Request By:
Mr. Richard Ross
Executive Director
Kentucky Board of Pharmacy
1228 U.S. 127, South
Frankfort, Kentucky 40601
Opinion
Opinion By: David L. Armstrong, Attorney General; George Geoghegan, III Assistant Attorney General
Your predecessor, J.H. Voige, requested that this Office re-examine OAG 83-452 in light of
United States v. Johnson, 221 U.S. 488 (1911);
United States v. Various Articles of Drugs, 332 F.2d 286 (3rd Cir. 1964); and
United States v. Various Articles of Drugs, 207 F.Supp. 480 (S.D.N.Y. 1962).
In OAG 83-333, at p. 2, this office said:
"It is the Opinion of this office that the distribution and sale of packages of birth control pills marked 'clinic use only', in a nonclinical setting, makes these misbranded drugs as defined in KRS 217.065(1), because these drugs are being distributed and sold in a manner contrary to what appears on the label. "
In OAG 83-452, which we are re-examining here, this office engaged in an extension of OAG 83-333. The Office said:
"It is the opinion of this office that the sale, delivery, holding or offering for sale of drugs marked 'sample,' 'not for sale,' 'physician pack, ' or similar wording, makes the drugs misbranded because they would be distributed and sold in a manner contrary to what appears on the label. " OAG 83-452, pp. 1 & 2.
Mr. Voige indicated in his letter that the items in question were marked "clinic pack" , "clinic package - not for retail pharmacy sales" or similar wording. His letter indicated that the items in question were labeled in a manner almost identical to the labelling discussed in OAG 83-333 and OAG 83-452. His letter, did, however, make it clear that the items would be sold to the ultimate consumer, not to a middle man. This, of course, was not a factor under consideration in either OAG 83-333 or OAG 83-452.
The fundamental rule of statutory construction is that the applicability and scope of the statute may be determined by ascertaining the legislative intent and purpose.
Brown v. Hoblitzell, Ky., 307 S.W.2d 739 (1958). However, to ascertain intent a court is limited to the words employed in enacting the statute, rather than speculating as to what may have been intended but not expressed.
Kentucky Ass'n. of Chiropractors v. Jefferson County Medical Society, Ky., 549 S.W.2d 817 (1977); and
Clark v. Clark, Ky.App., 601 S.W.2d 614 (1980). A court is required to give the words of a statute their plain meaning and cannot and restrictive language to the statute where it does not exist.
Bailey v. Reeves, Ky., 662 S.W.2d 832 (1984).
The statute which was examined in OAG 83-333, and in OAG 83-452, and which is being re-examined here, is KRS 217. 065(1) and it provides:
"Except for violations of KRS 218A.350, a drug or device shall be deemed to be misbranded:
(1) If its labeling is false or misleading in any particular . . . ."
In OAG 83-333 this office reasoned that the drugs were misbranded as labeled because they were " . . . being distributed and sold in a manner contrary to what appears on the label. " This same reasoning was utilized in OAG 83-452 which is being re-examined herein.
In
United States v. Johnson, 221 U.S. 488 (1911), the Supreme Court of the United States considered a case wherein the labels on the medication in question either stated or implied that the contents would cure cancer. The defendant drug manufacturer knew that the representation on the labels was false. The Court looked at the language of the statute. The statute condemned the misbranding of drugs but specifically described several ways in which drugs could be misbranded. The Court concluded that a misrepresentation as to curative effects of the medication was not contemplated by Congress in the misbranding statute.
Johnson, supra, is of no help in construing KRS 217. 065(1), because the phrase "false or misleading in any particular" is not qualified or limited by additional language.
In
United States v. Various Articles of Drugs, 332 F.2d 286 (3rd Cir. 1964); and in
United States v. Various Articles of Drugs, 207 F.Supp. 480 (S.D.N.Y. 1962) the Courts construed a different federal statute relating to misbranding. 21 USC § 352(a) provides that:
". . . a drug or device shall be deemed misbranded -- (a) if its labelling is false or misleading in any particular."
The drugs in question were labelled with such statements as, "sample - not for sale", "complimentary", "physician's sample - not to be sold", and they were held for sale to retail druggists. In both cases the Courts concluded that there was no misbranding because the labelling was not misleading to anyone involved.
In OAG 83-333 and 83-452 this office was troubled by the fact that the drugs were to be distributed in a manner conflicting with the label. Our reasoning was perhaps in error in those opinions. The fact that drugs are to be distributed in a manner inconsistent with the label does not necessarily mean that the label is misleading to anyone.
Certainly, as in United States v. Various Articles of Drugs, 332 F.2d 286, supra, and
United States v. Various Articles of Drugs, 207 F.Supp. 480, supra, the wholesalers and retailers are not misled. The situation described in Mr. Voige's letter is quite different. The drugs will be placed in the hands of an ultimate consumer. Thus the question which must be answered is whether the labels are misleading to the ultimate consumer.
There is no qualifying language in the statute. Therefore, the drugs are misbranded if they are misleading in any particular. The labelling described in Mr. Voige's letter certainly gives the impression to the ultimate consumer that there have been fewer people involved in the chain of sale and that the consumer is receiving a lower price on the medication than he would otherwise obtain. If the price charged is the standard price for the identical drugs on the market without the proposed labelling, then the consumer has been misled. On the other hand, if the price charged is less than the standard price for the identical drugs on the open market without the proposed labelling, then the consumer has not been misled. Whether the labelling constitutes misbranding under KRS 217.065(1) is directly related to whether the ultimate consumer has been misled. This is a question of fact which must be determined on a case-by-case basis.
It is our Opinion that, although OAG 83-333 and 83-452 may have been erroneous as to rationale, they were not necessarily erroneous as to result. In the event the drugs labelled as indicated in Mr. Voige's letter are distributed to an ultimate consumer and in the event the labelling misleads the ultimate consumer in any respect, there is a violation of KRS 217.065 (1). Further, the practice described in the immediately preceding sentence may also constitute a violation of KRS 517.020(1)(e), as well as a violation of the Consumer Protection Act, KRS Chapter 367, and more specifically KRS 367.170.