Pitlyk v. Ethicon, Inc.

IN THE UNITED STATES DISTRICT COURT FOR THE

EASTERN DISTRICT OF MISSOURI

EASTERN DIVISION

DENISE PITLYK, et al., )

)

Plaintiffs, )

)

v. ) Case No. 20-cv-00886-SRB

)

ETHICON, INC., et al., )

)

Defendants. )

ORDER

Before the Court is Plaintiff Denise Pitlyk (“Ms. Pitlyk”) and William Pitlyk’s

(collectively, the “Plaintiffs”) Amended Motion to Exclude Certain Opinions and Testimony of

John R. Wagner, M.D. (Doc. #44). For the reasons set forth below, the motion is DENIED.

I. BACKGROUND

Plaintiffs are residents of Missouri. On December 19, 2006, Ms. Pitlyk underwent

implantation of a TVT-Secur (“TVT-S”) pelvic mesh device to treat stress urinary incontinence.

The TVT-S was sold, manufactured, and/or designed by Defendants Ethicon, Inc. and Johnson &

Johnson (collectively, the “Defendants”). Dr. John McCarthy performed the surgery in

Chesterfield, Missouri. The mesh device allegedly caused various injuries to Ms. Pitlyk,

including “severe pelvic floor pain, systemic pain, blood in urine . . . and chronic and severe

fatigue.” (Doc. #38-1, p. 6.) Ms. Pitlyk subsequently had two surgeries to remove or revise

mesh.

On December 30, 2014, Plaintiffs directly filed suit in a multidistrict litigation (“MDL”)

case related to allegedly defective TVT-S products. Plaintiffs’ Short Form Complaint asserts the

following claims against Defendants: 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); violation of consumer protection laws (Count XIII);

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, pp. 4-

5.) On or about June 17, 2020, this case was remanded from the MDL court to this Court for

further proceedings. (Doc. #49.)

Plaintiffs now move to preclude certain opinions offered by Defendants’ general and

case-specific expert, Dr. John R. Wagner. Plaintiffs argue that Dr. Wagner’s opinions are not

admissible under Federal Rules of Evidence 702 and 703, and Daubert v. Merrell Dow

Pharmaceuticals, Inc., 509 U.S. 579 (1993). Defendants oppose the motion, and the parties’

arguments are addressed below.

II. LEGAL STANDARD

Federal Rule of Evidence 702 governs the admission of expert testimony. See Fed. R.

Evid. 702; Wagner v. Hesston Corp., 450 F.3d 756, 758 (8th Cir. 2006). Rule 702 provides that

a “witness who is qualified as an expert . . . may testify in the form of an opinion or otherwise if:

(a) the expert’s . . . specialized knowledge will help the trier of fact to

understand the evidence or to determine a fact in issue; (b) the testimony is

based on sufficient facts or data; (c) the testimony is the product of reliable

principles and methods; and (d) the expert has reliably applied the principles

and methods to the facts of the case.

Fed. R. Evid. 702(a)-(d). Federal Rule of Evidence 703 provides in part that “[a]n expert may

base an opinion on facts or data in the case that the expert has been made aware of or personally

observed.” Fed. R. Evid. 703.

To fulfill its “gatekeeping” role, a court faced with a proffer of expert testimony must

determine at the outset whether the evidence “both rests on a reliable foundation and is relevant

to the task at hand.” Daubert, 509 U.S. at 597. Daubert emphasized that the inquiry required by

Rule 702 is intended to be flexible. Id. at 594. “The proponent of the expert testimony must

prove its admissibility by a preponderance of the evidence.” Lauzon v. Senco Prods., Inc., 270

F.3d 681, 686 (8th Cir. 2001).

