Commonwealth of Kentucky v. Janssen Pharmaceuticals, Inc. et al

Filing 23

MEMORANDUM OPINION AND ORDER by Chief Judge Joseph H. McKinley, Jr on 10/16/13: re 10 MOTION to Remand filed by Commonwealth of Kentucky. Fully briefed, this matter is ripe for decision. For the following reasons, the motion is GRANTED . In this case, when all the factors are considered, it seems clear to the Court that Defendants have failed to prove that there is a disputed, substantial federal questionor that the resolution of the question in federal court will not upset Congresss balancing of judicial responsibilities. The Commonwealths motion to remand is thus GRANTED. cc:counsel, Jefferson Circuit Court(Div III) (DJT)

UNITED STATES DISTRICT COURT
WESTERN DISTRICT OF KENTUCKY
LOUISVILLE DIVISION
CIVIL ACTION NO. 3:13-CV-00624-JHM
COMMONWEALTH OF KENTUCKY ex rel.
JACK CONWAY, ATTORNEY GENERAL,

PLAINTIFF

V.
JANSSEN PHARMACEUTICALS, INC., et al.

DEFENDANTS

MEMORANDUM OPINION AND ORDER
This matter is before the Court on the Commonwealth’s Motion to Remand [DN 10]. Fully

briefed, this matter is ripe for decision. For the following reasons, the motion is GRANTED.
I. BACKGROUND
This action focuses on Risperdal®, a prescription antipsychotic medicine which has been
approved by the Food and Drug Administration (“FDA”). Since its launch in 1994, Defendants
have advertised, sold, marketed, and distributed Risperdal to Kentucky’s health care providers,
pharmacies, and consumers. (Compl. [DN 1-2] ¶¶ 1-5.) On May 14, 2013, the Commonwealth of
Kentucky, through its Attorney General, filed a one-count complaint against Defendants in the
Jefferson Circuit Court, Division Three. (See id.) In that complaint, the Commonwealth alleges
that Defendants violated the Kentucky Consumer Protection Act (“KCPA”) by labeling and
promoting Risperdal in an unfair, false, misleading, or deceptive manner. (See id. ¶¶ 41-44.)
The Commonwealth’s complaint contains lengthy, detailed factual allegations regarding
Defendants’ conduct in testing and marketing Risperdal, as well as in concealing its risks. (Id. ¶¶
15-40.) Specifically, the Commonwealth alleges that Defendants knew that taking Risperdal would

increase the risks of diabetes, hyperglycemia, clinically significant weight gain, cerebrovascular
adverse events (including stroke in elderly patients with dementia), hyperprolactinemia, and other

1

serious health conditions. However, Defendants “never warned doctors and patients about the
serious risk of cerebrovascular adverse events in the elderly with dementia until mid-2003,”
“never warned . . . of the increased risk of diabetes and hyperglycemia until late 2003,” “never
warned . . . of the serious risk of increased weight gain,” and “only warned . . . about the
hyperprolactinemia risk associated with Risperdal beginning in mid-2007.” (Id. ¶ 18.) The
Commonwealth also alleges that Defendants “obfuscated, downplayed, misrepresented, hid, and
lied about vital safety information” concerning Risperdal use. (Id.)
As an example of this behavior, the Commonwealth alleges that Defendants concealed
clinical trial results. (Id. ¶¶ 19-24.) It also alleges that instead of warning about Risperdal’s risks,
Defendants merely listed weight gain and hyperglycemia as two of the drug’s sixty infrequent
adverse reactions, “incorrectly convey[ing] that weight gain and diabetes are infrequent adverse
effects, i.e., occur in less than one patient out of a hundred, when Defendants knew that weight
gain and diabetes occur at a much higher incidence rate in patients taking Risperdal.” (Id. ¶ 30.)
Further, the Commonwealth alleges that Defendants’ sale aids and promotional materials falsely
represented safety information regarding Risperdal’s risks, (id. ¶ 33), and that Defendants sent
Kentucky doctors a “Dear Doctor” letter which falsely stated that Risperdal “is not associated
with an increased risk of diabetes.” (Id. ¶ 40.)
On June 14, 2013, Defendants removed the Commonwealth’s action to federal court.
According to them, the FDA’s control over prescription drug labeling vis-à-vis the federal Food,
Drug & Cosmetic Act (“FDCA”) gives rise to substantial federal questions in this case. (See Not.
of Removal [DN 1].) The Commonwealth responds that removal was inappropriate, as Defendants

