Wolicki-Gables et al v. Arrow International, Inc. et al, No. 8:2008cv00151 - Document 126 (M.D. Fla. 2009)

Court Description: ORDER granting 66 Motion for Partial Summary Judgment; granting 80 Motion for summary judgment; denying without prejudice 81 Motion in limine; granting 82 Motion for summary judgment; denying 85 Motion for summary judgment. The Clerk of Court shall enter a final judgment in favor of Defendants against Plaintiffs Linda Wolicki-Gables and Robert Gables, and close this case. Signed by Judge Elizabeth A. Kovachevich on 7/22/2009. (JM)

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Wolicki-Gables et al v. Arrow International, Inc. et al Doc. 126 UNITED STATES MIDDLE DISTRICT DISTRICT TAMPA OF COURT FLORIDA DIVISION LINDA WOLICKI-GABLES, and ROBERT GABLES, etc., Plaintiffs, CASE NO. v. ARROW INTERNATIONAL, CODMAN JOHNSON GREG & SHURTLEFF, & JOHNSON, 8:08-CV-151-T-17TBM INC., INC., and NELSON, Defendants. ORDER This cause is before the Court Dkts. 66 Motion for Counts Dkt. Partial on: IV and VII Summary Judgment 7078 Depositions Dkt. 90 Response Dkt. 85 Motion Dkt. 101 Response Dkt. 80 Motion for Dkt. 82 Motion for Summary Judgment Dkt. 89 Order Dkts. 95100 for - Summary Judgment Summary Judgment Joinder Depositions Dkt. 102 Deposition Dkt. 103 Response Dkt. 115 Supplemental Authority Dkt. 81 Motion in Limine Plaintiffs' Dkt. 104 109 Exclude Response Dkt. to Experts Notice Dockets.Justia.com Case No. 8:08-CV-151-T-17TBM The Second Amended Complaint Count II Strict Liability Negligence Count III includes Consortium Count I the Arrow Arrow Arrow Count IV Strict Count V Negligence Codman Count VI Consortium Codman Count VII Strict J&J Count VIII Negligence Count IX Consortium J&J Count X Negligence Nelson Count XI Vicarious Liability Arrow Count XII XIII Vicarious Vicarious Liability Liability Codman Count Count XIV Consortium Nelson Count XV Consortium Arrow Count XVI Consortium Codman Count XVII Consortium J&J The Court claims for & Johnson A Stipulation of Count XI, Vicarious (Dkt. 69), Defendants Greg Nelson, I. Standard of discovery and show that J&J as (Dkt. J&J Defendants & Codman & Shurtleff, Prejudice was - Arrow, granted Inc., the Motion International, Inc., (Dkt. and Count (Dkt. Shurtleff, Experts V and Count VIII, Inc. 51). Dismissal with joined in filed as XV, to Consortium 7 9). Johnson & Johnson, for Summary Judgment and the Motion and of in Limine to 89). Review judgment should be disclosure there to Liability Codman Plaintiffs' Summary Codman Liability which was have Defendant Arrow Exclude Liability previously dismissed Count negligence and Johnson Arrow following claims; is no rendered materials genuine issue on as if the pleadings, file, and any affidavits to any material fact the and - Case No. 8:08-CV-151-T-17TBM that the movant Fed.R.Civ.P. is entitled to judgment as a matter of law. 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. The v. Catrett, appropriate of which facts Anderson v. resolved Liberty Lobby. of Atlanta. genuine return U.S. at in about favor of 2 F.3d 1112, "if the evidence a verdict 248. for But, U.S. substantive are material reasonable doubts are 477 the "[i]f 317 law will and which Inc.. the (1986). 477 facts facts U.S. and all the non-movant. 1115 is (11th Cir. such that guide a evidence determination are...irrelevant. 242, 248 (1986). justifiable See All inferences Fitzpatrick v. 1993). A dispute reasonable non-moving party." the the City is jury could See Anderson. 477 is merely colorable...or not significantly probative...summary judgment may be granted." Id. at is II. 249-50. Statement 1. Plaintiff On April Facts 30, 2002, Dr. Linda Wolicki-Gables and catheter Operative of for Note). treatment of Brian to James implant a chronic pain. performed drug surgery on delivery pump (Dkt. 103-3, Case No. 2. Gables 8:08-CV-151-T-17TBM The components implanted in included a pump that intrathecal catheter Plaintiff Linda Wolicki- released pain medication, through which the medicine was into the spinal canal, catheter to the The identifying information ARROW 3000 Cont. Serial No. 8035 IN U.S.A. CE 0128" follows: Co.: Exp. identifying No. AP-07009 Lot No.: 335918 Size: 105 cm, ID 0.5 mm Diopters: N/A MADE The for the pump linked the pump Implant Model: Codman/Arrow Model 4. connector that delivered intrathecal catheter. 3. and a metal an N/A Date: information 2006-03 for the catheter kit 66-8, 80). follows: Arrow Flextip Catalog No. Lot No. The catheter kit Intraspinal includes a connector. comes After implantation, adjusted the dosage (Dkt. individually. of the pain medication it was a (Dkt. p. 66-8, over a period of time, Plaintiff Linda Wolicki-Gables testified that Kit 312737 catheter connector also 5. Plus AP-07009 to 85). James to be administered to through the pump. common process Dr. p. The Dr. James start with a low dosage and gradually find a balance of the amount of medicine with the level of pain relief. Dr. James records state the diagnosis as the diagnosis Dr. James should have testified that although his "malfunctioning implanted device," stated "failed back surgery syndrome." testified that there was no finding during those days Case No. of 8:08-CV-151-T-17TBM any malfunction of 6. On August request, Dr. the 15, pump. 2002, at James performed a whether the infusion pump observed no leaks spread of {Dkt. the in dye. the was 7. 103-9, (Dkt. On Linda Wolicki-Gables' working properly. 103-6, to assess Dr. saw appropriate Procedure Note). James intrathecal After complained of pain the test, radiating to 103-7). July Progress 10, 2003, Note). Dr. "...When the through near needle the James Dr. In back out James' dye was entry both Clearly, pump is site, side Greg schedule it James states: came externally the patient was on function of The Nelson, for just coming of the bolus Linda Dr. (Dkt. and extravasated malfunctioning. Arrow Medical, We will the tested the pump records, nipple down sides. again injected, the and dripping the 95-109.) dye injection test Plaintiff Linda Wolicki-Gables the pump. pp. Plaintiff system and (Dkt. 96, rep for contacted. replacement of her malfunctioning pump. She is to continue on her present meds. reviewed her pump fact receiving refill the medication regular functioning is the just notes. bolus system of function She is through the We in the pump. It is malfunctioning..." 8. On executed an at Doctors Plaintiff inter July 2003, Plaintiff "Informed Consent Same Day signed, alia, to for technical performed, 15, the Surgery Linda to Treat Center. In Wolicki-Gables and Disclose the Informed Plaintiff Linda Wolicki-Gables admittance support and did not to the of room consent students in which Information" and the to the disposal did persons Consent not consent, required procedure [was] of any tissues or Case No. 8:08-CV-151-T-17TBM body parts...removed in accordance with customary practice. Plaintiff initialed "We want old pump." on the form (Dkt. 103- 11). 9. Same On July 15, 2003, Dr. James performed surgery at Day Surgery Center to replace the surgery, the pump was same pump was 10. removed, reimplanted. Defendant a (Dkt. Greg Nelson, Defendant Arrow International, connector was On July 17, Wolicki-Gables, properly, fine, 2003, sales Plaintiff's and identified no clinical 12. On July 29, 2003, and the for in the Operating Room 2003. examined Plaintiff Linda confirmed it was working surgical signs incision site looked of any infection. Plaintiff Linda Wolicki-Gables was unable to move her lower extremities, Sarasota Memorial Hospital 15, James refilled her pump, noted that replaced, representative was present Dr. During the 103-12). during the revision procedure of July 11. infusion pump. Doctors (Dkt. and was 103-15). Gables remained hospitalized until August admitted to Plaintiff Wolicki8, 2003, after which Plaintiff was transferred to another facility for rehabilitation. The discharge diagnosis was transverse myelitis of undetermined cause. 