Foster v. Ethicon, Inc.
| Decision Date | 26 March 2021 |
| Docket Number | 4:20-CV-04076-RAL |
| Citation | 529 F.Supp.3d 992 |
| Parties | Marsha FOSTER, and Alvin A. Jensen, Plaintiffs, v. ETHICON, INC., and Johnson & Johnson, Defendants. |
| Court | U.S. District Court — District of South Dakota |
Adam D. Peavy, Pro Hac Vice, Kathryn G. Hooten, Pro Hac Vice, Scott Love, Pro Hac Vice, William Moreland, Pro Hac Vice, Clark, Love & Hutson, PLLC, Houston, TX, Kasey L. Olivier, Olivier Miles Holtz, LLP, Sioux Falls, SD, for Plaintiffs.
Anita Modak-Truran, Pro Hac Vice, Butler Snow, LLP, Nashville, TN, Daniel E. Ashmore, Katelyn A. Cook, Gunderson, Palmer, Nelson & Ashmore, LLP, Rapid City, SD, Pamela L. Ferrell, Pro Hac Vice, Butler Snow LLP, Atlanta, GA, for Defendants.
This case began in the Southern District of West Virginia as part of the Ethicon multidistrict litigation (MDL). It is one of thousands of cases involving injuries patients allegedly suffered after being implanted with pelvic mesh products designed, manufactured, and sold by Ethicon, Inc., a wholly owned subsidiary of Johnson & Johnson. Plaintiffs Marsha Foster and Alvin Jensen sued Ethicon, Inc., and Johnson & Johnson (collectively "Ethicon"), claiming that an Ethicon product implanted in Ms. Foster was defectively designed and had inadequate warnings. Ethicon moved for partial summary judgment before the MDL judge, and that motion is now ripe for decision by this Court.
Ms. Foster, on a referral from her local physician, first saw Dr. Robert Ferrell on February 26, 2003, for stress urinary incontinence
. Doc. 107 at 19.2 One of the options Dr. Ferrell recommended to Ms. Foster was the TVT. Doc. 107 at 22–24; 29, 84–85. Because Dr. Ferrell was not yet trained on implanting the TVT, however, he asked Dr. Kevin Bray to perform the surgery. Doc. 107 at 33; 90–91. Dr. Ferrell met separately with Ms. Foster on March 19, 2003, to explain the risks and benefits of implanting the TVT. Doc. 107 at 24–26. Dr. Bray did not participate in any preoperative appointment or any informed consent conversations with Ms. Foster. Doc. 107 at 91; Doc. 27 p.2 at ¶ 4. On March 21, 2003, Dr. Bray implanted Ms. Foster with an Ethicon TVT to treat her stress urinary incontinence. Doc. 27 p.2 at ¶ 2; Doc. 26 p.2 at ¶¶ 1–2. Dr. Ferrell was present during and assisted Dr. Bray with the surgery. Doc. 27 p.2 at ¶¶ 3–4. After the surgery, Ms. Foster had postoperative appointments with Dr. Ferrell and seemed to have recovered from the surgery. Doc. 107 at 36–41.
More than seven years later, Ms. Foster returned to see Dr. Ferrell in December 2011 when she reported experiencing urinary problems. Doc. 27 p.2 at ¶ 5. She saw Dr. Ferrell again in March 2012, with the same problems. Doc. 27 p.2 at ¶ 6. Dr. Ferrell referred Ms. Foster to Dr. Matthew Barker. Doc. 27-3 at 7; Doc. 27 p.2 at ¶ 7. Ms. Foster saw Dr. Barker in September 2012, due to pelvic organ prolapse and voiding dysfunction. Doc. 27 p.2 at ¶ 7. In early December 2012, Dr. Barker performed pelvic reconstructive surgery on Ms. Foster. Doc. 27 p.3 at ¶ 8. Despite the surgery, Ms. Foster continued to experience and seek treatment for urinary problems, including urinary retention requiring self-catheterization, voiding difficulty, and infections. Doc. 27 p.3 at ¶ 9. Ms. Foster reports that she still suffers from life-changing complications, including vaginal pain, cramping, infections, urinary retention, and recurrent incontinence. Doc. 27 p.3 at ¶ 10; Doc. 26 p.2 at ¶ 4.
In February 2012, the Judicial Panel on Multidistrict Litigation opened an MDL to coordinate pretrial proceedings of all Ethicon pelvic mesh-related litigation ( Ethicon MDL). In re: Am. Med. Sys., Inc. Pelvic Repair Sys. Prods. Liab. Litig., 844 F. Supp. 2d 1359, 1360–62 (J.P.M.L. 2012) ; In re Ethicon, Inc. Pelvic Repair Sys. Prod. Liab. Litig., 299 F.R.D. 502, 508 (S.D.W. Va. 2014). The Ethicon MDL was assigned to the Honorable Joseph R. Goodwin in the Southern District of West Virginia. Am. Med. Sys., 844 F. Supp. 2d at 1362.
