Wolicki-Gables v. Arrow Intern., Inc.
| Decision Date | 22 July 2009 |
| Docket Number | Case No. 8:08-CV-151-T-17TBM. |
| Parties | Linda WOLICKI-GABLES, and Robert Gables, etc., Plaintiffs, v. ARROW INTERNATIONAL, INC., Codman & Shurtleff, Inc., Johnson & Johnson, and Greg Nelson, Defendants. |
| Court | U.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).
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.
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
Codman/Arrow
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:
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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