Opinion ID: 40779
Heading Depth: 2
Heading Rank: 1

Heading: The Evidence of Defect

Text: 49 After Gomez's surgery, the hospital destroyed Angio-Seal as medical waste. Gomez had to rely on circumstantial evidence to prove that the Angio-Seal used on her was defective. As the district court properly noted, however, the law does not distinguish between circumstantial and direct evidence. See, e.g., Holland v. United States, 348 U.S. 121, 140, 75 S.Ct. 127, 99 L.Ed. 150 (1954) (noting that circumstantial evidence is intrinsically no different than direct evidence). On a Rule 50 motion, the district judge could neither weigh the evidence presented nor make credibility determinations about it. See Ellis v. Weasler Eng'g, Inc., 258 F.3d 326, 337 (5th Cir.2001) (citing Reeves, 530 U.S. at 150, 120 S.Ct. 2097) (additional citations omitted). After a thorough review of the record, we find that Gomez met her standard for defeating the Rule 50 motion as it related to defect. 50 Dr. Seth Bilazarian, an interventional cardiologist, Dr. John Eidt, a vascular surgeon, and Dr. Steven Jones, a biomechanical engineer, testified about the Angio-Seal and how it worked to stop bleeding at a puncture site used to access the bloodstream in a catheterization procedure. All gave testimony that supported an inference that a positive extension of the anchor in relation to the bypass tube violated the FDA manufacturing specification, made the device defective, and that the device used on Gomez in March 1999 contained this defect. 51 Dr. Bilazarian testified that he had extensive experience in using Angio-Seals. He testified as to why he concluded that in Gomez's case, the anchor did not perform its intended function of keeping collagen from the inside of the artery. The pathology report showed that the mass removed from Gomez's right femoral artery contained fragments of suture material and collagen. Dr. Bilazarian testified that both came from the Angio-Seal: the suture is used to attach the anchor to the collagen plug; and Gomez's own collagen would not be found inside her blood vessel, but only in the artery wall itself. (Tr. at 169, 172). The contents of the mass supported an inference that the Angio-Seal anchor did not operate properly. Bilazarian testified that the pathology report was consistent with collagen causing a clot to form inside Gomez's artery, instead of on the outside artery wall. ( See id. at 173). Dr. Bilazarian testified that the medical records showed no evidence of other conditions, such as a clotting disorder, that could explain the clot on the inside of the artery. Dr. Bilazarian also testified that the medical records showed no evidence of causes for a collagen deposit inside the artery wall — such as a separation or dissection of the artery walls when the Angio-Seal was used — other than the improper operation of the Angio-Seal anchor. 52 The district court relied on a statement incorrectly attributed to Dr. Bilazarian in granting Kendall's Rule 50 motion. The district court stated that Dr. Bilazarian had testified that if he saw an Angio-Seal with the anchor extending past the bypass tube, he would simply tap it back into place and use it. The district court found this statement supported his conclusion that there was insufficient evidence of defect to allow the case to go to the jury. The record reveals that Dr. Bilazarian, along with other witnesses, testified that if he saw such an extension, he would not push the anchor back inside the tube and would discard it. (Tr. at 189). 53 Dr. John Eidt also testified that he would discard an Angio-Seal with a positive anchor extension and explained why: 54 When you push [the bracket through the hemostasis valve], it's kind of like going through barroom doors, you kind of have to push them open to get through. 55 I think there is — while the risk is that as you push the device through this sort of rubber seal, that if the extension, if the anchor is sticking out the end of the device it could malposition, it could cause it to rotate or change its relationship to the device so that when you do pull on it, when you get it in the artery instead of it being aligned the way it's supposed to, it's misaligned. 56 (Tr. at 319, 308-09). 57 Dr. Jones, the biomechanical engineer, explained that the hemostasis valve — the barroom doors — are made of silicon, a sticky viscous material harder than the plastic of the anchor. The bypass tube is intended to push through the hemostasis valve, while the anchor remains in the tube's protective sheath. Dr. Jones testified that if the anchor extended past the bypass tube and was the part of the Angio-Seal pushing through the hemostasis valve, the anchor could be damaged and mispositioned inside the artery. In its proper position, the anchor is flat against the inner artery wall. If it is damaged when inserted into the artery, it could be positioned at an angle to the artery wall instead of flush against it. When the surgeon uses the tamping tube to tamp the Angio-Seal collagen plug, an angled anchor could allow collagen to be tamped down into the artery itself. Dr. Eidt testified that he could move a positively-extended anchor back into the bypass tube. He was not asked, and did not testify, that he would do so before using the device on a patient. 