In Re Mentor Corp. Obtape Transobturator Sling Products Liability Litigation.

• Decision Date: 22 April 2010
• Docket Number: 3:07-cv-00130.,MDL Docket No. 2004.,3:07-cv-00101,Case No. 3:07-cv-00088,3:07-cv-00102,No. 4:08-MD-2004 (CDL).,4:08-MD-2004 (CDL).
• Citation: 711 F.Supp.2d 1348
• Parties: In re MENTOR CORP. ObTAPE TRANSOBTURATOR SLING PRODUCTS LIABILITY LITIGATION.
• Court: U.S. District Court — Middle District of Georgia

711 F.Supp.2d 1348

In re MENTOR CORP. ObTAPE TRANSOBTURATOR SLING PRODUCTS LIABILITY LITIGATION.

MDL Docket No. 2004.

No. 4:08-MD-2004 (CDL).

Case Nos. 3:07-cv-00088, 3:07-cv-00101, 3:07-cv-00102, 3:07-cv-00130.

United States District Court,

M.D. Georgia,

Columbus Division.

April 22, 2010.

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Henry G. Garrard, III, Blasingame, Burch, Garrard & Ashley PC, Adam Bryant Land, Andrew J. Hill, III, Gary Bryan Blasingame, Josh B. Wages, Blasingame, Burch, Garrard & Ashley PC, Athens, GA, James S. Rogers, James S Rogers Law Offices, Seattle, WA, Khaldoun A. Baghdadi, Walkup Melodia Kelly & Schoenberger, San Francisco, CA, for Plaintiff.

Charles A. Reid, III, Drinker Biddle & Reath, Florham Park, NJ, for Movant.

John Q. Lewis, Dustin Bradley Rawlin, Jones Day, Jonathan F. Feczko, Pearson N. Bownas, Cleveland, OH, for Mentor Corp. Obtape Transobturator Sling Products Liability Litigation.

ORDER

CLAY D. LAND, District Judge.

This multidistrict litigation proceeding includes various product liability actions against Mentor Worldwide LLC (“Mentor”) arising from the implantation of Mentor's suburethral sling product, ObTape Transobturator Tape (“ObTape”), to treat Plaintiffs for stress urinary incontinence. In these actions, claims for design and manufacturing defect, warranty, and failure to warn.¹ ObTape allegedly caused complications, including infection and erosion of ObTape through Plaintiffs' bodily tissues. In support of their claims, Plaintiffs rely upon the opinion testimony of several expert witnesses, who opine that ObTape had a design and/or manufacturing defect that proximately caused the injuries suffered by these Plaintiffs. These experts also opine that Mentor did not adequately warn Plaintiffs' physicians about the risks associated with ObTape.

Mentor argues that the testimony of Plaintiffs' experts on these issues is unreliable under Federal Rule of Evidence 702 and must be excluded (Doc. 156). Mentor maintains that without that expert testimony, Plaintiffs are unable to create genuine issues of material fact on design defect, manufacturing defect, failure to warn, and causation. Mentor also contends that Plaintiffs' claims for breach of implied warranty fail. Therefore, Mentor moves for summary judgment on all Phase I Georgia Plaintiffs' design defect claims (Doc. 154), as well as their manufacturing defect claims, failure to warn claims, and implied warranty claims (Doc. 140 in 3:07-cv-88 (Parker Plaintiffs); Doc. 142 in 3:07-cv-88 (Olson Plaintiffs); Doc. 114 in 3:07-cv-101 (Plaintiffs Stafford and Pinkney); Doc. 110 in 3:07-cv-102 (Crowther Plaintiffs); Doc. 111 in 3:07-cv-102 (Booth Plaintiffs); Doc. 112 in 3:07-cv-102 (Tucker Plaintiffs); Doc. 105 in 3:07-cv-130 (Plaintiff Mills); Doc. 106 in 3:07-cv-130 (Dover Plaintiffs); Doc. 108 in 3:07-cv-130 (Merritt Plaintiffs); Doc. 109 in 3:07-cv-130 (Looper Plaintiffs); and Doc. 110 in 3:07-cv-130 (Turner Plaintiffs)). Mentor also argues that the claims of Plaintiffs Dover, Merritt, and Olson are time-barred.

For the following reasons, the Court finds that Plaintiffs have produced sufficiently reliable expert testimony to create genuine issues of material fact as to design defect, manufacturing defect, failure to warn, and causation, but the Court finds that Plaintiffs' claims for breach of implied warranty fail. Mentor's motion to exclude the expert testimony is denied except as noted below. Mentor's motions for summary judgment as to the design defect, manufacturing defect, and failure to warn claims are denied. Mentor's motions for summary judgment as to the implied warranty claims are granted.²

SUMMARY JUDGMENT STANDARD

Summary judgment may be granted only “if the pleadings, the discovery and disclosure materials on file, and any affidavits show that there is no genuine issue as to any material fact and that the movant is entitled to judgment as a matter of law.” Fed.R.Civ.P. 56(c)(2). In determining whether a genuine issue of material fact exists to defeat a motion for summary judgment, the evidence is viewed in the light most favorable to the party opposing summary judgment, drawing all justifiable inferences in the opposing party's favor. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). A fact is material if it is relevant or necessary to the outcome of the suit. Id. at 248, 106 S.Ct. 2505. A factual dispute is genuine if the evidence would allow a reasonable jury to return a verdict for the nonmoving party. Id.

