The HONORABLE DEAN WHIPPLE, United States District Judge for 1

the Western District of Missouri.

___________

No. 95-3743

___________

Rhone-Poulenc Rorer *

Pharmaceuticals, Inc., *

*

Plaintiff - Appellant, *

* Appeal from the United States

v. * District Court for the

* Western District of Missouri.

Marion Merrell Dow, Inc., *

*

Defendant - Appellee. *

___________

 Submitted: April 10, 1996

 Filed: August 22, 1996

___________

Before MAGILL, Circuit Judge, HENLEY, Senior Circuit Judge, and LOKEN,

Circuit Judge.

___________

LOKEN, Circuit Judge.

This appeal challenges the district court's disposition of false

1

advertising claims by competing manufacturers of diltiazem, a "miracle

drug" for the treatment of hypertension and angina. The governing law is

the false advertising cause of action provided in § 43 of the Lanham Act,

15 U.S.C. § 1125(a)(1)(B). The court found both parties guilty of false

advertising. It awarded no damages to plaintiff Rhone-Poulenc Rorer

Pharmaceuticals ("RPR") and ordered RPR to undertake corrective advertising

to counter the effects of its Lanham Act violation. RPR appeals those

rulings. We vacate as not sufficiently specific that portion of the decree

requiring RPR to advise the marketplace of "the food effect" associated

with its product. We otherwise affirm.
 FDA will classify drugs as "bioequivalent" when their rate

2

and extent of absorption by the body make them interchangeable.

Drugs are bioequivalent when they have "the same strength and

similar bioavailability in the same dosage form." Bioavailability

is "the degree to which a drug or other substance becomes available

to the target tissue after administration." Dorland's Illustrated

Medical Dictionary 206 (27th ed. 1988). 

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I. Background.

Defendant Marion Merrell Dow ("MMD") introduced the first diltiazem

drug, Cardizem, in 1982. The FDA approved Cardizem for the treatment of

angina; it was also widely prescribed to treat hypertension. In 1989, MMD

introduced a sustained release Cardizem product that is taken twice per

day. MMD then developed Cardizem CD, a sustained release drug that is

taken only once per day. The FDA approved Cardizem CD for hypertension and

for angina. 

Diltiazem was a pioneer new drug, which means that the Cardizem

products enjoyed a ten-year period of market exclusivity under the HatchWaxman amendments to the Food, Drug, and Cosmetics Act. See 21 U.S.C.

§ 355(j)(4)(D); Abbott Labs. v. Young, 920 F.2d 984 (D.C. Cir. 1990), cert.

denied, 502 U.S. 819 (1991). Cardizem products were immensely successful,

generating sales of $1.1 billion in 1992 alone. By the early 1990's,

competing drug manufacturers were anxious to penetrate the diltiazem market

with less costly alternatives.

RPR launched its diltiazem drug in June 1992. RPR's Dilacor XR, a

once-per-day sustained release tablet, initially received FDA new drug

approval for the treatment of hypertension but not angina. FDA approval

as a new drug, which is more rigorous than approval as a generic

substitute, allowed Dilacor XR to compete with Cardizem CD during the

latter's period of market exclusivity. FDA classified Dilacor XR as a

"BC" drug -- one that is not necessarily "bioequivalent" -- rather than

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a bioequivalent "AB" drug. 
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Pharmacists may freely substitute among AB drugs, but only a prescribing

physician may substitute one BC drug for another. 

Given this FDA classification, to significantly penetrate the

diltiazem market RPR had to persuade physicians to prescribe its low-cost

product, Dilacor XR, as a substitute for Cardizem CD. MMD of course wanted

to persuade the same audience that this is an inappropriate substitution.

With this issue as the battleground, the two companies launched advertising

campaigns for the allegiance of doctors, pharmacists, and hospitals.

Because these are sophisticated consumers, the battle was waged with

technical advertisements in professional journals and with marketing

presentations by each company's sales representatives. RPR sought to

convince prescribing physicians that Dilacor XR is the "same as, only

cheaper" than Cardizem CD. MMD's message was, in essence, "not same as,"

and maybe not cheaper. 

The nature of the competing false advertising claims can be briefly

summarized. MMD's defensive advertising began with literature telling its

sales representatives that Dilacor XR might be only seventy-five percent

as bioavailable as Cardizem CD. After agreeing to discontinue that

unsubstantiated claim, MMD's next wave of promotional materials advised

sales representatives, doctors, and pharmacists that studies showed Dilacor

XR only fifty percent as bioavailable as Cardizem CD. In its third wave

of advertising, MMD released a four-page brochure in April 1993 reporting

the results of a comparative study conducted by an outside laboratory, the

"6730 Study." The results, as reported by MMD: "Dilacor XR delivers 81%

of a 180-mg dose relative to Cardizem CD" and "74% of a 540-mg dose." RPR

sued, contending that these false comparative bioavailability claims

violate the Lanham Act. 

