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50-State Survey: The Learned Intermediary Doctrine

The world is waiting as pharmaceutical drug manufacturers rush to create products that can cure and treat COVID-19. In all likelihood, these products will require a doctor’s prescription before patients can access it. Patients will surely have questions for their doctors, including concerns about side effects or potential complications from taking the medication.  But who has a duty to warn patients of any foreseeable potential side effects and risks?

 Most states have answered that question by adopting what’s called the “learned intermediary doctrine.” While pharmaceutical drug and medical device manufacturers owe a duty to consumers to warn them of any foreseeable risks associated with using their product, under the learned intermediary doctrine, that duty is fulfilled by providing a patient’s physician (i.e., a learned intermediary) adequate warning.[1] The doctrine focuses on the importance of the patient-physician relationship and recognizes that physicians are in the best position to inform their patients of risks associated with pharmaceutical drugs and medical devices.[2]  While the contours of the learned intermediary doctrine vary from state-to-state, most jurisdictions have adopted some version of it.

The following states have adopted the learned intermediary doctrine by either the supreme court or intermediary appellate court:

  • Alabama: Walls v. Alpharma USPD, 887 So.2d 881, 883 (Ala. 2004)
  • Alaska: Shanks v. Upjohn Co., 835 P.2d 1189, 1200 & n.17 (Alaska 1992)
  • Arizona: Watts v. Medicis Pharm. Corp., 365 P.3d 944, 947-51 (Ariz. 2016)
  • Arkansas: West v. Searle & Co., 806 S.W.2d 608, 613 (Ark. 1991)
  • California: Carlin v. Super. Ct., 920 P.2d 1347, 1354 (Cal. 1996)
  • Colorado: O’Connell v. Biomet, Inc., 250 P.3d 1278, 1281-82 (Colo. App. 2010)
  • Connecticut: Hurley v. Heart Physicians, P.C., 898 A.2d 777, 783-84 (Conn. 2006)
  • Delaware: Lacy v. G.D. Searle & Co., 567 A.2d 398, 400-01 (Del. 1989)
  • District of Columbia: Mampe v. Ayerst Labs., 548 A.2d 798, 801 & n.6 (D.C. 1988)
  • Florida: E.R. Squibb & Sons, Inc. v. Farnes, 697 So.2d 825, 827 (Fla. 1997)
  • Georgia: McCombs v. Synthes, 587 S.E.2d 594, 595 (Ga. 2003)
  • Hawaii: Craft v. Peebles, 893 P.2d 138, 155 (Hawaii 1995)
  • Idaho: Sliman v. Aluminum Co. of America, 731 P.2d 1267, 1270 (Idaho 1986)
  • Illinois: Urbaniak v. American Drug Stores, LLC, 126 N.E.3d 561, 566-70 (Ill. 2019);
    Happel v. Wal-Mart Stores, Inc., 766 N.E.2d 1118, 1127 (Ill. 2002)
  • Indiana: Ortho Pharm. Corp. v. Chapman, 388 N.E.2d 541, 548-59 (Ind. App. 1979)
  • Kansas: Savina v. Sterling Drug, Inc., 795 P.2d 915, 928 (Kan. 1990)
  • Kentucky: Larkin v. Pfizer, Inc., 153 S.W.3d 758, 761 (Ky. 2004)
  • Louisiana: Kampmann v. Mason, 921 So.2d 1093, 1094 (La. App. 2006)
  • Maryland: Rite Aid Corp. v. Levy-Gray, 894 A.2d 563, 577 (Md. 2006)
  • Massachusetts: Cottam v. CVS Pharmacy, 764 N.E.2d 814, 820 (Mass. 2002)
  • Michigan: Smith v. E.R. Squibb & Sons, Inc., 273 N.W.2d 476, 479 (Mich. 1979)
  • Minnesota: Mulder v. Parke Davis & Co., 181 N.W.2d 882, 885 n.1 (Minn. 1970)
  • Mississippi: Miss. Code Ann. § 11-1-63(c)(ii) (DATE); Janssen Pharmaceutica, Inc. v. Bailey, 878 So.2d 31, 57 (Miss. 2004)
  • Missouri: Krug v. Sterling Drug, Inc., 416 S.W.2d 143, 146-47 (Mo. 1967)
  • Montana: Stevens v. Novaritis Pharms. Corp.,247 P.3d 244, 259 (Mont. 2010)
  • Nebraska: Freeman v. Hoffman-La Roche, Inc., 618 N.W.2d 827, 841-42 (Neb. 2000)
  • Nevada: Klasch v. Walgreen Co., 264 P.3d 1155, 1159 (Nev. 2011)
  • New Jersey: N.J. Stat. Ann. § 2A:58C-4 (DATE); Perez v. Wyeth Laboratories, Inc., 734 A.2d 1245, 1257 (N.J. 1999) (note exception for direct-to-consumer advertised products in Perez v. Wyeth Laboratories, Inc., 734 A.2d 1245, 1256 (N.J. 1999))
  • New Mexico: Serna v. Roche Labs., Div. of Hoffman-LaRoche, Inc., 684 P.2d 1187, 1189 (N.M. App. 1984)
  • New York: Spensieri v. Lasky, 723 N.E.2d 544, 549 (N.Y. 1999)
  • North Carolina: N.C. Gen. Stat. § 99B-5(c) (1995) (DATE)
  • Ohio: Ohio Rev. Code Ann. § 2307.76(C) (DATE); Howland v. Purdue Pharma, L.P., 821 N.E.2d 141, 146 (Ohio 2004)
  • Oklahoma: Edwards v. Basel Pharms., 933 P.2d 298, 300-01 (Okla. 1997)
  • Oregon: Oksenholt v. Lederle Labs., 656 P.2d 293, 296-97 (Or. 1982)
  • Pennsylvania: Coyle v. Richardson-Merrell, Inc., 584 A.2d 1383, 1385 (Pa. 1991)
  • Tennessee: Pittman v. Upjohn Co., 890 S.W.2d 425, 429 (Tenn. 1994)
  • Texas: Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 154-59 (Tex. 2012)
  • Utah: Schaerrer v. Stewart’s Plaza Pharmacy, Inc., 79 P.3d 922, 928-29 (Utah 2003)
  • Virginia: Pfizer, Inc. v. Jones, 272 S.E.2d 43, 44 (Va. 1980)
  • Washington: Washington State Physicians Ins. Exch. & Ass’n v. Fisons Corp., 858 P.2d 1054, 1061 (Wash. 1993)
  • West Virginia: W. Va. Code § 55-7-30 (DATE)
  • Wyoming: Rohde v. Smiths Med., 165 P.3d 433, 438 (Wyo. 2007)