FACTUAL BACKGROUND

The evidence relevant to the pending motions for summary judgment can be divided into two categories-evidence that relates to all Plaintiffs' claims and individualized evidence that relates with specific particularity to one or more Plaintiffs. The Court will discuss each category of evidence separately, starting with the evidence that is relevant to all Plaintiffs' claims. The record, with all reasonable inferences construed in favor of Plaintiffs, establishes the following.

I. Evidence Relevant to All Plaintiffs' Claims

Mentor developed a suburethral sling called ObTape Transobturator Tape (“ObTape”), which was used to treat women with stress urinary incontinence (“SUI”). ObTape was cleared for sale by the U.S. Food and Drug Administration (“FDA”) via the FDA's 510(k) regulatory process. ObTape was a Class II medical device, available only through a prescription from a physician. It was sold to hospitals and physicians, not directly to patients. Every ObTape package included a Product Insert Data Sheet (“PIDS”) which contained the following statement regarding “Adverse Reactions”:

No undesirable effects that could be directly attributed to the polypropylene fibers have been reported in the literature. As with all foreign bodies, the ObTape is likely to trigger any existing infection, which can result in fistular formation and/or expulsion of the device. The following events have been reported very rarely:

Vaginal Erosion

Urethral Erosion

Infection

Patients should be monitored regularly after the device has been implanted.

No undesirable effects directly attributed to materials used in the Introducer Needles have been reported in the literature.

(Ex. 1 to Mentor's Mot. for Summ. J. as to Design Defect Claims (Doc. 154), Wyatt Decl., Jan. 12, 2010 [hereinafter Wyatt Decl.], Ex. A, ObTape Product Insert Data Sheet 2 (emphasis added) [hereinafter ObTape PIDS].) The PIDS also instructs that patients “should immediately report any onset of bleeding or dysuria.” ( Id.) In addition, the PIDS states: “If explantation is necessary, Mentor will analyze the explanted device[.]” ( Id.)

As discussed in more detail below, Plaintiffs were implanted with ObTape to treat SUI. Plaintiffs contend that the defective design and/or manufacture of ObTape caused complications that resulted in significant injuries, including serious infections and erosion of the tape through their bodily tissues. In support of their claims, Plaintiffs rely primarily upon the testimony of various expert witnesses who have had direct clinical experience with ObTape, as well as the expert testimony of a former Mentor employee, Dr. Catherine Ortuno.

Dr. Ortuno is a former employee of Mentor-Porges.³ She is a medical doctor who received her medical degree from CHU Cochin Port-Royal (University of Paris V). (Attach. A to Ex. 4 to Pls.' Separate Statement of Material Facts, Ortuno Curriculum Vitae.) She began working for Porges in 1996 as a junior project manager for clinical trials, and she was also responsible for device vigilance. ( Id.) In 2001, she became Senior Project Manager for Women's Health Products, and she also served as Device Vigilance and Clinical Research Officer. In that role, she was in charge of the vigilance database for Mentor-Porges products, including ObTape, and she was also in charge of clinical trials. She received complaints from the field about Mentor's products, including ObTape and its predecessor, Uratape. Her job duties required her to evaluate, investigate, and report adverse events reported to Mentor-Porges regarding ObTape. (Ortuno Dep. 73:24-74:3, Oct. 19, 2009.) With Uratape, Dr. Ortuno “observed an increased rate of vaginal erosions.” (Ex. 4 to Pls.' Separate Statement of Material Facts, Ortuno Rule 26 Report 4 [hereinafter Ortuno Rule 26 Report].) Dr. Ortuno believed that the increased rate of erosions was caused either by Uratape's silicone patch or by the structure of the Uratape mesh. ( Id.) According to Dr. Ortuno, ObTape has the same mesh structure as Uratape, but it lacks the silicone patch. ( Id.; see also Ortuno Dep. 29:12-14.) After ObTape was launched, Mentor received reports of serious complications, and Dr. Ortuno concluded: “The cause could no longer be the silicone patch which had been removed from the product. The cause was the structure of ObTape.” (Ortuno Rule 26 Report 4; accord Ortuno Dep. 300:6-20; see also id. at 233:6-25 (noting that ObTape complications were more severe than complications associated with competing product).)

In addition to the opinions of Dr. Ortuno, Plaintiffs also rely upon the opinions of several medical experts. These experts include: Dr. Linda Brubaker, a board-certified obstetrician and gynecologist (“OB/GYN”) specializing in urogynecologic surgery; Dr. Suzanne Bush, a surgeon who performs urogynecologic surgery; Dr. Michel Cosson, a professor of gynecology and obstetrics at the Medical University Lille; Dr. John Davis, a physician who treats patients with stress urinary incontinence; Dr. Paul Ducheyne, a bioengineering professor at the University of Pennsylvania; Dr. Ahmed El-Ghannam, a professor of mechanical, biomaterials, and tissue engineering at the University of North Carolina at Charlotte; Dr. James Hiller, a surgeon who performs urogynecologic surgery; Dr. Mickey Karram, a board-certified OB/GYN; Dr. Kenneth Mitchell, a surgeon who...