author: Justice COOPER. Justice WINTERSHEIMER.

text:
    Robert I. LARKIN; and Barbara A. Larkin, Petitioners, v. PFIZER, INC.; and G.D. Searle & Co., Respondents.
    No. 2002-SC-0746-CL.
    Supreme Court of Kentucky.
    June 17, 2004.
    Rehearing Denied Feb. 17, 2005.

      Harry D. Rankin, Luann Devine, Green-ebaum, Doll & McDonald, PLLC, Coving-ton, Counsel for Petitioners.
    William Kennedy Simpson, Rheanne D. Falkner, David Warner Mushlin, Thompson, Miller & Simpson, PLC, Louisville, Counsel for Respondent Pfizer, Inc.
    Susan Simpson Wettle, Sheryl G. Snyder, Frost, Brown, Todd, LLC, Louisville, Irene C. Keyse Walker, Robert C. Tucker, Tucker, Ellis & West, LLP, Cleveland, OH, Counsel for Respondent G.D. Searle & Co.
    E. Andre Busald, Busald, Funk, Zevely, PSC, Florence, Counsel for Amicus Curiae Kentucky Academy of Trial Attorneys (Kata).
    David T. Schaefer, Woodward, Hobson & Fulton, Louisville, Counsel for Amicus Curiae Product Liability Advisory Council.
    Marie Alagia Cull, Cull, Hayden & Vance, PSC, Frankfort, Counsel for Ami-cus Curiae Pharmaceutical Research and Manufacturers of America.
   Opinion of the Court by

Justice COOPER.

This matter reaches us by a request for certification of a question of law from the United States Court of Appeals for the Sixth Circuit. CR 76.37. The operable facts as set forth in the request for certification are as follows:

“Robert Larkin is a 69-year-old resident of Indiana who has been a paraplegic since his involvement in an automobile accident in 1964. Dr. Jeffrey Reynolds has been Larkin’s internist since 1988. Over the years, Dr. Reynolds has prescribed Larkin a variety of nonsteroidal anti-inflammatory drugs to alleviate the significant musculoskeletal pain Larkin suffers as a result of his paraplegia.

“In July 1988, Larkin visited Dr. Reynolds’s Louisville office with complaints of a head cold. At the time, Larkin had blisters in his mouth and on his arms and legs. Dr. Reynolds prescribed one medication to treat Larkin’s sinus infection and another to treat his blistering.

“Several weeks later, in August 1988, Larkin again visited Dr. Reynolds’s office, complaining of sinusitis and shoulder pain. Dr. Reynolds gave Larkin a six-pill sample package of Zithromax, an antibiotic manufactured and distributed by Pfizer, Inc., to treat Larkin’s sinusitis. Dr. Reynolds instructed Larkin to take two Zithromax pills the first day and one each day thereafter, until the pills were gone. The Zi-thromax sample package did not contain any written instructions or warning information, and Larkin does not recall any further discussion about the medication with Dr. Reynolds. In addition to providing him with the Zithromax, Dr. Reynolds also changed Larkin’s prescribed anti-inflammatory medication to Daypro, a drug manufactured by G.D. Searle & Go. Larkin had the Daypro prescription filled at a drug store but testified that he does not remember receiving any literature containing instructions or warnings.

“In late September 1998, Larkin first noticed an itchy rash breaking out on his left arm and shoulder. As his condition worsened, Larkin developed large fluid-filled blisters over a large portion of his body. When the blisters drained, his skin sloughed off. In early October, Dr. Reynolds diagnosed Larkin’s condition as toxic epidermal necrolysis and Stevens-Johnson syndrome. It was Dr. Reynolds’s opinion that these conditions resulted from Lar-kin’s taking either Daypro or Zithromax, or both.

“Larkin was admitted to a hospital burn unit for treatment of his wounds and was discharged some ten days later. Since then, Larkin — who previously had been able to move about with crutches — has been confined to a wheelchair, and his general strength has deteriorated.

“Toxic epidermal necrolysis (along with its milder form known as Stevens-Johnson syndrome) is a severe, sometimes life-threatening, skin condition that is often drug induced. More than 100 drugs have been implicated in cases of toxic epidermal necrolysis, including the antibiotic Zithro-max and the non-steroidal anti-inflammatory Daypro.”

“The physician package insert that accompanies Daypro (and is incorporated in the Physician’s Desk Reference) provides that Stevens-Johnson syndrome and toxic epidermal necrolysis are ‘adverse reactions’ experienced ‘at an incidence of less than 1%.’ Dr. Reynolds was aware that these conditions were associated with Day-pro — as well as ‘all’ other non-steroidal anti-inflammatory drugs — at the time he prescribed the medication to Larkin.” He did not, however, inform Larkin of this risk. Dr. Reynolds testified, T wouldn’t call it a common side effect that we would normally discuss.’ When asked why it was not his practice to inform patients taking Daypro of the risk of Stevens-Johnson syndrome and toxic epidermal necrolysis, he stated:

Mostly it’s the time element, to go over all possibilities of reactions, and there’s other reactions that are as severe as Stevens-Johnson. I mean there’s numerous possibilities, as you know, by just reading the [Physician’s Desk Reference] and looking at the thickness of it, that, from a clinical standpoint, it’s an impossibility to try to completely inform your patients of any medicine that they’re being prescribed.

According to Dr. Reynolds, when prescribing non-steroidal anti-inflammatory medications, he would typically discuss with patients the gastrointestinal side effects or ‘say if something ... doesn’t seem right, in particular, when starting a new medicine ... then you need to let me know.’

“The package insert and Physician’s Desk Reference entry for Zithromax provide under the heading ‘warnings’ that ‘serious allergic reactions including ... Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported rarely in patients on [Zithromax] therapy.’ Under the heading ‘adverse reactions,’ it indicates that Stevens-Johnson syndrome and toxic epidermal necrolysis are reported ‘rarely’ by patients taking the drug. Dr. Reynolds testified that he was aware of the association between Zithromax (and many other antibiotics) and Stevens-Johnson syndrome and toxic epidermal necroly-sis at the time he provided the drug to Larkin but that he did not discuss it with his patient.”

⅜ ⅜ ⅜ ⅜ ⅜ ⅜

Larkin and his wife sued Pfizer, Inc., and G.D. Searle & Co. for damages under theories of negligence, breach of warranty, and strict liability. They did not sue Dr. Reynolds. In his order granting summary judgment to Pfizer and Searle, United States District Court Judge Thomas B. Russell concluded that Zithromax and Daypro were both “the types of desirable but unavoidably unsafe products described by the Restatement (Second) of Torts, § 402(A), comment k,” and, therefore, “the crucial question ... is whether the manufacturer provided an adequate warning.” Larkin v. Pfizer, Inc., No. 3:99CV-649-R, slip op. at 5, 2001 WL 34065029 (W.D.Ky. Feb. 8, 2001) (internal quotes omitted).

The question certified to us by the Sixth Circuit Court of Appeals is:

Whether the learned intermediary doctrine should apply in Kentucky to a case involving an allegation that a manufacturer of a prescription drug failed to warn the ultimate consumer of risks associated with that drug, even though the manufacturer informed the prescribing physician of those risks?

For the reasons explained in this opinion, our answer to the certified question is: ‘Tes.”

I. THE RULE.

In McMichael v. American Red Cross, Ky., 532 S.W.2d 7, 9-11 (1975), our predecessor court adopted comment k to the Restatement (Second) of Torts § 402A, which states an exception to the rule of strict liability:

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, notwithstanding the unavoidable high degree of risk which they involve. Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician. It is also true in particular of many new or experimental drugs as to which, because of lack of time and opportunity for sufficient medical experience, there can be no assurance of safety, or perhaps even of purity of ingredients, but such experience as there is justifies the marketing and use of the drug notwithstanding a medically recognized risk. The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk.

Restatement (Second) of Torts § 402A cmt. k (1965) (emphasis added). Thus, the fact that a particular drug might produce unfortunate side effects makes it “unavoidably unsafe” but not “unreasonably dangerous” (emphasis added), and strict liability will not obtain if “proper warning is given, where the situation calls for it.” Id. The “learned intermediary” rule defines “proper warning” in the context of a prescription drug (or medical device). The American Law Institute (A.L.I.) has stated the rule as follows:

A prescription drug or medical device is not reasonably safe due to inadequate instructions or warnings if reasonable instructions or warnings regarding foreseeable risks of harm are not provided to:
(1) prescribing and other health-care providers who are in a position to reduce the risks of harm in accordance with the instructions or warnings; or (2) the patient when the manufacturer knows or has reason to know that health-care providers will not be in a position to reduce the risks of harm in accordance with the instructions or warnings.

Restatement (Third) of Torts: Prods. Liab. § 6(d) (1998). Section 6(d)(1) states the learned intermediary rule, an exception to the general rule that a manufacturer’s duty to warn of any risks or dangers inherent in the product runs to the ultimate consumer. Id. at § 2 cmt. i. “The obligation of a manufacturer to warn about risks attendant to the use of drugs and medical devices that may be sold only pursuant to a health-care provider’s prescription traditionally has required warnings directed to health-care providers and not to patients.... Subsection (d)(1) retains the ‘learned intermediary’ rule.” Id. cmt. b.

The rule originated in Marcus v. Specific Pharmaceuticals, 191 Misc. 285, 77 N.Y.S.2d 508 (N.Y.Sup.Ct.1948), in which a physician prescribed two suppository tablets per day for a thirteen-month-old child even though the proper prescription for a child that age was one-half tablet per day. In dismissing the complaint against the manufacturer of the suppository, the court observed:

[I]t is difficult to see on what basis this defendant can be liable to plaintiff. It made no representation to plaintiff, nor did it hold out its product to plaintiff as having any properties whatsoever. To physicians it did make representations. And should any of these be false it might be claimed with propriety that they were made for the benefit of the ultimate consumers. But there is no such claim.... Nor is there any reason to expect that if a doctor did choose to rely on the information given by the manufacturer he would prescribe without knowing what that information was. In the absence of any such grounds for belief there would be no negligence.

Id. at 509-10. The term “learned intermediary” was coined in Sterling Drug., Inc. v. Cornish, 370 F.2d 82 (8th Cir.1966):

[I]n this case we are dealing with a prescription drug rather than a normal consumer item. In such a case the purchaser’s doctor is a learned intermediary between the purchaser and the manufacturer. If the doctor is properly warned of the possibility of a side effect in some patients, and is advised of the symptoms normally accompanying the side effect, there is an excellent chance that injury to the patient can be avoided. .

Id. at 85.

