Kennedy v. Ethicon, Inc.

RAMONA KENNEDY and RODNEY KENNEDY, Plaintiffs, v. ETHICON, INC. and JOHNSON & JOHNSON, Defendants.

No. 5:20-cv-00185

UNITED STATES DISTRICT COURT EASTERN DISTRICT OF PENNSYLVANIA

July 20, 2020

OPINION

Defendants' Motion for Summary Judgment, ECF No. 71 — GRANTED

Joseph F. Leeson, Jr. United States District Judge

I. INTRODUCTION

This is a product liability action which originated as part of a multidistrict litigation. Ramona Kennedy ("Kennedy") and her husband Rodney Kennedy (collectively, "Plaintiffs") sue to recover damages for injuries suffered as a result of alleged defects in a transvaginal pelvic mesh product manufactured and marketed by Defendants Ethicon, Inc. and Johnson & Johnson (collectively, "Defendants"). The pelvic mesh at issue was implanted into Kennedy on September 23, 2009, at the recommendation of her physician to treat a medical condition known as a cystocele.¹

This action was commenced in the multidistrict litigation court on July 2, 2013, and transferred to this Court upon the completion of discovery in January 2020. Defendants nowmove for summary judgment as to each of Plaintiffs' eighteen purported claims,² contending that (1) Plaintiffs' claims are barred by Pennsylvania's two-year statute of limitations for personal injury actions; (2) Plaintiffs' claims premised on strict liability fail because Pennsylvania law does not recognize strict liability claims involving prescription medical devices such as Defendants' pelvic mesh; (3) Plaintiffs' design defect claims fail because (i) they are preempted by federal law, (ii) Plaintiffs cannot meet their burden of proof, and (iii) Plaintiffs cannot establish causation; and (4) Kennedy's derivative loss of consortium claim fails in the absence of any underlying claim.

For the reasons set forth below, the Court finds that there can be no genuine factual dispute that Plaintiffs' claims accrued no later than May 4, 2011. They are therefore barred bythe applicable two-year statute of limitations, and Defendants' motion for summary judgment is granted.

II. BACKGROUND

A. The undisputed material facts³

As far as the factual record is concerned, Defendants' motion for summary judgment rests almost exclusively on the issue of when Kennedy became aware, or should have become aware, that her medical conditions were caused by Defendants' pelvic mesh. Because Kennedy's deposition testimony is the primary vehicle for the facts each side thinks supports its position with respect to when Kennedy was put on notice, the Court reviews the undisputed "objective" facts regarding her treatment first — such as the dates of procedures and her doctors' characterizations of her conditions — before addressing the representations made in Kennedy's deposition testimony.

1. Ramona Kennedy's conditions and treatment

In June 2009, at the age of sixty years old, Ramona Kennedy presented to her OB-GYN, Dr. Dominic Cammarano, who diagnosed her with a third-degree cystocele, a condition in which the bladder drops from its normal position in the pelvis and bulges into the vagina. Plaintiffs' Response and Statement of Additional Material Facts ("Pls.' SAMF") [ECF No. 75-1] ¶ 24.⁴ Dr.Cammarano recommended implantation of an anterior Prolift medical device, a transvaginal mesh product designed and marketed by Defendants, to treat her condition. Id.; Defendants' Statement of Undisputed Material Facts ("Defs.' SOMF") [ECF No. 71-1] ¶ 6. Dr. Cammarano performed the Prolift implantation on September 23, 2009, at which time he also implanted an Advantage Fit TVT device to treat stress urinary incontinence. Pls.' SAMF ¶ 24; Defs.' SOMF ¶ 2. Kennedy did not suffer any intra-operative or immediate post-operative complications. Id.

In March 2011, Kennedy began experiencing severe abdominal pain, which she initially attributed to pancreatitis. Defs.' SOMF ¶ 7. After a CT scan revealed the existence of a bladder stone, Kennedy was referred to a urologist, Dr. Constantine Harris. Id. ¶ 8. Dr Harris initially evaluated Kennedy on March 31, 2011. Id. ¶ 9. After reviewing her past medical history and performing a physical examination, Dr. Harris concluded, as stated in his examination notes, that Kennedy's "bladder stone [was] most likely the result of mesh erosion." Id. ¶ 10; Pls.' SAMF ¶ 25. As to his initial examination of Kennedy, Dr. Harris testified at his deposition as follows: "In my experience, patients that - women who have bladder stones, most times it's attached to something in the bladder. With [Kennedy's] history of a Prolift and a TVT, that was the most likely explanation for a fairly large stone in the bladder."⁵ Defs.' SOMF ¶ 11.

On April 1, 2011, Dr. Harris performed a cystoscopy that revealed a 2-3 cm bladder calculus adherent to Kennedy's bladder wall; pursuant to the operative report, Dr. Harris' impression continued to be that "[t]he stone may be adherent to exposed TVT or Prolift mesh." Id. ¶ 12; Pls.' SAMF ¶ 25.

