By now, the learned intermediary rule is so well established that new opinions addressing core learned intermediary issues, as opposed to applying the rule to specific fact patterns, are relatively uncommon. The last one of those we covered was the Seventh Circuit’s prediction that Wisconsin would adopt the learned intermediary rule, almost a year ago in In re Zimmer, NexGen Knee Implant Products Liability Litigation, 884 F.3d 746 (7th Cir. 2018).
We’ve got another.
In Ideus v. Teva Pharmaceuticals USA, Inc., ___ F. Supp.3d ___, 2019 WL 912121 (D. Neb. Feb. 19, 2019), the court, applying Nebraska law, held that the learned intermediary rule applied to a copper intra-uterine device (“IUD”). The foundational learned intermediary question in Nebraska was decided in Freeman v. Hoffman-La Roche, Inc., 618 N.W.2d 827, 841 (Neb. 2000), adopting the rule as enunciated in Restatement (Third) of Torts, Products Liability §6(d) (1998), but the plaintiff in Ideus invoked purported “exceptions” in an attempt to avoid the rule. The most on-point of those exceptions was “for prescription contraceptives.” 2019 WL 912121, at *2.
Ideus thoroughly trashed that supposed exception, pointing out that the Eighth Circuit got it wrong thirty years ago in Hill v. Searle Laboratories, 884 F.2d 1064, 1070 (8th Cir. 1989), when it predicted that Arkansas would adopt such an exception. But in West v. Searle Co., 806 S.W.2d 608, 614 (Ark. 1991), the Arkansas Supreme Court rejected the West prediction and the purported contraceptive exception. 2019 WL 912121, at *3. This discussion reminds us of what recently happened in Arizona, with the en banc Ninth Circuit getting “Spalding” embossed in its collective forehead from the Arizona Supreme Court’s forceful (and unanimous) rejection of its mythical tort “duty to report” to the FDA.
So, with West both non-binding (being a different state’s law) and discredited even in that state, Ideus followed the clear majority rule, and overwhelming recent trend, and rejected the idea of a “contraceptive exception” to the learned intermediary rule. First, “determining what contraceptive fits [a patient’s] particular criteria necessarily requires the knowledge and advice of a physician.” 2019 WL 912121, at *4. Therefore, there was “no reason to distinguish between a patient’s final choice to use a particular contraceptive and a patient’s final decision relating to any other course if treatment.” Id.
[T]he fact that the patient makes the final choice among suggested contraceptives (or decides not to use any at all) does not constitute a distinction which makes the [learned intermediary] rule inapplicable. [The Court] can readily conceive of situations in which a physician gives the patient a choice of courses to follow. There is, for example, a patient’s choice between continuing to endure a physical ailment or submitting to surgery or some other course of treatment; an obese person’s choice among diets suggested by the doctor; and a surgery patient’s choice of anesthesia. . . .
In any such situation which may come to mind, the patient is expected to look to the physician for guidance and not to the manufacturer of the products which he may use or prescribe in the course of treatment.
Id. (quoting Terhune v. A.H. Robins Co., 577 P.2d 975, 978 (Wash. 1978)). Nothing inherent in contraceptives justified singling them out for an exception to the learned intermediary rule:
[W]hatever differences there may be between contraceptives and “typical” prescription drugs, they have one important thing in common: both are always prescribed by a physician or through the services of a physician. And when a patient relies on the skill and knowledge of a physician in any particular method of treatment, the learned intermediary doctrine ought to apply. This is no less true for prescription contraceptives as for any other prescription medication.
Id. (citation omitted).
Finally, Ideus relied upon Nebraska’s adoption of the Third Restatement §6(d)’s version of the learned intermediary rule, which did not recognize any exception for contraceptives.
[T]hat section of the Restatement acknowledges circumstances under which the doctrine might not be applicable. . . . [N]othing in the record or the parties’ arguments . . . suggest[s] with respect to contraceptives in general . . . that a health care provider is not in a position to reduce the risk of any foreseeable harm to the patient. In other words, the Nebraska Supreme Court did acknowledge the possibility of exceptions to the learned intermediary doctrine, when it expressly adopted § 6(d) of the Restatement − but nothing suggests that such an exception should be recognized here.
