United States District Court, W.D. Kentucky, Louisville Division
COMMONWEALTH OF KENTUCKY ex rel. JACK CONWAY, ATTORNEY GENERAL, PLAINTIFF
JANSSEN PHARMACEUTICALS, INC., et al., DEFENDANTS
Decided October 15, 2013
For Commonwealth of Kentucky, ex rel. Jack Conway, Attorney General, Plaintiff: Aaron Ament, Clay A. Barkley, Sean J. Riley, LEAD ATTORNEYS, Kentucky Attorney General- Civil & Envirnonmental Law Div., Frankfort, KY; Fletcher V. Trammell, Robert W. Cowan, LEAD ATTORNEYS, Bailey Peavy Bailey PLLC, Houston, TX; LeeAnne Applegate, Todd E. Leatherman, LEAD ATTORNEYS, Kentucky Attorney General, Frankfort, KY; Tad Thomas, LEAD ATTORNEY, Thomas Law Office, PLLC, Louisville, KY.
For Janssen Pharmaceuticals, Inc., formerly known as Ortho-McNeil-Janssen Pharmaceuticals, Inc., formerly known as Janssen Pharmaceutica, Inc., Janssen Research and Development, LLC, agent of Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Johnson & Johnson, Inc., Defendants: Charles M. Pritchett, Jr., Sheryl G. Snyder, Theresa A. Canaday, LEAD ATTORNEYS, Frost Brown Todd LLC - Louisville, Louisville, KY; Edward M. Posner, LEAD ATTORNEY, Drinker Biddle & Reath LLP - Philadelphia, Philadelphia, PA.
Joseph H. McKinley, Jr., Chief United States District Judge.
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.
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 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 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.
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, 125 S.Ct. 2363, 162 L.Ed.2d 257 (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.
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 ...