13. Memorial (Dkt. Plaintiff Wolicki-Gables was readmitted to Sarasota Hospital 103-17). time Dr. on August Dr. "No pus 2003 Raymond Priewe Priewe found a note states: 11, for the removal removed the pump. superficial skin infection; in pump pocket or dorsal spine, of the pump At Dr. that Preiwe's only Case No. 8:08-CV-151-T-17TBM superficial 14. Memorial of skin." p. the pump was Hospital. Plaintiff's 15. request 77, removal, After (Dkt. save The pump and catheter parts, or such test as the waste is testified that to place it under the universal Linda Burns with him when The relationship Shurtleff, is at now a of in connector, are 2003 he Sarasota in the custody left. Inc. December, there was p. 1998 & discarded 102, p. 60). no policy that would from taking the connector to shows Defendants the Codman Johnson: Greg Nelson forms Venture Medical Devices, Inc., which served as a distributor of Arrow's implantable pump products to Pre-March, 2002 a in 49.) Greg Nelson Johnson of Surgery Center. to be (Dkt. chronology of events Defendant and 102, absence as waste Day situation" Greg Nelson (Dkt. the the policy to discard medical "red bag rep. following of Same biohazardous protocol. sales in discarded Doctors further testified that have prohibited 16. in the part, accordance with the policies Linda Burns cultured counsel. Small to 39). a Arrow in Florida pursuant contract; designed, manufactured and distributed the pump and catheter kit like those implanted Plaintiff; in & Case No. 8:08-CV-151-T-17TBM March 1, 2002 Codman acquired Arrow's pump division. Codman assumed the distribution contract between Arrow and VMD; VMD continued as an independent contractor authorized to distribute Codman products; April 30, 2002 Pump and catheter kit implanted in Plaintiff; Greg Nelson attended the implant procedure and delivered the pump; July, 2003 Greg Nelson became a Codman employee. 17. Medical The distribution contract between Arrow and Venture Devices, Inc. to be construed as provides that: "nothing creating a principal/agent in the Agreement relationship, employer/employee relationship, Par. an or a joint venture or partnership." is 18. Plaintiffs Johnson catheter Defendants did not kit. design, Plaintiffs and catheter and Johnson 19. Exh. E, 17). that Defendant Arrow designed, tested and sold the subject pump and catheter kit. admit of the pump Inc. 66, Defendant Arrow admits manufactured, & (Dkt. & & Shurtleff, manufacture, test contest only the kit by Defendants or Inc. sell and Johnson the pump and alleged distribution Codman & Shurtleff, Johnson. In Count X of Plaintiffs allege a Codman the Second Amended Complaint negligence claim as to (Dkt. Defendant Greg Nelson, based on the alleged breach of the duty to use reasonable the to the instruction and education of physicians drug delivery system so that it would be 8 30), as care in implantable reasonably safe for its Case No. 8:08-CV-151-T-17TBM intended use. ensure that Plaintiffs the also allege a breach implantable drug delivery system was properly before allowing it to be implanted. allege a duty to ensure that Nelson's that presence Plaintiffs of the duty to in the Plaintiffs operating functioning Plaintiffs consented to room, and a duty further Defendant to verify consented the destruction of the pump parts removed. In the Second Amended Complaint, allegations which refer to the Plaintiffs liability of include no Defendant Nelson on the basis of Defendant Nelson's distribution of the products. The allegations Codman of of Defendants of Defendant Nelson while a Paragraph 7 and Johnson & refer Johnson, subject to the liability based on the actions representative or employee of Defendants. 20. November James Dr. 19, Brian 2008, James was January 7, testified that Plaintiffs. (Dkt. common practice sales 95, p. 12.) for sales representatives not participate Dr. James 2009 and he had only a in the Dr. October (Dkt. are not 15, February 4, 2008, 2009. vague recollection James testified that representatives attend surgical procedures. that deposed on 95, p. of device 9.) in the Dr. sterile surgical procedure. (Dkt. of James periods where the was a testified field and do 95, pp. "A. The decisions regarding patient care that I'm immediately involved in are under my discretion and my decisions. What I don't see when I'm not around I obviously don't have any say-so in. there's it companies to further testified: I mean, Dr. product's 9-11). Case No. 8:08-CV-151-T-17TBM brought in where it's handled. I don't participate in that. I'm not aware what's going on. My decisions are not involved. There's periods when the product is then given to the staff of the facility. I'm not involved in many of the decisionmaking that-any of those encounters, I would not be involved in that. I'm involved in the immediate surgical field and patient care issues Dkt. p. 95., Dr. regarding that." Lines 11, 6-18). James testified as to Plaintiff Linda Wolicki-Gables' revision surgery, surgery. Dr. relying upon the medical records of that James testified that the revision surgery was performed because the bolus function of the pump did not work when Dr. July 10, James procedure, tested it on 2003. after the catheter was cut, pump did work. Dr. James During the the bolus revision function of the testified: Q. When you went in intraoperatively and cut the catheter so there was no potential catheter blockage or crimp, the bolus function of the pump worked just fine. A. Apparently. Q. Now, you made the decision to put original pump back in, correct? the A. According to the operative note I new connector was used to connect the have, intrathecal presently catheter in catheter, the the patient, system. It catheter to the that was pump was then bolused and rechecked with the dye and spread within the spinal canal where it's supposed to go was 10 a Case No. 8:08-CV-151-T-17TBM confirmed. No leaks were seen. Then I took out the old medication that was in the pump, because I did not think she had been receiving it; or I wasn't wanted to drop the dosage down certain; just to be-it's better sorry to be safe than and I in that aspect to avoid any respiratory depression or potential overdose. So that's what was done. Q. So I'm-all right. Strike that. The decision was made after you bolused the pump and saw that the bolus function was working fine to return the original pump into Ms Gables' pump pocket, A. Apparently. Q. So the That's what report, 95, 21. not only apparently. happened based on the operative Right. pp. 36-38). In his deposition of testified that he has implantation of James only-well, correct. A. (Dkt. correct. intrathecal pain pumps. for use, 2009, Dr. James a wealth and depth of experience further testified that instructions February 4, (Dkt. 72-2, intrathecal pain pumps and that Dr. James was aware p. in the 193). come with of all information offered by the manufacturer before performing implantation, Dr. an including all of the known complications reported by the manufacturer associated with the intrathecal pain pump. (Dkt. 72-2, 22. October p. Defendant 1, 2008. an independent 2003. 199-200) . Nelson was deposed on September Defendant Nelson testified that recollection of the 2008 and he did not have surgery performed on July 15, Defendant Nelson testified that, 11 20, in general, the reason Case No. 8:08-CV-151-T-17TBM for his presence in the Operating Room was so products were on hand in the 66-7, event Defendant Nelson they were needed. testified that his {Dkt. role was p. 34). limited to handing a package containing the part to an operating room nurse, who would hand the part to doctor (Dkt. to 66-8, examination of that, in a a scrubbed-in p. 89), the pump fluid) {Dkt. connector is (Dkt. 66-9, 66-9, a p. p. one-time 149). modification 18, 2008, 2008. free use routine to flow of CSF testified remove it's been connected. replacement of a (Dkt. 66-9, p. 2008, Defendant connector to be a 152). Plaintiff Linda Wolicki-Gables was September 24, the testified that the Defendant Nelson testified that of the device September 29, deposed on September 2008 and October 30, Plaintiff Linda Wolicki-Gables testified: Q. Did Doctor-What do you recall Dr. James telling you about the potential complications of the procedure? A. You know, I trusted Dr. James with my life. He put the pump in and he was going to fix the pump. He was going to take it out and put a new one in. Q. Do you potential A. recall him telling you of any complications from the procedure? No. Q. You understood there was infection? 12 the (cerebro-spinal Defendant Nelson device once it the physician's Defendant Nelson it was 14 9). Nelson did not deem the 21. and test. the who would hand and observation of revision surgery, connector to visualize nurse, a risk of Case No. 8:08-CV-151-T-17TBM A. {Dkt. 78-4, There p. is always a risk of infection. 