0 MELVENY & MYERS LL P - Mesh Medical Device …...Inc. v_ Linda Batiste Dear Mrs. Matz: On behalf...

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TELEPHONE (202) 3 8 3-5 300

FACSIMILE (202) 383-54 14

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Fifth District Court of Appeals 600 Commerce Street, Suite 200 Dallas, Texas 75202

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Re: Cause No. 05-14-00864-CV, Johnson & Johnson and Ethicon, Inc. v_ Linda Batiste

Dear Mrs. Matz:

On behalf of Appellants Johnson & Johnson and Ethicon, Inc., I am tendering this letter brief regarding a new case, decided since the time briefing was completed in the above-referenced appeal. I ask that you please distribute a copy of this letter and the attached case to the panel members for the September 16, 2015 oral argument.

I attach the opinion of the U.S. Court of Appeals for the Fourth Circuit in Lewis v. Johnson & Johnson, 601 F. App'x 205 (4th Cir. 2015). This case bears directly on two issues raised here : first, whether Texas law requires a design-defect plaintiff to show that a defect injured her; and second, whether Appellee's proof of causation was legally sufficient. On both scores, Lewis confirms that this Court should reverse and render judgment for Appellants.

Similar to Appellee here, the Lewis plaintiff brought a design-defect claim against Johnson & Johnson and Ethicon, Inc. under Texas law stemming from her implantation with the TVT medical device. The Fourth Circuit affirmed a directed verdict for defendants "because Lewis failed to proffer any expert testimony that a defect in the TVT caused her" alleged injuries. 601 F. App'x at 212.

ACCEPTED05-14-00864-cv

FIFTH COURT OF APPEALSDALLAS, TEXAS

8/27/2015 1:39:41 PMLISA MATZ

CLERK

FILED IN5th COURT OF APPEALS DALLAS, TEXAS8/27/2015 1:39:41 PM LISA MATZ Clerk

Mrs. Lisa Matz, Clerk August 4, 2015

The Lewis court considered and squarely rejected the argument of Appellee here that "Texas law does not require [her] to connect her injuries to specific defects in the TVT [sic]" because "[Civil Practice & Remedies Code] Section 82.005(a)(2) does not define the causation inquiry in a device case." Appellee Br. 26-27. The Fourth Circuit swiftly dispatched this argument in a footnote:

Lewis' s assertion that a plaintiff need merely establish that the TVTand not some defect in it-caused her injuries fails. Although, as Lewis notes, a Texas statute codifying the specific causation requirement in design defect cases does not, by its own terms, "apply to" medical device cases, the section also "is not declarative ... of the common law .. . and shall not be construed to restrict the courts of this state in developing the common law with respect to any product which is not subject to this section." Tex. Civ. Prac. & Rem. Code § 82.005(d)(2), (e) (201 1). The Supreme Court of Texas has been clear that Texas common law requires a plaintiff in a strict liability design defect case to show both the defective condition of a product and a causal connection between that defect and a plaintiffs injuries. Lucas v. Tex. Indus., Inc. , 696 S.W.2d 372, 377 (Tex. 1984); Armstrong Rubber Co. v. Urquidez, 570 S.W.2d 374, 376 (Tex. 1978)).

601 F. App'x at 210 n.2 (emphasis in original).

The Lewis court's application of Texas law on other issues is likewise instructive. There, the Fourth Circuit concluded that the plaintiffs proof of causation on her various defect theories---e.g., particle loss, mesh "degradation," and use of "heavyweight," "small-pore" mesh-was legally insufficient. See 601 F. App'x at 210-12. Appellee here alleged virtually identical injuries and pursued virtually identical defect theories, and her proof was at least as lacking as the Lewis plaintiffs. ·

Respectfully submitted,

Steplien D. Brody x Counsel for Appellants\J Johnson & Johnson and Ethicon, Inc.

