We’ve made no secret of our distaste for the so called “heeding presumption” – that juries may presume that any alternative “adequate” warning would have been heeded by the plaintiff (or, in prescription medical product cases, the prescriber). We have a topic header on this subject with multiple posts decrying such presumptions, both generally and in the particular context of prescription medical products.
The biggest conceptual problem is that there are two fundamentally different kinds of warnings. Most warnings concern a product’s use – that if you use (or don’t use) the product in a certain way, you are likely to get hurt; and if you follow the warning, you won’t. Examples are not driving a riding lawnmower parallel to a slope (because you’ll tip over) or only handling asbestos while using a respirator (because breathing asbestos can do nasty things to you). Most step-by-step directions also fall in this category.
While so-called “use” warnings occasionally arise as to prescription medical products – overdose instructions come to mind – that type of warning is not what most litigation involving these products is about. Rather, with prescription-only products, most of the relevant risks arise whenever the product is used. A warning about an inherent risk – a so-called “risk warning” – serves an entirely different purpose.
With inherent risks, people are warned so they can decide whether that risk outweighs the benefits that might be gained from using the product. The only way to avoid the risk is not to use the product at all. All prescription medical products have inherent risks – which is why the FDA requires a physician’s prescription in the first place. For a case discussing the distinctions between these two types of warnings in detail, read Thomas v. Hoffman-LaRoche, Inc., 949 F.2d 806, 814 (5th Cir. 1992) (applying Mississippi law), which you can find later in this post.
What happens when a heeding presumption is imposed concerning a risk warning? In that situation, “heeding” the warning can only mean not using the product at all, because that’s the only way to avoid the risk. So applying a “heeding presumption” to an inherent risk lets plaintiffs argue, in effect, that the product should never have been sold – that every “reasonable” person would have “heeded” an adequate warning and not used it. But we know that’s simply not true. For example, millions still smoke cigarettes, although those risks have been public knowledge for decades. Millions more use drugs and medical devices even though they carry the FDA’s strongest “black box” warnings. A “heeding presumption” in this situation is contrary to fact and to common sense. For that reason, some courts treat the heeding presumption in prescription medical product cases as meaning only that the prescribing physician would have factored the additional information in an “adequate” warning into his or her decisionmaking calculus. E.g., Eck v. Parke, Davis & Co., 256 F.3d 1013, 1021 (10th Cir. 2001) (wrong to “construe [a treater’s] ‘heeding’ an adequate warning to mean [s/he] would have given the warning”) (applying Oklahoma law); In re Diet Drug Litigation, 895 A.2d 480, 490-91 (N.J. Super. Law Div. 2005).
Heeding presumptions are something that exists in some states (Massachusetts, Missouri, Oklahoma), doesn’t in others (California, Connecticut, Alabama), and is limited in still others (New, Jersey, Pennsylvania, Texas). A reader recently suggested (we apologize, we seem to have lost that email) that we do a 50-state survey of where the various states stand on this subject – along the lines of the post we did in 2008 on informal interviews with treating physicians.
We thought that was a good idea, although it took us more time than we had hoped to put this together. So what follows is our best interpretation of the position of the fifty states (plus DC and Puerto Rico) on whether any presumption arises when a plaintiff claims an inadequate warning (almost every case) that a hypothetical warning (never in fact given) would have been heeded.
One thing we have discovered of particular note (at least to us), is that the heeding presumption is an area where the federal courts have run amok, ignoring their obligations under the Erie Doctrine to leave major expansions of state-law liability – flipping the burden of proof in warning cases certainly qualifies – to state courts. By our count, federal judges have trampled over state sovereignty with respect to the heeding presumption in no fewer than eleven states – Alaska, Colorado (despite contrary state-court authority), Georgia, Hawaii, Illinois, Iowa, Kentucky, Maine, New York (despite contrary state-court authority), South Dakota, and Wyoming.
Finally, because various states have taken quite different approaches to whether a heeding presumption exists at all and if so how it is applied, careful counsel will want to consider in appropriate circumstances the application of choice of law principles to such presumptions. See Restatement (Second) of Torts §134 & comment b (1970).
Restatement of Torts
The heeding presumption is derived from language in Restatement (Second) of Torts §402A, comment j (1965) that dealt with the opposite situation − presuming that an adequate warning, when given, will be read and heeded. “Where warning is given, the seller may reasonably assume that it will be read and heeded.” Id. That helped defendants, but not much, in warning claims since when warnings are adequate, defendants win anyway. It was actually more directed to the effect of warnings on design defect claims than on warning claims themselves. Courts wasted no time, however, in turning that presumption on its head, and creating something that the Restatement’s drafters had never contemplated, a presumption that whenever a warning was inadequate, any adequate alternative offered by the plaintiff would have been read and heeded. This helped plaintiffs a lot, since it effectively eliminated their burden of proving causation.
When the Restatement (Third) of Torts, Products Liability §2 (1998) superseded §402A, however, no such presumption was recognized at all in any context. Quite the contrary, Third Restatement’s drafters criticized comment j’s presumption language as “unfortunate” and stated that it shouldn’t be followed. See Restatement (Third) of Torts, Products Liability §2, reporters notes to comment l (1998). To the extent that a particular jurisdiction that previously permitted a heeding presumption with reference to Restatement §402A, comment j has subsequently adopted the Third Restatement, it can be argued that the heeding presumption has been/should be abolished.
There is no heeding presumption in Alabama. A “failure-to-warn-adequately case should not be submitted to the jury unless there is substantial evidence that an adequate warning would have been read and heeded and would have prevented the accident.” Deere & Co. v. Grose, 586 So. 2d 196, 198 (Ala. 1991). Accord Gurley v. American Honda Motor Co., 505 So.2d 358, 361 (Ala. 1987) (cited in Deere). See Barnhill v. Teva Pharmaceuticals USA, Inc., 819 F. Supp.2d 1254, 1262 (S.D. Ala. 2011) (“Alabama courts have not recognized such a [heeding] presumption”) (citing Deere).
In an nonprecedential, memorandum opinion, the Ninth Circuit predicted that the Alaska Supreme Court would adopt the heeding presumption because of that court’s history of following Restatement comments generally. Ellis v. Coleman Co., 2000 WL 1131893, at *2 (9th Cir. 2000) (in table at 232 F.3d 894). Ellis is non-citable under Ninth Circuit rules, and since then no Alaska court has followed it.
Arizona’s intermediate appellate courts have recognized a heeding presumption in strict liability warning cases. Golonka v. General Motors Corp., 65 P.3d 956, 968-69 (Ariz. App. 2003); Dole Food Co. v. N. Carolina Foam Industries, Inc., 935 P.2d 876, 883, (Ariz. App. 1996). The Arizona Supreme Court has expressly declined to rule on this issue. Gosewisch v. American Honda Motor Co., 737 P.2d 376, 380 (Ariz. 1987) (superseded by statute on other grounds).
“The court determines whether the manufacturer has rebutted the presumption and, if so, the presumption is destroyed, the existence or non-existence of the presumed fact must be determined as if the presumption had never operated in the case, and the jury is never told of the presumption.” Golonka, 65 P.3d at 971-72 (citations and quotation marks omitted). In prescription medical product cases, physician testimony has often destroyed the presumption. King-Washington v. Eli Lilly & Co., 394 F. Appx. 827, 829 n.2 (2d Cir. 2010); Head v. Eli Lilly & Co., 394 F. App’x 819, 820-21 (2d Cir. 2010) (applying Arizona law); Gove v. Eli Lilly & Co., 394 F. Appx. 817, 818 (2d Cir. 2010) (applying Arizona law); D’Agnese v. Novartis Pharmaceuticals Corp., 952 F. Supp.2d 880, 892-93 (D. Ariz. 2013); Carter v. APP Pharmaceuticals, LLC, 2013 WL 5532767, at *7-8 (D. Ariz. Aug. 13, 2013); Gebhardt v. Mentor Corp., 191 F.R.D. 180, 184-85 (D. Ariz. 1999), aff’d, 15 F. Appx. 540 (9th Cir. 2001).
Arkansas recognizes a heeding presumption. Bushong v. Garman Co., 843 S.W.2d 807, 811 (Ark. 1992). “This presumption may be rebutted by evidence which persuades the trier of fact that an adequate warning or instruction would have been futile under the circumstances.” Id. This presumption was applied to pharmaceutical cases in In re Prempro Products Liability Litigation, 586 F.3d 547, 569 (8th Cir. 2009) (applying Arkansas law). Most presumptions in Arkansas “disappear” once “the opponent does offer evidence to the contrary.” Orient Insurance Co. v. Cox, 238 S.W.2d 757, 763 (Ark. 1951). This rule has not been applied, either way, to the heeding presumption in Arkansas as far as we can tell.
California does not recognize any heeding presumption. Corbo v. Taylor-Dunn Manufacturing Co., 2014 WL 576268 (Cal. App. Feb. 14, 2014) (unpublished/noncitable); Huitt v. Southern California Gas Co., 116 Cal. Rptr.3d 453, 467-68 (Cal. App. 2010); Johnson v. Johnson & Johnson, 2010 WL 4108429, at *13 (Cal. App. Oct. 20, 2010) (presumption argument “borders on frivolous”) (unpublished/noncitable). The leading prescription medical product case on point is Motus v. Pfizer Inc., 196 F. Supp.2d 984 (C.D. Cal. 2001), aff’d, 358 F.3d 659 (9th Cir. 2004):
Plaintiff has cited no California case using comment j to shift either the burden of proof as to causation or the burden of going forward to a defendant in a failure-to-warn case. Moreover, even if California had adopted the rebuttable presumption in failure-to-warn cases generally, California courts would not necessarily apply that presumption in the prescription drug context, which raises distinct policy concerns.
