Here’s another “little list” that came about because of Bexis updating chapter two (information-based claims) of his book. This one includes all cases where, due to the ordinary burden of proof, warning claims were dismissed on causation grounds where there was simply no evidence in the record about the prescribing physician’s actions. The reasons for the prescriber’s unavailability differ. S/he could be dead, disappeared, or for whatever reason never deposed.
Obviously, the rationale of these cases doesn’t fly in jurisdictions where a “heeding presumption” puts the onus on the defendant to come up with affirmative proof of lack of causation.
First, some cases from Texas, one of a few states that has addressed this issue repeatedly. In Centocor, Inc. v. Hamilton, 372 S.W.3d 140 (Tex. 2012), the Texas Supreme Court pointed out that the plaintiff’s questioning of the prescriber was simply inadequate. “Instead of proving that greater risk of [the condition would have changed [the prescriber’s] decision to prescribe [the drug], [plaintiffs] elicited no evidence to that effect.” Id. at 172. Also under Texas law, the Fifth Circuit in Pustejovsky v. PLIVA, Inc., made clear that the party with the burden of proof loses when the prescriber simply doesn’t remember anything:
[Plaintiff] has not carried her burden. As [plaintiff] admits, [the prescriber] did not recall ever reading the package insert for the drug or consulting the Physician's Desk Reference. Her lack of memory, of course, does not preclude the possibility that she had read these materials, but neither can it sustain [plaintiff’s] burden.
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. . . . Certainly, these scenarios are possible. Ultimately, however, without any summary-judgment evidence to support them, they remain nothing more than possibilities. . . . While [plaintiff] can imagine any number of scenarios to fill the gaps in [the prescriber’s] memory, she has provided evidentiary support for none of them. Accordingly, [plaintiff] fails to demonstrate a genuine issue of material fact regarding causation.
623 F.3d 271, 277 (5th Cir. 2010) (emphasis added). The basic reasoning was affirmed in Skotak v. Tenneco Resins, Inc., also under Texas law. The district court granted summary judgment:
[Plaintiffs] cannot meet their burden on this issue. They have not identified with any certainty the doctor who administered [the drug] to [the dcecedent]. The one physician who they have identified is deceased. There is no one who can testify as to the identity of the physician, whether any warning was received by him, whether such a warning was adequate, and whether an adequate warning would have changed the actions of the physician. [Plaintiffs] have the burden of proving inadequacy of warning and cause of the injury. Since they have produced no evidence in this regard, summary judgment must be granted on the theory of inadequate warnings.
953 F.2d 909, 911 (5th Cir. 1992). The Fifth Circuit affirmed for essentially the same reason:
Because [plaintiffs] bore the burden of proof at trial on the issues of adequacy of the warning and causation, [defendant] was not required to produce evidence negating the existence of a material fact; rather, [its] burden was only to point out the absence of evidence supporting the nonmoving party’s case. [Defendant] satisfied its burden.
Id. at 913 (citations and quotation marks omitted). See also A.B. vs. Ortho-McNeil-Janssen Pharmaceuticals, 2013 WL 2917651, at *28 (Pa. C.P. Philadelphia Co. April 5, 2013) (“although [the prescriber’s] lack of memory does not preclude the possibility he reviewed [defendant’s] work, his inability to testify to any article . . . cannot sustain Plaintiffs’ burden of proving causation”) (applying Texas law).
Two second circuit appeals in Zyprexa litigation make the same basic point. The party bearing the burden of proof (usually plaintiff) has to ask the right questions to the prescribing physician. “Because [plaintiff] would have the burden of establishing proximate cause at trial, his failure to offer any evidence that [the prescriber] was unaware that [the condition] was a risk associated with [the drug] when he prescribed it warranted granting summary judgment in favor of [defendant],” McClamrock v. Eli Lilly & Co., 504 F. Appx. 3, 3 (2d Cir. 2012) (applying North Carolina law). A plaintiff’s failure to depose the prescriber at all supports the same result:
[Plaintiff] elected not to depose [the prescriber], which precludes him from relying on speculation as to her knowledge. In sum, because [plaintiff] would have the burden of establishing proximate cause at trial, the absence of any record evidence that [the prescriber] was unaware of the risk . . . associated with [the drug] warrants granting summary judgment in favor of [defendant] under the learned intermediary doctrine.
Greaves v. Eli Lilly & Co., 503 F. Appx. 70, 72 (2d Cir. 2012) (applying Rhode Island law).