Although the rule largely applies to prescription drugs, some courts have extended it to cases involving prescription medical implants and devices. See, e.g., Willett v. Baxter Int’l, Inc., 929 F.2d 1094, 1098 (5th Cir.1991) (artificial heart valve); Phelps v. Sherwood Med. Indus., 836 F.2d 296, 303 (7th Cir.1987) (heart catheter); Brooks v. Medtronic, Inc., 750 F.2d 1227, 1231-32 (4th Cir.1984) (cardiac pacemaker); Lee v. Baxter Healthcare Corp., 721 F.Supp. 89, 95 (D.Md.1989), aff'd, 898 F.2d 146 (4th Cir.1990) (silicone breast implants). Thus, the A.L.I. included such devices within the purview of section 6(d). Obviously, the rule applies only to prescription drugs and devices and not to over-the-counter products. “A consumer of over-the-counter drugs is, as it were, self-prescribing and is intended, expected, and indeed encouraged by the drug industry to do so. He must, therefore, also be given such information by the manufacturer as will permit him to self-prescribe with a minimum of risk.” Torsiello v. Whitehall Labs., 165 N.J.Super. 311, 398 A.2d 132, 139-40 (App.Div.1979).

II. THE RATIONALE.

Three basic rationales have been articulated to support the rule. The first and best rationale is that the prescribing physician is in a superior position to impart the warning and can provide an independent medical decision as to whether use of the drug is appropriate for treatment of a particular patient.

The rationale supporting this “learned intermediary” rule is that only healthcare professionals are in a position to understand the significance of the risks involved and to assess the relative advantages and disadvantages of a given form of prescription-based therapy. The duty then devolves on the healthcare provider to supply to the patient such information as is deemed appropriate under the circumstances so that the patient can make an informed choice as to therapy.

Restatement (Third) of Torts: Prods. Liab., supra, at § 6 cmt. b.

Prescription drugs are likely to be complex medicines, esoteric in formula and varied in effect. As a medical expert, the prescribing physician can take into account the propensities of the drug, as well as the susceptibilities of his patient. His is the task of weighing the benefits of any medication against its potential dangers. The choice he makes is an informed one, an individualized medical judgment bottomed on a knowledge of both patient and palliative.

Reyes v. Wyeth Labs., 498 F.2d 1264, 1276 (5th Cir.1974).

The entire system of drug distribution in America is set up so as to place the responsibility of distribution and use upon professional people. The laws and regulations prevent prescription type drugs from being purchased by individuals without the advice, guidance and consent of licensed physicians and pharmacists. These professionals are in the best position to evaluate the warnings put out by the drug industry.

Gravis v. Parke-Davis & Co., 502 S.W.2d 863, 870 (Tex.Civ.App.1973). See also West v. Searle & Co., 305 Ark. 33, 806 S.W.2d 608, 613 (1991) (“[A] physician must prescribe the drug, the patient relies upon the physician’s judgment in selecting the drug, and the patient relies upon the physician’s advice in using the drug. That is to say that there is an independent medical decision by the learned intermediary that the drug is appropriate.”); Vitanza v. Upjohn Co., 257 Conn. 365, 778 A.2d 829, 841 (2001) (“The learned intermediary doctrine stands for the proposition that, as a matter of law, the prescribing physician of a prescription drug is the person best able to take or recommend precautions against the harm.”); Martin v. Ortho Pharm. Corp., 169 Ill.2d 234, 214 Ill.Dec. 498, 661 N.E.2d 352, 357 (1996) (“[P]re-scribing physicians, and not pharmaceutical manufacturers, are in the best position to provide direct warnings to patients concerning the dangers associated with prescription drugs.”); Restatement (Third) of Torts: Prods. Liab., supra, at § 6 cmt. d (“When prescribing health-care providers are adequately informed of the relevant benefits and risks associated with various prescription drugs and medical devices, they can reach appropriate decisions regarding which drug or device is best for specific patients.”).

The second rationale for the rule is that manufacturers lack effective means to communicate directly with each patient. Reaves v. Ortho Pharm. Corp., 765 F.Supp. 1287, 1290 (E.D.Mich.1991) (“patients are unlikely to understand technical medical information regarding the nature and propensities” of prescription drugs); West, 806 S.W.2d at 613 (“[I]t is virtually impossible in many cases for a manufacturer to directly warn each patient.”); Gravis, 502 S.W.2d at 870 (“We hold that it is unreasonable to demand that the manufacturer of drugs specifically warn each and every patient that receives drugs prescribed by the physician or other authorized persons.”).

The third rationale for the rule is that imposing a duty to warn upon the manufacturer would unduly interfere with the physician-patient relationship. West, 806 S.W.2d at 613. See also Seley v. G.D. Searle & Co., 67 Ohio St.2d 192, 423 N.E.2d 831, 840 (1981) (“The patient is expected to place primary reliance upon the physician’s judgment, and to follow his advice and instructions as to use of' the drug.”). Furthermore, since the typical manufacturer’s warning provides a list with scores of potential side effects, no matter how minute the possibility of occurrence, the lay consumer might overreact to such warnings and forego beneficial, or even vital, medical treatment. See David G. Owen, M. Stuart Madden & Mary J. Davis, Madden & Owen on Products Liability § 22:14 (3d ed. 2003) (“[A] patient faced with an overwhelming number of warnings ... may decide not to take a medication prescribed by his physician

III. ADEQUACY OF WARNING.

Even though the manufacturer’s duty to warn runs only to the learned intermediary, that warning must still be adequate. Pittman v. Upjohn Co., 890 S.W.2d 425, 429 (Tenn.1994)("[T]he learned intermediary doctrine does not shield a drug manufacturer from liability for inadequate warnings to the physician.”). If the manufacturer fails to adequately warn the learned intermediary, then it may be liable to the injured patient-consumer. McEwen v. Ortho Pharm. Corp., 270 Or. 375, 528 P.2d 522, 529 (1974) (“Although the duty of the ethical drug manufacturer is to warn the doctor, rather than the patient, the manufacturer is directly hable to the patient for a breach of such duty.” (citations omitted)). See also Proctor v. Davis, 291 Ill.App.3d 265, 225 Ill.Dec. 126, 682 N.E.2d 1203, 1213 (1997) (manufacturer cannot evade duty to warn physician by hoping doctors will learn of dangers themselves).

An adequate warning has been defined as one “sufficient to apprise the general practitioner as well as the ‘unusually sophisticated medical man’ of the dangerous propensities of the drug.” McEwen, 528 P.2d at 529 (quoting Parke-Davis & Co. v. Stromsodt, 411 F.2d 1390, 1400 (8th Cir.1969)). “ ‘[I]t is incumbent upon the manufacturer to bring the warning home to the doctor.” ’ Id. (quoting Paul D. Rheingold, Products Liability — The Ethical Drug Manufacturer’s Liability, 18 Rutgers L.Rev. 947, 993 (1964)). “Several cases have held that a package insert may be sufficient for the warning to be adequate as a matter of law.” Wyeth Labs., Inc. v. Fortenberry, 530 So.2d 688, 692 (Miss.1988). See also Plummer v. Lederle Labs., 819 F.2d 349, 357 (2d Cir.1987); Chambers v. G.D. Searle & Co., 441 F.Supp. 377 (D.Md.1975), aff'd 567 F.2d 269 (4th Cir.1977) (per curiam). The warning may also be adequate if posted in the Physician’s Desk Reference. Wolfgruber v. Upjohn Co., 72 A.D.2d 59, 423 N.Y.S.2d 95, 97 (1979) (“[W]here the warning given to the prescribing physician by the manufacturer through the Physician’s Desk Reference (PDR), package inserts and other literature gives specific detailed information on the risks of the drug, the manufacturer has been held absolved from liability as a matter of law.”).

Thus, providing an adequate warning to the prescribing physician relieves the manufacturer of its duty to warn the patient regardless of how or if the physician warns the patient. E.R. Squibb & Sons v. Farnes, 697 So.2d 825, 827 (Fla.1997) (“Whether the physician in fact reads the warning, or passes its contents along to the recipient of the drug is irrelevant.”). Cf. Mazur v. Merck & Co., 964 F.2d 1348, 1368 n. 30 (3d Cir.1992) (irrelevant whether Center for Disease Control (CDC) actually warned vaccinees; real issue was whether manufacturer reasonably relied on CDC’s promise to warn where manufacturer had furnished CDC with all necessary information).

IV. EXCEPTIONS.

Section 6(d)(2) of the Restatement (Third) of Torts: Prods. Liab., supra, states the exception to the learned intermediary rule, i.e., the manufacturer must adequately warn the ultimate consumer (patient) when the manufacturer knows or should know that the advisory role of the health care provider will be greatly diminished.

[I]n certain limited therapeutic relationships the physician or other health-care provider has a much-diminished role as an evaluator or decisionmaker. In these instances it may be appropriate to impose on the manufacturer the duty to warn the patient directly. See Subsection (d)(2).

Id. cmt. b.

Courts have carved out exceptions to the learned intermediary rule “where there is a lack of communication between patients and their physicians or where patients essentially control the selection of the product.” Vitanza, 778 A.2d at 847. None of these exceptions apply to the facts of this case; however, a brief summary explains why the A.L.I. added subsection (d)(2) to Section 6.

The most often recognized exception is for mass immunizations. Davis v. Wyeth Labs., Inc., 399 F.2d 121, 131 (9th Cir.1968) (recognizing exception for a mass immunization for polio because the immunization was “dispensed to all comers at mass clinics without an individualized balancing by a physician of the risks involved”). See also Petty v. United States, 740 F.2d 1428, 1440 (8th Cir.1984); Givens v. Lederle, 556 F.2d 1341, 1345-46 (5th Cir.1977); Reyes v. Wyeth Labs., Inc., 498 F.2d 1264, 1276-77 (5th Cir.1974); Cunningham v. Charles Pfizer & Co., 532 P.2d 1377, 1381 (Okla.1974). However, most courts hold that manufacturers have fulfilled their duty to warn if they either obligated or reasonably relied upon the purchaser, e.g., the CDC, and provided the purchaser with all relevant and accurate information. Mazur, 964 F.2d at 1366-68; Reyes, 498 F.2d at 1276-77; Davis, 399 F.2d at 131; Walker v. Merck & Co., 648 F.Supp. 931, 935 (M.D.Ga.1986), aff'd, 831 F.2d 1069 (11th Cir.1987).

A second exception, recognized by several jurisdictions, is for oral contraceptives.

The oral contraceptive thus stands apart from other prescription drugs in light of the heightened participation of patients in decisions relating to use of “the pill;” the substantial risks affiliated with the product’s use; the feasibility of direct warnings by the manufacturer to the user; the limited participation of the physician (annual prescriptions); and the possibility that oral communications between physicians and consumers may be insufficient or too scanty standing alone fully to apprise consumers of the product’s dangers at the time the initial selection of a contraceptive method is made as well as at subsequent points when alternative methods may be considered. We conclude that the manufacturer of oral contraceptives is not justified in relying on warnings to the medical profession to satisfy its common law duty to warn, and that the manufacturer’s obligation encompasses a duty to warn the ultimate user.

