UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF NEW YORK
December 19, 1985
Thompson Medical Co., Inc.
The opinion of the court was delivered by: BRODERICK
Vincent L. Broderick, District Judge.
What follows will by my disposition at the end of a bench trial in this matter.
This action was begun on September 9, 1985. Prior to that time, an order to show cause had been filed and it was determined that we would have a fairly brief discovery period and then a trial and it was agreed that that trial constituted a plenary trial.
At the time that the summons and complaint were filed in this matter, the parties were engaged in litigation before Judge Lowe of this court in which the defendant in this case was the plaintiff and was challenging the advertising of the plaintiff in this case. That other litigation before Judge Lowe is 85 Civ. 4928.
According to the plaintiff, a study, known as Harris III, came to plaintiff's attention in the course of discovery in the case before Judge Lowe and it apparently was the surfacing of the Harris III study which occasioned the commencement of this action.
I agreed to accept this action as related to an earlier action brought by the present plaintiff in this action, CIBA-GEIGY Corp., against Thompson Medical Co., Inc. This action is a suit under the Lanham Act in which charges are also made which are predicated upon New York's General Business Law.
The plaintiff, CIBA-GEIGY, manufacturers and markets, among other things, over-the-counter appetite suppressants under the trade names of ACUTRIM and ACUTRIM II.
The defendant, Thompson, markets but does not manufacture numerous appetite suppressant products. Among those products are one known as DEXATRIM-15 and another known as Extra Strength DEXATRIM.
ACUTRIM, ACUTRIM II, DEXATRIM-15 and Extra Strength DEXATRIM all contain phenylpropanolamine hydrochloride. That will be the last time during the course of this opinion that I attempt to wrestle with that word. It will be known hereafter as PPA.
PPA has been accepted by an FDA panel reviewing over-the-counter appetite suppressants as safe and effective. A tentative or a proposed monograph by this panel so characterized PPA. The Food and Drug Administration permits the marketing of PPA in over-the-counter drugs for appetite suppressant purposes so long as the maximum amount of PPA in the appetite suppressant product does not exceed 75 milligrams per day.
Now, the proposed or tentative monograph that I referred to with respect to appetite suppressants was published in 1982. It did, without analysis or without any apparent analysis, accept PPA as safe and effective. But it did not, per se, address the question of the effectiveness of PPA products.
Insofar as I am aware, there has been no final action taken by either that panel or by the FDA with respect to the monograph.
I referred to an earlier action before me and in that action, in which the plaintiff here was plaintiff, CIBA-GEIGY challenged the marketing of a product of defendant Thompson called DEXATRIM-18. A preliminary injunction hearing was held in that action and after that hearing I issued an oral opinion in which I preliminarily enjoined Thompson from marketing DEXATRIM-18. The parties settled that action shortly thereafter and there was no order issued memorializing or implementing the oral opinion which I rendered except that the final settlement between the parties was filed and was so ordered by me and according to the terms of that final settlement, my oral opinion remained in full force and effect.
In the present action before me, plaintiff, CIBA-GEIGY, seeks an injunction permanently prohibiting the defendant Thompson from claiming in labeling, in advertising or in promotional materials either that DEXATRIM-15 provides effective appetite suppression for 15 hours or that DEXATRIM-15 contains 75 milligrams of PPA. Plaintiff seeks, in addition to the injunction, a recall, monetary damages and attorney's fees.
Defendant Thompson has asserted three counterclaims. These three counterclaims don't lend themselves to facile capsulization. They are, in substance, as follows:
First, that the plaintiff, CIBA-GEIGY misrepresented my opinion in the prior case of January 30, 1984 and that that misrepresentation took place in submissions to the various television networks in support of CIBA-GEIGY's advertising for ACUTRIM. Thompson alleges in this first counterclaim that because of such misrepresentation the networks improperly agreed to televise CIBA-GEIGY's advertisements.
The second counterclaim which the defendant asserts has to do with claims which CIBA-GEIGY makes with respect to ACUTRIM and ACUTRIM II. Defendant asserts that CIBA-GEIGY's advertising and promotional materials represent or claim that ACUTRIM and ACUTRIM II last sixteen and seventeen hours respectively and that Extra Strength DEXATRIM lasts twelve hours. Thompson asserts that these claims constitute a claim of comparative or superior duration and they are based on the false premise that 60 nanograms per milliliter of blood is the minimum level at which PPA is an effective appetite suppressant.
