Par Sterile Products, LLC v. Fresenius Kabi USA, LLC

Filing 47

MEMORANDUM Opinion and Order. The Court grants in part and denies in part defendant's motion to dismiss 26 . Plaintiff's Lanham Act and corresponding state law claims based on false representations of FDA approval survive. Plaintiff' ;s claims based on false or misleading representations in defendant's contracts are dismissed with prejudice because they do not relate to advertising or promotion. Plaintiff's claims that defendant's product's labeling and packa ging deceptively imply that plaintiff's product is less effective than defendant's are dismissed without prejudice. Any claims based on representations that the defendant's product is "safe" or "effective" are dismissed without prejudice. Signed by the Honorable Jorge L. Alonso on 3/17/2015. Notice mailed by judge's staff (ntf, ) Modified on 3/17/2015 (ntf, ).

UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF ILLINOIS
EASTERN DIVISION
PAR STERILE PRODUCTS, LLC,
Plaintiff,
v.
FRESENIUS KABI USA LLC,
Defendant.

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No. 14 C 3349
Judge Jorge L. Alonso

MEMORANDUM OPINION AND ORDER
Plaintiff Par Sterile Products, LLC (“Par”) alleges in its complaint that defendant
Fresenius Kabi USA, LLC (“Fresenius”) has violated Section 43(a) of the Lanham Act, the
Illinois Deceptive Trade Practices Act, and the Illinois Consumer Fraud and Deceptive Business
Practices Act by falsely advertising and promoting its vasopressin injection product. Fresenius
has moved to dismiss Par’s complaint pursuant to Federal Rules of Civil Procedure 12(b)(1) and
12(b)(6). For the reasons set forth below, the motion is denied in part and granted in part.
BACKGROUND
Both plaintiff and defendant manufacture and market pharmaceuticals, including a
vasopressin injection product.

Par’s vasopressin product, Vasostrict, is FDA-approved.

Fresenius’s Vasopressin Injection 1 product is not.
In its brief, Par helpfully describes the historical and regulatory backdrop for this dispute.
Vasopressin is a natural hormone that has been used in medicine for over one hundred years,
since before drugs had to be approved by the Food and Drug Administration (“FDA”) or, indeed,
before the FDA even existed. In 1938, Congress passed the Food, Drug and Cosmetic Act

1

Because Fresenius’s product has no brand name, the Court will simply refer to it as “Vasopressin Injection,” with a
capital “V” and “I,” as Par does in the complaint.

(“FDCA”), which required all “new drugs” to be approved for safety.

In 1962 Congress

amended the FDCA to require “new drugs” to be approved for effectiveness for a particular use
as well. However, grandfather clauses exempted drugs from both requirements if they had been
on the market prior to the relevant enactment date and met certain other requirements. (See
Compl. Ex. 3, Food and Drug Admin., Guidance for FDA Staff and Industry: Marketed
Unapproved Drugs—Compliance Policy Guide 9-12 (2011).)
The modern prescription drug market is made up of not only FDA-approved drugs but
also numerous unapproved drugs. Approved drugs include branded drugs, which have FDAapproved New Drug Applications, and generic versions of branded drugs, which have FDAapproved Abbreviated New Drug Applications. Unapproved drugs include pre-1938 and pre1962 “grandfathered” drugs and other drugs that are marketed without FDA approval, possibly
illegally. (Opp’n to Mot. to Dismiss at 2-3 (citing 21 U.S.C. § 255(b), (j)).) Fresenius does not
state whether its product has grandfather status.
In recent years, the FDA has encouraged drug makers to seek FDA approval for their
products. In its September 19, 2011 document issued to provide guidance to the drug industry,
which Par has attached to its complaint as Exhibit 3, the FDA stated that when a company
obtains approval of a product that other companies are marketing without approval, the “FDA is
more likely to take enforcement action against remaining unapproved drugs.” (Compl. Ex. 3 at
7.) However, the document continued, “we intend to take into account the circumstances once
the product is approved in determining how to exercise our enforcement discretion with regard to
the unapproved products.” (Id.) The FDA outlined certain enforcement priorities, with the
upshot being, as Par puts it in its brief, “absent overriding safety concerns, the FDA generally

