Troutman v. Curtis

• Decision Date: 20 June 2008
• Docket Number: No. 94,667.,94,667.
• Citation: 185 P.3d 930
• Parties: Sandra TROUTMAN, Larry Gales, and Gerald Crooks, Appellants, v. Jeffrey CURTIS, M.D.; Stormont Vail Healthcare, Inc.; and Perclose, Inc., Appellees.
• Court: Kansas Supreme Court

185 P.3d 930

Sandra TROUTMAN, Larry Gales, and Gerald Crooks, Appellants, v. Jeffrey CURTIS, M.D.; Stormont Vail Healthcare, Inc.; and Perclose, Inc., Appellees.

No. 94,667.

Supreme Court of Kansas.

June 20, 2008.

J. Todd Hiatt, of Ralston, Pope & Diehl, L.L.C., of Topeka, argued the cause, and Eugene B. Ralston and Kevin L. Diehl, of the same firm, were with him on the briefs for appellants.

Donald Patterson, of Fisher, Patterson, Sayler & Smith, LLP, of Topeka, and Brian J. Mooney, of Gordon & Rees LLP, of San Francisco, California, argued the cause and were on the briefs for appellees.

The opinion of the court was delivered by BEIER, J.:

Plaintiffs Sandra Troutman, Larry Gales, and Gerald Crooks brought this action after they suffered complications arising out of cardiac catheterization procedures. We accepted their petition for review of the Court of Appeals' decision affirming the district court's summary judgment in favor of defendant Perclose, Inc. (Perclose), the maker of the suturing device used in plaintiffs' procedures.

After this court heard oral argument in April 2007 in this case, the United States Supreme Court granted certiorari in Riegel v. Medtronic, Inc., ___ U.S. ___, 128 S.Ct. 999, 169 L.Ed.2d 892 (2007). That case involved a preemption defense identical to that raised by Perclose in this case, i.e., successful pursuit of and compliance with the premarket approval process of the Food and Drug Administration (FDA) means state tort law claims arising out of use of an approved device are subject to federal preemption under the Medical Device Amendments of 1976, 21 U.S.C. § 360c et seq. (2000), of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq. (2000).

We then issued an Order to Show Cause to the parties in this case, directing them to demonstrate why a decision in this case should not be held pending the filing of a decision in Riegel. The parties' responses to the order agreed that our decision should be held.

On February 20, 2008, the Supreme Court ruled 8-1 in Riegel that the premarket approval process (PMA) used by Perclose for the suturing device at issue here leads to federal preemption of state tort claims challenging the safety and effectiveness of the device because the claims are based on requirements different from or in addition to those set out by federal law. See Riegel, ___ U.S. at ___, 128 S.Ct. at 1007; 21 U.S.C. § 360k(a)(1).

The district court and the Court of Appeals had relied on such preemption to dispose of plaintiffs' entire case. Under these circumstances, the only question remaining for our decision is whether plaintiffs have already pursued or may still pursue any claim that Perclose failed to meet the FDA's requirements under the "rigorous" PMA process. See Riegel, ___ U.S. at ___, 128 S.Ct. at 1004. The Supreme Court recognized, and the parties before us wisely agree, that such a claim would not be preempted. See Riegel, ___ U.S. at ___, 128 S.Ct. at 1011 (preemption provision in § 360k(a)(1) does not prevent state from providing damages remedy for claims premised on violation of FDA requirements; such state duties parallel, rather than add to, federal requirements).

This court's standard of review on appeal from summary judgment is a familiar one:

"`"Summary judgment is appropriate when the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, 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. The trial court is required to resolve all facts and inferences which may reasonably be drawn from the evidence in favor of the party against whom the ruling is sought. When opposing a motion for summary judgment, an adverse party must come forward with evidence to establish a dispute as to a material fact. In order to preclude summary judgment, the facts subject to the dispute must be material to the conclusive issues in the case. On appeal, we apply the same rules and where we find reasonable minds could differ as to the conclusions drawn from the evidence, summary judgment must be denied." [Citation omitted.]'" Nungesser v. Bryant, 283 Kan. 550, 566, 153 P.3d 1277 (2007).

When relevant facts are uncontroverted, we review summary judgment de novo. Klein v. Oppenheimer & Co., Inc., 281 Kan. 330, Syl. ¶ 7, 130 P.3d 569 (2006).

In this case, plaintiffs' petition alleged only that Perclose had been "negligent in its design, testing, inspection, manufacturing, sale, [and] warning post and pre-sale" of its suturing device and that Perclose was strictly liable for plaintiffs' injuries.

Perclose directs our attention to one of the interrogatories it propounded to plaintiff Troutman, which asked: "Is it contended that the incident alleged in the petition was caused in whole or in part by a violation of a statute, regulation or code provision? If so, state: ... [t]he specific manner in which it is alleged that each such provision was not complied with or violated." After lodging an objection that the question would be better directed to an expert, Troutman replied:

"[W]e believe that there was a bacterial infection acquired by not following [Joint Commission on Accreditation of Healthcare Organizations] guidelines and/or [Centers for Disease Control] guidelines set forth for handling infectious disease and/or guidelines set forth by Stormont Vail HealthCare, Inc. for handling infectious disease. These will include state and federal regulations."

Perclose filed its motion for summary judgment, arguing that "each and every count directed against this defendant is federally preempted by the Medical Device Amendments, 21 U.S.C. Section 360k(a)." Plaintiffs, for purposes of the motion, partially controverted only one paragraph of the uncontroverted facts alleged by Perclose: "24. The design of the [suturing device] was approved by FDA as safe and effective." Plaintiffs' response read: "Plaintiff does not controvert Statement 24 to the extent that FDA approval of a medical device under the PMA procedure only assures a bare minimum of safety and effectiveness and is not intended to supplant liability for negligence or other wrongdoing." Plaintiffs then responded to Perclose's legal argument on preemption and asserted that federal law had no impact on any claim that Perclose

"failed to comply with the design, manufacturing process, and warning labels the manufacturer submits to the FDA. If these issues are approved by the FDA, the manufacturer must abide by them or face potential liability....

"Discovery in this case is not yet complete. Plaintiff has received only some of the documentation regarding FDA approval of the [suturing device] and expects to request and acquire much more as discovery continues. Plaintiff expects to receive training guidelines, treatment protocols, and other similar materials through discovery, and we do not yet know if Defendant Perclose or the other defendants in this case complied with these guidelines and protocols. Therefore, even if this Court should [agree with Perclose's preemption argument], [s]ummary [j]udgment is inappropriate at this point. Plaintiff[s'] claim for negligence includes the potential failure of Perclose to comply with the guidelines as submitted to and which were approved by the FDA."

It appears undisputed that whatever expert disclosure and discovery deadlines were set by the district court, they had not passed at the time Perclose filed its motion. The record on appeal contains no final pretrial conference order.

The district court issued its Memorandum Decision and Order, ruling in favor of Perclose on the preemption issue on August 13, 2004. The same day, plaintiffs filed a response to Perclose's earlier reply in support of the motion. For the first time, in the August 13 response, plaintiffs also advanced an argument under Kansas notice pleading that the broad language of their petition should be understood to encompass a claim that Perclose failed to comply with FDA requirements.

On August 18, 2004, the district court sent a letter to the parties, upholding the August 13 ruling. It also rejected a motion for reconsideration filed by plaintiffs, which had included the following:

"The Court has apparently dismissed Plaintiffs' negligence claim that was premised on the failure of Defendant Perclose to follow applicable federal and state guidelines. Plaintiffs filed a negligence claim in...