Summary
explaining that while there were "'alternative techniques' for repairing a ventral hernia using Marlex Mesh," the plaintiff failed to show that there was an alternative safer design
Summary of this case from Wiltgen v. Ethicon, Inc.Opinion
CIV. NO. 98-2007 SECTION "T" (2)
March 31, 2000
ORDER AND REASONS
Plaintiff Teddy Linsley has filed this action against C.R. Bard, Inc. ("Bard") and Davol, Inc. (collectively "Defendants"), alleging that she has suffered injuries because of an unreasonably dangerous product called Marlex Mesh, a monofilament polypropylene surgical mesh manufactured and sold by Bard. This cause came for a hearing on a previous date upon the Motion of the Defendants for Summary Judgment. The Court, having studied the legal memoranda and exhibits submitted by the parties, the record, the arguments of counsel, and the applicable law, hereby GRANTS the Motion of the Defendants for Summary Judgment pursuant to Rule 56(c) of the Federal Rules of Civil Procedure.
I. Background
In June 1990, Linsley developed a ventral incisional hernia in her abdomen where she had received an incisional for gastric bypass surgeries in the mid and late 1980's. On June 27, 1990, E. Michael O'Bryan, M.D. perform surgery at Slicell Memorial Hospital wherein Linsley underwent takedown of a large amount of ventral abdominal adhesions with a resection of the anterior abdominal wall where Linsley had numerous bowel adhesions. Dr. O'Bryan then used a full sheet of Marlex Mesh to repair the abdominal wall defect.
In March 1993, Linsley developed a recurrent hernia at the same location. On March 4, 1993, Dr. O'Bryan performed surgery at Northshore Regional Medical Center to repair the hernia defect. During the hernia repair, Dr. O'Bryan noted a large amount of small bowel densely adhering to the Marlex Mesh, which was inspected, but no evidence of bowel perforation was noted. The Marlex Mesh that Dr. O'Bryan had placed in 1990 "was still in opposition and the majority of it was still functioning well." Dr. O'Bryan repaired the hernia utilizing the same Marlex Mesh placed in 1990 and Linsley was discharged with no complications.
In early 1997, Linsley began to experience fever and pain in her abdominal area. On April 8, 1997, Linsley underwent surgery by Earl Gravios, M.D. which revealed a bowel fistula and infection where the Marlex Mesh implanted in 1990 had eroded into the bowel and a fistula had developed. Dr. Gravios removed the Marlex Mesh and performed surgery for repair of the bowel fistula. Linsley was treated for the infection and later underwent additional treatment and surgery for repair of her bowel and for the infection. On June 3, 1998, Linsley sued Defendants, alleging that the Marlex Mesh was unreasonably dangerous in the cause of her injuries.
II. Legal Analysis
A. Law on Summary Judgment
The Federal Rules of Civil Procedure instructs that summary judgement is proper "if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law." FED. R. Civ. P. 56(c). A genuine issue of fact exists only "if the evidence is such that a reasonable jury could return a verdict for the nonmoving party." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). Under proper circumstances, federal courts favor awarding summary judgment: "Summary judgment reinforces the purpose of the Rules, to achieve the just, speedy, and inexpensive determination of actions, and, when appropriate, affords a merciful end to litigation that would otherwise be lengthy and expensive." Fontenot v. Upjohn Co., 780 F.2d 1190, 1197 (5th Cir. 1986).
The party moving for summary judgment bears the initial responsibility of informing the district court of the basis for its motion, and identifying those portions of the record which it believes demonstrate the absence of a genuine issue of material fact. Stults v. Conoco, Inc., 76 F.3d 651, 655-56 (5th Cir. 1996) (citing Skotak v. Tenneco Resin, Inc., 953 F.2d 909. 912-13 (5th Cir.) (quoting Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986)), cert. denied, 506 U.S. 832 (1992)). When the moving party has carried its burden under Rule 56(c), the nonmoving party may not merely argue the existence of a factual dispute.Anderson, 477 U.S. at 248. Instead, the nonmoving party must come forward with "specific facts showing that there is a genuine issue for trial." Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986); Tubacex, Inc. v. M/V RISAN, 45 F.3d 951, 954 (5th Cir. 1995).