Speaking of Zyprexa, the trial judge reached the same conclusion under California law in a third case:
With respect to causation, California law requires the plaintiff to produce evidence that a different warning would have altered the prescribing physician's conduct. . . . It is the plaintiff’s burden to offer evidence supporting his claim. [Plaintiff] offered no evidence suggesting that his physicians would have altered their prescription decisions had [the drug’s] warning been different, as required under California’s learned intermediary doctrine. Fact discovery is now closed. [Plaintiff] has failed to support his claim.
In re Zyprexa Products Liability Litigation, 2009 WL 3596982, at *11 (E.D.N.Y. Oct. 20, 2009).
Pennsylvania is another fertile jurisdiction for warning causation dismissals based upon failure to elicit any testimony from prescribing physicians. Many of these opinions were won by members of this blogging team during fen-phen litigation in Philadelphia.
The mere fact that [plaintiff] failed to provide evidence from [the prescriber] provides no justification for a change or expansion of existing law. Any absence or death of a material witness in any litigation is a risk that falls upon the party who depends upon that witness to satisfy his burden, in this case [plaintiff’s] burden. Without some evidence that [the prescriber] would have changed his prescribing habits, there can be no issue to present to the jury.
Gronniger v. American Home Products Corp., 2005 WL 3766685, at *4 (Pa. C.P. Philadelphia Co. Oct. 21, 2005).
The burden to produce such an explanatory record falls on the Plaintiff . . ., who has the burden to prove causation which cannot be satisfied with mere assertions. Without evidence from [the prescriber], himself, that he would not have prescribed the [drug], [plaintiff] is unable to establish that [the defendant’s] failure to warn was the proximate cause of her injury. . . .
Contrary to [plaintiff’s] assertions, the affidavit of [an expert], attesting to what a “reasonable doctor” would have done had a different warning been supplied is insufficient evidence to create a material issue of fact and satisfy her burden on proximate causation. . . . [T]he evidence required to establish a reasonable likelihood is evidence that the learned intermediary, namely, [the prescriber], and only [the prescriber], would provide to the effect that he, [the prescriber], would have altered his behavior. Accordingly, an affidavit or testimony of [an expert] as to what a “reasonable doctor” would have done with appropriate knowledge is not admissible, is irrelevant and is contrary to the legal standard long established under Pennsylvania law.
Id. at *5 (citations omitted) (emphasis original). See Fripps v. Wyeth Pharmaceuticals, 2012 WL 1452556 (Pa. C.P. Philadelphia Co. April 19, 2012) (summary judgment granted; the “only doctor named who may or may not have prescribed” the drug “does not remember [plaintiff], nor the last time she treated her, nor why she was on [the drug] in the first place. Moreover, she cannot even recall prescribing it.”); Adams v. Wyeth, 74 Pa. D. & C.4th 500, 509 (Pa. C.P. Philadelphia Co. 2005) (plaintiff “failed to state a prima facie case”; plaintiff “offers absolutely no evidence, either testimonial or documentary, regarding [the prescriber’s] prescribing of [the drug] for her” and “merely assumes that [the prescriber] is dead, based on his age at the time he prescribed”);Leffler v. American Home Products Corp., 2005 WL 2999712, at *5 (Pa. C.P. Philadelphia Co. Oct. 20, 2005) (“The mere fact that for some unknown reason Plaintiff did not take the deposition of [the prescriber’], to preserve his testimony during his lifetime while the instant case was pending, provides no justification for a change or expansion of existing law”); Olsen v. Wyeth, Inc., 2005 WL 1528633, at *3 (Pa. C.P. Philadelphia Co. June 20, 2005) (“the court cannot presume proximate cause”; “plaintiff submitted no evidence to the jury from which they could find for the plaintiff on the issue of proximate causation”); Vega v. Wyeth, Inc., 2005 WL 1528663, at *4 (Pa. C.P. Philadelphia Co. June 20, 2005) (“Pennsylvania courts have stated that without evidence from the prescribing physician that he or she would not have prescribed the drugs, plaintiffs are unable to establish the required proximate causation between failure to warn and injury”); Anderson v. Wyeth, 2005 WL 1383174, at *6 (Pa. C.P. Philadelphia Co. June 7, 2005) (summary judgment granted; “[a]ny absence or death of a material witness in any litigation is a risk that falls upon the party who depends upon that witness to satisfy his burden, in this case the Plaintiffs’ burden”; prescriber died without being deposed).
