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granting summary judgment where the doctor "relied on his own knowledge and training in Lim's treatment" and the defendants' "warnings would not have altered his decision" to implant a TVT-O device
Summary of this case from McBroom v. Ethicon, Inc.Opinion
CIVIL ACTION NO. 3:20-CV-780-KHJ-LGI
2021-02-12
Deserie LIM, Plaintiff v. ETHICON, INC., Ethicon, LLC, and Johnson & Johnson, Defendants
Christopher Justin Broome, Kevin J. White, Shane F. Langston, Rebecca M. Langston, Langston & Langston, PLLC, Jackson, MS, for Plaintiff. David B. Thomas-Transfer Attorney, Susan M. Robinson-Transfer Attorney, Thomas Combs & Spann, Charleston, WV, Benjamin McRae Watson, Kasey M. Adams, William M. Gage, Butler Snow LLP, Ridgeland, MS, for Defendants Ethicon, Inc., Johnson & Johnson. David B. Thomas-Transfer Attorney, Susan M. Robinson-Transfer Attorney, Thomas Combs & Spann, Charleston, WV, William M. Gage, Butler Snow LLP-Ridgeland, Ridgeland, MS, for Defendant Ethicon, LLC. Ethicon, LLC, pro se.
Christopher Justin Broome, Kevin J. White, Shane F. Langston, Rebecca M. Langston, Langston & Langston, PLLC, Jackson, MS, for Plaintiff.
David B. Thomas-Transfer Attorney, Susan M. Robinson-Transfer Attorney, Thomas Combs & Spann, Charleston, WV, Benjamin McRae Watson, Kasey M. Adams, William M. Gage, Butler Snow LLP, Ridgeland, MS, for Defendants Ethicon, Inc., Johnson & Johnson.
David B. Thomas-Transfer Attorney, Susan M. Robinson-Transfer Attorney, Thomas Combs & Spann, Charleston, WV, William M. Gage, Butler Snow LLP-Ridgeland, Ridgeland, MS, for Defendant Ethicon, LLC.
Ethicon, LLC, pro se.
ORDER
Kristi H. Johnson, UNITED STATES DISTRICT JUDGE This action is before the Court on the Motion for Summary Judgment [50] and Motion to Exclude or Limit Case-Specific Testimony and Opinions of Matthew E. Karlovsky, M.D., F.A.C.S. ("Motion to Exclude") [52] filed by Defendants Ethicon, Inc., Ethicon, LLC, and Johnson & Johnson (collectively "Defendants"). For the reasons below, the Court grants Defendants’ Motion for Summary Judgment [50] and denies as moot the Motion to Exclude [52].
I. Facts and Procedural History
Most of the relevant facts in this products liability action are uncontested. On December 7, 2010, Plaintiff Deserie Lim ("Lim") visited Dr. Paul Seago with complaints of pelvic pain, and he found a mass on her ovary. Dr. Seago recommended a hysterectomy. Lim returned a month later complaining of urinary incontinence. Dr. Seago recommended he implant an Ethicon Gynecare TVT System ("TVT-O") concurrently with a hysterectomy. He performed the surgery the next day. Dr. Seago noted Lim suffered from extensive pelvic adhesions and post-operatively diagnosed her with pelvic inflammatory disease.
The Court's recitation of Lim's initial implantation of the TVT-O comes from the agreed undisputed facts listed in the parties’ memoranda.
Lim's problems continued. She saw Dr. Seago again about two years later, complaining of painful intercourse, vulvar pain, and urinary frequency. Ex. F [61] to Response, at 5. About eight months later, she visited the emergency room of Mississippi Baptist Medical Center with "sharp vaginal pains ... like something [was] cutting her inside" and rectal pain. Id. The on duty nurse practitioner stated there was "some exposure" of the TVT-O device mesh. Id. Lim sought treatment from urogynecologist Dr. Robert Harris, and she continued having symptoms—most of which she attributes to the TVT-O. Id. at 5-7. Lim had the TVT-O removed on July 17, 2013. Id. at 7. She continued to have multiple symptoms and underwent many other procedures, including several bladder instillations and placement of a transvaginal urethrolysis autologous fascia lata sling. Id. at 7-13.
Lim claims the TVT-O caused the following injuries: "depression, pain, scarring, webbing, bleeding, stress urinary incontinence ..., hives, ... rectal pain, vaginal wall prolapse, and the need for multiple revision surgeries." Memo. in Opposition [54] at 2. She also claims she "suffered from mesh exposure, leg spasms, bladder infections, cystocele, rectocele, pain with sex, and vaginal wall prolapse as a result of her TVT[-O] implant" as well as "chronic vaginal pain." Id.