Thus, where the record taken as a whole could not lead a rational trier of fact to find for the nonmoving party, there is no "genuine issue for trial." Matsushita Elec. Indus. Co., 475 U.S. at 588. Finally, the Court notes that substantive law determines the materiality of facts and only "facts that might affect the outcome of the suit under the governing law will properly preclude the entry of summary judgment." Anderson, 477 U.S. at 248.
The Court next examines the substantive law that applies to the products liability claims raised by the plaintiff. Plaintiff claims that Marlex Mesh was unreasonably dangerous because of: (1) its design and (2) its failure to adequately warn physicians qualified to perform ventral hernia repairs of the possible dangers.
B. Unreasonably Dangerous in Design
Linsley's first theory asserts that Marlex Mesh was unreasonably dangerous in design. To prevail under Louisiana's Product Liability Act ("LPLA"), Linsley must prove that:
(1) There existed an alternative design for the product that was capable of preventing the claimant's damages; and
(2) The likelihood that the product's design would cause the claimant's damage and the gravity of that damage outweighed the burden on the manufacturer of adopting such alternative design and the adverse effect, if any, of such alternative design on the utility of the product.
LA. REV. STAT. § 9:2800.56 (emphasis added).
As proof that an alternative design was available to Bard, Linsley points to comments made by a Dr. Paul H. Jordan in a 1985 medical journal. Dr. Jordan suggests that one possible method for preventing adhesion between the intestines and the Marlex Mesh is to place a sheet of silastic between them. Moreover, Linsley asserts that Bard "had to know" of Dr. Jordan's suggestion in 1990 because Bard tested this type of product in 1992. However, Linsley is unable to present any specific facts to show that Bard had an alternative design in 1990. This Court disagrees that Linsley's "had to know" theory is sufficient to withstand Defendants' motion for summary judgement on this issue. See Liberty Lobby, 477 U.S. at 249 (after the moving party has carried its summary judgment burden, the opposing party must set forth specific facts showing a genuine issue for trial and may not rest upon the mere allegations or denials of its pleadings);Matsushita, 475 U.S. at 584-86 (the opposing party must rebut with specific facts that amounts to more than some metaphysical doubt as to the material facts).
Dr. Jordan merely shows that in 1985 there existed "alternative techniques" for repairing a ventral hernia using Marlex Mesh, and not that in 1990 Bard had an alternative design for Marlex Mesh, as required by LA. REV. STAT. § 9:2800.56. Theroit v. Danek Medical, Inc., 168 F.3d 253, 255 (5th Cir. 1999) (held that in order to prove that a product has a defective design, the plaintiff must show that an alternative design existed capable of preventing the claimant's damage); Reeves v. AcroMed Corp., 44 F.3d 300, 308 (5th Cir.), cert. denied, 515 U.S. 1104 (1995) (held that "Louisiana law requires a plaintiff to establish the existence of an alternative safer design for the product," to prevail on a claim for defective design). Thus, Linsley has failed to come forth with sufficient evidence to create an issue of material fact to support her claim that Marlex Mesh was unreasonably dangerous in design and Bard and Defendants are entitled to summary judgment on this issue.
C. Unreasonably Dangerous for Failing to Adequately Warn
Linsley's second theory under the LPLA is that the Marlex Mesh was unreasonably dangerous due to the absence of adequate warning. Specifically, Linsley asserts that Defendants should have provided warning that Marlex Mesh increased the risk of dense bowel adhesions when implanted intraperitoneally. In opposition, Bard contends that it does not have a duty to warn that Marlex Mesh was not dangerous to an extent beyond that which would be contemplated by a physician qualified to perform ventral hernia repairs. First, this Court must decide whether Dr. Suzanne Parisian's report, which is Linsley's primary support for her opposition to the defendants' motion for summary judgement, is admissible. Second, this Court will evaluate whether an issue of material fact exists in regard to the adequacy of the warning.
