§63.11 Learned Intermediary Doctrine

The Case: Pittman v. Upjohn Co ., 890 S.W.2d 425 (Tenn. 1994).

The Basic Facts : Plaintiff's decedent mistakenly took a prescription drug thinking it was aspirin. Suit was filed against the prescription drug manufacturer.

The Bottom Line:

• "Drug manufacturers have a duty to exercise ordinary and reasonable care not to expose the public to an unreasonable risk of harm from the use of their products. See O'Hare v. Merck & Company, [381 F.2d 286, 291 (8th Cir. 1967)]. Manufacturers of prescription drugs, like the manufacturers of any other unavoidably dangerous product, have a duty to market and distribute their products in a way that minimizes the risk or danger. They may discharge their duty by distributing the drugs with proper directions and adequate warnings to those who foreseeably could be injured by the use of their products. See [RESTATEMENT (SECOND) OF TORTS, § 402A comment k (1965)]; Stanback v. Parke, Davis & Co., 657 F.2d 642, 644 (4th Cir.1981); Buckner v. Allergan Pharmaceuticals, [400 So.2d 820, 822 (Fla. Dist. Ct. App. 1981)]; Wooderson v. Ortho Pharmaceutical Corp., [681 P.2d 1038, 1050 cert. denied, 469 U.S. 965 (1984)]." 890 S.W.2d at 428-29.
• "The means whereby the product is dispersed is significant in determining to whom appropriate warnings should be given. As noted by the Court of Appeals in Laws v. Johnson, [799 S.W.2d 249 (Tenn. Ct. App. 1990)]:

  In considering the issue at bar it is necessary to recognize there is one body of the law relating to 'proprietary or patent medicine' and the other relating to 'ethical drugs' dispensed only by prescription. In dispensing 'proprietary or patent' medicine all warnings relating to the use of the drug must be given to the consumer of the drug. In dispensing 'ethical or prescription' drugs all warnings relating to the use of the drug must be given to the doctor or physician prescribing the drug. Id. at 251."

  Id . at 429.
• "Under the 'learned intermediary doctrine,' makers of unavoidably unsafe products who have a duty to give warnings may reasonably rely on intermediaries to transmit their warnings and instructions. See [RESTATEMENT (SECOND) OF TORTS, § 388 comment n, (1965)]; Whitehead v. Dycho Co., [775 S.W.2d 593, 598 (Tenn. 1989)]; Brushwood & Simonsmeier, Drug Information for Patients, 7 J. Legal Med. 279, 284 (1986)]. Physicians are such intermediaries because of the pivotal role they play in the unique system used to distribute prescription drugs. [W. Page Keeton, et al., Prosser and Keeton on the Law of Torts, § 98, at 688 (5th ed. 1984)]. Accordingly, a majority of jurisdictions now recognize that the manufacturer of an unavoidably unsafe prescription drug can discharge its duty to warn by providing the physician with adequate warnings of the risks associated with the use of its drug. Stone v. Smith, Kline & French Laboratories, [731 F.2d 1575, 1579-80 (11th Cir. 1984)]; Reyes v. Wyeth Laboratories, [498 F.2d 1264, 1276 (5th Cir.), cert. denied, 419 U.S. 1096 (1974)]; [3 L. Frumer & M. Friedman, Products Liability § 50.03[c], at 50-229 (1992)]; [Brushwood & Simonsmeier, Drug Information for Patients, 7 J. Legal Med. 279, 284-88 (1986)]. However, physicians can be learned intermediaries only when they have received adequate warnings. Amore v. G.D. Searle & Co., [748 F.Supp. 845, 850 (S.D. Fla. 1990)]. Thus, the learned intermediary doctrine does not shield a drug manufacturer from liability for inadequate warnings to the physician. Tracy v. Merrell Dow Pharmaceuticals, Inc., [569 N.E.2d 875, 878 (Ohio 1991)]." Id. at 429.
• "Warnings concerning prescription drugs generally are adequate when they contain a full and complete disclosure of the potential adverse reactions to the drug. A reasonable warning not only conveys a fair indication of the dangers involved, but also warns with the degree of intensity required by the nature of the risk. Seley v. G.D. Searle & Co., [423 N.E.2d 831, 837 (Ohio 1981)]. Among the criteria for determining the adequacy of a warning are:

  1. the warning must adequately indicate the scope of the danger; 2. the warning must reasonably communicate the extent or seriousness of the harm that could result from misuse of the drug; 3. the physical aspects of the warning must be adequate to alert a reasonably prudent person to the danger; 4. a simple directive warning may be inadequate when it fails to indicate the consequences that might result from failure to follow it and, ... 5. the means to convey the warning must be adequate.