Due to the liberalization of expert testimony admission standards signaled by Daubert

and its progeny, and the codification of this trend in Rule 702, the Eighth Circuit has held that

expert testimony should be liberally admitted. Johnson v. Mead Johnson & Co., LLC, 754 F.3d

557, 562 (8th Cir. 2014) (“Daubert and Rule 702 thus greatly liberalized what had been the strict

. . . standards for admission of expert scientific testimony.”); Robinson v. GEICO Gen. Ins. Co.,

447 F.3d 1096, 1100 (8th Cir. 2006) (“A review of the caselaw after Daubert shows that the

rejection of expert testimony is the exception rather than the rule.”) (citations and quotations

omitted). As long as the expert testimony “rests upon good grounds, based on what is known, it

should be tested by the adversary process with competing expert testimony and cross-

examination, rather than excluded by the court at the outset.” Johnson, 754 F.3d at 562 (citations

and quotations omitted). The exclusion of expert testimony is proper “only if it is so

fundamentally unsupported that it can offer no assistance to the jury[.]” Wood v. Minn. Mining

& Mfg. Co., 112 F.3d 306, 309 (8th Cir. 1997) (citations and quotations omitted).

III. DISCUSSION

Plaintiffs move to exclude Dr. Wagner from offering several opinions at trial. Each

opinion is addressed below.

A. Opinions regarding whether the relevant instructions for use (“IFU”) are

adequate, including the warnings the IFUs should or should not include.

Plaintiffs move to exclude Dr. Wagner’s opinion that the IFU applicable to Ms. Pitlyk’s

mesh device was adequate and did not need additional warnings. Plaintiffs argue that Dr.

Wagner is not qualified to offer such opinions. Plaintiffs emphasize that Dr. Wagner has never

been involved in writing or preparing an IFU for any product or the product in this case, has

never been asked to serve as a consultant on product development or IFUs, and has never been

asked to provide any input regarding warning statements.

Upon review of the record, Plaintiffs’ arguments are rejected. Dr. Wagner graduated

medical school from Mount Sinai School of Medicine in 1987. He then completed an internship

and residency at University Hospital in Stony Brook, New York. Dr. Wagner is a board certified

urogynecologist. He currently specializes in female incontinence and pelvic reconstructive

surgery.

Based on his background and experience, Defendants contend that Dr. Wagner is

qualified to offer opinions that relate to the accuracy—and not the adequacy—of the IFUs.

Defendants highlight three such opinions: “(1) Dr. Wagner’s statement that ‘[t]he possible risk

of extrusion or erosion is addressed in the IFU for TVT Secur;’ (2) his statement that ‘[t]he

Warnings section of the TVT Secur IFU in use at the time of the Plaintiff’s implant specifically

discusses detrusor instability;’ and (3) his statement that he ‘disagree[s] with Dr. Raybon’s

opinions regarding the TVT Secur IFU.’” (Doc. #45, p. 3.) Defendants represent that “Dr.

Wagner’s report does not include any opinions on the adequacy of the IFU.” (Doc. #45, p. 3.)

Based on the current record, the Court finds that Dr. Wagner’s opinions relate to the

accuracy and not the adequacy of the IFUs. Consequently, Dr. Wagner may offer opinions

regarding the accuracy of the relevant IFUs at trial. See In re Ethicon Inc. Pelvic Repair Sys.

Prods. Liab. Litig., 2016 WL 4958312, at * 3 (S.D. W. Va. Aug. 25, 2016) (recognizing that “an

expert who is a urogynecologist may testify about the specific risks of implanting mesh and

whether those risks appeared on the relevant IFU”). Plaintiffs may reassert their objections at

trial if Dr. Wagner is asked about or offers testimony regarding the adequacy of any alleged

warnings.

B. Opinions or testimony that complications from Dr. Wagner’s patients in clinical

practice are uncommon or rare.

Next, Plaintiffs move to exclude “any and all opinions and testimony regarding Dr.