1. Admissibility of Dr. Parisian's Report
Linsley presents the expert report of Dr. Parisian, a registered pathologist, as the primary evidentiary support for her opposition to the defendant's motion for summary judgment. When a court must consider an expert testimony in support of, or in opposition to, a motion for summary judgment, the court must determine if the evidence contained in the expert report is admissible. United States v. Hangar One, Inc., 563 F.2d 1155, 1157 (5th Cir. 1977). Thus, if a party offers expert opinion evidence at a hearing on a motion for summary judgment, the court must determine if such evidence would be admissible at a trial on the merits. Elliott v. Massachusetts Mut. Life Ins. Co., 388 F.2d 362, 366 (5th Cir. 1968); see Claar v. Burlington Northern R.R. Co., 29 F.3d 499, 500-03 (9th Cir. 1994) (since expert affidavits in opposition to motion for summary judgment did not comply withDaubert, no disputed issues of fact were presented by the opposing party and summary judgment was proper). "Evidence inadmissible at trial cannot be used to avoid summary judgment."Salas v. Carpenter, 980 F.2d 299, 305 (5th Cir. 1992) (quotingBroadway v. City of Montgomery, 530 F.2d 657, 661 (5th Cir. 1976)).
Due to the technical and scientific nature of Linsley's claims, Linsley relies solely on expert opinions to raise material issues of fact as to several essential elements of her product liability claims. In particular, she offers Dr. Parisian's expert report for support on the issues of adequacy of warning and causation. The Court therefore must review the expert opinion testimony in light of Federal Rules of Evidence 702 to determine if such expert opinion evidence is admissible. FED. R. EVID. 702.
Rule 702 provides that
[i]f scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise.Id. Furthermore, the United States Supreme Court held that Rule 702 confides to the district court some "gatekeeping responsibility" to ensure that only reliable expert testimony is admitted. Daubert v. Merrill Dow Pharmaceuticals, Inc., 509 U.S. 579, 597 (1993). Moreover, the Court clarified that the gatekeeper role of the district court applies to all expert testimony, not just scientific testimony. Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137 (1999).
Linsley asserts that Dr. Parisian has the requisite "knowledge, skill, experience, training, and education under Rule 702," to testify as an expert regarding the labeling that was provided to Dr. O'Bryan in 1990. In support, Linsley points to several facts such as: (1) Dr. Parisian is a Board Certified Pathologist; (2) Dr. Parisian has been qualified as an expert in several other product liability cases; and (3) Dr. Parisian worked for the United States Public Health Services (specifically, the FDA and Armed Forces Institute of Pathology) from 1991 to 1995. As her strongest authority for allowing Dr. Parisian to testify as an expert in this case, Linsley cites Porterfield v. Ethicon, Inc., 183 F.3d 464 (5th Cir. 1999) (affirming district court's grant of summary judgment on product liability case because the plaintiff failed to present evidence that failure to warn was a producing cause of her injury).
In Porterfield, Dr. Parisian was retained to provide expert testimony with regard to FDA labeling. Specifically, Dr. Parisian was asked to provide expert testimony about allergies in terms of what was known in the literature and what should appear in the labeling. Porterfield is distinguishable, however because this case centers around the knowledge of one skilled in the art of ventral adhesion repair and Dr. Parisian clearly states in her deposition that: (1) she has never worked with Marlex Mesh or any other type of surgical mesh; (2) she is not a surgeon nor is she capable of providing any opinions on the surgical use of Marlex; (3) she has never performed any medical research, other than medical literature research, of Marlex Mesh; (4) she is not familiar with LPLA or its requirements for labeling; and (5) she has conducted medical literature research for this case, but has never published anything with regard to surgical meshes or bowel adhesions.
Therefore, after reviewing the information provided by both parties, this Court concludes that, in accordance with Rule 702, Dr. Parisian is only allowed to provide expert testimony in a limited capacity. Specifically, Dr. Parisian may only offer expert testimony as to whether the Marlex Mesh labeling is acceptable under FDA standards. This Court finds it necessary to exclude any testimony she may offer toward causation or adequacy of labeling under LPLA because the record shows that any such testimony would be both unsubstantiated and unreliable. See Watkins v. Telsmith. Inc., 121 F.3d 984, 989-90 (5th Cir. 1997) (affirming the exclusion of a plaintiffs expert's opinion underDaubert in a product liability case).
2. Adequacy of the Warning
The LPLA provides that
[a] product is unreasonably dangerous because an adequate warning about the product has not been provided if, at the time the product left its manufacturer's control, the product possessed a characteristic that may cause damage and the manufacturer failed to use reasonable care to provide an adequate warning of such characteristic and its danger to users and handlers of the product.
LA. REV. STAT. § 9:2800.57(A).