Mrs. Lisa Matz, Clerk August 4, 2015

Attachment

cc w/ attachment:

EDWARDS & DE LA CERDA, P.L.L.C. Peter de la Cerda [email protected] 3031 Allen St. , Ste. I 00 Dallas, TX 75204 P: (214) 550-5239 F: (214) 722-2101

cc w/ attachment:

CAPSHAW & AS SOCIA TES Richard A. Capshaw [email protected] 3031 Allen St. , Ste. 201 Dallas, TX 75204 P: (214) 761 -6610 F: (214) 761-6611

cc w/ attachment:

MATTHEWS AND AS SOCIA TES David P. Matthews [email protected] 2509 Sackett St. Houston, TX 77098 P: (713) 522-5250 F: (713) 535-7184

cc w/ attachment:

FREESE & GOSS, PLLC Tim K. Goss [email protected] 3031 Allen St., Ste. 200 Dallas, TX 75204 P: (214) 761 -6610 F: (214) 761-6688

Lewis v. Johnson & Johnson, 601 Fed.Appx. 205 (2015)Prod.Liab.Rep. (CCH) P 19,572

© 2015 Thomson Reuters. No claim to original U.S. Government Works. 1

SynopsisBackground: Patient commenced action in diversity againstmanufacturer, alleging failure-to-warn and design defectproducts liability claims resulting from implantation oftension-free vaginal tape to treat stress urinary incontinence(SUI). The United States District Court for the SouthernDistrict of West Virginia, Joseph R. Goodwin, J., 2014WL 186869, granted summary judgment for manufacturer,and denied reconsideration, 2014 WL 457544, and grantedjudgment as matter of law on her design defect claim. Patientappealed.

Holdings: The Court of Appeals held that:

[1] allegedly inadequate warning was not cause of patient'sinjury allegedly resulting from tension-free vaginal tape;

[2] district court did not abuse its discretion in excludingportions of testimony from specialist in hernia surgery; and

[3] patient had to present expert testimony establishing causallink between alleged defects in tension-free vaginal tape andher injuries.

Affirmed.

West Headnotes (3)

[1] Products LiabilityWarnings or instructions

Products LiabilityImplants and prosthetic devices

Allegedly inadequate warning was not causeof patient's injury allegedly resulting fromtension-free vaginal tape, and thus patientcould not prevail on failure-to-warn claimunder Texas law, since physician relied on herown experience and examination of patient indeciding to prescribe device, and not on device'swarning.

Cases that cite this headnote

[2] EvidenceDue care and proper conduct in general

District court did not abuse its discretion inexcluding portions of testimony from specialistin hernia surgery regarding patient's painand mesh explant, in patient's action againstmanufacturer alleging design defect productsliability claims resulting from implantationof tension-free vaginal tape to treat stressurinary incontinence (SUI), since specialistwas not expert in pathology or stress urinaryincontinence, he did not receive training orboard-certification in pathology, and he hadnever treated patient, performed surgery to treatSUI, or collected and studied mesh explants fromSUI patients.


[3] Products LiabilityImplants and prosthetic devices

Products Liability



Design defect

Texas law required patient on her designdefect claim to present expert testimonyestablishing causal link between alleged defectsin tension-free vaginal tape (TVT) and herinjuries, since issue of whether any of thosedefects caused patient's pain involved complexand technical medical issues beyond commonknowledge and experience; patient alleged thatTVT's heavyweight, small-pore mesh causeddegradation, scar tissue, and nerve entrapment,which in turn caused her pelvic pain anddyspareunia, and she also alleged that themechanical cutting of TVT's mesh caused looseparticles, which in turned caused pain duringintercourse.


*206 Appeal from the United States District Court for theSouthern District of West Virginia, at Charleston. Joseph R.Goodwin, District Judge. (2:12–cv–04301; 2:12–md–02327).

Attorneys and Law Firms

ARGUED: Adam Steffen Davis, Wagstaff & Cartmell LLP,Kansas City, Missouri, for Appellant. David B. Thomas,Thomas Combs & Spann, PLLC, Charleston, West Virginia,for Appellee. ON BRIEF: Julie L. Rhoades, Matthews& Associates, Houston, Texas, for Appellant. Charles C.Lifland, Los Angeles, California, Stephen D. Brody, David K.Roberts, O'Melveny & Myers LLP, Washington, D.C.; PhilipJ. Combs, Thomas Combs & Spann, PLLC, Charleston, WestVirginia; Christy D. Jones, Butler Snow LLP, Ridgeland,Mississippi, for Appellees.

Before MOTZ and DIAZ, Circuit Judges, and DAVIS, SeniorCircuit Judge.

Opinion

*207 Affirmed by unpublished PER CURIAM opinion.

Unpublished opinions are not binding precedent in thiscircuit.

PER CURIAM:

Texas resident Carolyn Lewis brought this diversity productsliability suit against Ethicon, Inc., a subsidiary of Johnson &Johnson. She seeks damages for injuries allegedly resultingfrom tension-free vaginal tape (TVT) manufactured byEthicon. Lewis appeals the grant of summary judgment on herfailure-to-warn claim, and the judgment as a matter of law onher design defect claim. We affirm.

