Photo of Bexis

There’s a reason why prescribing physicians and implanting surgeons are called “learned” intermediaries.  The law presumes that licensed doctors know what they are doing.  That means that prescribers can make risk/benefit analyses to determine what prescription drugs or medical devices their patients need.  As part of that process, such physicians necessarily also evaluate what risks they should tell – and not tell − their patients.

One consequence of a physician’s presumed medical competence is that a learned intermediary is within his/her rights to disregard a manufacturer’s warning altogether, to decide that a particular risk was not severe enough to make a difference, or to conclude that such a risk did not exist or was not material in the context of a particular patient’s medical needs.  In all of these situations, the prescriber’s independent evaluation of what risks to credit, which to ignore, and which to omit in counseling patients breaks the causal chain of , entitling a manufacturer defendant to judgment on a warning claim concerning such risks.  This scenario was the “third hypothetical” in our “Learned Intermediary Rule 201” post back in 2008.

Today we examine it in more detail.

These propositions were employed recently in Himes v. Somatics, LLC, 2022 WL 989469 (9th Cir. April 1, 2022) (the companion case to this).  The plaintiffs’ causation allegations foundered in Himes because the treating physician did not believe that the claimed risks of electroconvulsive therapy were all that big of a deal, and thus did not warn about it.

[The prescriber’s] testimony, however, does not establish that he would have altered his prescribing conduct.  On the contrary: (i) as to the risk of permanent memory loss, had [he] been told about the risk, he testified that it “wouldn’t stop” him from using [this product] because “[a]ll drugs and all things have memory loss,” (ii) as to the risk of inability to formulate new memories, [he] testified that it would be a “significant” concern but that he “would have to see it also [him]self” and that he is “not seeing that with [his] patients,” and (iii) as to the risk of brain injury, [he] testified that he would be reluctant to use [the treatment] if that were a risk but that he does not believe that this is an actual risk.”

Id. at *3 (emphasis original).  Given this testimony, the plaintiffs could not “show that stronger manufacturer warnings would have altered the physician’s prescribing conduct.”  Id.

Under the learned intermediary rule, “[t]he burden [is] on the plaintiff to demonstrate that the additional non-disclosed risk was sufficiently high that it would have” causally altered the plaintiff’s treatment.  Thomas v. Hoffman-LaRoche, Inc., 949 F.2d 806, 817 (5th Cir. 1992) (applying Mississippi law).  So we decided to look for learned intermediary rule cases where warning causation failed because, as in Himes, the prescriber was not impressed with the purported risk and thus would not have done anything differently, warning or no.  Here’s what we found.

An early case making this point is Dyer v. Best Pharmacal, 577 P.2d 1084 (Ariz. App. 1978), where a hypertensive patient was injured after being injected with the defendant’s drug – despite warnings that “expressly directed the doctor administering the drug to refrain from giving it to a patient with hypertension.”  Id. at 1088.

[W]e believe that a drug manufacturer cannot be required legally to foresee that a licensed physician will disregard express warnings regarding a drug’s use. . . .  Just as a drug manufacturer cannot be required to foresee a physician’s negligence, neither can it be required to foresee that a patient might mislead a physician about her physical condition in order to obtain a prescription drug.


Two other oldies but goodies are Plummer v. Lederle Laboratories, 819 F.2d 349 (2d Cir. 1987) (applying California law), and Stanback v. Parke, Davis & Co., 657 F.2d 642 (4th Cir. 1981) (applying Virginia law), both of which involved vaccines.  In Plummer, the prescribing physician “had a practice of failing to warn his patients of the risk” at issue.  The physician’s deliberate decision to refrain from warning broke the causal chain.  “[E]ven if the warnings had been stronger, a reasonable jury could not have concluded that [the prescriber] would have warned.”  Id. at 359.  In Stanback the prescriber had a similar practice of not warning of a “slight risk,” which led to the same result:

[The prescriber] averred that he had not found it necessary and did not make it his practice to advise patients about the risks associated with flu vaccinations.  Whatever may be said about [his] policies and decisions from the standpoint of the patient, it is clear that they precluded [the manufacturer’s] failure to warn from having any effect whatsoever on [plaintiff’s] injury.