have failed to show that there is a substantial federal question. According to the Commonwealth,
the Court must remand the case to the Jefferson Circuit Court, Division Three. (See Pl.’s Mot. to

2

Remand [DN 10].) On September 18, 2013, the Court heard oral arguments on this issue. It now
finds that the Commonwealth’s motion to remand is GRANTED.
II. DISCUSSION
As the removing party, Defendants bear the burden of establishing federal jurisdiction.
See Alexander v. Elec. Data Sys. Corp., 13 F.3d 940, 948–49 (6th Cir. 1994). “All doubts as to
the propriety of removal are resolved in favor of remand.” Coyne v. Am. Tobacco Co., 183 F.3d
488, 493 (6th Cir. 1999). In the present case, Defendants argue that they have established federal
jurisdiction under 28 U.S.C. § 1331. (See Not. of Removal [DN 1] 1.) Section 1331 states that
“district courts shall have original jurisdiction of all civil actions arising under the Constitution,
laws, or treaties of the United States.” 28 U.S.C. § 1331. The Supreme Court has explained that a
plaintiff’s claim may arise under federal law if the plaintiff pleads: (1) a cause of action created by
federal law or (2) “state-law claims that implicate significant federal issues.” Grable & Sons Metal

Prods., Inc. v. Darue Eng’g & Mfg., 545 U.S. 308, 312 (2005). Here, Defendants argue that the
Commonwealth’s state-law KCPA claim will require the application of the Food, Drug, & Cosmetic

Act (“FDCA”), thus implicating significant federal issues. The Commonwealth counters that
federal jurisdiction is lacking and that remand is appropriate.
The Sixth Circuit has held that for a state-law claim to implicate a significant federal
issue: “(1) the state-law claim must necessarily raise a disputed federal issue; (2) the federal
interest in the issue must be substantial; and (3) the exercise of jurisdiction must not disturb any
congressionally approved balance of federal and state judicial responsibilities.” Mikulski v.
Centerior Energy Corp., 501 F.3d 555, 568 (6th Cir. 2007) (citing Grable & Sons Metal Prods.,
Inc., 545 U.S. at 319). The parties’ arguments track this framework.

3

1.

Disputed Federal Issue

Defendants argue that the Commonwealth’s KCPA claim is based on a disputed federal
issue because it is premised on the alleged misplacement of risk information on Risperdal’s
label. (See Defs.’ Mem. in Opp. to Pl.’s Mot. to Remand [DN 13] 4-9.) As discussed above, in its
complaint, the Commonwealth alleges that Defendants violated the KCPA by listing certain risks
as infrequent adverse reactions instead of as warnings, “incorrectly convey[ing] that weight gain
and diabetes are infrequent adverse effects, i.e., occur in less than one patient out of a hundred,
when Defendants knew that weight gain and diabetes occur at a much higher incidence rate in
patients taking Risperdal.” (Compl. [DN 1-2] ¶ 30.) Defendants argue that the Commonwealth’s
right to relief turns on construing and applying the FDCA, which specifies the information that
must be put in each section of a package insert of an FDA-approved medicine. See 21 C.F.R. §
201.57 (outlining the requirements on the content and format of labeling for prescription drugs).
According to Defendants, the existence of a disputed federal issue is most apparent with
respect to the placement of risk information regarding hyperprolactinemia. In its complaint, the
Commonwealth alleges that Defendants’ Risperdal labeling did not “disclose any warning that
Risperdal has the potential to cause hyperprolactinemia until mid-2007 . . . .” (Compl. [DN 1-2]
¶ 31.) This allegation seems to relate to the fact that risk information on hyperprolactinemia was
not placed in the “Warnings and Precautions” section of Risperdal’s label until mid-2007. (See
Aug. 2007 Package Insert, Ex. from Oral Arg.). However, Defendants highlight that ever since
Risperdal was first approved in the early 1990s, its label included the same risk information on
hyperprolactinemia—only in the “Precautions” section. (See Dec. 1993 Package Insert, Ex. from
Oral Arg.) Thus, Defendants argue that the Commonwealth’s “label claims” are based on the alleged