2

does not take enforcement actions to halt the marketing of unapproved drugs.” 2 (Opp’n to Mot.
to Dismiss at 4-5.)
Par had previously sold Pitressin, an unapproved vasopressin product like Fresenius’s
Vasopressin Injection, but on September 26, 2012, in accord with the FDA guidance, Par
submitted a New Drug Application (“NDA”) to the FDA for a vasopressin injection product
called Vasostrict. (Compl. ¶ 17.) Par alleges that it went to considerable expense to establish the
product’s safety to the satisfaction of the FDA (Id. ¶ 30), and Vasostrict was finally approved by
the FDA on April 17, 2014 (Id. ¶¶ 18, 28). Par filed this suit shortly thereafter.
Par alleges, in short, that Fresenius misrepresents its Vasopressin Injection as safe,
effective and FDA-approved, when in fact Par markets the only FDA-approved vasopressin
injection product on the market.

Fresenius allegedly represents to wholesale generic drug

purchasers, distributors, group purchasing organizations, and integrated delivery networks that it
is in compliance with all applicable laws, which these purchasers take to mean that the
Vasopressin Injection is FDA-approved (Compl. ¶¶ 43-46); represents that its product is
“generic” in providing drug and pricing information to drug and pricing databases known as
“price lists,” which buyers believe include only FDA-approved drugs (Id. ¶¶ 47-56); and places
its drug on the market with the sort of standard labeling and packaging typical of FDA-approved
drugs, as if its Vasopressin Injection is FDA-approved (Id. ¶¶ 57-65).
ANALYSIS
Fresenius contends in its motion to dismiss that (1) Par has no standing under the Lanham
Act, (2) Par’s purported Lanham Act claim is really an impermissible private attempt to enforce

2

Par puts this language in quotation marks and cites to the FDA Guidance attached as Exhibit 3, as if to attribute
this statement to the FDA, but this language does not appear in the guidance document. It is apparently Par’s own
summary of the FDA’s enforcement priorities.

3

the Food, Drug and Cosmetics Act (“FDCA”), and (3) Par’s factual allegations are insufficient to
state a valid Lanham Act claim.
Section 43(a)(1)(B) of the Lanham Act permits a suit against anyone who “in commercial
advertising or promotion, misrepresents the nature, characteristics, qualities or geographic origin
of his or her or another person’s goods, services, or commercial activities.” 15 U.S.C. §
1125(a)(1)(B). To state a claim under this section, plaintiffs must allege:
(1) a false statement of fact by the defendant in a commercial advertisement about
its own or another’s product; (2) the statement actually deceived or has the
tendency to deceive a substantial segment of its audience; (3) the deception is
material, in that it is likely to influence the purchasing decision; (4) the defendant
caused its false statement to enter interstate commerce; and (5) the plaintiff has
been or is likely to be injured as a result of the false statement, either by direct
diversion of sales from itself to defendant or by a loss of goodwill associated with
its products.
Hot Wax, Inc. v. Turtle Wax, Inc., 191 F.3d 813, 819 (7th Cir.1999).
I.

Standing
Fresenius moves to dismiss Par’s complaint for lack of Lanham Act standing under Rule

12(b)(1). When considering a Rule 12(b)(1) motion to dismiss, a district court accepts as true all
well-pleaded factual allegations and draws reasonable inferences from the allegations in favor of
the plaintiff. Kelley v. Med-1 Solutions, LLC, 548 F.3d 600, 604 (7th Cir. 2008) (citing Capitol
Leasing Co. v. FDIC, 999 F.2d 188, 191 (7th Cir. 1993)). The court may also look beyond the
allegations of the complaint and consider affidavits and other documentary evidence. Capitol
Leasing, 999 F.2d at 191.
Fresenius claims that Par has no standing to bring a Lanham Act claim because it has not
yet begun to sell Vasostrict. (Mem. in Supp. of Mot. to Dismiss at 4-5.) Fresenius cites cases
for the proposition that a Lanham Act claim based on injury to a product that the plaintiff has not
yet begun to sell must be dismissed for lack of standing. See, e.g., ITC Ltd. v. Punchgini, Inc.,
4