325). Plaintiff Wolicki-Gables testified in detail as heard and saw before and after the surgery of July (Dkt. 78-3, 78-4, testified that after the pp. 312-341) (Dkt. 15, she 2003. Plaintiff Wolicki-Gables Defendant Greg Nelson was surgery. to what 78-4, p. present 327.) and spoke to her Plaintiff Wolicki- Gables testified that she recalled Defendant Nelson telling her that cut the Defendant her back. Nelson (Dkt. 78-4, later testified that p. 331). junction, 15, 2003. Michael Meriwether, testified that connection in Plaintiff Linda Wolicki-Gables speak with room after surgery of July Dr. and did a Plaintiff's best recollection was that Defendant Nelson did not 23. catheter, there was Plaintiff (Dkt. in the 78-4, pp. recovery 356-357). Plaintiff's medical expert, an obstruction at the connector catheter but the obstruction resulted from something unrelated to the product's design or manufacture: Q. However, because of some idiosyncratic complication with the patient, whether it was scar tissue, whether it was a granuloma or, with regard to some technique by the surgeon, a tie-down on the suture, something impaired the ability of the properly designed and properly manufactured system to function as designed? A. (Dkt. 74, Dr. p. I would say, yes. 72-73). Meriwether testified that implanted device might "fail" as a properly designed and the term 13 is used medically, but Case No. that does 8:08-CV-151-T-17TBM not mean that the device was Edward Reese, Ph.D., defective. (Dkt. 74, p. 64). 24. testified that the Plaintiffs' regulatory expert, specific malfunction of the device was a clog in the catheter connector. Dr. Reese further testified that a connector can become clogged without being defective. also testified that, if medicine is reservoir through its continuous spinal cord, (Dkt. 75-5, 75-2, 25. 2008. Dr. out Reese of the pump infusion mechanism into the there would be no clog in the catheter connector. p. 483-484). opinion as to a (Dkt. flowing Dr. p. Dr. Dr. Reese did not design defect, 173, 75-4, Reese pp. only as render an expert to a manufacturing defect. 291-292). submitted his Initial Report on September Reese submitted an Amended Report on December 8, Dr. Reese submitted a further Amended Report on January 11, Dr. Reese submitted a further Amended Report on 2009. 26, Dr. Reese was deposed on January 13, 1, 2008. 2009. February 16, 2009, and February 2009. 26. In his deposition, Dr. Reese testified that Dr. Reese did not include any criticism of Greg Nelson in any report, "signed or scribble amended to this moment" (Greg Nelson) 3, pp. being present (1/13/2009) in an OR on April 30, 2002. of him (Dkt. 242-243.) 27. A "Class 360c(a)(1)(C) is III" medical device under 21 one U.S.C. : a) for which the Agency could not establish[] that a less stringent classification would provide reasonable assurance of safety and effectiveness; 14 75- Case No. b) 8:08-CV-151-T-17TBM which is purported or represented to be for a use supporting or sustaining human life or for which a use of substantial importance in preventing impairment c) which illness 27. of human health; represents or The a in for or potential unreasonable risk of injury. FDA-approved labeling ("IFU")for the Arrow Pump with Bolus is Model 3000 Safety Valve (Instructions 30 mL Constant for Flow Use Implantable states: ADVERSE EFFECTS Possible adverse potential risks delivery device path occlusion, seroma, or effects of the Pump are associated with any those implanted drug and include: catheter thrombosis, bolus vessel thrombosis, pump dislodgement, recurrent hematoma, infection, extravasation, catheter shear, dislodgment or leakage, and migration. Drug extravasation may result if the instructions for use are not followed correctly during a Pump refill (see page 13) or bolus procedure (see page 19).... SUSPECTED PUMP CATHETER OCCLUSION If difficulty is encountered in administering fluids via the Bolus route,..., consider the following possible causes before proceeding to Fibrinolytic Therapy: The Arrow Special Bolus Needle may not be perpendicular to the Pump and fully inserted through the septum, making contact with the needle stop. Reinsert in contact with needle The needle septum and may be flush the needle stop. occluded. to The catheter may be radiologically. until Remove confirm patency. kinked. 15 Confirm from it is the Case No. 8:08-CV-151-T-17TBM If the occlusion persists after taking the above steps, proceed to prepare appropriate Fibrinolytic agent (urokinase, streptokinase) according to hospital pharmacy guidelines.... If occlusion continues 4, (Dkt. call 80-1, 28. provides for technical p. 3, p. to persist after steps assistance.... 1 through 22). The Medical Device Amendments' preemption clause "no State....may establish or continue in effect with respect to a device intended for human use any requirement—(1) which any requirement is different from or applicable under this in addition to, chapter to the device and to safety or effectiveness (2) which relates of the device or to any other matter included in a requirement applicable chapter." U.S.C. 360k(a). III. A. 21 Motions Count Count Sec. for Summary Judgment - summary judgment argues that in International, favor of Plaintiffs' Device Amendments, Food, Discussion I Strict Liability - Arrow II - Negligence - Arrow Defendant Arrow the to the device under this Drug 21 moves Defendant Arrow. claims U.S.C. Inc. Defendant Arrow are preempted by the Medical Sec. and Cosmetic Act, for entry of 360(c), 21 U.S.C. et seq., Sec. Plaintiffs cannot provide evidence sufficient to Plaintiffs' strict liability claim as Plaintiffs Plaintiffs' Greg Nelson. respond that there {"MDA"), 301, et to seq., and sustain required under Florida law. is no preemption of claim based on the acts and/or omissions of Defendant Plaintiffs contend that 16 Defendant Nelson should Case No. 8:08-CV-151-T-17TBM have disallowed the replacement of the connector or replacement of the pump kit). system Plaintiffs argue that through the presence of "off label" Defendant Greg Nelson at use provided the replacement Plaintiffs argue (the infusion pump and catheter Defendant Arrow International Inc., Plaintiff Linda Wolicki-Gables involved in suggested on July of the 15, 2003, the was directly subject product, connector to Dr. Defendant's Motion James surgery of having at that time. for Summary Judgment should be denied. 1. Off Label Use "Off label" use of a medical device occurs when the medical device is used in a manner that varies in some way from the instructions which are in the device's approved uses. The Federal labeling, Food, Drug limited to FDA- and Cosmetic Act regulates the manufacture and marketing of medical devices, the practice of medicine. practice of medicine, A physician may, lawfully prescribe a prescription medication, v. Evers. F.2d 1043 453 F.Supp (5th Cir. of the 1441, 1981). use of drugs The 21 U.S.C. recognizes insert, dosage of conditions of without informing Food and Drug Administration. 1449-50 (M.D. Further, legally marketed medical device. Administration of the different or may otherwise vary the use from those approved in the package or obtaining approval as part Ala. not 1978), U.S. aff'd, 643 a physician may modify a The Food and Drug no difference between the "off label" and devices. Food and Sec. Drug Administration Modernization Act 396, provides: 17 of 1997, Case No. 8:08-CV-151-T-17TBM "Nothing in this interfere with practitioner Chapter shall be the authority of a to to a patient 3000 ("infusion pump") ("catheter kit") approved by the premarket approval submit are approval process detailed Class is each 470, 477 a as the FDA then Once a labeling, would affect as the the 21 U.S.C. to make be device's such initial which application. 999, 1007 (2008); PMA, a manufacturer must adverse events 803.50, 21 United Rieael States v. Medtronic. Supreme Court Inc.. held 128 that 18 device. a FDA a supplemental the same Inc.. device it criteria 128 S.Ct. receives becomes aware 21 C.F.R. Sees. 999 (2008) 803.53. In the for Medtronic. FDA when approval, a manufacturer evaluated under Once 518 attribute which If is v. S.Ct. of specifications, application using Lohr. premarket an inform the patients v. an average efficacy without 814.39(c). in Inc. or any other Rieqel C.F.R. The premarket and efficacy of receives 360e(D)(6)(A)(I). changes, Kit which were spending design, safety or Sec. submitted, its Intraspinal through the safety Medtronic, device Safety in which manufacturers reviews, manufacturing processes, PMA must or Bolus 80-13). process to submission. (1996). Plus devices ("PMA")(Dkt. "rigorous" the Pump with medical change wishes legally care practitioner- Flextip the manufacturer may not approval. or care any Drug Administration information 1,200 on III process which hours Implantable and Arrow Food and their devices, U.S. health limit Preemption The Arrow Model Valve to for any condition disease within a legitimate patient relationship." Express health prescribe or administer marketed device 2. construed the preemption the clause of of Case No. 8:08-CV-151-T-17TBM the MDA barred common effectiveness FDA. The are a imposes in addition conditions