As part of this second counterclaim, Thompson asserts that the predicate for CIBA-GEIGY's claim is presumably various bioavailability studies and that such studies are an improper basis upon which to predicate such claims.
The third counterclaim asserted by Thompson is in substance that CIBA-GEIGY's claim of superior duration over Extra Strength DEXATRIM conveys a message of superior weight loss and thus of superior efficacy. Thompson asserts that this claim of superior efficacy is false because CIBA-GEIGY has neither conducted nor has had available to it comparative weight loss studies which would show that ACUTRIM causes dieters to lose more than weight then DEXATRIM.
The defendant Thompson seeks to enjoin plaintiff from:
First, describing ACUTRIM as a 16-hour product or ACUTRIM II as a 17-hour product;
Second, making any duration claims for its products until it has available to it scientific proof that there is a minimum blood level related to effective weight loss and proof that a longer duration of that minimum blood level leads to greater weight loss and;
Third, representing that 60 nanograms per milliliter is a minimum effective level for PPA or representing that this Court, in its prior opinion, held that 60 nanograms per milliliter is the minimum effective level for PPA.
The defendant has also asserted as an affirmative defense that CIBA-GEIGY's complaint is barred by the stipulation and agreement between the parties which ended the prior litigation.
As I have already said, a plenary trial was held on these various claims on November 11 through November 15 of this year. Subsequently, the parties made closing arguments and filed and refiled and refiled post-trial papers and what is contained now in what I have to say constitutes my findings of fact and conclusions of law.
I have already mentioned that the parties were before me previously in January of 1984 litigating the validity of Thompson's claim that DEXATRIM-18 was a 18-hour product. I do not intend to quote in any great length from the prior opinion and I am assuming familiarity with it. So far as it is applicable, I incorporate it by reference into this opinion.
I do wish to make, however, one or two observations about that opinion and its relevance to the litigation now before me.
Firstly, my "finding" that 60 nanograms per milliliter was the minimum effective level for PPA in the blood stream was not a scientific determination nor was it a determination that there had been a scientific determination. Indeed, I expressly stated in that opinion that I was not qualified to make such a finding. And I now quote from that prior opinion:
"The FDA has not yet found what an effective does is or what the limitations are on an effective dose and its panel has not made such a finding. I certainly am not qualified to make such a finding. In due course, presumably that finding will be made after sufficient studies have been reviewed by the FDA, studies that will presumably relate effectiveness to intake into blood level and to bioavailability studies and bioequivalency studies.
"All of the witnesses who testified that have expertise in this area made it clear that no one of them could fix a point at which PPA was effective because the necessary clinical studies related to pharmaceutical studies have not yet been done." Transcript, 1/30/84 at 11.
My 60 nanogram per milliliter holding, to the extent that it was a holding in that prior opinion, may perhaps be characterized as a legal estoppel holding. It was applied to prohibit claims from being made that a product was effective when the blood level readings fell below 60 nanograms per milliliter. It did not, however, authorize the converse. It did not authorize a claim that a product was not effective if the blood levels fell below 60 nanograms per milliliter absent clinical proof to support such a claim.
Without citing in great detail to the prior opinion, I note that I pointed out that DEXATRIM was a product of Thompson, that Thompson had been the leader in this field of the use of PPA as an appetite suppressant and I held in substance that Thompson was bound to representations it had previously made. And those representations, in great measure, fell in the area of 60 nanograms per milliliter being a minimum blood level. When I say that Thompson was the market leader, it follows that CIBA and its products were followers in the field.
Now, applying this in this case, that opinion in the former case prohibited Thompson from advertising that its products were effective when the blood level readings fell below 60 nanograms per milliliter, at lease until such time as competent scientific or clinical proof established a precise minimum therapeutic level.
That finding did not allow either Thompson or CIBA-GEIGY to claim that a competitor's product was not effective when blood level readings fell below 60 nanograms per milliliter since such claims would not be supported by competent scientific proof.