misplacement of risk information in Risperdal’s label. In other words, Defendants propose that
the Commonwealth’s theory is that Defendants were violating the KCPA when the risk information

4

was in the “Precautions” section; however, when that information was moved to the “Warnings
and Precautions” section in 2007, Defendants were no longer violating the KCPA. Defendants
argue that since the FDCA specifies the information that must be put in each section of a package
insert of an FDA-approved medicine, a disputed issue of federal law exists. (See Def.’s Mem. [DN

13] 6-7.)
The Commonwealth responds that Defendants have mischaracterized their allegations by
wrongly limiting the scope of the dispute to the proper location of risk information on the FDAapproved drug label. According to the Commonwealth, federal law is implicated here only, if at
all, through Defendants’ federal-based defenses—i.e. their efforts to shield themselves from liability

by virtue of the fact that Risperdal’s labels were FDA-approved. (See Pl.’s Mem. in Supp. of its
Mot. to Remand [DN 10-1] 5-7.) The Commonwealth maintains that this cannot support removal
jurisdiction. See Mikulski, 501 F.3d at 560 (holding that to “determine whether the claim arises
under federal law,” the Court must examine “the ‘well pleaded’ allegations of the complaint and

ignore potential defenses”). In support of this argument, the Commonwealth highlights that it
makes no allegations regarding the FDA’s labeling decisions; the complaint never even mentions
the FDA. According to the Commonwealth, it simply alleges that Defendants took actions to
omit and downplay serious risk information, despite their awareness of risks. (See Compl. [DN
1-2] ¶ 44.) The Commonwealth thus suggests that its claims are not based on disputed federal issues.

The Court finds Defendants’ argument more persuasive. In this case, it is undisputed that
to succeed on its KCPA claim, the Commonwealth must show that Defendants engaged in unfair,
false, misleading, or deceptive practices. See K.R.S. § 367.170. While the Commonwealth never
mentions the FDA in its complaint, it seems clear to the Court that part of its proof will involve
interpreting the FDCA’s provisions to determine whether Defendants actually misplaced certain risk
information on Risperdal’s labels. (See Compl. [DN 1-2] ¶ 44.) In this respect, it will be necessary

5

for the parties to interpret various FDCA provisions—and it seems almost certain that their
interpretations will differ. Therefore, the Court finds that there is a disputed federal issue.

However, the nature of the disputed federal issue in this case is limited. Specifically, the
only issue is whether Defendants complied with the FDCA’s labeling provisions in light of their
knowledge concerning Risperdal’s various risks. The Court notes at the outset that this issue will
be decided in the context of state law and whether Defendants’ compliance, or non-compliance,
with the FDCA indicates that Defendants acted in an unfair, false, deceptive, or misleading manner.

2.

Substantial Federal Interest

The Court must next determine whether the federal interest in the disputed issue is
substantial. The Sixth Circuit has held that courts must consider four factors in this analysis:
(1) whether the case includes a federal agency, and particularly, whether that
agency’s compliance with the federal statute is in dispute; (2) whether the federal
question is important (i.e., not trivial); (3) whether a decision on the federal
question will resolve the case (i.e., the federal question is not merely incidental to
the outcome); and (4) whether a decision as to the federal question will control
numerous other cases (i.e., the issue is not anomalous or isolated).
Mikulski, 501 F.3d at 570. Importantly, “no single factor is dispositive and these factors must be
considered collectively, along with any other factors that may be applicable in a given case.” Id.
Here, the Court finds that the factors weigh against characterizing the federal interest as substantial.

