MR. JUSTICE CLARK
delivered the opinion of the court:
The parents of a minor child brought this action to recover damages for injuries suffered by the child during the fetal stage, the injuries having allegedly been caused by a drug, administered to the mother during delivery of the child. In the first three counts, Parke Davis & Co., the manufacturer of the drug in question, was named as defendant. Counts I and II, sounding in strict liability in tort, sought, respectively, recovery on behalf of the child for his injuries and recovery for plaintiffs’ mental anguish and distress. Count III sought the same recovery as count I, but was based on breach of warranty. Defendant’s motion to dismiss all three counts was granted by the circuit court of Cook County. The appellate court affirmed that portion of the order which dismissed counts I and II and reversed that portion of the order which dismissed count III. (58 Ill. App. 3d 349.) We granted plaintiffs leave to appeal.
The facts as stated by plaintiffs’ first amended complaint are accepted as true for purposes of this appeal (Court v. Grzelinski (1978), 72 Ill. 2d 141, 146; Genaust v. Illinois Power Co. (1976), 62 Ill. 2d 456, 460; Gertz v. Campbell (1973), 55 Ill. 2d 84, 87), and are, substantially, as follows.
Ellen Woodill, the minor child’s mother, entered Central Du Page Hospital as an obstetrical patient on or about November 22, 1973, at a time when the fetus was in high station. Pursuant to her physician’s order for the inducement of uterine contractions, she was infused intravenously with the prescription drug, Pitocin. The product information disseminated to the medical profession by the defendant did not contraindicate the use of Pitocin for this purpose. On or about the same date, the child, delivered by the vaginal route, was born with brain damage, permanent blindness and quadriplegia. The complaint alleges that the use of Pitocin was the proximate cause of the child’s injuries, and, with regard to the counts sounding in strict liability in tort, that defendant’s failure to warn physicians and patients of the danger in using Pitocin while a fetus is in high station rendered the drug “not reasonably safe.”
The issue of primary concern in this appeal is whether, in an action seeking to hold a defendant strictly liable for failure to warn of a danger attendant to the use of a product, the plaintiff must allege and prove that the defendant knew or should have known of the danger.
It is well recognized that a failure to warn of a product’s dangerous propensities may serve as the basis for holding a manufacturer or seller strictly liable in tort. (Lawson v. G. D. Searle & Co. (1976), 64 Ill. 2d 543, 551; see Annot., 53 A.L.R.3d 239 (1973); Noel, Products Defective Because of Inadequate Directions or Warnings, 23 Sw. L.J. 256 (1969).) The product is in a “defective condition unreasonably dangerous” (Restatement (Second) of Torts, sec. 402A (1965)), not because of some defect inherent in the product itself, but because of the absence of an adequate warning accompanying the product.
The plaintiffs particularly rely upon Lawson v. G. D. Searle & Co. (1976), 64 Ill. 2d 543, to support their position that the defendant may be held strictly liable for failure to warn, even absent knowledge or reason to know of the danger. In Lawson, the plaintiffs sued, under strict tort liability, to recover damages for death and injuries allegedly resulting from the use of defendant’s contraceptive drug. This court upheld jury verdicts in favor of the defendant. It is true, as plaintiffs point out, that the jury instructions on the theory of strict liability which the court quoted with approval (64 Ill. 2d 543, 547) did not contain any requirement that the defendant have knowledge or reason to know of the danger before it could be held liable for failure to warn. The warning-related issue decided by the court, however, was not whether the defendant was required to issue a warning absent knowledge or reason to know of the danger, but whether a warning was, in fact, given and whether it was, in fact, sufficient. The court held simply that there was sufficient evidence from which the jury could have decided these two questions in defendant’s favor. (64 Ill. 2d 543, 553.) Inasmuch as the court was not confronted with the knowledge issue, the case is not dispositive of that issue.
In Suvada v. White Motor Co. (1965), 32 Ill. 2d 612, this court joined the growing trend of decisions to remove the last vestiges of the privity requirement in products liability actions. The court further expressed its agreement with the view that liability in such cases is governed by the law of strict liability in tort, and not by the law of contract warranties. (32 Ill. 2d 612, 621.) The arguments advanced to support the imposition of strict liability in food cases were cited by the Suvada court as reasons for extending strict liability to products other than food. These arguments include the public interest in human life and health, the manufacturer’s invitations and solicitations to use the product, its representations that the product is safe and suitable for use, and the justice of imposing the loss on the one creating the risk and reaping the profit. (32 Ill. 2d 612, 619.) If, as the court thought then, the foregoing arguments justified extending strict liability beyond food to a used reconditioned tractor, the product involved in Suvada, certainly they justify the application of strict liability to drugs.