to" at Id., approval imposes Court notes premarket at "the reasonable premarket FDA in The its assurance which contributed manner the obligation injury if premarket it device is of or in which based and must or The on serious injury, FDA has newly withdraw ineffective reported under 19 the if the from the reason that a Id. After reporting to inform the studies FDA of concerning should device may to death have caused or in a serious to withdraw data it the know or malfunctioned the power approval labeling. received reasonably the or Supreme deviations likely cause or contribute recurred. unsafe or scientific knows incidents approval information, or to from, are The effectiveness." include death that would and the "[pjremarket form provides subject applicant to approved are the or has devices device which report that for the both which 1007. no whether that at application, the investigations to MDA" almost whether plaintiff's found the law on If a by the clause "different bar Court device state determine to Id., with safety new clinical of...and then under a approval that if requirements applies Supreme approval determine requirements devices." of safety and the MDA preemption FDA requirements. be made determined requirements, must impose requires to approval, that court must 'requirements' approval FDA has a preemption 1006. the for determining court specific individual specifications the a issue the claims. First, so, are met, to explains device-specific If law claims challenging device given premarket two-pronged test manufacturers. "specific Court preempted. PMA process state a medical Supreme establishes claims of law claims or existing determines conditions in that its a Case No. In claims which 8:08-CV-151-T-17TBM Rieqel. supra, alleging were a failure established Such claims are from federal see Blunt v. views federal law the FDA the Id. Rieael v. Medtronic. 167 in Wveth do not based on implied preemption. supra, controls Since the preemption claims involving medical v. preempted. to or differ to abrogate the (11th Cir. 17, Court 129 1187 that tort claims Levine. v. supra, the MDA contains Rieqel individual The S.Ct. held state Wveth 1999); 2009). Levine. devices, of devices Feb. preempt to prescription medication. for medical standards not add supra, Supreme relating preemption provision are F.3d 1367 (Wis. States approval federal that 1011. N.W.2d United the which do not at Medtronic. 760 further notes PMA process claims, the decision which and comply with through Medtronic. also notes in to "parallel" decision in Goodlin v. (2009), Supreme Court requirements. The Court Court the v. an is express Medtronic. and derivative approved through premarket approval. Under Rieael Model 3000 Valve, 30 and The Court claims PMA Kit Plaintiffs' In establish the for supra, considers the PMA approval Implantable approval requirements requirements FDA requirements 3. Flow supplemental therefore impose Medtronic. mL Constant the Intraspinal v. whether different Pump with of the specific Plaintiffs' from, or in the Bolus Flextip to of Plus those state Safety devices. law addition to, the those medical devices. Strict Liability Claim Amended Complaint, Arrow defectively designed, Plaintiffs manufactured, 20 allege tested, that Defendant and/or sold the Case No. 8:08-CV-151-T-17TBM implantable drug delivery systems in a defective condition unreasonably dangerous to its ultimate user, Wolicki-Gables, in the Plaintiff Linda following respects: a) failing to reasonably design the implantable drug delivery system in a manner which would have prevented injury to those like Linda Wolicki-Gables; b) failing to reasonably manufacture the implantable drug delivery systems in a reasonable manner; c) failing to reasonably provide adequate warnings regarding the defective and unreasonably dangerous implantable drug delivery system, having actual or constructive knowledge of the hazards associated with In West v. 1976), the product. Caterpillar Tractor. 336 So.2d 80, 84 (Fla. the Florida Supreme Court adopted the doctrine of strict liability as (Second) stated by the American Law of Torts, "(1) Sec. Institute Restatement 402A: One who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate user or consumer, or to his property if (a) the seller is engaged in the business selling such a product, and (b) it is expected to and does reach the of user or consumer without substantial change in the condition in which it is 21 sold, Case No. 8:08-CV-151-T-17TBM (2) The rule stated in Subsection (1) applies although (a) the care in seller the product, (b) the product a user or that prove by a See F.Supp.2d 1314, The 820. time control, and 3) defect, See Florida "a product that condition." (Civil). could A when to the claim, evidence: 1) if that kit, defective; 2) system left the defect & Upiohn the Sec. in Co., the pump 565 of Class the defect III if user, it is 21 C.F.R. a manufacturing in a condition and the product substantial is change expected affecting Instruction strict rendered the even if the FDA's manufacturing practices. claim is that the expressly 22 strict PL 4 liability claim unreasonably dangerous, finds 814, is a manufacturing defect the LLC. 360e(c)(l); Florida Standard Jury Court defect the 2008). user without devices followed consideration, manufacturing that fact-finder considering a subject medical manufacturer Fla. defective See find liability the the pump Pharmacia U.S.C. law, reach the of manufacturing practices unreasonably dangerous to and does v. 21 is bought Plaintiff Linda Wolicki-Gables' (N.D. FDA regulates Under preponderance the 1320 not any contractual seller." at Colville medical devices. his Linda Wolicki-Gables was system proximately caused injuries. of consisting of the pump and catheter existed Defendant Arrow's has entered into the Plaintiff the defect possible liability manufacturing defect the Arrow pump system, implanted into and sale consumer from or strict Plaintiffs must exercised all and relation with To prove has preparation After liability preempted, and therefore Case No. grants 8:08-CV-151-T-17TBM Defendant Arrow's Motion for Summary Judgment as to this issue. To a prove a claim plaintiff must show distributed the defect renders that for that product it unreasonably dangerous plaintiff's 1337, 181 1346 injury. (M.D. F.3d 1250, The 21 U.S.C. the defect product is in a condition (11th Cir. condition 21 substantial C.F.R. change affecting when used as the benefits." (Civil). A could find See liability the 814. expressly preempted, Judgment as of risk of reach its cause 289 of the F.Supp.2d Bic Corporation. Florida of the design danger in Standard Jury its to law, when design the the user, and user without A product if "the is product design outweighs Instruction even PL 5 liability claim rendered finds Defendant 23 foreseeable by the subject if the manufacturer addressed to design. the Court issue. the strict design defect this the an ordinary consumer would expect and grants to Under condition. FDA regulations consideration, a III medical devices. in a manner reasonably Florida if a v. reason unreasonably dangerous, complied with all Summary Jennings fact-finder considering a medical devices After or that safely as that Crosman Corp.. "if by because intended or the manufacturer, the proximate has 1999). expected to and does to perform as and design, or product unreasonably dangerous is unreasonably dangerous the the design of Class the product fails is defective manufactured that (quoting design defect, in a for unreasonably dangerous 360e(c)(l); is defendant question, 2003) FDA regulates See the liability See Marzullo v. Fla. 1255 strict The that this Arrow's Court claim is Motion notes that, for even if Case this No. 8:08-CV-151-T-17TBM claim were Plaintiff's as not preempted, expert to defective The FDA content labels. 801.109, See 814. The the requirement that use the product safely, relevant hazards, precautions" To for in scientific 289 the light and F.Supp.2d liability completely After of of for were not for 1337, issue in a a at issue an opinion side 21 on how to alia to 801.109. warn, a manufacturer that the "any and C.F.R. failure a or defendant did was known and prevailing best the time available Fla. 711 So.2d 1167, to at See Marzullo {M.D. a risk inter from generally recognized 1347 strict warn 1172 (Fla. if the of Crosman Corp.. 2003)(quoting liability even v. or Feravorni v. 4th DCA 1998). claim could product's A find labeling FDA regulations. and the however, to warn would Court finds therefore grants Summary Judgment are and devices layperson effects is 801.1, that consideration, case such describes, the defendant knowledge conformed to this to [for] particular the failure preempted, failure 21 exempt directions distribution. expressly preempted, Motion render C.F.R. liability that considering for not 360e(c)(l); the package product Hyundai Motor Co.. fact-finder because of prescription regulations if strict and medical manufacture does the prescribing physician. adequately warn knowable fails and appearance 21 there be plaintiff must prove not Reese, contraindications, establish distributor of Dr. claim design. regulates medical device 801.15, witness, this as to this available The this Defendant issue. Plaintiffs' fail. that strict Even claim is Arrow's if claim liability claim subject medical devices only by prescription. 