Case 2:11-cv-00195 Document 387 Filed 08/12/13 Page 1 of 11 PageID #: 30774 IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA CHARLESTON DIVISION IN RE: C. R. BARD, INC. PELVIC REPAIR MDL NO.: 2187 SYSTEM PRODUCTS LIABILITY LITIGATION THIS DOCUMENT RELATES TO: ) DONNA CISSON and DAN CISSON ) 2:11-cv-00195 PLAINTIFFS MOTION FOR JUDGMENT AS A MATTER OF LAW ON DEFENDANT S AFFIRMATIVE DEFENSES COME NOW Plaintiffs, Donna and Dan Cisson, pursuant to Fed. R. Civ. P. 50(a) and move for judgment as a matter of law in their favor on Defendant C. R. Bard, Inc. s (hereinafter Defendant or Bard ) Affirmative Defenses of Assumption of Risk, Comparative Fault and Mitigation of Damages and show the Court as follows: Factual and Procedural Background Plaintiffs submit that the testimony of Donna Cisson and that of Dr. Brian Raybon, the physician who implanted Mrs. Cisson with the Avaulta Plus product, are dispositive of Bard s affirmative defenses of assumption of risk, comparative negligence, and mitigation of damages. Therefore, a brief synopsis of this testimony as it relates to these affirmative defenses is provided here. Mrs. Cisson testified that, at the time of her Avaulta Plus procedure, she had never heard that the product was defective and she was not aware of the dangers that she now knows are associated with the defective design of the product. (8/5/13 T., 80:15 80:20, 87:04 87:09). Mrs. Cisson had never heard about shrinkage, contraction, scarification or pore size as these issues relate to transvaginal mesh, and more specifically, the Avaulta Plus. (8/6/13 T., 43:09 43:15). -1-
Case 2:11-cv-00195 Document 387 Filed 08/12/13 Page 2 of 11 PageID #: 30775 Mrs. Cisson testified that she knows that all medical procedures and medicines have risks. (8/5/13 T., 129:1 129:14). Additionally, she testified that she has consented to other medical procedures throughout her life and was aware that these procedures had risks. (Id. at 130:19 132:23, 137:07 142:05). When asked why she consented to the Avaulta Plus procedure, Mrs. Cisson testified that she trusted Dr. Raybon and did not believe that he would recommend a defective product. (Id. at 76:8 76:12, 78:24 79:03, 178:11 178:14). Mrs. Cisson further testified that she would not have consented to the Avaulta Plus procedure if Dr. Raybon had not recommended it. (Id. at 79:01 79:24). Dr. Brian Raybon was a preceptor for Bard and was integrally involved in teaching other doctors how to use the Avaulta Plus. (7/30/13 T., 12:06 15:15). Dr. Raybon testified that he taught hundreds of doctors how to use the Avaulta Plus. (Id. at 12:19 12:22). Despite his relationship with the company, however, Dr. Raybon testified that critical information was not conveyed to him by Bard which prevented him from understanding the nature and extent of the defects in the product, even though Bard was aware. (7/30/13 T., 102:22 104:11 (was not told the mesh would shrink 30%-50%, but instead was told no more than 15%); 104:12-18 (was not told that mesh was overengineered with respect to strength for the biologic quality); 104:19 105:8 (was not told that mesh design formed a rigid scar plate and did not integrate well over time with host tissue); 105:09-20 (was not told that the minimum pore size necessary was 2.5-3 mm); 106:25-107:23 (was not told that Bard never had any data on mesh shrinkage); 107:24-109:13 and 111:21-112:6 (was not told that Avaulta Plus had a higher risk of delayed healing, extrusion and rejection because of the attached pig-skin sheet, but instead was told that the pigskin was intended to reduce erosions); 109:14-111:20 (was not told that Bard had a warning -2-