In Suvada the court set forth the elements of an action sounding in strict liability in tort.
“The plaintiffs must prove that their injury or damage resulted from a condition of the product, that the condition was an unreasonably dangerous one and that the condition existed at the time it left the manufacturer’s control.” 32 Ill. 2d 612, 623.
Also, in connection therewith, the court quoted with approval section 402A of the Restatement (Second) of Torts (1965), which provides:
“(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 the product, and
(b) the user or consumer has not bought the product from or entered into any contractual relation with the seller.” 32 Ill. 2d 612, 621.
In support of the decision of the appellate court, the defendant argues that comment j of this section requires that a manufacturer have knowledge or reason to know of the danger before it can be held liable for failure to warn. Comment j provides, in pertinent part:
“Directions or warning. In order to prevent the product from being unreasonably dangerous, the seller may be required to give directions or warning, on the container, as to its use.
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MR. JUSTICE CLARK
delivered the opinion of the court:
The parents of a minor child brought this action to recover damages for injuries suffered by the child during the fetal stage, the injuries having allegedly been caused by a drug, administered to the mother during delivery of the child. In the first three counts, Parke Davis & Co., the manufacturer of the drug in question, was named as defendant. Counts I and II, sounding in strict liability in tort, sought, respectively, recovery on behalf of the child for his injuries and recovery for plaintiffs’ mental anguish and distress. Count III sought the same recovery as count I, but was based on breach of warranty. Defendant’s motion to dismiss all three counts was granted by the circuit court of Cook County. The appellate court affirmed that portion of the order which dismissed counts I and II and reversed that portion of the order which dismissed count III. (58 Ill. App. 3d 349.) We granted plaintiffs leave to appeal.
The facts as stated by plaintiffs’ first amended complaint are accepted as true for purposes of this appeal (Court v. Grzelinski (1978), 72 Ill. 2d 141, 146; Genaust v. Illinois Power Co. (1976), 62 Ill. 2d 456, 460; Gertz v. Campbell (1973), 55 Ill. 2d 84, 87), and are, substantially, as follows.
Ellen Woodill, the minor child’s mother, entered Central Du Page Hospital as an obstetrical patient on or about November 22, 1973, at a time when the fetus was in high station. Pursuant to her physician’s order for the inducement of uterine contractions, she was infused intravenously with the prescription drug, Pitocin. The product information disseminated to the medical profession by the defendant did not contraindicate the use of Pitocin for this purpose. On or about the same date, the child, delivered by the vaginal route, was born with brain damage, permanent blindness and quadriplegia. The complaint alleges that the use of Pitocin was the proximate cause of the child’s injuries, and, with regard to the counts sounding in strict liability in tort, that defendant’s failure to warn physicians and patients of the danger in using Pitocin while a fetus is in high station rendered the drug “not reasonably safe.”
The issue of primary concern in this appeal is whether, in an action seeking to hold a defendant strictly liable for failure to warn of a danger attendant to the use of a product, the plaintiff must allege and prove that the defendant knew or should have known of the danger.
It is well recognized that a failure to warn of a product’s dangerous propensities may serve as the basis for holding a manufacturer or seller strictly liable in tort. (Lawson v. G. D. Searle & Co. (1976), 64 Ill. 2d 543, 551; see Annot., 53 A.L.R.3d 239 (1973); Noel, Products Defective Because of Inadequate Directions or Warnings, 23 Sw. L.J. 256 (1969).) The product is in a “defective condition unreasonably dangerous” (Restatement (Second) of Torts, sec. 402A (1965)), not because of some defect inherent in the product itself, but because of the absence of an adequate warning accompanying the product.
The plaintiffs particularly rely upon Lawson v. G. D. Searle & Co. (1976), 64 Ill. 2d 543, to support their position that the defendant may be held strictly liable for failure to warn, even absent knowledge or reason to know of the danger. In Lawson, the plaintiffs sued, under strict tort liability, to recover damages for death and injuries allegedly resulting from the use of defendant’s contraceptive drug. This court upheld jury verdicts in favor of the defendant. It is true, as plaintiffs point out, that the jury instructions on the theory of strict liability which the court quoted with approval (64 Ill. 2d 543, 547) did not contain any requirement that the defendant have knowledge or reason to know of the danger before it could be held liable for failure to warn. The warning-related issue decided by the court, however, was not whether the defendant was required to issue a warning absent knowledge or reason to know of the danger, but whether a warning was, in fact, given and whether it was, in fact, sufficient. The court held simply that there was sufficient evidence from which the jury could have decided these two questions in defendant’s favor. (64 Ill. 2d 543, 553.) Inasmuch as the court was not confronted with the knowledge issue, the case is not dispositive of that issue.
