Source: https://www.druganddevicelawblog.com/2014/11/who-heeds-heeding-presumption.html
Timestamp: 2019-09-21 21:45:39
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Home » Who Heeds The Heeding Presumption?
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.
“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).
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).
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.”
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.
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).
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).
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.
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.
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).
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:
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).
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.
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).
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.
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).
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.
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.
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.
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).
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”).
The Ohio heeding presumption is rebuttable, and was rebutted in Seley:
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).
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.
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).
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).
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.
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).
[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.
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).
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).
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.
By our count, the heeding presumption has been adopted by a state court (at any level) in nineteen jurisdictions: Arizona, Arkansas, the District of Columbia, Indiana, Kansas, Louisiana, Maryland, Massachusetts, Missouri, New Jersey, New York, North Dakota, Ohio, Oklahoma, Pennsylvania, Texas, Utah, Vermont, and Wisconsin. In four of those states (New Jersey, Pennsylvania, Texas, and Wisconsin) the heeding presumption has either been abolished by statute (Wisconsin) or eliminated in all (Pennsylvania, Texas) or most (New Jersey) cases involving prescription medical products. In New York (as in pre-statute Wisconsin), there is at least as much state-court authority against the heeding presumption as in favor of it. So in the prescription medical product area, there are fourteen jurisdictions that allow a generally applicable heeding presumption in the drug/device cases that we typically defend.
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.