MacDonald v. Ortho Pharm. Corp., 394 Mass. 131, 475 N.E.2d 65, 70 (1985). See also Odgers v. Ortho Pharm. Corp., 609 F.Supp. 867, 878-79 (E.D.Mich.1985); Stephens v. G.D. Searle & Co., 602 F.Supp. 379, 381 (E.D.Mich.1985); contra Reaves v. Ortho Pharm. Corp., 765 F.Supp. 1287, 1291 (E.D.Mich.1991) (rejecting oral contraceptive exception as stated in Odgers and Stephens). Virtually every other jurisdiction that has addressed the issue has rejected an exception for oral contraceptives. See In re Norplant Contraceptive Liab. Litig., 955 F.Supp. 700, 704-05 (E.D.Tex.1997), and cases cited therein.

A third exception, recognized only by New Jersey, is for direct-to-consumer advertised drugs.

[Wjhen mass marketing of prescription drugs seeks to influence a patient’s choice of a drug, a pharmaceutical manufacturer that makes direct claims to consumers for the efficacy of its product should not be unqualifiedly relieved of a duty to provide the proper warnings of the dangers or side effects of the product.

Perez v. Wyeth Labs., Inc., 161 N.J. 1, 734 A.2d 1245, 1247 (1999). Cf. Whitley v. Cubberly, 24 N.C.App. 204, 210 S.E.2d 289, 292 (1974) (in non-strict-liability jurisdiction, sufficient instructions do not absolve drug manufacturer of liability where manufacturer over-promoted drug, inducing medical community not to “adequately heed the warnings given”).

V. OTHER JURISDICTIONS.

To date, the courts of thirty-four states have specifically adopted the learned intermediary rule by common law decision. In addition, in Peterson v. Parke Davis & Co., 705 P.2d 1001 (Colo.Ct.App.1985), the Colorado Court of Appeals, though not specifically adopting the rule (Colorado is not a strict liability jurisdiction), held that the manufacturer was not required to warn anyone other than the attending physician, Id. at 1003-04. And in Mampe v. Ayerst Laboratories, 548 A.2d 798 (D.C.1988), the District of Columbia Court of Appeals, while not specifically adopting the rule, recognized that the prescribing physician is the “user” of a prescription drug to whom the warning must be given. Id. at 801. Furthermore, federal courts applying state laws have either interpreted the laws of nine other states and Puerto Rico as having adopted the rule or a facsimile thereof, or predicted that those jurisdictions would ultimately adopt it. No court that has directly addressed the issue as an exception to the common law duty to warn has rejected the learned intermediary rule, per se.

VI. ARGUMENTS AGAINST ADOPTION.

The Larkins argue that Kentucky should reject the learned intermediary rule primarily on the basis of the holding in Montgomery Elevator Co. v. McCullough, Ky., 676 S.W.2d 776 (1984), that a manufacturer’s duty to warn the ultimate consumer is “non-delegable.” Id. at 782. However, in so holding, Montgomery quoted dictum in Minert v. Harsco Corp., 26 Wash.App. 867, 614 P.2d 686, 691 (1980). Minert, however, was decided two years after the Supreme Court of Washington adopted the learned intermediary rule in Terhune v. A.H. Robins Co., 577 P.2d at 977, and Minert, decided by an intermediate appellate court, did not purport to overrule the higher court’s decision. Additionally, neither Minert nor Montgomery factually resemble the case sub judice. Minert involved a claim of defective scaffolding; Montgomery involved a defective department store escalator. Obviously, Minert and Montgomery involved the type of “duty to warn” then described in the Restatement (Second) of Torts § 388 (1965), adopted by Lloyd v. Lloyd, Ky., 479 S.W.2d 623, 625 (1972) (involving a defective lawnmower), viz:

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
(c) fails to exercise reasonable care to inform them of its dangerous condition or of the facts which make it likely to be dangerous.

Now see Restatement (Third) of Torts: Prods. Liab. § 2 cmt. i (1998) (manufacturer’s duty to warn). Although Montgomery did not adopt the concept of “reasonable care” expressed in section 388(e), it is obvious that escalators, scaffolding, and lawn mowers are chattels of a different nature from prescription drugs. Moreover, Washington’s adoption of both the learned intermediary rule for prescription drugs and the “nondelegable duty” rule for other chattels indicates that the two rules are compatible., Thus, Montgomery does not mandate rejection of the learned intermediary rule with respect .to the duty to warn of adverse side effects of prescription drugs.

Next, the Larkins claim that the General Assembly’s failure to mention the learned intermediary rule in the Product Liability Act, KRS 411.300, eb seq., indicates a legislative intent not to adopt the rule in Kentucky. Were we to accept this reasoning, no need would exist for the learned intermediary rule, or any warning at all, because the Product Liability Act, KRS 411.320, entitled “Circumstances under which defendant is liable,” makes no mention of a duty to warn. It is purely a common law duty. See generally Post v. Am. Cleaning Equip. Corp., Ky., 437 S.W.2d 516 (1968).

Alternatively, the Larkins claim that adoption of the learned intermediary rule is a matter of public policy that should be left to the legislature. Reda Pump Co. v. Finch, Ky., 713 S.W.2d 818, 821 (1986) (“[T]he establishment of public policy is the prerogative of the General Assembly.”), superseded by statute on other grounds as recognized by Ingersoll-Rand Co. v. Rice, Ky., 775 S.W.2d 924, 930 (1988). Of course, in Reda Pump, the General Assembly had established a public policy by declaring that the contributory negligence doctrine would apply in product liability actions, whereas this Court had abrogated contributory negligence in favor of comparative negligence in common law actions. Hilen v. Hays, Ky., 673 S.W.2d 713, 720 (1984). Regardless, we do not view the adoption of an almost universally accepted exception to a common law rule as a matter of public policy. Only three jurisdictions have adopted the learned intermediary rule by statute, see N.J. Stat. Ann. § 2A:58C-4 (1987); N.C. GemStat. § 99B-5(c) (1996); Ohio Rev.Code Ann. § 2307.76(C) (1988), and all three enacted their statutes after their courts had adopted the rule by common law. See Calabrese, 392 A.2d at 604-05 (1978 New Jersey case); Holley, 330 S.E.2d at 233 (1985 North Carolina case); Seley, 423 N.E.2d at 836-37 (1981 Ohio case). Furthermore, the learned intermediary rale is consistent with our informed consent statute, KRS 304.40-320, which anticipates that doctors will inform their patients of any risks or dangers inherent in proposed treatment:

[T]he claimant’s informed consent shall be deemed to have been given where:
(2) A reasonable individual, from the information provided by the health care provider under the circumstances, would have a general understanding of the procedure and medically or dentally acceptable alternative procedures or treatments and substantial risks and hazards inherent in the proposed treatment or procedures

(Emphasis added.)

Finally, we reject the argument that adopting the learned intermediary rule would immunize manufacturers of prescription drugs from products liability claims. Manufacturers still have a duty to warn; the rule only identifies the party to be warned, ie., the health care provider who prescribes the drugs. If the manufacturer fails to adequately warn the prescribing health care provider, the manufacturer is directly liable to the patient for damages resulting from that failure. Proctor v. Davis, supra; McEwen v. Ortho Pharm. Corp., supra; Pittman v. Upjohn Co., supra.

Accordingly, having adopted comment k of the Restatement (Second) of Torts § 402A in McMichael, 532 S.W.2d at 9-11 (prescription drugs not unreasonably unsafe if adequate warning is given of possible adverse side effects), we now adopt Restatement (Third) of Torts: Products Liability § 6(d) (duty to warn of possible side effects satisfied if adequate warning given to patient’s health care provider, subject to exceptions). The posture of this case does not require us to decide which, if any, of the recognized exceptions to this rule should be adopted in Kentucky.

THE LAW IS SO CERTIFIED.

GRAVES, JOHNSTONE, and KELLER, JJ., concur.

WINTERSHEIMER, J., dissents by separate opinion, with LAMBERT, C.J., and STUMBO, J., joining that dissenting opinion.

Dissenting opinion by

Justice WINTERSHEIMER.

I respectfully dissent from the majority opinion because the decision to adopt the so-called learned intermediary doctrine as an exception to the clear and unambiguous provisions of the Product Liability Act, KRS 411.300, is a matter solely within the discretion of the General Assembly, and not the judiciary. The so-called learned intermediary doctrine provides a type of summary immunization for pharmaceutical manufacturers and makes the adequacy of warnings to the ultimate consumer a question of law for the court and not a question of fact for the jury.

In Kentucky, the Product Liability Act applies to all damage claims arising from use of products, regardless of legal theory advanced. KRS 411.300(1). See Monsanto Co. v. Reed, Ky., 950 S.W.2d 811 (1997). The majority has attempted to supersede statutory law with the common law. Our sister court in Oregon was faced with substantially similar facts and arrived at the proper conclusion that statutes, not the common law, govern strict products liability claims and defenses to those claims. See Griffith v. Blatt, 334 Or. 456, 51 P.3d 1256, 1261 (2002). There, the Oregon Supreme Court declined to incorporate the learned intermediary doctrine into the statutory scheme of strict products liability because the defense was a common law defense but the underlying claim was brought by the statutory action. Likewise, by enacting the Product Liability Act, the Kentucky Legislature has preempted the field of strict products liability claims by defining “any action” in KRS 411.300(1). Nowhere in the Product Liability Act is there an incorporation of the common law defense of the learned intermediary doctrine. Instead, the majority has made such legislation by judicial fiat, but it is an unfortunate addition for the reasons below.

This Court should take notice of the abundantly obvious fact that the development of direct to consumer pharmaceutical advertising has indelibly changed the realities of physician/patient relationships. Anyone who watches television is regtilarly bombarded with a variety of pharmaceutical products which suggest that the ultimate consumer ask his physician to prescribe a particular advertised product.

This case provides a scenario where the application of the so-called learned intermediary doctrine involves an allegation that the manufacturer of a prescription drug failed to warn the ultimate consumer of the risks associated with that drug, even though the manufacturer advised the prescribing physician of such risks.

A review of the legislative approach to product liability indicates that by the clear and unambiguous language of the Act, the legislature did not intend that such a doctrine be an exception to product liability. Cf. Reda Pump Co. v. Finch, Ky., 713 S.W.2d 818 (1986). Reda Pump Co., supra, is an example of the Legislature, not this Court, adjusting the Product Liability Act. Only three years after that decision, effective July 15, 1988, the Legislature enacted a revised KRS 411.182, which statutorily overruled Reda Pump Co. and KRS 411.320(3) thereby incorporating comparative negligence into the Product Liability Act where previously there was none. See Ingersoll-Rand Co. v. Rice, Ky.App., 775 S.W.2d 924 at 930 (1989).

Strict liability for defective products of any kind was codified in the Restatement (Second) of Torts § 402A in 1964. This Court adopted a form of strict liability in Dealers Transport Co. v. Battery Distributing Co., Ky., 402 S.W.2d 441 (1966). In some states, product liability law has been developed through judicial decisions. Some states have taken a statutory approach. In 1978, the Kentucky General Assembly codified the common law product liability and since that time the court has generally held that any major changes or additions to that law is within the province of the legislature. See Reda Pump Co.