Lim filed this product liability action in the U.S. District Court for the District of West Virginia, as a member case of the multidistrict litigation In Re: Ethicon Inc., Pelvic Repair System Products Liability Litigation , MDL No. 2327. She alleges Defendants are responsible for the damages caused by the TVT-O. Defendants filed the present motions in the District of West Virginia after the close of discovery. Pretrial Order [35]. The case was transferred to this Court on November 20, 2020. Transfer Order [74].
II. Motion for Summary Judgment [50]
A. Standard
When considering a motion for summary judgment, the Court must "grant summary judgment if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." Fed. R. Civ. P. 56(a). "A fact is ‘material’ if, under the applicable substantive law, ‘its resolution could affect the outcome of the action.’ " Patel v. Tex. Tech Univ. , 941 F.3d 743, 747 (5th Cir. 2019) (quoting Sierra Club, Inc. v. Sandy Creek Energy Assocs., L.P. , 627 F.3d 134, 138 (5th Cir. 2010) ). "An issue is ‘genuine’ if ‘the evidence is such that a reasonable [factfinder] could return a verdict for the nonmoving party.’ " Jones v. United States , 936 F.3d 318, 321 (5th Cir. 2019) (quoting Anderson v. Liberty Lobby, Inc. , 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986) ). In analyzing a motion for summary judgment, "the judge's function is not [her]self to weigh the evidence and determine the truth of the matter but to determine whether there is a genuine issue for trial." Klocke v. Watson , 936 F.3d 240, 246 (5th Cir. 2019) (quoting Anderson , 477 U.S. at 249, 106 S.Ct. 2505 ).
"If the burden at trial rests on the non-movant, the movant must merely demonstrate an absence of evidentiary support in the record." Bayle v. Allstate Ins. Co. , 615 F.3d 350, 355 (5th Cir. 2010) (quoting Hamilton v. Segue Software, Inc. , 232 F.3d 473, 477 (5th Cir. 2000) ). Once the movant meets this requirement, "the burden shifts to the non-movant to produce evidence of the existence of such an issue for trial." Id. (quoting Miss. River Basin Alliance v. Westphal , 230 F.3d 170, 174 (5th Cir. 2000) ). The non-movant must present more than "speculation, improbable inferences, or unsubstantiated assertions." Jones , 936 F.3d at 321 (quoting Lawrence v. Fed. Home Loan Mortg. Corp. , 808 F.3d 670, 673 (5th Cir. 2015) ). "A failure on the part of the nonmoving party to offer proof concerning an essential element of its case necessarily renders all other facts immaterial and mandates a finding that no genuine issue of fact exists." Adams v. Travelers Indem. Co. of Conn. , 465 F.3d 156, 164 (5th Cir. 2006) (citing Saunders v. Michelin Tire Corp. , 942 F.2d 299, 301 (5th Cir. 1991) ).
B. Mississippi Product Liability Act Claims
The Parties agree that Mississippi law governs Lim's claims. Memo. in Support [51] at 4; Memo. in Opposition [54] at 6. The Mississippi Supreme Court has held the Mississippi Products Liability Act ("MPLA") "provides the exclusive remedy for products-liability claims." Elliott v. El Paso Corp. , 181 So. 3d 263, 268 (Miss. 2015) (quoting Lawson v. Honeywell Int'l, Inc. , 75 So. 3d 1024, 1027 (Miss. 2011) ) (internal quotations omitted). Defendants argue the MPLA subsumes all of Lim's claims because the MPLA provides the sole remedy for damages caused by defective products. Although Lim agrees "that product liability actions are governed by the [MPLA]" and presents only arguments under the MPLA, she argues her fraudulent concealment, constructive fraud, negligent misrepresentation, breach of warranty, and consumer fraud claims are "not duplicative" of her MPLA claims. Memo. in Opposition [54] at 7, 14-17. Lim, however, supports these claims by merely "re-assert[ing] her arguments in support of her MPLA Failure to Warn claim." Id. at 14. She makes the same re-assertion for her remaining claims as well. Id. at 14-17. Defendants move for summary judgment on all of Lim's claims, arguing both under the MPLA and under common law. See Memo. in Support [51] at 4-19. Lim, who has the burden to prove her claims at trial, also bears the burden of demonstrating that summary judgment is not warranted. See Ragas v. Tenn. Gas Pipeline Co. , 136 F.3d 455, 458 (5th Cir. 1998) (citing Celotex Corp. v. Catrett , 477 U.S. 317, 321-25, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986) ) ("Once a movant who does not have the burden of proof at trial makes a properly supported motion, the burden shifts to the nonmovant to show that a summary judgment should not be granted."). Because Lim only makes arguments for her MPLA claims, the Court analyzes those claims only and assumes Lim concedes her other claims are subsumed by the MPLA or are otherwise waived. See id.