In Suvada v. White Motor Co. (1965), 32 Ill. 2d 612, this court joined the growing trend of decisions to remove the last vestiges of the privity requirement in products liability actions. The court further expressed its agreement with the view that liability in such cases is governed by the law of strict liability in tort, and not by the law of contract warranties. (32 Ill. 2d 612, 621.) The arguments advanced to support the imposition of strict liability in food cases were cited by the Suvada court as reasons for extending strict liability to products other than food. These arguments include the public interest in human life and health, the manufacturer’s invitations and solicitations to use the product, its representations that the product is safe and suitable for use, and the justice of imposing the loss on the one creating the risk and reaping the profit. (32 Ill. 2d 612, 619.) If, as the court thought then, the foregoing arguments justified extending strict liability beyond food to a used reconditioned tractor, the product involved in Suvada, certainly they justify the application of strict liability to drugs.
In Suvada the court set forth the elements of an action sounding in strict liability in tort.
“The plaintiffs must prove that their injury or damage resulted from a condition of the product, that the condition was an unreasonably dangerous one and that the condition existed at the time it left the manufacturer’s control.” 32 Ill. 2d 612, 623.
Also, in connection therewith, the court quoted with approval section 402A of the Restatement (Second) of Torts (1965), which provides:
“(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 the product, and
(b) the user or consumer has not bought the product from or entered into any contractual relation with the seller.” 32 Ill. 2d 612, 621.
In support of the decision of the appellate court, the defendant argues that comment j of this section requires that a manufacturer have knowledge or reason to know of the danger before it can be held liable for failure to warn. Comment j provides, in pertinent part:
“Directions or warning. In order to prevent the product from being unreasonably dangerous, the seller may be required to give directions or warning, on the container, as to its use. The seller may reasonably assume that those with common allergies, as for example to eggs or strawberries, will be aware of them, and he is not required to warn against them. Where, however, the product contains an ingredient to which a substantial number of the population are allergic, and the ingredient is one whose danger is not generally known, or if known is one which the consumer would reasonably not expect to find in the product, the seller is required to give warning against it, if he has knowledge, or by the application of reasonable, developed human skill and foresight should have knowledge, of the presence of the ingredient and the danger. Likewise in the case of poisonous drugs, or those unduly dangerous for other reasons, warning as to use may be required.” (Restatement (Second) of Torts sec. 402A comment j (1965).)
Specifically, defendant points to the language in the comment which provides that the seller is required to give warning if “he has knowledge, or by the application of reasonable, developed human skill and foresight should have knowledge,” of the danger. The plaintiffs argue, however, that to predicate the defendant’s liability for failure to warn upon whether he knew or should have known of the danger is to revert to a negligence standard. The plaintiffs aver that the inquiry would then focus on the conduct of the manufacturer defendant rather than on the unreasonably dangerous condition of the product created by the failure to warn. There are decisions from other jurisdictions which support the plaintiffs’ averment: Little v. PPG Industries, Inc. (1978), 19 Wash. App. 812, 579 P.2d 940, aff'd as modified (1979), 92 Wash. 2d 118, 594 P.2d 911; Hamilton v. Hardy (1976), 37 Colo. App. 375, 549 P.2d 1099; Haugen v. Minnesota Mining & Manufacturing Co. (1976), 15 Wash. App. 379, 550 P.2d 71; Berkebile v. Brantly Helicopter Corp. (1975), 462 Pa. 83, 337 A.2d 893. These decisions hold that failure to warn in strict liability, as opposed to negligence, imposes liability upon the defendant regardless of whether the manufacturer’s conduct was reasonable (e.g., Little v. PPG Industries, Inc. (1978), 19 Wash. App. 812, 822, 579 P.2d 940, 947). Rather, knowledge of the danger is assumed under strict liability. Berkebile v. Brantly Helicopter Corp. (1975), 462 Pa. 83, 101, 337 A.2d 893, 902.