Now, one of Thompson's complaints in this case is that CIBA-GEIGY submitted my opinion in the prior litigation in support of CIBA-GEIGY's argument that DEXATRIM or Extra Strength DEXATRIM does not work when the blood level of PPA is below 60 nanograms per milliliter and it is Thompson's argument in this litigation that in making that sort of a claim, a claim of noneffectiveness below the 60 nanogram level, CIBA-GEIGY misled the television stations and ultimately misled the public as to the nature of the Thompson product.
I do not intend to expand what I have characterized as my estoppel finding in the previous case to allow such "not effective" claims, whether those claims are made explicitly or implicitly.
In this trial, as in the previous trial, none of the experts who testified, and Lord knows we had a lot of them, was able to opine as to the level, if any, at which PPA ceases to be effective. Now here I would refer to Dr. Lasagna, Dr. Williams, Dr. Meyer, and Dr. Cabana. Maybe I better even mention Dr. Silverman although I think I should say as a footnote that nothing in this opinion relies in any way on anything that Dr. Silverman said.
So we have a complete void in the way of expert opinion as to where and whether PPA ceases to be effective. It would be inequitable to allow either party to seize upon this void to make claims about its competitor's product or products without clinical evidence to support such a claim.
There was testimony in the recent trial before me directed to the question of whether 60 nanograms per milliliter was the minimum therapeutic level for appetite suppression, testimony by Doctors Cabana and Meyer.
Dr. Cabana had testified as to his "therapeutic window" approach and that approach, as I understand it, is that one looks at the performance of the immediate release drugs which may be given two or three times a day depending on whether the dose is a dose of 25 or 37 and 1/2 milligrams and then a comparison is made between the trough immediately before another dosage and the sustained release drug.
Applying this therapeutic window approach of Dr. Cabana one finds, and Dr. Cabana found, a minimum value of close to 60 nanograms per milliliter. But both he and Dr. Meyer candidly conceded that they did not know what the minimum effective therapeutic level was.
Dr. Cabana also testified that a range of therapeutic effectiveness may be determined but in his judgment there was not rigid level below which one will move from effectiveness to ineffectiveness. And he saw no scientific validity in an approach which employed such a rigid level.
Dr. Lasagna, who is apparently conceded to be the "father of clinical pharmacology," testified that he knew of evidence that required maintenance of moment-to-moment levels with respect to PPA in terms of sustaining its effectiveness either as an appetite suppressant or as an agent in the aid of weight loss.
In this connection I note, and I note it only in passing because it was referred to only in passing in the course of the testimony, that the Food and Drug Administration permits the use of PPA at a lesser daily amount than 75 milligrams, to wit 50 milligrams. I will not speculate beyond saying that we have no testimony at all before me with respect to where the differences between 75 milligrams per day and 50 milligrams per day come into play here.
It is perhaps arguable that the lack of any scientific opinion as to a minimum effective level of PPA would lend support to the position that Thompson took in the previous litigation in which it may be recalled it was argued by Thompson that the minimum effective level might be as low, as I believe it was, 30 nanograms per milliliter. I continue to adhere to my determination at that time that Thompson is estopped from challenging a 60 nanogram per milliliter minimum. But as I have already noted, this holding applies only with respect to affirmative advertising about the duration of one's own product. It does not apply to not-effective claims.
The precise issue presented to me in the former litigation was the validity of Thompson's claim that its product had an 18-hour duration. By contract that had been entered into between the parties prior to that litigation, Thompson was precluded from contesting the validity of plaintiff's advertisements and thus, in that litigation, I did not place the imprimatur of this court upon CIBA-GEIGY's advertising and on its product. That contract, incidentally, I believe expired or its effectiveness expired in September, 1984.
I did, in that prior litigation, accept Dr. Cabana's scientific testimony but I did not rule on the plaintiff's advertisements within the specific context of a Lanham Act challenge or a New York General Business Law challenge.
Furthermore, to the extent that the defendant Thompson sought to present the issue of CIBA-GIEGY'S advertisement to me by way of affirmative defense in that original case, the parties, in effect, withdrew the issue from my determination before any final judgment was entered.
Coming now to the situation today or at least the situation as it was when the November trial in this action was had, the products of the parties all make implicit if no explicit claims of effectiveness for a specified period of time. I will not review all of these claims but I will, just for sampling purposes, review a few.
Extra Strength DEXATRIM claims that it curbs appetite, that it helps one eat less, that there is no stronger 12-hour capsule.
