Wolicki-Gables v. Arrow Intern., Inc.

Decision Date22 July 2009
Docket NumberCase No. 8:08-CV-151-T-17TBM.
Citation641 F.Supp.2d 1270
PartiesLinda WOLICKI-GABLES, and Robert Gables, etc., Plaintiffs, v. ARROW INTERNATIONAL, INC., Codman & Shurtleff, Inc., Johnson & Johnson, and Greg Nelson, Defendants.
CourtU.S. District Court — Middle District of Florida

T. Patton Youngblood, Jr., Youngblood Law Firm, Tampa, FL, for Plaintiffs.

Charles D. Bavol, Melissa D. Krepps, Nancy Jean Stewig, Bavol Judge, PA, Edward W. Gerecke, Penelope A. Dixon, David J. Walz, Carlton Fields, PA, Tampa, FL, for Defendants.



This cause is before the Court on:

                Dkt. 66        Motion for Partial Summary
                               Judgment Counts IV and VII
                Dkts. 70-78    Depositions Dkt. 90 Response
                Dkt. 85        Motion for Summary Judgment
                Dkt. 101       Response
                Dkt. 80        Motion for Summary Judgment
                Dkt. 82        Motion for Summary Judgment
                Dkt. 89        Order—Joinder
                Dkts. 95-100   Depositions
                Dkt. 102       Deposition
                Dkt. 103       Response
                Dkt. 115       Supplemental Authority
                Dkt. 81        Motion in Limine to Exclude
                               Plaintiffs' Experts
                Dkt. 104       Response
                Dkt. 109       Notice

The Second Amended Complaint includes the following claims:

                Count I      Strict Liability      Arrow
                Count II     Negligence            Arrow
                Count III    Consortium            Arrow
                Count IV     Strict Liability      Codman
                Count V      Negligence            Codman
                Count VI     Consortium            Codman
                Count VII    Strict Liability      J & J
                Count VIII   Negligence            J & J
                Count IX     Consortium            J & J
                Count X      Negligence            Nelson
                Count XI     Vicarious Liability   Arrow
                Count XII    Vicarious Liability   Codman
                Count XIII   Vicarious Liability   J & J
                Count XIV    Consortium            Nelson
                Count XV     Consortium            Arrow
                Count XVI    Consortium            Codman
                Count XVII   Consortium            J & J

The Court previously dismissed Count V and Count VIII, claims for negligence as to Defendants Codman & Shurtleff, Inc. and Johnson & Johnson (Dkt. 51).

A Stipulation of Dismissal with Prejudice was filed as to Count XI, Vicarious Liability—Arrow, and Count XV, Consortium—Arrow (Dkt. 69), which was granted (Dkt. 79).

Defendants Codman & Shurtleff, Inc., Johnson & Johnson, and Greg Nelson, have joined in the Motion for Summary Judgment of Defendant Arrow International, Inc., and the Motion in Limine to Exclude Plaintiffs' Experts (Dkt. 89).

I. Standard of Review

Summary judgment should be rendered if the pleadings, the discovery and disclosure materials on file, and any affidavits show that there is no genuine issue as to any material fact and that the movant is entitled to judgment as a matter of law. Fed.R.Civ.P. 56(c).

"The plain language of Rule 56(c) mandates the entry of summary judgment after adequate time for discovery and upon motion, against a party who fails to make a showing sufficient to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial."

Celotex Corp. v. Catrett, 477 U.S. 317, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986).

The appropriate substantive law will guide the determination of which facts are material and which facts are ... irrelevant. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). All reasonable doubts about the facts and all justifiable inferences are resolved in favor of the non-movant. See Fitzpatrick v. City of Atlanta, 2 F.3d 1112, 1115 (11th Cir.1993). A dispute is genuine "if the evidence is such that a reasonable jury could return a verdict for the non-moving party." See Anderson, 477 U.S. at 248, 106 S.Ct. 2505. But, "[i]f the evidence is merely colorable ... or is not significantly probative ... summary judgment may be granted." Id. at 249-50, 106 S.Ct. 2505.

II. Statement of Facts

1. On April 30, 2002, Dr. Brian James performed surgery on Plaintiff Linda Wolicki-Gables to implant a drug delivery pump and catheter for treatment of chronic pain. (Dkt. 103-3, Operative Note).

2. The components implanted in Plaintiff Linda Wolicki-Gables included a pump that released pain medication, an intrathecal catheter through which the medicine was delivered into the spinal canal, and a metal connector that linked the pump catheter to the intrathecal catheter.