482 F.3d 135, 170-71 (2d Cir. 2007); PDK Labs, Inc. v. Friedlander, 103 F.3d 1105, 1112 (2d
Cir. 1997); Alphamed Pharms. Corp. v. Arriva Pharms., Inc., 391 F. Supp. 2d 1148, 1163 (S.D.
Fla. 2005).
Par contends that these cases are distinguishable because the harm alleged in them was
remote, speculative and ill-defined. (Opp’n to Mot. to Dismiss at 12-14.) The Court agrees.
Unlike the products in the cited cases, Par’s product is already FDA-approved, fully developed
and ready for sale. In other words, Par has a concrete competing product to compare with
Fresenius’s Vasopressin Injection. Allegations that sales of Vasostrict are likely to suffer due to
misrepresentations made by Fresenius in advertising or promoting its Vasopressin Injection are
sufficient to satisfy the Lanham Act’s standing requirement. See 15 U.S.C. 1125(a)(1) (person
who uses false advertising “shall be liable in a civil action by any person who believes that he or
she is or is likely to be damaged”) (emphasis added); Lexmark Int’l, Inc. v. Static Control
Components, Inc., 134 S. Ct. 1377, 1389-90 (2014) (Lanham Act false advertising cause of
action protects against “unfair competition,” which is “concerned with injuries to . . . present and
future sales”) (emphasis added); Hot Wax, 191 F.3d at 819 (Lanham Act plaintiff must establish
that it “has been or is likely to be injured as a result of the false statement”) (emphasis added);
see also Warner-Lambert Co. v. Breathasure, Inc., 204 F.3d 87, 93 (3d Cir. 2000) (“[A] plaintiff
must prove that it has a reasonable basis for believing that it is likely to suffer injury.”) (emphasis
added). The allegations of the complaint adequately demonstrate Par’s standing.
II.

Par’s Lanham Act Claims

Fresenius also moves to dismiss Par’s complaint under Rule 12(b)(6). “A motion under
Rule 12(b)(6) tests whether the complaint states a claim on which relief may be granted.”
Richards v. Mitcheff, 696 F.3d 635, 637 (7th Cir. 2012). Under Rule 8(a)(2), a complaint must

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include “a short and plain statement of the claim showing that the pleader is entitled to relief.”
Fed. R. Civ. P. 8(a)(2). The short and plain statement under Rule 8(a)(2) must “give the
defendant fair notice of what the claim is and the grounds upon which it rests.” Bell Atl. Corp. v.
Twombly, 550 U.S. 544, 555 (2007) (ellipsis omitted). Fresenius contends that Par’s complaint
must also comply with Rule 9(b), which requires a plaintiff alleging fraud to “state with
particularity the circumstances constituting fraud.” Fed. R. Civ. P. 9(b).
Under federal notice-pleading standards, a plaintiff’s “[f]actual allegations must be
enough to raise a right to relief above the speculative level.” Twombly, 550 U.S. at 555. Stated
differently, “a complaint must contain sufficient factual matter, accepted as true, to ‘state a claim
to relief that is plausible on its face.’” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting
Twombly, 550 U.S. at 570). “A claim has facial plausibility when the plaintiff pleads factual
content that allows the court to draw the reasonable inference that the defendant is liable for the
misconduct alleged.” Id. (citing Twombly, 550 U.S.at 570, 556 (2007)). “In reviewing the
sufficiency of a complaint under the plausibility standard, [courts must] accept the well-pleaded
facts in the complaint as true, but [they] ‘need[ ] not accept as true legal conclusions, or
threadbare recitals of the elements of a cause of action, supported by mere conclusory
statements.’” Alam v. Miller Brewing Co., 709 F.3d 662, 665–66 (7th Cir. 2013) (quoting
Brooks v. Ross, 578 F.3d 574, 581 (7th Cir. 2009)).
A. The Lanham Act and the FDCA
Fresenius claims that Par impermissibly attempts to enforce the FDCA via the Lanham
Act. In its complaint, Par seeks an order enjoining Fresenius from selling its Vasopressin
Injection and ordering it to “recall and remove its misleading, unapproved products from the
distribution supply chains.” (Compl., Prayer for Relief, ¶¶ A, F.) It is well-settled, as Fresenius

