- Warnings go to physicians because they are the only people who know both a particular patient’s medical history as well as the risk/benefit profile of the drug/device being prescribed.
- Limiting warning duties to physicians makes the common law consistent with warning duties imposed by the FDA.
- Routing prescription drug/device information through the doctor preserves the physician/patient relationship from outside interference.
- The complicated medical terminology necessary to explain the risk/benefit profile of prescription drugs/devices is difficult for ordinary patients to understand.
- Practical difficulties often preclude drug/device companies from direct communication with patients.
But plaintiffs don’t make direct-to-patient warning claims only against drug/device companies. They’ll also tried to get around the learned intermediary rule by claiming that other entities in the drug/device (but mostly drug) distribution chain should have warned patients directly. Such claims have most frequently been made against pharmacies. Sometimes the plaintiffs are really serious about pharmacy warning claims, but more often pharmacies are sued on failure to warn theories for tactical reasons – such as adding a non-diverse (that’s a resident of the plaintiff’s home state, for you non-lawyers) defendant to prevent the case from being removed from state to federal court.
In either case, representing manufacturer defendants, we’d usually not have a pharmacist around complicating the case. A recent decision, Kowalski v. Rose Drugs of Dardanelle, Inc., slip op., ___ S.W.3d ___, 2011 WL 478601 (Ark. Feb. 9, 2011), says we we're right about that, at least in Arkansas. Interestingly, at least from the caption, it appears that Kowalski wasn’t a product liability suit at all, but a simple negligence action. The parties were a doctor, who prescribed a veritable cornocopia of drugs to the decedent, and the pharmacy. Evidently, the decedent took a bunch of these drugs all at once and died from what the court called “mixed drug intoxication.” Slip op. 2 (ordinarily we’d use the Westlaw pagination, but for some bizarre reason WL doesn’t provide any for Arkansas slips). There’s no indication in the opinion whether the decedent made an honest mistake or was trying to get high (as we'll see, several of these drugs were controlled substances).
Anyway, the claim against the doctor wasn’t involved in the Kowalski appeal. The claim against the pharmacy alleged that – even though every one of the prescriptions was regular and proper on its face – the pharmacy had a duty not to fill them because, taken together, the drugs could be fatal. The Arkansas Supreme Court, joining a substantial majority of other jurisdictions, said no. A pharmacist has no duty to inquire behind a facially regular prescription.
The court first rejected a quasi-negligence per se argument grounded in “certain duties imposed by regulations” upon pharmacists. Slip op. at 7. The court declined to base civil liability upon any of these regulations. The Controlled Substances Act, the court held, was designed to prevent distribution of certain drugs “outside the ordinary scope of . . . professional practice.” Id. at 8. The prescriptions in Kowalski, however, were regular – for proper amounts and for legitimate medical treatment. So the Controlled Substances Act did not apply. Id. at 9-10.
Additional federal pharmacy-related requirements were imposed by the Omnibus Budget Reconciliation Act of 1990, but the Kowalski court held that this statute created no private right of action. Slip op. at 11-12. The plaintiff also advanced Arkansas state pharmacy regulations, but none of these created any duty of pharmacists to warn either patients or prescribing physicians. Id. at 13-14.
That left the plaintiff in Kowalski with only common-law arguments that pharmacists should have a duty to warn patients (or prescribers) about regular prescriptions that could possibly cause some sort of harm. The court joined the majority of jurisdictions – basing its decision on the necessary implication of the learned intermediary rule (already adopted in Arkansas) that, if drug manufacturers only had to warn physicians, certainly the obligations on pharmacies could be no broader:
We believe, however, that the better approach is that adopted by the majority of jurisdictions that there is no general duty to warn imposed on pharmacists. Many of the jurisdictions that have refused to impose a general duty to warn have done so on the basis that the learned-intermediary doctrine places the duty to warn with the prescribing physician. Oftentimes, the underlying rationale for applying the learned-intermediary doctrine is to protect the patient-physician relationship by preventing pharmacists from second-guessing the physicians or otherwise interfering with the patient-physician relationship.Slip op. at 16-17 (really long string citation omitted). In addition to protecting the physician patient relationship, the purpose of the learned intermediary rule in ensuring that decisions were made by the person most knowledgeable of both the patient’s condition and the risks and benefits of the proposed therapy also came into play:
The relationship between the physician-patient-manufacturer applies equally to the relationship between the physician-patient and pharmacist. In both circumstances the patient must look to the physician, for it is only the physician who can relate the propensities of the drug to the physical idiosyncrasies of the patient. It is the physician who is in the best position to decide when to use and how and when to inform his patient regarding risks and benefits pertaining to drug therapy. We cannot say that [the defendant pharmacy] had a general duty to warn, to refuse to fill the prescriptions, or to inquire of [the prescribing physician]. The duty to warn of the medications’ dangers was with [the prescriber] who prescribed the drugs.