I.

In 2009, urogynecologist Muriel Boreham diagnosed Lewiswith stress urinary incontinence (SUI), a condition causingurine leakage during physical exertion. After a series of tests,Dr. Boreham recommended the insertion of a TVT meshdevice to correct the SUI.

In October of that year, Dr. Boreham implanted a TVT inLewis. At a follow-up visit, Dr. Boreham told Lewis that she“was healing” and implied that Lewis could resume sexualactivity with her husband. Lewis attempted to do so, butfound that she suffered from pain during sexual activity.She also developed intermittent pelvic pain during dailyactivities. Lewis never returned to or further consulted withDr. Boreham.

Almost three years later, on July 25, 2012, Lewis filedthis action in the Northern District of Texas, seekingcompensatory and punitive damages. Pursuant to theMultidistrict Litigation Statute, 28 U.S.C. § 1407, the casewas later transferred to the Southern District of West Virginia.Prior to trial, in May 2013, Lewis visited urologist Dr.Philippe Zimmern to discuss her symptoms. Dr. Zimmern toldLewis about the option of “explant” surgery to remove partsof the TVT. Lewis elected to have the procedure. After Dr.Zimmern performed the surgery in September 2013, Lewis'spain decreased noticeably, but she was still not “a hundredpercent better.”

In December 2013, Ethicon moved for summary judgment,which the district court granted as to Lewis's failure-to-warnclaim. At trial on her remaining claims, Lewis presentedtestimony from current and former Ethicon employees andfrom five experts. At the conclusion of Lewis's case, the courtrequested briefing on the possibility of a directed verdict.After the parties briefed the issue and the district court heardargument, it directed a verdict for Ethicon on Lewis's designdefect claim. Lewis noted a timely appeal.



II.

We first address the district court's grant of summaryjudgment to Ethicon on Lewis's failure-to-warn claim.

A.

We review a district court's grant of summary judgment denovo. Glynn v. EDO Corp., 710 F.3d 209, 213 (4th Cir.2013).In so doing, we apply the same legal standards as the districtcourt. We view the evidence in the light most favorable tothe non-moving party, and affirm the grant of the motion onlywhere there is no genuine dispute as to a material fact and themoving party is entitled to judgment as a matter of law. SeeNader v. Blair, 549 F.3d 953, 958 (4th Cir.2008).

To prevail on a failure-to-warn claim under Texas law, whichthe parties agree applies in this case, a plaintiff must showboth that the warning was inadequate, and that the inadequatewarning “was a producing cause of the plaintiff's conditionor *208 injury.” Porterfield v. Ethicon, Inc., 183 F.3d 464,468 (5th Cir.1999) (per curiam) (applying Texas law). Toestablish a “producing cause,” a plaintiff must show that awarning's alleged inadequacies “would have changed [the]prescribing physician['s] decision to prescribe” the device.Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 172 (Tex.2012).Under Texas law, a device manufacturer's duty to warn ofrisks extends only to the physician prescribing the device,“the learned intermediary,” and not to the “end user” ofthe device. Id. at 157. When a plaintiff offers no evidencethat a different warning would have changed her physician'sdecision to prescribe a device, the inadequate warning cannot

have caused the plaintiff's injury. Id. at 170–71. 1

1 Citing McNeil v. Wyeth, 462 F.3d 364, 373 (5thCir.2006), Lewis argues that a plaintiff may prevail on afailure-to-warn claim by showing that a stronger warningwould have led the plaintiff to withhold consent to theprocedure. But McNeil explicitly acknowledges that therelevant test is whether the “alleged inadequacy caused[the plaintiff's] doctor to prescribe the drug.” 462 F.3dat 372 (quotations and citation omitted). And McNeilcertainly does not alter the rule that courts must lookto the prescribing doctor's behavior in deciding whetherthe inadequate warning is the “producing cause” of aplaintiff's injury. Moreover, the Supreme Court of Texasrecently reaffirmed that the inquiry under Texas law

remains whether the warning would have changed thedecision of the prescribing physician. Centocor, 372S.W.3d at 170; see also Ackermann v. Wyeth Pharm., 526F.3d 203, 208 (5th Cir.2008).

B.