DEXATRIM-15 claims that that it is the longest lasting DEXATRIM, that it gives all day appetite control, that "if you want to lose weight nothing works harder than Extra Strength DEXATRIM."
I note also that DEXATRIM-15 has a disclaimer: "The exact correlation between the level of appetite control ingredient and the level of appetite surpression [sic] has not been established in clinical studies."
ACUTRIM is claimed to be a 16-hour product, a product which delivers sixteen full hours of controlled even appetite suppressant to curb hunger and aid weight loss without caffeine.
ACUTRIM II claims, among other things, "the longest lasting appetite suppressant," "helps you eat less" and "lose weight."
With respect to both ACUTRIM and ACUTRIM II, there are claims in the way of graphs. The graph on ACUTRIM compares ACUTRIM's relatively even level to the leading caffeine-free capsule which peaks high and declines rapidly. The graph does show hours, four to sixteen, and there is no reference that the peaking refers to blood level, which it presumably does.
On ACUTRIM II, the graph compares ACUTRIM II to DEXATRIM Extra Strength. ACUTRIM II reaches seventeen hours. DEXATRIM Extra Strength reaches twelve hours. Again there is no indication on the packaging that blood level is involved.
Also in the way of claims are the television commercials of CIBA-GEIGY, the ice cream sundae commercial and the nighttime commercial, which also contained bar graphs.
The nighttime commercial contains dialogue which says that, "That twelve hour appetite suppressant you took this morning just wore off," and it goes on to suggest that ACUTRIM lasts longer than any other appetite suppressant.
I find that the claims by the plaintiff, particularly the claims in the two commercials, are comparative claims of superiority over the products of the defendant.
Now, the plaintiff has contended throughout a paper battel which long pre-dated this particular lawsuit, in attempting to convince the three major networks to accept advertising with respect to ACUTRIM, that the claims that it was asserting were claims only of superior duration and no claims of therapeutic advantage. And the plaintiff has continued to maintain this position through this litigation.
In a post-trial affidavit by Mr. Morrison, which strictly speaking I suspect is not an exhibit in this case, Mr. Morrison said, " CIBA's advertising only claims superior duration; the message of clinical or therapeutic superiority is, at most, implied."
Now, I'm not dealing with that as evidence in the case. I'm dealing with it as argument in the case. But whether the claim is explicit or implicit, and in my judgment it is an explicit claim of superiority, it implicates rights under the Lanham Act.
In support of its superiority claims, the plaintiff only has blood level data and that data, at its best, is only relevant to duration. I referred earlier to the tentative monograph. I frankly do not know on what basis the panel made what apparently was an assumption of safety and efficacy. Certainly there was nothing before me in this trial or in the previous trial which constituted facts which were also facts which were before that panel when it made the finding of safety and efficacy.
Presumably it made that finding, among other things, on various presentations by Thompson and by others of past experiments but the only predicate for efficacy which I have and which, so far as I know, either plaintiff or defendant has, is that the panel has said that PPA is effective for appetite suppression and hence for weight loss.
The plaintiff before me did argue that there were some weight loss studies, its Weintraub weight loss study and weight loss studies of the defendant, and that those studies could be or should be compared and if they were compared they would establish the plaintiff's superiority or the superiority of the plaintiff's products.
I don't accept that argument or that logic. The limited evidence produced in the trial before me with respect to those studies was at best inconclusive with respect to the relative weight loss capabilities of DEXATRIM and ACUTRIM in their various manifestations and I decline to make any finding predicated upon such inconclusive evidence.
Analyzing what is before me in terms of the Lanham Act, if consumers perceive the advertising for plaintiff's products as setting forth either explicitly or implicitly the therapeutic superiority of plaintiff's products over defendant's products, then, since those advertisements do not have clinical support, they may not continue to run.
The consumer reaction surveys submitted during the trial have established that a not insubstantial amount or number of consumers take away from CIBA-GEIGY's advertisements a perception that CIBA-GEIGY has claimed that ACUTRIM, in its various manifestations, is therapeutically superior to DEXATRIM. That is, that the claims asserted are claims of more effective appetite suppression leading to weight loss.