On the other hand, a line of decisions, including several in our own appellate court, have stated that knowledge is an essential element in a failure-to-warn case. Mahr v. G.D. Searle & Co. (1972), 72 Ill. App. 3d 540; Knapp v. Hertz Corp. (1978), 59 Ill. App. 3d 241, 246; Peterson v. B/W Controls, Inc. (1977), 50 Ill. App. 3d 1026, 1029; Neal v. Whirl Air Flow Corp. (1976), 43 Ill. App. 3d 266, 272; Stanfield v. Medalist Industries, Inc. (1975), 34 Ill. App. 3d 635, 639; Bristol-Myers Co. v. Gonzales (Tex. 1978), 561 S.W.2d 801, 804; Nissen Trampoline Co. v. Terre Haute First National Bank (Ind. App. 1975), 332 N.E.2d 820, rev’d on other grounds (1976), 265 Ind. 457, 358 N.E.2d 974; Singer v. Sterling Drug, Inc. (7th Cir. 1972), 461 F.2d 288; Oakes v. E. I. DuPont de Nemours & Co. (1969), 272 Cal. App. 2d 645, 650, 77 Cal. Rptr. 709, 713; Phillips v. Kimwood Machine Co. (1974), 269 Or. 485, 498, 525 P.2d 1033, 1039.
We think that the imposition of a knowledge requirement is a proper limitation to place on a manufacturer’s strict liability in tort predicated upon a failure to warn of a danger inherent in a product. We do not agree with the plaintiffs that to require knowledge to be alleged and proved is to infuse negligence principles into strict liability. Indeed, liability based upon a failure to warn adequately of dangers (Restatement (Second) of Torts sec. 402A, comment j (1965)) is itself a doctrine borrowed from negligence. (See Kirby v. General Paving Co. (1967), 86 Ill. App. 2d 453, 457.) Yet the failure-to-warn theory in strict liability has been upheld as a distinguishable doctrine from its counterpart in negligence, based on the fact that it is the inadequacy of the warning that is looked to, rather than the conduct of the particular manufacturer, to establish strict liability. (Little v. PPG Industries, Inc. (1979), 92 Wash. 2d 118, 121-23, 594 P.2d 911, 914.) In a concurring opinion in Little it is stated:
“Dean W. Page Keeton has articulated the applicable standard in the following manner:
a product is unreasonably dangerous at the time of sale if the ordinary man, knowing the risks and dangers actually involved in its use, would not have marketed the product without supplying more information about the risks and dangers involved in its use and ways to avoid harm therefrom.
Keeton, Products Liability — Inadequacy of Information. 48 Tex. L. Rev. 398, 403-04 (1970).” (Emphasis added.) (92 Wash. 2d 118, 127, 594 P.2d 911, 916.)
The opinion continues that, while reasonableness is implicit in the foregoing standard, it is an objective standard and is not to be read to mean whether the particular manufacturer or supplier was reasonable in the circumstances. (92 Wash. 2d 118, 127-28, 594 P.2d 911, 917.) The proper inquiry is whether it would have been reasonable for a drug manufacturer to have given a warning and whether that warning would have been adequate under similar circumstances. Mahr v. G.D. Searle & Co. (1979), 72 Ill. App. 3d 540, 562.
In a similar vein, a recent opinion in this court clarified this same point with regard to a case sounding in strict liability based on the defective design of a liquified-petroleum-gas tank car:
“Any misapprehension that negligence is the standard of liability stems only from the injection of a ‘reasonableness’ element in determining whether a defective condition is unreasonably dangerous. As Prosser states, a strict liability design case resembles a negligence action because the reasonableness of the manufacturer’s design choice is a key issue (Prosser, Torts sec. 96, at 644-45 (4th ed. 1971)). Despite the resemblance, however, the elements of the plaintiff’s proof remain those of an action in strict liability.” Rucker v. Norfolk & Western Ry. Co. (1979), 77 Ill. 2d 434, 439.
We perceive that requiring a plaintiff to plead and prove that the defendant manufacturer knew or should have known of the danger that caused the injury, and that the defendant manufacturer failed to warn plaintiff of that danger, is a reasonable requirement, and one which focuses on the nature of the product and on the adequacy of the warning, rather than on the conduct of the manufacturer. The inquiry becomes whether the manufacturer, because of the “present state of human knowledge” (Restatement (Second) of Torts sec. 402A, comment k (1965)), knew or should have known of the danger presented by the use or consumption of a product. Once it is established that knowledge existed in the industry of the dangerous propensity of the manufacturer’s product, then the plaintiff must establish that the defendant did not warn, in an adequate manner, of the danger. Such a rule is entirely consistent with the principles of strict liability, as first recognized and adopted as applicable to all products in Suvada v. White Motor Co. (1965), 32 Ill. 2d 612.