This Court has previously recognized that manufacturers of products have a nondelegable duty to warn consumers of the dangers connected with the use of their products. See Grayson Fraternal Order of Eagles Aerie No. 3738, Inc. v. Claywell, Ky., 736 S.W.2d 328 (1987). There is really no logical reason for determining that the generally applicable non-delegable duty does not apply to prescription medicine. It must be remembered that the legislature has the sole responsibility for determining public policy where a statutorily established right is in question. Commonwealth v. Wilkinson, Ky., 828 S.W.2d 610 (1992); Surrogate Parenting Associates v. Commonwealth, Ky., 704 S.W.2d 209 (1986).

The comparative fault amendments adopted in 1998 did not incorporate the so-called learned intermediary doctrine as an exception to liability. There is no question that pharmaceutical manufacturers believe they have very effective methods to communicate directly with consumers. In the first four months of year 2000, pharmaceutical manufacturers’ spending has increased 58% when compared to the first four months of 1999. Caroline L. Nadel, The Societal Value of Prescription Drug Advertisements in the New Millennium: Targeted Consumers Become the Learned, 9 J.L. and Pol’y 451, 480 (2001). Consumer marketing has made the pharmaceutical industry the 13th largest advertiser in the United States. See Mitchell S. Berger, A Tale of Six Implants: The Perez v. Wyeth Laboratories Norplant Case and the Applicability of the Learned Intermediary Doctrine to Direct-To-Consumer Drug Promotion, 55 Food & Drug Law Journal 525 (2000). One study cited by a recent commentary on this subject noted that “patients may make appointments for the sole purpose of requesting a new ‘miracle drug’ they have seen on television, having no knowledge of whether the drug is truly appropriate for their particular situation.” See Andrea M. Greene, Pharmaceutical Manufacturers’ Liability for Direct Marketing and Over-promotion of Prescription Drugs to Product Users, 26 Am. J. Trial Advoc. 661 (2003). This same study found that as many as a third of the patients asked for information on the drug while one in four asked for the drug itself. Id., at note 6. Three quarters of those patients that asked their doctor to write the prescription for the drug received one. Id. Such direct demand for drug products is due to the manufacturer’s direct-to-consumer promotion. Given that the manufacturers are now directly marketing and benefiting by increased sales, they must also assume increased share in the risks and duties pertinent to selling a product.

Pharmaceutical companies are in the best position to ensure that adequate warnings are provided to customers. As noted in Perez v. Wyeth Labs., Inc., 161 N.J. 1, 734 A.2d 1245 (1999):

Our medical-legal jurisprudence is based on images of health care that no longer exist. At an earlier time, medical advice was received ... from a physician.... [Today,] medical services are in large measure provided by managed care organizations. Medicines are purchased in the pharmacy department of supermarkets and often paid for by third-party providers. Drug manufacturers now directly advertise products to consumers on radio, television, the internet, billboards on public transportation, and in magazines.
Perez, supra, 734 A.2d at 1246.

This case can have a profound effect on the health and well being of individuals in this Commonwealth. It is an important matter of public policy that should be properly decided by the legislature. The matter needs public and legislative debate which is supported by evidence of its value or otherwise. Such' a process can best be obtained through legislative investigative hearings as a matter of public policy. Kentucky product liability law is statutory and amendments to the law are within the discretion of the General Assembly.

LAMBERT, C.J., and STUMBO, J., join this dissent.

      . We need not address here the effect, if any, on these precedents of the enactment of the National Childhood Vaccine Injury Act of 1986, which provides in part:
      No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, solely due to the manufacturer’s failure to provide direct warnings to the injured party (or the injured party’s legal representative) of the potential dangers resulting from the administration of the vaccine manufactured by the manufacturer.
      42 U.S.C. § 300aa-22(c). But see Allison v. Merck & Co., 110 Nev. 762, 878 P.2d 948, 960-61 (1994) (The National Childhood Vaccine Injury Act does not require dismissal of vaccine suits so long as claimants elect not to accept compensation from the government as authorized by the Act).

      . However, prior to the decision in Perez, New Jersey had codified the learned intermediary rule in N.J. Stat. Ann. § 2A:58C-4, which included a rebuttable presumption that advertisements that complied with Federal Drug Administration (FDA) regulations provided a sufficient warning. Thus, Perez adopted the exception subject to the statutory presumption. Perez, 734 A.2d at 1259. One commentator has noted that the ultimate re-suit appears to be a victory for plaintiffs but actually narrows the chance of recovery “by leaving a cause of action equivalent to mere agency review.” Patrick Cohoon, An Answer to the Question Why the Time Has Come to Abrogate the Learned Intennediary Rule in the Case of Direct-To-Consumer Advertising of Prescription Drugs, 42 S. Tex. L.Rev. 1333, 1341 (2001).

      . Alabama: Stone v. Smith, Kline & French Labs., 447 So.2d 1301, 1304-05 (Ala.1984);
      Alaska: Shanks v. Upjohn Co., 835 P.2d 1189, 1200 (Alaska 1992);
      Arizona: Gaston v. Hunter, 121 Ariz. 33, 588 P.2d 326, 341 (App.1978);
      Arkansas: West v. Searle & Co., 305 Ark. 33, 806 S.W.2d 608, 614-15 (1991);
      California: Brown v. Superior Court, 44 Cal.3d 1049, 245 Cal.Rptr. 412, 419, 751 P.2d 470 (1988);
      Connecticut: Vitanza v. Upjohn Co., 257 Conn. 365, 778 A.2d 829, 836-39 (2001);
      Delaware: Lacy v. G.D. Searle & Co., 567 A.2d 398, 400 (Del.1989);
      Florida: Felix v. Hoffmann-LaRoche, Inc., 540 So.2d 102, 104 (Fla.1989);
      Georgia: Hawkins v. Richardson-Merrell, Inc., 147 Ga.App. 481, 249 S.E.2d 286, 288 (1978);
      Hawaii: Craft v. Peebles, 78 Hawai’i 287, 893 P.2d 138, 155-56 (1995) (adopting learned intermediary rule for silicone breast implants);
      Illinois: Kirk v. Michael Reese Hosp. & Med. Ctr., 117 Ill.2d 507, 111 Ill.Dec. 944, 513 N.E.2d 387, 393 (1987);
      Indiana: Ortho Pharm. Corp. v. Chapman, 180 Ind.App. 33, 388 N.E.2d 541, 548-49 (1979);
      Kansas: Wooderson v. Ortho Pharm. Corp., 235 Kan. 387, 681 P.2d 1038, 1049-51 (1984);
      Louisiana: Cobb v. Syntex Labs., Inc., 444 So.2d 203, 205 (La.Ct.App.1983);
      Maryland: Nolan v. Dillon, 261 Md. 516, 276 A.2d 36, 40 (1971);
      Massachusetts: MacDonald v. Ortho Pharm. Corp., 394 Mass. 131, 475 N.E.2d 65, 68-69 (1985);
      Michigan: Smith v. E.R. Squibb & Sons, 405 Mich. 79, 273 N.W.2d 476, 479 (1979); Minnesota: Mulder v. Parke Davis & Co., 288 Minn. 332, 181 N.W.2d 882, 885 n. 1 (1970);
      Mississippi: Wyeth Labs., Inc. v. Fortenberry, 530 So.2d 688, 691 (Miss.1988);
      Missouri: Krug v. Sterling Drug, Inc., 416 S.W.2d 143, 146-47 (Mo.1967);
      Montana: Hill v. Squibb & Sons, 181 Mont. 199, 592 P.2d 1383, 1387-88 (1979); Nebraska: Freeman v. Hoffman-LaRoche, Inc., 260 Neb. 552, 618 N.W.2d 827, 842 (2000);
      New Jersey: Calabrese v. Trenton State Coll., 162 N.J.Super. 145, 392 A.2d 600, 604-05 (App.Div.1978), aff'd, 82 N.J. 321, 413 A.2d 315 (1980);
      New Mexico: Perfetti v. McGhan Med., 99 N.M. 645, 662 P.2d 646, 649 (App.1983); New York: Martin v. Hacker, 83 N.Y.2d 1, 607 N.Y.S.2d 598, 628 N.E.2d 1308, 1311 (1993);
      Ohio: Seley v. G.D. Searle & Co., 67 Ohio St.2d 192, 423 N.E.2d 831, 836-37 (1981); Oklahoma: Cunningham v. Charles Pfizer & Co., 532 P.2d 1377, 1381 (Okla.1974);
      Oregon: McEwen v. Ortho Pharm. Corp., 270 Or. 375, 528 P.2d 522, 529 (1974) (however, in Griffith v. Blatt, 51 P.3d 1256, 1261-62 (Or.2002), the Supreme Court of Oregon held that the subsequent enactment of a strict liability statute, Or.Rev.Stat. § 30.900, that specifically included a duty to warn but did not include the learned intermediary rule as an exception to that duty precluded application of the rule in an action brought under the statute);
      Pennsylvania: Coyle v. Richardson-Merrell, Inc., 526 Pa. 208, 584 A.2d 1383, 1385 (1991);
      Tennessee: Pittman v. Upjohn Co., 890 S.W.2d 425, 429-30 (Tenn.1994);
      Texas: Gravis v. Parke-Davis & Co., 502 S.W.2d 863, 870 (Tex.Civ.App.1973);
      Utah: Barson v. E.R. Squibb & Sons, 682 P.2d 832, 835 (Utah 1984);
      Virginia: Pfizer, Inc. v. Jones, 221 Va. 681, 272 S.E.2d 43, 44 (1980);
      Washington: Terhune v. A.H. Robins Co., 90 Wash.2d 9, 577 P.2d 975, 977 (1978).

      . Violette v. Smith & Nephew Dyonics, Inc., 62 F.3d 8, 13 (1st Cir.1995) (interpreting Maine law); Guevara v. Dorsey Labs., 845 F.2d 364, 366 (1st Cir.1988) (interpreting Puerto Rico law); Brooks v. Medtronic, Inc., 750 F.2d at 1231 (4th Cir.1984) (interpreting South Carolina law); Petty v. United States, 740 F.2d at 1440 (8th Cir.1984) (interpreting Iowa law in a case where the federal government statutorily assumed the duty to warn, and then applying the mass immunization exception); Brochu v. Ortho Pharm. Corp., 642 F.2d 652, 656 (1st Cir.1981) (interpreting New Hampshire law); Ehlis v. Shire Richwood, Inc., 233 F.Supp.2d 1189, 1196 (D.N.D.2002) (interpreting North Dakota law); Menges v. Depuy Motech, Inc., 61 F.Supp.2d 817, 830 (N.D.Ind.1999) (interpreting Wisconsin law); Pumphrey v. C.R. Bard, Inc., 906 F.Supp. 334, 337-38 (N.D.W.Va.1995) (interpreting West Virginia law); Foyle v. Lederle Labs., 674 F.Supp. 530, 536 (E.D.N.C.1987) (interpreting North Carolina law and citing Holley v. Burroughs Wellcome Co., 74 N.C.App. 736, 330 S.E.2d 228, 233 (1985), aff'd, 348 S.E.2d 772 (1986), for the proposition that in North Carolina, a non-strict liability jurisdiction, warnings are only required to be given to person responsible for patient's care); McElhaney v. Eli Lilly & Co., 575 F.Supp. 228, 231 (D.S.D.1983) (interpreting South Dakota law).