In August 2015, Ms. Foster and Mr. Jensen filed this case in the Southern District of West Virginia as part of the Ethicon MDL. Doc. 1. Their short-form complaint pleaded the following claims: negligence (Count I); strict-liability – manufacturing defect (Count II); strict liability – failure to warn (Count III); strict liability – defective product (Count IV); strict liability – design defect (Count V); common law fraud (Count VI); fraudulent concealment (Count VII); constructive fraud (Count VIII); negligent misrepresentation (Count IX); negligent infliction of emotional distress (Count X); breach of express warranty (Count XI); breach of implied warranty (Count XII); gross negligence (Count XIV); unjust enrichment (Count XV); loss of consortium (Count XVI); punitive damages (Count XVII); and discovery rule and tolling (Count XVIII). Doc. 1. Judge Goodwin assigned the cases in the Ethicon MDL to various "waves" to be prepared for trial. Doc. 6. Ms. Foster and Mr. Jensen's case was assigned to Wave 8. Doc. 6.
While this case was pending in West Virginia, Ethicon moved for summary judgment on Counts II–IV, Counts VI–IX, Counts XI–XIII, and Counts XV and XVI. Doc. 25. Ms. Foster opposed the motion as to Counts III (strict liability – failure to warn) and IV (strict liability – defective product) but did not oppose summary judgment on the other counts addressed in Ethicon's motion.3 Doc. 27. The parties recently stipulated that the following counts should be dismissed with prejudice: Counts II, VI–IX, XI–XIII, and XV.4 Doc. 106. In April 2020, Judge Goodwin transferred Ms. Foster's case to this Court. Doc. 36. Ethicon's motion for summary judgment on Counts III and IV remains pending and is ripe for decision.
Under Rule 56(a) of the Federal Rules of Civil Procedure, summary judgment is proper "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). Rule 56(a) places the burden initially on the moving party to establish the absence of a genuine issue of material fact and entitlement to judgment as a matter of law. Fed. R. Civ. P. 56(a) ; see also Celotex Corp. v. Catrett, 477 U.S. 317, 322–23, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). Once the moving party has met that burden, the nonmoving party must establish that a material fact is genuinely disputed either by "citing to particular parts of materials in the record" or by "showing that the materials cited do not establish the absence ... of a genuine dispute." Fed. R. Civ. P. 56(c)(1)(A), (B) ; Gacek v. Owens & Minor Distrib., Inc., 666 F.3d 1142, 1145–46 (8th Cir. 2012) ; see also Mosley v. City of Northwoods, 415 F.3d 908, 910 (8th Cir. 2005) (). A party opposing a properly supported motion for summary judgment "may not merely point to unsupported self-serving allegations, but must substantiate his allegations with sufficient probative evidence that would permit a finding in his favor, without resort to speculation, conjecture, or fantasy." Reed v. City of St. Charles, 561 F.3d 788, 790–91 (8th Cir. 2009) (). In ruling on a motion for summary judgment, the facts and inferences fairly drawn from those facts are "viewed in the light most favorable to the party opposing the motion." Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587–88, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986) (quoting United States v. Diebold, Inc., 369 U.S. 654, 655, 82 S.Ct. 993, 8 L.Ed.2d 176 (1962) (per curiam)).
Ethicon argues that Ms. Foster's strict liability – failure-to-warn claim fails because she cannot show causation and that South Dakota does not recognize her claim for "strict liability – defective product." This Court addresses these arguments in turn.
The parties agree that South Dakota law applies because South Dakota is where Ms. Foster lives and had the TVT implanted. Doc. 26 at 3; Doc. 27 at 4. Plaintiffs bringing a strict liability failure-to-warn claim in South Dakota must prove that the failure to warn was the legal cause of their injuries. Karst v. Shur-Co., 878 N.W.2d 604, 613 (S.D. 2016) ; Nationwide Mut. Ins. Co. v. Barton Solvents, Inc., 855 N.W.2d 145, 150–51 (S.D. 2014) ; Burley v. Kytec Innovative Sports Equip., Inc., 737 N.W.2d 397, 409–11 (S.D. 2007). Berg v. Johnson & Johnson Consumer Cos., 983 F. Supp. 2d 1151, 1160 (D.S.D. 2013) (). "[T]o prove causation in a failure-to-warn claim, a plaintiff must show that adequate warnings would have made a difference in the outcome, that is, that they would have been followed." Karst, 878 N.W.2d at 613 (). "[T]he evidence must be such as to support a reasonable inference, rather than a guess, that the existence of an adequate warning may have prevented the accident before the issue of causation may be submitted to the jury." Id. at 614 (citation omitted).
Two doctrines are relevant to the parties’ causation arguments. First, Ethicon relies on the learned intermediary doctrine. Under this doctrine, a manufacturer of medical devices or pharmaceuticals satisfies its duty to warn by providing the appropriate information to the treating physician. Ehlis v. Shire Richwood, Inc., 367 F.3d 1013, 1016 (8th Cir. 2004) ; Dan B. Dobbs et al., Dobbs’ Law of Torts § 466 (2d ed. June 2020 update) (...
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