[1] Lewis presented no evidence that Dr. Boreham reliedon the warning in Ethicon's patient brochure in deciding toprescribe the TVT. Dr. Boreham herself testified that she didnot recall whether she had a TVT patient brochure at thetime of Lewis's surgery, and that if she had one, she mighthave given it to Lewis or used the picture of the procedure inthe brochure to explain how the device works. Dr. Borehamfurther stated that she would not have verified the accuracyof the information in the brochure. None of this testimonyestablishes that Dr. Boreham considered the patient brochurewarning, let alone relied on it, in deciding to prescribe theTVT to Lewis.

Nor did Lewis offer evidence that Dr. Boreham relied onthe TVT's instructions for use in deciding to prescribe thedevice. Although Dr. Boreham testified that she had readthe document during her surgical fellowship in 2002, shestated that she did not read it again before prescribing theTVT to Lewis in 2009. Moreover, when asked whether sherelied on the instructions for use in prescribing the TVT,Dr. Boreham answered: “I did not.” Dr. Boreham testifiedthat she instead relied on Lewis's symptoms, bladder diary,urodynamics, physical exam, and discussions regarding herdesired outcomes in deciding to prescribe the TVT.

This evidence does not establish that “but for the inadequatewarning,” Dr. Boreham “would not have used or prescribed”the TVT. Ackermann, 526 F.3d at 208 (quotation omitted)(emphasis added). When a physician relies on her ownexperience and examination of a patient in deciding toprescribe a device, and not on the device's warning, thewarning is not the cause of the patient's injury.

The Fifth Circuit, applying Texas law, has so held. InPustejovsky v. PLIVA, Inc., the court upheld a grant ofsummary judgment to the defendants on a failure-to-warnclaim where the prescribing physician testified that she hadnot read or relied on the medical device's package insert. 623F.3d 271, 277 (5th Cir.2010). *209 Similarly, in Porterfield,the court upheld a grant of summary judgment to a surgeonwho testified that he had not read the device's instructions foruse or any other literature from the manufacturer. 183 F.3d



at 468. Lewis attempts to distinguish these cases on the basisthat Dr. Boreham did, at one time, read the instructions foruse, but she offers no evidence to rebut Dr. Boreham's owntestimony that she did not rely on the document in decidingto prescribe the TVT.

Accordingly, we agree with the district court that Lewisdid not offer sufficient evidence to create a dispute as tomaterial fact regarding whether a different warning wouldhave changed Dr. Boreham's decision to prescribe the TVT.

III.

[2] We next address Lewis's challenge to the districtcourt's exclusion of parts of Dr. Uwe Klinge's expertopinion testimony. Lewis argues that the court erroneouslyprevented Dr. Klinge from connecting his observations aboutthe condition of Lewis's mesh with her pain. We reviewevidentiary rulings, including rulings on the admissibility ofexpert testimony, for abuse of discretion. United States v.Davis, 690 F.3d 226, 257 (4th Cir.2012). When reviewinga district court's rulings on expert opinion testimony, theSupreme Court has instructed that “deference ... is thehallmark of abuse-of-discretion review.” Gen. Elec. Co. v.Joiner, 522 U.S. 136, 143, 118 S.Ct. 512, 139 L.Ed.2d 508(1997).

Before trial, Ethicon moved to exclude portions of Dr.Klinge's expert report related to the TVT mesh. It did so on thegrounds that Dr. Klinge, a former hernia specialist and not apathologist, was unqualified to offer expert testimony on thatissue, and that his testimony was unreliable. The district courtgranted the motion. It found that Dr. Klinge's testimony wasunreliable, noting that his report did not explain how he hadselected the TVT samples on which his opinions were basedand did not indicate that his analysis “controlled for error orbias.”

At trial, Ethicon again raised these issues at sidebars and inobjections, including a continuing objection, throughout Dr.Klinge's direct examination. Although the court allowed Dr.Klinge to testify regarding the general characteristics of meshsamples explanted from Ms. Lewis, it concluded that Dr.Klinge was not qualified to offer testimony regarding specificcausation. On this basis, it sustained several of Ethicon'sobjections. Lewis challenges three of these rulings: first,the ruling preventing Dr. Klinge from opining on whether“entrapped nerves in this slide ... would indicate chronic pain

for Ms. Lewis”; second, the striking of Dr. Klinge's answerto the question whether plaintiff's slides “would relate to anycomplications of pain in Ms. Lewis”; and third, the striking ofDr. Klinge's opinion that loose particles from the TVT “canvery good explain the manifestation of pain” in Ms. Lewis.