Federal Agency. Defendants argue that the first factor supports a finding that a substantial
federal interest is at stake because the case includes a federal agency, the FDA, which is responsible

for both the format and the content of prescription drug labels. While Defendants concede that
the Commonwealth seeks no relief from the FDA, they maintain that the FDA is still included in
this case because it approved the Risperdal labels that are challenged by the Commonwealth.
(See Defs.’ Mem. [DN 13] 11.) Defendants cite Grable for the proposition that an agency can be

6

included in a case even if it is not a party to the action. 545 U.S. at 315-16 (discussing the IRS’
involvement and inclusion in a quiet title action even though it was not a party).
The Commonwealth counters that this first factor weighs against a finding that the federal
interest is substantial. Essentially, it argues that the FDA is not included in this case in the Grable
sense because its actions are not actually in dispute. In Grable, the parties’ dispute centered around

the actions of the IRS and their compatibility with a federal statute. 545 U.S. at 315; see Empire
Healthchoice Assurance, Inc. v. McVeigh, 547 U.S. 677, 700 (2006) (explaining Grable). Here,
however, the Commonwealth contends that it is not challenging any FDA action or whether the
FDA complied with federal regulations. According to the Commonwealth, the issue in this case
is simply whether Defendants disclosed their knowledge of various health risks at all: either to
the FDA or to health care providers, pharmacies, and consumers. The issue is not whether the
FDA properly applied the FDCA’s regulations to Risperdal’s labels. Thus, the Commonwealth
contends that the FDA is not involved in this case. It may continue to interpret and apply federal
regulations as it wishes. (See Pl.’s Mem. [DN 10-1] 9.)
The Court agrees with the Commonwealth that this factor weighs against characterizing
the federal interest as substantial. Defendants seem to overlook the fact that the FDA’s actions—
namely, its decisions to approve the placement of the subject risk information in certain sections
of Risperdal’s labels—are not being challenged here. Instead, the critical question is whether
Defendants’ actions relative to Risperdal’s labeling were unfair, deceptive, misleading, or false
so as to violate Kentucky law. As the Commonwealth correctly notes, the FDA is not included
here in the Grable sense. Its actions are not actually disputed. While Defendants will certainly
raise the defense that they did not violate the KCPA because the FDA deemed their conduct to
comply with federal law, the question is not whether the FDA should have applied its regulations

7

differently when approving Defendants’ proposed Risperdal labels. Therefore, the Court finds
that the FDA is not included in this action. The first factor supports the Commonwealth.
Importance of Federal Question. Defendants next argue that the second factor supports a
finding that a substantial federal interest is at stake. According to Defendants, the federal question is
important because a resolution of the Commonwealth’s “label claims” will require an interpretation

of the FDCA. (See Defs.’ Mem. [DN 13] 11-12.) In this regard, Defendants highlight that there is
a federal interest in the uniform application of the FDCA. Defendants also highlight that the
FDA has a significant interest in the uniform format of prescription labels. (See id.)
Defendants cite In re Zyprexa Prods. Liab. Litig., 2008 WL 398378 (E.D.N.Y. Feb. 12,
2008), to support their position that the federal question here is important. In that case, a federal
court chose to exercise jurisdiction in a lawsuit filed by the Montana Attorney General against a
pharmaceutical manufacturer. Id. at *7. In so doing, the court found that the Attorney General’s
state-law Montana Consumer Protection Act claim raised a substantial issue of federal law. The
court reasoned, in part, that Montana’s claims of off-label marketing would “necessarily raise
substantial federal questions by requiring the court to interpret the meaning of the FDCA and its
implementing regulations.” Id. at *5. Defendants argue that here, the Commonwealth’s label
claims would similarly raise a substantial federal question; the federal question here is important.
The Commonwealth responds that this second factor weighs against a finding that the
federal interest is substantial. The Commonwealth first distinguishes the In re Zyprexa decision.
In so doing, the Commonwealth notes that in In re Zyprexa, Montana was seeking to recover
costs allegedly incurred by the state’s Medicaid program as a result of the drug manufacturer’s
wrongful promotion of Zyprexa. Id. at *3. In deciding to exercise federal jurisdiction, the court
reasoned that the “question of the state’s obligation to reimburse its insured for prescription
drugs, using funds largely provided by the federal government, is essential to the state’s theory
8