24 this The at Case No. 8:08-CV-151-T-17TBM physician acts or and a seller himself of as the a learned patient. independent patient as well as Pharmaceuticals. the prescribe, dispense involved in the 400 question 683 of (Fla. the plaintiff. 1990). of the 5th DCA 1981). The given to the Felix v. it the warning is the adequate v. a Inc.. as MacMurdo. clear 540 the to warn device] warning accurate, Hoffman-LaRoche. such adequacy of [medical Upiohn is devices the The adequacy of Plaintiffs' Plaintiff Linda Wolicki-Gables which after which caused Dr. Plaintiff Dr. James was manufacturer prior the known insert." duty warning to aware is caused 562 a and So.2d 102, 105 Dr. of is that to perform a Wolicki-Gables of all affects Defendants James. 25 implanted surgery, contracted an Dr. James testified information offered by the are implantation, stated include is revision injuries. the which product contained a manufacturing to performing the adverse warn theory Plaintiffs' complications, Known to James Linda infection which caused The is whether case, defect, of an Allerqan In determining this that the products knowledge the medical the possibility that (Fla. inform 1989). In in case. inquiry law where unambiguous. (Fla. to exercise his Buckner v. So.2d 820 duty of to manufacturer community lawfully authorized to this injury alleged by So.2d 680, and into account and administer critical the physician of the patients, product. the medical warning, physician's a fulfilled by an adequate warning members of those the and characteristics taking Inc.. is is for his judgment, duty to warn It qualities which he prescribes intermediary between the fulfilled in the risk by of the including all "package infection. adequate Case No. 4. 8:08-CV-151-T-17TBM Plaintiffs' Negligence Claim Plaintiffs assert the same claims Plaintiffs raise under the strict liability theory under a negligence theory. strict liability theory, under the negligence the focus in on the product theory, of care was owed to the Under the the focus is injured parties, on itself; the whether a duty and whether the defendants breached that duty of care. In Count II, Plaintiffs allege that Plaintiff Linda Wolicki-Gables the design, manufacture, drug delivery system so intended use. a duty to assembly and that Plaintiffs that its duty by negligently designing, the use sale it would be allege Defendant Arrow owed reasonable of the care implantable reasonably safe for its Defendant Arrow breached manufacturing and assembling implantable drug delivery system by: (a) failing to reasonably design implantable drug delivery system the in which would have prevented injury like a manner to those Plaintiff Linda Wolicki-Gables; (b) failing to reasonably manufacture the implantable drug delivery system in a reasonable manner; and (c) failing to reasonably provide warnings regarding the defective unreasonably dangerous adequate and implantable drug delivery system, having actual or constructive knowledge of the hazards associated with the product. Plaintiffs allege suffered damages as negligence of a that Plaintiff Linda direct and proximate Defendant Arrow. 26 in Wolicki-Gables result of the Case No. 8:08-CV-151-T-17TBM Proof of negligent design and negligent manufacturing requires "evidence product." (M.D. Alvarez v. Feb. Fla. 1999 WL 2009)(citing establish a with 1, 1062135 requires of the existence of (S.D. prima Fla. facie Plaintiffs injuries. was causation is not speculation or verdict for Under reasonable 1309 failing to person do injury or damage be cause of the like Armstrong care is is the that in doing would not that circumstances. do a degree like under reasonably Negligence or contributes for injury the have occurred. loss, at best Industries. or damage, negligence, so the In order to be injury or damage, use care which that loss, a a circumstances, careful is a a person legal natural substantially that it can cause and to reasonably injury or regarded as negligence 27 to circumstances. like sequence produces but one of pure to direct a of something directly and in loss, such World failure it such are court if said that, would not v. factor in 4th DCA 1990). something of producing Reaves likely than not" remains probabilities the duty of either under continuous the negligence would do loss, or Plaintiffs' possibility of the matter law Arrow's substantial person would use under reasonably careful in "A mere Reasonable Negligence may consist or "more was/were a Florida Defendant is Inc.. of the evidence, it that and when (Fla. law, that 248264 in order to action, show the defendant. reasonably careful Further, of it becomes care. 1999). the Danek Medical, cause injuries. Florida 9, v. in 2009 WL proximate conjecture, 569 So.2d 1307, Broderick in a negligence act(s) enough; evenly balanced, Spring Co.. probability" the Defendant Arrow's the defect to prove by a preponderance Plaintiffs must bringing about Wire Apr. case "reasonable medical alleged negligence that General [a] a need not be damage legal the only Case No. cause. even if 8:08-CV-151-T-17TBM Negligence may be though it operates in if loss, the negligence injury or A find market the Court at the preempted, See this claim based the is and proximate on as offered to to Plaintiffs' causation inferences The in a Civil the Jury negligent design of in the of another, negligence, to producing such Instructions. design spite of subject claim could the FDA's medical for pre- devices, expressly preempted, this still FDA's and Summary Judgment establish inspection to injuries. devices of because of a causal quality storage are considering as negligent expressly Reese defect, link between recognizes facts not and no negligent that the a matter of all does jury; law only in and reasonable non-moving party. implement control, "appropriate," equipment and distribution effective. manufacture regulations quality assurance, controls, safe and not determined by determination as the Dr. design The Court ordinarily be develop and environmental and a were "good manufacturing practices" "sufficient" training, design fail the presence will favor of manufacturers claims Florida negligent plain and undisputed cases, that act substantially Arrow's Motion claim would the Court may make or same claim is Defendant an opinion evidence design as the injury or damage issue. If render time the design that therefore grants this the negligent of finds with considering for approval loss, 8. fact-finder liability cause of contributes damage. Model Charge No. legal combination such other cause occurs and to a A "adequate," personnel maintenance, testing, procedures, to assure fact-finder considering and negligent 28 require assembly could find Case No. 8:08-CV-151-T-17TBM liability for these claims, even though the there was complete compliance with FDA regulations controlling the manufacture and assembly of the subject medical devices, differing from or adding to As applying standards FDA's. to negligent manufacture and negligent assembly, Court finds that these claims are expressly preempted, therefore grants to this B. Defendant Arrow's Motion for Summary Judgment as III - Consortium - Arrow The Court has granted Defendant Arrow's Motion Judgment as to strict liability and negligence. liability and negligence, the Court consortium is preempted. The Court grants for Summary Count IV - Judgment Strict Defendant Codman Summary Judgment granted. as finds to this that the claim for claim. Liability - Codman joined in Defendant Arrow's Motion on the basis of express preemption, for which was The Court therefore grants Defendant Codman's Motion Defendants Codman for partial & Shurtleff, Inc. summary judgment undisputed record evidence establishes designed, for strict Defendant Arrow's for Summary Judgment on the basis of express have moved for Summary Because the claim for consortium is derivative of the claims C. and issue. Count Motion the manufactured, preemption. and Johnson on the basis & Johnson that the that Defendant Arrow tested and sold the subject medical devices. 