Case 2:11-cv-00195 Document 387 Filed 08/12/13 Page 3 of 11 PageID #: 30776 from the supplier of the raw material used to make the mesh that the material was not to be used in permanent implants in humans)). Dr. Raybon testified with conviction that the information above represents problems with the Avaulta Plus that would have led him to avoid implanting the product in his patients, including Donna Cisson. (Id. at 88:12 88:23, 102:02 104:04, 104:19 105:20, 108:10 109:09, 109:14 110:15). Dr. Raybon testified unequivocally that he did not inform and could not have informed Mrs. Cisson of all of the risks associated with the Avaulta product because he was unaware of all the risks. (Id., 112:13-18). He absolutely could not have warned her about the defective nature of the device because he was unaware himself. Rule 50(a) standard for judgment as a matter of law A Motion for Judgment as a Matter of Law is appropriate under Rule 50(a) if there is no legally sufficient evidentiary basis for a reasonable jury to find for a party on an issue. Fed.R. Civ. P. 50(a). The non-moving party must present more than a mere scintilla of evidence suggesting that reasonable minds could reach differing verdicts. Thorne v. All Restoration Services, Inc., 448 F.3d 1264, 1266 (11 th Cir. 2006). Instead, a claim or affirmative defense should only be submitted to the jury where there is a substantial conflict in the evidence as to the claim or affirmative defense. Id. Argument and Citation of Authority A. Defense Nos. 5 and 40: Assumption of Risk Assumption of risk is not a viable defense in a product liability action under Georgia law unless the consumer discovers the [product s] defect and is aware of the danger [emanating from that defect], but nevertheless proceeds unreasonably to make use of the product.... Coast Catamaran Corp. v. Mann, 321 S.E.2d 353, 356 (Ga. Ct. App. 1984), judgment aff d, 326-3-
Case 2:11-cv-00195 Document 387 Filed 08/12/13 Page 4 of 11 PageID #: 30777 S.E.2d 436 (disapproved of on other grounds by, Banks v. ICI Americas, Inc., 450 S.E.2d 671 (Ga. 1994)) (Emphasis added; brackets in original). The issue is a subjective one geared to the particular plaintiff and his situation.... Hightower v. Cox, 418 S.E.2d 613, 616 (Ga. Ct. App. 1992) (citing Coast Catamaran Corp., 321 S.E.2d 353, 356 (Ga. Ct. App. 1984)). In Hillman v. Carlton Co., 240 Ga.App. 432, 434 (1999), the Georgia Court of Appeals explained the distinction between an assumption of risk and comparative negligence: Assumption of risk means the plaintiff is fully aware of the dangerous defect or condition caused by defendant's negligence but freely chooses to proceed nonetheless. Contributory or comparative negligence means the plaintiff, though exposing himself to danger, nevertheless is unaware of the defendant's negligence and thus expects the defendant to act or to have acted with reasonable care. The assumption of risk defense is inapplicable on its face based on the evidence presented during this trial. Georgia law is well-established that one cannot assume the risk of the negligent act of another, in this case, Bard s negligence in failing to warn and designing the Avaulta products. See, e.g., Little Rapids Corp. v. McCamy, 218 Ga.App. 111, 113-114 (1995) ( Significantly, the rule [of assumption of risk] does not extend to assuming the risk of the negligent act of another. (Internal Citations Omitted)). Georgia s pattern jury charge on the assumption of risk defense in a products action, which succinctly and accurately summarizes Georgia law on this affirmative defense, is set forth below. (Georgia Suggested Pattern Jury Instructions, Volume I: Civil Cases, Fifth Edition). [1] As set forth in the pattern jury charge, the [1] 62.700 Assumption of the Risk Defense Every person has the duty to exercise ordinary care for his/her own safety. If a person discovers a product's defect and is aware of the danger but nevertheless proceeds unreasonably to make use of the product, taking a risk which in and of itself amounts to a failure to exercise ordinary care for his/her safety, he/she cannot later hold another person responsible for any injury suffered due to taking such a risk. If you find by a preponderance of the evidence that 1) the plaintiff knew of the danger posed by the defective product, 2) the plaintiff understood and appreciated the risks of that defect, and -4-