      . The dissenting opinion’s reliance on Griffith v. Blatt, 51 P.3d 1256 (Or.2002), is misplaced. First, Oregon’s product liability act, unlike our act, specifically authorizes a civil action "against a manufacturer ... for damages ... arising out of: ... (2) Any failure to warn regarding a product ....” Id. at 1261-62 (quoting Or.Rev.Stat. § 30.900). Second, the person seeking to invoke the learned intermediary rule in that case was a pharmacist who sold the product, not the manufacturer of the product. Id. at 1258.

      . KRS 411.320(3). The General Assembly subsequently superseded that provision by enacting KRS 411.182(1) which applies comparative fault to product liability actions. 1988 Ky. Acts, ch. 224, § 1.


source: Caselaw Access Project

author: Justice COOPER. Justice JOHNSTONE.

license: Public Domain

text:
    Flaminto THOMAS, Appellant, v. COMMONWEALTH OF KENTUCKY, Appellee.
    No. 2002-SC-0021-DG.
    Supreme Court of Kentucky.
    Nov. 18, 2004.
    Rehearing Denied Feb. 17, 2005.

      Irvin Halbleib, Jr., Louisville, Counsel for Appellant.
    Gregory D. Stumbo, Attorney General, Courtney J. Hightower, Assistant Attorney General, Criminal Appellate Division, Frankfort, Counsel for Appellee.
   Opinion of the Court by

Justice COOPER.

Appellant, Flaminto Thomas, and his wife, Dellithi Thomas, were convicted by a McCracken Circuit Court jury of criminal abuse in the second degree. KRS 508.110. Appellant was sentenced to three years in prison enhanced to seventeen years upon the jury’s additional verdict that he was a persistent felony offender (PFO) in the first degree. KRS 532.080(3). The Court of Appeals affirmed his criminal abuse conviction but reversed the PFO verdict because the documentation of Appellant’s prior felony convictions in Illinois did not contain the statutorily required judicial certification. KRS 422.040. Appellant seeks further review claiming (1) there was insufficient evidence to support his conviction of criminal abuse in the second degree; (2) the Commonwealth exercised its peremptory strikes in violation of Batson v. Kentucky, 476 U.S. 79, 106 S.Ct. 1712, 90 L.Ed.2d 69 (1986); and (3) an item of real evidence introduced at trial, a green, plastic, twenty-ounce Mountain Dew soda bottle containing cocaine residue, was insufficiently identified to authorize its admission into evidence. KRE 901. Finding no error, we affirm.

I. SUFFICIENCY OF THE EVIDENCE.

On the night of November 4-5, 1999, Dellithi Thomas was at home alone with two of her children in the rental mobile home that she shared with Appellant. The children had fallen asleep in the living room while watching a movie on television. At approximately 4:00 a.m., while Mrs. Thomas was asleep in the master bedroom, D.W., then age two, crawled into bed with her. She noticed that D.W. was extremely groggy but did not realize until approximately 6:30 a.m. that he was seriously ill. She later discovered that he had ingested five or six Valium pills that she kept in an unlocked curio box in the drawer of a dresser. When Appellant returned home, she told him what had happened. Appellant mixed milk and castor oil in a green, plastic, twenty-ounce Mountain Dew soda bottle and fed it to D.W. He then retired to the bedroom and went to sleep. At 9:00 a.m., Mrs. Thomas attempted to use the telephone in the trailer park rental office to call for help; however, the attendant had not yet arrived. Later, she sought help from her mother, Jeannie Herndon. Herndon instructed her to bring D.W. to her place of employment. When Herndon noticed that D.W. could not hold his head up, she and Mrs. Thomas transported him to the emergency room at Lourdes Hospital.

At the hospital, Mrs. Thomas initially denied knowing the cause of D.W.’s condition. Later, she told the attendant nurse that he had stuck his head into a heating vent, leading the nurse to believe that D.W. was suffering from carbon monoxide poisoning. Subsequent urine tests revealed the presence of both Valium and cocaine in his system. D.W. was extremely lethargic, could not hold his head up or talk, and at one point, almost stopped breathing and was placed on a respirator. Ultimately, he was airlifted to Vanderbilt Hospital and treated in the pediatric intensive care unit. There was no evidence that he sustained any long-term complications from the drug ingestion although there was medical testimony that it may be too early to make that determination.

Eventually, Mrs. Thomas was arrested and Appellant left Kentucky for Chicago, Illinois. Several days later, Herndon retrieved Mrs. Thomas’s belongings from the rental mobile home and stored them in her attic. While cleaning out the mobile home, she discovered an empty, green, plastic, twenty-ounce Mountain Dew bottle that contained a white residue subsequently determined to be cocaine.

KRS 508.110 states in pertinent part:

(1) A person is guilty of criminal abuse in the second degree when he wantonly abuses another person or permits another person of whom he has actual custody to be abused and thereby:
(a) Causes serious physical injury; or
(b) Places him in a situation that may cause him serious physical injury
(c) Causes torture, cruel confinement or cruel punishment; to a person twelve (12) years of age or less, or who is physically helpless or mentally helpless.

On a motion for a directed verdict of acquittal, all fair and reasonable inferences are drawn in the Commonwealth’s favor. Commonwealth v. Benham, Ky., 816 S.W.2d 186, 187 (1991). After learning that D.W. had ingested a substantial quantity of Valium, Appellant did not seek proper medical treatment but instead fed him a home remedy of milk and castor oil. Appellant asserts that the Commonwealth was precluded from advancing this theory of wanton criminal abuse because it was not specifically set forth in the indictment. This argument is unpreserved because Appellant failed to raise it at trial, RCr 9.22, and we perceive no manifest injustice, RCr 10.26, or any prejudice to Appellant. Washington v. Commonwealth, Ky.App., 6 S.W.3d 384, 386-87 (1999) (no prejudice where indictment charged defendant with “intentionally causing” injury, but jury instructions also permitted conviction upon a finding that defendant “attempted to cause” injury). See also Baker v. Commonwealth, Ky., 103 S.W.3d 90, 94 (2003) (no error where indictment but not instructions for use of a minor in a sexual performance included the word “induce,” as Appellant had notice of the statutory language and the evidence supported the instruction). In fact, defense counsel addressed Appellant’s defense to this theory in his closing argument: “Now the Commonwealth’s going to tell you that the failure to get medical care ... was wanton and they’re guilty of second-degree criminal abuse.” Counsel argued that D.W. was alert before going to the hospital and that the defendants had no way of knowing the gravity of his condition.

There is also the evidence that Appellant fed D.W. the mixture of milk and castor oil from a bottle that contained cocaine. While no witness testified that Appellant knew the bottle contained cocaine, the jury was free to infer that he did. Commonwealth v. Sawhill, Ky., 660 S.W.2d 3, 4 (1983) (standard of review is the same whether conviction is based on direct or circumstantial evidence). We conclude that the evidence was sufficient for a reasonable jury to believe beyond a reasonable doubt that Appellant was guilty of wanton criminal abuse. Benham, 816 S.W.2d at 187.

II. BATSON ISSUE.

We are again confronted with the recurring tension between the use of peremptory challenges and the equal protection right against purposeful racial discrimination in the jury selection process. Pursuant to Batson v. Kentucky, supra, the defense team challenged the prosecutor’s use of peremptory strikes to excuse all four African-American members of the jury panel. The prosecutor initially stated that he struck one juror because of his criminal history but could not remember why he struck the others. Upon re-examining his notes, he explained that his office was prosecuting one of the juror’s sons on drug charges. He stated that he struck the other two jurors solely on the basis of their demeanor, facial expressions, and responsiveness during voir dire. Noting that this case may have been racially charged, given that Appellant is African-American, whereas his co-defendant wife and the victim, D.W., are Caucasian, Appellant claims that the Commonwealth used demeanor as a pretext for racial discrimination in excusing two of the four African-American jurors.

Batson established a three-step process for determining whether a prosecutor’s peremptory challenges violate the Equal Protection Clause. First, the defendant must show a prima facie case of racial discrimination. If the trial court is satisfied with the defendant’s showing, the burden shifts to the prosecutor to state race-neutral reasons for the peremptory strikes. The trial court must then determine whether the defendant has sufficiently proven purposeful discrimination. Batson, 476 U.S. at 93-98, 106 S.Ct. at 1722-24.

Because the prosecutor stated his reasons for striking the four jurors in question, there is no need to determine if a prima facie showing was made; thus, we proceed to the second step. Commonwealth v. Snodgrass, Ky., 831 S.W.2d 176, 179 (1992) (citing Hernandez v. New York, 500 U.S. 352, 359, 111 S.Ct. 1859, 1866, 114 L.Ed.2d 395 (1991) (plurality opinion)). Appellant claims that demeanor is categorically inadequate as a race-neutral explanation for a peremptory strike. He is mistaken. As stated in Purkett v. Elem, 514 U.S. 765, 115 S.Ct. 1769, 131 L.Ed.2d 834 (1995) (per curiam), Appellant has erroneously combined the second and third steps of the Batson inquiry. In Purkett, the United States Supreme Court rejected outright the notion that certain race-neutral explanations are always pretextual or inadequate:

It is not until the third step that the persuasiveness of the justification becomes relevant — the step in which the trial court determines whether the opponent of the strike carried his burden of proving purposeful discrimination. At that stage, implausible or fantastic justifications may (and probably will) be found to be pretexts for purposeful discrimination. But to say that a trial judge may choose to disbelieve a silly or superstitious reason at step three is quite different from saying that a trial judge must terminate the inquiry at step two when the race-neutral reason is silly or superstitious. The latter violates the principle that the ultimate burden of persuasion regarding racial motivation rests with, and never shifts from, the opponent of the strike.

Id. at 768, 115 S.Ct. at 1771 (emphasis added) (reversing Eighth Circuit’s holding that prosecutor’s statement that he did not like juror’s looks was per se inadequate). A race-neutral reason “is not a reason that makes sense, but a reason that does not deny equal protection.” Id. at 769, 115 S.Ct. at 1771; McCurdy v. Montgomery County, 240 F.3d 512, 521 (6th Cir.2001) (“This non-racial explanation need not be particularly persuasive, or even plausible, so long as it is neutral.”) (internal quotations and citations omitted). See also Snodgrass, 831 S.W.2d at 179 (trial court can accept prosecutor’s reasons at face value). As demeanor is a race-neutral explanation, the Commonwealth met its burden of proof, shifting the burden back to Appellant. United States v. Marrowbone, 211 F.3d 452, 456 (8th Cir.2000) (“Inattentiveness and demeanor can be race-neutral reasons.”); United States v. Forbes, 816 F.2d 1006, 1010-11 (5th Cir.1987) (prosecutor’s intuitive assumption from juror’s posture and demeanor that she resented being in court was race-neutral reason). See also Stanford v. Commonwealth, Ky., 793 S.W.2d 112, 114 (1990) (juror’s flashy manner of dress, size, and perceived “slowness” were race-neutral reasons).