Here I look at some of the decided cases. For instance, in McNeilab, Inc. v. American Home Prods. Corp., the count noted that a qualitative rather than a quantitative determination is enough to support a conclusion that an advertisement 'tends ' to mislead, if the qualitative showing establishes that a not insubstantial number of consumers receive a false or misleading impression from it," 501 F. Supp. 517, 528 (S.D.N.Y. 1980) (emphasis in original).
I consider American Home Prods. v. Johnson & Johnson significant in terms of Mr. Morrison's suggestion that CIBA's advertising only claims superior duration and that the message of clinical or therapeutic superiority is at most implied. In that case, the Second Circuit said:
That Section 43(a) of the Lanham Act encompasses more than literal falsehoods cannot be questioned. . . . Were it otherwise, clever use of innuendo, indirect intimations, and ambiguous suggestions could shield the advertisement from scrutiny precisely when protection against such sophisticated deception is most needed. It is equally well established that the truth or falsity of the advertisement usually should be tested by the reactions of the public. 577 F.2d 160, 165 (2d Cir. 1978) (citations omitted).
The Second Circuit went on to say in American Home Products that the court's role is limited although, "it [is] in the district court's province as trier of fact to weigh the evidence, and in particular the opinion research." 577 F.2d at 167.
My inquiry must be, therefore, whether the advertisements have the tendency to mislead, confuse or deceive. And in doing this I should consider the entire advertisement and here of course we're dealing principally with two television commercials and I should not engage in piece-by-piece dissection. Our Court of Appeals again dealt with this in approving the following language from the American Brands case:
A court may, of course, construe and parse the language of the advertisement. It may have personal reactions as to the defensibility or indefensibility of the deliberately manipulated words. It may conclude that the language is far from candid and would never pass muster under tests otherwise applied - for example, the Securities Acts' injunction that "thou shalt disclose'; but the court's reaction is at best not determinative and at worst irrelevant. The question in such cases is --- what does the person to whom the advertisement is addressed find to be the message? American Brands Inc. v. R.J. Reynolds, 413 F. Supp. 1352, 1357 (S.D.N.Y. 1976) quoted in American Home Prods v. Johnson & Johnson, 577 F.2d at 165-66.
In this circuit, a party challenging a competitor's advertising assumes the burden of showing that the tests referred to by [its competitor] were not sufficiently reliable to permit one to conclude with reasonable certainly that they established the proposition for which they were cited. [I] should consider all relevant circumstances, including the state of the testing art, the existence and feasibility of superior procedures, the objectivity and skill of the persons conducting the tests, the accuracy of their reports, and the results of other pertinent tests. Proctor & Gamble co. v. Chesebrough-Pond's Inc., 747 F.2d 114, 119 (20 Cir. 1984).
Now, the plaintiff has relies upon the Procter & Gamble case where it was said that "each plaintiff bears the burden of showing that the challenged advertisement is false and misleading," Id. citations omitted). That the defendant bears the burden of affirmatively proving falsity is a position I don't find the cases in this circuit sustaining.
In the Coca Cola case, the Second Circuit said, "[w]hen the challenged advertisement is implicitly rather than explicitly false, its tendency to violate the Lanham Act by misleading, confusing or deceiving, should be tested by public reaction," Coca-Cola v. Tropicana Prods., Inc., 690 F.2d 312, 317 (2d Cir. 1982) (citations omitted).
While the plaintiff has argued that its advertisements do not assert a scientific establishment of superiority, plaintiff uses not only in its television advertisement but in its packaging a bar graph that must, in a consumer's mind, stand for the existence of some kind of scientific proof.
I should say at this point that I am not at all sure that I have to reach the question of what the consumer's attitude is. The clear message that comes from the comparison of the DEXATRIM 12-hour product to the 16-hour product or 17-hour product is that DEXATRIM is ineffective after twelve hours. That is a claim of ineffectiveness. It is a claim which must be a false claim because there is no clinical proof that DEXATRIM is ineffective after twelve hours. It is an explicit claim. It is an establishment claim. And I so find.
Having so found, I will concede the possibility that I am wrong and that it is only implicitly a claim of ineffectiveness and I will proceed to analyze public reaction.
In essence there were two types of consumer reaction surveys submitted to me for consideration in this case; one by the plaintiff, one by the defendant. Both of those surveys or types of surveys were, in my judgment, flawed.
The defendant submitted three mall intercept studies conducted by a market research firm and presented a consumer psychologist witness, Dr. Dupont.