Under the MPLA, Lim must establish "that at the time the product left the control" of Defendants:
(i) 1. The product was defective because it deviated in a material way from the manufacturer's or designer's specifications or from otherwise identical units manufactured to the same manufacturing specifications, or
2. The product was defective because it failed to contain adequate warnings or instructions, or
3. The product was designed in a defective manner, or
4. The product breached an express warranty or failed to conform to other express factual representations upon which the claimant justifiably relied in electing to use the product; and
(ii) The defective condition rendered the product unreasonably dangerous to the user or consumer; and
(iii) The defective and unreasonably dangerous condition of the product proximately caused the damages for which recovery is sought.
Miss. Code Ann. § 11-1-63(a). Lim asserts claims of (1) manufacturing defect, (2) failure to warn, and (3) design defect under § 11-1-63(a)(i)(1) through (3). Lim does not directly argue Defendants breached an express warranty under § 11-1-63(a)(i)(4), except to again "re-assert[ ] all arguments in support of her MPLA Failure to Warn and Design Defect claims" under her common law claim for breach of express warranty. Memo. in Opposition [54] at 17. The Court therefore only analyzes whether a genuine issue of material fact exists as to the product liability claims brought under § 11-1-63(a)(i)(1) through (3).
C. Manufacturing Defect
A manufacturing defect claim under the MPLA requires a showing that a product "deviated in a material way from the manufacturer's or designer's specifications or from otherwise identical units manufactured to the same manufacturing specifications." Miss. Code Ann. § 11-1-63(a)(i)(1). Defendants assert, "Plaintiff has no evidence that the product received by Plaintiff deviated from Ethicon's specifications or from otherwise identical units." Memo. in Support [51] at 12. Lim responds by "request[ing] the Court draw all reasonable inferences from the record in her favor, find that a genuine issue of material fact exists, and deny Defendant[s’] Motion for Summary Judgment on the manufacturing defect claim." Memo. in Opposition [54] at 14.
Lim bears the burden of proving her manufacturing defect claim at trial. Once Defendants meet their initial burden to demonstrate that Lim has no evidence, Lim must show there is a genuine issue for trial on this claim. See Bayle , 615 F.3d at 355. " Rule 56 does not impose upon the district court a duty to sift through the record in search of evidence to support a party's opposition to summary judgment." Adams , 465 F.3d at 164 (quoting Ragas , 136 F.3d at 458 ). Additionally, from the record before it, the Court sees no evidence supporting a theory that the TVT-O device implanted in Lim deviated from Defendants’ specifications or from otherwise identical units. Because Lim produces no evidence to support her manufacturing defect claim under the MPLA, the Court finds summary judgment appropriate for this claim and dismisses it with prejudice.
D. Design Defect
Defendants argue Lim's design defect claim under the MPLA fails because she has produced no evidence of a safer alternative design available at the time of sale. The MPLA "provides that in a design defect claim, a manufacturer is not liable unless the design of the product is both defective and unreasonably dangerous." Williams v. Bennett , 921 So.2d 1269, 1274 (Miss. 2006). A product may be defective without being "unreasonably dangerous." Id. To succeed on a design defect claim under the MPLA, Lim must establish the following:
(1) The danger presented by the product's design was known or should have been known to the manufacturer (i.e. the danger was foreseeable); (2) the product failed to function as expected (as a result of a design characteristic); (3) an alternative design existed that would not impair the product's usefulness or desirability; and (4) the alternative design would have to a reasonable probability prevented the harm.
Id. (emphasis omitted). Lim must further "prove that the defect existed at the time the product left the manufacturer's control and that it proximately caused the injury." Id. (citation omitted).