Id. at 992. See Id. at 994-95 (“Given that other no other court applying California law in this context has adopted the presumption, and several courts have failed to do so when the presumption could have been critical, this Court will not apply it here”). Accord Lord v. Sigueiros, 2006 WL 1510408, at *3-4 (Cal. Super. April 26, 2006), aff’d, 2007 WL 4418019, at *2-3 (Cal. App. Dec. 19, 2007) (unpublished/noncitable); Tucker v. Wright Medical Technology, Inc., 2013 WL 1149717, at *15-16 (N.D. Cal. March 19, 2013); Latiolais v. Merck & Co., 2007 WL 5861354, at *4 (C.D. Cal. Feb. 6, 2007), aff’d, 302 F. Appx. 756 (9th Cir. 2008).
Several prescription medical product cases in other jurisdictions have similarly applied California law and recognized the state’s rejection of the heeding presumption. Mattson v. Bristol-Meyers Squibb Co., 2013 WL 1758647, at *4 n.9 (D.N.J. Apr. 22, 2013) (applying California law); In re Aredia & Zometa Products Liability Litigation, 2009 WL 2497692, at *2 (M.D. Tenn. Aug. 13, 2009) (applying California law); Tamraz v. BOC Group, Inc., 2008 WL 2796726, at *3 (N.D. Ohio July 18, 2008) (applying California law); Nix v. SmithKline Beecham Corp., 2007 WL 2526402, at *2 (D. Ariz. Sept. 5, 2007) (applying California law).
A Colorado appellate court rejected a general heeding presumption in Potthoff v. Alms, 583 P.2d 309, 311 (Colo. App. 1978), and although Colorado courts have applied the comment j presumption as written, they have yet to apply any “converse” heeding presumption to help plaintiffs. None of that, however stopped the Tenth Circuit from stating (in dictum; the case wasn’t about a plaintiff’s heeding a warning) that such a presumption existed in Colorado in Staley v. Bridgestone/Firestone, Inc., 106 F.3d 1504, 1509 (10th Cir. 1997). Applying Colorado law in a prescription medical product case, the court in In re NuvaRing Litigation, 2013 WL 1874321 (N.J. Super. Law Div. April 18, 2013), held that “[n]o heeding presumption exists to temporarily shift the burden to Defendants.” Id. at *26.
There is no heeding presumption in Connecticut. As discussed in DeJesus v. Craftsman Machine Co., 548 A.2d 736 (Conn. App. 1988), a statute, C.G.S. §52-572q(c), “specifically places upon [plaintiff] the burden of proving proximate cause.” 548 A.2d at 744. The statute states,” “the claimant shall prove by a fair preponderance of the evidence that if adequate warnings or instructions had been provided, the claimant would not have suffered the harm.”
Since Delaware never adopted strict liability or Restatement (Second) of Torts §402A (1965), no heeding presumption has been recognized under Delaware law.
District of Columbia
The District of Columbia adopted a heeding presumption in Payne v. Soft Sheen Products, Inc., 486 A.2d 712, 725 (D.C. 1985); see also East Penn Manufacturing Co. v. Pineda, 578 A.2d 1113, 1125 (D.C. 1990).
The presumption, when applied to prescription medical products, has usually been held rebutted by prescriber testimony. Mampe v. Ayerst Laboratories, 548 A.2d 798, 802 (D.C. 1988); Dyson v. Pharmacia & Upjohn, Inc., 129 F. Supp.2d 19, 21 (D.D.C. 2001), aff’d, 21 F. Appx. 2 (D.C. Cir. 2001).
Oddly, given the size of the state, we found nothing discussing the heeding presumption in any product liability case under Florida law. The only state court case even approximating the rule was Sta-Rite Industries, Inc. v. Levey, 909 So. 2d 901 (Fla. App. 2004), which in a factual discussion stated “it must be assumed that a sufficiently emphatic warning would have made the difference.” Id. at 906. Levey mentioned neither “heeding” nor a “presumption,” and discussed no case law that did.
In prescription medical product cases, the warning causation discussion in Christopher v. Cutter Laboratories, 53 F.3d 1184, 1192-93 (11th Cir. 1995) (applying Florida law), suggests that no such presumption applies, at least in the context of prescription medical products. So do a couple of Fosamax cases. See In re Fosamax Products Liability Litigation, 688 F. Supp.2d 259, 265 (S.D.N.Y. 2010) (listing Florida as among the “states where Plaintiff has the burden of production on this aspect of causation”); In re Fosamax Products Liability Litigation, 647 F. Supp.2d 265, 277-82 (S.D.N.Y. 2009) (addressing warning causation without ever mentioning a heeding presumption (applying Florida law). The Fosamax cases did not mention Sta-Rite.
As far as we can tell, no Georgia appellate court has ever ruled on whether, in general, a heeding presumption should be adopted in any product liability case. We’d call the question “open.” A couple of trial courts, in dictum, have purported to recognize some sort of a “burden shifting” in pharmaceutical warning defect cases. In both cases, the purported presumption, if that’s what it is, was rebutted as a matter of law and summary judgment was entered – and affirmed on appeal.
In Porter v. Eli Lilly & Co., 2008 WL 544739 (N.D. Ga. Feb. 25, 2008), aff’d, 291 F. Appx. 963, 964 (11th Cir. 2008), the court predicted that Georgia would, in a prescription medical product case, adopt a “burden-shifting rebuttable presumption,” but not one that would eliminate plaintiff’s traditional obligation to prove causation:
[T]he court assumes that Georgia will apply the presumption in comment j to §402A. The court finds that there is no indication in Georgia law, however, that it would apply this comment in the manner of a “heeding presumption” that would vitiate the need for a plaintiff to establish proximate cause for her injuries.
Id. at *11. The same type of physician testimony that defeats causation under the learned intermediary rule also rebuts the any burden-shifting presumption. Id. at *12; accord Dietz v. SmithKline Beecham Corp., 2008 WL 5329295, at *3-4 (N.D. Ga. Dec. 9, 2008) (same result as in Deitz; also holding that any presumption does not affect applicability of learned intermediary rule), aff’d, 598 F.3d 812 (11th Cir. 2010).
Without citing any Hawaii law, Forsyth v. Eli Lilly & Co., 1998 WL 35152135 (D. Haw. Jan. 5, 1998), mentioned a heeding presumption (under Oklahoma law), and denied summary judgment because the defendant failed to provide affirmative prescriber testimony defeating causation. Id. at *5. That’s the only heeding presumption case we could find in Hawaii.
We found nothing adopting, or rejecting, a product liability heeding presumption in Idaho – only hundred-year-old train whistle cases making the same point that the ALI did in §402A, comment j (and not the judicially invented converse).
There are no Illinois appellate state-law cases discussing the heeding presumption, at least under Illinois law. One older case, Mahr v. G. D. Searle & Co., 390 N.E.2d 1214, 1233 (Ill. App. 1979), applied the Texas heeding presumption, which as discussed below, Texas courts have since held does not apply to prescription medical products. In Begley v. Bristol-Myers Squibb Co., 2013 WL 144177, at *8 (D.N.J. Jan. 11, 2013), aff’d, 544 F. Appx. 120 (3d Cir. 2013) (applying Illinois law), the court noted the questionable status of Illinois heeding presumption precedent, but did not have to decide the question.
Some federal courts had charged in where Illinois state courts have yet to tread. Most egregious is Rutz v. Novartis Pharmaceutical Corp., 2012 WL 6569361 (S.D. Ill. Dec. 17, 2012), which went ahead and applied a presumption even after admitting that “the issue of whether a ‘heeding presumption’ applies has not been clearly addressed by the Illinois Supreme Court.” Id. at *7. Likewise, in Erickson v. Baxter Healthcare, Inc., 151 F. Supp.2d 952 (N.D. Ill. 2001), the court, citing Mahr, applied a heeding presumption under Illinois law. Id. at 970. The entire analysis in Erikson is one sentence: “In any event, the plaintiffs are entitled at this stage to a presumption that a learned intermediary would have heeded the warnings given.” Id. See also Mason v. Smithkline Beecham Corp., 2010 WL 2697173, at *9 (C.D. Ill. July 7, 2010) (discussing but not deciding heeding presumption issue; finding disputed issue of fact); Giles v. Wyeth, 500 F. Supp.2d 1063, 1069 (S.D. Ill. 2007) (same).
An intermediate Indiana appellate court was an early adopter of the heeding presumption. Ortho Pharmaceutical Corp. v. Chapman, 388 N.E.2d 541, 555 (Ind. App. 1979) (“[w]here warnings are inadequate, however, the presumption [in comment j] is in essence a presumption of causation”). However, that
presumption does not do away with the plaintiff’s obligation to prove causation:
[T]he “read-and-heed” presumption does not completely dispose of the causation issue in a failure-to-warn case. The most the presumption does is establish that a warning would have been read and obeyed. It does not establish that the defect in fact caused the plaintiff’s injury. The plaintiff invoking the presumption must still show that the danger that would have been prevented by an appropriate warning was the danger that materialized.