Id. at 18-19 (citations and quotation marks omitted).
We’ve mentioned the “majority rule” rejecting pharmacy liability several times. So we'll prove it - here’s our list of decisions so holding:
Alabama
Springhill Hospitals, Inc. v. Larrimore, 5 So.3d 513, 518-19 (Ala. 2008); Walls v. Alpharma USPD, Inc., 887 So.2d 881, 886 (Ala. 2004); Orr v. Wyeth-Ayerst Laboratories Co., 1999 WL 33548162, at * 2-5 (Ala. Cir. Aug. 2, 1999); In re Rezulin Products Liability Litigation, 133 F. Supp.2d 272, 292-93 (S.D.N.Y. 2001) (applying Alabama law); Wiggins v. American Home Products Corp., 2001 WL 34013629, at *3 (N.D. Ala. Oct. 2, 2001); Sanks v. Parke-Davis, 2000 WL 33910097, at *4 (M.D. Ala. Oct. 30, 2000); Lansdell v. American Home Products Corp., 1999 WL 33548541, at *5-7 (N.D. Ala. Oct. 26, 1999); Harrell v. Wyeth-Ayerst Laboratories, 1999 WL 33548540, at *1 (S.D. Ala. Feb. 1, 1999).
Arkansas
Kowalski v. Rose Drugs of Dardanelle, Inc., ___ S.W.3d ___, 2011 WL 478601 (Ark. Feb. 9, 2011); Cheatham v. Teva Pharmaceuticals, 726 F. Supp.2d 1021, 1023-24 (E.D. Ark. 2010); Kohl v. American Home Products Corp., 78 F. Supp.2d 885, 892 (W.D. Ark. 1999)
California
Murphy v. E.R. Squibb & Sons, Inc., 710 P.2d 247, 250-53 (Cal. 1985); San Diego Hospital Ass’n. v. Superior Court, 35 Cal. Rptr.2d 489, 492 (Cal. App. 1994); In re Baycol Products Litigation, 2003 WL 22331294, at *2-3 (D. Minn. May 19, 2003) (applying California law).
Connecticut
Levesque v. Cluett, 2007 WL 4305676, at *3 (Conn. Super. Oct. 16, 2007); Deed v. Walgreen Co., 927 A.2d 1001, 1003-04 (Conn. Super. 2007); Plante v. Lomibiao, 2005 WL 1090180, at *3-4 (Conn. Super. Mar. 31, 2005); Deed v. Walgreen Co., 2004 WL 2943271, at *5 (Conn. Super. Nov. 15, 2004); Nobles v. Astrazeneca Pharmaceuticals, 832 A.2d 1241, 1243 (Conn. Super. 2003), vacated in part on other grounds, 2003 WL 22245379 (Conn. Super. Sept. 10, 2003); White v. Stop & Shop Cos., 1998 WL 559730, at *2 (D. Conn. Aug. 17, 1998).
District of Columbia
Raynor v. Richardson-Merrell, Inc., 643 F. Supp. 238, 246-47 (D.D.C. 1986); Ealy v. Richardson-Merrell, Inc., 1987 WL 159970, at *2-3 (D.D.C. Jan. 12, 1987)
Florida
McLeod v. M.S. Merrell Co., 174 So.2d 736, 738-39 (Fla. 1965); Estate of Johnson v. Badger Acquisition LLC, 983 So.2d 1175, 1183-84 (Fla. App. 2008); Estate of Sharp v. Omnicare, Inc., 879 So.2d 34, 35-36 (Fla. App. 2004); Johnson v. Walgreen Co., 675 So.2d 1036, 1037 (Fla. App. 1996); Pysz v. Henry’s Drug Store, 457 So.2d 561, 562 (Fla. App. 1984); Bailey v. Janssen Pharmaceutica, Inc., 2006 WL 3665417, at *4 n.2 (S.D. Fla. Nov. 14, 2006); Layton v. SmithKline Beecham Corp., 2006 WL 2194498, at *3 (M.D. Fla. Aug. 2, 2006); In re Diet Drugs Products Liability Litigation, 2004 WL 1824357, at *5-6 (E.D. Pa. Aug. 12, 2004) (applying Florida law); In re Rezulin Products Liability Litigation, 2002 WL 511550, at *1 (S.D.N.Y. Apr. 4, 2002) (applying Florida law);
Georgia
Chamblin v. K-Mart Corp., 612 S.E.2d 25, 28-29 (Ga. App. 2005); Yarbrough v. Actavis Totowa, LLC, 2010 WL 3604674, at *3-4 (S.D. Ga. Sept. 13, 2010); Walker v. Jack Eckerd Corp., 434 S.E.2d 63, 67-69 (Ga. App. 1993).