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states, that “the FDCA does not create a private right of action,” and the authority to enforce the
FDCA “rests exclusively with the FDA.” (Mem. in Supp. of Mot. to Dismiss at 6 (citing
Schering-Plough Healthcare Prods., Inc. v. Schwarz Pharm., Inc., 586 F.3d 500, 509 (7th Cir.
2009)).) Further, Fresenius states that “courts have held that plaintiffs may not use Lanham Act
claims as an end-run around the FDCA’s prohibition on private enforcement,” id. at 8, and it
cites a long line of cases beginning with Mylan Laboratories, Inc. v. Matkari, 7 F.3d 1130, 1139
(4th Cir. 1993)), for the proposition that the mere implication, rather than an explicit statement,
that its Vasopressin Injection has FDA approval is insufficient to state a Lanham Act claim.
(Mem. in Supp. of Mot. to Dismiss at 9-10.)
Par responds that the cases Fresenius cites have been arguably abrogated by POM
Wonderful, LLC v. Coca-Cola Co., 134 S. Ct. 2228 (2014), which held that the FDCA does not
preclude Lanham Act claims pertaining to drugs because the two statutes serve distinct,
complementary purposes.

Par cites JHP Pharmaceuticals, LLC v. Hospira, Inc., No. CV 13-

07460, 2014 WL 4988016, at *5-6 (C.D. Cal. Oct. 7, 2014), in which the court held, applying
POM Wonderful, that Par’s 3 Lanham Act claim that the defendant misrepresented that its product
was FDA-approved, in part by describing it as “generic,” was not precluded by the FDCA and
could withstand a motion to dismiss.
This court agrees with the court in JHP Pharmaceuticals that the FDCA does not
preclude Lanham Act claims like the one Par asserts here. As in that case, Par asserts the
specific, particularized claim that a competitor injuriously misrepresents its product as FDAapproved by offering it for sale in certain marketing channels alongside FDA-approved generic
drugs. Whether Fresenius is actually deceiving consumers in violation of the Lanham Act by

3

Par is also the plaintiff in that case, which involves similar claims against a competitor selling an unapproved
epinephrine product.

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doing so remains in question at this early stage of the proceedings, but the dispute is of the sort
with which the Lanham Act is concerned to the extent it involves deception of consumers as to
the fact of whether a product carries the imprimatur of FDA approval, not whether the product is
safe and effective enough to be approved by the FDA. See POM Wonderful, 134 S. Ct. at 2238;
Alpharma, Inc. v. Pennfield Oil Co., 411 F.3d 934, 939 (8th Cir. 2005) (rejecting Mylan
Laboratories and similar cases). As long as there is no allegation that Fresenius must do
something that directly conflicts with the FDCA or an FDA regulation, or may not do something
that the FDCA or an FDA regulation specifically requires (not merely authorizes), Par’s Lanham
Act claim is not precluded by the FDCA. See POM Wonderful, 134 S. Ct. at 2241.
B. FDA approval and price lists
Fresenius replies that POM Wonderful has no application to this motion, that POM
Wonderful does not overrule or abrogate the Mylan Laboratories line of cases, and that
Fresenius’s motion to dismiss is not based on preclusion at all. Rather, Fresenius reiterates its
contention that, under Mylan Laboratories and its progeny, the mere implication, rather than an
explicit statement, that the Vasopressin Injection has FDA approval is insufficient to state a
Lanham Act claim. (Reply in Supp. of Mot. to Dismiss at 7.)
The court would be inclined to agree with Fresenius, except that Par does not merely
allege that Fresenius has implied that Vasopressin is FDA-approved. Par also alleges that
“buyers believe all prescribed drugs identified on the Price Lists are . . . FDA-approved.”
(Compl. ¶ 54.)

Importantly, Par further alleges that, according to some surveys, 91% of

pharmacists are actually confused about whether all drugs that appear on industry price lists are
FDA-approved. (Id.) The court in JHP Pharmaceuticals found a claim using similar language,
even without the reference to the survey of pharmacists, to be sufficient to survive a motion to

