Costa v. Johnson & Johnson

CourtDistrict Court, D. Rhode Island
DecidedMarch 28, 2023
Docket1:17-cv-00452
StatusUnknown

This text of Costa v. Johnson & Johnson (Costa v. Johnson & Johnson) is published on Counsel Stack Legal Research, covering District Court, D. Rhode Island primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Costa v. Johnson & Johnson, (D.R.I. 2023).

Opinion

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF RHODE ISLAND

___________________________________ ) BIANCA COSTA and ) JOHN COSTA, ) ) Plaintiffs, ) ) v. ) C.A. No. 17-452 WES ) JOHNSON & JOHNSON and ) ETHICON, INC., ) ) Defendants. ) ___________________________________)

MEMORANDUM AND ORDER WILLIAM E. SMITH, District Judge. Before the Court is Defendants Johnson & Johnson’s and Ethicon, Inc.’s Motion for Summary Judgment (“Defs.’ MSJ”), ECF No. 38. For the reasons that follow, Defendants’ Motion is GRANTED as to Counts II, IV and V of the Complaint, ECF No. 1, and DENIED as to Counts I, III, VI, and VII. I. Background A. Facts The following facts are either undisputed or viewed in the light most favorable to Plaintiffs. See Cadle Co. v. Hayes, 116 F.3d 957, 959 (1st Cir. 1997). On October 10, 2014, Plaintiff Bianca Costa underwent surgery at Women and Infants Hospital Division of Gynecology in Providence, Rhode Island, performed by Dr. Kyle Wohlrab. Defs.’ Statement Undisp. Facts (“Defs.’ SUF”) ¶¶ 1, 2 , ECF No. 39; Pls.’ Statement Undisp. Facts (“Pls.’ SUF”) ¶ 7, ECF No. 43. The surgery was to correct stress urinary incontinence and uterovaginal prolapse and involved implantation of TVT-Exact, a pelvic mesh manufactured by Defendants. Defs.’ SUF ¶ 1; Pls.’ SUF ¶ 7. Dr. Wohlrab was aware

of Ms. Costa’s comorbidities at the time of the surgery, which included a stroke in 2005, histories of deep vein thrombosis and hypertension, systemic lupus erythematosus, and chronic immunosuppression due to the use of Prednisone and Imuran to treat the lupus. He concluded that there were no absolute contraindications for Ms. Costa to have the TVT-Exact implanted. Defs.’ SUF ¶ 4; Pls.’ SUF ¶¶ 2, 3. Dr. Wohlrab had knowledge of the risks associated with the TVT-Exact from the Instructions for Use (“IFU”) that Defendants provided with the product. Defs.’ SUF ¶ 5; Pls.’ SUF ¶ 4. The IFU listed the following risks: retropubic bleeding; dysuria; detrusor instability; punctures or lacerations of vessels, nerves,

bladder, or bowel that may require surgical repair; local irritation at the wound site; extrusion; erosion; fistula formation; inflammation; potentiation of existing infection; and temporary or permanent lower urinary tract infection (“UTI”). Pls.’ SUF ¶ 4. Dr. Wohlrab was also aware of additional risks, not listed in the IFU, from his own training and research, including: acute or chronic pain with intercourse; acute or chronic pain; vaginal scarring; infection; urinary problems such as urinary frequency, urgency, dyspareunia, retention, obstruction, or incontinence; organ or nerve damage; wound complications; neuromuscular problems in the pelvic floor muscles, lower extremities, or abdominal area; the need for additional

surgeries to treat an adverse event; recurrent failure of the TVT or mesh; foreign body response; and contraction or shrinkage of the tissues. Defs.’ SUF ¶¶ 5, 7. In 2015, Defendants revised the IFU to add additional risks that were not included in the previous version. Pls.’ SUF ¶ 23. These added risks are: foreign body response; acute and/or chronic pain; voiding dysfunction; pain with intercourse which, in some patients, may not resolve; neuromuscular problems including acute and/or chronic pain in the groin, thigh, leg, pelvic, and/or abdominal area; recurrence of incontinence; bleeding, including hemorrhage or hematoma; need for one or more revision surgeries; seroma; urge incontinence; urinary frequency; urinary retention;

adhesion formation; atypical vaginal discharge; pain or discomfort to patient’s partner during intercourse from exposed mesh; and death. See Pls.’ SUF ¶ 24. Following her surgery in 2014, Ms. Costa experienced recurrent UTIs, pelvic pain, painful voiding, dyspareunia, and incomplete sensation of bladder emptying. Defs.’ SUF ¶ 12; see Pls.’ SUF ¶ 11. Cystoscopies performed in 2016 revealed foreign material that eroded into the urethra and narrowing of the lumen. Pls.’ SUF ¶ 12. On June 13, 2016, Ms. Costa underwent surgery to remove the TVT-Exact and repair the urethra. Defs.’ SUF ¶ 11; Pls.’ SUF ¶ 15. Following this surgery, Ms. Costa continued to experience urinary incontinence with urethral erosion and a