657 F.2d at 645.

The newest reported appellate decision we’ve found on this issue is In re Taxotere (Docetaxel) Products Liability Litigation, 994 F.3d 704 (5th Cir. 2021) (applying Louisiana law).  That oncologists prescribing lifesaving standard-of-care treatment in the face of “aggressive cancer” are not impressed by a risk of – permanent hair loss – is not surprising.  Id. at 710. That “common and widely known side effect” of many “chemotherapy drugs,” id. at 709, had no effect on the prescribing decision:

[Other] treatments, however, were less efficacious and would not have reduced [plaintiff’s] risk of recurrence to the same degree as [this drug].  [Plaintiff] has not identified any testimony from [the prescriber] that . . . a warning of potentially permanent hair loss − as opposed to temporary hair loss − would have led [the prescriber] to prescribe [something else].

Id. at 710 (citation and quotation marks omitted).  Accord In re Taxotere (Docetaxel) Products Liability Litigation, 859 F. Appx. 692, 694 (5th Cir. 2021) (no causation where prescriber “testified unequivocally that she would have prescribed the drug regardless of any changes made to its warning label because it was such an effective treatment for the type of cancer from which [plaintiff] was suffering”) (applying Colorado law).

Another recent decision is Hubbard v. Bayer HealthCare Pharmaceuticals, Inc., 983 F.3d 1223 (11th Cir. 2020) (applying Georgia law).  Causation was defeated, in part, by the prescribing physician’s testimony that “he did not consider the information contained in the [updated] label to be significant enough to change his prescribing practices.”  Id. at 1233.  He “did not consider the additional information contained in the [updated] label to significantly add to his corpus of knowledge” so “failure to include this information in the previous . . . label could not have caused” plaintiff’s injuries.  Id. at 1235.

Our 2008 post discussed Ackermann v. Wyeth Pharmaceuticals, 526 F.3d 203 (5th Cir. 2008) (applying Texas law), where the prescribing psychologist did not discuss risk of suicide with clinically depressed patients that did not seem to be suicidal.

[H]e testified that he would not have warned [the decedent] about the possibility of an increased risk of suicide primarily based on his belief that the suggestion would either plant seeds in the patient’s mind that suicide was an option or would discourage the patient from pursuing pharmacological treatment. . . .  Other than some possible future legal requirement mandating that he tell patients about potential increased risk for suicide, [the prescriber] stated that he would continue his normal practice of balancing the risks and benefits of the drug with the treatment needs of the patient when deciding what to disclose to patients.

Id. at 210-11.  That conscious decision precluded any warning inadequacies from being causal.  “[N]o genuine issue of material fact exists regarding whether the inadequacy of the warning was a producing cause of [the decedent’s] death.”  Id. at 212.  See also Rodriguez v. Stryker Co., 680 F.3d 568, 576-77 (6th Cir. 2012) (no proof that hypothetical “Dear Doctor letter” or on-product warning would have causal effect given that risk had arisen only once in implanter’s several thousand similar surgeries) (applying Tennessee law); Eck v. Parke, Davis & Co., 256 F.3d 1013, 1021 (10th Cir. 2001) (no warning causation notwithstanding heeding presumption where prescriber testified that “the risk of him having a problem due to his [condition] was much greater than him taking the [drug]”) (applying Oklahoma law); Porterfield v. Ethicon, Inc., 183 F.3d 464, 468 (5th Cir. 1999) (no warning causation where implanter “testified that the use of [device] outweighed the possible risks because without the [device], the likelihood of successful[ surgery] would have been diminished”) (applying Texas law); McCalla v. Warner-Lambert, 1995 WL 762988, at *1, 99 F.3d 402 (table) (2d Cir. Dec. 27, 1995) (no causation where prescriber “had read the warning,” but “did not advise [plaintiff] of this risk” because other risks were “much greater than the ‘between one and ten in a million’ risk of” plaintiff’s injury) (applying New York law).

