Krolikowski, M. v. Ethicon Womens' Health

Superior Court of Pennsylvania·Decided August 11, 2020·No. 2025 EDA 2019·Unpublished

Opinion

NON-PRECEDENTIAL DECISION - SEE SUPERIOR COURT I.O.P. 65.37

MALGORZATA KROLIKOWSKI : IN THE SUPERIOR COURT OF : PENNSYLVANIA

Appellant :

:

:

v. :

:

:

ETHICON WOMENS’ HEALTH AND : No. 2025 EDA 2019 UROLOGY A DIV. OF ETHICON, INC., : ETHICON, INC., JOHNSON & : JOHNSON, GYNECARE, SECANT : MEDICAL, SECANT MEDICAL INC., : PRODESCO, INC., AND SECANT : MEDICAL LLC., :

Appeal from the Judgment Entered June 7, 2019 In the Court of Common Pleas of Philadelphia County Civil Division at No(s): 140102704

BEFORE: BOWES, J., McCAFFERY, J., and FORD ELLIOTT, P.J.E. MEMORANDUM BY McCAFFERY, J.: FILED AUGUST 11, 2020 Malgorzata Krolikowski (Appellant) appeals from the judgment entered in the Philadelphia County Court of Common Pleas in favor of Ethicon Womens’ Health and Urology a Div. of Ethicon, Inc., Ethicon, Inc., Johnson & Johnson, Gynecare, Secant Medical, Secant Medical Inc., Prodesco, Inc., and Secant Medical LLC (collectively Appellees). A jury found Appellant did not prove she was entitled to damages for the negligent design, manufacture, and marketing of the Gynecare TVT-Secur pelvic mesh implant (pelvic mesh implant). On appeal, she contends the trial court abused its discretion when it permitted one of her treating physicians to offer an expert opinion when the physician

was not qualified as an expert before or during trial. For the reasons below, we affirm.

The relevant facts underlying Appellant’s claim are as follows. In 2008, at the age of 43, Appellant began experiencing stress urinary incontinence, which is “mainly leakage at laughing, coughing and sneezing,” and urge- related leakage. N.T., 4/5/19 (AM), at 17, 22; N.T., 4/8/19 (PM I), at 21. She was referred to Dr. Matthew Fagan, a urogynecologist, who recommended surgery. N.T., 4/5/19 (AM), at 25-26; Fagan’s Combined Deposition, 4/2/19, at 6. On November 4, 2008, Appellant was implanted with the pelvic mesh device, described as a “mid-urethral mesh sling.” Fagan’s Combined Deposition at 12, 22. Dr. Fagan’s medical records for a follow-up appointment, in February of 2009, stated that Appellant reported her “urgency went away,” and she was “overall 80 percent better with stress urinary incontinence.”1 Id. at 21.

In 2010, Appellant began experiencing heavy bleeding due to fibroids, and pain during intercourse (dyspareunia). N.T., 4/5/19 (AM), at 36-38, 66. In 2011, she underwent a uterine embolization procedure to correct the bleeding caused by her fibroids. Id. at 43-44, 52. After seeing an ad about mesh implant complications in 2013, Appellant visited several doctors

complaining of continued urinary leakage, which she described as worse than

1 At trial, Appellant testified that she did not recall telling Dr. Fagan she was “80 percent better” because she was still having symptoms, and she “wasn’t happy.” N.T., 4/5/19 (AM), at 35.

it was before the 2008 implantation of the pelvic mesh device. Id. at 54, 58- 59, 65. One of those doctors was urogynecologist Dr. Lily Arya, whom Appellant saw twice, on July 20 and August 10, 2015. In 2015, Appellant also began experiencing urinary leakage during intercourse. Id. at 47-48.