Kovach v. Caligor Midwest, 913 N.E.2d 193, 199 (Ind. 2009). See Peters v. Judd Drugs, Inc., 602 N.E.2d 162, 165 (Ind. App. 1992) (presumption rebutted by failure to read warning).
Indiana’s heeding presumption “may be rebutted with evidence that an adequate warning would not have been heeded.” In re Fosamax Products Liability Litigation, 688 F. Supp.2d 259, 266 (S.D.N.Y. 2010) (applying Indiana law). Once the heeding presumption is rebutted, “it serves no further purpose,” and drops from the case. Craven v. Niagara Machine & Tool Works, Inc., 417 N.E.2d 1165, 1171 (Ind. App. 1981) (red flag is on other issue).
Presumptions of this type are not regarded as evidence but rules of law which guide the order of proof and establish the bounds of a prima facie case. Once the duty of going forward with evidence has been discharged, the presumption is functus officio and has no proper place in jury instructions.
Peavler v. Bd. of Commissioners of Monroe County, 557 N.E.2d 1077, 1083 (Ind. App. 1990).
Without any guidance from Iowa state courts, federal courts have adopted a limited heeding presumption – one not applicable to “learned intermediary” situations.
We affirm the district court’s application of a rebuttable presumption to the proximate cause issue. The district court relied on the factual distinctions between the physician-patient situation . . . and the mass-immunization context of this case to justify the use of the rebuttable presumption.
Petty v. United States, 740 F.2d 1428, 1437-38 (8th Cir. 1984) (applying Iowa law). Accord Brazzell v. United States, 788 F.2d 1352, 1359 (8th Cir. 1986) (following Petty) (applying Iowa law). Yet another federal court predicted a heeding presumption in a non-prescription medical product case in Rowson v. Kawasaki Heavy Industries, Ltd., 866 F. Supp. 1221, 1233-40 (N.D. Iowa 1994), discussing a bunch of cases but nothing from Iowa.
For its part, the Iowa Supreme Court still hasn’t considered the heeding presumption. However, since Iowa has since adopted the Third Restatement of Torts, and the court has specifically discussed the Third Restatement’s rejection of §402A, comment j, we think it’s unlikely to follow the federal courts down this road. See Leaf v. Goodyear Tire & Rubber Co., 590 N.W.2d 525, 528-29 (Iowa 1999).
The heeding presumption is alive and well in Kansas. The Kansas Supreme Court adopted it in Wooderson v. Ortho Pharmaceutical Corp., 681 P.2d 1038, 1057-58 (Kan. 1984). “Defendant may rebut this presumption by establishing that although the prescribing physician would have read and heeded the warning or additional information, the warning would not have changed the course of treatment.” Baughn v. Eli Lilly & Co., 356 F. Supp.2d 1177, 1181 (D. Kan. 2005). Once that happens, the presumption goes away. “If [defendant] provides credible evidence to rebut the presumption, the presumption disappears and the burden shifts back to plaintiffs to affirmatively prove causation.” Miller v. Pfizer Inc., 196 F. Supp.2d 1095, 1127, (D. Kan. 2002), aff’d, 356 F.3d 1326 (10th Cir. 2004). Accord Vanderwerf v. SmithKlineBeecham Corp., 529 F. Supp.2d 1294, 1310-12 (D. Kan. 2008).
Kentucky is another state in which a federal court, ostensibly predicting state law, made up a heeding presumption. Snawder v. Cohen, 749 F. Supp. 1473, 1479-80 (W.D. Ky. 1990) (applying heeding presumption despite “find[ing] no Kentucky case which affirmatively applies this presumption”). Snawder was a mass vaccine case, so the issue as to prescription medical products involving the learned intermediary rule remains open in Kentucky. Cf. Smith v. Parker-Hannifin Corp., 2014 WL 1418288, at *8 (W.D. Ky. Apr. 14, 2014) (same prediction in non-prescription medical product case).
Louisiana has adopted the heeding presumption. Bloxom v. Bloxom, 512 So.2d 839, 850 (La. 1987). “The presumption may, however, be rebutted if the manufacturer produces contrary evidence which persuades the trier of fact that an adequate warning or instruction would have been futile under the circumstances.” Id. (presumption rebutted by failure to read); accord Isgitt v. State Farm Insurance Co., ___ So.3d___, 2013 WL 5628873, at *5-6 (La. App. Oct. 16, 2013) (presumption rebutted by prior knowledge); Safeco Insurance Co. v. Baker, 515 So.2d 655, 657-58 (La. App. 1987) (presumption rebutted by failure to read); Moguel v. Rheem Manufacturing Co., 2013 WL 3947170, at *7 (E.D. La. July 31, 2013) (same).
The heeding presumption has been applied in prescription drug cases. Sharkey v. Sterling Drug, Inc., 600 So. 2d 701, 711 (La. App. 1992) (OTC drug that had been prescribed); Felice v. Valleylab, Inc., 520 So.2d 920, 927 (La. App. 1987) (presumption rebutted by prescriber failure to read); Burks v. Abbott Laboratories, 917 F. Supp.2d 902, 918 (D. Minn. 2013) (question of fact over rebuttal) (applying Louisiana law); Simon v. Baxter Health Care Corp., 1989 WL 101560, at *2-4 (E.D. La. Aug. 31, 1989) (presumption rebutted by prior knowledge and other prescriber testimony), aff’d mem., 915 F.2d 1569 (5th Cir. 1990).
No Maine state court has ever recognized a heeding presumption, but once again the federal courts have stepped in and done so. In Koken v. Black & Veatch Construction, Inc., 426 F.3d 39, 50 (1st Cir. 2005) (applying Maine law), the First Circuit derived a heeding presumption from nothing more than a block quotation of comment j that was discussed for other reasons in Bernier v. Raymark Industries, Inc., 516 A.2d 534, 538 (Me. 1986). In Doe v. Solvay Pharmaceuticals, Inc., 350 F. Supp.2d 257 (D. Me. 2004), any such presumption was rebutted in a prescription medical product case:
[T]here is no evidence that if the warning had been adequate, she would not have received [the drug], since her treating physician considered the warning adequate and she received [the drug].
Id. at 273-74.
Maryland has adopted the heeding presumption. United States Gypsum Co. v. Mayor of Baltimore, 647 A.2d 405, 413 (Md. 1994); Eagle-Picher Industries, Inc. v. Balbos, 604 A.2d 445, 468-69 (Md. 1992). The presumption is rebutted by “evidence that the personalities or dispositions of the [plaintiffs] were such that they clearly would have ignored warnings.” Balbos 604 A.2d at 469. See Waterhouse v. R.J. Reynolds Tobacco Co., 162 F. Appx. 231, 234-35, (4th Cir. 2006) (presumption rebutted by prior knowledge) (applying Maryland law).
Under the Maryland rule . . . a presumption continues to exist as a question for the jury once evidence is introduced to meet or rebut it, unless the Court determines that the rebuttal evidence overcomes the presumption as a matter of law.
Samuel v. Ford Motor Co., 112 F. Supp.2d 460, 463 (D. Md. 2000), aff’d, 95 F. Appx. 520 (4th Cir. 2004). See White v. R.J. Reynolds Tobacco Co., 109 F. Supp. 2d 424, 435 (D. Md. 2000) (presumption rebutted by plaintiff’s ignoring existing warnings).
The Maryland heeding presumption was mentioned in a prescription medical product case in Grinage v. Mylan Pharmaceuticals, Inc., 840 F. Supp.2d 862 (D. Md. 2011), as part of the court’s holding that plaintiff had failed to plead causation with respect to claims purporting to avoid generic drug preemption. Id. at
Massachusetts has adopted the heeding presumption. Evans v. Lorillard Tobacco Co., 990 N.E.2d 997, 1023-24 (Mass. 2013) (following Harlow v. Chin, 545 N.E.2d 602, 606 (Mass. 1989)). In Knowlton v. Deseret Medical, Inc., 930 F.2d 116, 123 (1st Cir. 1991) (applying Massachusetts law), the court applied a heeding presumption to prescription medical products. Id. at 123.
The presumption is rebuttable:
[D]efendant must then come forward with sufficient evidence to rebut that presumption, and . . . once the presumption is rebutted, plaintiff must produce sufficient evidence to create a triable issue on the question of causation.
Garside v. Osco Drug, Inc., 976 F.2d 77, 81 (1st Cir. 1992) (citing Knowlton, 930 F.2d at 123). See In re Neurontin Marketing & Sales Practices & Products Liability Litigation, 2010 WL 3169485, at *3-4 (D. Mass. Aug. 10, 2010) (presumption rebutted by failure to read label, which warned of precise symptoms plaintiff suffered); Kelley v. Eli Lilly & Co., 517 F. Supp.2d 99, 106-07 (D.D.C. 2007) (presumption rebutted where plaintiff failed to establish that the prescriber ever prescribed the drug) (applying Massachusetts law); Wasylow v. Glock, Inc., 975 F. Supp. 370, 378 (D. Mass. 1996) (presumption rebutted by failure to read).
There is no heeding presumption in Michigan. The closest any Michigan court has come is Allen v. Owens-Corning Fiberglas Corp., 571 N.W.2d 530 (Mich. App. 1997), which permitted an “inference,” not a “presumption” of causation in certain warning defect cases where “the lack of warning is undisputed, and the person exposed is dead.” Id. at 535. In a prescription drug case, the same court held, “the plaintiff does have the burden of proving that had [the prescriber] been adequately warned he would have pursued a course of treatment to avoid or reduce injury.” Muilenberg v. Upjohn Co., 320 N.W.2d 358, 366 (Mich. App. 1982).