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dismiss. 2014 WL 4988016, at **7-8; see also Morningware, Inc. v. Hearthware Home Prods.,
Inc., 673 F. Supp. 2d 630, 638-39 (N.D. Ill. 2009).
A Lanham Act claim of false advertising may be based on either (1) a statement or
representation of fact in advertising that is literally false, or (2) statements or misrepresentations
that, even if ambiguous or literally true, were misleading in context, as shown by actual
consumer deception. See Hot Wax, Inc. v. Turtle Wax, Inc., 191 F.3d 813, 820 (7th Cir. 1999);
LG Elecs. U.S.A., Inc. v. Whirpool Corp., 661 F. Supp. 2d 940, 948 (N.D. Ill. 2009). Fresenius
seems to suggest that the second theory of false advertising is unavailable, under the Mylan
Laboratories line of cases, if the allegedly false advertising concerns whether a product is FDAapproved. 4 The Court fails to see any reason why it should so hold, particularly in light of POM
Wonderful, which emphasized that both the Lanham Act and the FDCA can typically be
enforced in full alongside one another, given their complementary purposes. 5
Mylan Laboratories and its progeny are frequently cited for the proposition, as stated in
Mylan Laboratories itself, that the mere act of placing a pharmaceutical product on the market,
without more, cannot support a Lanham Act claim. See Mylan Labs., Inc. v. Matkari, 7 F.3d
1130, 1139 (4th Cir. 1993). While that may be true, this Court understands Par to be making a
slightly different claim. Par is alleging that, by placing a product on the market in a particular
marketing channel—namely, the industry price lists—and by making certain representations
4

It is uncertain whether Par would concede that it is making a claim of implied falsity, not literal falsity. Par
contends in its brief that Fresenius represents its Vasopressin Injection as “a ‘generic’ product, which is literally
false.” (Opp’n to Mot. to Dismiss at 10.) In any case, it is not necessary to determine at this stage whether
Fresenius’s advertising is literally false or merely misleading in context; it is enough to determine whether Par states
a claim under either theory. See Morningware, Inc. v. Hearthware Home Prods., Inc., 673 F. Supp. 2d 630, 638-39
(N.D. Ill. 2009); see also LG Elecs., 661 F. Supp. 2d at 948 (“Regardless of the theory advanced by the plaintiff,
‘whether a claim is either false or misleading is an issue of fact rather than law.’”) (quoting Mead Johnson & Co. v.
Abbott Labs., 209 F.3d 1032, 1034 (7th Cir. 2000)).
5
Although POM Wonderful appeared to leave open the possibility that a Lanham Act claim might be precluded in
certain cases that fall within the exclusive purview of the FDA, see JHP Pharms., 2014 WL 4988016, at *4, whether
a product is FDA-approved is a simple, easily verifiable matter, not the sort of complex inquiry that might be
beyond the Court’s competence or might require the Court to invade the FDA’s rule-making authority.

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about its products such as that the product is “generic,” Fresenius is representing that its product
is an FDA-approved generic drug and deceiving consumers, as demonstrated by a consumer
survey. This case is distinguishable from the Mylan Laboratories cases, which involved no such
claim. See JHP Pharm., 2014 WL 4988016, at *7; Mut. Pharm. Co. v. Ivax Pharms., Inc., 459
F. Supp. 2d 925, 941-42 (C.D. Cal. 2006) (distinguishing Mylan Laboratories where plaintiff
alleged that defendant used price lists, “a specialized marketing channel . . . that, through its use,
conveys the false implication its drug is approved by the FDA”). The Court rejects Fresenius’s
contention that Par must allege that Fresenius explicitly stated that its Vasopressin Injection was
FDA-approved. Par states a claim by alleging that Fresenius made misleading statements that
actually confused and deceived consumers as to whether the Vasopressin Injection was FDAapproved. See Morningware, 673 F. Supp. 2d at 638-39.
Fresenius also contends that Par fails to state a claim premised on the price lists because
the price lists are not Fresenius’s advertising; rather, they are controlled by third parties. (Mem.
in Supp. of Mot. to Dismiss at 13-14.) Par correctly responds that the issue of whether Fresenius
bears any responsibility for misrepresentations made by the price lists, like the issue of whether
the price lists are misleading at all, is a fact issue that may not be decided on a motion to dismiss.
(Opp’n to Mot. to Dismiss at 11.) “[L]iability under the Lanham Act has been construed to
extend beyond those who actually misrepresent goods or directly place such goods in commerce
. . . to any person who knowingly causes a false representation to be used in connection with
goods and services in commerce.” Grant Airmass Corp. v. Gaymar Indus., Inc., 645 F. Supp.
1507, 1511-12 (S.D.N.Y. 1986) (citing Inwood Labs., Inc. v. Ives Labs., Inc., 456 U.S. 844, 85455 (1982)). Fresenius can be held liable if Par can prove, as it alleges in the complaint, that
“Fresenius knows that buyers believe all prescribed drugs identified on the Price Lists are . . .