Although a prosecutor theoretically could fabricate a demeanor-based pretext for a racially-motivated peremptory strike, the third step in Batson alleviates this concern by permitting the court to determine whether it believes the prosecutor’s reasons. Yarborough v. State, 947 S.W.2d 892, 896 (Tex.Crim.App.1997) (en banc) (“[Sjubjective evaluations of venire members could be used to disguise violations of the Equal Protection Clause. But this does not mean that such evaluations must always be held to have no weight. Trial judges are not without ability to detect pretexts.”). Given the trial court’s unique ability to evaluate the demeanor of both the jurors and the prosecutor, its ruling stands unless clearly erroneous. Washington v. Commonwealth, Ky., 34 S.W.3d 376, 379-80 (2000); Stanford v. Commonwealth, 793 S.W.2d at 114. Appellant points to nothing in the record that compels us to disturb the trial court’s finding. This is not a case like Washington where it was clear from the record that the prosecutor offered pretexts for striking an African-American juror. In Washington, the prosecutor first denied striking the juror then, after it was proven that he had used a peremptory strike against the juror, claimed he did so because of the juror’s youth, even though the juror was forty-three years old. 34 S.W.3d at 379. Here, the issue turns solely on the prosecutor’s credibility and the judge’s opportunity to personally observe the demeanor of both the prosecutor and the jurors. As such, there is nothing in the record upon which to base a finding of clear error.

III. IDENTIFICATION OF REAL EVIDENCE.

When Jeannie Herndon went to the Thomases’ rented mobile home to retrieve her daughter’s belongings, she found a green, plastic, twenty-ounce Mountain Dew soda bottle containing a chunky, crystalline, white residue. Because she knew that Appellant had fed D.W. a milk and castor oil mixture from such a bottle, Herndon, wearing gloves, placed the bottle in a plastic garbage bag and knotted it. She then called Detective Jerry Jones, who was investigating the case, and told him of her discovery. Jones told Herndon to keep the bottle and that he would come by her house and retrieve it. However, he failed to do so. Herndon stored the bottle in her attic with her daughter’s other belongings. Six days before trial, Herndon remembered the bottle, found it in her attic still in the plastic garbage bag, and gave it to the prosecutor. A test of the residue in the bottle revealed it to be cocaine. (The bottle was not tested for the presence of milk or castor oil.)

Appellant contends that the Commonwealth did not introduce sufficient evidence to prove that the bottle containing the cocaine residue was the same bottle that he used to feed the mixture of milk and castor oil to D.W. or, if it was, that the cocaine was in the bottle when he so used it. Our discussion begins with KRE 901(a), governing the foundation required for the admission of tangible evidence:

The requirement of ... identification as a condition precedent to admissibility is satisfied by evidence sufficient to support a finding that the matter in question is what the proponent claims.

Logically, a proper foundation requires the proponent to prove that the proffered evidence was the same evidence actually involved in the event in question and that it remains materially unchanged from the time of the event until its admission. Beason v. Commonwealth, Ky., 548 S.W.2d 835, 837 (1977). See also McCormick on Evidence § 212, at 8 (John W. Strong ed., 5th ed.1999). The necessary foundation depends upon the nature of the evidence. Evidence readily identifiable and impervious to change may be admitted based solely on testimony that it appears to be the actual object in an unchanged condition. Beason, 548 S.W.2d at 837. See also Grundy v. Commonwealth, Ky., 25 S.W.3d 76, 80 (2000) (same). However, the more fungible the evidence, the more significant its condition, or the higher its susceptibility to change, the more elaborate the foundation must be. E.g., Rabovsky v. Commonwealth, Ky., 973 S.W.2d 6, 8 (1998) (laboratory-tested blood sample); Mollette v. Ky. Pers. Bd., Ky.App., 997 S.W.2d 492, 495 (1999); Paul C. Gianelli, Chain of Custody and the Handling of Real Evidence, 20 Am.Crim. L.Rev. 527, 537 (1983) (“[I]f the condition of an object, not merely its identity, is the relevant issue, a chain of custody may be required to establish that the object had not been altered....”).

The evidence here does not fit neatly into either category. Ordinarily, a bottle is considered to be a readily identifiable object. Edward J. Imwinkelried, The Identification of Original Real Evidence, 61 Mil. L.Rev. 145, 150 (1973) (common items that have qualified as readily identifiable objects have included tools, bags, bottles, tires, a piece of rope). Undoubtedly, millions of green, plastic, twenty-ounce Mountain Dew soda bottles have been manufactured. However, only one was found inside the Thomas residence after Appellant fed D.W. the milk and castor oil mixture from such a bottle. Thus, Appellant’s primary challenge to the admission of the evidence is whether the condition of the bottle remained unchanged with respect to the presence of the cocaine. He mounts such a challenge with good reason, as the cocaine residue exponentially increases the bottle’s probative value by proving the corpus delicti, ie., showing how cocaine was introduced into D.W.’s body.

Thus, the required foundation lies somewhere in the middle of the continuum, between mere testimony as to the object’s identity and condition and proof of chain of custody.

Suppose that the condition of an article is a critical issue in the case.... The chain-of-custody is very weak and leaves serious doubt in the judge’s mind. However ... each witness testified that he believed that the exhibit was the same object he had previously seen and that it appeared to be in the same condition .... Standing alone, the testimony would not support the exhibit’s admission .... Yet the testimony is logically relevant and admissible, and the cumulative effect of the testimony and the chain-of-custody evidence might persuade the judge to admit the object.

Imwinkelried, supra, at 165. Such a fusion of standards is neither unusual nor unprecedented. The near universal recognition that the chain of custody need not be absolute illustrates this principle. Rabovsky, 973 S.W.2d at 8; Mollette, 997 S.W.2d at 495. The presence of the cocaine does not make the bottle, itself, more or less readily identifiable as the one from which Appellant fed the mixture of milk and castor oil to D.W. But, its presence is what elevates that act to a criminal offense. Thus, stronger proof than mere identification is required to dispel concerns that the cocaine entered the bottle after the occurrence of the act, ie., to establish that the bottle was materially unchanged from the time of the act until the time its contents were tested.

Appellant first claims that because Herndon did not witness the event, she could not testify that the bottle she found was the one he used to feed the milk and castor oil to D.W. Were we to accept that argument, any real evidence collected by someone other than a testifying eyewitness would be excluded. State v. Bohe, 447 N.W.2d 277, 280 (N.D.1989) (“By strictly interpreting [Appellant’s] argument, no physical evidence would be admissible unless the police officers actually witnessed the crime or event of which the physical evidence came about.... [TJhere would always be a defect in the chain of custody unless the physical evidence was retrieved immediately after the commission of the crime.”). We have never held that real evidence is per se inadmissible absent eyewitness testimony or direct evidence. In fact, our rule permitting identification of evidence by linking it to the events in question by time, place, and circumstance belies Appellant’s argument. Barth v. Commonwealth, Ky., 80 S.W.3d 390, 402 (2001) (sticks admissible as possible weapon used to beat victim because they matched welts on his back, even though victim never saw the weapon with which he was beaten); Grundy, 25 S.W.3d at 79-80 (concrete found at crime scene admissible as possible weapon although victim did not see the object used to strike him in the back of his head); Sweatt v. Commonwealth, Ky., 550 S.W.2d 520, 523 (1977) (gun admissible even though victim who was hit on the head with it was unable to positively identify it); Comment, Preconditions for Admission of Demonstrative Evidence, 61 Nw. U.L.Rev. 472, 479 (1966) (“The situation may arise where there are no witnesses who can directly connect the object with the place and time of injury. One such case is where an apparently relevant object is found shortly after the time at issue and close to the place at issue. In this situation, analysis of physical facts surrounding the finding and an attempt to indicate by those facts the relative certainty of the identification become the important trial methods.”). See also State v. Shelman, 159 N.C.App. 300, 584 S.E.2d 88, 92 (2003) (unnecessary to prove exact history of drugs before they were tested); Imwinkelried, supra, at 169 (“If [the courts] had addressed the question, they probably would have held that if the other evidence of similarity is sufficiently pervasive, personal testimony is unnecessary. It is the fact of similarity which renders the evidence logically relevant; and in principle, the fact of similarity admits of both direct and circumstantial proof. Direct, personal testimony of similarity is unnecessary.”).

The Commonwealth sufficiently linked the bottle to the crime. Herndon found the bottle at the scene of the crime approximately five days after Appellant fed the victim from a green, plastic, twenty-ounce Mountain Dew bottle. She testified that the white residue that subsequently tested positive for cocaine was in the bottle when she found it. These facts illustrated a reasonable probability that the bottle admitted into evidence was the instrumentality by which cocaine was introduced into D.W.’s body. Cf. Cook v. Commonwealth, Ky., 401 S.W.2d 51, 53 (1966) (blue paint stain on a wood block allegedly thrown at a ear with blue paint on its wheels linked the block to the crime). While this evidence falls short of absolute proof of identity, our law does not require it. See Higgins v. Commonwealth, 142 Ky. 647, 134 S.W. 1135, 1138 (1911) (“The proof need not positively show the connection; but there must be proof rendering the inference reasonable or probable from its nearness in time and place or other circumstances.”). See also Johnston v. State, 541 N.E.2d 514, 516 (Ind.1989) (inability to conclusively prove that items found in a bag were the same ones used in the crime not fatal to admissibility); State v. Sneed, 571 So.2d 735, 740 (La.Ct.App.1990) (“lack of positive identification goes to weight of the evidence rather than admissibility”); State v. Comeaux, 524 So.2d 863, 865 (La.Ct.App.1988) (pieces of glass from a burglary laying outside and not collected until three months after the crime admissible even though witness could not “scientifically state” that they came from the window broken during the crime; lack of positive identification goes to weight, not admissibility); DeLuna v. State, 501 P.2d 1021, 1024-25 (Wyo.1972) (positive proof of identity of instrumentality of crime not required); Imwinkelried, supra, at 172 (identity can be proven by circumstantial evidence).

Appellant next contends that the Commonwealth was unable to prove that the integrity of the bottle was preserved because it was unable to account for it for an extended period of time. This argument relates to the sufficiency of proof that the cocaine did not enter the bottle after he used it to feed the mixture of milk and castor oil to D.W. We initially note that the requirement of unchanged condition is “to be read in light of the principle that such evidence is admissible if the trial judge determines that there is a reasonable probability that the evidence has not been altered in any material respect since the time of the crime.” United States v. Jackson, 649 F.2d 967, 973 (3d Cir.1981) (internal quotation and citation omitted). Thus, the trial court’s decision stands absent an abuse of discretion. Id.; Grundy, 25 S.W.3d at 80 (trial court granted wide discretion because required foundation depends on the nature of the evidence); see also United States v. Lane, 591 F.2d 961, 962-63 (D.C.Cir.1979) (“So long as the court is persuaded that as a matter of normal likelihood the evidence has been adequately safeguarded, the jury should be permitted to consider and assess it in light of the surrounding circumstances.”).