No heeding presumption exists in Minnesota. The Minnesota Supreme declined to decide the issue in Kallio v. Ford Motor Co., 407 N.W.2d 92, 99–100 (Minn. 1987). An unreported Minnesota appellate court later rejected the presumption as “contrary to Minnesota law.” Yennie v. Dickey Consumer Products, Inc., 2000 WL 1052175, at *1 (Minn. App. Aug. 1, 2000).
Asked to predict a heeding presumption under Minnesota law, the court in Ramstad v. Lear Siegler Diversified Holdings Corp., 836 F. Supp. 1511 (D. Minn. 1993), declined to adopt “the far-reaching [heeding presumption] doctrine urged by plaintiffs” where “Minnesota courts . . . have not adopted such a presumption.” A decade later, the Eighth Circuit did the same thing in Tuttle v. Lorillard Tobacco Co., 377 F.3d 917, 925 (8th Cir. 2004) (“we do not believe the Minnesota state courts would adopt the rebuttable presumption”). See Kapps v. Biosense Webster, Inc., 813 F. Supp.2d 1128, 1157 n.22 (D. Minn. 2011) (following Tuttle); Stringer v. Nat’l Football League, 749 F. Supp.2d 680, 692 (S.D. Ohio 2009) (following Tuttle) (applying Minnesota law); Treuchel v. Eli Lilly & Co., 2009 WL 5216930, at *11 (E.D.N.Y. Dec. 21, 2009) (following Tuttle and Yennie) (applying Minnesota law); Ramstad v. Lear Siegler Diversified Holdings Corp., 836 F. Supp. 1511, 1516 (D. Minn. 1993) (“a Minnesota state court would not adopt the far-reaching doctrine urged by plaintiffs”).
The Mississippi Supreme Court has never recognized any heeding presumption. A Mississippi intermediate appellate court observed that “the Mississippi Supreme Court had a perfect opportunity to adopt a heeding presumption in [Wyeth Laboratories, Inc. v.] Fortenberry, [530 So.2d 688 (Miss. 1988),] but apparently declined to do so.” Harris v. International Truck & Engine Corp., 912 So. 2d 1101, 1109 (Miss. App. 2005). Instead, the Mississippi Supreme Court “explicitly placed on the plaintiff the burden of proving that the allegedly inadequate warnings had been followed.” Id.
Urged to create this novel presumption for Mississippi, the Fifth Circuit refused in Thomas v. Hoffman–La-Roche, Inc., 949 F.2d 806 (5th Cir. 1992). “No Mississippi court has adopted a presumption of causation on facts similar to those in this case, and the failure of the Mississippi Supreme Court to mention such a presumption in [a similar case] strongly suggests that such a presumption does not exist under Mississippi law.” Id. at 813. Thomas went on to discuss more thoroughly than any other court why the heeding presumption is a particularly bad idea with respect to products, such as prescription medical products, where warnings are about inherent risks, since “heeding” amounts to not using such products at all:
[W]e recognize that there are two very different types of warnings that might be associated with a particular product: (1) an unavoidable risk warning; and (2) a preventable risk warning. The first type of warning details a risk that a consumer cannot avoid if the consumer chooses to use the product. Typically, warnings associated with medical drugs fall into this category. . . . The only question for the potential consumer of [such a] product is whether the potential benefit to be obtained from using the product outweighs this risk. . . .
Typically, the choice facing the user in the preventable risk situation is between using the product safely and using the product unsafely. The choice, however, presented by an unavoidable risk warning is not between the safe use and the unsafe use of a product, but between using and not using the product. The consumer can choose to use the product and face its risks, or choose not to use the product and lose its potential benefits. Generally, using the product will present the less risky of these two alternatives. . . . Unless the plaintiff can establish that using the product is, for the average consumer, the more risky alternative, the [same rule] would seem to establish a rebuttable presumption that the consumer would not have changed his decision to use the product if warned of the unavoidable risk.
For this reason, we reject [plaintiff’s] contention that causation is presumed, given an inadequate warning, in the context of an unavoidable risk. . . . We are willing to assume that the failure to give an adequate warning of a known risk entitles the plaintiff to a rebuttable presumption that the learned intermediary would have read and heeded a proper warning. But “heed” in this context means only that the learned intermediary would have incorporated the “additional” risk into his decisional calculus.
Id. at 813-14 (footnotes and citations omitted). See Smith v. Johnson & Johnson, 2011 WL 3876997, at *11 (S.D. Miss. Aug. 31, 2011) (“[t]he burden remains on the plaintiff to demonstrate that the additional non-disclosed risk was sufficiently high that it would have changed the treating physician’s decision to prescribe the product for the plaintiff”), aff’d, 483 F. Appx. 909 (5th Cir. 2012).
Missouri is another long-time adherent to the heeding presumption. Moore v. Ford Motor Co., 332 S.W.3d 749, 762-63 (Mo. 2011); Arnold v. Ingersoll-Rand Co., 834 S.W.2d 192, 194 (Mo. 1992). Prior knowledge precludes resort to this presumption. “[A] preliminary inquiry before applying the presumption is whether adequate information is available absent a warning.” Moore, 332 S.W.3d at 762. During that inquiry, “the burden is on plaintiffs to show that lack of [prior] knowledge.” Id. at 762 (quoting Arnold, 834 S.W.3d at 194). Thus, “[t]he presumption should be recognized . . . only if there is a ‘legitimate jury question whether the plaintiff did not already know the danger.’” Tenbarge v. Ames Taping Tool Systems, Inc., 190 F.3d 862, 866 (8th Cir. 1999) (quoting Arnold, 834 S.W.3d at 194) (applying Missouri law).
“The heeding presumption is a rebuttable one.” Moore, 332 S.W.3d at 763. “Such a presumption may be rebutted by evidence that [the recipient] would not have read or heeded an additional warning.” Bachtel v. TASER International, Inc., 747 F.3d 965, 971 (8th Cir. 2014) (applying Missouri law).
In recent years, courts applying Missouri law have applied the heeding presumption in cases involving prescription medical products. Johnson v. Medtronic, Inc., 365 S.W.3d 226, 232-33 (Mo. App. 2012) (presumption rebutted by failure to read); Winter v. Novartis Pharmaceuticals Corp., 739 F.3d 405, 408 (8th Cir. 2014) (applying Missouri law); Bohnenstiehl v. Wright Medical Group, Inc., 2014 WL 319652, at *3 (E.D. Mo. Jan. 29, 2014); Cox v. KLS Martin, L.P., 2013 WL 4434390, at *4 (W.D. Mo. Aug. 14, 2013); In re NuvaRing Products Products Liability Litigation, 2013 WL 3716389, at *10 (E.D. Mo. July 12, 2013); Carr-Davis v. Bristol Myers-Squibb Co., 2013 WL 322616, at *8 (D.N.J. Jan. 28, 2013) (presumption inapplicable due to prior prescriber knowledge) (applying Missouri law); Lemmon v. Wyeth, 2012 WL 2848161, at *12, *15 (E.D. Mo. July 11, 2012); Hanrahan v. Wyeth, Inc., 2012 WL 2395881, at *10, 13 (E.D. Mo. June 25, 2012).
There is no heeding presumption in Montana. In Riley v. American Honda Co., 856 P.2d 196, 199-200 (Mont. 1993), the court held:
We are unwilling to shift the respective parties’ burdens in such a fashion. In order to rebut a presumption of causation, the defendant would need to prove that the warning would not have altered the plaintiff’s conduct or that the plaintiff’s own negligence caused the injury. A defendant certainly is in no better position to rebut a presumption which totally excuses a plaintiff from meeting the causation element than a plaintiff is in establishing the causation element as part of the prima facie case.
Id. at 200.
No Nebraska case has ever discussed the heeding presumption, as far as we know.
The Nevada Supreme Court rejected the heeding presumption in Rivera v. Philip Morris, Inc., 209 P.3d 271 (Nev. 2009).
[W]e conclude that Nevada law does not support recognizing a heeding presumption. It is a firmly rooted part of Nevada law that the plaintiff in a strict product liability case bears the burden of proving all the elements of his case, including causation.
Id. at 277.
New Hampshire does not have a heeding presumption. In Wilson v. Bradlees of New England, Inc., 250 F.3d 10 (1st Cir. 2001), the First Circuit, exercising proper Erie restraint, recognized “that New Hampshire had not adopted the ‘read and heed’ presumption and we will not do so on its behalf.” Id. at 15-16. Cf. Bartlett v. Mutual Pharmaceutical Co., 731 F. Supp. 2d 135, 147 (D.N.H. 2010) (recognizing that any heeding presumption was “questionable” after Wilson; holding that any presumption had been rebutted by the prescriber’s failure to read), aff’d on other grounds, 678 F.3d 30 (1st Cir. 2012), rev’d on other grounds, 133 S. Ct. 2466 (2013).