urethrovaginal fistula. Defs.’ SUF ¶ 12; Pls.’ SUF ¶ 16. Ms. Costa underwent a third surgery on May 30, 2017, after a small fistula was discovered mid-urethra. Pls.’ SUF ¶ 20. On October 19, 2018, Ms. Costa underwent an additional procedure to have an autologous rectus fascial sling placed at the bladder neck to address recurrent urinary stress incontinence. Pls.’ SUF ¶ 22. According to the doctor’s notes in January 2019, the sling worked well for forty-five days before Ms. Costa’s original stress incontinence returned. Pls.’ SUF ¶ 21. As a result of the implantation of the TVT-Exact and its ensuing complications, Ms. Costa continues to suffer from incontinence, UTIs, pain in the pelvis and abdomen, and permanent

damage to the urethra. Defs.’ SUF ¶ 12; Pls.’ SUF ¶ 25. B. Procedural History Plaintiffs filed this lawsuit on September 29, 2017. Compl. 1. On October 23, 2017, the action was conditionally transferred to the Southern District of West Virginia pursuant to 28 U.S.C. § 1407 to be consolidated with other actions involving common questions of fact as part of a multi-district litigation (“MDL”) against Defendants. Conditional Transfer Order (CTO-235), ECF No. 5. On June 5, 2020, the action was conditionally remanded to this Court pursuant to 28 U.S.C. § 1407(a) following the completion of coordinated or consolidated pretrial proceedings in the Southern District of West Virginia. Conditional Remand Order, ECF No. 9.

Following discovery, Defendants filed this Motion for Summary Judgment. Defs.’ MSJ 1. II. Legal Standard Summary judgment is appropriate when “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). In deciding a motion for summary judgment, the Court views the record in the light most favorable to the non-moving party and draws all inferences in that party’s favor. Cadle Co., 116 F.3d at 959. It is the Court’s function “to determine whether there is a genuine issue for trial,” not to weigh evidence or assess credibility. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 252 (1986).

The burden is on the movant to demonstrate an “absence of any genuine issue of material fact.” Borges ex rel. S.M.B.W. v. Seranno-Isern, 605 F.3d 1, 5 (1st Cir. 2010) (citing Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986)). If the movant satisfies this burden, the nonmovant must produce “significant[ly] probative” evidence “demonstrat[ing] that a trier of fact could reasonably resolve that issue in her favor.” Id. If the nonmovant fails to do so, summary judgment is appropriate. Id. The parties agree that Rhode Island law applies to Plaintiffs’ substantive claims under the most significant relationship test. See Harodite Indus., Inc. v. Warren Elec. Corp., 24 A.3d 514, 526 (R.I. 2011); Defs.’ Mem. Supp. Mot. Summ. J. (“Defs.’ Mem.”) 3,

ECF No. 38-1; Pls.’ Mem. Supp. Opp’n Defs.’ Mot. Summ. J. (“Pls.’ Opp’n”) 3 n.1, ECF No. 40-1. III. Discussion A.

Free access — add to your briefcase to read the full text and ask questions with AI

Related

Anderson v. Liberty Lobby, Inc.
477 U.S. 242 (Supreme Court, 1986)
Borges Ex Rel. SMBW v. Serrano-Isern
605 F.3d 1 (First Circuit, 2010)
Cadle Co. v. Hayes
116 F.3d 957 (First Circuit, 1997)
Ropes & Gray LLP v. Jalbert (In Re Engage, Inc.)
544 F.3d 50 (First Circuit, 2008)
Greaves v. Eli Lilly & Co.
503 F. App'x 70 (Second Circuit, 2012)
Prutch v. Ford Motor Co.
618 P.2d 657 (Supreme Court of Colorado, 1980)
Thomas v. Amway Corp.
488 A.2d 716 (Supreme Court of Rhode Island, 1985)
Mills v. State Sales, Inc.
824 A.2d 461 (Supreme Court of Rhode Island, 2003)
Salk v. Alpine Ski Shop, Inc.
342 A.2d 622 (Supreme Court of Rhode Island, 1975)
DiPetrillo v. Dow Chemical Co.
729 A.2d 677 (Supreme Court of Rhode Island, 1999)
Sama v. Cardi Corp.
569 A.2d 432 (Supreme Court of Rhode Island, 1990)
Fiorenzano v. Lima
982 A.2d 585 (Supreme Court of Rhode Island, 2009)
Hodges v. Brannon
707 A.2d 1225 (Supreme Court of Rhode Island, 1998)
Parrillo v. Giroux Co., Inc.
426 A.2d 1313 (Supreme Court of Rhode Island, 1981)
Calise v. Hidden Valley Condominium Ass'n
773 A.2d 834 (Supreme Court of Rhode Island, 2001)
Lariviere v. Dayton Safety Ladder Co.
525 A.2d 892 (Supreme Court of Rhode Island, 1987)
Raimbeault v. Takeuchi Manufacturing (U.S.), Ltd.
772 A.2d 1056 (Supreme Court of Rhode Island, 2001)

Cite This Page — Counsel Stack

Bluebook (online)
Costa v. Johnson & Johnson, Counsel Stack Legal Research, https://law.counselstack.com/opinion/costa-v-johnson-johnson-rid-2023.