2019 WL 912121, at *5 (citations and quotation marks omitted).
Thus, Ideus predicted that “the Nebraska Supreme Court would following the overwhelming majority of decisions that have applied the learned intermediary doctrine to cases involving contraceptives.” Id. The court followed with an impressive string citation to well over a dozen cases applying the learned intermediary rule to contraceptives of various types. Id. This being the DDLaw Blog, however, we will provide our own, even more extensive, list of such cases:
State Supreme Court Cases:
Martin v. Ortho Pharmaceutical Corp., 661 N.E.2d 352, 356-57 (Ill. 1996); Shanks v. Upjohn Co., 835 P.2d 1189, 1200 (Alaska 1992); West v. Searle & Co., 806 S.W.2d 608, 613-14 (Ark. 1991); Humes v. Clinton, 792 P.2d 1032, 1039-41 (Kan. 1990); Lacy v. G.D. Searle & Co., 567 A.2d 398, 400-01 (Del. 1989); Tetuan v. A.H. Robins Co., 738 P.2d 1210, 1228 (Kan. 1987); Wooderson v. Ortho Pharmaceutical Corp., 681 P.2d 1038, 1052 (Kan. 1984), McKee v. Moore, 648 P.2d 21, 25 (Okla. 1982); Seley v. G.D. Searle & Co., 423 N.E.2d 831, 839-40 (Ohio 1981); Terhune, 577 P.2d at 978; Vaughn v. G.D. Searle & Co., 536 P.2d 1247, 1248 (Or. 1975); McEwen v. Ortho Pharmaceutical Corp., 528 P.2d 522, 528 (Or. 1974).
Other State Cases:
Wyeth-Ayerst Laboratories Co. v. Medrano, 28 S.W.3d 87, 91 (Tex. App. 2000); Plenger v. Alza Corp., 13 Cal. Rptr.2d 811, 819 n.6 (Cal. App. 1992); Taurino v. Ellen, 579 A.2d 925, 928 (Pa. Super. 1990); Brecher v. Cutler, 578 A.2d 481, 485 (Pa. Super. 1990); Rhoto v. Ribando, 504 So.2d 1119, 1123 (La. App. 1987); Eiser v. Feldman, 507 N.Y.S.2d 386, 387-88 (N.Y. App. Div. 1986); Taylor v. Wyeth Laboratories, Inc., 362 N.W.2d 293, 297 & n.11 (Mich. App. 1984); Cobb v. Syntex Laboratories, 444 So.2d 203, 205 (La. App. 1983); Reeder v. Hammond, 336 N.W.2d 3, 5 (Mich. App. 1983); Ortho Pharmaceutical Corp. v. Chapman, 388 N.E.2d 541, 548-49, 553, 557 (Ind. App. 1979); Hamilton v. Hardy, 549 P.2d 1099, 1110 (Colo. App. 1976), overruled on other grounds, State Board of Medical Examiners v. McCroskey, 880 P.2d 1188 (Colo. 1994); Leibowitz v. Ortho Pharmaceutical Corp., 307 A.2d 449, 457 (Pa. Super. 1973); Carmichael v. Reitz, 95 Cal. Rptr. 381, 400-01 (Cal. App. 1971) (contraceptive prescribed for other purpose); Hayes-Jones v. Ortho-McNeil Pharmaceutical, 2012 WL 3164558 (N.J. Super. Law Div. Aug. 3, 2012) (applying Virginia law).
Federal Courts of Appeals:
Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F.3d 281, 292-93 (6th Cir. 2015) (applying New York law); In re Norplant Contraceptive Products Litigation, 165 F.3d 374, 379 (5th Cir. 1999) (applying Texas law); Odom v. G.D. Searle & Co., 979 F.2d 1001, 1003-04 (4th Cir. 1992) (applying South Carolina law); Beyette v. Ortho Pharmaceutical Corp., 823 F.2d 990, 992-93 (6th Cir. 1987) (applying Michigan law); Brochu v. Ortho Pharmaceutical Corp., 642 F.2d 652, 656 (1st Cir. 1981) (applying New Hampshire law); Lindsay v. Ortho Pharmaceutical Corp., 637 F.2d 87, 91 (2d Cir. 1980) (applying New York law).