New Jersey adopted the heeding presumption in Coffman v. Keene Corp., 628 A.2d 710, 717-19 (N.J. 1993); see Sharpe v. Bestop, Inc., 713 A.2d 1079, 1085 (N.J. Super. App. Div. 1998), aff’d, 730 A.2d 285 (N.J. 1999). In prescription medical product liability litigation, the presumption applies only where a prescribing physician is unavailable to testify. In McDarby v. Merck & Co., 949 A.2d 223 (N.J. Super. App. Div. 2008), after acknowledging the heeding presumption, id. at 267-68, the court held that it had no place where the prescriber was available to testify:
[W]e do agree with [defendant] that . . . the judge’s use of the heeding presumption in her legal analysis and jury instructions was not legally required. That presumption, precedent demonstrates, is primarily applicable in circumstances in which plaintiff lacks the ability to prove by direct evidence that a proper warning, if given, would have been heeded. But here, direct evidence in the form of the deposition testimony of [plaintiff’s] treating physician existed, rendering use of a presumption unnecessary.
Id. at 269 (citation omitted) (emphasis added).
The New Jersey heeding presumption is rebuttable:
If, however, the defendant presents rebuttal evidence such that reasonable minds could differ as to whether the warning, if given, would have been heeded by the plaintiff, the defendant has satisfied its burden of production and the plaintiff loses the benefit of the presumption.
Sharpe, 713 A.2d at 1086. If entirely unrebutted, the heeding presumption allows a court to “determine as a matter of law that the warning would have been heeded.” Coffman, 628 A.2d at 716.
“[T]he presumption normally disappears in the face of conflicting evidence.” Calderon v. Machinenfabriek Bollegraaf Appingedam BV, 667 A.2d 1111, 1116, (N.J. Super. App. Div. 1995) (quoting commentary to N.J.R.E. 301). “[T]he presumption, if rebutted, will vanish.” In re Diet Drug Litigation, 895 A.2d 480, 483 (N.J. Super. Law Div. 2005) (citing Sharpe). “[U]nder New Jersey law, there is a general prohibition against calling presumptions to the attention of a jury.” Graves v. Church & Dwight Co., 631 A.2d 1248, 1257 (N.J. Super. App. Div. 1993) (proper not to instruct jury on heeding presumption).
The heeding presumption has been applied under New Jersey law in a number of prescription medical product cases. In McDarby, discussing Strumph v. Schering Corp., 626 A.2d 1090 (N.J. 1993), the court acknowledged that prior prescriber awareness of relevant risks was a situation where “the presumption would have been rebutted as a matter of law.” 949 A.2d at 268. The presumption may be rebutted, in a prescription medical product case, with “evidence that . . . the plaintiffs’ health care professionals, if provided with the warning information, would have prescribed [the drug] anyway and would not have communicated the risk information . . . to the plaintiffs.” In re Diet Drug Litigation, 895 A.2d 480, 492 (N.J. Super. Law Div. 2005) (pre-McDarby decision). See Baker v. App Pharmaceutical LLP, 2012 WL 3598841, at *9 (D.N.J. Aug. 21, 2012) (holding presumption rebutted as a matter of law due to prior prescriber knowledge and failure to read drug warnings).
No New Mexico case has applied a heeding presumption. Cf. Magoffe v. JLG Indutries, Inc., 2008 WL 2967653, at *33 (D.N.M. May 7, 2008) (mentioning possibility of presumption while granting summary judgment against all claims), aff’d, 375 F. Appx. 848 (10th Cir. 2010).
The situation in New York is extremely murky. The New York Court of Appeals has never addressed the heeding presumption. Some time ago, the Second Circuit described matters thusly, concluding that the purported presumption was nothing more than a permissible jury inference:
[Plaintiff] somewhat misstates the matter by asserting that New York recognizes a “heeding presumption,” but she is correct in contending that in some circumstances, New York permits the trier to infer that a warning would have been heeded and thereby to conclude that the absence of a warning that was reasonably required to be given was a proximate cause of an injury. Appellee cites no New York decision that refers to a “presumption” of heeding.
Raney v. Owens-Illinois, Inc., 897 F.2d 94, 95 (2d Cir. 1990) (applying New York law); See Topliff v. Wal-Mart Stores E. LP, 2007 WL 911891, at *43 (N.D.N.Y. Mar. 22, 2007) (given Raney, court was”skeptical of Plaintiff’s characterization of the failure-to-warn law in New York as providing a “presum[ption] that a user would have heeded the warnings if they had been given”). The situation rather reminds us of the morass that existed with respect to medical monitoring before the Court of Appeals put that issue to rest in Caronia v. Philip Morris.
On the other side of the legal ledger, precedent supporting a New York presumption began with cases involving plaintiffs seeking to excuse their failure to read warnings by quibbling over the warning’s conspicuousness. Johnson v. Johnson Chemical Co., 588 N.Y.S.2d 607, 611 (N.Y.A.D. 1992); Baker v. St. Agnes Hospital, 421 N.Y.S.2d 81, 86 (N.Y.A.D. 1979); Monell v. Scooter Store, Ltd., 895 F. Supp.2d 398, 414 (N.D.N.Y. 2012); Santoro v. Donnelly, 340 F. Supp.2d 464, 486 (S.D.N.Y. 2004); Anderson v. Hedstrom Corp., 76 F. Supp. 2d 422, 441-42 (S.D.N.Y. 1999). The oldest case adopting a heeding presumption in a prescription medical product case, Hoffman-Rattet v. Ortho Pharmaceutical Corp., 516 N.Y.S.2d 856, 861 (N.Y. Sup. Ct. 1987), was effectively a conspicuousness case, since it turned on “allegedly inadequately conveyed updated warnings.”
Without much discussion, some federal courts broadened the presumption that arose in conspicuousness cases into something of “general” applicability. Bee v. Novartis Pharmaceutical Corp., ___ F. Supp.2d ___, 2014 WL 1855632 at *12 (E.D.N.Y. May 9, 2014); see Roman v. Sprint Nextel Corp., 2014 WL 5026093, at *15 (S.D.N.Y. Sept. 29, 2014); In re Fosamax Products Liability Litigation, 924 F. Supp.2d 477, 486 (S.D.N.Y. 2013); Davids v. Novartis Pharmaceutical Corp., 857 F. Supp. 2d 267, 286 (E.D.N.Y. 2012); Saladino v. Stewart & Stevenson Services, Inc., 704 F. Supp. 2d 237, 249, 2010 WL 1292264 (E.D.N.Y. 2010); Adesina v. Aladan Corp., 438 F. Supp.2d 329, 338 (S.D.N.Y. 2006); Henry v. Rehab Plus Inc., 404 F. Supp.2d 435, 442 (E.D.N.Y. 2005). Once again we see the pattern of federal courts engaging in unwarranted expansion of state law.
Other courts applying New York law are incompatible with any heeding presumption. The Appellate Division held, in a prescription medical product case:
Contrary to plaintiff’s argument, in this State, it remains plaintiff’s burden to prove that defendant’s failure to warn was a proximate cause of his injury (and this burden includes adducing proof that the user of a product would have read and heeded a warning had one been given.
Sosna v. American Home Products, 748 N.Y.S.2d 548, 549 (N.Y. App. Div. 2002).
In a failure-to-warn action, a plaintiff bears the burden to prove that defendant’s failure to warn was a proximate cause of his injury and this burden includes adducing proof that the user of a product would have read and heeded a warning had one been given. In the case of prescription medications, where warnings are directed to prescribing physicians, a plaintiff must demonstrate that had a different, more accurate warnings been given, his physician would not have prescribed the drug in the same manner.
Alston v. Caraco Pharmaceutical, Inc., 670 F. Supp.2d 279, 285 (S.D.N.Y. 2009) (citation to Sosna omitted). Accord Reis v. Volvo Cars, Inc., 901 N.Y.S.2d 10, 13 (App. Div. 2010) (“failure to warn claims should have been dismissed because . . . there is no proof in the record that [plaintiff] would have read and heeded a warning”); Santos v. Ford Motor Co., 893 N.Y.S.2d 537, 538 (N.Y.A.D. 2010) (quoting Sosna); Mulhall v. Hannafin, 841 N.Y.S.2d 282, 287 (N.Y.A.D. 2007) (“well settled law” imposes on plaintiffs “the obligation to adduce proof that had a warning been provided, she would have read the warning and heeded it”); Perez v. Radar Realty, 824 N.Y.S.2d 87, 89 (N.Y.A.D. 2006) (“Plaintiff testified that he made no attempt to read or to obtain assistance in reading the product label and, accordingly, the alleged labeling deficiency could not have caused the complained-of harm.”); Banks v. Makita U.S.A., 641 N.Y.S.2d 875, 877 (N.Y.A.D. 1996) (“a plaintiff whose claim is based on inadequate warnings must prove . . . that if adequate warnings had been provided, the product would not have been misused”); Menna v. Walmart, 2013 WL 3958247, at *3 (N.Y. Sup. Ct. 2013) (“no proof that the plaintiff would have read and heeded a warning about any risk”); Hayes v. New York, 2013 WL 5278879, at *15 (N.D.N.Y. Sept. 18, 2013) (“Plaintiff has failed to offer any evidence that even if a different warning had been issued, the user of the product . . . would have read and heeded that warning”); In re Nuvaring Litigation, 2013 WL 1874321, at *33 (N.J.Super. L. D. April 18, 2013) (following Mullhall; burden on plaintiff) (applying New York law).
New York cases applying a heeding presumption recognize that it is “rebutted by specific facts showing that the warning would have been futile.” Bee, 2014 WL 1855632 at *12; Saladino, 704 F. Supp.2d at 249; Santoro, 340 F. Supp.2d at 486.
