Parks v. Guidant Corp.

• Decision Date: 21 November 2005
• Docket Number: No. 2:05 CV 042 PS.,2:05 CV 042 PS.
• Citation: 402 F.Supp.2d 964
• Parties: Evelyn J. PARKS and Michael Parks, Plaintiffs, v. GUIDANT CORPORATION, Guidant Sales Corporation, Guidant Holdings, Inc., Defendants.
• Court: U.S. District Court — Northern District of Indiana

402 F.Supp.2d 964

Evelyn J. PARKS and Michael Parks, Plaintiffs, v. GUIDANT CORPORATION, Guidant Sales Corporation, Guidant Holdings, Inc., Defendants.

No. 2:05 CV 042 PS.

United States District Court, N.D. Indiana, Hammond Division.

November 21, 2005.

Kenneth J. Allen, William James Lazarus, Kenneth J. Allen and Associates PC, Valparaiso, IN, for Plaintiffs.

Alison G. Fox, Baker & Daniels, South Bend, IN, Thomas G. Stayton, Baker & Daniels, Indianapolis, IN, for Defendants.

OPINION AND ORDER

SIMON, District Judge.

Plaintiffs filed this products liability case in Indiana state court and Defendants removed it under the federal officer removal statute, 28 U.S.C. § 1442(a)(1). Before the Court is Plaintiffs' Motion for Remand. [Doc. 15.] Our jurisdiction hinges on whether Defendants acted under the direction of a federal agency and whether Defendants' removal was timely. For the reasons set forth below, Plaintiffs' motion is GRANTED with each party to bear its own attorneys' fees.¹

BACKGROUND

The claims in this case arise out of the alleged malfunction of a medical device designed, manufactured, and sold by one or more Defendant. Plaintiffs allege that a defibrillator worn by Plaintiff Evelyn Parks malfunctioned, shocked her more than 40 times, and sent her into an extended coma. On December 22, 2004, Plaintiffs filed suit in state court in Lake County, Indiana. The Complaint named Guidant Corporation, Guidant Sales Corporation, and Guidant Holdings, Inc. as defendants.²

On February 3, 2005, Defendants Cardiac Pacemakers, Inc. and Guidant Sales Corporation removed the case to federal court pursuant to 28 U.S.C. § 1442(a)(1), the "federal officer" removal statute. Defendants do not assert any other basis for federal jurisdiction. Plaintiffs are Washington residents but filed suit in Defendants' home state of Indiana. Thus, Defendants could not remove the case on diversity grounds. See 28 U.S.C. § 1441(b). On March 4, 2005, Plaintiffs moved to remand the case to Indiana state court. Plaintiffs contend that removal is improper because: 1) the federal officer removal statute does not apply to this case; and 2) Defendants' removal was untimely. Plaintiffs also seek to recover attorneys' fees associated with their Motion for Remand under 28 U.S.C. § 1447(c). Because we find that the federal officer removal statute does not apply here, we do not address the timeliness of the removal.

DISCUSSION

A defendant seeking removal bears the burden of establishing federal subject matter jurisdiction. Disher v. Citigroup Global Markets Inc., 419 F.3d 649, 654 (7th Cir.2005). Federal removal jurisdiction is statutory in nature and is to be strictly construed. See Shamrock Oil & Gas v. Sheets, 313 U.S. 100, 108, 61 S.Ct. 868, 85 L.Ed. 1214 (1941). Removal is proper if it is based on statutory permissible grounds and if it is timely. Boyd v. Phoenix Funding Corp., 366 F.3d 524, 529 (7th Cir.2004). "As a general rule, absent diversity jurisdiction, a case will not be removable if the complaint does not affirmatively allege a federal claim." Beneficial Nat'l Bank v. Anderson, 539 U.S. 1, 8, 123 S.Ct. 2058, 156 L.Ed.2d 1 (2003) (quoting Louisville and Nashville R.R. Co. v. Mottley, 211 U.S. 149, 152, 29 S.Ct. 42, 53 L.Ed. 126 (1914)). This general rule, known as the well-pleaded complaint rule, has two exceptions: 1) when Congress expressly provides otherwise; or 2) when a federal statute completely preempts the state-law cause of action. Id. Because Defendants do not allege complete preemption as a basis for removal [Doc. 23-1 at 9, n. 6.], only the first exception is at issue here.

In 28 U.S.C. § 1442(a), Congress expressly provided for the removal of cases brought against federal officers when the subject matter of the case involves action taken by federal officials under color of their office. The purpose behind the federal officer removal statute is to prevent state courts from exercising jurisdiction over federal officials when their actions are authorized by the federal authority they possess. Willingham v. Morgan, 395 U.S. 402, 406, 89 S.Ct. 1813, 23 L.Ed.2d 396 (1969); see also Mesa v. California, 489 U.S. 121, 126, 109 S.Ct. 959, 103 L.Ed.2d 99 (1989). If federal officials could not remove such cases to federal court, states could effectively thwart federal action and disrupt the operation of the federal government. Id. § 1442(a) should not be read in a narrow or limited manner, nor should its purpose be frustrated by a narrow, grudging interpretation. Id. at 405-07.

