Opinion ID: 1977162
Heading Depth: 2
Heading Rank: 1

Heading: Failure to Warn Claims Negligence and Strict Liability

Text: In Counts 1 and 2, negligence and strict liability, Ms. Gourdine alleges that Lilly owed a duty to Mr. Gourdine to warn Ms. Crews about the risks of the combination of Humalog and Humulin N. The negligence count of a products liability claim comports with longstanding common law tort principles, Nissen Corp. v. Miller, 323 Md. 613, 619, 594 A.2d 564, 567 (1991), and the injured party must allege (1) that the defendant was under a duty to protect the plaintiff from injury, (2) that the defendant breached that duty, (3) that the plaintiff suffered actual injury or loss, and (4) that the loss or injury proximately resulted from the defendant's breach of the duty. Doe v. Pharmacia & Upjohn Co., Inc., 388 Md. 407, 414, 879 A.2d 1088, 1092 (2005); Dehn v. Edgecombe, 384 Md. 606, 619, 865 A.2d 603, 611 (2005); Horridge v. St. Mary's County Dept. of Soc. Services, 382 Md. 170, 182, 854 A.2d 1232, 1238 (2004); Patton v. USA Rugby, 381 Md. 627, 635-36, 851 A.2d 566, 570 (2004). We acknowledged that duty to warn can undergird a negligence case in Twombley v. Fuller Brush Co., 221 Md. 476, 158 A.2d 110 (1960), a product liability action against a supplier of spot remover, and later refined the concept in Moran v. Faberge, Inc., 273 Md. 538, 543-44, 332 A.2d 11, 15 (1975) (citations omitted), in which we stated, that a manufacturer's duty to produce a safe product, with appropriate warnings and instructions when necessary, is no different from the responsibility each of us bears to exercise due care to avoid unreasonable risks of harm to others. Whether any such unreasonable risk exists in a given situation depends on balancing the probability and seriousness of harm, if care is not exercised, against the costs of taking appropriate precautions. However, we observe that in cases such as this the cost of giving an adequate warning is usually so minimal, amounting only to the expense of adding some more printing to a label, that this balancing process will almost always weigh in favor of an obligation to warn of latent dangers, if the manufacturer is otherwise required to do so. We also adopted Section 388 of the Restatement (Second) of Torts (1965), Chattel Known to be Dangerous for Intended Use, as a general principle in the duty to warn area: One who supplies directly or through a third person a chattel for another to use is subject to liability to those whom the supplier should expect to use the chattel with the consent of the other or to be endangered by its probable use, for physical harm caused by the use of the chattel in the manner for which and by a person for whose use it is supplied, if the supplier (a) knows or has reason to know that the chattel is or is likely to be dangerous for the use for which it is supplied, and (b) has no reason to believe that those for whose use the chattel is supplied will realize its dangerous condition, and (c) fails to exercise reasonable care to inform them of its dangerous condition or of the facts which make it likely to be dangerous. Moran, 273 Md. at 543-44, 332 A.2d at 15. In Moran, a products liability action against a cologne manufacturer alleging negligent failure to warn of concealed dangers, we recognized a framework for analysis in negligent failure to warn cases: Based on this negligence law we think that in the products liability domain a duty to warn is imposed on a manufacturer if the item it produces has an inherent and hidden danger about which the producer knows, or should know, could be a substantial factor in bringing injury to an individual or his property when the manufacturer's product comes near to or in contact with the elements which are present normally in the environment where the product can reasonably be expected to be brought or used. Id. at 552, 332 A.2d at 20. [9] This framework substantially mirrors that of a strict liability action, which was defined by Judge John C. Eldridge, writing for this Court, in Phipps v. General Motors Corp., 278 Md. 337, 341, 363 A.2d 955, 957 (1976). In Phipps, Judge Eldridge adopted Section 402A of the Restatement (Second) of Torts (1965), Special Liability of Seller of Product for Physical Harm to User or Consumer (1) One who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate user or consumer, or to his property, if (a) the seller is engaged in the business of selling such a product, and (b) it is expected to and does reach the user or consumer without substantial change in the condition in which it is sold. (2) The rule stated in Subsection (1) applies although (a) the seller has exercised all possible care in the preparation and sale of his product, and (b) the user or consumer has not bought the product from or entered into any contractual relation with the seller. and summarized the elements of an action in strict liability: The essential elements of an action in strict liability are set forth in § 402A. For recovery, it must be established that (1) the product was in defective condition at the time that it left the possession or control of the seller, (2) that it was unreasonably dangerous to the user or consumer, (3) that the defect was a cause of the injuries, and (4) that the product was expected to and did reach the consumer without substantial change in its condition. However, in an action founded on strict liability in tort, as opposed to a traditional negligence action, the plaintiff need not prove any specific act of negligence on the part of the seller. The relevant inquiry in a strict liability action focuses not on the conduct of the manufacturer but rather on the product itself. Id. at 344, 363 A.2d at 958. Judge Eldridge went on to explain that the theory of strict liability is not a radical departure from traditional tort concepts and that: Despite the use of the term strict liability, the seller is not an insurer, as absolute liability is not imposed on the