of damages and presents an unavoidable central and disputed federal issue.” Id. at *3-4. In
addition, the court noted that there is “no state-law equivalent of ‘off-label.’” Id. at *5. But in
this case, Kentucky seeks civil penalties under the KCPA. It does not seek federally-funded
Medicaid reimbursement payments. Also, there are no issues regarding any off-label promotion
of Risperdal. (See Pl.’s Reply [DN 15] 7.)
Further, the Commonwealth argues that at most, the mere interpretation of certain FDCA
provisions will be at issue. The Commonwealth cites In re Vioxx Prods. Liab. Litig., 843 F.
Supp. 2d 654 (E.D. La. 2012), for support. In that case, the Kentucky Attorney General filed a
state Kentucky Consumer Protection Act suit against the drug manufacturer of Vioxx to recover
civil penalties and injunctive relief under the KCPA, alleging that that the manufacturer failed to
disclose certain study results to the FDA or to the public. Id. at 668. After the action was removed,

the federal court remanded it, finding that the action did not raise a substantial federal question.
Id. at 668-70. It held that while the complaint “alleges facts regarding Merck’s conduct vis a vis
the FDA . . . those facts are only some allegations among many.” Id. at 669.
Notably, the In re Vioxx court distinguished the In re Zyprexa decision, holding that the
specific federal dimensions present in Montana’s case were lacking in Kentucky’s case. It noted
that in In re Vioxx, Kentucky sought “civil penalties pursuant to the KCPA and not federallyfunded Medicaid reimbursement payments.” Id. It also noted that there were “no issues of off-label
promotion of Vioxx.” Id. The Commonwealth argues that the facts here are similar to In re Vioxx.

The Court agrees with the Commonwealth that In re Zyprexa is distinguishable from this
case—and that In re Vioxx is persuasive authority. Thus, the Court holds that this second factor
weighs in favor of remand. The federal question here is not important. At most, the interpretation
of certain FDCA provisions will be at play—and any interpretation will be done in the context of
state law when analyzing Defendants’ knowledge and disclosure of certain risks on Risperdal’s
9

labeling. While Defendants argue that In re Vioxx does not control the outcome of this case
since the federal issue is not a mere element of the Commonwealth’s “label claims” (but is the
crux of those claims), the Court finds that this argument ignores the true character of the
Commonwealth’s complaint. Like the complaint in In re Vioxx, the complaint here seeks civil
consumer protection penalties and injunctive relief for Defendants’ alleged concealment of risk
information from Kentucky health care providers, pharmacies, and consumers. Any allegation as
to the proper labeling of Risperdal is only part of the Commonwealth’s larger state-law claim.
Contrary to Defendants’ position, the Commonwealth does not separately assert “label claims.”
Instead, a review of the complaint reveals that it asserts a KCPA claim—and labeling considerations

are only raised as proof of Defendants’ alleged KCPA violations. As in In re Vioxx, any federal
question in this case will be resolved in the context of whether Defendants’ labeling constitutes a
violation of Kentucky law. The second factor supports the Commonwealth.
Case’s Resolution. Defendants next argue that the third factor supports a finding that a
substantial federal interest is at stake because the Commonwealth’s “label claims” will fail if it
cannot establish that certain risk information should have been placed in the “Warnings” section
of Risperdal’s label. Defendants maintain that the answer to the federal question in this case will
be dispositive of the Commonwealth’s “label claims.” (See Defs.’ Mem. [DN 13] 15-16.)
The Commonwealth counters that this third factor weighs against a finding that the
federal interest is substantial because the so-called “label claims” are only some of its allegations
among many. As an example, the Commonwealth highlights that it has alleged that Defendants
failed to disclose certain known health risks altogether and that they sent a “Dear Doctor” letter
to Kentucky doctors which contained false information. (See Compl. [DN 1-2] ¶¶ 26-29, 40.)
The Commonwealth argues that these allegations are also part of its KCPA claim. (See Pl.’s Mem.