Throughout this period, RPR's advertising urged doctors and

pharmacists to switch their patients from Cardizem products to the low-cost

Dilacor XR. In its counterclaims, MMD attacked this
 Doctors may prescribe an FDA-approved drug for non-approved

3

uses, but the manufacturer may not promote non-approved uses.

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advertising as falsely telling medical professionals that Dilacor XR is

freely substitutable for Cardizem products when in fact Dilacor XR is not

FDA-approved for angina, physicians should monitor patients who switch

3

from Cardizem CD because Dilacor XR does not have "similar

bioavailability," and the two drugs are absorbed differently when taken

with a meal (the "food effect").

After a bench trial, the district court found that MMD's early

literature claiming that Dilacor XR has only seventy-five percent or fifty

percent bioavailability violated the Lanham Act. It enjoined MMD from

making those claims. However, it found that MMD's advertising based upon

the 6730 Study was not false, and it declined to award RPR money damages

because RPR failed to prove damage resulting from MMD's earlier false

advertising. 

Turning to MMD's counterclaims, the district court found that RPR's

advertising "contain[ed] a hidden message encouraging indiscriminate

substitution" that is false in two respects -- Dilacor XR is not approved

for treatment of angina, and Dilacor XR has a "food effect" that creates

a risk of injury if physicians do not monitor patients who are switched to

Dilacor XR. Based upon these violations, the court enjoined RPR to "take

necessary steps" to advise sales representatives, physicians, pharmacists,

and patients (1) of "the food effect associated with Dilacor XR," (2) that

physicians should "carefully monitor and titrate" (adjust the dosages) when

they switch patients from Cardizem CD to Dilacor XR, and (3) that "Dilacor

XR is not approved to treat angina." 

Following the district court's September 1994 decision, RPR filed a

motion to correct the judgment, which the court denied. MMD moved to

enforce the court's order, and the court granted that motion without

further explanation of what compliance is required. 
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RPR appeals. It argues that MMD was guilty of false advertising based on

the 6730 Study, that the district court erred in denying RPR money damages,

and that the court erred in ordering RPR to conduct corrective advertising

disclosing that Dilacor XR is not approved to treat angina and has a "food

effect."

II. MMD's Advertising.

MMD advertised Dilacor XR's lower bioavailability in order to

persuade medical professionals that Dilacor XR is not a comparable

substitute and to undercut Dilacor XR's price advantage. The trial

evidence showed that MMD's first claim of seventy-five percent

bioavailability was false because it had no substantiation. The second

claim of fifty percent bioavailability was false because it was based upon

an obvious misinterpretation of data from prior studies. But MMD's third

claim of 74% to 81% bioavailability was based upon the specially

commissioned 6730 Study. The bona fides of that Study became a principal

subject of the trial.

The Lanham Act prohibits "commercial advertising or promotion [that]

misrepresents the nature, characteristics, qualities, or geographic origin

of [the advertiser's] or another person's goods, services, or commercial

activities." 15 U.S.C. § 1125(a)(1)(B). False advertising decisions in

other circuits have consistently distinguished between two types of

comparative advertising claims: "my product is better than yours," versus

"tests prove that my product is better than yours." To successfully

challenge the first type of claim, a Lanham Act plaintiff must prove that

defendant's claim of superiority is false. But to successfully challenge

the second type of claim, where defendant has hyped the claim of

superiority by attributing it to the results of scientific testing,

plaintiff must prove only "that the tests [relied upon] were not

sufficiently reliable to permit one to conclude with reasonable certainty

that they established the proposition for which they were cited." Castrol,

Inc. v. Quaker State Corp., 977 F.2d 57, 62-63
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(2d Cir. 1992), quoting Procter & Gamble Co. v Chesebrough-Pond's, Inc.,

747 F.2d 114, 119 (2d Cir. 1984). Accord BASF Corp. v. Old World Trading

Co., 41 F.3d 1081, 1089-91 (7th Cir. 1994); Mylan Labs., Inc. v. Matkari,

7 F.3d 1130, 1138 (4th Cir. 1993), cert. denied, 114 S. Ct. 1307 (1994);

McNeil-P.C.C., Inc. v. Bristol-Myers Squibb Co., 938 F.2d 1544, 1549 (2d

Cir. 1991). The district court applied this standard for "tests prove"

claims to MMD's advertising based upon the 6730 Study. Neither party

challenges the standard, and we agree it is a correct application of Lanham

Act § 43.

