In re Guidant Corp. Implantable Defibrillators

428 F.Supp.2d 1014

In re: GUIDANT CORP. IMPLANTABLE DEFIBRILLATORS PRODUCTS LIABILITY LITIGATION

This Document Relates to: Peter Wislocki, as trustee of the Spouse and next of kin of Louis Wislocki, decedent, Plaintiff, v. Guidant Corporation and Guidant Sales Corporation Defendants;

Patricia Machalowski, individually and as Trustee for the next of kin of John Machalowski, Plaintiff, v. Guidant Corporation; Cardiac Pacemakers, Inc.; and Guidant Sales Corporation Defendants.

No. MDL05-1708(DWF/AJB).

No. MDL05-2957(DWF/AJB).

No. MDL05-2958(DWF/AJB).

United States District Court, D. Minnesota.

April 27, 2006.

Carole Bosch, Mark E. Burton, Jr., and Rachel Abrams, Hersh & Hersh, San Francisco, CA, and Joseph M. Crosby, Crosby Law Firm, St. Paul, MN, for Plaintiff Peter Wislocki.

Gale D. Pearson, Wayzata, MN, Matthew J. Schumacher, St. Paul, MN, and Stephen J. Randall, Pearson, Randall & Schumacher, PA, Minneapolis, MN, Stephen A. Sheller, and Susan J. Herczeg, Sheller, Ludwig & Badey, Philadelphia, PA, and Martha K. Wivell, Minneapolis, MN, for Plaintiff Patricia Machalowski.

Timothy A. Pratt, and Deborah A. Moeller, Shook Hardy & Bacon LLP, Kansas City, MO, and Joseph M. Price, Faegre & Benson LLP, Minneapolis, MN, for Defendants.

MEMORANDUM OPINION AND ORDER

FRANK, District Judge.

The above-entitled matters came before the Court on March 8, 2006, pursuant to Motions to Remand brought by Plaintiffs Peter Wislocki and Patricia Machalowski. Consistent with the Court's Order dated March 14, 2006, the Court grants the Plaintiffs' Motions to Remand.

Background

Plaintiff Patricia Machalowski, individually and as trustee for the next of kin of John Machalowski, filed suit against Guidant Corporation, Cardiac Pacemakers, Inc., and Guidant Sales Corporation (collectively, "Guidant") in Hennepin County District Court on December 14, 2005. Plaintiff Machalowski's Complaint alleges eight counts related to the alleged failure of an implantable cardiovirtual defibrillator, manufactured by Guidant, that was implanted into Patricia Machalowski's husband, John Machalowski: (1) strict products liability; (2) negligence; (3) breach of implied warranties; (4) breach of express warranty; (5) fraudulent concealment; (6) consumer fraud; (7) unlawful trade practices; and (8) wrongful death. Guidant removed the case on December 22, 2005, pursuant to 28 U.S.C. § 1442(a).

Plaintiff Peter Wislocki, as trustee for the spouse and next of kin of Louis Wislocki, decedent, filed suit against Guidant in Ramsey County District Court on December 5, 2005. Plaintiffs are Indiana residents. Plaintiff Wislocki's suit alleges that the, automatic implantable cardioverter defibrillator manufactured by Guidant and implanted into Louis Wislocki failed, causing Louis Wislocki's death. Plaintiff Wislocki's suit alleges the following counts: (1) strict liability—failure to warn; (2) strict liability—defective design; (3) negligence; (4) breach of implied warranties; (5) breach of express warranty; (6) fraud; (7) fraud by concealment; (8) negligent misrepresentation; (9) violations of the Minnesota Deceptive Trade Practices Act, Minn.Stat. § 325D.44; (10) violations of the Minnesota False Statement in Advertisement Act, Minn.Stat. § 325F.67; and (11) violations of the Minnesota Prevention of Consumer Fraud Act, Minn.Stat. § 325F.69. Guidant removed Plaintiff Wislocki's suit on December 22, 2005, pursuant to 28 U.S.C. § 1442(a).

Plaintiffs Machalowski and Wislocki moved to have their cases remanded. Both Plaintiffs assert that no federal subject matter jurisdiction exists to support removal. Guidant opposes Plaintiffs' motions for remand.