South Carolina cases agree. In Sauls v. Wyeth Pharmaceuticals, 846 F. Supp.2d 499, 502-503 (D.S.C. 2012), the court held that the plaintiff bears the burden of proof, and if the prescriber dies before being deposed, the plaintiff loses as a result::
Defendants contend they are entitled to summary judgment because Plaintiff is unable to establish proximate causation. The court agrees. [The prescriber] is the only physician to have prescribed [the drug] to [plaintiff]. . . . [The prescriber], however, died four years after the commencement of this law suit, and neither his medical nor pharmaceutical records pertaining to [plaintiff] could be located. Significantly, [plaintiff] failed to preserve any testimony prior to [the prescriber’s] death. . . . [Plaintiff], therefore, is unable to proffer any admissible evidence showing what [the prescriber] would have done if Defendants’ . . . medications were accompanied by a different, purportedly adequate, warning. Numerous courts have concluded that a plaintiff fails to carry her burden in establishing proximate cause in the absence of any evidence demonstrating how an adequate warning would have altered a physician’s prescription decision.
Id. at 502-03 (citing several of the above cases). Accord Blyth v. GlaxoSmithKline LLC, 2010 WL 5676311 (Pa. C.P. Philadelphia Co. Dec. 14, 2010) (summary judgment granted; “it is the plaintiffs' burden to establish causation” but the prescriber “is unable to offer testimony in this case because he died . . . before this case was filed, and all of his medical records have been destroyed in the normal course of business”) (applying South Carolina law).
Minnesota law produces the same result. In Kapps v. Biosense Webster, Inc., 813 F. Supp. 2d 1128 (D. Minn. 2011), plaintiff failed to depose a critical prescriber – killing off a “Dear Doctor” letter-based warning claim:
[Plaintiff] did not depose [the prescriber], who was manipulating the [device] when [the accident happened]. [Plaintiff] thus has no evidence that a “Dear Doctor” letter warning [the prescriber] . . . would have prevented the [accident]. There is not a shred of evidence in the record that, had [the prescriber been warned . . ., he would have done anything differently
Id. at 1157. Thompson v. Zimmer Inc., 2013 WL 5406628, at *3-4 (D. Minn. Sept. 25, 2013), followed Kapps and also granted summary judgment where the plaintiff “chose not to depose” the prescriber at all. Id. at *3. Thus, “there was no evidence” what the prescriber might have done had he received a different warning. Id. at *3-4. “Simply put, there is no evidence from which a jury could conclude that a warning would have caused [the prescriber] to do anything differently,” and summary judgment was appropriate. Id. at *4.
Other states have similar rulings of one sort of another. In Rhodes v. Bayer Healthcare Pharmaceuticals, Inc., 2013 WL 1282450, 1 *4 (W.D. La. March 28, 2013), plaintiff’s counsel neglected to ask the prescriber the critical questions at his deposition, leading to summary judgment.
[T]he record contains no affirmative evidence that [plaintiff’s] treating physician would have changed his decision to prescribe. . . . Plaintiffs’ counsel never asked [the prescriber] during his deposition whether he would have changed his decision . . . if an allegedly different warning had been given. In fact, when asked if he had an opinion about whether the current [drug] warning was adequate, [the prescriber] simply responded that he could not “answer one way or the other.”
Plaintiffs bear the burden to show that a proper warning would have changed the decision of [the prescriber]. . . . [T]there is an utter lack of evidence with regard to this issue. Plaintiffs' warning claim is barred by the learned intermediary doctrine and summary judgment in favor of [defendant] is appropriate.
Id. at *3-4 (citations and quotation marks omitted). Summary judgment was granted under Colorado law in another failure-to-depose case in In re Trasylol Products Liability Litigation, 2013 WL 1192300, at *15 n.27 (S.D. Fla. March 22, 2013) (“Plaintiffs present no evidence whatsoever that the doctor who made the decision to use [the drug] . . . would not have made the decision . . . with a different warning”). In Brasher v. Sandoz Pharmaceuticals Corp., 2001 WL 36403362 (N.D. Ala. Sept. 21, 2001), the court granted summary judgment, noting that physician causation was too “tenuous” and “simply insufficient” when based solely “an ‘assumption’” about what the prescriber might have done, rather than on affirmative testimony. Id. at *14 n.23. Finally, plaintiffs were dismissed under New York and West Virginia law in In re NuvaRing Litigation, 2013 WL 1874321 (New Jersey Super. Law Div. April 18, 2013). See id. at *33 (“Plaintiffs Opposition provides only argument, no evidence, that Plaintiffs doctor . . . would have changed his decision to prescribe”; New York plaintiff); 36 (plaintiff “has not provided any evidence” and relied on a heeding presumption which West Virginia did not recognize).
We can’t say whether plaintiffs are cutting more corners recently or whether defendants have been making more convincing arguments based on the burden of proof in failure-of-proof cases. We can’t do anything about the first of these alternative explanations, but this post is our contribution to the second.