The Supreme Court of Washington reached similar result in Terhune v. A.H. Robins Co., 577 P.2d 975 (Wash. 1978), where the implanting surgeon also chose not to warn the plaintiff of the relevant risk:

[Plaintiffs’] argument overlooks the fact that the decision to give the brochure to the plaintiffs was made by the doctor.  He was fully aware of the danger . . . and yet did not see fit, at least according to the plaintiffs’ testimony, to advise them of it.  We must assume that the decision not to give this advice was the result of the exercise of judgment on the physician’s part, just as would be a decision not to warn a patient of the possible side effects of any given drug.

Id. at 979.  Accord Wyeth Laboratories, Inc. v. Fortenberry, 530 So.2d 688, 691 (Miss. 1988) (no causation where prescriber “read the warning on the package insert and decided not to warn the [plaintiffs]”); Dunn v. Lederle Laboratories, 328 N.W.2d 576, 583-84 (Mich. App. 1983) (no causation where “[t]he doctor testified that, knowing the low incidence . . ., he chose not to warn [plaintiff] and that this was the customary practice in the profession”) (emphasis original).

A New Jersey appellate court ended up at the same place, holding that a drug prescriber’s testimony that the claimed risk wasn’t that big a deal justified summary judgment on causation grounds:

Despite the efforts of plaintiffs’ counsel to equate [this risk] with a serious, permanent condition about which [the prescriber] was obligated to warn and would have warned [plaintiff], the doctor’s final answers to this line of questioning repeated his earlier testimony that [the risk] was such a rare occurrence that he did not believe it was necessary to warn the patient about its potential occurrence. . . .  

[The prescriber] testified that 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 with [plaintiff’s condition] who had tried other medications would benefit greatly by its use.

Gaghan v. Hoffman-La Roche, Inc., 2014 WL 3798338 at *17 (N.J. Super. App. Div. Aug. 4, 2014) (applying California law).  “In sum, the evidence was not sufficient for the jury to conclude that [defendant’s] allegedly inadequate warnings were the proximate cause” of plaintiff’s claimed injuries.  Id.  See In re Accutane Litigation, 2016 WL 5958375, at *19, *27, 33, *47-48 (N.J. Super. Law Div. Oct. 12, 2016) (no causation where prescribers “d[id] not think that [the drug] causes [plaintiff’s claimed injury]”; “felt the drug was ‘appropriate’ for Plaintiff because ‘she was resistant to other treatments’”; thought the risk was largely “hubbub”; “would ‘most likely not’ discuss it with his patient because he only discussed common risks,” or did “not believe there is a real association between” the drug and the claimed risk) (applying Georgia, Missouri, New Jersey, and New York law); In re Accutane Litigation, 2016 WL 355843 at *7-8 (N.J. Super. Law Div. Jan. 29, 2016) (no causation where the prescriber “did not, and does not, view the [claimed] risk as a probable result of [the drug] that needs to be discussed with patients”).

An objective way of reaching the same result in the absence of prescriber testimony is to compare relative risks.  In Willett v. Baxter International, Inc., 929 F.2d 1094, 1099 (5th Cir. 1991) (applying Louisiana law), the claimed risk of product failure “was less than 0.03 percent per annum.”  Id. at 1099.  Comparatively, “[t]he mortality risk of the operation was roughly five percent, and the post-operative risk of mortality from other factors was four percent per annum.”  Id.  Willett held that minuscule unwarned-of risk “insufficient to establish that the allegedly inadequate warning was a factual cause” of plaintiff’s claimed injuries.  Id.  Accord Graham v. American Cyanamid Co., 350 F.3d 496, 514 (6th Cir. 2003) (risk differences between two types of vaccines held insufficient to justify a warning that one was “preferred”); Thomas, 949 F.2d at 817 (as a matter of law a “possibility of rare seizures . . . is too remote to create a genuine issue of fact with respect to warning causation”) (footnote omitted).