The following jurisdictions have neither accepted or rejected the learned intermediary theory. Federal courts, however, have made an Erie prediction that the jurisdictions would adopt the learned intermediary doctrine:

  • Iowa: Petty v. United States, 740 F.2d 1428, 1440 (8th Cir. 1984); see also McCormick v. Nikkel & Assocs., Inc., 819 N.W. 2d 368, 375 (Iowa 2012) (court noting in construction subcontractor dispute that court “recognize[s] various ‘no duty’ rules in the warning area” such as the learned intermediary doctrine but citing no Iowa cases applying the doctrine)
  • New Hampshire: Brochu v. Ortho Pharm. Corp., 642 F.2d 652, 656 (1st Cir. 1981)
  • North Dakota: Ehlis v. Shire Richwood, Inc., 367 F.3d 1013, 1017 (8th Cir. 2004)
  • Puerto Rico: Guevara v. Dorsey Labs., Div. of Sandoz, Inc., 845 F.2d 364, 366 (1st Cir. 1988)
  • Rhode Island: Greaves v. Eli Lilly and Co., 503 F. App’x 70, 71-72 (2d. Cir. 2012)
  • South Carolina: Odom v. G.D. Searle &. Co., 979 F.2d 1001, 1004 (4th Cir. 1992)
  • South Dakota: McElhaney v. Eli Lilly & Co., 575 F. Supp. 228, 231 (D.S.D. 1983), aff’d, 739 F.2d 340 (8th Cir. 1984)
  • Wisconsin: In re Zimmer, 884 F.3d 746, 751-52 (7th Cir. 2018)

Although the Maine Supreme Judicial Court has not adopted or applied the learned intermediary doctrine, the First Circuit has predicted that Maine would adopt the learned intermediary doctrine, and a trial court in Maine has applied the doctrine for pharmacists:

  • Maine: Violette v. Smith & Nephew Dyonics, Inc., 62 F.3d 8, 13 (1st Cir. 1995); Tardy v. Eli Lily and Co., 2004 WL 1925536, *1-3 (Super. Ct. Me. 2004)

Vermont has only a state trial court order discussing the learned intermediary doctrine:

  • Vermont: Estate of Baker v. Univ. of Vt., No. 233-10-03, 2005 WL 6280644 (Vt. Super. May 4, 2005)

[1] David G. Owen & Mary J. Davis, Owen & Davis on Prod. Liab. § 9:25, Westlaw (database updated May 2020).

[2] Id.

Finis