29 Case No. 8:08-CV-151-T-17TBM Plaintiffs as have moved to Defendants Codman Greg Nelson on the catheter & for entry of partial Shurtleff, Johnson issue of distribution of the kit medical devices. determination that Inc., summary judgment Defendants Johnson and Greg Nelson are Plaintiffs Codman & & Johnson and subject pump and seek the Court's Shurtleff, all distributors of Inc., the Johnson & subject medical devices. Plaintiffs liability of paragraph 7 argue that Defendants of the Defendant Nelson. Plaintiffs alleged the vicarious Codman Plaintiffs that a request only Defendants Codman and Johnson as & Second Amended Complaint, the Court determines Nelson to act and Johnson that, Defendant & Johnson, for the to the in actions of extent that Nelson is a distributor, Johnson authorized Defendant distributor of the subject products and are liable as distributors. The undisputed record evidence in this that, at the time of the catheter medical devices Devices, Inc., Inc. initial implantation of the pump and on April 30, 2002, Venture Medical operated by Defendant Greg Nelson, distributor of the Devices, case establishes is subject medical devices. not a party to this case. was the Venture Medical Pursuant to the distribution contract between Defendant Arrow and Defendant Nelson, later assumed by Devices, Inc. was to act as an the medical devices. descriptive actual legal Health Care status of Defendant Codman, labels However, in a independent the Court contract is Inc., the parties 843 So.2d that the use of not determinative 842, depends upon the 30 contractor in selling notes relationship of the parties. Plan, Venture Medical 854 Villazon (Fla. language of the v. 2003). of the Prudential The contract Case No. 8:08-CV-151-T-17TBM and all the circumstances in their dealing with each other. .Id at 854. Generally, the existence of an agency relationship is a question of fact; any supportive however, when the moving party fails to produce evidence or when the evidence presented is unequivocal that reasonable persons conclusion, question of that determined by the court. (Fla. could reach but fact becomes Rubin v. a Gabav. So.2d law to be 988, 990 4th DCA 2008) . Actual agency requires: that the agent will act undertaking; the agent. {Fla. and 3) 1) for him; The 2) the agent's acceptance of the control by the principal See Goldschmidt v. 1990). acknowledgment by the principal key element Holman, is 571 over the actions So.2d 422, Dorse v. Armstrong World (Fla. 1987)(principal must not just the outcome the existence of Pinion v. Industries. such a Inc.. control means itself). n. 5 to So.2d achieve The party who Harvester Co., of the agent. 513 relationship carries International 424 of establishing actual agency is the control by the principal over the actions See one question of 979 so seeks 1265 n. 4 the outcome, to establish the burden of proof. 390 So.2d 154 (Fla. 3d DCA 1980). There is Shurtleff, means no evidence Inc. Defendant or Defendant requires: purported principal; and Johnson & 3) 2) a 1) a devices. representation by the reliance on that change Defendant Codman Johnson controlled the Nelson used to sell medical Apparent agency third party; in the record that representation by a in position by the 31 third party in & Case No. reliance 8:08-CV-151-T-17TBM upon Properties, such Inc., representation. 683 So.2d 513, 514 principal's actions may also give See Chase Manhattan Brvan, Mortgage Barra & Jorgensen, 1997)(existence of expressly, by estoppel, The Court has and Defendant managing the acts of & 2nd DCA 1996). Scott, Royce, 694 So.2d 827, relationship may be 832 A Harris, (Fla. 4th DCA established ratification). for some evidence that Defendant Codman Johnson participated in directing or Defendant Nelson, control was communicated to has v. Henderson to apparent authority. apparent authority, looked Johnson Ilaen v. (Fla. rise Corp. P.a., agency See Plaintiffs and for evidence that at the relevant time, such but found none. A partnership exists when two or more persons or agree to join together in a business or venture common benefit, for their each contributing money or property or services, and each having an partnership is join together interest in the profits. responsible Each member of a for the negligence of any partner if such negligence occurs while the partner is acting on behalf of the partnership and within the scope of the partnership's business. See Florida Civil The Court has Shurtleff, Inc., each had an interest The Court in concludes Defendant Devices, as an Johnson the profits and has implantation, Inc. Instructions. looked for evidence Defendant of medical devices, Jury & that Comment on 3.3c. Defendant Codman & Johnson and Defendant Nelson of Defendant Nelson's sales 30, of found none. that on April 2002, the date Greg Nelson operated Venture Medical independent contractor, 32 and not as an agent, Case No. employee 8:08-CV-151-T-17TBM or partner of Defendants relying on the parties' the distribution The intent as International, tested and sold the pump Complaint law, the notes 30). doctrine retailers, Court and Family Enterprises v. However, cannot not the there. Court Defendants asserted against rest. to Plaintiffs' Motion Motion the Court grants Defendants Court D. Count This strict Motion claim a and See Samuel 1067, 1068 notice a of Florida Friedland (Fla. or 1994). claim which the is claims on which Complaint through the claims a response through After consideration, Summary Judgment of and Johnson Partial claim based Defendant for Codman. & Johnson. Summary as on The Summary Judgment therefore grants for Summary Judgment under The Judgment. Codman derivative Codman's Motion preemption, - for negligence expanded to complaint Partial Inc. Motion Consortium is for devices. a that, the grounds their that Second Amended Summary Judgment, Shurtleff, Plaintiffs' - and only been Summary Judgment. liability against Defendant express VI a entitled to the Motion CodmanS denies for the So.2d into amend for in recognizes 630 read are cannot assert distributors. Defendants, Plaintiffs Defendants' of manufactured, kit medical liability has Amoroso. establishes designed, Greg Nelson strict wholesalers Inc. Plaintiffs The of further and catheter that Defendant (Dkt. and Johnson, expressed in the provisions record evidence Defendant Arrow claim against Johnson agreement. undisputed The Court Codman and to this 33 the claim of Court on Defendant the has granted basis Codman's consortium claim. of Case No. E. 8:08-CV-151-T-17TBM Count VII - Defendant Strict Liability - Johnson Johnson & Johnson joined in Judgment of Defendant Arrow on the basis which the Johnson Court & granted. Johnson's & The Motion Johnson the Motion for Summary of express preemption/ Court therefore grants Defendant for Summary Judgment on the same basis. F. Count IX - Consortium - This claim is Plaintiffs has assert as preemption, Motion G. derivative as to granted Defendant Judgment to Johnson X the Defendant strict - Negligence Plaintiffs Gables' to a instruct Nelson's presence any devices - as to this Arrow's Motion Summary express Johnson Plaintiffs representative, and educate & Johnson's allege that owed a duty to Plaintiff Linda Wolicki- the pain pump was to verify Plaintiff's consent to Defendant and to not dispose of Plaintiff. that Defendant Nelson joined in Defendant for Summary Judgment based on express preemption. Because the Court granted Defendant Arrow's Judgment, of for consortium claim. in the operating room, notes The Court Nelson sales removed from The Court claim Johnson. & Defendant operating surgeon to ensure that functioning properly, liability the basis In the Second Amended Complaint, as strict Johnson liability on and therefore grants Defendant Nelson, Johnson Johnson § Johnson's Motion for Summary Judgment Count of & the Court grants Motion for Summary Defendant Nelson's Motion 34 for Summary Case No. 8:08-CV-151-T-17TBM Judgment. If Plaintiffs' negligence claim still negligence procedure, The Court which is in his was present capacity as at the initial according to the medical notes that critical Dr. of procedures. Dr. Reese does Defendant not relied on his confirmed that the pump was as to this products expert at In addition, own experience functioning. Dr. in performing such at the role was limited to sterile packages After consideration, for Summary Judgment revision procedure of if necessary, carrying to have "back'up" available "scrub in" for the procedure and did not enter the sterile field. Nelson did not