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December 19, 1985

Ciba-Geigy Corp.,
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. *fn1"

 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 ...

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