To demonstrate that a defect in the TVT-O's design caused her injuries, Lim points to the expert report of Dr. Danial Elliot who opines the TVT-O suffers from various defects, including "roping, curling, fraying, particle loss, degradation, contraction and shrinkage, chronic foreign body reaction and decreased pore size." Ex. G [62] to Response, at 37. Lim contends Dr. Karlovsky testified at his deposition that these defects caused Lim's injuries. In his expert report, Dr. Karlovsky stated the mesh sling Lim received "was found to be thickened and rolled up." Ex. F [61] to Response, at 22. Accepting this as true for purposes of this motion, Lim must present an alternative design that would have prevented the harm caused by the thickening and rolling up of the TVT-O, that would have been available at the time of sale, and that would not have reduced the utility, usefulness, practicality, or desirability of the TVT-O.
Despite repeated references to this deposition, Lim did not attach any excerpts from the transcript of this deposition to her Response and did not list the transcript as an exhibit to her Response. [53] at 2.
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To establish her manufacturing defect claim under the MPLA, Lim "must ... offer a feasible design alternative." Williams , 921 So. 2d at 1275. In other words, Lim must "establish[ ] a design defect by proving a product could have been made safer by the adoption of a reasonable alternative design." Id. The reasonable alternative design must have been available at the time of sale, and it must be shown that the "omission of such an alternative design rendered the product not reasonably safe." Id. "A feasible design alternative is a design that would have to a reasonable probability prevented the harm without impairing the utility, usefulness, practicality or desirability of the product to users or consumers." Moss v. Batesville Casket Co., Inc. , 935 So. 2d 393, 403 (Miss. 2006) (quoting Miss. Code Ann. § 11-1-63(f)(ii) ).
Lim presents no evidence of an alternative design. She purports to quote from Dr. Elliot's report for the proposition that "using an ‘alternative product like a suture product, as with the Burch procedure, or using a pubovaginal sling ... or an allograft sling, like Repliform, instead of the Prolenepolypropylene mesh used in TVT-O, would have been safer, feasible alternatives ...’ " Memo. in Opposition [54] at 12. Lim also quotes Dr. Elliot as stating, "a shorter, lighter weight, larger pore mesh sling with less Prolene material (e.g. Ultrapro)" would have been a safer alternative design. Id. Neither of these quotes is found in Dr. Elliot's report, and in fact, Dr. Elliot does not discuss alternative designs for the TVT-O anywhere in his report. See Ex. G [62] to Response.
Even if the Court considered evidence not properly presented, Dr. Elliot has at best opined that "synthetic meshes that are low-weight, large-pore size, high porosity, monofilament, and capable of maintaining their elasticity under load will have the better results with fewer complications." Ex. G [62] to Response, at 10. Dr. Elliot at no point, however, presents this type of mesh as an alternative design for the TVT-O. Additionally, the report from Lim's other expert, Dr. Vladimir Iakovlev, undermines the notion that this type of mesh is a safer alternative design for the TVT-O, stating: "[S]ofter lighter weight designs are more prone to folding than the stiffer heavier weight meshes ... This property reduces advantages of the lighter weight mesh and the overall result can be worse than for a stiffer mesh that remains flat." Ex. H [64] to Response, at 69. Dr. Iakovlev also explains that mesh folding is "a serious problem in larger vaginal devices," leading to "[s]ome of these devices [being] withdrawn from use and/or reclassified as a high-risk device." Id. Nothing in the record suggests, and none of Lim's experts opine, that a lighter-weight, larger-pore mesh would not have reduced the "utility, usefulness, practicality or desirability" of the mesh used in the TVT-O. See Moss , 935 So. 2d at 403 (citing Miss. Code Ann. § 11-1-63(f)(ii) ).
The Court's independent review of Dr. Karlovsky's report is no help to Lim either. Although Dr. Karlovsky does state in his report that "a reasonable alternative Ms. Lim could have considered in 2011 for her stress incontinence would have been an autologous fascial sling which she ultimately underwent in 2016," Ex. F [61] to Response at 32, he does not and cannot present this as an alternative design for the TVT-O. Defendants state that an autologous fascial sling "involve[s] harvesting tissue from another part of the patient's body and implanting it in the pelvic area by abdominal incision." Memo. in Support [51] at 10. Lim does not contest this definition, and Dr. Karlovsky's report appears to support it, stating Lim received "a transvaginal urethrolysis, autologous fascia lata sling with donor site from the left thigh, and rectocele repair," which was obtained by making an incision "in the left thigh to harvest the fascia lata." Ex. F [61] to Response at 13. From the record, it does not appear that the TVT-O could be modified to be an autologous fascial sling, as such a sling does not involve any implantation of a medical device.
