Carey v. Shiley, Inc.

Decision Date16 December 1998
Docket NumberCivil No. 4-97-CV-10182.
Citation32 F.Supp.2d 1093
PartiesRobert F. CAREY, an individual, and Norma Carey, an individual, Plaintiffs, v. SHILEY, INC., a California corporation; Pfizer, Inc., a Delaware corporation; and Grindley Manufacturing, Inc., a California corporation, Defendants.
CourtU.S. District Court — Southern District of Iowa

Todd M. Boothroyd, Ronald M. Sotak, James A. Brewer, Newbrough Johnston Brewer & Maddux, Ames, IA, James T. Capretz, Richard J. Radcliffe, Capretz & Radcliffe, Newport Beach, CA, Terence R. Quinn, Quinn Eisland Day & Barker, Belle Fourche, SD, for Robert F. Carey and Norma Carey.

Robert D. Houghton, Shuttleworth & Ingersoll, Cedar Rapids, IA, Alan F. Goott, Steven J. Glickstein, Maris Veidemanis, Bert Slonim, Liza I. Karsai, Kaye Scholer Fierman Hays & Handler, New York City, for Shiley Inc., Pfizer Inc. and Grindley Mfg., Inc.

ORDER

LONGSTAFF, District Judge.

The Court has before it several motions for summary judgment filed July 17, 1998, by defendants. Plaintiffs resisted the motions September 25, 1998, and defendants filed reply briefs October 21, 1998. The motions are now considered fully submitted.1

I. BACKGROUND

Plaintiffs Robert and Norma Carey filed the above-captioned lawsuit against defendants Shiley, Inc. ("Shiley"), Pfizer, Inc. ("Pfizer"), and Grindley Manufacturing, Inc. ("Grindley").2 The Careys' claims stem from an artificial heart valve implant Robert Carey received in 1980. Physicians explanted the valve prosthesis in 1993. In an eight count complaint, plaintiffs allege negligence (Count I) against all three defendants, and the following against defendants Shiley and Pfizer: negligent misrepresentation (Count II); fraud and deceit (Count III); breach of express warranty (Count IV); breach of implied warranty (Count V); strict liability (Count VI); intentional infliction of emotional distress ("IIED") (Count VII); and loss of consortium (Count VIII).

A. Factual Background

The facts set forth herein are either undisputed or viewed in a light most favorable to the nonmoving party. On May 5, 1980, plaintiff Robert Carey ("Mr.Carey") underwent surgery during which physicians replaced his mitral heart valve.3 In place of the natural valve, the doctors implanted a Bjork-Shiley 60~. Convexo-Concave artificial heart valve (the "CC valve"). At some point after plaintiff received the implant, it became apparent that the CC valve carried with it the risk of a mechanical failure known as "strut fracture." A strut fracture in a CC valve may result in death or serious injury to the person wearing the implant. In 1986, Shiley withdrew the CC valve from the United States market. Defendant estimates that more than 80,000 CC valves were implanted prior to the market withdrawal.

In February 1985, Mr. Carey's cardiologist, Dr. Lewis January, informed Mr. Carey that the CC valve carried with it a risk of strut fracture. Mr. Carey's subsequent cardiologist, Dr. Allyn Mark,4 as well as other treating physicians, also discussed the strut fracture risk with him in the early 1990s. Dr. Mark did not recommend elective replacement of the CC valve. Mark Deposition, at 41-42.

Dr. Mark diagnosed Mr. Carey with aortic valvular disease in October 1993.5 Mark Deposition, at 46-47. Dr. Mark considered Mr. Carey's condition serious enough to warrant aortic valve replacement. Id. After discussions and decision-making involving the Careys and various physicians, Mr. Carey underwent valve replacement surgery in December 1993. During the course of the surgery, Dr. Nicholas Rossi replaced Mr. Carey's natural aortic valve with an artificial valve. Additionally, Dr. Rossi removed the CC valve and replaced it with a new mitral valve prosthesis.

Mr. Carey suffered post-operative complications, which he alleges required him to undergo the following procedures: reopening of the surgical incision to cleanse an infection and insert tubes for antibiotic therapy; surgical removal of a chest tube which had become entangled in a chest wire; surgical removal of a chest wire that was protruding from Mr. Carey's chest; removal of a Pick tube that was clotting or leaking, followed by surgical insertion of a Hickman tube in Mr. Carey's shoulder to replace the Pick tube; and removal of the Hickman tube. Mr. Carey alleges additional complications arising from the December 1993 surgery: enterobacter mediastinitis, an infection in his sternal incision that extended to his chest, causing a sternal infection; sleep disorders and delusions; a blood stream infection; and atrial fibrillation, which "led his heart to be cardioverted back to sinus rhythm, only to again revert back to atrial fibrillation many months later." Plaintiff's Memo. of Law in Support of Opposition to Defendants' Mtn. for Summary Judgment (Causation), at 10.

Plaintiffs bring this action seeking damages resulting from problems related to the CC valve.