The Ninth Circuit rejected a similar plaintiff argument in the context of adequacy rather than causation in Adams v. Synthes Spine Co., 298 F.3d 1114 (9th Cir. 2002).  Plaintiff claimed that the warning had to be inadequate because “no one follows it.”  Id. at 1118.  Adams disagreed, given the implanting surgeon’s “understanding was that the device shouldn’t be removed, even though the manufacturer said it should be.”  Id.

That the surgeons usually did not remove the device does not show that they didn’t understand the warning, just that they generally didn’t agree with the recommendation. . . .  [T]he risk of the surgery to remove the plate exceeded the risk of leaving it in, because in most cases it wouldn’t break.  A second surgery could safely be left for the rare cases when it broke. . . .  That physicians didn’t follow the recommendation doesn’t show that they couldn’t or didn’t read it and understand it, just that in their medical judgment, it wasn’t wise to follow it.

Id.  That the medical community had concluded, contrary to the defendant’s warning, that “one surgery is better than two,” id. at 1119, could just as easily have been a warning causation rather than a warning adequacy argument – but in any event Adams affirmed summary judgment.

A raft of federal district courts have reached similar results.  In Rouviere v. DePuy Orthopaedics, Inc., 560 F. Supp.3d 774 (S.D.N.Y. 2021), reconsideration denied, 2021 WL 5854283 (S.D.N.Y. Dec. 9, 2021), there was “simply no evidence that a warning − if it had been given − would have been so material or important that [the implanter] would have heeded it or would have done something different.”  Id. at 800.  In In re Plavix Marketing, Sales Practices & Products Liability Litigation, 2017 WL 4838842 at *6-7 (D.N.J. Oct. 26, 2017) (applying California law), summary judgment was proper because the prescribers testified that the claimed product risks were too trivial to have mattered:

[B]oth [prescribers] testified . . . that even considering the bleeding risks and the additional warnings, they would have prescribed [the drug] to Plaintiff in light of various medical factors in connection with Plaintiff’s condition, particularly the fact that Plaintiff might have been intolerant of [an alternative treatment].

Id. at *7.  Because the “additional information” offered by plaintiff would “not [] have any impact on [the prescriber’s] decision to prescribe,” the plaintiff “fail[ed] to raise a genuine issue of material fact on causation.”  Id. at *9.

Summary judgment resulted in Smith v. Johnson & Johnson, 2011 WL 3876997 at *11 (S.D. Miss. Aug. 31, 2011), aff’d, 483 Fed. Appx. 909 (5th Cir. 2012), where the implanting surgeon discounted an allegedly misleading warning.  “[The implanter] testified that he remembered seeing the above statement in the “Adverse Reactions” section . . . and that he did not agree with it, explaining that he knew of adverse events.”  Id. at *11.  Being “aware of what he considered a stronger warning,” the implanter nonetheless stated that the defendant’s product “was in his opinion the best option.”  Id. at *12.

Warning causation likewise failed as a matter of law in Motus v. Pfizer, Inc., 196 F. Supp.2d 984, 995-96 (C.D. Cal. 2001), aff’d, 358 F.3d 659 (9th Cir. 2004) (another case we discussed in 2008), because the plaintiff failed to “produce[] evidence that the risk . . . associated with [the drug] is so high that it would have affected [the prescriber’s] (or any reasonable physician’s) decision to prescribe [the drug] to a [similarly situated] patient.”  Id. at 995 (footnote omitted).  After reviewing the plaintiff’s expert’s opinions, the prescriber in Miller v. Pfizer, Inc., 196 F. Supp.2d 1095, 1129 & n.107 (D. Kan. 2002), aff’d, 356 F.3d 1326 (10th Cir. 2004), denied “any clinically significant risk that would have affected his treatment” and “would have prescribed [the drug] because it was his medical judgment that it was in [the decedent’s best interest.”  Id. at 1129 n.107.  This testimony rebutted a heeding presumption and supported summary judgment.  Id. at 1128-29.