[Where a defendant can show, via “specific facts,” that any given warning would have been futile − either because any such warnings would not have been heeded or because the injury would have occurred, regardless of the given warnings − a defendant will have successfully rebutted the general presumption
Bee, 2014 WL 1855632, at *12
One such set of rebuttal facts is where the party to be warned “was fully aware of the hazard through general knowledge, observation or common sense.” Id.; accord Monel, 895 F. Supp.2d at 414. Also, “the presumption that a user would have heeded warnings can be rebutted by proof that an adequate warning would have been futile since plaintiff would not have read it.” Power v. Crown Controls Corp., 568 N.Y.S.2d 674, 675 (N.Y. Sup. Ct. 1990). A third set of facts is where “the risk was well understood . . . and therefore a warning would have made no difference.” Ramos v. Simon-Ro Corp., 2008 WL 4210487, at *12 (S.D.N.Y. Sept. 11, 2008).
We found no North Carolina case ever adopting (or rejecting) the heeding presumption. That’s not as surprising as it sounds, because North Carolina is one of a few states that never adopted strict liability, and thus §402A, at all. Indeed, North Carolina has a statute forbidding strict liability. N.C.G.S.A. §99B-1.1. That same statute also expressly imposes on plaintiffs the burden of proving causation in warning cases. See N.C.G.S.A. §99B-5(a) (requiring that the “claimant prove . . . that the failure to provide adequate warning or instruction was a proximate cause of the harm”).
North Dakota has adopted the heeding presumption, based on the comment j rationale. Crowston v. Goodyear Tire & Rubber Co., 521 N.W.2d 401, 410 (N.D. 1994); Butz v. Werner, 438 N.W.2d 509, 517 (N.D. 1989).
The presumption is rebuttable under the usual “more likely than not” evidentiary standard. Crowston, 521 N.W.2d at 410. Evidence of the plaintiff’s anti-social character, otherwise inadmissible, is admissible to rebut the presumption. Id. at 411. In a prescription medical product case “[t]he presumption that had an adequate warning been given it would have been read and heeded is rebutted by plaintiff’s testimony that he did not read the warning.” Harris v. McNeil Pharmaceutical, 2000 WL 33339657, at *3 n.3 (D.N.D. Sept. 5, 2000). Also sufficient to rebut the presumption is evidence that the prescriber “knew the risks of prescribing” and continues to do so. Ehlis v. Shire Richwood, Inc., 233 F. Supp.2d 1189, 1196-97 (D.N.D. 2002), aff’d, 367 F.3d 1013 (8th Cir. 2004)
Ohio adopted the heeding presumption in a prescription medical product case, relying on Restatement §402A, comment j. Seley v. G.D. Searle Co., 423 N.E.2d 831, 838 (Ohio 1981). Whether the heeding presumption survives Ohio’s complete and utter statutory abolition of common-law product liability causes of action, Ohio R.C. §2307.76, has as far as we know never been decided by any Ohio court. The statute certainly created no such presumption.
The Ohio heeding presumption is rebuttable, and was rebutted in Seley:
Where, as here, an adequate warning would have made no difference in the physician’s decision as to whether to prescribe a drug or as to whether to monitor the patient thereafter, the presumption . . . is rebutted, and the required element of proximate cause between the warning and ingestion of the drug is lacking.
Id. at 838-39 (citation omitted). At least in the absence of an alleged conspicuousness defect, evidence that the warning was never read also rebuts the presumption. Wade v. Diamant Boart, Inc., 179 F. Appx. 352, 355-56 (6th Cir. 2006); Phan v. Presrite Corp., 653 N.E.2d 708, 711 (Ohio App. 1994); Mohney v. USA Hockey, Inc., 300 F. Supp.2d 556, 578 (N.D. Ohio 2004).
In prescription medical product cases, “evidence that the doctors ignored the dosaging instructions served to defeat the presumption.” Daniel v. Fisons Corp., 740 N.E.2d 681, 685 (Ohio App. 2000). “Where a treating physician unequivocally testifies that an adequate warning would not have altered the course of treatment . . . there is no proximate cause between the lack of an adequate warning and the use of the drug.” Bowles v. Novartis Pharmaceutical Corp., 2013 WL 5297257, at *10 (S.D. Ohio Sept. 19, 2013); accord Miller v. ALZA Corp., 759 F. Supp.2d 929, 936 (S.D. Ohio 2010); In re NuvaRing Litigation, 2013 WL 1874321, at *38 (N.J. Super. Law Div. April 18, 2013) (applying Ohio law).
All common-law presumptions in Ohio are of the “bubble bursting” variety under Ohio R. Evid. 301. Forbes v. Midwest Air Charter, Inc., 711 N.E.2d 997, 999 (Ohio 1999). “[T]he effect of rebutting the presumption [is] ‘bursting the bubble,’ with the case then proceeding as if the presumption had never arisen.” Horsley v. Essman, 763 N.E.2d 245, 249 (Ohio App. 2001); accord, Forbes, 711 N.E.2d at 999 (holding that where evidence “was presented” jury should not have been charged on presumption).
Oklahoma adopted the heeding presumption early on, in Cunningham v. Charles Pfizer & Co., 532 P.2d 1377, 1382 (Okla. 1974), a prescription drug case. See also Eck v. Parke, Davis & Co., 256 F.3d 1013, 1019 (10th Cir. 2001) (applying Oklahoma law). “‘[H]eed’ in this context means only that the learned intermediary would have incorporated the ‘additional’ risk into [her] decisional calculus.” Id. at 1021 (citation and quotation marks omitted). “This does not create a presumption that the drug would not have been prescribed.” Ingram v. Novartis Pharmaceuticals Corp., 888 F. Supp.2d 1241, 1244 (W.D. Okla. 2012).
The presumption is rebuttable. It does not apply to persons “experienced with respect to the product and well aware of all the inherent risks.” Clark v. Continental Tank Co., 744 P.2d 949, 954 (Okla. 1987); accord Travelers Indemnity Co. v. Hans Lingl Anlagenbau Und Verfahrenstechnik GMBH & Co. KG, 189 F. Appx. 782, 787 (10th Cir. 2006) (applying Oklahoma law). “[O]nce the opposing party meets its burden to come forward with evidence rebutting the presumption, the presumption disappears.” Daniel v. Ben E. Keith Co., 97 F.3d 1329, 1332 (10th Cir. 1996) (applying Oklahoma law); accord Black v. M & W Gear Co., 269 F.3d 1220, 1232 (10th Cir. 2001) (presumption “disappears once the defendant comes forward with some evidence”) (applying Oklahoma law). Failure to read can also rebut the heeding presumption. T.G. v. Remington Arms Co., 2014 WL 2589443, at *6 (N.D. Okla. June 10, 2014); Freeland v. Ameristep, Inc., 2014 WL 1646948, at *8 (E.D. Okla. April 24, 2014); Britton v. Electrolux Home Products, Inc., 2006 WL 2934271, at *5 (W.D. Okla. Oct. 13, 2006).
In prescription medical product liability cases, “[d]efendants can rebut this presumption by showing that the prescribing doctor had knowledge of the risks associated with a particular drug.” Shepherd v. Eli Lilly & Co., 497 F. Appx. 143, 145 (2d Cir. 2012) (applying Oklahoma law). Defendants may also “rebut this presumption by establishing that although the prescribing physician would have ‘read and heeded’ the warning or additional information, this would not have changed the prescribing physician’s course of treatment.” Stafford v. Wyeth, 411 F. Supp. 2d 1318, 1320-21 (W.D. Okla. 2006) (citation and quotation marks omitted). A prescriber’s testimony that s/he “would still have prescribed” even knowing some then-unknown information also rebuts the presumption. Eck, 258 F.3d at 1021; Ingram, 888 F. Supp.2d at 1245.
[I]t is entirely proper in the context of a “learned intermediary” case to consider the affidavit or testimony of the actual treating physician in determining whether a manufacturer of a particular prescription drug has overcome the presumption that the treating physician would have heeded a proper warning and not prescribed the drug in question.
Woulfe v. Eli Lilly & Co., 965 F. Supp. 1478, 1485 (E.D. Okla. 1997).
In McPike v. Enciso’s Cocina Mejicana, Inc., 762 P.2d 315, 319 (Or. App. 1988), the court held that a plaintiff was “not entitled to have the jury instructed about the existence of the putative [heeding] presumption. Id. at 319. Thus, “there is not a presumption under Oregon law that an adequate warning would have been read and prevented the harm.” Parkinson v. Novartis Pharmaceutical Corp., 5 F. Supp.3d 1265, 1272 (D. Or. 2014).
Pennsylvania’s intermediate appellate court adopted the heeding presumption in Coward v. Owens-Corning Fiberglas Corp., 729 A.2d 614, 620-21 (Pa. Super. 1999). Earlier, the Third Circuit had predicted (erroneously, as it turns out) that Pennsylvania would adopt this presumption generally. Pavlik v. Lane Ltd./Tobacco Exporters International, 135 F.3d 876, 883-84 (3d Cir. 1998). The Pennsylvania Supreme Court has never spoken on the subject. See
Wolfe v. McNeil–PPC, Inc., 773 F. Supp.2d 561, 569 (E.D. Pa. 2011) (discussing lack of Pennsylvania Supreme Court support for heeding presumption).