Illinois
Frye v. Medicare-Glaser Corp., 605 N.E.2d 557, 559-61 (Ill. 1992); DiGiovanni v. Albertson's, Inc., 940 N.E.2d 73, 75-78 (Ill. App. 2010); Kasin v. Osco Drug Inc., 728 N.E.2d 77, 78-79 (Ill. App. 2000); Fakhouri v. Taylor, 618 N.E.2d 518, 519-22 (Ill. App. 1993); Leesley v. West, 518 N.E.2d 758, 761-63 (Ill. App. 1988); Eldridge v. Eli Lilly & Co., 485 N.E.2d 551, 553 (Ill. App. 1985); Stephens v. Hook-SupeRx, 359 Fed. Appx. 648, 650 (7th Cir. 2009) (applying Illinois law); In re Yasmin & Yaz Marketing, Sales Practices & Products Liability Litigation, 2010 WL 4904478, at *2-4 (S.D. Ill. Nov. 24, 2010); Stephens v. CVS Pharmacy, 2009 WL 1916402, at *2-3 (N.D. Ill. June 11, 2009); Happel v. Wal-Mart Stores, Inc., 286 F. Supp.2d 943, 946-47 (N.D. Ill. 2003); Jones v. Irvin, 602 F. Supp. 399, 401-02 (S.D. Ill. 1985); Grimmer v. Schmitz, 1985 WL 3031, at *1-2 (N.D. Ill. Oct. 8, 1985).
Indiana
Allberry v. Parkmor Drug, Inc., 834 N.E.2d 199, 202-03 (Ind. App. 2005); Ingram v. Hook’s Drugs, Inc., 476 N.E.2d 881, 886-87 (Ind. App. 1985); Peters v. Judd Drugs, Inc., 602 N.E.2d 162, 165 (Ind. App. 1992); Bobay v. Walgreen Co., 2009 WL 1940727, at *7-8 (N.D. Ind. June 30, 2009).
Kansas
Nichols v. Central Merchandise, 817 P.2d 1131, 1133 (Kan. App. 1991); In re Diet Drugs Products Liability Litigation, 2000 WL 1886594, at *2-3 (E.D. Pa. Dec. 7, 2000) (applying Kansas law).
Kentucky
Flint v. Target Corp., 2009 WL 8746, at *3-4 (W.D. Ky. Jan. 13, 2009); Smith v. Wyeth Inc., 488 F. Supp.2d 625, 628-29 (W.D. Ky. 2007); Foister v. Purdue Pharma, L.P., 295 F. Supp.2d 693, 706 (E.D. Ky. 2003).
Louisiana
Gassen v. East Jefferson General Hospital, 628 So.2d 256, 258-59 (La. App. 1993); Kinney v. Hutchinson, 449 So.2d 696, 698 (La. App. 1984); LeBlanc v. Wyeth, Inc., 495 F. Supp.2d 609, 615 (W.D. La. 2007); In re Diet Drugs Products Liability Litigation, 2004 WL 1925010, at *1 (E.D. Pa. Aug. 30, 2004) (applying Louisiana law); In re Rezulin Products Liability Litigation, 133 F. Supp.2d 272, 294 (S.D.N.Y. 2001) (applying Louisiana law); Pilet v. Ciba-Geigy Corp., 1996 WL 89262, at *3 (E.D. La. Feb. 28, 1996).
Maine
Tardy v. Eli Lilly & Co., 2004 WL 1925536, at *2-3 (Me. Super. Aug. 3, 2004).
Maryland
Hofherr v. Dart Industries, Inc., 853 F.2d 259, 263 (4th Cir. 1988) (applying Maryland law); Moore v. Wyeth-Ayerst Laboratories, 236 F. Supp.2d 509, 512-13 (D. Md. 2002).
Massachusetts
Cottam v. CVS Pharmacy, 764 N.E.2d 814, 819-20 (Mass. 2002); Kelley v. Eli Lilly & Co., 2007 WL 1238789, at *5, *7 (D.D.C. Apr. 27, 2007) (applying Massachusetts law).
Michigan
Saukas v. Walker Street Pharmacy, Inc., 2005 WL 1846289, at *1-2 (Mich. App. Aug. 4, 2005); Adkins v. Mong, 425 N.W.2d 151, 152-54 (Mich. App. 1988); Stebbins v. Concord Wrigley Drugs, Inc., 416 N.W.2d 381, 386-88 (Mich. App. 1987); Lemire v. Garrard Drugs, 291 N.W.2d 103, 105 (Mich. App. 1980).