Case 2:11-cv-00195 Document 387 Filed 08/12/13 Page 5 of 11 PageID #: 30778 assumption of the risk defense is applicable in a products liability action only [i]f a person discovers a product s defect and understood and appreciated the risks of that defect. (Emphasis added). Bard cannot meet its burden of proving such defense under the facts of this case; it certainly cannot prove it by showing that the Plaintiff accepted certain risks associated with her surgery. The evidence presented in this case is that Mrs. Cisson was not aware that the Avaulta Plus was defective and was not aware of the risks specifically related to the defect in the product. (8/5/13 T., 80:15 80:20, 87:07 87:09; 8/6/13 T.,43:09 43:15). The record is clear that Mrs. Cisson relied on the advice of Dr. Raybon in consenting to the implantation of the Avaulta Plus and that she did not believe that he would implant a defective device in her body. (Id. at 76:8 76:12, 78:24 79:24, 178:11 178:14). This evidence is completely undisputed. No reasonable jury could find, based on the evidence presented during the trial in this case, that Mrs. Cisson knew that the Avaulta Plus was defective at the time she consented to the implant procedure. Therefore, Bard s assumption of the risk defense fails as a matter of law. While it is Mrs. Cisson s subjective knowledge and understanding that is relevant to this inquiry, Dr. Raybon s testimony provides additional support for her lack of knowledge of a defect in the product. Mrs. Cisson s implanting physician, who was a preceptor for Bard, also was completely unaware of the nature and extent of the defects in the product; thus, a reasonable 3) the plaintiff knowingly and voluntarily exposed himself/herself to such a risk, then the plaintiff would not be entitled to recover, and you would return a verdict for the defendant. Center Chemical Co. v. Parzini, 234 Ga. 868 (1975) Sharpnack v. Hoffinger Industries Inc., 223 Ga. App. 833 (1996) Raymond v. Amanda Co., Ltd., 925 F. Supp. 1572 (N.D. Ga. 1996). -5-
Case 2:11-cv-00195 Document 387 Filed 08/12/13 Page 6 of 11 PageID #: 30779 jury could not find that Mrs. Cisson had knowledge contrary to that held by her doctor, again Bard s own preceptor. Bard has not refuted the testimony discussed above. Bard has presented no evidence that Mrs. Cisson subjectively understood or assumed any risk of having a defective product implanted in her body. Additionally, Bard has presented no evidence to establish that Mrs. Cisson knew that the Avaulta Plus product being implanted in her body was defective or that she was aware of any danger that was associated with any such defective condition. Mrs. Cisson did know that there were some risks associated with this procedure, just as she knows that that there are risks associated with all medical procedures. (8/5/13 T., 129:1 129:14). However, this does not support the contention that she knew the Avaulta Plus was defective, which was Bard s burden to show. Bard has not satisfied its burden, and it has presented no evidence to contradict the testimony of Donna Cisson that she did not know the product being implanted in her body was or could be defective. In denying summary judgment on Plaintiffs motion on this affirmative defense, the Court held that Bard was entitled to argue in the alternative. Throughout the course of this trial, Bard has never argued in the alternative that Mrs. Cisson knew that the Avaulta Plus was defective. Bard has never conceded that the Avaulta Plus was defective, or that there is evidence upon which the jury could find the Avaulta Plus defective. Instead, Bard s defense has been solely that the product is not defective in any way. Given Bard s defense, it is logically impossible for Bard to now contend that there is a question of fact on its assumption of risk defense. Therefore, Bard s affirmative defense of assumption of risk must fail. The only evidence that has been presented on this issue is that Mrs. Cisson did not know that the Avaulta Plus was defective and that she was unaware of the dangers associated with the -6-