Because this case involves a medical device, Louisiana law applies the "learned intermediary doctrine" to claims of failure to warn involving medical devices which are dispensed by a physician. Zachary v. Dow Corning Corp., 884 F. Supp. 1061, 1065 (M.D. La. 1995). "The `learned intermediary doctrine' provides that the manufactures of prescription medical products have a duty only to warn physicians, rather than patients, of the risks associated with the use of the product." Harris v. Danek Medical, Inc., 1999 U.S. Dist. LEXIS 18893, *11 (M.D. La. 1999) (citingWillett v. Baxter Intern., Inc., 929 F.2d 1094, 1098-99 (5th Cir. 1991)). Marlex Mesh was and is a prescription medical device, which requires that it be used only upon order of a qualified physician, thus the warning required is not to the general public or to the patient, but to the prescribing physician. Id. Under this doctrine, the plaintiff must show: (1) that the defendant failed to warn the physician of a risk associated with the use of the product, not otherwise known to the physician, and (2) that the failure to warn the physician was both a cause in fact and the proximate cause of the plaintiffs injury. Theriot v. Danek Medical, Inc., 168 F.3d 253, 256 (5th Cir. 1999); Willett, 929 F.2d at 1098-99. Therefore, the plaintiff must show that a proper warning would have changed the decision of the treating physician, i.e. that "but for" the inadequate warning, the treating physician would not have used or proscribed the product.Id.
Even though Dr. O'Bryan has indicated that he was a ware of the potential complications from placing Marlex Mesh directly against the bowel, Linsley argues that Bard did not fully and fairly disclose to Dr. O'Bryan all of the risks of use of Marlex Mesh because Bard never adequately tested its device. This same argument was raised in the Fifth Circuit case of Theriot v. Danek Medical, Inc., 168 F.3d 253 (5th Cir. 1999). Linsley asserts that this case is factually distinguishable from Theroit, 168 F.3d at 256, because the physician testified that he "was fully appraised of the potential risks of the product," whereas Dr. O'Bryan states that he was not aware of Marlex Mesh's "heightened risks" of dense abdominal adhesion when implanted intraperitoneally. However, Linsley has provided no material facts to substantiate her allegations of a "heightened risk."
The only evidence in support of her theory that Marlex Mesh presents a "heightened risk," is a study conducted, in 1992, that shows Marlex Mesh has a greater percentage of adhesion than Marlex Mesh with a Gore Surgical membrane attached to the side exposed to the bowel. However, as the Court stated above, attaching a Gore Surgical membrane to the exposed side of the Marlex Mesh, in 1990, was nothing more than a suggested surgical technique. Moreover, Linsley has failed to present any evidence to support that, of the products available in 1990, Marlex Mesh posed a "heightened risk."
On the other hand, Bard has presented undisputed expert testimony by physicians certified to repair an incisional ventral hernia who stated that they were well aware of the potential dangers inherent with using Marlex Mesh. Specifically, Dr. O'Bryan testified that he was trained on Marlex Mesh and was well aware, in 1990, that Marlex Mesh can adhere to the bowel and that bowel fistulas can result when the mesh is placed directly against the bowel. In fact, Dr. O'Bryan performed a recurrent hernia repair, in 1993, on Linsley and observed first hand the dense adhesion to the lower bowel, but he did not find it to be unusual or even necessary to remove. Additionally, Linsley's own medical expert reviewed Dr. O'Bryan's reports and cleared him of any wrong doing. As a result, Linsley is only left with the argument that Bard did not adequately test its product, thus Bard could not properly inform Dr. O'Bryan of the risks associated with the product.
The Fifth Circuit noted that such an argument boils down to the plaintiffs belief that she should be permitted to proceed to trial if the defendant could not show that it adequately tested its product. Theroit, 168 F.3d at 256. The Fifth Circuit held that there was "no basis in the LPLA or case law for such a rule." Id. In light of this holding, Bard and Defendants are entitled to summary judgment on the issue of inadequate warning.
Accordingly,
IT IS ORDERED that the Motion of C.R. Bard, Inc. and Davol, Inc. for Summary Judgment (Doc. 27) be, and the same hereby is GRANTED, dismissing Plaintiff's claims of design defect and inadequate warning pursuant to the Louisiana Products Liability Act.
New Orleans, Louisiana, this 30th day of March, 2000.