come which never left Defendant into contact with the pump on 7/15/2003, the sterile field. Dr. James testified that the decisions made while he performed surgery were his Reese admitted that any Dr. James by The Court for the and to observe preparation of the Defendant Nelson did not on 7/15/2003, (Cite). and in the decision-making during that procedure. in their relayed to James The undisputed facts show that Defendant Nelson did surgeon's use, Dr. opinion the 8/15/2002, Defendant Nelson's Motion Nelson's products. of that procedure. Nelson's presence Nelson was present not participate Defendant sales issue. Defendant 7/15/2003. a render an James tested the pump on the Court grants the implantation records implantation procedure of 4/30/2002. testified that he not preempted, fails. Defendant Greg Nelson, representative, claim is is Reese was aware of no Defendant Nelson during not interaction between 7/15/2003 procedure. Dr. information the aware of any evidence that Dr. Even own decisions. James if the 35 and Defendant finder of fact procedure. establishes Nelson during infers that the Case No. 8:08-CV-151-T-17TBM Defendant that Nelson did surgery, establishes tell Dr. James the Court that James, Reese while does Dr. replace Dr. not know of that After was Dr. connector James claim involving Defendant Summary Judgment Nelson's Court Dr. that Dr. James judgment, Dr. grants and James' Defendant Plaintiffs' negligence participation in the surgery. consent to Defendant Nelson's presence undisputed knew facts that claim based show that Plaintiff Defendant Nelson's liability under Fla. Stat.. limited is a is sales Plaintiffs the consent could not admit looked privacy and HIPAA contradict that the the Defendant deposition, consent to explain how 7/15/2003 damaged The a Court Defendant Judgment The Court as to 36 this to notes 766.103, doctor. never received or saw Defendant Nelson know Defendant Nelson's consent Defendant admits Linda Defendant further Law, form himself Reese 7/15/2003, did not medical did not to informed nor Consent Nelson Plaintiff Plaintiff. Summary Dr. Nelson the OR. for not consent regulations. lack her James 7/15/2003 surgery. at of practitioners. Defendant Wolicki-Gables' In Dr. Florida Medical that lack in the OR on in the OR. to medical of the Wolicki-Gable representative, form for have the on neither Linda presence that Motion to alleged Plaintiffs' unable during that surgery, own medical as to Nelson James any evidence alone. the As Nelson Dr. acted within consideration, for the with performing exercised his Nelson's Motion revision interaction James the James testified discretion. some Defendant Nelson had a duty to affirmatively should not testified that Dr. have of due to patient that no facts Plaintiff Nelson's Linda presence in Wolicki-Gables was presence grants issue. in the OR on Defendant Nelson's Case No. As 8:08-CV-151-T-17TBM to Plaintiffs' claim for negligence based on Plaintiffs' alleged injury from the absence of evidence revision procedure, establishing a causal there is a complete connection between Defendant Nelson's presence in the OR on 7/15/2003 and Plaintiff Linda Wolicki-Gables' injury. Defendant Nelson was present While it is undisputed that in the OR on 7/15/2003, the Court is not aware of any evidence which documents any interaction between Dr. James grants and Defendant Nelson during the procedure. The Court Defendant Nelson's Motion for Summary Judgment as to this issue. As to Plaintiffs' of the pain pump, on 7/15/2003 that Dr. Reese testified that Dr. James should have Reese, According judgment by Dr. resulted in an off the to indicated in the Dr. Dr. James' James as use decisions such not a medical doctor, during the testified removed and replaced everything catheter connector, and intrathecal Reese, of medical the exercise went beyond the product label that the replacement as pump, James advised who is should have originally implanted: catheter. Dr. label" resulted in an "off label" use of the pain pump and Defendant Nelson procedure. Dr. claim based on an alleged "off use, although Dr. labeling and Reese acknowledges catheter connector itself was used exactly FDA approved labeling to connect the pump to catheter. The Court has already recognized that within the context FDCA does not of medical regulate treatment is "off not label prohibited, the practice of medicine. 37 use," as the Case No. 8:08-CV-151-T-17TBM The Court label use" is notes not Defendant Nelson, that Dr. that a claim for negligence based on "off pleaded in the Second Amended Complaint a representative. sales Reese concedes that Dr. judgment was within Dr. free James did in to do what The Court Dr. recognizes James' that the James' for violations of the FDCA. and that replacing only the FDCA and its there also notes but, a Dr. James was connector. regulations prohibit even is no private There is to exercise of medical discretion, off-label promotion by manufacturers, were present in this case, The Court as if such a claim right of action complete absence of evidence as to any claim for negligence based on "off label" marketing and promotion by Defendant Nelson, Plaintiffs' claim for negligence against "off label use." Summary Judgment The Court grants as to this as well as Defendant Nelson for Defendant Nelson's Motion for issue. In the Second Amended Complaint, Plaintiffs allege: 69. GREG NELSON had a duty to ensure that prior to being present in the operating room on July 15, 2003, and prior to destroying or discarding any part(s) of the subject pump removed from MRS. GABLES that he first very whether MRS. GABLES consented to his presence in the operating room and to said destruction or discarding of any part(s) or the pump itself. 71. As a direct and proximate result of Defendant, GREG NELSON's actions of intentionally and recklessly destroying the subject part{s) removed from the subject pump during the July 15, 2003 surgery, Defendant has precluded Plaintiffs from determining to what extent, if any, other defects within the subject pump existed and/or contributed to her current physical problems. In his deposition, Plaintiff Robert 38 Gables testified that Case No. 8:08-CV-151-T-17TBM Defendant Nelson approached him after the 7/15/03 surgery, follows: Q. What outside else did he the tell you in the lobby or lobby area? A. It was in the lobby area. Told me that he had-he was in the room. They had taken the connectors, connection-some kind of connections out of the pump where-after removing the pump from my wife's body and removing the catheter, they turned it over, took out the connections, replaced them, cut a piece of catheter away, and placed it back in, reattached it to the body, and then sewed her up. Q. Anything this else initial A. Yeah. Q. And what A. that he told you during conversation? I asked him where He did he the parts were. say? call said he had to take them back to the for them to test them, I could him in ten business days. Exh. A, manufacturer (Dkt. 82, Q. When spoke A. pp. to About 63,64, 11. 18-9.) did you-when was Greg the next time you Nelson? two weeks later. Q. What prompted you-how did it come about that you talked to Greg Nelson two weeks later? A. I got the number of Arrow. 39 as Case No. 8:08-CV-151-T-17TBM Q. I'm sorry? A. Of—I believe it was Arrow. I was Arrow at the that time. He gave ne number that—it was a think it I'm not Greg Nelson and I it because what happened was, a sure. number don't remember who answered Linda yelled for me as I was in the middle of the conversation. So I didn't actually look, know, it being blah, blah, for like, blah, a you know, you Greg Nelson, subsidiary company of Johnson & Johnson or something like that. You know what I'm saying? I didn't look at any of that. He gave me a number. I called Greg, who was not in. I left a message. He got back to me about a day and a half later. I asked him where the equipment was the pump. of. I that we wanted He told me that says, which time, didn't feel from it was disposed what are you talking about? At I got very, very upset. And he like taking any abuse from me and he hung up on me. {Dkt. 82, Exh. A, pp. 67-68, 11. Q. With Mr. Nelson. conversation with Mr. calling to parts A. I that No. follow up on the status about you can't. I could call you days, want So the substance of the Nelson is that you were of the had been removed? I wanted to could go 16-17). and get know how I could go—how getting the parts. says, why not? in ten days, them. You He says, told me I ten business Ten business days, I them. And he said, They were destroyed. I said, For what reason? He says, That's our policy. After we check them out we destroy them, and there was nothing wrong with them. 40 Case No. 8:08-CV-151-T-17TBM Q. Anything conversation else on you can remember from that the phone with Mr. Nelson? A. Yeah, I didn't believe him because he—I said, you promised them to me. And I told him it was in writing that I was supposed to get the materials and he told me I was going to get the materials and then he discarded them. And he says, click, and that was it. Q. A. (Dkt. 82, Have No. Exh. you ever A., pp. spoken to him since? 