Plaintiff submitted an ASI day after recall test.
The defects I find in these tests are attributable to either actual defects in the studies or defects which are inherent in a random questioning of consumers. The problems with consumer surveys have been dealt with in other cases in this district and circuit. The American Home Products case dealt with inherent weaknesses of test data. I quote:
Questions of reliability are raised because the two television commercial tests upon which the district court relied focused, to a considerable extent, on audience recall rather than on immediate impressions. Delayed recall measure consumer interest and advertising persuasiveness as well as message content. The Gallup and Robinson, Inc. (G&R) test was conducted approximately 24 hours after the commercial was aired by the use of telephone interviews with persons who claim to have watched the program accompanying the commerical. The ASI Market Research, Inc. (ASI) testing was performed at special screenings for a specially selected audience. The viewers were questioned about their reactions both during and one hour after the screening. Some of the people tested by both surveys either had bad memories or paid little attention to the television commercial, resulting in inaccurate descriptions, not only of the claims made but even of the products discussed. But such inaccuracies, we suppose, are to be expected in advertising research 577 F.2d at 167 n.15.
Judge Sweet has suggested that because of what he called the "quick and dirty" nature of mall intercept surveys, those surveys should receive particularly close scrutiny. R.J. Reynolds Tobacco Co. v. Loew's Theatres, Inc., 511 F. Supp. 867, 876 (S.D.N.Y. 1980) In this particular case, the mall intercept studies presented by the defendants used leading questions consistently utilizing the phrase "did the commercial suggest?"
The mall intercept surveys control questions with respect to ACUTRIM, such as the doctors' recommendations questions, received an inordinate amount of "yes" answers.
Now, I have taken these problems into account in analyzing the surveys, in determining the appropriate weight they deserve, and I have discounted the significance of the high figures in the Oxtoby-Smith surveys accordingly. I don't think it's necessary or proper, however, to disregard those studies.
I find, after a careful review of the survey evidence, including the verbatim responses to plaintiff's day-after recall and to defendant's mall-intercept surveys to the extent that there were such responses, that a not insubstantial number of consumers were misled and deceived by the ACUTRIM commercials. I find that in the view of the consumers, those commercials claimed more than greater duration and the consumers received more than merely messages of longer duration from those commercials. The messages received by the consumers included "greater weight loss", "more active ingredients," "stronger at night," "more effective."
Dr. Dupont's analysis of these surveys is helpful and I credit that analysis but I do that only after giving consideration also to Professor Cohen's critique of the mall surveys and the documents in evidence concerning the mall surveys from Dorothy Watson and concerning the plaintiff's studies from Gerald Ostrov.
Dr. Dupont concluded that the messages that the consumers receive from the plaintiff's commercials include the following:
That twelve hours after taking a 12-hour appetite suppressant, a user of that product would become hungrier or very hungry and probably eat.
That ACUTRIM lasts four hours or more longer than any other appetite suppressant.
That this duration claim seems to be translated by consumers to one of greater overall efficacy for ACUTRIM in terms of suppressing appetite and helping one to lose weight.
Dr. Dupont concluded that the message that consumers are taking is, and I quote, "they understand the express claim of greater duration and they translate that to mean because it lasts longer it works better and probably will help me lose more weight. And it's not terribly surprising."
Now, after considering all of the above, I conclude that plaintiff's commercials make therapeutic claims in addition to the claim of superior duration, claims with respect to which plaintiff does not have clinical support. I further conclude that a not insubstantial number of consumers perceive the commercial in that way.
Since plaintiff is claiming implicitly or explicitly that its products are therapeutically superior, such claims must be supported by well controlled clinical studies. And here i quote from 21 C.F.R. 320.28 (1987):
"Correlation of in vivo bioavailability data with an acute pharmacological effect or clinical evidence of safety and effectiveness may be required if needed to establish the clinical significance of a special claim, e.g., in the case of a controlled release preparation."
Now that particular regulation was written by Dr. Cabana. In the course of the trial before me he downplayed its significance, stating that the FDA rarely invoked its use.
It is clear to me, however, that bioavailability studies, whatever their nature, do not constitute surrogates for well-controlled clinical studies. Such bioavailability studies are directed to the rate and extent of absorption. They can be related to therapeutic effectiveness only when there are clinical studies with respect to products establishing the therapeutic effectiveness of those products, at which point other products can be shown to be bioequivalent to those products.