The district court did not abuse its discretion in making theserulings. Dr. Klinge was a specialist in hernia surgery, notpathology or stress urinary incontinence. He did not receivetraining or board-certification in pathology. Dr. Klinge hadnever treated Lewis, performed surgery to treat SUI, orcollected and studied mesh explants from SUI patients. Thedistrict court was clearly within its discretion in concludingthat Dr. Klinge's opinions regarding Lewis's pain and meshexplant were beyond his area of expertise, and so did notabuse its discretion in excluding those portions of Dr. Klinge'stestimony.

*210 IV.

Finally, we consider Lewis's contention that the district courterred in directing a verdict for Ethicon on her design defectclaim.

A.

We review the grant of a motion for a directed verdict denovo. Teague v. Bakker, 35 F.3d 978, 985 (4th Cir.1994).“[T]he test is essentially whether, without weighing theevidence or considering the credibility of the witnesses, therecan be but one conclusion as to the verdict that reasonablejurors could have reached.” Gairola v. Va. Dept. of Gen.Servs., 753 F.2d 1281, 1285 (4th Cir.1985) (quotation andcitation omitted). We affirm “when any verdict in favorof the nonmoving party necessarily will be premised uponspeculation and conjecture” because “a mere scintilla ofevidence is not enough to defeat a motion for a directedverdict.” Id. (quotation and citation omitted).

To avoid a directed verdict, “the plaintiff must presentsufficient evidence to establish a prima facie case.” Id. UnderTexas law, “[t]o recover for a products liability claim alleginga design defect, a plaintiff must prove that (1) the productwas defectively designed so as to render it unreasonablydangerous; (2) a safer alternative design existed; and (3) thedefect was a producing cause of the injury for which theplaintiff seeks recovery.” Timpte Indus., Inc. v. Gish, 286



S.W.3d 306, 311 (Tex.2009). The district court directed averdict for Ethicon based on the third element.

With respect to this element, “[a] plaintiff must establish acausal connection between the defective condition and theplaintiff's injuries or damages.” Am. Tobacco Co., Inc. v.Grinnell, 951 S.W.2d 420, 434 (Tex.1997) (internal citation,

alteration, and quotations omitted). 2 That is, the defect in theproduct “must be a substantial factor in bringing about theinjury, and a cause without which the injury would not havehappened.” BIC Pen Corp. v. Carter, 346 S.W.3d 533, 541(Tex.2011).

2 Lewis's assertion that a plaintiff need merely establishthat the TVT—and not some defect in it—causedher injuries fails. Although, as Lewis notes, a Texasstatute codifying the specific causation requirement indesign defect cases does not, by its own terms, “applyto” medical device cases, the section also “is notdeclarative ... of the common law ... and shall not beconstrued to restrict the courts of this state in developingthe common law with respect to any product which is notsubject to this section.” Tex. Civ. Prac. & Rem.Code §82.005(d)(2), (e) (2011). The Supreme Court of Texashas been clear that Texas common law requires a plaintiffin a strict liability design defect case to show both thedefective condition of a product and a causal connectionbetween that defect and a plaintiff's injuries. Lucas v.Tex. Indus., Inc., 696 S.W.2d 372, 377 (Tex.1984);Armstrong Rubber Co. v. Urquidez, 570 S.W.2d 374, 376(Tex.1978).

Whether expert opinion testimony is necessary to prove aplaintiff's theory of causation is a question of law. MackTrucks, Inc. v. Tamez, 206 S.W.3d 572, 583 (Tex.2006).Texas law does not always require that an expert conclusivelyopine that the defect in a product caused the plaintiff'sinjury. Kindred v. Con/Chem, Inc., 650 S.W.2d 61, 63(Tex.1983). Rather, in many cases, a jury may infer causation,“like any other ultimate fact,” from circumstantial evidence.Gladewater v. Pike, 727 S.W.2d 514, 518 (Tex.1987).

However, the Supreme Court of Texas has repeatedly madeclear that “[e]xpert testimony [on causation] is requiredwhen an issue involves matters beyond jurors' commonunderstanding.” Mack Trucks, 206 S.W.3d at 583. In aproducts liability case, proof other than expert testimonyprovides sufficient evidence of causation *211 “only whena layperson's general experience and common understandingwould enable the layperson to determine from the evidence,

with reasonable probability, the causal relationship” betweenthe defect and the injury. Id. at 583.

