FERRING PHARMACEUTICALS INC. v. WATSON PHARMACEUTICALS, INC.

Filing 54

OPINION. Signed by Judge Dennis M. Cavanaugh on 4/4/13. (DD, )

NOT FOR PUBLICATION
UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY

FERRING PHARMACEUTICALS INC., :
Plaintiff,
V.

:

Hon. Dennis M. Cavanaugh

OPINION
Civil Action No. 12-cv-05824 (DMC) (JAD)

WATSON PHARMACEUTICALS,
Defendant.

DENNIS M. CAVANAUGH. U.S.D.J.:
This matter comes before the Court upon Motion for Preliminary Injunction by Plaintiff
Ferring Pharmaceuticals Inc. (“Plaintiff’ or “Ferring”) to enjoin Defendant Watson
Pharmaceuticals (Defendant” or “Watson”) from further statements and for corrective
advertising. (P1.’s Mot, for Prelim. Injunc., Nov. 9, 2012, ECF No. 29), Pursuant to FED. R. Civ.
P. 78, no oral argument was heard. The Court has reviewed the submissions of the parties, and for
the reasons set forth below, Plaintiff’s request for relief is denied.
I.

BcKGRouNDI

A.

THE PRODUCTS

Ferring and Watson are pharmaceutical companies that market competing products used
for in vitro fertilization in a process referred to as assisted reproductive technology (“ART”).

reproductive products are used to assist woman in establishing and maintaining pregnancies
I The facts contained herein have been adopted from the Parties’ respective moving papers.

The

through progesterone supplementation. The traditional method for progesterone supplementation
is through intramuscular injections. Ferring’s product, Endometrin, and Watson’s product,
Crinone, are vaginal inserts of progesterone that supplement or replace daily intramuscular shots.
Progesterone is a natural hormone often prescribed following ovulation and egg retrieval to help
prepare the uterine lining to receive a fertilized egg after implantation. Ferring’s Endometrin is
delivered in capsule form and applied two or three times per day. Watson’s Crinone product is a
gel delivered via applicator and is applied once daily. There are currently no other vaginal inserts
for ART approved by the Food and Drug Administration (“FDA”).
B. SEPTEMBER

11,2012

PREsENTATIoNs AND WEBcA5T5

Ferring has brought the instant Lanham Act false-advertising claim against Watson,
alleging that several of Watson’s advertising materials promoting Crinone are false or misleading.
Ferring’s Complaint alleges that the advertisements “in effect” paint Endometrin as “dangerous,
not effective, and disliked by consumers.” (Compi.

¶ 1). Ferring further alleges that Watson’s

marketing materials improperly state or imply that Crinone is superior to other products, including
Ferring’s Endometrin. Ferring states that Watson hosted and invited doctors and healthcare
professionals to two events on September 11, 2012, at which Dr. Kaylen M. Silverberg detailed the
qualities and success rates of Crinone in an effort to influence attendees to purchase the product.
On that date, Dr. Silverberg, a paid consultant of Watson, made two presentations on Crinone,

streamed at 7:30 p.m. and 9:00 p.m. throughout the United States and viewed medical
professionals in-person and over the Internet via a password (individually “7:30 p.m. Webcast”
and 9:OO p.m. Webcast” and collectively “Dr. Silverberg Webcasts”). During the I)r. Silverberg
Webcasts, Ferring alleges several false statements were made about Endometrin, implying that

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Endometrin is not effective and Crinone is the only proven and trustworthy product for
progesterone delivery.
C.

SUBSTANCE OF STATEMENTS

Three statements in particular made during Dr. Silverberg’ s Webcasts form the basis for
Ferring’s Motion for Preliminary Injunction. Ferring takes issue with: (1) Dr. Silverberg’s
reference to a “Black Box warning” on Endometrin; (2) Dr. Silverberg’s claims of patient

preference for Crinone; and (3) Dr. Silverberg’s claims that Endometrin has not been proven
effective for women over thirty-five years of age.
1. Black Box Claims

During the 7:30 p.m. Webcast, Dr. Silverberg indicated that “if you read the package

insert2

for Endometrin there is a Black Box warning showing the efficacy has not been demonstrated with
[...j Endometrin for patients 35 years of age and older.” (Michalek Dccl., Exh. 5, Nov. 9, 2012,
ECF No, 28-2). Ferring asserts that Endometrin does not now have, nor has it ever had, a Black
Box warning. A Black Box warning is of special note to those in the medical community as it
contains the strongest warnings required by the FDA, and signifies that medical studies indicate
the drug carries a significant risk of serious, or in some cases, life-threatening adverse effects.
(Beitsos Dccl.