We emphasize that we do not view our holding that knowledge is an element of a failure-to-warn case to be a weakening of the statement in Cunningham v. MacNeal Memorial Hospital (1970), 47 Ill. 2d 443. There it was stated in refutation of the defendant’s assertion that there was no way to detect serum hepatitis virus in whole blood that “[t] o allow a defense to strict liability on the ground that there is no way, either practical or theoretical, for a defendant to ascertain the existence of impurities in his product would be to emasculate the doctrine and in a very real sense would signal a return to a negligence theory.” (47 Ill. 2d 443, 453.) (Currently, an act is in effect which provides that the only bases for liability for the tortious injecting, transfusing or transplanting of human whole blood, blood products, and human bones, organs and tissue are in instances of negligence or willful misconduct. (Ill. Rev. Stat. 1977, ch. 91, par. 181.) However, that act is to be repealed effective July 1, 1981. (Ill. Rev. Stat. 1977, ch. 91, par. 184.)) Later in Cunningham, we distinguished between strict liability based on a defect in a product, such as was involved therein, and where, as here, a warning may be required because a product is unavoidably unsafe. We referred to the “exception” created by comment k to section 402A of the Restatement (Second) of Torts:
“ ‘k. Unavoidably unsafe products. There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. Since the disease itself invariably leads to a dreadful death, both the marketing and the use of the vaccine are fully justified ***. Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. ***’ [Emphasis in original.] We believe it clear that the exception set forth in the quoted comment relates only to products which are not impure and which, even if properly prepared, inherently involve substantial risk of injury to the user.” 47 Ill. 2d 443, 456.
Therefore, the pleading requirement that a manufacturer know or should know of the dangerous propensity of the product is limited to complaints which allege a breach of the duty to warn adequately. Whether it is necessary to allege knowledge where liability is predicated on the defective design of the product is not before us.
We believe our holding in this case is justified because a logical limit must be placed on the scope of a manufacturer’s liability under a strict liability theory. To hold a manufacturer liable for failure to warn of a danger of which it would be impossible to know based on the present state of human knowledge would make the manufacturer the virtual insurer of the product, a position rejected by this court in Suvada. (Winnett v. Winnett (1974), 57 Ill. 2d 7, 11.) Strict liability is not the equivalent of absolute liability. There are restrictions imposed upon it. For example, we have previously held that where an injury is not foreseeable, that is, objectively predictable, no liability will ensue based on strict liability. (Winnett v. Winnett (1974), 57 Ill. 2d 7, 12-13.) Also, where the plaintiff knows of the risk of injury presented by the use of a dangerously defective product but assumes the risk nonetheless, the manufacturer is absolved from liability. Court v. Grzelinski (1978), 72 Ill. 2d 141, 149; Williams v. Brown Manufacturing Co. (1970), 45 Ill. 2d 418, 430.
This court is acutely aware of the social desirability of encouraging the research and development of beneficial drugs.- We are equally aware that risks, often grave, may accompany the introduction of these drugs into the marketplace. We simply think, however, in accordance with comments j and k of section 402A of the Restatement (Second) of Torts, that where liability is framed by the manufacturer’s duty to warn adequately of dangers which may arise from the use of a drug, that liability should be based on there being some manner in which to know of the danger. Otherwise the warning itself, which is the focus of the liability, would be a meaningless exercise.
Since we are enunciating the requirement that knowledge must be alleged in a complaint for the first time in this opinion, substantial justice would seem to require that the plaintiffs be given an opportunity to amend their complaint to comply with this decision. We therefore affirm the appellate court as to count I and remand to the circuit court with directions to give the plaintiffs reasonable time to amend count I of their complaint.
The appellate court concluded, as an alternative ground for holding that count II failed to state a cause of action, that strict liability should not be extended to include recovery for the plaintiffs’ emotional distress and mental anguish. (58 Ill. App. 3d 349, 355.) We agree, and we adopt the decision of the appellate court on this point.
We also adopt that portion of the court’s opinion which held that count III of plaintiffs’ complaint stated a cause of action for breach of warranty. 58 Ill. App. 3d 349, 355-56. See Berry v. G.D. Searle & Co. (1974), 56 Ill. 2d 548, 554.
For the foregoing reasons, the judgment of the appellate court is affirmed as to counts I, II and III, and this cause is remanded to the circuit court of Cook County with directions.
Judgment affirmed; cause remanded, with directions.