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FDA approved.”

(Compl. ¶ 54.)

See Mut. Pharm. Co., 459 F. Supp. 2d at 942-43

(pharmaceutical company can be held liable to competitor for third-party internet retailer’s
misrepresentation that the company’s product is FDA-approved if plaintiff can prove that the
company knew of the misrepresentations).
Par’s allegations as to its claim that is based on Fresenius’s advertising of its Vasopressin
Injection via price lists are sufficient to state a claim under the Lanham Act. The motion to
dismiss is denied as to this claim.
C. Contracts and Compliance with Applicable Laws
Fresenius contends that Par’s allegation that Fresenius misrepresented in its contracts
with purchasers that its Vasopressin Injection “complies with all relevant state and federal laws,
including the FDCA when, in fact, [it does] not” is deficient because any such misrepresentations
would not be in “commercial advertising and promotion,” as the statute requires. (Mem. in
Supp. of Mot. to Dismiss at 9-10 (citing Compl. ¶¶ 43-44).) As Fresenius states, the Seventh
Circuit has defined “advertising and promotion” as “promotion to anonymous recipients, as
distinguished from face-to-face communication,” and explained that an “advertisement read by
millions . . . is advertising, while a person-to-person pitch by an account executive is not.” Id.
(citing First Health Grp. Corp. v. BCE Emergis Corp., 269 F.3d 800, 803-04 (7th Cir. 2001)).
Fresenius also argues that representations made to a particular purchaser in the context of
negotiating or executing a transaction are not “advertising” or “promotion.” Id. (citing Solers,
Inc. v. Hartford Cas. Ins. Co., 36 F. App’x 740, 743 (4th Cir. 2002); Johnson Controls, Inc. v.
Exide Corp., 152 F. Supp. 2d 1075, 1081-82 (N.D. Ill. 2001); C=Holdings B.V. v. Asiarim Corp.,
992 F. Supp. 2d 223, 243 (S.D.N.Y. 2013)).

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Par, citing Neuros Co. v. KTurbo, Inc., 698 F.3d 514, 522 (7th Cir. 2012) and Lidochem,
Inc. v. Stoller Enters., Inc., 500 F. App’x 373, 381 (6th Cir. 2012), responds only that
misrepresentations to “specialized . . . purchasers” may qualify as “advertising” or “promotion,”
despite the fact that they are not disseminated to the public at large. The cases Par cites are
inapposite. Neither Neuros nor Lidochem involved misrepresentations made in the course of
negotiating or executing a transaction with a particular purchaser; both involved disseminating
false information about a competitor’s product, albeit to a small “class of consumers,” to prevent
consumers from trading with the competitor. See Neuros, 698 F.3d at 522; Lidochem, 500 F.
App’x at 379. The false representations Par alleges with regard to Fresenius’s contracts are more
like the “person-to-person pitch” that the Seventh Circuit expressly excluded from the definition
of “advertising” in First Health Group Corp. v. BCE Emergis Corp., 269 F.3d 800, 803-04 (7th
Cir. 2001), than the statements in Neuros or Lidochem. Par has produced no authority squarely
supporting its position, and the Court must conclude that Fresenius’s statements in its contracts
or contract negotiations are not advertising.
Par’s claims premised on Fresenius’s contracts, unlike Par’s claims premised on
Fresenius’s use of the price lists, amount to no more than claims that Fresenius violated the
Lanham Act by putting an unapproved drug on the market, as in Mylan Laboratories, Inc. v.
Matkari, 7 F.3d 1130, 1139 (4th Cir. 1993), because they do not rest on any statements made in
advertising or promotion. Par fails to state a claim based on misrepresentations made in or by
Fresenius’s contracts.

Any claim that Fresenius violated § 43(a) of the Lanham Act by

representing in its contracts or contract negotiations that its product is in compliance with
applicable laws, or that it implied that its product is FDA-approved by doing so, is dismissed.