¶ 9, Nov. 9, 2012, ECF No. 28-1),

Endometrin’s packaging does in fact state,

“[ejfficacy in women 35 years of age and older has not been clearly established,” (Michalek
Dccl., Exh. 6). Ferring thus takes issue, not with the content of the statement itself, but the
mistaken pronouncement that the wording is contained in a Black Box warning.
Dr. Silverberg was alerted to the inaccuracy of the statement after the 7:30 Webcast and the

“package insert” is a document that accompanies a drug and contains prescribing information, describes side
effects, and provides additional information about the medication.

2 A

3

9:00 p.m. Webcast did not contain such a statement. Dr. Silverberg has since certified to Ferring
and this Court that, in the thture, he will not repeat this statement. (Silverberg Cert., Dec. 3, 2012,
ECF No. 34-3).
2.

Crinone and Endometrin Comparisons

Ferring also objects to particular statements Dr. Silverberg made regarding patient
preference for Crinone over Endometrin. Ferring asserts that there is no support whatsoever for
the percentages utilized by Dr. Silverberg to support a patient preference for Crinone.

The

substance of the remarks in question, made during the 7:30 p.m. Webcast are contained in the
transcript of the event. (Phillips Cert., Exh. 1, Dec. 3, 2012, ECF No. 35-2). They include Dr.
Silverberg’s statement that:
When you look at Crinone compared to Endometrin, similar findings. 94 percent of
patients thought that Crinone was easier to incorporate into their daily lifestyle, probably
because it’s given once a day compared to three times a day for Endometrin. 82 percent
thought that it was more convenient or I’m sorry, that may be 88 percent, 94 percent
thought that it was more comfortable to use Crinone than the Endometrin.
Now looking at Crinone compared to Endometrin, telephone survey, 94 percent ofpatients
thought that Crinone was easier to incorporate into a daily lifestyle than the Endometrin
given three times a day. 88 percent thought it was more convenient. 84 percent thought it
was more comfortable to use.
(Michalek Dccl., Exh. 5 at 20:12-20, Exh. 7 at 19:21-20:1). Ferring asserts that Watson did not
produce the questions and answers to the survey, nor any evidence that the individual women
being interviewed used both Crinone

Endometrin, and were therefore able to make a

comparison between the two. The percentages utilized by Dr. Silverberg —94%, 88%, and 84%

—

Ferring alleges, were not figures garnered from comparing the two products, but merely
represented the percentage of women who liked Crinone. Ferring asserts that other women in the
study were reported to like Endometrin, but that those statistics were not utilized. Ferring argues
4

Watson heralds the findings as a

‘comparative

study,” when it was in

fact

no such thing. Ferring

cites to FDA requirements for maintaining the accuracy of preference claims about
pharmaceuticals. (See g Michalek Dccl., Exh. 11) (“Patient preference claims should be
supported by well-designed and controlled head-to-head studies using well-developed instruments
that can evaluate all determinants of patient preference.). Ferring asserts Dr. Silverberg failed to
meet these guidelines and thus the comparative statements contained in the presentation were
improper. Watson concedes that the percentage figures used were inaccurate and the survey
described ultimately found that 68.1% of the patients preferred Crinone over Endometrin,
However. Watson asserts that the study was, in actuality, a survey of women who used both
Crinone and Endornetrin.

3. Age Restriction Claims
Ferring also finds fault with Dr. Silverberg’s remarks concerning the efficacy
and Endometrin in women over thirty-five years and older. During the 7:30 p.m.

of

Crinone

presentation.