Mississippi
Moore v. Memorial Hospital, 825 So.2d 658, 662 (Miss. 2002); Collins v. American Home Products Corp., 343 F.3d 765, 769 n.1 (5th Cir. 2003) (applying Mississippi law); In re Baycol Products Litigation, 2004 WL 1118642, at *4 (D. Minn. May 17, 2004) (applying Mississippi law); In re Diet Drugs Products Liability Litigation, 2004 WL 966263, at *2-3 (E.D. Pa. May 12, 2004) (applying Mississippi law); In re Rezulin Products Liability Litigation, 2003 WL 21396744, at *3 (S.D.N.Y. June 17, 2003) (applying Mississippi law); In re Diet Drugs Products Liability Litigation, 220 F. Supp.2d 414, 422 (E.D. Pa. 2002) (applying Mississippi law).
Nevada
Sanchez v. Wal-Mart Stores, Inc., 221 P.3d 1276, 1280-84 (Nev. 2009).
New York
In re New York County Diet Drug Litigation, 691 N.Y.S.2d 501, 502 (N.Y.A.D. 1999); Bichler v. Willing, 397 N.Y.S.2d 57, 58-59 (N.Y.A.D. 1977); Ullman v. Grant, 450 N.Y.S.2d 955, 956-57 (N.Y. Sup. 1982); Winters v. Alza Corp., 690 F. Supp.2d 350, 354 (S.D.N.Y. 2010); Fagan v. AmerisourceBergen Corp., 356 F. Supp.2d 198, 212-14 (E.D.N.Y. 2004); Negrin v. Alza Corp., 1999 WL 144507, at *3-5 (S.D.N.Y. 1999) (applying New York law).
North Carolina
Batiste v. American Home Products Corp., 231 S.E.2d 269, 274-76 (N.C. App. 1977).
Pennsylvania
Coyle v. Richardson-Merrell, Inc., 584 A.2d 1383, 1386-88 (Pa. 1991); Makripodis v. Merrell-Dow Pharmaceuticals, Inc., 523 A.2d 374, 376-79 (Pa. Super. 1987); Ramirez v. Richardson-Merrell, Inc., 628 F. Supp. 85, 87-88 (E.D. Pa. 1985).
South Carolina
Madison v. American Home Products Corp., 595 S.E.2d 493, 495-96 (S.C. 2004).
Texas
Morgan v. Wal-Mart Stores, Inc., 30 S.W.3d 455, 460-66 (Tex. App. 2000); Wimm v. Jack Eckerd Corp., 3 F.3d 137, 142 (5th Cir. 1993) (applying Texas law); In re Diet Drugs Products Liability Litigation, 2004 WL 1535828, at *9 (E.D. Pa. July 6, 2004) (applying Texas law); In re Rezulin Products Liability Litigation, 133 F. Supp.2d 272, 294 (S.D.N.Y. 2001) (applying Texas law); Speer v. United States, 512 F. Supp. 670, 679-80 (N.D. Tex. 1981), aff’d without op., 675 F.2d 100 (5th Cir. 1982).
Utah
Schaerrer v. Stewart’s Plaza Pharmacy, Inc., 79 P.3d 922, 929-30 (Utah 2003).
Washington
McKee v. American Home Products Corp., 782 P.2d 1045, 1049 (Wash. 1989); Silves v. King, 970 P.2d 790, 794 (Wash. App. 1990); Luke v. Family Care & Urgent Medical Clinics, 246 Fed. Appx. 421, 425 (9th Cir. 2007) (applying Washington law).
Vermont
Estate of Baker v. University of Vermont, 2005 WL 6280644 (Vt. Super. May 4, 2005).
Virginia
Gressman v. Peoples Service Drug Stores, Inc., 1988 WL 619115, at *6-8 (Va. Cir. 1988).
West Virginia
W. Va. Code § 30-5-2; Vagenos v. Alza Corp., 2010 WL 2944683, at *3-5 (S.D.W. Va. July 23, 2010); Ashworth v. Albers Medical, Inc., 395 F. Supp.2d 395, 407-08 (S.D.W. Va. 2005); In re Baycol Products Litigation, 2003 WL 22038708, at *7-8 (D. Minn. Feb. 25, 2003) (applying West Virginia law); Baker v. Purdue Pharma L.P., 2002 WL 34213424, at *3-5 (S.D.W. Va. Mar. 28, 2002); In re Rezulin Products Liability Litigation, 133 F. Supp.2d 272, 294 (S.D.N.Y. 2001) (applying West Virginia law). Note: While the statute will control the precise question, some of the cases apply the learned intermediary rule, which the West Virginia Supreme Court has subsequently rejected.
Wyoming
Van Dyke v. United States, 388 Fed. Appx. 786, 793 (10th Cir. 2010).