Naturally flowing from the discretionary nature of this inquiry is the principle that an unbroken chain of custody is generally unnecessary. “Chain of custody” is not an end in itself, but a term of art describing a means of proving an object’s authenticity. McCormick, supra, § 212, at 9 (“[FJoundational requirements are essentially requirements of logic, and not rules of art.”). Any gaps go to the weight, rather than the admissibility of the evidence, and the proponent need only demonstrate a reasonable probability that it has not been altered in any material respect. McKinney v. Commonwealth, Ky., 60 S.W.3d 499, 511 (2001); Rabovsky, 973 S.W.2d at 8; Mollette, 997 S.W.2d at 495. Thus, in line with liberal chain of custody requirements, the mere fact that evidence has been misplaced, insecurely kept, or unstored for a significant period of time is not per se fatal to admissibility. Gilmore v. United States, 742 A.2d 862, 870-72 (D.C.1999) (bottle containing bomb residue admissible although police officer had misplaced it for eight months and then found it in his locker in a paint can); State v. Bales, 246 Iowa 446, 68 N.W.2d 95, 96 (1995) (that evidence was not found until two months after the crime affected weight rather than admissibility); Sneed, 571 So.2d at 740 (evidence that was misplaced for ten years and inexplicably reappeared in sheriffs office admissible); Comeaux, 524 So.2d at 864-65 (three-month delay; evidence had been sitting outside, at the scene of the crime); Bohe, 447 N.W.2d at 279-80 (one-month delay in finding tire iron after crime did not require exclusion); Kelly v. State, 52 Okla.Crim. 125, 3 P.2d 244 (App.1931) (evidence found on defendant’s premises several months after the offense and his incarceration properly admitted). Notably, however, this is not a case where the proponent is utterly unable to account for the whereabouts of evidence over a period of time. After finding the bag containing the bottle stored in the attic of her home, Herndon was able to account for its whereabouts while it was “missing.” Gilmore, 742 A.2d at 872.

That aside, the most relevant factors are the circumstances surrounding the preservation of the evidence and the likelihood of tampering by intermeddlers. Pendland v. Commonwealth, Ky., 463 S.W.2d 130, 133 (1971) (“All possibility of tampering does not have to be negated. It is sufficient in these cases that the actions taken to preserve the integrity of the evidence are reasonable under the circumstances.”). See also Gallego v. United States, 276 F.2d 914, 917 (9th Cir.1960); United States v. S.B. Penick & Co., 136 F.2d 413, 415 (2d Cir.1943); Imwinkelried, supra, at 159. Both factors weigh in favor of admission of the evidence in this case. In Pendland, supra, we held that storing cut marijuana plants in a plastic bag in a private garage sufficiently preserved their integrity. Id. at 133: Similarly, Herndon stored the bottle in a tied garbage bag in the attic of her home. See DeLuna, 501 P.2d at 1024 (noting that drugs in question were stored in “a private home and not a public place”). Furthermore, Appellant makes no specific claim of tampering by intermeddlers, and “speculation ... is not enough to destroy ... integrity.” Brown v. Commonwealth, Ky., 449 S.W.2d 738, 740 (1969). See also Pendland, 463 S.W.2d at 133 (noting the absence of evidence of tampering). No evidence in the record suggests that Herndon tampered with the bottle or that any other individual altered it while it was stored in her home. Nor does the record indicate that in-termeddlers tampered with the bottle before its recovery. There was no evidence that anyone other than Appellant and his wife had access to their residence after the incident occurred and before Herndon found the bottle. We conclude that the trial court properly exercised its discretion in admitting the bottle and the results of the test of its contents.

The dissenting opinion correctly notes that two “Bruton violations” apparently occurred during this trial. Bruton v. United States, 391 U.S. 123, 88 S.Ct. 1620, 20 L.Ed.2d 476 (1968). One such violation was specifically waived and the other was not preserved for review. Appellant did not raise the issue in either his brief to the Court of Appeals or his brief to this Court. The issue was not addressed at oral argument and Appellant has not requested review for palpable error. KRE 103(a)(2)(e). Since Appellant has never assigned these incidents as errors requiring reversal for a new trial, we do not sua sponte address them in this opinion. Assignments of error are made by appellants, not appellate courts. United States v. Janus Indus., 48 F.3d 1548, 1559 (10th Cir.1995); cf. Chism v. Commonwealth, 286 Ky. 314, 150 S.W.2d 694, 695 (1941) (declining to search the record for unassigned error).

Accordingly, the decision of the Court of Appeals is affirmed.

LAMBERT, C.J.; GRAVES, KELLER, and WINTERSHEIMER, JJ., concur.

JOHNSTONE, J., dissents by separate opinion with STUMBO, J., joining that dissenting opinion.

Dissenting Opinion by

Justice JOHNSTONE.

I respectfully dissent.

It is not an overstatement to say that the Mountain Dew bottle was critical to the Commonwealth’s case against Appellant. And, as the majority opinion acknowledges, the Mountain Dew bottle in this case presented a novel issue concerning foundational requirements. However, I do not agree with the majority’s conclusion that a sufficient foundation was established for introduction of the bottle. The circumstances surrounding the Mountain Dew bottle, coupled with its intensely damaging effect on Appellant’s defense, warranted a stronger foundation for admission. The foundation that was established was incomplete, and relied in part on inadmissible testimony.

The most obvious problem in the foundation is that it failed to link the bottle to the Appellant. While the chain of custody satisfactorily established that the bottle taken from the Thomases’ home was in essentially the same condition as the day Jeannie Herndon pulled it out of her attic, no satisfactory foundation was laid linking the bottle to the Appellant. “The Commonwealth bears the burden of identifying and tracing the chain of custody from the defendant to its final custodian.” Commonwealth v. Hubble, Ky., 730 S.W.2d 532, 534 (1987) (emphasis in original). Appellant never stated that he fed the child the milk and castor oil mixture from a Mountain Dew bottle; the jury only heard Appellant state that he fed the child the mixture without identification of a certain vessel. Moreover, the Commonwealth did not test the bottle for the presence of milk or castor oil, a test that presumably could have linked the bottle to Appellant far more conclusively.

The only competent evidence tending to prove that Appellant fed the child from the Mountain Dew bottle came from the testimony of Detective Jerry Jones and Jeannie Herndon. Detective Jones testified that Appellant’s wife stated, during a second interview, that Appellant fed the child the milk and castor oil mixture from a green, plastic Mountain Dew bottle. Jeannie Herndon later testified that Appellant’s wife had told her that Appellant fed the child from a Mountain Dew bottle. Both of these statements should not have been admitted into evidence. Detective Jones’s statement was admitted in clear violation of the rule set forth in Bruton v. United States prohibiting the admission of a non-testifying codefendant’s confession that inculpates the defendant at a joint trial. 391 U.S. 123, 88 S.Ct. 1620, 20 L.Ed.2d 476 (1968). Jeannie Herndon’s testimony, as used to establish that Appellant used a Mountain Dew bottle to feed the child, was clearly inadmissible hearsay. Inexplicably, both Detective Jones’s and Jeannie Herndon’s testimonies were permitted without objection from defense counsel. Nonetheless, I believe that Appellant’s substantial rights were affected by the admission of this testimony, which in turn was critical to admission of the Mountain Dew bottle, the most damaging evidence in an otherwise purely circumstantial case. I believe that reversal pursuant to RCr 10.26 is warranted.

STUMBO, J., joins this dissent.


author: Justice LAMBERT.

text:
    COMMONWEALTH OF KENTUCKY, Kentucky Commission on Human Rights Appellant, v. PENDENNIS CLUB, INC., et. al. Appellee
    No. 2002-SC-0508-DG.
    Supreme Court of Kentucky.
    Nov. 18, 2004.
    As Modified Nov. 23, 2004.
    Rehearing Denied Feb. 17, 2005.
    Gregory D. Stumbo, Attorney General of Kentucky, D. Brent Irvin, Assistant Attorney General, Frankfort, Morgan G. Rans-dell, Staff Attorney, Kentucky Commission on Human Rights, Louisville, Counsel for Appellant.
    D. Patton Pelfrey, Robert W. Dibert, Frost Brown Todd, LLC, Louisville, Counsel for Appellee, Pendennis Club, Inc.

      John 0. Shelter, Smith & Smith Attorneys, Louisville, Counsel for Appellee, Louisville Country Club.
    Richard G. Griffith, Jeffrey J. Chapuran, Stoll, Keenon & Park, LLP, Lexington, Counsel for Appellee, Idle Hour Country Club.
   Opinion of the Court by

Justice LAMBERT.

Under Kentucky law, tax deductions are disallowed for amounts paid to any club that discriminates on the basis of race in its membership practices or in affording full and equal enjoyment of its benefits. The Kentucky Commission on Human Rights (KCHR) seeks a declaration that it has authority to investigate private clubs to determine if they engage in discriminatory conduct in such a manner that members would be prohibited from deducting club payments. We hold that it does. The General Assembly has expressed its intent to enable the KCHR to investigate any club — public, quasi-public, or private — ■ to determine whether it denies full and equal enjoyment of its membership and benefits on account of race. The opinion of the Court of Appeals is reversed, and this matter is remanded for further proceedings.

The direct question before this Court is whether the Appellant, KCHR, has the statutory authority to investigate the Ap-pellees, private clubs, to determine whether they discriminate on the basis of race. KCHR asserts such authority under a number of statutory provisions, including those disallowing deductions for amounts paid by members to any discriminatory club.

Initially, it is important to identify what this case is not about. This case is not about whether the clubs actually engage in discriminatory practices. Though possible racial discrimination is the underlying allegation of the complaint filed with the KCHR, no evidence on that issue has yet been heard. It is simply not known whether the clubs discriminate because of race. Indeed, the KCHR seeks a declaratory judgment to clarify its power (or lack of power) to investigate that question. Neither is this a case about the rights of clubs nor them members. Bona fide private clubs have the statutory right in this state to discriminate in affording the benefits of membership without fear of legal liability. Private clubs engaged in expressive association also have a constitutional right to be free from “forced inclusion of unwanted personjs].” Moreover, this case is not about the right of the state to disallow tax deductions to clubs that have a “whites only” or “blacks only” policy. That power is obvious. While a state may not interfere with the associational rights of truly private clubs in the absence of a compelling government interest, it may refuse to approve objectionable conduct by withholding state benefits such as tax deductions. Finally, there is no doubt that the General Assembly has the power to grant the KCHR authority to investigate the activities of any club to assure that its members are not taking tax deductions that are unavailable. What this case is about is whether the General Assembly has granted the KCHR authority to so investigate. Resolution of this question depends on construction of statutes that define the breadth of KCHR’s investigatory powers when complaints are filed with the agency.