Case 2:11-cv-00195 Document 387 Filed 08/12/13 Page 7 of 11 PageID #: 30780 defects in the product. Therefore, judgment as a matter of law should be granted in favor of Plaintiffs on Bard s asserted affirmative defense of assumption of risk. B. Defenses Nos. 14-15: Comparative Negligence of Plaintiff Under the comparative negligence doctrine of Georgia, a plaintiff whose negligence is less than that of the defendant is not denied recovery, but his damages are reduced by the jury in proportion to the degree of fault attributable to him. Bridges Farms, Inc. v. Blue, 267 Ga. 505 (1997). The plaintiff s recovery can only be reduced if her negligence proximately caused her injury. Id. at 506. In the present action, there is a complete absence of evidence that could support a finding that Mrs. Cisson was negligent or at fault in any way that contributed to or caused her injuries. Raybon, himself a Bard preceptor, testified that Mrs. Cisson was a compliant patient who did nothing to cause her own injuries. (7/30/13 T., 85:20 86:10, 113:02 113:06). Bard not only has presented no evidence of negligence by Mrs. Cisson, Bard also not presented any evidence of any act or omission by Mrs. Cisson that in any way caused or contributed to her injuries. Specifically, Bard has not delivered on the evidentiary promises contained in its Opposition to Plaintiffs Motion for Partial Summary Judgment on Defendant s Affirmative Defenses. (Dkt. No. 203). In its summary judgment response brief, Bard argued that it would present evidence that three distinct acts and omissions that contributed to Mrs. Cisson s injuries. First, Bard referenced evidence that Mrs. Cisson s failure to lose weight before and after her implant surgery contributed to her injuries. (Id. at pg. 7). However, Bard has not presented any evidence to support this contention and specifically did not elicit any testimony to this effect from its urogynecology expert, Dr. Vincent Lucente. Second, Bard argued that summary judgment was inappropriate due to evidence that Mrs. Cisson did not use Estrace estrogen -7-
Case 2:11-cv-00195 Document 387 Filed 08/12/13 Page 8 of 11 PageID #: 30781 cream as instructed by her physicians. (Id. at pg. 8). However, at trial, Bard expressly abandoned this argument. (8/5/13 T., 103:12 104:14). Finally, Bard argued that it would present evidence that Mrs. Cisson s failure to seek a second opinion or attempt conservative treatment contributed to her injuries. (Dkt. No. 203 at 8). At trial, Dr. John Miklos, the physician who explanted the center portion of Mrs. Cisson s Avaulta Plus, testified that conservative treatment was not appropriate and that the mesh needed to be removed. (Miklos T., 44:19 45:18). Further, Mrs. Cisson did seek a second opinion from Dr. Joshua Sepesi after treating with Dr. Raybon. (8/5/13 T., 91:23 96:23). Dr. Sepesi referred Mrs. Cisson to Dr. Miklos for a possible revision surgery and she took this advice. (Id. at 96:18 97:07). Dr. Miklos was the third specialist that Mrs. Cisson had seen in hopes of finding some relief from her complications. A reasonable jury could not find that Mrs. Cisson acted unreasonably when she chose not to seek a fourth opinion. Additionally, Bard s expert, Dr. Lucente, testified that Dr. Miklos acted appropriately in the treatment of Mrs. Cisson and that he would not second guess his treatment. (8/9/13 T., 267:20 268:02, 269:23 270:15). Therefore, Bard has failed to present any evidence that Mrs. Cisson acted unreasonably in consenting to a revision surgery by Dr. Miklos or that this revision surgery was causally related to her injuries. Because there is no genuine issue of material fact regarding Bard s defense of comparative negligence, Plaintiffs are entitled to judgment as a matter of law in their favor as to this defense. C. Defense No. 5: Mitigation of Damages In Georgia, although a plaintiff must take ordinary and diligent steps to mitigate her injury to the extent practicable, it is the adverse party s burden to show that the plaintiff failed to properly mitigate her damages. Ga. Code Ann. 51-12-11 (West 2012); Moreland Auto Stop, -8-