RPR concedes that the 6730 Study results support the claims MMD made

in its advertising brochure. Thus, the issue before us is whether that

advertising was false because the 6730 Study is not a sufficiently reliable

basis for comparing the bioavailability of Dilacor XR and Cardizem CD. At

trial, RPR presented expert testimony that the 6730 Study was flawed in

design and execution, plus evidence that two RPR studies, the "113 Study"

and the "115 Study," did not have these flaws and refuted the

bioavailability conclusions of the 6730 Study. MMD countered with expert

testimony supporting the 6730 Study's methodology and attacking the RPR

studies. After weighing this conflicting evidence, the district court

concluded that the 6730 Study is a valid study "conducted by standards

accepted within the scientific community and consistent with FDA

principles." 

On appeal, RPR concedes that the district court was free to reject

RPR's evidence attacking the 6730 Study's methodology. But RPR argues that

the results of its two studies refuted the 6730 Study, thereby proving that

MMD's study did not scientifically establish the inferior bioavailability

of Dilacor XR. However, RPR's studies were not that conclusive. The

single-dose 113 Study was more limited in scope and did not necessarily

refute MMD's claims. The 115 Study was not available when MMD began

advertising the results of the 6730 Study, was criticized extensively by

MMD's
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experts, and also showed a reduced bioavailability for Dilacor XR, albeit

not as great as the difference found by the 6730 Study. 

After carefully reviewing this evidence, we conclude the district

court's finding that MMD did not falsely advertise the 6730 Study must be

upheld. We do not have a "definite and firm conviction that a mistake has

been made," the clear error standard in Anderson v. Bessemer City, 470 U.S.

564, 573 (1985). We note that Lanham Act liability for "tests prove"

advertising requires proof that the tests are not "sufficiently reliable"

to support the advertised conclusion with "reasonable certainty." To

ensure vigorous competition and to protect legitimate commercial speech,

courts applying this standard should give advertisers a fair amount of

leeway, at least in the absence of a clear intent to deceive or substantial

consumer confusion.

RPR also argues that it was entitled to money damages for MMD's

earlier false advertising. The Lanham Act provides that a successful

plaintiff "shall be entitled" to recover "any damages sustained." 15

U.S.C. § 1117(a). Plaintiff must prove both actual damages and a causal

link between defendant's violation and those damages. See ALPO Petfoods,

Inc. v. Ralston Purina Co., 913 F.2d 958, 968-69 (D.C. Cir. 1990).

"[P]laintiff may not recover if he fails to prove that the defendant's

actions caused the claimed harm." Harper House, Inc., v. Thomas Nelson,

Inc., 889 F.2d 197, 209 (9th Cir. 1989), quoting Otis Clapp & Sons, Inc.

v. Filmore Vitamin Co., 754 F.2d 738, 745 (7th Cir. 1985).

In this case, RPR did not attempt to prove that it incurred increased

costs in countering MMD's false advertisements, one well-established method

of proving Lanham Act damages. See ALPO, 913 F.2d at 969. Rather, RPR

attempted to prove that MMD's false advertising resulted in $40 to $56

million of lost Dilacor XR sales. However, the district court found that

Dilacor XR sales "exceeded [RPR's] initial predictions" and that "Dilacor

XR is as
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well-positioned as should be reasonably expected at this stage in its

product history with or without [MMD's] anti-Dilacor campaigns." These

findings are not clearly erroneous and are directly responsive to RPR's

damage theory. Thus, the district court did not abuse its remedial

discretion in declining to award RPR damages. See Abbott Labs. v. Mead

Johnson & Co., 971 F.2d 6, 16-19 (7th Cir. 1992) (standard of review).

Likewise, because MMD discontinued its earlier false advertising and did

not violate the Lanham Act in advertising the 6730 Study results, the court

did not abuse its discretion in declining to order MMD to conduct

corrective advertising.

III. RPR's Advertising.

The district court found that RPR's advertisements conveyed a false

hidden message encouraging indiscriminate substitution of Dilacor XR for

Cardizem CD. It ordered RPR to engage in corrective advertising regarding

the fact that Dilacor XR is not FDA-approved to treat angina, the need to

monitor and titrate patients who switch from Cardizem CD to Dilacor XR, and

Dilacor XR's food effect. RPR concedes that its advertisements encouraged

physicians to consider the two drugs freely substitutable, and it does not

appeal the order that it must effectively disclose the need to monitor and

titrate patients who switch drugs. But RPR does contend that the district

court erred in ordering corrective advertising disclosing that Dilacor XR

is not approved to treat angina and has a "food effect."

A. Regarding the limited FDA approval issue, RPR notes that it has

truthfully advertised Dilacor XR as approved for the treatment of

hypertension. The district court erred, RPR argues, because a Lanham Act

plaintiff alleging that advertising is false because it conveys a false

implicit message must prove actual consumer confusion, and MMD presented

no such proof. See Johnson & Johnson * Merck Consumer Pharm. Co. v.

Smithkline Beecham Corp., 960 F.2d
 Furthermore, MMD presented evidence of consumer confusion.