It has been more than ten years since the inception of this litigation. In those ten years, the parties have been heard in three levels of the Kentucky Court of Justice, and in the United States District Court and the United States Circuit Court.

In 1991, Louis Coleman filed complaints against the Pendennis Club, Inc., the Louisville Country Club, and the Idle Hour Country Club claiming that they engaged in discriminatory membership practices. The KCHR dismissed Coleman’s complaints, reasoning that the clubs were exempt from the Kentucky Civil Rights Act (Act) pursuant to KRS 344.180(1). One month later, then State Representative Anne Northup wrote a letter to the state Attorney General requesting an opinion “with regard to the discriminatory practices of private clubs and organizations.” She asserted that in KRS 141.010(ll)(d) the legislature had granted the KCHR authority to investigate clubs to assure that the Commonwealth was not enabling discriminatory clubs to benefit from membership tax deductions. Representative Northup, the sponsor of the amendment that altered KRS 141.010, sought clarification of the effect of the amended statute. Shortly after receiving the inquiry, the Attorney General’s office rendered an opinion stating that the KCHR was not prohibited from investigating private clubs, even though the clubs cannot be held liable for denying the benefits of club membership because of race. Two years later, Human Rights Commissioner Mae Cleveland filed complaints alleging unlawful discrimination by .the clubs. Those complaints are the genesis of this case. In June of 1994 the clubs moved to dismiss, and their motion was denied.

The clubs then sought a declaratory judgment and injunctive relief in federal court. The United States District Court ruled that KRS 141.010(ll)(d) did not “confer authority upon the Commission to investigate private clubs.” This ruling was vacated by the United States Court of Appeals for the Sixth Circuit. The Sixth Circuit held that the lower court should have abstained from ruling on the case while administrative proceedings were underway. The case was remanded to the United States District Court for dismissal. The KCHR proceeded to the Jefferson Circuit Court seeking a declaratory judgment as to its power to investigate the clubs. The Jefferson Circuit Court ruled for the clubs, holding that KRS 344.130 “specifically exempted private clubs from the KCHR’s domain.” The Court of Appeals affirmed, agreeing fully with the circuit court’s rationale. We granted discretionary review.

The Kentucky General Assembly established the KCHR to safeguard the rights of citizens to be free from discrimination on the basis of race and other enumerated characteristics. To fulfill its mandate, the KCHR was empowered, inter alia■, to investigate, hold public hearings, and require answers to interrogatories. To further assure that its intent was not frustrated, the Legislature enacted KRS 844.020(2), requiring a statutory interpretation that fulfills the purposes of the Act. This Court has construed the Act liberally. The General Assembly has directed that all statutes be construed in a manner that furthers the objectives for which the statute was enacted. Exceptions to the Act’s coverage are interpreted narrowly.

The clubs contend that the exemption in KRS 344.130 bars the KCHR from investigating private clubs because they are expressly excluded from KCHR oversight. This is a significant overstatement. KRS 344.130 states that private clubs are not places of public accommodation, resort, or amusement. Consequently, KRS 344.130 exempts private clubs from KRS 344.120, but not from the entire chapter. For example, while a private club that racially discriminates in affording full and equal enjoyment of its benefits may not be held hable for damages, a private club with eight or more employees could be civilly hable if it discriminated on the basis of race in its employment practices. In such a situation the KCHR would have authority to exercise its powers under KRS 344.180 and KRS 344.190, and the club would be held accountable for its iniquitous employment practices. The exemption for private clubs is not all-encompassing. To so hold would be contrary to the purposes of the Act and would frustrate legislative intent.

This is not a novel proposition. In Watson v. Fraternal Order of Eagles the United States Court of Appeals for the Sixth Circuit held that the private club exemption in Title II of the federal Civil Rights Act of 1964 prohibiting discrimination in public accommodations does not preclude recovery on an alternative theory of liability, such as 42 U.S.C.1981. This is sound. Here, as in Watson, the private club exemption does not “give the clubs carte blanche to violate all other antidiscrimination laws.” Although it protects private clubs from a violation of KRS 344.120, the exemption found in KRS 344.130 is inapplicable to the issue before us.

On the other hand, the KCHR must have statutory authority before it may investigate. KRS 141.010(ll)(d) states that no deduction mil be allowed for payments made to any club that has been determined by the “agency established by the General Assembly and charged with enforcing the civil rights laws of the Commonwealth, not to afford full and equal membership and full and equal enjoyment of its goods, services, facilities,, privileges, advantages, or accommodations to any person because of race.” Despite this language, the clubs respond that KRS 141.010(ll)(d) does not grant the KCHR authority to investigate. The clubs offer numerous arguments to escape from statutory coverage. For one, they argue that the language of KRS 141.010(ll)(d) parallels the language in the public accommodation provision found in KRS 344.120. However, KRS 141.010(ll)(d) distinguishes itself on two counts. First, it applies to “any club” without limitation. KRS 141.010(ll)(d) does not limit the investigation to non-private clubs. It grants authority over “any club.” Second, KRS 141.010(ll)(d) does not limit itself to clubs that fail to afford full and equal enjoyment of its benefits and public accommodations, the concern of the exemption. While it does deal with public accommodations, it also expressly includes clubs that fail to “afford full and equal membership” because of race. Such language regarding membership cannot be found in KRS 344.120 or 344.130, and the exemption of KRS 344.130 cannot be read to grant immunity from KRS 141.010(ll)(d).

Furthermore, the clubs assert that the language used in KRS 141.010(ll)(d) cannot grant the KCHR independent authority to make determinations because it is drafted in the past tense. We agree that the language in this section is drafted in the past tense, but disagree as to what it says about legislative intent. The language is written in the past tense because the Revenue Cabinet cannot deny a tax deduction until the KCHR has made a determination that the club discriminates.

Though KRS 141.010(11)® does not expressly grant the KCHR authority to investigate, it does so by clear implication. The KCHR is an “agency established by .the General Assembly and charged with enforcing the civil rights laws of the Commonwealth.” As such, it has the power under KRS 141.010(ll)(d) to make determinations. Inherent in that power is the power to investigate. This proposition was firmly established by Chief Justice John Marshall, where the Court noted that powers under the United States Constitution were not limited to what is explicitly enumerated in the text. In M’Culloch, Chief Justice Marshall was interpreting the United States Constitution, but the same principle applies here. To supply this authority, the United States Constitution has the necessary and proper clause, and in Kentucky the General Assembly has directed interpretation of statutes to further their purpose.

In further support of this proposition, our decision in Strong v. Chandler is informative. In Strong we held that the Attorney General’s statutory power to institute actions to recover payments included the power to inspect documents to determine whether to bring a legal action. All members of this Court joined in holding that powers granted by statute are not limited to those expressly stated, but include the means necessary to effect statutory objectives. We held it a “common sense concept,” and determined that the General Assembly intended to give such authority to the Attorney General. Similarly, we hold today that even though KRS 141.010(ll)(d) does not explicitly create the KCHR’s investigatory powers, they exist by implication. It is necessary for the KCHR to collect information before it can reach the determination authorized by statute. In other words, the power to make determinations includes the power to investigate.

In sum, KRS 141.010(ll)(d) grants the KCHR authority to determine whether private clubs discriminate. If it determines that the clubs do not discriminate, the matter is closed. If it determines that the clubs in fact discriminate because of race, the KCHR must inform the Revenue Cabinet for further appropriate action. Truly private clubs have a constitutional right to discriminate because of race. The Commonwealth of Kentucky has decided, however, to refuse endorsement of such conduct by disallowing a tax deduction to members of discriminatory clubs. To assure that no such tax deduction is taken, the KCHR has been authorized to investigate.

Thirteen years ago the Kentucky General Assembly resolved that members of discriminatory clubs should have no sanctuary in the tax code. This Court has now clarified KCHR authority to progress toward fulfillment of that public policy.

Accordingly, the decision of the Court of Appeals is reversed and this cause is remanded to the trial court for further consistent proceedings.

COOPER, JOHNSTONE, KELLER, and STUMBO, JJ., concur.

GRAVES and WINTERSHEIMER, JJ., concur in result only.

      . KRS 344.130.

      . Boy Scouts of America v. Dale, 530 U.S. 640, 648, 120 S.Ct. 2446, 147 L.Ed.2d 554 (2000).

      .See Roberts v. United States Jaycees, 468 U.S. 609, 623, 104 S.Ct. 3244, 82 L.Ed.2d 462 (1984).

      . KRS 344.010-344.990.

      . OAG 91-197. KRS 344.120 states that it shall be unlawful for a place of public accommodation to deny its benefits to people because of the person's race. KRS 344.130 states that private clubs are not places of public accommodation, thereby removing private clubs from the purview of KRS 344.120.

      . KRS 141.010(1 l)(d) is a tax statute that calls for the KCHR to make a determination as to whether clubs discriminate because of a number of listed characteristics. If a club is in fact discriminatory, then the Revenue Cabinet is directed to disallow deductions for amounts paid by members to that club.

      . Louisville Country Club v. Watts, No. 97-5758 and 98-5829, 178 F.3d 1295, 1999 WL 232683, at 3 (6th Cir.1999) (per curium).

      . Id. See also Younger v. Harris, 401 U.S. 37, 91 S.Ct. 746, 27 L.Ed.2d 669 (1971).

      . KRS 344.020 and 344.170.

      . KRS 344.180 and 344.190.

      . See Dep't of Corr. v. Furr, Ky., 23 S.W.3d 615, 617 (2000); Toyota Motor Mfg., U.S.A., Inc. v. Epperson, Ky., 945 S.W.2d 413, 415 (1997).

      . KRS 446.080(1).

      . See Kreate v. Disabled Am. Veterans, Ky., App., 33 S.W.3d 176, 181 (2000).

      . See supra note 4.

      . KRS 344.040.

      . KRS 344.180 and 344.190 set forth the powers and duties of the KCHR.

      . KRS 344.020 and 446.080(1) (calling for courts to construe statutes in such a way as to advance the legislative goal).

      . 915 F.2d 235 (6th Cir.1990).

      . 42 U.S.C.1981.

      . This reasoning is especially persuasive because the Kentucky's Civil Rights Act borrowed heavily upon its federal counterpart in its design; and, in fact, the Legislature expressly provided that furthering the execution of the federal Civil Rights Act was a major purpose of chapter 344.

      . 915 F.2d at 240.

        . M’Culloch v. Maryland, 17 U.S. (4 Wheat.) 316, 4 L.Ed. 579 (1819) (such power may be exercised by Congress whenever it becomes an appropriate means of exercising any of the powers expressly granted).

      . Strong v. Chandler, Ky., 70 S.W.3d 405 (2002).

      . Id. at 406-07.

      . Id. at 410.