Wagner’s perceived safety and efficacy rates with the TVT-Secur product from his own

practice.” (Doc. #43, p. 5.) Plaintiffs state they “anticipate that Dr. Wagner may attempt to

bolster his opinions by testifying regarding his own practice and experience involving mesh

implants and suggest that complications from mesh implants are uncommon or rare or words to

that effect.” (Doc. #43, pp. 4-5.) Plaintiffs argue that such testimony should be excluded

because “Dr. Wagner did not include in his report any opinions and/or statements regarding what

his personal safety or efficacy rates are.” (Doc. #43, p. 5) (citing Fed. R. Civ. P. 26(a)(2)(B)(i)).

Defendants acknowledge that although Dr. Wagner’s case-specific report does not

include the complication rate of his TVT-Secur patients, his case-specific report states that it is

based in part on his general report. (Doc. #44-1, p. 2.) Dr. Wagner’s general report states in part

that “After TVT Secur was introduced, it quickly became my primary mid-urethral sling of

choice.” (Doc. #45-1, p. 45.) Dr. Wagner further states that “the initial benefits of the TVT

Secur sling, particularly in terms of patient discomfort, were immediately apparent,” and that he

“found very few clinical failures in [his] practice, despite using the TVT Secur as [his] primary

urethral sling.” (Doc. #45-1, p. 45.)

Under these circumstances, the Court finds that Dr. Wagner’s testimony regarding his

TVT-Secur patients was properly disclosed under Rule 26. The Court further finds that Dr.

Wagner’s education and experience renders him qualified to offer those opinions at trial.

Plaintiffs’ request to exclude such testimony is therefore denied.

C. Opinions regarding the cause of Ms. Pitlyk’s injuries.

Finally, Plaintiffs argue that Dr. Wagner’s causation opinions should be excluded

because he did not perform a reliable differential diagnosis. “A differential diagnosis determines

all of the possible causes for the patient’s symptoms and then eliminates each of these potential

causes until reaching one that cannot be ruled out, or deduces which of those that cannot be

excluded is the most likely.” Johnson, 754 F.3d at 560 n.2. “Differential diagnoses are

generally admissible,” but “should be excluded if they are scientifically invalid.” Junk v.

Terminix Int’l Co., 628 F.3d 439, 449 (8th Cir. 2010).

Plaintiffs contend that “[i]t appears that Dr. Wagner came into his opinions with the idea

that all of plaintiff’s problems were caused by other factors and he was not willing to seriously

consider the possibility that the TVT-Secur mesh device was the cause of her injuries.” (Doc.

#43, p. 6.) Plaintiffs emphasize that Dr. Wagner admitted during his deposition that he was

unable to rule out the mesh or TVT-Secur device as the cause of Ms. Pitlyk’s injuries.

The Court finds that Dr. Wagner’s opinions should not be excluded. His report expressly

states that:

I have formed a differential diagnosis where I have considered all the possible

etiologies of Ms. Pitlyk’s symptoms, including the TVT Secur, and then ruled out

or deemed less likely the potential causes that I do not feel are supported by the

evidence in the factual record or in the peer-reviewed medical literature.

(Doc. #44-1, p. 25.) Dr. Wagner then discusses Ms. Pitlyk’s symptoms and explains why he

believes they are “not due to the TVT Secur sling[.]” (Doc. #44-1, pp. 25-36.)

The Court finds that Plaintiffs’ arguments regarding Dr. Wagner, including his deposition

testimony, go to the weight and not the admissibility of his opinions. Johnson, 754 F.3d at 564

(recognizing that “a differential expert opinion can be reliable even ‘with less than full

information’” and that “such considerations go to the weight to be given the testimony by the

factfinder, not its admissibility”). Consequently, and at this time, the Court declines to exclude

Dr. Wagner’s opinions on the basis that he did not perform an adequate differential diagnosis.

IV. CONCLUSION

Accordingly, Plaintiffs’ Amended Motion to Exclude Certain Opinions and Testimony of

John R. Wagner, M.D. (Doc. #44) is DENIED.

IT IS SO ORDERED.

/s/ Stephen R. Bough

STEPHEN R. BOUGH

UNITED STATES DISTRICT JUDGE

Dated: August 12, 2020