Mullin v. Guidant Corp., 29829.

• Decision Date: 12 May 2009
• Docket Number: No. 29829.,29829.
• Citation: 114 Conn.App. 279,970 A.2d 733
• Court: Connecticut Court of Appeals
• Parties: Leslie MULLIN et al. v. GUIDANT CORPORATION.

970 A.2d 733

114 Conn.App. 279

Leslie MULLIN et al. v. GUIDANT CORPORATION.

No. 29829.

Appellate Court of Connecticut.

Argued January 12, 2009.

Decided May 12, 2009.

Harold J. Geragosian, New Britain, for the appellants (plaintiffs).

Andrew D. Carpenter, pro hac vice, Kansas City, MO, with whom were Frank H. Santoro, Hartford and Scott D. Kaiser, Kansas City, MO, and, on the brief, Calum B. Anderson and R. Cornelius Danaher, Jr., Hartford, for the appellee (defendant).

DiPENTIMA, GRUENDEL and SCHALLER, Js.

GRUENDEL, J.

The plaintiffs, Leslie Mullin and Vincent Mullin, appeal from the judgment of the trial court dismissing their product liability action. On appeal, the plaintiffs claim that the court improperly concluded that their two count complaint was preempted by the Medical Device Amendments of 1976, 21 U.S.C. § 360c et seq. (MDA). We agree with the court that the plaintiffs' action is preempted by federal law. The court, however, improperly concluded that it lacked subject matter jurisdiction over the case. Therefore, although the defendant, Guidant Corporation, nevertheless prevails, we must reverse the judgment of the trial court dismissing the plaintiffs' action and remand the case with direction to render judgment in favor of the defendant.¹

The record, viewed in the light most favorable to the plaintiffs; see Martinelli v. Fusi, 290 Conn. 347, 350, 963 A.2d 640 (2009); reveals the following facts. In July, 1999, Leslie Mullin, who at the time was in her early thirties, suffered a cardiac arrest and respiratory distress. She was resuscitated successfully and transported to a hospital where medical personnel diagnosed her as having suffered from a ventricular fibrillation arrest. After additional testing, her physician recommended that she receive an implantable cardioverter defibrillator (implant).² The implantation was performed on July 9, 1999, using a Ventak Mini IV Model 1793 manufactured by the defendant.

Some two years later, in October, 2001, Leslie Mullin's implant began beeping. Her physicians determined that the device was malfunctioning and had reverted to a "failsafe" mode. The physicians recommended that the implant be removed and replaced as soon as possible. On November 8, 2001, the device was replaced with a different model, which also was manufactured by the defendant. The hospital and medical expenses associated with the replacement of the implant were borne by the defendant.

On October 25, 2004, the plaintiffs filed their two count complaint in the Superior Court. In the first count, the plaintiffs asserted a cause of action under the Connecticut Product Liability Act, General Statutes § 52-572m et seq. The count contained several allegations relating to the implant's safety, design, manufacture and distribution, including breach of implied and expressed warranties, failure to evaluate the safety of the implant and subjecting Leslie Mullin to unreasonable danger. In the second count, the plaintiffs claimed that Vincent Mullin, Leslie Mullin's husband, suffered physical and emotional distress, loss of consortium and fiscal expense as a result of the failure of his wife's implant. The defendant filed an answer to the complaint in which it denied liability and asserted several special defenses, including federal preemption of the plaintiffs' causes of action.

On December 14, 2007, the defendant filed a motion for summary judgment. In its motion and accompanying memorandum, the defendant asserted that it was entitled to judgment as a matter of law because (1) there was no evidence that the implant was defective or that there had been a breach of any warranty and (2) the plaintiffs' claims were preempted by federal law. On April 8, 2008, the court issued its memorandum of decision in which it found that the causes of action were preempted by the MDA and that the court therefore lacked subject matter jurisdiction to hear the case. It thus treated the defendant's motion for summary judgment as a motion to dismiss under our holding in Lewis v. Chelsea G.C.A. Realty Partnership, L.P., 86 Conn.App. 596, 607, 862 A.2d 368 (2004), cert. denied, 273 Conn. 909, 870 A.2d 1079 (2005), and dismissed the plaintiffs' action. This appeal followed.