4

One physician testified that an RPR representative told him that

RPR's formulation of diltiazem "is the same as Cardizem CD." MMD

produced affidavits from other physicians stating that they had

been told by RPR representatives that the drugs are the same. MMD

also produced RPR physician surveys suggesting that consumers

viewed the two products as interchangeable. Cf. PPX Enters., Inc.

v. Audiofidelity Enters., Inc., 818 F.2d 266, 271 (2d Cir. 1987).

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294, 297-98 (2d Cir. 1992). We note that other Second Circuit cases have

said that implicit falsity "should be tested by public reaction," not that

a plaintiff such as MMD must prove confusion by consumer research. CocaCola Co. v. Tropicana Prods., Inc., 690 F.2d 312, 317 (2d Cir. 1982). But

we need not resolve that issue because consumer confusion need not be

proved if advertising is literally false.4

In assessing whether advertising is literally false, "a court must

analyze the message conveyed in full context." Castrol, Inc. v. Pennzoil

Co., 987 F.2d 939, 946 (3d Cir. 1993). Here, the record clearly supports

the district court's finding that RPR's advertisements were literally

false. The court focused on RPR advertisements featuring images such as

two similar gasoline pumps or airline tickets with dramatically different

prices, accompanied by the slogan, "Which one would you choose." The court

found that these ads falsely represented that the two drugs may be

indiscriminately substituted, in effect, a representation that Dilacor XR

"has certain qualities that it in fact does not actually have." Abbot

Labs., 971 F.2d at 14. Because the implicit message was literally false,

the issue became one of remedy -- what corrective advertising would be

appropriate. The district court determined that the false message would

be remedied if RPR adequately explained the differences in the two

products, including the fact that Dilacor XR is not approved to treat

angina. There was no abuse of discretion in adopting that remedy. See

First Bank v. First Bank Sys., Inc., 84 F.3d 1040, 1044 (8th Cir. 1996)
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(standard of review); Pfizer, Inc. v. Miles, Inc., 868 F. Supp. 437, 444

(D.Conn. 1994) (no false advertising when product differences are

explained). 

B. Turning to the food effect issue, we agree with RPR that one of

the district court's critical findings is clearly erroneous. The evidence,

particularly RPR's 113 Study, suggests that taking Dilacor XR with food

will increase its overall extent of absorption by about nineteen percent,

whereas taking Cardizem CD with food will decrease its overall extent of

absorption by about thirteen percent. The district court translated that

evidence into the following finding: "within an hour of taking [Dilacor

XR] after eating a high fat meal, a patient will experience a release of

between 19% to 33% of the 24 hour dose." But the evidence addressed the

overall, twenty-four hour extent of absorption, not the amount of product

released during the first hour. Based upon this misinterpretation of the

evidence, the court accused RPR of "callous indifference toward the

individuals ingesting its product" because "[a] patient with a weak heart

who undergoes this quick release of up to 33% of the total daily dosage

within an hour could experience serious health problems." 

Although the court's finding of a quick release is not supported by

the record, the evidence does support the general finding of a "food

effect" because the bioavailability of Dilacor XR and Cardizem CD are more

dissimilar if the products are taken during or after a meal. Indeed, FDA

requires that RPR packaging caution consumers that Dilacor XR should be

taken on an empty stomach. The issue then is how the district court's

erroneous finding affects the validity of its order requiring RPR to advise

physicians, pharmacists, and patients of Dilacor XR's food effect.

Rule 65(d) of the Federal Rules of Civil Procedure requires that

"[e]very order granting an injunction . . . shall be specific in terms

[and] shall describe in reasonable detail . . . the act or
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acts sought to be restrained." The Rule "is designed to prevent

uncertainty and confusion on the part of those to whom the injunction is

directed, to avoid the possible founding of contempt citations on an order

that is too vague to be understood, and to ascertain that the appellate

court knows precisely what it is reviewing." Calvin Klein Cosmetics Corp.

v. Parfums de Coeur, Ltd., 824 F.2d 665, 669 (8th Cir. 1987). Particularly

in light of the erroneous finding regarding the nature of Dilacor XR's food

effect, we conclude that this portion of the permanent injunction violates

Rule 65(d) and must therefore be vacated. On remand, MMD may request

additional injunctive relief regarding Dilacor XR's food effect, but it

should advise the district court what specific corrective advertising

disclosures are requested and why such injunctive relief is necessary over

and above the disclosures imposed upon RPR by the FDA. 

We vacate one portion of the district court decree: "that RhonePoulenc should take necessary steps to advise sales representatives,

physicians, pharmacists and patients of . . . the food effect associated

with Dilacor XR." In all other respects, the judgment of the district

court is affirmed. RPR's motion to clarify the record on appeal is denied.

A true copy.

Attest:

CLERK, U. S. COURT OF APPEALS, EIGHTH CIRCUIT.