[DN 10-1] 11.) The Commonwealth maintains that its case is similar to In re Vioxx because even
10

if Kentucky did attempt to prove that Defendants failed to comply with the FDCA by misplacing
certain information in their labels, that question would be resolved in the context of whether that
conduct constituted a violation of Kentucky law. See In re Vioxx, 843 F. Supp. 2d at 669.
The Court agrees with the Commonwealth that this factor weighs against finding that the
federal interest is substantial. As in the In re Vioxx decision, the question of whether Defendants
complied with the FDCA with respect to placing certain risk information in the proper sections
of Risperdal’s label will be resolved in the context of whether that conduct violated Kentucky
law. The question will be whether Defendants had the requisite knowledge such that they should
have placed the risk information in a different section of Risperdal’s label under the FDCA—and
whether their alleged failure to place such information in a different section violated the KCPA.
Further, the Court believes that the facts of this case are similar to those in Mikulski. In
that case, the Sixth Circuit found that certain federal issues would not be dispositive of the case,
noting that if those issues were resolved in favor of the defendant, the plaintiffs could still
prevail. 501 F.3d at 571. The same can be said here. If the federal issues are resolved in favor of
Defendants (i.e. the Commonwealth fails to establish that Defendants had knowledge of certain
risks such that they should have placed risk information in the “Warnings” section of Risperdal’s
label under the FDCA), the Commonwealth could still prevail in its KCPA case. To do so, it would
only need to demonstrate that some other conduct of Defendants was misleading, deceptive, unfair,

or false—and the Commonwealth has alleged that such conduct was present (i.e. in Defendants’
alleged failure to disclose their knowledge of certain health risks altogether and in Defendants’
sending of a “Dear Doctor” letter to Kentucky doctors). Thus, the Court finds that resolving the
federal issue will not necessarily conclude this action.1 The third factor supports the Commonwealth.

1

In this respect, the Court notes that Defendants seem to misconstrue the nature of the third factor, arguing
that the resolution of the federal question will resolve the Commonwealth’s “label claims.” (See Defs.’ Mem. [DN

11

Impact on Other Cases. Defendants argue that the fourth factor supports a finding that a
substantial federal interest is at stake because a decision on any federal question will impact the
FDA, as well as other state-Plaintiff enforcement actions involving the labeling of prescription
drugs. According to Defendants, the Commonwealth’s “label claims” raise questions of statutory
and regulatory construction—and questions about applying federal labeling law to Risperdal’s
label. Defendants argue that similar questions will necessarily recur in other enforcement actions,
whether they involve Risperdal or the prescription medicines of other pharmaceutical companies.
The Commonwealth responds that Defendants have failed to show that any federal issues
resolved in this forum will necessarily “control” other cases, as required by Mikulski. Further,
the Commonwealth maintains that Defendants have failed to show that any federal issues resolved in

this forum will necessarily “control” the FDA. The Commonwealth proposes that while it, and
other states, will certainly continue to enforce their respective consumer protection laws, the
FDA will be able to persist in its mission, as directed by Congress. According to the Commonwealth,

it will be of no consequence to the FDA whether this case is resolved in federal court rather than
state court. (See Pl.’s Mem. [DN 10-1] 11-12.)
The Court agrees with the Commonwealth and holds that this fourth factor weighs against