Dr. Silverberg compared the efficacy of Crinone and Endometrin for women thirty-five and over
and relied upon two relevant medical studies. In characterizing Crinone, Dr. Silverberg stated
that it, unlike other products, had been established in women throughout the entire reproductive
spectrum from twenty-two to forty-seven years of age, including women age thirty-five and older.
Ferring asserts the studies cited to during the 7:30 p.m. Webcast did not stand for the asserted
proposition. Furthermore, Dr. Silverberg stated during the same presentation that Endometrin
“was not found to be efficacious for women over the age of 35.” (Michalek I)ecl., Exh, 5 at
19:25-20:3) (“Webcast #1 Tr.). Ferring asserts that the studies relied upon and cited to by Dr.
Silverberg say nothing about Endometrin and that Watson has produced no data to support its

claim that Endometrin does not work for women thirty-five years and older.

Watson. through

Dr. Silverberg. asserts that the data from the relevant study does in fact support the assertions
contained in Dr. Silverberg’s Webcasts. (Silverberg Cert.
II.

¶11

17-21, Dec. 3,2012. ECF No. 34-3).

LEGAL STAN DARD

Injunctive relief is an “extraordinary remedy, which should be granted only in limited
circumstances.” Novartis Consumer Health, Inc. v. Johnson & Johnson—Merck Consumer
Pharms. Co., 290 F.3d 578, 586 (3d Cir. 2002) (quotation and citation omitted); Kos Pharm. Inc. v.
Andrx Corp., 369 F.3d 700, 708 (3d Cir. 2004); see also Am. Tel. & Tel. Co. v. Winback &
Conserve Program. Inc., 42 F.3d 1421, 1427 (3d Cir.1994). “A decision to grant or deny a
preliminary injunction is within the sound discretion of the district court.” Sanofi—Aventis
Deutschland GmbH v Glenmark Pharms Inc 2010 WL 2428561 (D NJ June 9 2010) (uting
,

Oakley, Inc. v, Sunglass Hut Int’l, 316 F.3d 1331, 1339 (Fed. Cir. 2003)); see also Spartacus, Inc.
v. Borough of McKees Rocks, 694 F.2d 947, 949 (3d Cir. 1982). To determine whether a
preliminary injunction should be granted, a district court must consider four factors:
(1) whether the movant has shown a reasonable probability of success on the merits; (2) whether
the movant will be irreparably injured by denial of the relief; (3) whether granting preliminary
relief will result in even greater harm to the nonmoving party; and (4) whether granting
prelirninaiy relief will bc in the public intetest

Gerardi v Pelullo, 16 F 3d 1363 1373 (3d

Cir,1 994); gg also ACLU of N.J. v. Black Horse Pike Reg’l Bd. of Educ., 84 F.3d 1471, 1477 n. 2
(3d Cir. 1996); Opticians Ass’n of Am. v. Indep. Opticians of Am., 920 F.2d 187, 191—92 (3d Cir.
1990); CIBA—GEIGY Corp. v. Bolar Pharm. Co., Inc., 747 F.2d 844, 850 (3d Cir. 1984) cert
denied 471 U.S. 1137 (1985). The moving party bears the burden of showing that these factors

6

weigh in favor of granting the injunction. Kos Pharm. Inc.. 369 F.3d at 708.

On1v ifihe movant

produces evidence sufficient to convince the [court] that all four factors favor preliminary relief
should the injunction issue.” Opticians Ass’n of Am., 920 F.2d at 192; see also Nutrasweet Co. v.
Vit—Mar Enter. Inc., 176 F.3d 151, 153 (3d Cir.1999); Am, Tel. & Tel, Co., 42 F.3d at 1427
(citation omitted).
The Third Circuit has accorded particular weight to the first two of the injunction factors:
irreparable harm and likelihood of success on the merits. Hoxworth v. Blinder. Robinson & Co..
903 F.2d 186, 197 (3d. Cir. 1990) (quoting In re Arthur Treacher’s Franchisee Litig.. 689 F.2d
1137, 1143 (3d Cir. 1982) ([W]e cannot sustain a preliminary injunction ordered by the district
court where either or both of these prerequisites are absent.”)); see also Scholastic Funding Grp.,
LLC v. Kimble, Civ. No. 07-557, 2007 WL 1231795, at *28 (D.N.J. Apr. 24,2007). Nonetheless,
the district court should only award preliminary injunctive relief upon weighing all four factors,
Am. Tel. & Tel. Co., 42 F.3d at 1427, (citing Duraco Prod, Inc. v. Joy Plastic Enter. Ltd., 40 F.3d
1431. 1438 (3d Cir.1994).)
III.