3. The identifying information for the pump follows:

                          ARROW                Implant Model
                          Model 3000           Cont. No. AP-07009
                          Serial No. 8035      Lot No.: 335918
                          MADE IN U.S.A.       Size: 105 cm, ID 0.5 mm
                          CE 0128"             Diopters: N/A
                                               Co.: N/A
                                               Exp. Date: 2006-03

4. The identifying information for the catheter kit follows:

                          Arrow Flextip Plus Intraspinal Kit
                          Catalog No. AP-07009
                          Lot No. 312737

The catheter kit includes a connector. (Dkt. 66-8, p. 80). The catheter connector also comes individually. (Dkt. 66-8, p. 85).

5. After implantation, over a period of time, Dr. James adjusted the dosage of the pain medication to be administered to Plaintiff Linda Wolicki-Gables through the pump. Dr. James testified that it was a common process to start with a low dosage and gradually find a balance of the amount of medicine with the level of pain relief. Dr. James testified that although his records state the diagnosis as "malfunctioning implanted device," the diagnosis should have stated "failed back surgery syndrome." Dr. James testified that there was no finding during those days of any malfunction of the pump. (Dkt. 96, pp. 95-109.)

6. On August 15, 2002, at Plaintiff Linda Wolicki-Gables' request, Dr. James performed a dye injection test to assess whether the infusion pump was working properly. Dr. James observed no leaks in the system and saw appropriate intrathecal spread of the dye. (Dkt. 103-6, Procedure Note). After the test, Plaintiff Linda Wolicki-Gables complained of pain radiating to the pump. (Dkt. 103-7).

7. On July 10, 2003, Dr. James again tested the pump (Dkt. 103-9, Progress Note). In Dr. James' records, Dr. James states:

"... When the dye was injected, it just came back out through the nipple and extravasated near the needle entry site, coming externally and dripping down the side of the patient on both sides. Clearly, the bolus function of the pump is malfunctioning. The rep. for Arrow Medical, Greg Nelson, was contacted. We will schedule Linda for replacement of her malfunctioning pump.

She is to continue on her present meds. We reviewed her pump refill notes. She is in fact receiving the medication through the regular functioning system of the pump. It is just the bolus function is malfunctioning ..."

8. On July 15, 2003, Plaintiff Linda Wolicki-Gables executed an "Informed Consent to Treat and Disclose Information" at Doctors Same Day Surgery Center. In the Informed Consent Plaintiff signed, Plaintiff Linda Wolicki-Gables did not consent, inter alia, to the admittance of students and persons required for technical support to the room in which the procedure [was] performed, and did not consent to the disposal of any tissues or body parts ... removed in accordance with customary practice. Plaintiff initialed "We want old pump." on the form (Dkt. 103-11).

9. On July 15, 2003, Dr. James performed surgery at Doctors Same Day Surgery Center to replace the infusion pump. During the surgery, the pump was removed, a connector was replaced, and the same pump was reimplanted. (Dkt. 103-12).

10. Defendant Greg Nelson, sales representative for Defendant Arrow International, was present in the Operating Room during the revision procedure of July 15, 2003.

11. On July 17, 2003, Dr. James examined Plaintiff Linda Wolicki-Gables, refilled her pump, confirmed it was working properly, noted that Plaintiff's surgical incision site looked fine, and identified no clinical signs of any infection.

12. On July 29, 2003, Plaintiff Linda Wolicki-Gables was unable to move her lower extremities, and was admitted to Sarasota Memorial Hospital (Dkt. 103-15). Plaintiff Wolicki-Gables remained hospitalized until August 8, 2003, after which Plaintiff was transferred to another facility for rehabilitation. The discharge diagnosis was transverse myelitis of undetermined cause.

13. Plaintiff Wolicki-Gables was readmitted to Sarasota Memorial Hospital on August 11, 2003 for the removal of the pump (Dkt. 103-17). Dr. Raymond Priewe removed the pump. At that time Dr. Priewe found a superficial skin infection; Dr. Priewe's note states: "No pus in pump pocket or dorsal spine, only superficial skin." (Dkt. 77, p. 39).

14. After removal, the pump was cultured at Sarasota Memorial Hospital. The pump and catheter is now in the custody of Plaintiff's counsel.

15. Small parts, such as the connector, in the absence of a request to save or test the part, are discarded as waste in accordance with the policies of Doctors Same Day Surgery Center. Linda Burns testified that in 2003 the policy to discard medical waste is to place it in a "red bag situation" to be discarded under the universal biohazardous protocol. (Dkt. 102, p. 60). Linda Burns further testified that there was no policy that would have prohibited sales rep. Greg Nelson from taking the connector with him when he left. (Dkt. 102, p. 49.)

16. The following chronology of events shows the relationship of Defendant Greg Nelson to Defendants Codman & Shurtleff, Inc. and Johnson & Johnson:

                         December, 1998    Greg Nelson forms Venture
                                           Medical Devices, Inc., which
                                           served as a distributor of
                                           Arrow's implantable pump
                                           products in

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