In Viguers v. Philip Morris USA, Inc., 837 A.2d 534 (Pa. Super. 2004), aff’d, 881 A.2d 1262 (Pa. 2005), the same intermediate court limited the heeding presumption to employment-related situations, thereby excluding consumer products and prescription medical products. Id. at 537-538 (reasoning that the heeding presumption is warranted only as to products that a plaintiff had no choice but to use). Accord Moroney v. General Motors Corp., 850 A.2d 629, 634 & n.3 (Pa. Super. 2004); Goldstein v. Phillip Morris, Inc., 854 A.2d 585, 587 (Pa. Super. 2004).
Thus, in Pennsylvania, “proximate cause is not presumed” in prescription medical product cases. Demmler v. SmithKline Beecham Corp., 671 A.2d 1151, 1155 (Pa. Super. 1996). Rather, a plaintiff must “show that had the defendant issued a proper warning,” s/he “would have altered his behavior and the injury would have been avoided.” Id. The plaintiff must produce evidence “of sufficient weight to establish . . . some reasonable likelihood that an adequate warning would have prevented [the plaintiff] from receiving the drug.” Lineberger v. Wyeth, 894 A.2d 141, 147 (Pa. Super. 2006). Accord Dopson-Troutt v. Novartis Pharmaceuticals Corp., 975 F. Supp.2d 1209, 1212-14 (M.D. Fla. Sept. 23, 2013) (applying Pennsylvania law); Clark v. Eli Lilly & Co., 2009 WL 1514427, at *14 (E.D.N.Y. May 29, 2009).
Another ground for rejecting the heeding presumption in Pennsylvania also exists. Pennsylvania does not apply strict liability to prescription medical product liability litigation. Lance v. Wyeth, 84 A.3d 434, 438 (Pa. 2014); Hahn v. Richter, 673 A.2d 888, 890-91 (Pa. 1996). As the heeding presumption is a strict liability concept, several trial courts have held that any heeding presumption in Pennsylvania cannot apply to prescription medical products for that reason. Fecho v. Eli Lilly & Co., 914 F. Supp.2d 130, 145-47 (D. Mass. 2012) (applying Pennsylvania law); Adams v. Wyeth, 74 Pa. D. & C.4th 500, 511-12 (Pa. C.P. 2005); Lineberger v. Wyeth, 72 Pa. D. & C.4th 35, 45 (Pa. C.P. 2005), aff’d, 894 A.2d 141, 150-51 (Pa. Super. 2006); Gronniger v. American Home Products Corp., 2005 WL 3766685, at *5-6 (Pa. C.P. Oct. 21, 2005); Leffler v. American Home Products Corp., 2005 WL 2999712, at *5 (Pa. C.P. Oct. 20, 2005); Berry v. Wyeth, 2005 WL 1431742, at *7 (Pa. C.P. June 13, 2005); Anderson v. Wyeth, 2005 WL 1383174, at *6 (Pa. C.P. June 7, 2005).
When applicable, the heeding presumption in Pennsylvania is rebuttable:
While the heeding presumption benefits a failure to warn plaintiff, it does not change the fact that he still bears the burden of persuasion. . . . “The heeding presumption [is] rebuttable, and thus, when the opponent of the presumption has met the burden of production thus imposed . . . the office of the presumption has been performed; the presumption is of no further effect and drops from the case.”
Coward, 729 A.2d at 621 (quoting Pavlik, 135 F.3d 876, at 883). When rebutted “the presumption would vanish.” Petree v. Victor Fluid Power, Inc., 831 F.2d 1191, 1196 n.2 (3d Cir. 1987) (applying Pennsylvania law); accord Kenney v. Deere & Co., 2000 WL 254316, at *6 (E.D. Pa. Mar. 7, 2000) (presumption “disappears . . . where defendant presents rebuttal evidence”).
We didn’t find any decision applying Puerto Rico law that mentioned a heeding presumption.
The heeding presumption has not been mentioned by any case applying Rhode Island law that we could find.
“There is no such [heeding] presumption under South Carolina law, and we are unwilling to create one.” Odom v. G.D. Searle & Co., 979 F.2d 1001, 1003 (4th Cir. 1992); accord Sauls v. Wyeth Pharmaceuticals, 846 F. Supp.2d 499, 503 (D.S.C. 2012); Fisher v. Pelstring, 817 F. Supp.2d 791, 811 (D.S.C. 2011). Since South Carolina now follows the Third Restatement of Torts, Branham v. Ford Motor Co., 701 S.E.2d 5, 14-16 (S.C. 2010), that’s not likely to change.
In another example of federal courts running roughshod over the limits of their diversity jurisdiction, the Eighth Circuit predicted South Dakota would follow a heeding presumption in Schilf v. Eli Lilly & Co., 687 F.3d 947, 949 (8th Cir. 2012), a prescription drug case, simply because it had previously predicted that the state would adopt other parts of Restatement §402A, comment j.
In Payne v. Novartis Pharmaceutical Corp., 767 F.3d 526 (6th Cir. 2014), the Sixth Circuit discussed the heeding presumption as applied in other states and concluded that “Tennessee has not adopted any of these presumptions.” Id. at 533. Nothing we have found is to the contrary.
Texas is where the heeding presumption began, in Technical Chemical Co. v. Jacobs, 480 S.W.2d 602, 606 (Tex. 1972) (citing only a student law review note, 50 Tex. L. Rev. 577 (1972), as support). Things looked to be headed south when Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1281-82 (5th Cir. 1974) (applying Texas law), applied the presumption in a mass vaccination case. Then an Illinois court got into the act, predicting that Texas would apply the heeding presumption to a prescription drug. Mahr v. G.D. Searle & Co., 390 N.E.2d 1214, 1233 (Ill. App. 1979) (applying Texas law).
But that’s as far as it went. Over the years, in cases (unlike Jacobs and Reyes) where an actual learned intermediary actually prescribed a product, Texas courts did not apply any heeding presumption. See Porterfield v. Ethicon, Inc., 183 F.3d 464, 468 (5th Cir. 1999) (applying Texas law); Skotak v. Tenneco Resins, Inc., 953 F.2d 909, 912-13 (5th Cir. 1992) (applying Texas law); Wyeth-Ayerst Laboratories Co. v. Medrano, 28 S.W.3d 87, 95 (Tex. App. 2000); Stewart v. Janssen Pharmaceutica, Inc., 780 S.W.2d 910, 911 (Tex. App. 1989); Cooper v. Bowser, 610 S.W.2d 825, 832 (Tex. Civ. App. 1980); Koenig v. Purdue Pharma Co., 435 F. Supp.2d 551, 556-57 (N.D. Tex. 2006); Gerber v. Hoffmann-La Roche Inc., 392 F. Supp.2d 907, 920-21 (S.D. Tex. 2005); Brumley v. Pfizer, Inc., 149 F. Supp.2d 305, 313-14 (S.D. Tex. 2001); Dyer v. Danek Medical, Inc., 115 F. Supp.2d 732, 741 (N.D. Tex. 2000); In re
Norplant Contraceptive Products Liability Litigation, 955 F. Supp. 700, 710-11 (E.D. Tex. 1997), aff’d, 165 F.3d 374 (5th Cir. 1999); In re Rezulin Products Liability Litigation, 331 F. Supp.2d 196, 201 (S.D.N.Y. 2004) (applying Texas law). Contra Guzman v. Synthes (USA), 20 S.W.3d 717, 720-721 (Tex. App. 1999) (applying presumption, but finding it rebutted); Anderson v. Sandoz Pharmaceuticals Corp., 77 F. Supp.2d 804, 809 (S.D. Tex. 1999).
In Ackermann v. Wyeth Pharmaceuticals, 526 F.3d 203 (5th Cir. 2008) (a Herrmann/Bexis collaboration), the Fifth Circuit looked at this history and concluded that the Texas heeding presumption (assuming it existed at all after Texas adopted the Third Restatement) does not apply in any prescription medical product case:
[N]either Texas nor federal courts applying Texas law have applied the read-and-heed presumption to pharmaceutical cases involving learned intermediaries. In fact, Texas has explicitly rejected . . . Comment j’s “read-and-heed” presumption for policy reasons and because it has been superseded by Restatement (Third) of Torts: Products Liability §2. Additionally, the relevant cases show the plaintiff bore the burden of showing that the inadequacy of the warning was a producing cause of injury.
Further, we doubt the Texas Supreme Court would apply such a presumption here, when it would not serve its intended purposes. The read-and-heed presumption has been justified because it excuses plaintiff from the necessity of making self-serving assertions that he would have followed adequate instructions. . . . In the learned-intermediary context, however, it is [the prescriber], not [plaintiff], who had to testify about his decision to prescribe [the drug].
Id. at 212-13 (citations, footnote, and quotation marks omitted). Since Ackermann, courts applying Texas law have not applied the heeding presumption in prescription medical product cases. Ebel v. Eli Lilly & Co., 321 F. Appx. 350, 357-58 & n.5 (5th Cir. 2009) (applying Texas law); Solomon v. Bristol-Myers Squibb Co., 916 F. Supp.2d 556, 563-64 (D.N.J. 2013) (applying Texas law).
Utah has adopted the presumption against preemption, using the Restatement §402A, comment j rationale. House v. Armour of America, Inc., 929 P.2d 340, 347 (Utah 1996). As in every other state, the presumption is rebuttable. Id.; accord Dowdy v. Coleman Co., 2013 WL 949495, at *1 (D. Utah Mar. 11, 2013) (rebutted by failure to follow other warnings about product).