  Serna v. Roche Laboratories , [684 P.2d 1187, 1189 (N.M. Ct. App. 1984)]." Id.
• "The adequacy of a drug manufacturer's warnings is normally a question of fact. Abbot v. American Cyanamid Co., [844 F.2d 1108, 1115 (4th Cir.), cert. denied, 488 U.S. 908 (1988)]; Mahr v. G.D. Searle & Co., [390 N.E.2d 1214, 1230 (Ill. Ct. App. 1979)]; Reeder v. Hammond, [336 N.W.2d 3, 5 (Mich. Ct. App. 1983)]. It becomes a question of law only when the instructions are accurate and unambiguous. Miles Laboratories, Inc. v. Superior Court of Orange County, 133 Cal.App.3d 587, 184 Cal.Rptr. 98, 104 (1982); Felix v. Hoffman-LaRoche, Inc., [540 So.2d 102, 105 (Fla. 1989)]." Id. at 429-30.
• "Pittman challenges the adequacy of The Upjohn Company's warnings concerning Micronase in two particulars. First, he asserts that The Upjohn Company did not adequately direct physicians to warn their patients of the adverse effects of Micronase and of the precautions to be taken if these effects manifest themselves. Second, he asserts that The Upjohn Company's warnings should have advised physicians to warn their patients not to share their Micronase with others. Both of these issues can be disposed of as a matter of law." Id. at 430.
• "The Upjohn Company's materials concerning Micronase contain the following precautions:

  Hypoglycemia: All sulfonylureas are capable of producing severe hypoglycemia. Proper patient selection and dosage and instructions are important to avoid hypoglycemic episodes.
  
  Information for Patients: Patients should be informed of the potential risks and advantages of Micronase and of alternative modes of therapy. They also should be informed about the importance of adherence to dietary instructions, of a regular exercise program, and of regular testing of urine and/or blood glucose.
  
  The risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development should be explained to patients and responsible family members. Primary and secondary failure should also be explained."

  Id . at 430.
• "In the section dealing with overdoses, The Upjohn Company's materials state:

  Overdosage of sulfonylureas, including Micronase Tablets, can produce hypoglycemia. Mild hypoglycemic symptoms, without loss of consciousness or neurological findings, should be treated aggressively with oral glucose and adjustments in drug dosage and/or meal patterns. Case monitoring should continue until the physician is assured that the patient is out of danger. Severe hypoglycemic reactions with coma, seizure, or other neurological impairment occur infrequently, but constitute medical emergencies requiring immediate hospitalization...."

  Id . at 430.
• "The adequacy or need for a warning should be evaluated in light of the expertise of the users of the product. Mozeke v. International Paper Co., 933 F.2d 1293, 1297 (5th Cir.1991); Guevara v. Dorsey Laboratories, [845 F.2d 364, 367 (1st Cir. 1988)]. Where a product is marketed solely to professionals experienced in using the product, the manufacturer may rely on the knowledge that a reasonable professional would apply in using the product. Pavlides v. Galveston Yacht Basin, Inc., [727 F.2d 330, 338 (5th Cir. 1984)]; Tracy v. Merrell Dow Pharmaceuticals, Inc., [569 N.E.2d 875, 878-79 (Ohio 1991)]." Id.
• "Physicians are, under this analysis, users of prescription drugs. The Upjohn Company, therefore, could rely on their professional expertise and good judgment in preparing its warnings and precautions concerning Micronase. Since it fully and fairly disclosed the drug's potential for harmful side effects and appropriate precautions, The Upjohn Company had the right to assume that the prescribing physicians would provide adequate warnings and instructions. These instructions plainly inform physicians that Micronase can cause mild and severe hypoglycemia. They clearly advise physicians to explain the symptoms of hypoglycemia to their patients and responsible family members, and to give instructions regarding the precautions to be taken should those symptoms become manifest." Id.
• "Upjohn's warning to the physician and the pharmacist was sufficient to meet both assertions of inadequacy made by the plaintiff. In the face of the extensive information given by Upjohn to the physician and pharmacist, the plaintiff's claim that the warning regarding the adverse effect of Micronase and the precautions to be taken was inadequate obviously is without merit. The plaintiff's second assertion, that Upjohn should have advised physicians to warn their patients not to share Micronase with others, is also without merit on this record. The literature given the physician and the pharmacist contained an admonition more complete than the advice that the patient should not share her Micronase with others. The Upjohn literature stated that the 'risk of hypoglycemia, its symptoms and treatment, and conditions that predisposed to its development should be explained to patients and responsible family members.' Had this advice been followed by the physician or the pharmacist, Richards and her 'responsible family members' would have known of the dangers of Micronase. The Upjohn Company's warnings and instructions to prescribing physicians were sufficient to discharge its duty to those persons to whom it owed a duty to warn." Id. at 430-31.
• "There is no genuine issue of disputed, material fact with regard to The Upjohn Company's duty to warn in this case. Its warning was sufficient as a matter of law; consequently, it is entitled to summary judgment in its favor." Id. at 431.

Other Sources of Note: King v. Danek Medical, Inc. , 37 S.W.3d 429 (Tenn. Ct. App. 2001) (application of the doctrine in a pedicle screw products liability case).

Recent Cases: Nye v. Bayer Cropscience, Inc. , No. E2008-01596-COA-R3-CV, 2009 WL 3295137 (Tenn. Ct. App. Oct. 14, 2009) (holding that rationale of the learned intermediary doctrine fits sales of defective products to commercial users but finding the doctrine has not been extended beyond pharmaceutical and medical device product liability cases and therefore the trial court erred in instructing the jury on basis of this doctrine).