On January 28, 2014, Appellant filed a complaint against Appellees, asserting claims of strict products liability and negligence. The case proceeded to a jury trial commencing in March of 2019. Both parties presented expert witnesses, who offered opinions as to the causation. Appellant’s sole claim on appeal concerns the videotaped deposition testimony of Dr. Arya. Dr. Arya was not designated as an expert witness, but rather, testified as one of Appellant’s treating physicians. After Dr. Arya reviewed her findings and recommendations for Appellant based upon her medical notes, the following exchange occurred:

[Appellees’ counsel]: And so at this point in your assessment of [Appellant], did you feel that she was experiencing any complications associated with her sling?

[Dr. Arya]: So the sling was not working. That’s a failure, but I wouldn’t call that a complication. I call — the term that I use is — recurrent stress urinary incontinence. Any surgical procedure may not work.

So this is a failure of her sling. I wouldn’t call it a complication of her sling.

Arya’s Combined Deposition, 4/2/19, at 57.

Before the videotaped deposition was played for the jury, Appellant objected to this exchange as “improper expert opinion testimony,” noting “[t]hese treating physicians are called to give opinions that are specific to the

client and their care and treatment of them, and this extends beyond that.” N.T., 3/22/19, at 103, 105. Appellant’s argument continued as follows:

[Appellant’s counsel]: . . . The problem that I have is where we get into this “failure” versus “complication” thing. Like those words are very important words in this case. And what the jury understands a failure to mean versus what the jury understands complication to mean, it’s going to go into their determination of whether or not this product was defective.

THE COURT: Well, I mean, so you have the mesh implanted and now you’re incontinent and you weren’t before, that’s a complication. You have the mesh implanted in order to resolve incontinence and it doesn’t work, that’s a failure.

What’s so difficult about — am I wrong about that?

[Appellant’s counsel]: I don’t want to say that you’re wrong, Your Honor, but I think it’s a little more complicated than that actually, because they put the sling in to treat stress urinary incontinence.

THE COURT: Okay.

[Appellant’s counsel]: So when a woman leaks, you put the sling in to treat it. If it doesn’t work, yes, you could call that a failure.

THE COURT: It failed.

[Appellant’s counsel]: You could call that a failure, but the problem with calling it a failure is the defense is going to get up and argue to the jury — as it is their right to do — that sometimes medical devices just don’t work and that just happens and that doesn’t mean that the device is defective.

[Appellees’ counsel]: That’s right.

[Appellant’s counsel]: But we’re arguing that the failure rates that they knew about and that they were seeing, the extremely high failure rates as soon as they put the device on the market in this case, failure equals defect. Because if it fails in every single woman that you put it in —

THE COURT: You’re just going to have to argue that to the jury. I overrule the objection.

[Appellant’s counsel]: Fair enough, Your Honor.

Would Your Honor just consider redacting that one sentence: “Any surgical procedure may not work,” because it’s not specific to [Appellant] and it’s an overly broad statement about surgical procedures not working and —

THE COURT: No. I think that explains the meaning of the word “failure[.]” . . .

Id. at 109-11.

The jury trial lasted more than three weeks. On April 17, 2019, the jury returned a verdict for Appellees. Specifically, the jury concluded Appellant proved Appellees “negligently designed, marketed, or sold” the device, but that “the negligent design, marketing or sale” of the device was not “a factual cause of her injuries[.]” Verdict Sheet, 4/17/19, at Questions 4, 5.2 Appellant filed a timely post-trial motion, which was denied following argument on June 4, 2019. That same day, the trial court entered judgment on the verdict. This timely appeal followed.3 Appellant raises one issue on appeal:

Did the trial court abuse its discretion by permitting Dr. Arya, one of [Appellant’s] treating physicians, to offer an expert opinion on causation when (a) [Appellees] did not designate Dr. Arya as an

2 The jury also concluded Appellant failed to prove the pelvic mesh device “contained a design defect that rendered it unreasonably dangerous.” Verdict Sheet at Question 1.

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Krolikowski, M. v. Ethicon Womens' Health, (Pa. Ct. App. 2020).

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