finding that the federal interest is substantial. In this respect, the Court again turns to Mikulski.
There, the Court found that it was “of no consequence to the IRS whether this case, or any like it,
is resolved in federal court rather than the state court.” 501 F.3d at 572. In so finding, the Court
noted that the “IRS’s ability to collect taxes in accordance with the law is unaffected by the
judicial forum.” Id. The same can be said here for the FDA. Regardless of whether Defendants
13] 15-16.) However, in analyzing the third factor, a court’s focus must be on whether a resolution of the federal
question will impact “the case.” See Mikulski, 501 F.3d at 570. Here, the case involves the KCPA and whether it has
been violated. A resolution of the federal question will not be dispositive of whether the Commonwealth prevails on
its KCPA claim. The Court reiterates that the Commonwealth does not actually allege any separate “label claims.”
Instead, it simply asserts a KCPA violation. Labeling considerations only come into play within the KCPA context.

12

are found to have misplaced certain risk information on Risperdal’s label, the FDA will continue
to enforce its labeling standards and specifications; its ability to do so will be the same regardless of
whether this action is resolved here or in state court. The fourth factor supports the Commonwealth.

Summary of Factors. In sum, the Court finds that the four substantiality factors identified
in Mikulski point toward a holding that the “federal interest in this case is not so substantial that it
compels a finding that these traditional state law claims actually ‘arise under’ federal law . . . .” 501

F.3d at 572. After all, the “mere presence of a federal issue in a state law cause of action does not
automatically confer federal question jurisdiction, either originally or on removal.” Id. at 565.
The Court notes that other courts have reached similar conclusions when considering
federal issues under the FDCA and whether they should exercise federal jurisdiction. See, e.g.,
Oregon ex rel. Kroger v. Johnson & Johnson, 832 F. Supp. 2d 1250, 1257 (D. Or. 2011) (“[T]he
application of the FDCA regulatory regime is not a federal interest that requires the experience,
solicitude, or uniformity provided by federal courts. To the contrary, the Supreme Court has
recognized that state courts have traditionally handled state claims with embedded FDCA
standards. . . . [E]ven a novel FDCA issue raised as part of a state cause of action would not typically

justify the exercise of federal jurisdiction.”) (internal citations omitted) (emphasis in original);
Durack v. MTC Fin., Inc., 2012 WL 2047731, at *2 (D. Nev. June 5, 2012) (noting that while
Plaintiff asserted that Defendants were in violation of the FDCA, that was “not the principal
claim[] on the face of Plaintiff’s pleading; the stated federal claim[] [is] not substantial and [is]
not clearly raised for dispute in this action. Plaintiff’s complaint is limited to . . . Nevada’s
Deceptive Trade Practices Act. While Plaintiff may have alleged that Defendants violated federal
law, the alleged violation is not pivotal.”) (internal citations omitted).

13

3.

Balance of Federal and State Judicial Responsibilities

Under the final step of the substantial federal question inquiry, the Court must “inquire
into the risk of upsetting the intended balance by opening the federal courts to an undesirable
quantity of litigation.” Mikulski, 501 F.3d at 573. In this case, Defendants argue that the risk of
opening the federal courts to an undesirable quantity of litigation is small. Defendants seem to
concede that the FDCA does not provide a federal cause of action. (See Defs.’ Mem. [DN 13]
17-18.) However, they propose that the absence of a private federal cause of action may, or may
not, be indicative of congressional intent as to the division between federal and state courts.
Compare Merrell Dow Pharm. Inc. v. Thompson, 478 U.S. 804 (1986) (relying on Congress’s
failure to provide a private federal cause of action to deny federal jurisdiction), with Grable &
Sons Metal Prods., Inc., 545 U.S. at 317-18 (finding that federal question jurisdiction existed
despite Congress’s failure to provide a federal cause of action under I.R.C. § 6335, the federal
tax provision on sales of seized property). Defendants argue that the inquiry is thus contextual.
According to Defendants, the context here indicates that the Court should exercise jurisdiction
because doing so would not disturb the balance of judicial responsibilities. They argue that in
cases where a violation of federal labeling law is the entire basis of a state’s claims, as it is here,
a district court’s exercise of jurisdiction would not open flood gates of litigation to federal courts.
The Commonwealth counters that the Supreme Court’s decision in Merrell Dow Pharm.
Inc. shows that Congress intended for there to be no federal private right of action under the
FDCA. See 478 U.S. at 811-12 (holding that there is no such action under the FDCA and noting
that “[t]he significance of the necessary assumption that there is no federal private cause of
action . . . cannot be overstated” because “the ultimate import of such a conclusion . . . is that it
would flout congressional intent to provide a private federal remedy for the violation of the