The prescriber in Colville v. Pharmacia & Upjohn Co., 565 F. Supp.2d 1314 (N.D. Fla. 2008) (also discussed in our 2008 post), made the decision “not [to] discuss this particular risk factor with her patients,” and continued that practice “even after [a] black box warning was added.”  Id. at 1322.  The doctor’s independent decision not to warn proved that “any inadequacy in the drug warning could not have been the proximate cause of the injury . . . [b]ecause [the prescriber] was aware of the risk factor and did not have a specific conversation with [plaintiff] about it.”  Id.

In Pumphrey v. C.R. Bard, Inc., 906 F. Supp. 334, 339 (N.D.W. Va. 1995), an “early [device] removal” warning could not have been causal where prescriber “made a considered judgment to leave the [device] in place for possible future” use.  Similar prescriber testimony supported a defense verdict in Cirba v. Janssen Pharmaceuticals, Inc., 2015 WL 4081909 (Pa. C.P. June 30, 2015):

[T]he testimony was relevant . . . as evidence concerning the risk/benefit analysis performed by one of [plaintiff’s] prescribers.  It was proper for her to testify that, based on her knowledge of the risks involved with the drug, she would have prescribed it to [plaintiff] in any event.

Id. at *3.  See Allain v. Wyeth Pharmaceuticals, Inc., 2018 WL 1071290, at *3 (N.D. Ala. Feb. 27, 2018) (purported off-label promotion non-causal where the prescriber “used his own medical judgment to determine that the potential benefits of [the drug] outweighed its risks”); Higgins v. Forest Laboratories, 48 F. Supp.3d 878, 891 (W.D. Va. 2014) (no causation where prescriber’s “clinical stance was that many more lives were saved by the [drugs] and their appropriate use than were lost”; prescriber believed “the overall benefit was massively on the side of using the” drugs) (applying Virginia law); Canady v. Ortho-McNeil Pharmaceutical, Inc., 2014 WL 4930675, at *3 (N.D. Ohio Oct. 1, 2014) (no causation where prescriber “knew of the risks associated with [the drug], yet felt the benefits outweighed the risk”) (applying Oregon law); Schmitt-Doss v. American Regent, Inc., 2014 WL 3853184, at *13 (W.D. Va. Aug. 5, 2014) (no causation where prescriber “had not witnessed his patients experiencing any negative side effects” during many years of use, which “led him to avoid warning patients”), aff’d, 599 F. Appx. 71 (4th Cir. 2015) (affirming “for the reasons stated by the district court”) (applying Virginia law); Brown v. Roche Laboratories, Inc., 2013 WL 2457950, at *8 (N.D. Ga. June 6, 2013) (no causation where the prescriber “believed that any risk associated with the drug was heavily outweighed by the benefits of treating what he suspected was . . . a potentially fatal condition”), aff’d, 567 F. Appx. 860 (11th Cir. 2014); In re Trasylol Products Liability Litigation, 2013 WL 1080552 at *12 (S.D. Fla. March 14, 2013) (no causation where prescriber “weighed the risks versus benefits of using the drug, and he decided that the potential benefits in [plaintiff’s] case outweighed the risks”) (applying Oklahoma law); In re Trasylol Products Liability Litigation, 2011 WL 2586218 at *4-5 (S.D. Fla. June 22, 2011) (no causation where prescriber “did not . . . believe that [the drug] had more than a slightly increased risk,” viewed plaintiff’s studies “with a grain of salt,” and “determin[ed] that [the drug’s] benefits outweighed its risks under the particular circumstances of [plaintiff’s] case”) (applying New Mexico law); In re Zyprexa Products Liability Litigation, 2009 WL 3596526 at *13 (E.D.N.Y. Oct. 16, 2009) (no causation where prescriber viewed the claimed risk as “medically insignificant”) (applying Louisiana law); In re Baycol Products Litigation, 2008 WL 6155700, at *10 (D. Minn. Sept. 22, 2008) (no causation where prescriber believed the risk was common to “all” of a class of drugs and prescribed “based on a risk-benefit analysis, finding in Plaintiff’s case, that the benefits outweighed the risks”) (applying California law); Madsen v. American Home Products Corp., 477 F.Supp.2d 1025, 1036 (E.D. Mo. 2007) (no causation where prescriber “questioned the relative risks of the adverse effects” versus the plaintiff’s condition and “continued to prescribe the . . . drugs after he obtained knowledge about the increased risk”); Ames v. Apothecon, Inc., 431 F. Supp. 2d 566, 568, 573 (D. Md. 2006) (no causation where prescriber testified that, “despite [plaintiff’s] adverse reaction, he increasingly prescribes [the drug] because it is more successful in treating resistant strains of bacteria than many other antibiotics”); Baraukas v. Danek Medical, Inc., 2000 WL 223508 at *4 (M.D.N.C. Jan. 13, 2000) (no causation where the implanting surgeon “formed an independent opinion of the efficacy of the . . . device and passed that opinion on to [plaintiff]”) (applying North Carolina law); In re Accutane Litigation, 2016 WL 5958375, at *27 (N.J. Super. Law Div. Oct. 12, 2016) (no causation where prescriber “made a conscious decision not to warn of [the risk] with no indication that the proposed warning would have changed that decision”) (applying Missouri and New Jersey law); Fripps v. Wyeth Pharmaceuticals, 2012 WL 1452556, at *?? (Pa. C.P. April 19, 2012) (no causation where physician “testified she believed she was merely refilling a prescription initiated by someone else and, thus, would never have conveyed any risks” to plaintiff); Owens v. Wyeth, 2009 WL 3244890, at *?? (Pa. C.P. Aug. 17, 2009) (no causation where prescriber “testified that the risk . . . was outweighed by the benefits, because given [plaintiff’s] weight at the time, [plaintiff] was . . . at risk for developing potentially fatal, obesity-related illnesses”), aff’d mem., 6 A.3d 572 (Pa. Super. 2010), vacated on other grounds, 88 A.3d 954 (Pa. 2014) (non-warning claim only); Cochran v. Wyeth, Inc., 2009 WL 6411752, at *?? (Pa. C.P. July 15, 2009) (no causation where the prescriber considered the risk “a very rare incidence rate”); Lineberger v. Wyeth, 72 Pa. D. & C.4th 35, 43-44 (Pa. C.P. 2005) (no causation where prescriber “testified that he selected . . . people who were very unlikely” to experience the relevant risk and thus “didn’t think it was a material risk for these patients”), aff’d, 894 A.2d 141 (Pa. Super. 2006).