DiscussioN
A.

IRREPARABLE IIARNI

This Court first addresses whether Plaintiff can demonstrate irreparable harm, since “[in]
the absence of irreparable injury, no preliminary injunction would lie, even if the other three
elements.

.

.

were found.” Nutrasweet Co. v. Vit-Mar Enterprises. Inc., 176 F.3d 151, 153 (3d

Cii’. 1999). “Establishing a risk of irreparable harm is not enough. A plaintiff has the burden of
proving a ‘clear showing of immediate irreparable harm’

“

absent injunctive relief.

Hoxworth v.

Blinder. Robinson & Co. Inc., 903 F.2d 186, 205 (3d Cii’. 1990) (citing ECRI v. McGraw—Hill.

7

Inc., 809 F.2d 223, 225 (3d Cir.1987)). Irreparable harm cannot be presumed, and “must be
established as a separate element, independent of any showing of likelihood of success.” King
Pharm, Inc. v. Sandoz, Inc., Civ, No. 08-5974, 2010 WL 1957640, at *5 (D.NJ. May 17, 2010)

(citing Winter v. Natural Resources Defense Counsel, Inc., 555 U.S. 7, 21-22 (2008)). “In order
to demonstrate irreparable harm the plaintiff must demonstrate potential harm which cannot be
redressed by a legal or an equitable remedy following a trial.” Instant Airfreight Co. v. C.F.
Airfreight, Inc., 882 F.2d 797, 801 (3d Cir. 1989). Thus, the “preliminary injunction must be the
only way of protecting the plaintiff from harm.” Id. (emphasis added); see also Acierno v. New
Castle County, 40 F.3d 645, 653 (3d Cir. 1994). Irreparable injury occurs when money damages
are difficult to ascertain or would be inadequate. In re Arthur Treache?s Franchise Litig., 689
F.2d 11 37, 1146 (3d Cir. 1982). Failure to establish irreparable injury automatically results in

denial of a preliminary injunction. Instant Airfreight Co., 882 F.2d at 800; see also Nutrasweet
Co., 176 F.3d at 153.
Ferring asserts that, without injunctive relief Ferring “will continue to suffer irreparable
harm from Watson falsely informing the marketplace that Endometrin is dangerous, not effective,
and disliked by women.” (Pl.’s Mot. Br. 28). Watson, in turn, argues that Ferring has not and
cannot meet its burden of demonstrating irreparable injury. (Def.’s Opp. Br. 2 1-22, Dec. 3,2012,
ECF No. 71 4). The Third Circuit has made clear that “the preliminary injunction device should
not be exercised unless the moving party shows that it specifically and personally risks irreparable

harm.” Liberty Lincoln-Mercury, Inc. v. Ford Motor Co., 563 F. 3d 533, 557 (3d Cir. 2009)
(citing Adams v. Freedom Forge Corp., 204 F.3d 475, 487 (3d Cir. 2000)).
Ferring must present evidence showing a likelihood of real irreparable harm and has not
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sufficiently made that showing. Ferring asserts that Watson “falsely asserting that Endometrin is
dangerous, ineffective, and disliked, relative to Crinone, ‘necessarily diminishes’ Endometrin’s
‘value in the minds of the consumer.” (Pl.’s Mot. Br. 29, Nov. 9, 2012, ECF No, 29-1). Ferring
further asserts that Watson deprived Ferring of a legitimate competitive interest and reduced
consumers’ incentive to select Endometrin. (Pl.’s Mot. Br. 29). To support these assertions,
Ferring points to the propensity of false information promulgated on the Internet to “propage[j,
endure[], and continue to do harm.” (PI.’s Mot. Br. 29). However, Dr. Silverberg agreed he
misstated the existence of a Black Box Warning on Endometrin during the 7:30 p.m. Webcast but
removed the statement during the subsequent 9:00 p.m. Webcast.

in his Certification to this

Court, Dr. Silverberg has promised he will never state in the future that “[fjor Endometrin, there is
a black box warning showing that efficacy has not been demonstrated with Endometrin for patients
35 years of age and older.” (Silverberg Cert.

¶ 10, Dec.

3, 2012, ECF No. 34-3). Dr. Silverberg

has further certified that, at the request of Watson, in future presentations concerning Crinone, he
will make only specified statements as to the efficacy of Endornetrin for women thirty-five (35)
years or older in accordance with the statement contained on the product’s package insert.