Although the primary beneficiaries of § 1442(a) are federal officers and agencies, a private party may also invoke the statute. Venezia v. Robinson, 16 F.3d 209, 211-12 (7th Cir.1994). This is because the statute contains a parenthetical reference that makes it applicable not only to federal officers but also to "(any person acting under that officer)..." 28 U.S.C. § 1442(a). The paradigm for removal by a nonfederal official is demonstrated by Venezia. In that case, an individual named Robinson acting under the authority of the FBI participated in a sting operation trying to ferret out people who were paying bribes to protect illegal poker machines. Robinson was hauled into state court in Illinois and had an injunction slapped on him. The case was removed to federal court under the federal officer removal statute because although Robinson was not a federal official himself he was "acting under" a federal official — the FBI agent with whom he was taking direction — and removal was therefore proper.

To remove a case to federal court under § 1442(a)(1), a private party must: (1) have acted under the direction of a federal agency or officer; (2) raise a colorable federal defense; and (3) demonstrate a causal nexus between the federal direction and the conduct in question. In re Methyl Tertiary Butyl Ether (MTBE) Products Liability Litigation, 342 F.Supp.2d 147, 154 (S.D.N.Y.2004) (citations omitted); see also Jewel v. UnumProvident Corp., 352 F.Supp.2d 122, 127 (D.Mass.2005).

To say the least, and for better or worse, we live in a highly regulated country. But mere participation in a regulated industry does not establish that a party is acting under the direction of a federal officer. In re MTBE Products Liability Litigation, 342 F.Supp.2d at 156; Virden v. Altria Group, Inc., 304 F.Supp.2d 832, 845-46 (N.D.W.Va.2004); Tremblay v. Philip Morris, Inc., 231 F.Supp.2d 411, 417 (D.N.H.2002). Rather, a defendant seeking to remove pursuant to § 1442(a) must provide "candid, specific and positive" allegations that the conduct complained of was undertaken pursuant to the directions of a federal office or agency. Willingham, 395 U.S. at 409, 89 S.Ct. 1813; see also Colorado v. Symes, 286 U.S. 510, 518-19, 52 S.Ct. 635, 76 L.Ed. 1253 (1932). In other words, the acts that form the basis of the state court suit must have been performed "pursuant to an officer's direct orders or to comprehensive and detailed regulations." Virden, 304 F.Supp.2d at 844. Thus, absent a showing that the complained of conduct is closely linked to detailed and specific regulations, a defendant will be unable to meet the first prong for private party removal — that the private party was acting under the direction of a federal officer. Virden, 304 F.Supp.2d at 845-46; Tremblay, 231 F.Supp.2d at 417.

According to Plaintiffs, federal officer removal does not apply here because Defendants cannot satisfy the first element for removal — that Defendants were "acting under" an officer of the United States. Defendants contend they satisfy the first element because they acted under the direction of the Food and Drug Administration, but this a far cry from the paradigm set forth in Venezia.

It is of course true that the FDA has comprehensive regulatory authority over the production of medical devices. Indeed, the device at issue in this case is a "Class III" medical device and, as such, is subject to rigorous and comprehensive FDA regulations. Defendants are required to submit a Premarket Approval Application that contains detailed information about the safety and efficacy of the device. After approval, the FDA requires Defendants to maintain certain records and to report any adverse events. Defendants contend that in adhering to the FDA's regulations, they have worked under the "meticulous supervision and direction of the FDA" and its officials. Therefore, Defendants submit, they satisfy the first element for removal. [Doc. 23-1 at 11-13.]

This analysis stretches the federal officer removal statute to its breaking point. While the FDA's regulation of class III medical devices may be rigorous, Defendants have not pointed to anything in the regulations to establish that Defendants acted under the direction of the FDA in the design, manufacture, or sale of the device at issue. The FDA does not tell Defendants how to act. The FDA does not direct Defendants how to design or manufacture the device at issue. The FDA simply requires manufacturers to provide "reasonable assurance" that the device is "safe and effective." 21 U.S.C. § 360c(a)(1)(C); 21 C.F.R. § 860.7. Absent detailed instruction or direction from the FDA, this is not enough to satisfy the first element.

Defendants stress that FDA regulations prohibit Defendants from making any changes to a device that impact its safety and effectiveness without first obtaining FDA consent. Defendants argue that once a device is approved, the specifications set forth in the PMA become "federal requirements from which the manufacturer cannot deviate." [Doc. 23-1 at 13.] The Court is not persuaded. Obviously, the FDA does not want medical device manufacturers altering an already-approved device without first running the changes by the FDA. But this post-approval requirement does not mean that the manufacturers are "acting under" the direction of the FDA, as that phrase is used in the federal officer removal statute. 28 U.S.C. § 1442(a)(1).

Were the...