I now address myself to DEXATRIM-15. It became clear during the trial that DEXATRIM-15 is not performing as the defendant wishes it were. It is not performing a 15-hour product under the estoppel of the previous case. This was effectively conceded by counsel in its post-trial submissions and is established by the Hazelton bioavailability study. And this fifteen hour failure is also confirmed by the study conducted by Dr. Williams on DEXATRIM-15 during July and August of 1985 and by the defendant's own Harris III study.
The Williams study and the Harris III study both suffer from problems in design or execution. I still deem them relevant in conjunction with all the other evidence on this question. In consideration of their defects I have discounted the weight which I accord to them.
I therefore enjoin Thompson from marketing the product DEXATRIM-15 until it has conducted appropriate, well-controlled tests to support a 15-hour duration claim consistent with the principles which were laid down in my opinion in the earlier trial.
Now, in light of this ruling, I find it unnecessary to rule upon plaintiff's contention that DEXATRIM-15 or that DEXATRIM is not a 75 milligram product.
The defendant has undertaken internal steps to insure the bioequivalence of its product. Defendant's counsel has informed me, by letter dated November 22 of this year, "because of CIBA's allegations with respect to the potency of the product, Thompson undertook in mid-October to quarantine and withdraw from distribution all the DEXATRIM-15 product manufactured prior to this year."
As part of my injunction with respect to DEXATRIM-15 I direct that the voluntary quarantine which counsel has informed me of with respect to that product will remain in effect until further order of the court.
Now, the defendant's first counterclaim is with respect to whether the plaintiff misrepresented my January 30, 1984 opinion as to DEXATRIM-15. In particular the defendant asserts that the plaintiff's communications with the networks with respect to the running of the commercials carried the following explicit claim:
"ACUTRIM efficacy support was confirmed in Judge Broderick's decision of January 30th, 1984 in CIBA-GEIGY versus Thompson Medical Co., 83 Civ. 8924 (VLB). Judge Broderick further established 60 nanograms per milliliter as the minimum efficacy level for the category based upon scientific and market data."
Now, that paragraph, in and or itself, could perhaps be characterized as false and misleading. However, the plaintiff at the time that letter was written, to Ally & Gargano, an advertising agency, had already forwarded to the networks a copy of the opinion and included in the same letter sentences which qualified that word "established."
Again I quote:
"CIBA provided support for its currently running ACUTRIM commercials to NBC in a submission dated February 15, 1983. This submission supported ACUTRIM efficacy based upon: 1) blood level results compared with FDA monograph dosing regimens and 2) competitive product duration claims dating back to 1979."
On January 21, the plaintiff communicated again with NBC that had received the original letter dated October 15 and said the following:
"The matter of duration was the focus of our Lanham Act suit" -- I'll leave out the citation. "Judge Broderick's guidelines for determining duration claims were based in large part upon minimum blood levels of 60 nanograms per milliliter as established by bioavailability studies and confirmed by documents in Thompson's own files including packaging and advertising for DEXATRIM Extra Strength and network submissions subporting [sic], 12 hours advertising for the DEXATRIM Extra Strength product."
Certainly plaintiff could have used a better choice of words in characterizing my 60-nanogram-per-milliliter determination but in the overall scheme of things, plaintiff's statements were not false or misleading.
Now, defendant also seeks to enjoin plaintiff's comparative advertising on all packages and in all advertisements. I have discussed and to a certain extent analyzed this advertising already.
Plaintiff's claim of four hours' longer duration is an explicit assertion that its product is therapeutically superior to defendant's product; that is that longer appetite suppression leads to greater weight loss. Now, if my finding that that is an explicit assertion is wrong, it is certainly an implicit assertion to the same effect.
The plaintiff argues that its comparative claims are solely durational claims and that the FDA does not regard a claim of superior duration as constituting a claim of superior efficacy. I find otherwise. I find it inconceivable that this advertising makes any sense or would have any impact if it did not convey the message of superior efficacy.
I note that Dr. Halperin testified or at least conceded that a claim of longer duration of appetite suppression implicitly constitutes a claim of greater weight loss.