Before addressing the plaintiffs' claims on appeal, we first set forth the applicable standards of review. "Practice Book § 17-49 provides that summary judgment shall be rendered forthwith if the pleadings, affidavits and any other proof submitted show that there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law. In deciding a motion for summary judgment, the trial court must view the evidence in the light most favorable to the nonmoving party.... The party moving for summary judgment has the burden of showing the absence of any genuine issue of material fact and that the party is, therefore, entitled to judgment as a matter of law." (Internal quotation marks omitted.) Byrne v. Burke, 112 Conn.App. 262, 267, 962 A.2d 825, cert. denied, 290 Conn. 923, 966 A.2d 235 (2009). Our review of the trial court's decision on a motion for summary judgment "is plenary and we must decide whether the trial court's conclusions are legally and logically correct and find support in the facts that appear in the record." (Internal quotation marks omitted.) Id., at 268, 962 A.2d 825. In addition, our review of the court's decision to dismiss the case for lack of subject matter jurisdiction is likewise plenary. Bloom v. Miklovich, 111 Conn.App. 323, 335, 958 A.2d 1283 (2008).

I

The dispositive issue on appeal is whether the MDA preempts the plaintiffs' claims arising under state law. Before addressing that substantive issue, however, we must first determine if the court properly treated the defendant's motion for summary judgment as a motion to dismiss for lack of subject matter jurisdiction. We conclude that it did not. Federal preemption of a state law or cause of action does not necessarily implicate the court's subject matter jurisdiction. "It is well established that, in determining whether a court has subject matter jurisdiction, every presumption favoring jurisdiction should be indulged." (Internal quotation marks omitted.) Lawton v. Weiner, 91 Conn.App. 698, 714, 882 A.2d 151 (2005).

Our Supreme Court has held that a claim of federal preemption of a state cause of action is waived unless pleaded as a special defense. See Stokes v. Norwich Taxi, LLC, 289 Conn. 465, 488-89, 958 A.2d 1195 (2008) ("[b]ecause the defendants did not file a special defense of federal preemption to the plaintiff's claims ... and did not object to any of the evidence introduced to support the plaintiff's claims ... the defendants waived this special defense"). It is axiomatic, however, that "[t]he subject matter jurisdiction requirement may not be waived by any party...." Peters v. Dept. of Social Services, 273 Conn. 434, 441, 870 A.2d 448 (2005). Because a preemption defense may be waived but jurisdictional defects may never be waived, we conclude that the MDA's preemptive effect does not implicate our courts' subject matter jurisdiction.³ Consequently, the court improperly dismissed the case for lack of subject matter jurisdiction.⁴

II

This determination does not indicate, however, that the court improperly concluded that the plaintiffs' claims were preempted and that the defendant was entitled to summary judgment. We begin our analysis of the preemption issue by providing some background on the federal statute at issue, the MDA.

A

"The Federal Food, Drug, and Cosmetic Act ... has long required [Food and Drug Administration (FDA)] approval for the introduction of new drugs into the market. Until the statutory enactment at issue here, however, the introduction of new medical devices was left largely for the States to supervise as they saw fit....

"The regulatory landscape changed in the 1960's and the 1970's, as complex devices proliferated and some failed. Most notably, the Dalkon Shield intrauterine device, introduced in 1970, was linked to serious infections and several deaths, not to mention a large number of pregnancies. Thousands of tort claims followed....

"Congress stepped in with the passage of the [MDA] which swept back some state obligations and imposed a regime of detailed federal oversight. The MDA includes an express pre-emption provision that states: `Except as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement—(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.' [21 U.S.C.] § 360k(a). The exception contained in subsection (b) permits the FDA to exempt some state and local requirements from pre-emption.

"The new regulatory regime established various levels of oversight for medical devices, depending on the risks they present.... The devices receiving the most federal oversight are those in Class III, which include replacement heart valves, implanted cerebella stimulators, and pacemaker pulse generators.... In general, a device is assigned to Class III if it cannot be established that a less stringent classification would provide reasonable assurance of safety and effectiveness, and the device is `purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health,' or `presents a potential unreasonable risk of illness or injury.' [21 U.S.C.] § 360c(a)(1)(C)(ii)....

"[The MDA] established a rigorous regime of premarket approval for new Class III Devices.... A manufacturer must submit what is typically a multivolume application.... It includes,...