For example, in Mack Trucks, the Supreme Court of Texasrequired expert testimony to establish causation because a“lay juror's general experience and common knowledge donot extend to whether design defects such as those alleged inthis case caused the releases of diesel fuel during a rolloveraccident.” 206 S.W.3d at 583. Similarly, in BIC Pen, thatcourt required expert testimony to establish causation because“the impact of [defects in a lighter] on how [the lighter] wouldhave functioned in the hands of a child ... is not an issue withina lay juror's general experience and common understanding.”346 S.W.3d at 542.

Texas courts have regarded expert testimony on causationas particularly vital in cases involving complex medicaldevices and medical diagnoses. “The general rule has longbeen that expert testimony is necessary to establish causationas to medical conditions outside the common knowledgeand experience of jurors.” Guevara v. Ferrer, 247 S.W.3d662, 665 (Tex.2007); see also Anderson v. Siemens Corp.,335 F.3d 466, 475 (5th Cir.2003) (applying Texas law)(“[o]rdinarily, expert testimony is needed to satisfy thereasonable medical probability standard for establishing acausal link.”).

B.

[3] Here, Lewis alleges that the TVT's heavyweight,small-pore mesh caused degradation, scar tissue, and nerveentrapment, which in turn caused her pelvic pain anddyspareunia. She also alleges that the mechanical cutting ofthe TVT's mesh caused loose particles, which in turn causedher injuries. Whether any of these defects caused Lewis'spain involves complex and technical medical issues beyondcommon knowledge and experience. We therefore agree withthe district court that Texas law required Lewis to presentexpert testimony establishing a causal link between thesealleged defects in the TVT and her injuries.

We also agree with the district court that Lewis's failureto present such expert testimony doomed her design defectclaim. Not one of Lewis's expert witnesses opined, let aloneopined to a reasonable degree of medical certainty, that adefect in the TVT caused Lewis's injuries. Dr. Zimmerntestified that the “presence” of the TVT caused Lewis's pain,but did not testify that a defect in the TVT caused her pain.



Moreover, he could not identify what characteristic of theTVT, defective or not, caused her pain. When asked whatproperty of the TVT caused Lewis's pain, Dr. Zimmernanswered: “It's anybody's guess.... We really don't know theanswer to that question.”

Dr. Bruce Alan Rosenzweig's testimony was similarlyinsufficient. He testified that “small particles” from a TVT“can fall off into the vagina,” and that these particles “canmigrate and cause pain during intercourse.” However, Dr.Rosenzweig did not testify that this happened in Lewis'scase. In fact, he acknowledged that he had never examinedor treated Lewis, and that his opinions were not specificallyabout her. As the district court explained, evidence “that aproduct can cause injuries is insufficient to show that it didcause those injuries in a particular case.” See also BIC Pen,346 S.W.3d at 545 (“specific causation involves whetherthe substance at issue in fact caused the particular injury atissue.”).

*212 The same shortcoming characterizes Dr. BerndKlosterhalfen's testimony. He opined that he “found in mostmeshes of patients suffering chronic pain ... destructive ordamaged nerve structures [or] nerve fibers in the interface ofthe mesh, just by contact of the mesh to the nerve fiber.” Buthis testimony failed to establish a causal link between a defectin Lewis's TVT and Lewis's injuries.

Nor did Dr. Howard Jordi's testimony establish a link betweena defect in Lewis's TVT and her pain. Dr. Jordi testified

to a reasonable degree of scientific certainty that the TVTdegraded in Lewis's body and that what remained wouldcontinue to degrade. But Dr. Jordi did not testify that thisdegradation, or any effect of it, caused Lewis's pain.

Finally, the testimony of Lewis's fifth expert, Dr. Klinge, didnot satisfy the reasonable medical probability standard thata design defect in the TVT caused Lewis's pain. AlthoughDr. Klinge opined that loose particles from the TVT “canvery good explain the manifestation of pain” in Lewis, thedistrict court did not abuse its discretion, as explained above,in finding him unqualified to share this opinion with the jury.

Lewis does not argue that the remaining testimony—by, forinstance, employees of the defendant—establishes causation.Thus, because Lewis failed to proffer any expert testimonythat a defect in the TVT caused her pelvic pain, the districtcourt did not err in directing a verdict for Ethicon.

V.

For the foregoing reasons, the judgment of the district court is

AFFIRMED.

All Citations

601 Fed.Appx. 205, Prod.Liab.Rep. (CCH) P 19,572

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0 MELVENY & MYERS LL P - Mesh Medical Device …...Inc. v_ Linda Batiste Dear Mrs. Matz: On behalf...

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