Dr. Harris performed a second cystoscopy on Kennedy on May 4, 2011, during which he removed the bladder stone and observed "[t]he blue fibers and translucent fibers of the mesh were clearly visible." Defs.' SOMF ¶ 17; Pls.' SAMF ¶ 26. Dr. Harris' notes indicate that "[t]he mesh was seen to dive submucosally at the lateral trigone," and "the mesh was also seen to pass submucosally close to the bladder neck on the left lateral wall." Pls.' SAMF ¶ 26. During the May 4, 2011 procedure, Dr. Harris successfully excised the exposed mesh. Defs.' SOMF ¶ 17.

Because her symptoms persisted after the first mesh removal procedure, on June 30, 2011, Kennedy presented to Dr. Harris for a follow-up visit and cystoscopy, at which time Dr. Harris noted two additional bladder stones.⁶ Pls.' SAMF ¶ 27. One bladder stone was visible "just above the left ureteral orifice," and another "on the left lateral wall," which corresponded "to the locations of the ends of the previous cystine mesh." Id. Both stones were "adherent to the wall" and, Dr. Harris noted, "likely underlying the mesh." Id. Following the cystoscopy, Dr. Harris diagnosed Kennedy with "recurrent calculi with previous mesh erosion," and recommended possible treatment options of (1) an endoscopic excision of the ends of the mesh and stone removal, or (2) an "open" procedure. Id. Dr. Harris recommended an endoscopic approach first before attempting an open procedure, and Kennedy agreed. Id.

On July 19, 2011, Kennedy underwent a second revision procedure, during which Dr. Harris performed a litholopaxy with cystoscopic removal of foreign body mesh. Pls.' SAMF ¶ 28. During the procedure, Dr. Harris noted two calculi adherent to the bladder mucosa, one "immediately medial to the left ureteral orifice," and the other "on the left wall near the bladder neck." Id. Dr. Harris excised "the visible mesh as deeply as possible," including "down to what appeared to be the outer detrusor layer of the bladder." Id. Visible mesh fibers were trimmed, and, at "the end of the procedure the only visible mesh was deep through the mucosa and detrusor muscle." Id.

On August 25, 2011, Kennedy presented to Dr. Harris for her next cystoscopy.⁷ Pls.' SAMF ¶ 29. Dr. Harris noted that during this procedure he observed "bullous edema on the left posterior wall [of the bladder] adjacent to the left ureteral orifice." Id. He also noted "a fibrinous material in the center of the area likely leading to the mesh" and "a large area of bullous edema with fibrinous material in the center of the left lateral wall" corresponding to "sites of prior stone removal and excision of mesh." Id. Following the procedure, Dr. Harris recommended an "open" procedure — as opposed to the previous endoscopic procedures — to "excise the involved areas of mesh," and Kennedy agreed. Id.

On September 12, 2011, Kennedy underwent a third mesh removal procedure — the "open" procedure. Pls.' SAMF ¶ 30. During this procedure, Dr. Harris excised two areas of eroded mesh, one "immediately lateral and cephalad to the left ureteral orifice," and one on "the left lateral wall above the bladder neck." Id.

In March 2012, Dr. Harris referred Kennedy to OB-GYN Dr. Jaime Long, who diagnosed Kennedy with mesh erosion into the bladder status post resection, recurrent urinary tract infections, urinary incontinence, and a rectocele, for which Dr. Long recommended a surgical repair. Pls.' SAMF ¶ 31. The surgical repair was performed on April 24, 2012. Id. However, prior to that, on April 12, 2012, Dr. Harris performed another cystoscopy on Kennedy to check for recurrent mesh erosion and recurrent bladder calculi, at which time he noted that there was "no evidence of mesh extrusion or erosion" and "no new stones." Defs.' SOMF ¶ 18.

On November 27, 2012, Kennedy underwent a fourth mesh removal procedure, this time performed by urologist Dr. Ariana Smith. Pls.' SAMF ¶¶ 33-34.

2. Kennedy's deposition testimony

At her deposition, Kennedy testified at length regarding her many medical treatments. Both sides point to testimony of Kennedy which they contend supports their respective positions: in the case of Defendants, that Kennedy was aware that the mesh was the cause of her ongoing medical conditions as early as March 2011; in the case of Plaintiffs, that Kennedy did not have such knowledge — or at least knowledge insufficient to trigger the limitations period — until she saw Dr. Long in 2012.

The Court recites the portions of Kennedy's testimony cited by Defendants first, followed by the portions cited by Plaintiffs. The Court reproduces the relevant portions of the deposition without characterization.

a. Testimony cited by Defendants

Q: Understood. And when you met with Dr. Harris, he was the next doctor you met with to discuss the issues you were having with incontinence and the urgency and the frequency we have been discussing?

A: Well, really the first time I saw Dr. Harris was when I had found out that I had the bladder stones and then he told me that they were attached to the mesh and had gone through my

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