seller for any injury resulting from the use of his product. Proof of a defect in the product at the time it leaves the control of the seller implies fault on the part of the seller sufficient to justify imposing liability for injuries caused by the product. Id. at 351-52, 363 A.2d at 963. See also Harig v. Johns-Manville Products Corp., 284 Md. 70, 84, 394 A.2d 299, 306-07 (1978) ([T]he major distinction between an action in strict liability in tort and one founded on traditional negligence theory relates to the proof which must be presented by the plaintiff.). In Owens-Illinois, Inc. v. Zenobia, 325 Md. 420, 601 A.2d 633 (1992), we addressed the issue of whether the seller's knowledge of a defect, or lack thereof, would affect liability. Judge Eldridge, again writing for this Court, noted that most courts addressing the issue require knowledge of defect, as elucidated in Comment j of the Restatement Section 402A: Comment j explains that the seller is required to give warning against [the danger], if he has knowledge, or by the application of reasonable, developed human skill and foresight should have knowledge, of the ... danger. The comment goes on to distinguish a product containing an adequate warning from a defective product, stating: a product bearing such a warning, which is safe for use if it is followed, is not in defective condition, nor is it unreasonably dangerous.    [T]he majority of courts which have considered a failure to warn case in the context of strict liability have either expressly or implicitly held that a manufacturer of a product, which is defective only because of the lack of an adequate warning, is not liable when the failure to warn resulted from an absence of knowledge of the dangerous quality of that product. Moreover, the courts reason, the presence of the required knowledge can be established by evidence that the dangerous quality of the product should have been known by a manufacturer because it was known in the scientific or expert community.    Consequently, in a failure to warn case governed by the Restatement § 402A and Comment j, negligence concepts to some extent have been grafted onto strict liability. In such cases, a majority of courts hold that an element of knowledge or state of the art evidence is directly pertinent to a cause of action under § 402A of the Restatement (Second) of Torts, and liability is no longer entirely strict. Id. at 433-35, 601 A.2d at 640-41. Judge Eldridge also reflected that our adoption of Section 402A in the Phipps case included the knowledge element of its Comment j. Id. at 438 n. 8, 601 A.2d at 641 n. 8. [10] We have recognized, therefore, that negligence concepts and those of strict liability have morphed together, as a result, in failure to warn cases. See ACandS, Inc. v. Asner, 344 Md. 155, 168, 686 A.2d 250, 256 (1996), quoting Owens-Illinois, Inc., 325 Md. at 435 n. 7, 601 A.2d at 640 n. 7 (1992) (Consequently, in a failure to warn case governed by the Restatement § 402A and Comment j, negligence concepts to some extent have been grafted onto strict liability.); Phipps, 278 Md. at 351, 363 A.2d at 963 (1976) (Thus, the theory of strict liability is not a radical departure from traditional tort concepts.); Mazda Motor of Am., Inc. v. Rogowski, 105 Md.App. 318, 325, 659 A.2d 391, 394, cert. denied, 340 Md. 501, 667 A.2d 342 (1995) (Certainly, it is true that a strict liability claim based on failure to warn bears a strong resemblance to a claim of negligence. Concepts of duty, breach, causation, and damages are present in both.). [11] Duty, thus, is an essential element of both negligence and strict liability causes of action for failure to warn. Seminally, however, we note our divergence from the duty analyses of the trial court and the Court of Special Appeals, because both relied on the learned intermediary doctrine, with citation to Nolan v. Dillon, 261 Md. 516, 523, 276 A.2d 36, 40 (1971), to determine that Lilly did not owe a duty to Mr. Gourdine. In Nolan, a negligence and breach of warranty action, this Court was faced with the question of whether the warnings which American Home gave regarding the use of Sparine were adequate to warn of possible venous thrombosis or arteriolar spasm; the package insert contained a warning that use of the drug has resulted in localized thrombophlebitis or vascular spasm of digital vessels. In answering the question, we analyzed the reasonableness of the written warnings, without adopting the learned intermediary doctrine, id. at 523, 276 A.2d at 40; that case clearly lacks the express adoption of the learned intermediary doctrine undertaken by other courts. See e.g. Stone v. Smith, Kline & French Labs., 447 So.2d 1301, 1303 (Ala.1984); Shanks v. Upjohn Co., 835 P.2d 1189, 1200 (Alaska 1992); West v. Searle & Co., 305 Ark. 33, 806 S.W.2d 608, 614 (1991); Stevens v. Parke, Davis & Co., 9 Cal.3d 51, 107 Cal. Rptr. 45, 507 P.2d 653, 661 (1973); Vitanza v. Upjohn Co., 257 Conn. 365, 778 A.2d 829, 835 (2001); Lacy v. G.D. Searle & Co., 567 A.2d 398, 400 (Del.1989); Felix v. Hoffmann-LaRoche, Inc., 540 So.2d 102, 104 (Fla.1989); McCombs v. Synthes, 277 Ga. 252, 587 S.E.2d 594, 595 (2003); Kirk v. Michael Reese Hosp. & Med. Ctr., 117 Ill.2d 507, 111 Ill.Dec. 944, 513 N.E.2d 387, 393 (1987); Humes v. Clinton, 246 Kan. 590, 792 P.2d 1032 (1990); Larkin v. Pfizer, Inc., 153 S.W.3d 758, 770 (Ky.2004); Wyeth Labs., Inc. v. Fortenberry, 530 So.2d 688, 691 (Miss.1988); Hill v. Squibb & Sons, E. R., 181 Mont. 199, 592 P.2d 1383, 1387-88 (1979); Freeman v. Hoffman-La Roche, Inc., 260 Neb. 552, 618 N.W.2d 827, 842 (2000); Niemiera by Niemiera v. Schneider, 114 N.J. 550, 555 A.2d 1112, 1117 (1989); Martin v. Hacker, 83 N.Y.2d 1, 607 N.Y.S.2d 598, 628 N.E.2d 1308, 1311 (1993); Seley v. G.D. Searle & Co., 67 Ohio St.2d 192, 423 N.E.2d 831 (1981); Pittman v. Upjohn Co., 890 S.W.2d 425, 431 (Tenn.1994). The learned intermediary doctrine, thus, is not an issue that we need to explore in the present case.