A similar no-causation situation arose in Alston v. Caraco Pharmaceuticals, Inc., 670 F. Supp.2d 279 (S.D.N.Y. 2009), where the defendant’s “physicians knew that [the drug] could cause addiction, yet continued to prescribe [it] to treat Plaintiff’s . . . pain.”  Id. at 285.  Where the prescribers did “not alter their conduct, despite being apprised of the possible risks . . . a more stringent warning would have had no practical effect on the physicians’ actions.”  Id.  “Plaintiff has not shown that a failure to warn . . . was the proximate cause of his injuries, as his physicians were aware of the risks . . . and exercised their own clinical judgment in deciding to continue to prescribe.”  Id. at 286.

Indeed, even an alleged failure to warn about a serious risk can be noncausal where the prescriber had no better treatment options:

[O]ther evidence in the record shows that [when the drug was prescribed], Plaintiff did not have other . . . medication options that would have worked. . . .  Plaintiffs’ treating physician during her hospitalizations, testified that no other . . . medications available [then] were viable options to treat [plaintiff]. . . .  I currently can’t think of another medication that was widely used. . . .”

Swanson v. Abbott Laboratories, 2017 WL 5903362, at *10 (S.D. Ohio Nov. 28, 2017).  The prescriber ruled out the only possible alternative because it was “associated with side effects that I think potentially are more problematic than what typically might occur with [the drug at issue].”  Id.  Accord Mattson v. Bristol-Meyers Squibb Co., 2013 WL 1758647, at *5 (D.N.J. April 22, 2013) (prescriber “insisted that despite the risks, it was important that these drugs were prescribed to Plaintiff to prevent further complications”; “because the medical benefits for Plaintiff’s condition outweighed the risks, the doctor was confident that the treatment he had provided for Plaintiff was medically necessary and appropriate”) (applying California law); In re Alloderm® Litigation, 2015 WL 5022613, at *6 (N.J. Super. Law Div. Aug. 14, 2015) (no causation given prescriber’s “medical judgment that the use of a [plaintiff’s alternative product] was not a viable option for” plaintiff; the prescriber “would not have used another product regardless of [any] warning”).