Case 2:11-cv-00195 Document 387 Filed 08/12/13 Page 9 of 11 PageID #: 30782 Inc. v. TSC Leasing Corp., 454 S.E.2d 626, 628 (Ga. Ct. App. 1995) (quoting Central Nat. Ins. Co. of Omaha v. Dixon, 373 S.E.2d 849, 852 (Ga. Ct. App. 1988) ( While it is true that [the plaintiff] had a duty to mitigate its damages, [t]he burden is upon the party asserting that the opposite party could have lessened his damages, and such proof must include sufficient data to allow the jury to reasonably estimate how much the damages could have been mitigated. ) (Emphasis added). As set forth in Bard s response to Plaintiffs summary judgment motion (Dkt. No. 203, p. 13), a plaintiff must be negligent in failing to mitigate her damages in order to provide a basis for the defense of mitigation of damages. Again, however, Bard has presented absolutely no evidence that Mrs. Cisson failed to take reasonably diligent steps to mitigate her damages upon sustaining injuries attributable to Bard s defective product. As set forth above, Mrs. Cisson s doctor has testified that she complied with his instructions, and she did nothing that could have caused her own injuries. (7/30/13 T., 85:20 86:10, 113:02 113:06). Additionally, the arguments set forth above regarding Bard s comparative negligence affirmative defense are equally dispositive of Bard s affirmative defense of mitigation of damages. Bard has simply failed to present evidence to support its defenses, and those defenses must fail as a matter of law. Plaintiffs are entitled to judgment as a matter of law on Bard s mitigation of damages defense pursuant to Rule 50. Conclusion Plaintiffs are entitled to Judgment as a Matter of Law on Bard s defenses of Assumption of Risk, Comparative Fault, and Mitigation of Damages because there is no evidence that would support any of the aforementioned affirmative defenses, and no reasonable jury could find in -9-
Case 2:11-cv-00195 Document 387 Filed 08/12/13 Page 10 of 11 PageID #: 30783 favor of Bard on such defenses. For these reasons, Plaintiffs respectfully ask that the Court grant their Motion for Judgment as a Matter of Law as set forth above. This 12 th day of August, 2013. Blasingame, Burch, Garrard & Ashley, P.C. P.O. Box 832 Athens, GA 30603 (706) 354-4000 By: /s/ Henry G. Garrard, III Henry G. Garrard, III hgg@bbgbalaw.com Georgia Bar No. 286300 Gary B. Blasingame gbb@bbgbalaw.com Georgia Bar No. 062900 James B. Matthews, III jbm@bbgbalaw.com Georgia Bar No. 477559 Andrew J. Hill, III ajh@bbgbalaw.com Georgia Bar No. 353300 Josh B. Wages jbw@bbgbalaw.com Georgia Bar No. 730098 Counsel for the Plaintiffs -10-
Case 2:11-cv-00195 Document 387 Filed 08/12/13 Page 11 of 11 PageID #: 30784 CERTIFICATE OF SERVICE I hereby certify that on August 12, 2013, I electronically filed the foregoing document with the Clerk of the Court using the CM/ECF system which will send notification of such filing to the CM/ECF participants registered to receive service in this action. Blasingame, Burch, Garrard & Ashley, P.C. P.O. Box 832 Athens, GA 30603 (706) 354-4000 By: /s/ Henry G. Garrard, III Henry G. Garrard, III hgg@bbgbalaw.com Georgia Bar No. 286300 Gary B. Blasingame gbb@bbgbalaw.com Georgia Bar No. 062900 James B. Matthews, III jbm@bbgbalaw.com Georgia Bar No. 477559 Andrew J. Hill, III ajh@bbgbalaw.com Georgia Bar No. 353300 Josh B. Wages jbw@bbgbalaw.com Georgia Bar No. 730098 Counsel for the Plaintiffs -11-