Discussion

The party seeking removal and opposing remand bears the burden of establishing federal subject matter jurisdiction. In re Business Men's Assur. Co. of Amer., 992 F.2d 181, 183 (8th Cir.1993). Generally, a state court action may only be removed if a federal district court would have original jurisdiction to hear the case. 28 U.S.C. § 1441(a).

Here, Guidant asserts that removal is proper pursuant to 28 U.S.C. § 1442(a)(1). Section 1442(a)(1) permits removal by the following:

The United States or any agency thereof or any officer (or any person acting under that officer) of the United States or of any agency thereof, sued in an official and individual capacity for any act under color of such office or on account of any right, title or authority claimed under any Act of Congress for the apprehension or punishment of criminals or the collection of the revenue.

28 U.S.C. § 1442(a)(1). Section 1442(a) requires that a defendant: "(1) act under the direction of a federal officer; (2) show a nexus or `causal connection' between the alleged conduct and the official authority; (3) have a colorable federal defense; and (4) be a `person' within the meaning of the statute." Watson v. Philip Morris Companies, Inc., 420 F.3d 852, 855 (8th Cir. 2005).

Guidant contends that in designing, manufacturing, marketing, and distributing the medical devices at issue in these cases, it acted pursuant to rigorous federal regulations and under the continuous supervision and direction of the Federal Food and Drug Administration ("FDA"). Guidant points to the comprehensive pre-and post-approval authority that the FDA wields over Guidant's devices to ensure that the devices are safe and effective. Specifically, Guidant outlines the detailed pre-market approval ("PMA") application process with which Guidant must comply to bring its "Class III" medical devices to market. This application process requires Guidant to provide to the FDA reports regarding the safety and efficacy investigations performed on Guidant's devices, statements regarding the components and operation of the devices, descriptions of manufacturing and processing controls, information about compliance with performance standards, samples of the devices, and labeling information. 21 U.S.C. § 360e(c)(1); 21 C.F.R. § 814.20. The FDA continues its oversight after a PMA application has been approved. The FDA may impose additional testing, labeling, and distribution requirements even after granting PMA approval. 21 C.F.R. § 814.44; 21 C.F.R. § 814.82(a). The FDA may also revoke its approval if the device manufacturer fails to comply with any post-approval requirements. 21 C.F.R. § 814.82(c).

The FDA also has authority to issue recall orders if it finds that "there is a reasonable probability that [the device] ... would cause serious, adverse health consequences or death." 21 C.F.R. § 810.10. In fact, the FDA classified recent Guidant physician communications regarding the devices at issue here as a "Class I recall," subjecting Guidant's devices to additional FDA oversight and control.

Guidant contends that because it acted within the bounds of this FDA regulation and oversight, it acted under the direction of the "United States or an[ ] agency thereof' in producing the devices in question, and that it continues to act under color of federal office in attempting to take corrective action to minimize the risk of additional device failures. 28 U.S.C. § 1442(a)(1). In other words, Guidant contends that it acted under the direction of the FDA because it submitted a PMA application and later recalled the defibrillators that are at issue in this litigation. It is on these bases that Guidant asserts that federal jurisdiction exists.

In support of its position, Guidant points to the Eighth Circuit Court of Appeals' decision in Watson v. Philip Morris Companies, Inc., 420 F.3d 852 (8th Cir.2005). In Watson, the Eighth Circuit held that consumer litigation brought against tobacco companies was properly removed to federal court pursuant to 28 U.S.C. § 1442(a). The plaintiff-consumers filed suit in Arkansas state court, alleging that the cigarette manufacturer deceptively marketed its cigarettes as "light" or "lowered tar and nicotine" in violation of an Arkansas consumer protection statute. Id. at 854. The defendant-cigarette manufacturer removed the action pursuant to § 1442(a)(1). Id. The Watson court held that the question of whether a defendant was "acting under" the direction of a federal officer depended on the detail and specificity of the federal direction of the defendant's activities and the government's exercise of control over the defendant. Id. at 856-57. The court noted that "[m]ere participation in a regulated industry is insufficient to support removal unless the challenged conduct is `closely linked to detailed and specific regulations.'" Id. at 857 (quoting Virden v. Altria Group, Inc., 304 F.Supp.2d 832, 844 (N.D.W.Va.2004) (citations omitted)).

In analyzing whether the defendant in Watson was acting under the direction of a federal officer, the court noted that the FTC exercised "comprehensive, detailed regulation" and performed ongoing monitoring of the cigarette industry, including...