasis original).

The same result obtains in prescription drug litigation.  “Would like to have known” prescriber testimony, never linked to the plaintiff’s treatment, failed in Vanderwerf v. SmithKlineBeecham Corp., 529 F. Supp.2d 1294 (D. Kan. 2008).  Such abstract testimony was no big whoop given other patient-specific testimony the disproved causation:

The above testimony establishes that [the prescriber] may not have used [the drug] “in a certain individual,” but it does not explain what type of individual or why [the prescriber] may not have given [the drug] to that type of individual.  The reference has no apparent relation to [plaintiff’s decedent].  [The prescriber] clearly testified that even today, he would still prescribe [the drug] for [plaintiff’s decedent].  The speculative argument that [he] “may not” have used [the drug] “in a certain individual” does not raise a genuine issue of material fact.

Id. at 1312.

Ditto in Nix v. SmithKline Beecham Corp., 2007 WL 2526402 (D. Ariz. Sept. 5, 2007) (applying California law).  Abstract prescriber “would have liked to have known” testimony could not establish a genuine issue of fact on proximate causation in a learned intermediary case.

But merely raising the possibility that [the prescriber] might have acted differently is not enough to satisfy Plaintiffs’ burden of proof on causation.  As noted above, Plaintiff must provide affirmative evidence that “an adequate warning to the prescribing physician would have altered the physician’s conduct. . . .  Plaintiffs must come forward with evidence from which a reasonable jury could return a verdict for the nonmoving party.  Plaintiffs have provided no such evidence on the issue of causation.

Id. at *3 (citations and quotation marks omitted).

“Would have liked to have known” testimony from a prescriber also failed to create a triable causation case in Cross v. Forest Laboratories, 102 F. Supp.3d 896 (N.D. Miss. 2015).  The line of questioning was based on a false predicate – the claimed information did not, in fact, exist at the pertinent time.

This data was published in 2006 and was not available to [the prescriber] at the time he made the prescription, so the court fails to see how data published in 2006 could have affected [the prescriber] in 2004.  Further, even if, in 2004, [the prescriber] had had the data and had done further research, he might have still prescribed [the drug].  There is no affirmative and specific evidence provided by plaintiffs that suggest an adequate warning would have changed [the prescriber’s] conduct in a way to prevent [the claimed injuries].

Id. at 904.  Absent plaintiff-specific prescriber testimony that some change in prescriber conduct would have prevented injury, the defendant was entitled to summary judgment on causation.  Id. at 905 (“Plaintiffs have failed to show an adequate warning would have altered [the prescriber’s] conduct in any way.”).

Now, the caveats.  If the plaintiff successfully uses “would have liked to have known” questions as a springboard for more substantive questions concerning whether the prescriber would not have recommended a drug or implanted a device, then causation is likely established on the basis of affirmative answers to the latter questions.  Defendants should be prepared to distinguish those types of decisions in a situations where, as above, the prescriber’s testimony is hypothetical or abstract and is not  tied to his or her treatment of that specific plaintiff.  In such cases, it is the latter testimony – about possible alteration of a plaintiff’s treatment – that matters, not any “would have liked to know” statements.

Finally, we would also like to caution that plaintiffs might get away pure “like to know” tactics in states that allow a “heeding presumption” in prescription medical product liability litigation.  Such a presumption – which we consider invalid − effectively flips the burden of proof.  Thus, a holding that prescriber “would want to know” testimony defeated summary judgment did so because “[a]t no point” did the prescriber” suggest that he would have disregarded” such information.  Anderson v. Sandoz Pharmaceuticals Corp., 77 F. Supp. 2d 804, 809 n.7 (S.D. Tex. 1999).  However, Anderson was expressly abrogated in Ackermann v. Wyeth Pharmaceuticals, 526 F.3d 203, n.16 (5th Cir. 2008), which held that Texas did not recognize a heeding presumption.