House expressly distinguished the “unavoidable” risk situation typically of prescription medical products. 929 P.2d at 347 (holding that risk in question was not “truly unavoidable”). Once again, federal courts have not been so reticent. In Tingey v. Radionics, 193 F. Appx. 747 (10th Cir. 2006), the court, without discussion, extended the heeding presumption to a medical device. Id. at 759.
Vermont has recognized a heeding presumption by inverting the Restatement §402A, comment j language. Needham v. Coordinated Apparel Group, Inc., 811 A.2d 124, 129 (2002); Town of Bridport v. Sterling Clark Lurton Corp., 693 A.2d 701, 704-05 (Vt. 1997) (conspicuousness case); Menard v. Newhall, 373 A.2d 505, 506 (Vt. 1977). The presumption is rebuttable:
A presumption, of itself alone, contributes no evidence and has no probative quality. It takes the place of evidence, temporarily, at least, but if and when enough rebutting evidence is admitted to make a question for the jury on the fact involved, the presumption disappears and goes for naught. In such a case, the presumption does not have to be overcome by evidence; once it is confronted by evidence of the character referred to, it immediately quits the arena.
Menard, 373 A.2d at 506-07 (presumption rebutted by failure to follow instructions) (citation and quotation marks omitted); accord Bridport, 693 A.2d at 704. “[I]f the manufacturer can show that the user was warned of the risk and chose to ignore the warning, the presumption disappears, because there is no reasonable basis to assume that the user would have heeded a warning from the manufacturer.” Kellogg v. Wyeth, 762 F. Supp. 2d 694, 701 (D. Vt. 2010).
A Vermont trial court applied the presumption in a prescription drug case. Levine v. American Home Products, Inc., 2003 WL 25648135 (Vt. Super. Dec. 23, 2003) (presumption can be rebutted with “evidence that [the prescriber] disregarded the label’s warning and thus would have disregarded any strengthened warning”), aff’d, 944 A.2d 179 (Vt. 2006), aff’d, 555 U.S. 555 (2009). So have several Vermont federal courts. Drake v. Allergan Corp., No. 2:13-cv-234, slip op. at 13-14 (D. Vt. Oct. 31, 2014); Kellogg, 762 F. Supp.2d at 701 & n.4 (assuming application to prescription medical products because defendant did not dispute issue); Blanchard v. Eli Lilly & Co., 207 F. Supp.2d 308, 321 (D. Vt. 2002).
Having never adopted strict liability or §402A, Virginia law logically would not adopt the heeding presumption. Recently the Virginia Supreme Court held, “Virginia does not observe a heeding presumption.” Ford Motor Co. v. Boomer, 736 S.E.2d 724, 733 (Va. 2013) (footnote omitted). Accord Robinson v. McNeil Consumer Healthcare, 671 F. Supp. 2d 975, 991 (N.D. Ill. 2009), aff’d, 615 F.3d 861 (7th Cir. 2010) (applying Virginia law); Hayes-Jones v. Ortho-McNeil Pharmaceutical, 2012 WL 3164558, at *11 (N.J. Super. Law Div. Aug. 3, 2012) (applying Virginia law). Cf. Stanback v. Parke, Davis & Co., 657 F.2d 642, 646 & n.5 (4th Cir. 1981) (even if a heeding presumption might apply to other products, Virginia law would not apply it to prescription medical products).
We weren’t able to find any Washington state court decision adopting a heeding presumption. We did find this:
[Plaintiff] also encourages the Court to adopt the “read and heed” presumption. . . . Under this doctrine, a court will presume that had adequate warning been given it would have been heeded. This presumption is not currently recognized in Washington law, which law the Court must apply in this case.
Luttrell v. Novartis Pharmaceutical Corp., 894 F. Supp.2d 1324, 1345 n.16 (E.D. Wash. 2012) (granting summary judgment on warning causation where prescriber knew the risk and restarted plaintiff on drug after symptoms developed), aff’d, 555 F. Appx. 710 (9th Cir. 2014). This court thus engaged in proper Erie restraint.
“[T]he West Virginia Supreme Court of Appeals has never adopted a heeding presumption.” Muzichuck v. Forest Laboratories, Inc., C.A. No. 1:07CV16, slip op. at 30 (N.D.W. Va. Jan. 13, 2015). Accord In re NuvaRing Litigation, 2013 WL 1874321, *35-36 (N.J. Super. Law Div. April 18, 2013) (“West Virginia does not apply a heeding presumption”). Neither have we been able to locate any state or federal West Virginia case ever employing a heeding presumption.
The Wisconsin Supreme Court has never discussed the heeding presumption, and the Court of Appeals has swung both ways. In Tanner v. Shoupe, 596 N.W.2d 805, 817-18 (Wis. App. 1999), the court relied upon a comment j heeding presumption. However, in a more recent prescription medical product case, the same court held, that “[e]ven in the event that a warning is inadequate, proximate cause is not presumed.” Kurer v. Parke, Davis & Co., 679 N.W.2d 867, 876 (Wis. App. 2004) (patient ignored drug warnings to seek medical attention if certain symptoms developed). See Menges v. Depuy Motech, Inc., 61 F. Supp.2d 817, 830 (N.D. Ind. 1999) (“a plaintiff must not only show that a manufacturer’s warning was inadequate, but that such inadequacy affected the prescribing physician’s use of the product”) (applying Wisconsin law).
In Michaels v. Mr. Heater, Inc., 411 F. Supp.2d 992 (W.D. Wis. 2006), an expansive-minded federal court decided to follow Tanner rather than Kurer. 411 F. Supp.2d at 1006. Both Tanner and Michaels involved non-prescription products, which meant that “the facts of this case are more analogous to those confronted by the court in Tanner than in Kurer. 411 F. Supp.2d at 1007. However, a few months after Michaels, the Wisconsin Court of Appeals again took the Kurer route, this time in a non-prescription medical product case, holding “[a] plaintiff who has established both a duty and a failure to warn must also establish causation by showing that, if properly warned, he or she would have altered behavior and avoided injury.” Schreiner v. Wieser Concrete Products, Inc., 720 N.W.2d 525, 528 (Wis. App. 2006).
Most recently, in the 2011 the Wisconsin legislature enacted tort reform, requiring “the claimant” in all product liability cases to “establish all of the following by a preponderance of the evidence” including, “[t]hat the defective condition was a cause of the claimant’s damages.” Wis. Stat. §895.047(1)(e). If a heeding presumption ever existed under Wisconsin law, this statutory assignment of the burden of proof on causation should kill it.
In the absence of any Wyoming precedent, the court in Thom v. Bristol-Myers Squibb Co., 353 F.3d 848 (10th Cir. 2003) (applying Wyoming law), predicted that the state would apply a heeding presumption in a prescription medical product case. Id. at 855-56. The presumption was rebuttable by “testimony that a different warning would not have made a difference in the actions of the physician.” Id. at 855. Such rebuttal evidence includes “when a physician fails to read or rely on a drug manufacturer’s warnings,” id. at 856, but Thom found the evidence inconclusive. Id. at 857.
During the ensuing decade, no Wyoming court has followed Thom as to the heeding presumption.
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Finally, we’ve seen a number of courts, such as Thom, make statements to the effect that the heeding presumption is recognized in a “vast majority of jurisdictions.” 353 F.3d at 855. As we hope the above analysis has demonstrated, that’s simply not so.
If we’re discussing prescription medical product liability cases specifically, then to that nineteen, we would then add the three states (New Jersey, Pennsylvania, and Texas) that have excluded otherwise applicable heeding presumptions from all or most such cases. Thus, in prescription medical product case, specifically, jurisdictions rejecting a heeding presumption outnumber those recognizing it by 22-14, or at least 21-15, depending on how New York is counted. There is essentially no law at all in seven jurisdictions: Delaware (which never had strict liability), Florida (where the lack of precedent most surprises us), Idaho, Nebraska, New Mexico, Puerto Rico, and Rhode Island. If we were to add those to the “no” column, that would raise the number of no-heeding presumption jurisdictions to as many as 29.Thus the only way that the heeding presumption can reach any sort of majority – let alone a “vast” one – is to include the nine jurisdictions in which federal courts have improperly predicted the expansion of state tort liability by recognizing a heeding presumption in the absence of any supporting state-court precedent: Alaska, Georgia, Hawaii, Illinois, Iowa, Kentucky, Maine, South Dakota, and Wyoming. To those, we’ll also mention the two states (Colorado and New York) where federal courts have made predictions despite contrary state intermediate court authority. In Iowa, the federal prediction does not extend to cases involving prescription medical products that physicians actually prescribed.
On top of all that, almost every early adopter of the heeding presumption did so on the basis of language in Restatement (Second) of Torts §402A, comment j (1965), that (as we discussed at the beginning of this post) is not only omitted but specifically repudiated in the Third Restatement of Torts. Restatement (Third) of Torts, Products Liability §2, reporters notes to comment l (1998). All of the states adopting the heeding presumption did so prior to the ALI’s adoption of the Third Restatement, except Pennsylvania (which followed a pre-Third Restatement federal decision). Conversely, no state appellate court, with that one exception, has made an initial decision to adopt a heeding presumption since the ALI gave comment j its seal of disapproval in 1998.Majority? Schmajority. The real numbers tell a far different tale.