Federal District Courts:
Lussan v. Merck Sharp & Dohme Corp., 2017 WL 2377504, at *3 (E.D. La. June 1, 2017); Gonzalez v. Bayer Healthcare Pharmaceuticals, Inc., 930 F. Supp.2d 808, 813 (S.D. Tex. 2013); Hanhan v. Johnson & Johnson, 2013 WL 5939720, at *3 (N.D. Ohio Nov. 5, 2013) (applying California law); James v. Ortho-McNeil Pharmaceutical, Inc., 2011 WL 3566844, at *3 (N.D. Ohio Aug, 12, 2011) (applying Louisiana law); In Re Yasmin & Yaz (Drospirenone) Marketing, Sales Practices & Products Liability Litigation, 692 F. Supp.2d 1025, 1033-34 (S.D. Ill. 2010), aff’d, 643 F.3d 994 (7th Cir. 2011); Mendez Montes De Oca v. Aventis Pharma, 579 F. Supp.2d 222, 228 (D.P.R. 2008); In re Norplant Contraceptive Products Liability Litigation, 215 F. Supp.2d 795, 809-10 (E.D. Tex. 2002) (applying law of all fifty states); Nelson v. Dalkon Shield Claimants Trust, 1994 WL 255392, at *4 (D.N.H. June 8, 1994); MacPherson v. Searle & Co., 775 F. Supp. 417, 424-25 (D.D.C. 1991); Reaves v. Ortho Pharmaceutical Corp., 765 F. Supp. 1287, 1291 (E.D. Mich. 1991); Zanzuri v. G.D. Searle & Co., 748 F. Supp. 1511, 1514-15 (S.D. Fla. 1990); Amore v. G.D. Searle & Co., 748 F. Supp. 845, 849-50 (S.D. Fla. 1990); Allen v. G.D. Searle & Co., 708 F. Supp. 1142, 1147-48 (D. Or. 1989); Spychala v. G.D. Searle & Co., 705 F. Supp. 1024, 1032 (D.N.J. 1988); Kociemba v. G.D. Searle & Co., 680 F. Supp. 1293, 1305-06 (D. Minn. 1988); Dupre v. G.D. Searle & Co., 1987 WL 158107, at *4 (D.N.H. April 28, 1987); Skill v. Martinez, 91 F.R.D. 498, 507 (D.N.J. 1981), aff’d per curiam, 677 F.2d 368 (3d Cir. 1982); Steinmetz v. A.H. Robins Co., 1981 U.S. Dist. Lexis 14314, at *3-5 (D. Or. Aug. 27, 1981); Goodson v. Searle Laboratories, 471 F. Supp. 546, 548 (D. Conn. 1978); Dunkin v. Syntex Labs, Inc., 443 F. Supp. 121, 123 (W.D. Tenn. 1977); Chambers v. G. D. Searle & Co., 441 F. Supp. 377, 381 (D. Md. 1975), aff’d per curiam, 567 F.2d 269 (4th Cir. 1977) (applying District of Columbia law).
Secondarily, the plaintiff in Ideus tried to assert the so-called “direct to consumer” advertising exception to the learned intermediary rule. The decision disposed of that contention in a footnote:
For the same reason, to the extent that [plaintiff] claims the direct consumer marketing exception to the learned intermediary doctrine applies, that argument has no merit. If anything, it further supports the Court’s conclusion the contraceptives and other prescription drugs are not actually distinguishable.
Ideus, 2019 WL 912121, at *4 n.3 (citations omitted). We don’t have to provide a list of cases here, because we’ve thoroughly addressed the almost universal rejection of the direct-to-consumer exception before. That post was in January, 2011. However, for the sake of completeness, here are more recent cases also rejecting any direct to consumer exception:
Watts v. Medicis Pharmaceutical Corp., 365 P.3d 944, 950-51 (Ariz. 2016); Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 159-64 (Tex. 2012) (reversing lower court adoption); Shah v. Forest Laboratories, Inc., 2015 WL 3396813, at *6 (N.D. Ill. May 26, 2015); Thomas v. Abbott Laboratories, 2014 WL 4197494, at *6 (C.D. Cal. July 29, 2014); McKay v. Novartis Pharmaceuticals Corp., 934 F. Supp.2d 898, 910 (W.D. Tex. 2013), aff’d, 751 F.3d 694 (5th Cir. 2014); In re Avandia Marketing, Sales Practices & Products Liability Litigation, 2013 WL 3486907, at *2 (E.D. Pa. July 10, 2013); Calisi v Abbott Laboratories, 2013 WL 5462274, at *3 (D. Mass. Feb. 25, 2013); DiBartolo v. Abbott Laboratories, 914 F. Supp.2d 601, 614-15 (S.D.N.Y. 2012); Swoverland v. GlaxoSmithKline, 2011 WL 6001864, at *2 (D. Conn. Oct. 5, 2011); James, 2011 WL 3566844, at *3.
Why the plaintiff in Ideus was desperate to avoid the learned intermediary rule was obvious from the rest of the opinion – the defendant’s warning was adequate as a matter of law because it warned physicians of exactly the risk that plaintiff blamed for her injuries. Her only hope was to require a manufacturer warning directly to her (which wasn’t given):
[Plaintiff] has not even named the physician who prescribed and placed her IUD − much less demonstrated that had that physician been given the proper warning, she would not have placed [the device]. . . . [T]he package insert expressly warned about the possibility of breakage, embedment, and the difficulties of removing [device], making the warning adequate as a matter of law. A warning is adequate if it accurately and unambiguously coveys the scope and nature of the risk to the prescribing physician.
2019 WL 912121, at *6 (citations omitted).
Astute readers will note that many of the cases in our (and Ideus’) string cites are pretty old – more from the 1970s to 1990s than afterwards. It’s a stroll down memory lane, and we hope it will stay that way. As Bexis’ book points out, concerning this erstwhile exception to the learned intermediary rule, “The trend of judicial decisions has shown little acceptance of this exception . . ., and several of the decisions that initially recognized it are now of questionable validity.” Beck & Vale, “Drug and Medical Device Product Liability Deskbook” §2.03[e], at 2.03-70 (2018). Indeed, subtracting the “questionable” jurisdictions, leaves only one – Massachusetts – definitely still following it. So it’s no more widely accepted nowadays than the direct to consumer exception peculiar to New Jersey.