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D. Misleading Labeling and Packaging
In its complaint, Par makes allegations relating to the labeling of Fresenius’ Vasopressin
Injection and directed to the safety and effectiveness of the product:
Fresenius’ deficient package insert, labels, advertising, promotion, which (1)
include indications that have not been approved as safe and effective by the FDA,
and (2) omit specific recommendations to dosing and administration, . . . will
cause confusion and lead purchasers to mistakenly conclude that Par’s
VASOSTRICT product is less effective than Fresenius’ unapproved Vasopressin
Injection product when in fact the opposite is true.” (Compl. ¶ 63.)
Fresenius asserts that this claim “fails for the same reasons it did in JHP [Pharmaceuticals].”
(Reply in Supp. of Mot. to Dismiss at 15.) The court agrees. Just as in JHP Pharmaceuticals,
Par does not plead any facts to show that the implied message that Vasostrict is less effective
than Fresenius’s Vasopressin Injection is actually transmitted to consumers, nor does it plead any
facts on which the court might base a finding that Vasostrict is not less effective than
Vasopressin. See JHP Pharm., 2014 WL 4988016, at *10. The Court cannot draw a reasonable
inference that Fresenius’s statements are misleading based on the allegations Par has made. This
claim is dismissed.
E. “Safe” and “Effective”
Par alleges throughout its complaint—not only in connection with the labeling and
packaging of the Vasopressin Injection—that Fresenius makes misrepresentations as to whether
its product is “safe” and “effective.” The court in JHP Pharmaceuticals rejected any claims
based on these allegations:
A determination of whether the Defendants’ products are “safe” or “effective”
might well fall within the primary jurisdiction of the FDA, or even be precluded
entirely. However, the Court need not decide these issues today. Par alleges no
facts to show that Defendants’ products are either unsafe or ineffective. The
repeated inclusion of such language may well be mere rhetorical excess on Par’s
part. However, to the extent that any of the Plaintiff’s arguments about FDA
approval rest on a determination of either safety or effectiveness, such arguments
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suffer a fatal lack of factual sufficiency. Thus, the sole question with respect to
the surviving claim against Defendants is whether it [misrepresents] its products
as being “FDA-approved,” and not any question of safety or effectiveness.
JHP Pharms., 2014 WL 4988016, at *8. Par’s allegations in this case suffer from similar
deficiencies, and this Court reaches a similar conclusion. Par’s complaint does not contain
sufficient factual matter for the court to reasonably infer that Fresenius’s Vasopressin Injection is
not safe or effective. Any claims based on the allegations that Fresenius represents that its
product is safe and effective, as distinct from whether it is FDA-approved, must be dismissed as
conclusory and potentially precluded.
III.

Par’s State Law Claims

Par makes additional claims under the Illinois Deceptive Trade Practices Act and the
Illinois Consumer Fraud and Deceptive Business Practices Act. (Compl. ¶¶ 74-88.) Fresenius
contends that these claims rise or fall with the Lanham Act claims because they are premised on
the same assertions and are to be resolved according to the same principles. (Mem. in Supp. of
Mot. to Dismiss Compl. at 14-15 (citing Spex, Inc. v. Joy of Spex, Inc., 847 F. Supp. 567, 579
(N.D. Ill. 1994), Pure Imagination, Inc. v. Pure Imagination Studios, Inc., No. 03 C 6070, 2004
WL 2967446, at *13 (N.D. Ill. Nov. 15, 1994).) Par does not contest this assertion or present
any authority to the contrary. The state law claims survive to the extent they are based on the
allegations that Fresenius’s advertising (which does not include statements made in contracts or
contract negotiations) misleads consumers to believe that its Vasopressin Injection is FDAapproved. They are otherwise dismissed.

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CONCLUSION
For the reasons set forth above, the Court grants in part and denies in part defendant’s
motion to dismiss [26]. Plaintiff’s Lanham Act and corresponding state law claims based on
false representations of FDA approval survive. Plaintiff’s claims based on false or misleading
representations in defendant’s contracts are dismissed with prejudice because they do not relate
to advertising or promotion. Plaintiff’s claims that defendant’s product’s labeling and packaging
deceptively imply that plaintiff’s product is less effective than defendant’s are dismissed without
prejudice.

Any claims based on representations that the defendant’s product is “safe” or

“effective” are dismissed without prejudice.
SO ORDERED.

ENTERED:

March 17, 2015
_____________________
JORGE L. ALONSO
United States District Judge

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