14

federal statute”). As such, the proper jurisdictional question is whether Congress intended for the
Court to expand federal question jurisdiction to include claims involving federal prescription drug
labeling law. See id. at 813-17. The Commonwealth argues there is no support for such a contention.

The Court agrees with the Commonwealth that this final factor weighs against exercising
federal jurisdiction. Several courts have emphasized that the Supreme Court has not recognized a
federal remedy for FDCA violations—and have noted that allowing such actions would upset the
balance of judicial responsibilities. See, e.g., Marcus v. Med. Initiatives, Inc., 2013 WL 718630,
at *5 (M.D. Fla. Feb. 27, 2013) (“Regarding the FDCA regime in particular, the Supreme Court
has put great weight on Congress’s decisions (1) not to create a federal remedy for violations of
the FDCA, while (2) selectively declining to pre-empt most state causes of action based on
FDCA standards. That is, Congress has affirmatively decided to keep such actions out of federal
courts while tolerating overlapping regulation and litigation in state forums. All of this strongly
suggests there is no need in drug-related consumer protection cases for the ‘experience,
solicitude, and hope of uniformity that a federal forum offers.’ Within the context of the FDCA
regime in particular, the Supreme Court [in Merrell Dow] has therefore concluded ‘that the presence
of a claimed violation of the [FDCA] statute as an element of a state cause of action is insufficiently
‘substantial’ to confer federal-question jurisdiction.”); Grable & Sons Metal Prods., Inc., 545 U.S. at

318 (“For if the federal labeling standard without a federal cause of action could get a state claim
into federal court, so could any other federal standard without a federal cause of action.”) This
Court similarly concludes that exercising federal jurisdiction over the Commonwealth’s action
here would upset the balance of judicial responsibilities.
The Court rejects Defendants’ argument that its exercise of jurisdiction would not open
flood gates since the Court would only be permitting claims premised entirely on federal labeling

law. As discussed above, any allegation about the placement of certain risk information on
15

Risperdal’s label is only part of the Commonwealth’s KCPA claim. Further, while Defendants
claimed in their oral argument that exercising federal jurisdiction would not open flood gates because
only cases brought by the state involving violations of federal labeling law would give rise to federal
jurisdiction—not cases brought by individual consumers involving such violations—the Court finds
that this argument is also without merit. The Court sees no difference in the two scenarios. If the
Court were to find that the Commonwealth’s claims gave rise to federal jurisdiction here, it would
similarly find that an individual plaintiff’s claims based on the same facts would give rise to
jurisdiction. Defendants arguments are accordingly rejected.
Therefore, the Court concludes that it must remand the Commonwealth’s case to state court.

The FDCA does not provide a cause of action against entities like Defendants. See Merrell Dow
Pharm. Inc., 478 U.S. at 811-12. This absence of liability “suggests that Congress did not intend
for federal courts to exercise jurisdiction.” PremierTox, Inc. v. Ky. Spirit Health Plan, Inc., 2012
WL 1950424, at *7 (W.D. Ky. May 30, 2012). In this case, when all the factors are considered, it
seems clear to the Court that Defendants have failed to prove that there is a disputed, substantial
federal question—or that the resolution of the question in federal court will not upset Congress’s
balancing of judicial responsibilities. The Commonwealth’s motion to remand is thus GRANTED.

III. CONCLUSION
For the reasons set forth above, IT IS HEREBY ORDERED that Commonwealth’s
Motion to Remand [DN 10] is GRANTED.

cc:

October 15, 2013

counsel of record
Jefferson Circuit Court, Division Three

16