Given the expert testimony presented by Lim, the Court finds she has not put forth sufficient evidence that a lighter-weight, larger-pore mesh or an autologous fascial sling would have been safer alternative designs for the TVT-O. She has presented no evidence that sets forth either of these as alternative designs for the TVT-O. In fact, Lim's experts do not discuss alternative designs at all in their reports. She also has not established that these designs would not impact the "usefulness or desirability" of the TVT-O, especially when Lim's own expert opines one of these designs can create "a serious problem." See Ex. H [64] to Response at 69; Williams , 921 So. 2d at 1274. And none of Lim's experts state that any alternative design "would have to a reasonable probability prevented" the injuries suffered by Lim. Id.
The Court therefore finds that Lim has failed to produce sufficient evidence to support her MPLA design defect claim and, as such, summary judgment is proper.
E. Failure to Warn
Defendants argue Lim cannot produce evidence to prove her failure to warn claim under the MPLA because, under the learned intermediary doctrine, she cannot show an adequate warning would have prevented Dr. Seago from implanting the TVT-O. Lim responds that the learned intermediary doctrine does not apply and that Defendants owed a duty to adequately warn to her, not her doctor.
"An adequate warning is one reasonable under the circumstances." Janssen Pharmaceutica, Inc. v. Bailey , 878 So. 2d 31, 55 (Miss. 2004) (citations omitted). Under the learned intermediary doctrine, "[t]he general rule is ‘that where prescription drugs are concerned, a manufacturer's duty to warn only extends to physicians and not to laymen.’ " Id. at 57 (quoting Swayze v. McNeil Labs., Inc. , 807 F.2d 464, 470 (5th Cir. 1987) ). The Mississippi Supreme Court has indicated the learned intermediary doctrine applies in product liability cases involving medical devices. Moore ex rel. Moore v. Memorial Hosp. of Gulfport , 825 So. 2d 658, 662 n.6 (Miss. 2002) (citing Cather v. Catheter Tech. Corp. , 753 F. Supp. 634 (S.D. Miss. 1991) ).
The dispositive question under this doctrine is whether the warnings Defendants gave to the learned intermediary, here Dr. Seago, were enough to warn him of the possible complications. Wyeth Labs., Inc. v. Fortenberry , 530 So. 2d 688, 691 (Miss. 1988). Even assuming Defendants’ warnings to Dr. Seago were inadequate, Lim has "the burden of showing that an adequate warning would have altered [Dr. Seago's] conduct." Id. (citations omitted).
Lim does not claim any additional warning by Defendants to Dr. Seago would have caused him not to implant the TVT-O. Instead, Lim focuses on her mistaken contention that the learned intermediary doctrine does not apply in cases with medical devices. As the Court previously explained, it does. See Moore , 825 So.2d at 662 n.6. She also complains of Dr. Seago's failure to warn her before the surgery. These arguments are not enough to overcome her burden on summary judgment.
Dr. Seago testified that, based on his own medical training and research, he was aware of the risks associated with implanting the TVT-O. Ex. C [50-3] to Motion for Summary Judgment at 60:9-64:3, 64:20-65:1. He admitted that if Defendants’ documentation for the TVT-O had listed all known risks, he would not have changed his decision to implant the TVT-O in Lim. Id. at 64:8-12. Dr. Seago also testified that the documentation provided by Defendants with the TVT-O is not something he would typically consult before implanting the device into a patient and that he had not become familiar with the documentation before implanting the TVT-O in Lim. Id. at 78:13-25.
Based on the testimony of Lim's treating physician Dr. Seago, he did not rely on any of Defendants’ warnings in his decision to implant the TVT-O. Dr. Seago instead relied on his own knowledge and training in Lim's treatment. Defendants’ warnings would not have altered his decision as he did not consult the TVT-O's accompanying documentation. The Court therefore grants summary judgment on Plaintiff's failure to warn claim under the MPLA.
III. Motion to Exclude [52]
Defendants move to exclude the expert opinion and testimony of Dr. Matthew E. Karlovsky. Because the Court finds that Defendants’ Motion for Summary Judgment [50] should be granted even if Dr. Karlovsky's expert opinion is considered, the Motion to Exclude [52] is denied as moot.
IV. Conclusion
The Court has considered all the arguments set forth by the parties. Those arguments not addressed would not have changed the outcome of the Court's decision. For these reasons, the Motion for Summary Judgment [50] is GRANTED. The Motion to Exclude [52] is DENIED AS MOOT.
SO ORDERED AND ADJUDGED this the 12th day of February, 2021.