69-70, 11. 15-9). Defendant Nelson has no recollection of speaking with Plaintiff Gables after the surgery of 7/15/2003, that he did not remove the purpose of this accepts Reese, Plaintiff or Motion Robert Plaintiffs' discard the connector. for Summary Judgment, Gables' expert catheter version of witness, and testified the testified as the Court facts. follows: Q. If you assume, would you agree with me, sir, that on page 64, line 7, Mr. Gables testified that that Greg Nelson to the that he catheter had been manufacturer A. Yes, Q. If you was told by Greg had to connector removed, for take or back the to them to test that's what it says assume that Mr. Nelson them, referring components the them? in the Gables is depo. correct, that is exactly what Mr. Nelson should have done, returned the removed components to the manufacturer for testing. Correct? A. Absolutely. 41 Dr. For Case No. 8:08-CV-151-T-17TBM Q. So if Gables' you believe-according to what Mr. recollection of what the events were, it wasn't Greg Nelson that discarded the components. He shipped them back to the manufacturer, and after the manufacturer examined them, they were discarded. A. Well, as I testimony here had said, there's conflicting compared to Greg Nelson's deposition Correct? testimony. Q. If you believe what Mr. Gables said concerning his recollection of events, Greg Nelson did not discard the components that was removed on A. Correct. (Objection omitted). Dr. C.F.R. Reese 803.50), possession (Dkt. also of 75-5, The 75-5, not require returned device pp. 433-435, 11. Court from 11. regulation a manufacturer after an Dr. 15-23). to retain evaluation Reese 803.50,(21 is complete. retracted his Plaintiff Linda Wolicki-Gables 75-5, notes counsel, rendered an In his 446-449, federal 18-2). pp. that 453-454, the pump Plaintiff Linda Wolicki-Gables has pp. Correct? Defendant Nelson discarded or disposed of any (Dkt. Plaintiff's 2003. testified that does removed 7/15/2003. (Dkt. 15, a opinion that component July and opinion deposition, Dr. is and 11-17). catheter now in Plaintiffs' as 11. the Sir, am I put your hands not on removed from custody of expert witness, Dr. Reese, to the alleged manufacturing defect. Reese testified as Q. on correct the you've product? 42 follows: never seen, Case No. 8:08-CV-151-T-17TBM A. That's correct. Q. You've never examined the catheter, whether it be the pump catheter or the intrathecal catheter- A. Correct. Q. -for any evidence of crimping; is that correct? A. There Q. Is is that no evidence of crimping. correct? You've never A. That's looked at correct. responsible How would you and know? it. But should the know, doctors who who are looked at it, including Dr. James and Dr. Preiwe, indicated no reference to any crimping. Q. of My question of you, sir, your individual analysis, looked for A. (Dkt. 75-4, Dr. such evidence? Correct. pp. 313-314, Reese further alternative causes exclude is you, in terms have never those 11. 23-17). testified that Dr. Reese to blockage in the connector, alternative identified but did not causes: Q. Okay. And in your opinion, something was done improperly in the manufacturing process that resulted in a blockage at the point of the coupling, A. Yes. Q. What A. yes? Um-hmm. alternative- 43 Case No. 8:08-CV-151-T-17TBM Q. -causes of the blockage did you consider? A. Well, again, with your one possibility is-following analogy of a pipe, experience, at least most of to a pipe, a drain pipe or a being clogged up because you we've all had us, with regards water pipe, have a continual daily deposition of, if you will, for lack of a term, rust that ultimately closes the pipe, or within the continual leads to artery system where build-up a heart cardiovascular, of plaque that attack or other neurological you have ultimately type of failures. In this particular case, the other considerations would be, the body has a natural tendency of wanting to reject materials, so we could have an interaction or a crystallization, if you will, of meds going through that built up and eventually would have clogged up with that. Do the connector. I could go on you want me to go on with that? Q. Well, I would like to know whether you identified and excluded any alternative causes, and I'd like to know what they were. A. No, I did not exclude 11. any alternative 12-17). causes. {Dkt. 75-4, As to pp. 311-312, Plaintiffs' claim for negligence based on acts subsequent to the revision procedure of 7/15/2003, evidence of there no evidence is improper disposal of a the catheter connector expert witness, actual Dr. inspection The Court grants of by there is no Defendant Nelson. causal connection between and any alleged injury. Further, the loss of Plaintiffs' Reese was able to render his opinion without the pump, catheter and catheter connector. Defendant Nelson's Motion for Summary as to this issue. 44 Case No. H. 8:08-CV-151-T-17TBM Count XII - Vicarious The Court Judgment as has to negligence. granted Defendant Nelson's Motion Plaintiff Linda Wolicki-Gables' Defendant Codman. found that Defendant negligent, no negligence Mobil Oil Corp. v. as negligence. to granted Court grants J. as for imputed to 648 this So.2d 119, 121 Defendant Codman's Liability - was not Codman. (Fla. Motion has See 1995). for Summary Johnson & Johnson Defendant Nelson's Motion for Summary Johnson & claim for negligent, & Johnson's Motion no Johnson. for The Summary " issue. Consortium - Nelson This claim is derivative of the claims. Court Defendant imputed to Defendant Johnson Defendant to the Defendant Defendant Codman, Since Defendant Nelson was not Count XIV - Gables' Since Plaintiff Linda Wolicki-Gables' negligence can be Judgment claim for issue. - Vicarious The Court agent can be therefore grants Count XIII Judgment Nelson, Bransford. Judgment as to this I. for Summary At the time of 7/15/03 medical procedure, Nelson was employed by The Court Liability - Codman Plaintiff Linda Wolicki- The Court has granted Defendant Nelson's Motion for Summary Judgment as those claims, and therefore grants Defendant Nelson's Motion for Summary Judgment as 45 to this issue. Case No. K. 8:08-CV-151-T-17TBM Count XVI This claims. for Consortium - claim is Since the the Court Judgment as to This claims. - Since Motion Johnson's IV. Given in Court to which all Codman the Johnson of for Summary Johnson Linda Defendant Judgment Court Summary & Plaintiff granted as to grants Judgment disposition of Judgment, Wolicki-Gables' Johnson & Plaintiff Linda Defendant as to join. The Court this Johnson & issue. Motion Shurtleff, Inc., Motion Codman Nelson & join, for in issues not Summary Johnson 46 & this in Limine, therefore denies for it in the Motion Judgment Inc., Judgment Johnson it granted; in is Summary Johnson case necessary for the Shurtleff, is in the Motion Accordingly, Arrow's Defendants the is raised Defendant that it issues prejudice. and Gregory & the Summary Defendants ORDERED Codman's Motion Limine in Limine without Johnson has Summary for resolve in which Defendant Court claims, for ORDERED Codman's Motion Plaintiff Linda Wolicki-Gables' derivative the Court's the Motions Defendant issue. for Motion Motion to granted Consortium - the Wolicki-Gables' as has grants claim is Johnson's 80), Court this Count XVII Codman derivative of Plaintiff Linda Wolicki-Gables' Summary Judgment claims, L. - (Dkt. further of is & Defendants and Gregory Nelson Case No. 8:08-CV-151-T-17TBM (Dkt. 82) is granted; ORDERED that (Dkt. ORDERED (Dkt. 85) is & 66); that it is it Partial Inc. & Court is Motion & of Johnson is for Partial Summary Judgment further in Limine y of shall enter a International, Johnson, this Inc., (Dkt. 81) is denied Codman judgment & in favor of Shurtleff, Plaintiffs, Inc., and case. July, in Chambers, in Tampa, 2009. to: parties final and Greg Nelson and against I Copies and Johnson Judgment further the Motion DONE and ORDERED All Summary prejudice. Defendants Arrow close for Shurtleff, denied; The Clerk of Johnson further Plaintiffs' ORDERED that without is the Motion Defendants Codman granted it and counsel of record 47 Florida on this

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