(Silverberg Cert.

¶ 22).

Furthermore, there has been no showing that the information contained in

the Dr. Silverberg’s Webcasts is still available online to be accessed by consumers.
Given that Ferring has not alleged facts sufficient to prove that it was harmed, or that the
alleged harm was irreparable and could only be cured by a preliminary injunction, Ferring is
unable to satisfy its burden of showing this factor weighs in favor of granting a preliminary
injunction. Therefore, the Motion for a Preliminary Injunction must, by necessity, fail.
B.

LIKELIHOOD OF SuccEss ON THE MERITs

9

Although this Court has already determined that Ferring has not demonstrated irreparable
harm, and is therefore not entitled injunctive relief, it will briefly address allegations regarding a
likelihood of success on the merits in further support of denial of Ferring’s motion. A “likelihood
of success on the merits” for the purposes of a preliminary injunction analysis does not require “a
moving party to demonstrate ‘a certainty of prevailing, but rather

.

.

.

a reasonable probability of

eventual success in the litigation.” Assisted Living Assoc. of Moorestown. L.L.C. v.
Moorestown Tp., 996 F. Supp. 409, 433 (D.N.J. 1998) (citation omitted).

Ferring raises claims

of, and seeks injunctive relief for, false advertising in violation of the Lanham Act. The Lanharn
Act prohibits any false or misleading description or representation of fact that “in commercial
advertising or promotion, misrepresents that nature, characteristics, qualities, or geographic
origm” of goods.

15 U.S.C.

§

11 25(a)(l )(B). A defendant violates the prohibition when: “1) the

defendant has made false or misleading statements as to his own product [or another’s]; 2) that
there is actual deception or at least a tendency to deceive a substantial portion of the intended
audience; 3) that the deception is material in that it is likely to influence purchasing decisions; 4)
that the advertised goods traveled in interstate commerce; and 5) that there is a likelihood of injury
to the plaintiff in terms of declining sales, loss of good will etc.”

Warner-Lambert Co. v.

Breathasure, Inc.. 204 F.3d 87, 9 1-92 (3d Cir. 2000).
Ferring asserts initially that Watson’s advertisements are false because Watson’s claims
are unsubstantiated.

(P1.’s Mot. Br. 17). Ferring relies on the Third Circuit’s acknowledgment

that “although the plaintiff normally has the burden to demonstrate that the defendant’s advertising
is false, a court may find that a completely unsubstantiated advertising claim by defendant is per se
false without additional evidence from the plaintiff to that effect.” (P1.’ s Mot. Br. 17) (citing

10

Novartis Consumer l-lealth, Inc. v. Johnson & Johnson-Merck Consumer Pharm. Co., 290 F.3d
578, 590 (3d Cir, 2002)).

However, the Court does not agree that it is clear, at this stage. that the

substance of the advertising claim was completely unsubstantiated.” Watson has demonstrated
that at least some support exist to form the basis of the statements. In either case, the Court need
not make a determination as to the likelihood of success of Ferring’s claims, because, as mentioned
above, Ferring has failed to demonstrate irreparable harm.
C.

HARNI TO DEFENDANTS AND PUBLIC INTEREST

The Third Circuit has “held that these latter two factors should be taken into account only
when they are relevant.” Am. Tel. and Tel. Co. v. Winback and Conserve Program, inc., 42 E.3d
1421, 1427 n. 8 (3d Cir.1994); see also Hoxworth, 903 F.2d at 196. These factors are only
relevant if Plaintiff has first established “both a likelihood of success on the merits and the
probability of irreparable harm if relief is not granted” because a preliminary inlunction cannot be
sustained where either or both of these prerequisites are absent.” Id. (internal citations omitted).
Since at least one of these prerequisites is absent, this Court need not address the potential harm to
Defendants from or the public interest in granting a preliminary injunction.
IV.

CoNcLusioN

For the foregoing reasons, Ferring’s Motion for Preliminary Injunction is denied. An
appropriate Order accompanies this Opinion.

Dems M. Cavanaugh, U.S
Date:
cc

April203
All C unsci of Recoid
Joseph A. Dickson, U.S.M.J.
.

11

.J.