Such situations occurred repeatedly in the Zyprexa MDL.  In In re Zyprexa Products Liability Litigation, 649 F. Supp.2d 18 (E.D.N.Y. 2009) (applying Arizona law):

The factual record requires a finding that, given the serious psychiatric problems manifested by [plaintiff], his favorable response to [the drug], and the ineffectiveness of a number of other medications, his doctors exercised their professional judgment to prescribe this drug.

Id. at 33.  With “no indication that an alternative warning would have had any impact on plaintiff’s . . . medical treatment,” any “failure to warn cannot be shown to be a causal factor.”  Id.  “[I]n light of the fact” that the drug “in contrast to other medications − effectively controlled the symptoms of [plaintiff’s] serious . . . condition,” the Second Circuit affirmed summary judgment.  Head v. Eli Lilly & Co., 394 F. Appx. 819, 821 (2d Cir. 2010) (no “evidence that [plaintiff’s prescribers] would have altered their decision”).  See In re Zyprexa Products Liability Litigation, 653 F. Supp. 2d 181, 184 (E.D.N.Y. 2009) (no causation even if prescriber unaware of risk since drug was “an appropriate prescription choice,” plaintiff was “in crisis,” the drug “provide[d plaintiff] substantial benefit”) (applying Arkansas law); In re Zyprexa Products Liability Litigation, 2009 WL 5062109, at *15 (E.D.N.Y. Dec. 10, 2009) (drug prescribed after “alternative medications did not alleviate [plaintiff’s] symptoms, and [plaintiff’s] health deteriorated”), aff’d, 394 F. Appx. 817 (2d Cir. 2010) (applying Arizona law); In re Zyprexa Products Liability Litigation, 2009 WL 2487305, at *14 (E.D.N.Y. July 27, 2009) (no causation where “use [of the drug] was maintained even after [the risk manifested] because of its substantial benefits to the patient”) (applying Virginia law); In re Zyprexa Products Liability Litigation, 2009 WL 1850970 at *15 (E.D.N.Y. June 22, 2009) (no causation where plaintiff was unable to tolerate the other [alternative drugs], and he had such a great clinical response to [this drug]”; nonprescription “could have put the plaintiff at risk to himself and those around him”), reconsideration denied, 2009 WL 2160999 (E.D.N.Y. July 8, 2009) (applying California law); In re Zyprexa Products Liability Litigation, 2009 WL 1851062, at *14 (E.D.N.Y. June 22, 2009) (no causation where “plaintiff’s prescribing physician and other health care providers made the decision to order and maintain [the drug] treatment for a patient who faced debilitating and dangerous psychiatric problems that several other drugs had failed to manage,” and “the decision was made . . . to continue use of this drug that had a considerable and positive impact on [plaintiff’s] psychiatric stability and well being”) (applying Missouri law); In re Zyprexa Products Liability Litigation, 2009 WL 1404978 at *14 (E.D.N.Y. May 15, 2009) (drug was “one of a series” of alternatives tried; prescriber “chose to prescribe it in hopes of managing [plaintiff’s] substantial medical challenges”), aff’d, 396 Fed. Appx. 715 (2d Cir. 2010) (applying Pennsylvania law).

Thus, a prescriber’s/implanter’s deposition testimony that s/he does not believe that the relevant product risk:  (1) existed at all; (2) was serious enough to justify including it in the informed consent discussion; or (3) was serious enough to require different treatment, given the plaintiff’s medical condition – under the precedent we’ve discussed, provides good grounds for summary judgment, because such testimony is one way to defeat the causation element of the plaintiff’s claim under the learned intermediary rule.

It’s no surprise that we love – and plaintiffs hate – the learned intermediary rule.