B. Standard of Review

Summary judgment is properly granted when the record, viewed in the light most favorable to the nonmoving party, shows that there is no genuine issue of material fact, and the moving party is entitled to judgment as a matter of law. Fed.R.Civ.P. 56(c); Walsh v. United States, 31 F.3d 696, 698 (8th Cir. 1994). The moving party must establish its right to judgment with such clarity that there is no room for controversy. Jewson v. Mayo Clinic, 691 F.2d 405, 408 (8th Cir. 1982). "[T]he mere existence of some alleged factual dispute between the parties will not defeat an otherwise properly supported motion for summary judgment; the requirement is that there be no genuine issue of material fact." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247-48, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986) (emphasis added). An issue is "genuine" if the evidence is sufficient to persuade a reasonable jury to return a verdict for the nonmoving party. Id. 477 U.S. at 248, 106 S.Ct. 2505. "As to materiality, the substantive law will identify which facts are material.... Factual disputes that are irrelevant or unnecessary will not be counted." Id.

C. Defendants' Motions for Summary Judgment

Defendants seek summary judgment on several grounds, each filed in a separate motion. In the interest of efficiency, the Court will consider the several motions for summary judgment in this single Order. Defendants seek summary judgment as to plaintiffs' express and implied warranty claims (Counts IV and V). Additionally, defendants seek summary judgment on all counts on the ground of lack of causation. Defendants also seek summary judgment on all counts arguing that plaintiffs' claims are pre-empted by federal law. Defendants seek partial summary judgment as to plaintiffs' claims for emotional distress damages which occurred prior to the replacement of Mr. Carey's heart valve, and for Count VII (intentional infliction of emotional distress). Finally, defendants seek partial summary judgment as to plaintiffs' defective manufacture claims (Counts I, IV, and VI).

D. Breach of Express and Implied Warranty Claims

Defendants filed a motion for partial summary judgment as to plaintiff's breach of warranty claims (Counts IV and V). Plaintiffs filed a statement of non-opposition to this motion. Accordingly, summary judgment in favor of defendants and against plaintiffs is granted as to Counts IV and V.

II. CAUSATION

Defendants argue that they are entitled to summary judgment because plaintiffs cannot establish a material issue of fact regarding causation, an element necessary to prove each claim.

A. Negligence

"Causation is an element essential for finding a party liable in a tort action." Iowa Elec. Light and Power Co. v. General Elec. Co., 352 N.W.2d 231, 234 (Iowa 1984). Under Iowa law, a negligence claim requires proof that the defendant's negligent actions proximately caused the plaintiff's injuries.6 See Banks v. Harley-Davidson, Inc., 73 F.3d 213, 215 (8th Cir.1996); Spaur v. Owens-Corning Fiberglas Corp., 510 N.W.2d 854, 858 (Iowa 1994) (citation omitted). To establish proximate cause under Iowa law, a plaintiff must prove that the alleged defect was a "substantial factor" in producing the plaintiff's injuries, and that the injury would not have occurred "but for" the alleged defect.7 Banks, 73 F.3d at 215; Spaur, 510 N.W.2d at 858 (citation omitted). "Substantial" means the defect had such an effect in producing the injury as to lead a reasonable person to regard it as the cause. Iowa Uniform Jury Instruction 700.3; see also Benn v. Thomas, 512 N.W.2d 537, 539-40 (Iowa 1994). Proximate cause is usually an issue for the jury under Iowa law; however, to survive a motion for summary judgment, a plaintiff must show a genuine fact dispute surrounding the issue. Banks, 73 F.3d at 215-16.

In arguing that plaintiffs' case lacks causation, defendants submit that Mr. Carey underwent surgery in 1993 to replace his diseased and failing aortic valve, and that the CC valve explant was incidental to the aortic implant. As a procedure incidental to the aortic implant, defendants argue that the CC valve replacement did not cause the injuries of which plaintiffs complain. Plaintiffs characterize the 1993 surgery differently, arguing that Mr. Carey consented to the aortic valve surgery only because it presented an opportunity to have the CC valve explanted. They argue that if the CC valve had not carried with it the risk of strut fracture, which could be alleviated by explanting the valve during open heart surgery, Mr. Carey would not have agreed to the open heart surgery and the accompanying aortic valve implant.

Supporting their opposition to summary judgment, plaintiffs present the following material facts: (1) testimony of Dr. Allyn Mark indicating that Mr. Carey's CC valve had thrombus or fibrin strains on it, and that surgery may have been necessary to replace the CC valve even if Mr. Carey did not have aortic valve disease; (2) testimony of Dr. Nicholas Rossi regarding the wisdom of explanting...

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    ...Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986); Carey v. Shiley, Inc., 32 F.Supp.2d 1093, 1096 (S.D.Iowa 1998). To preclude the entry of summary judgment, the nonmoving party must make a showing sufficient to establish the existen......
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  • The 10,000 pound gorilla: federal preemption in class III medical device cases.
    • United States
    • Florida Bar Journal Vol. 80 No. 9, October - October 2006
    • October 1, 2006
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