58 Kendall argued that Gomez presented insufficient evidence that this deviation— an anchor extending beyond the bypass tube — was present in the Angio-Seal used in her surgery or that it was a defect. The evidence showed that the Angio-Seal specifications called for the anchor to be fully within the bypass tube, no more than .05 inches away from the end of that tube. (Tr. at 516). Dr. Jones testified that an anchor extension is on the list of major defects for the Angio-Seal. The evidence at trial showed that the devices supplied to the Ochsner Clinic came from two lots, 100804 and 100858. Kendall followed required protocol and tested 100 randomly-selected Angio-Seals from each of these lots before releasing them for shipment. The tests showed that in one of the lots, 2% of the devices tested had positive anchor extensions that were nonconforming. Jones testified that FDA-approved quality assurance inspections require an entire lot to be discarded if a random test of devices within the lot reveal a defect in 1 out of 1,000 devices (a defect rate of 0.01%). Lot number 100804 had two defective Angio-Seals within the 100 samples: one with an anchor extension of 0.13 inches and one with an anchor extension of 0.14 inches. (Tr. at 483). Lot number 100858 also had two Angio-Seals within the 100 samples with deviations in the anchor position, but this lot had negative, not positive, anchor extensions. The record showed that the bulk of the devices supplied to the Ochsner Clinic came from lot number 100804, which had a 2% incidence of positive anchor extensions. (Tr. at 282, 328, 491-92; Ex. 46). 59 The testimony supported an inference that the lot supplying the majority of the devices shipped to the Ochsner Clinic during the relevant period had a positive anchor extension rate of 1 out of 50 devices, or 2%, well in excess of the FDA standards requiring disposal of the entire lot. Jones testified that a company releasing a lot with such a high incidence of noncomforming devices is pretty much guaranteed [to] send[] out devices that exceed that specification. (Tr. at 483). 60 Under Kendall's FDA-required procedures, [a] record of a nonconformance ... requires quarantine of the discrepant material, review, and disposition by the Material Review Board, and a preventive action response by a designated individual. ( Id. ). Tamara Yount, the Kendall Quality Assurance and Regulatory Affairs directors when Kendall released the two lots at issue, corroborated much of Dr. Jones's testimony about the specifications in the two lots that were the source of the Angio-Seals sent to the Ochsner Clinic. Yount remembered the two lots with the anchor extensions and testified that these were the only two lots that had such deviations. (Tr. at 641-43). 61 Yount served on the Material Review Board that reviewed the deviations from manufacturing specifications and authorized the release of the devices. A Material Review Board cannot authorize release of noncomforming devices unless it determines that the deviation will have no clinical effect. (Tr. at 668). In her testimony, Yount conceded that the positive anchor extensions were not in compliance with the specifications. (Tr. at 656). Yount testified that the Material Review Board determined that the positive anchor extensions would have no clinical effect on how the Angio-Seals operated. (Tr. at 650). Yount admitted that the Board conducted no regular meetings and did not meet on this issue; kept no minutes; and performed no tests to determine the potential effects of a positive anchor extension in human surgical procedures. 62 Yount's testimony showed that after Kendall discovered the anchor extension problem, it determined the likely cause. The employees placing Angio-Seals in packages were putting the devices too close to the package sealer bars, which could cause the tubes to be pushed back when the package was sealed. Kendall retrained its employees to avoid this problem. Yount agreed with Gomez's witnesses that the purpose of requiring the anchor to be inside the bypass tube is to have the bypass tube push past the hemostasis valve. Yount's testimony did not show that the Material Review Board specifically considered the effect of having the anchor, rather than the tube, push open the valve. 63 The jury heard testimony from witnesses, including Dr. Bilazarian, Dr. Eidt, and Dr. Jones, that the anchor could be damaged if it extended beyond the bypass tube and had to push past the hemostasis valve. (Tr. at 650, 668-72). Kendall emphasizes that Dr. Christopher White, Gomez's treating physician and the only witness who actually observed the Angio-Seal used, did not record any indication of a positive anchor extension and had no recollection that he had ever seen one. Medical witnesses who had also used Angio-Seals testified that a physician might not notice an anchor extension in preparing to use the device at the end of a surgical procedure. (Tr. at 325). The fact that Dr. White disagreed with some of Gomez's expert and fact witnesses, however, or that there were inconsistencies in some of the testimony of the witnesses Gomez called, does not support granting the Rule 50 motion. The evidence could support an inference that the Angio-Seal used on Gomez had a positive anchor extension and that this condition was a defect. Gomez presented sufficient evidence to have the jury weigh it and make the credibility judgments necessary to resolve any conflicts. Accord Ellis, 258 F.3d at 337-38.