I don't mean anything that I have said thus far to be a technical criticism of CIBA-GEIGY's advertisements. They are good advertisements and they are very humorous advertisements. But they are advertisements that the consumer understands to say that the plaintiff's product lasts longer and is more effective in maintaining appetite suppression and in achieving weight loss.
I've already noted the problems I have with the consumer surveys but considering those surveys in conjunction with Professor Cohen's critique and my own perception of the commercials, I conclude that the advertisements make therapeutic superiority claims without the necessary clinical support.
It is at least unofficial FDA doctrine that "any labeling claim of clinical advantage such as greater effectiveness and/or reduced incident of side effects, must be substantiated by appropriate well-controlled clinical studies" FDA Guidelines by Commissioner Skelly, Defendant's Exhibit C.
Plaintiff has no clinical evidence to support its claim of superior therapeutic advantage over DEXATRIM and thus plaintiff's comparative advertisements are false and deceptive pursuant to the Federal Trade Commission Act and New York law.
As I noted earlier, plaintiff may not seize upon my having enjoined defendant from claiming its product is effective when its blood level drops below 60 nanograms per milliliter as the basis for claiming that defendant's product is not effective when it drops below that level. Plaintiff has no scientific or clinical evidence to support such a claim and it is false and deceptive to the consumer to make such a representation.
Thompson also seeks to enjoin CIBA-GEIGY from claiming that its products, ACUTRIM and ACUTRIM II, are 16- and 17-hour products respectively. Defendant has introduced nothing to persuade me to change my opinion as stated on January 30, 1984 in which I adopted Dr. Cabana's determination:
"that the bioavailability study which had been conducted at plaintiff's instance, [ALZA] and which was the predicate for plaintiff's graph was a scientifically appropriate study and that it in fact supported fully the claims which were contained in plaintiff's graph." Transcript, 1/30/84, at 6.
Dr. Cabana reiterated in this trial his conclusion that the two studies supported CIBA's claims that CIBA's product was a 16-hour product. Thus with respect to ACUTRIM 16 I decline to enjoin plaintiff from advertising that its product has 16-hour duration. I find, however, that plaintiff may not claim that ACUTRIM II has a duration of 17 hours.
Dr. Williams, himself a witness for the plaintiff, conceded that the data generated from the study he conducted on ACUTRIM II does not provide a basis for advertising that ACUTRIM II is a 17-hour product. Although he testified on direct examination that the raw data showed greater than seventeen hours above 60 nanograms per milliliter, he candidly admitted on cross-examination that his data did not support such a claim.
Dr. Leeson testified that he does not know whether ACUTRIM II suppresses appetite for any longer than ACUTRIM.
Plaintiff is therefore enjoined from the continued marketing of ACUTRIM II as a 17-hour product until it has conducted appropriate tests to justify such a claim.
I think the next thing that I have to say is dictum. I have resisted an inclination to enjoin the continued marketing of either of these products until appropriate clinical tests have been conducted. We are in an area here where each one of the parties has a tremendous financial investment and there was testimony as to the millions that were involved in advertising.
I recognize, from the testimony of various of the witnesses offered by both sides, how difficult it would be to prepare, to plan an appropriate clinical study in this area. And I also recognize the dangers involved in financing a clinical study which may turn out to be not very helpful but will always be available in the next lawsuit.
At the same time, there is a public out there that is entitled to something more than attractive, entertaining and humorous advertisements. I say this is dictum because I have been persuaded by my law clerk that there are limits on the power of a federal judge and that I cannot reach beyond the case in controversy.
The ultimate relief that the defendant has sought on its counterclaims is a bit disingenuous. It has sought to enjoin plaintiff from making 16- or 17-hour claims but seeks to continue to market its product as a 15-hour product. The relief that I am ordering is very specific. The defendant may not market DEXATRIM-15 as a 15-hour product. Plaintiff may not market ACUTRIM II as a 17-hour product and plaintiff may not make comparative superiority claims without clinical proof of therapeutic advantage.
I am not restraining either party from making durational claims if those durational claims are adequately supported. But they must be explicitly delineated as blood level durational claims and nothing more. Without clinical proof of what these blood levels mean and thus what effect, if any, these products have on appetite suppression and hence on weight loss, it would be false and deceptive to claim that a certain result would obtain when one has no support whatsoever for that claim.