Krolikowski, M. v. Ethicon Womens' Health

CourtSuperior Court of Pennsylvania
DecidedAugust 11, 2020
Docket2025 EDA 2019
StatusUnpublished

This text of Krolikowski, M. v. Ethicon Womens' Health (Krolikowski, M. v. Ethicon Womens' Health) is published on Counsel Stack Legal Research, covering Superior Court of Pennsylvania primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

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

Opinion

J-A17023-20

NON-PRECEDENTIAL DECISION - SEE SUPERIOR COURT I.O.P. 65.37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 J-A17023-20

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.

-2- J-A17023-20

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

-3- J-A17023-20

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 —

-4- J-A17023-20

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

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Bluebook (online)
Krolikowski, M. v. Ethicon Womens' Health, Counsel Stack Legal Research, https://law.counselstack.com/opinion/krolikowski-m-v-ethicon-womens-health-pasuperct-2020.