We really don’t see the purpose in a separate cause of action for breach of implied warranty in a case involving a prescription medical product. Warranty claims are for ham sandwiches and lawn chairs, where the term “merchantable” has some coherent meaning. Prescription medical products are just that – available only by a physician’s prescription. The prescriber, as learned intermediary, makes an individualized professional judgment whether to prescribe these products. Except in unusual situations, where there’s physical contamination or a counterfeit product, an implied warranty of merchantability makes no sense and adds nothing except a different statute of limitations.
We like the analysis of the Pennsylvania courts on this issue, and we offer it as a model for other states. In a case where the plaintiff attempted to bring implied warranty claims against a pharmacist, the intermediate appellate court pointed out how the restricted marketing system for prescription medical products invalidated the assumptions that underlay implied warranty causes of action.
[D]rugs are not available to the general public but may be obtained only upon the prescription of a licensed physician. This restriction upon the availability of such drugs has been imposed because of the inherently dangerous properties of such drugs. . . . Thus, we find that the very nature of prescription drugs themselves precludes the imposition of a warranty of fitness for “ordinary purposes”, as each individual for whom they are prescribed is a unique organism who must be examined by a physician who is aware of the nature of the patient’s condition as well as the medical history of the patient.
Makripodis v. Merrell-Dow Pharmaceuticals, Inc., 523 A.2d 374, 376-77 (Pa. Super. 1987) (rejecting applicability of implied warranty of merchantability) (emphasis added). In short, implied warranty claims are based upon products being inherently save for ordinary use – “The essence of the warranty of merchantability is that the item sold is fit for the ordinary purposes for which such goods are used.” Id. at 376. The requirement of a physician’s prescription is based upon the opposite characteristic, that drugs cannot be made safe for ordinary use, and thus need to be evaluated by a professional. Id. at 377 (“some products” cannot “be made safe for their intended and ordinary use. . . . “[D]rugs. . .for this very reason cannot legally be sold except to physicians, or under the prescription of a physician”) (quoting Restatement (Second) of Torts §402A, comment k (1965)).
Thus the only “warranties” logically applicable with respect to prescription drugs are not those of the UCC:
(1) the drug is the right drug,
(2) it is in the strength and quantity prescribed,
(3) if compounded, that proper compounding methods were used
(4) the drug is pure and unadulterated, and
(5) the label accords with the directives of the physician’s prescription.
Id. at 377 (not a quote but a paraphrase). Because general UCC implied warranties cannot apply to prescription drugs, those claims were properly dismissed. Id.
The presence of the learned intermediary physician means that there’s no need for any implied warranty. “It is perfectly reasonable to assume, for example, that a physician. . .possesses the necessary skill and expertise to select a product for use in medical treatment which is fit for its intended purpose.” Cafazzo v. Central Medical Health Services, Inc., 668 A.2d 521, 526 (Pa. 1995).
This same rationale applies equally to manufacturers as well as intermediate sellers of prescription medical products. “[A] generalized warranty is not appropriate given that each person for whom a drug is prescribed is a unique organism who must be examined by a physician who is aware of the nature of the patient’s condition as well as the medical history of the patient.” Colacicco v. Apotex, Inc., 432 F. Supp. 2d 514, 549 (E.D. Pa. 2006). “A patient’s inability to assess and weigh the potential risks inherent in these products is precisely the reason that they are dispensed only by prescription, and that prescription medical product manufacturers have a duty to warn learned intermediaries, not the public or the patient.” Taylor v. Danek Medical, Inc., 1998 WL 962062, at *14 (E.D. Pa. Dec. 29, 1998).
The discussion in Makripodis analyzing the nature of prescription drugs applies in the instant action. [The drug here], like most prescription drugs, may never be able to be manufactured so that it is safe for every user. Nonetheless, the public utility of the drug may outweigh the potentially dangerous risk [it] poses to some individuals. Therefore, the Makripodis holding that prescription drugs preclude the imposition of a warranty of fitness for ordinary purposes in cases against pharmacists would reasonably appear to apply in this case against the drug manufacturer. Accordingly, we find that there is no cause of action for a breach of implied warranty in prescription drug cases involving drug manufacturers.
Luke v. American Home Products Corp., 1998 WL 1781624, at *6 (Pa. C.P. Northampton Co. Nov. 18, 1998) (emphasis added). Pennsylvania law thus takes the position that, in ordinary cases, “[p]laintiffs got the effective [drug] they bargained for,” Heindel v. Pfizer, Inc., 381 F. Supp.2d 364, 379-80 (D.N.J. 2004) (applying Pennsylvania law), and an additional implied warranty serves no purpose. Accord Davenport v. Medtronic, Inc., 302 F. Supp. 2d 419, 442 (E.D. Pa. 2004); Murray v. Synthes, U.S.A., Inc., 1999 WL 672937, at*9 (E.D. Pa. Aug. 23, 1999); Burton v. Danek Medical Inc., 1999 WL 118020, at *7 (E.D. Pa. Mar. 1, 1999); Albertson v. Wyeth, Inc., 63 D. & C.4th 514, 536 (Pa. C.P. Philadelphia Co. 2003).
We think this reasoning is compelling, and ensures that the law remains sensitive to the unique attributes of – and unique marketing system applicable to – prescription medical products. We commend the Pennsylvania approach to other states.