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In re Mentor Corp. Obtape Transobturator Sling Products Liability Litigation

United States District Court, M.D. Georgia, Columbus Division

February 22, 2017

IN RE MENTOR CORP. OBTAPE TRANSOBTURATOR SLING PRODUCTS LIABILITY LITIGATION No. 4:08-MD-2004 (CDL) No. 4:14-cv-207 (Luciano)

          ORDER

          CLAY D. LAND CHIEF U.S. DISTRICT COURT JUDGE.

         Defendant Mentor Worldwide LLC developed a suburethral sling product called ObTape Transobturator Tape, which was used to treat women with stress urinary incontinence. Plaintiff Juana Luciano was implanted with ObTape and asserts that she suffered injuries caused by ObTape. Mrs. Luciano brought a product liability action against Mentor, contending that ObTape had design defects that proximately caused her injuries. Mrs. Luciano also asserts that Mentor did not adequately warn her physicians about the risks associated with ObTape. Her husband Ronald brought a loss of consortium claim. Mentor seeks summary judgment as to Mrs. Luciano's claims sounding in strict liability, her breach of express warranty claim, her failure to warn claims, and her punitive damages claim. Mrs. Luciano does not oppose Mentor's summary judgment motion on her strict liability, breach of express warranty, continuing duty to warn, and punitive damages claims. Mentor's summary judgment motion is therefore granted as to these claims. Mrs. Luciano does oppose summary judgment on her claim that Mentor did not adequately warn her physician of the risks of ObTape before her implant surgery. As discussed below, the Court denies Mentor's summary judgment motion as to Mrs. Luciano's pre-implant failure to warn claim (ECF No. 38 in 4:14-cv-207).

         SUMMARY JUDGMENT STANDARD

         Summary judgment may be granted only “if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed.R.Civ.P. 56(a). In determining whether a genuine dispute 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 (1986). A fact is material if it is relevant or necessary to the outcome of the suit. Id. at 248. A factual dispute is genuine if the evidence would allow a reasonable jury to return a verdict for the nonmoving party. Id.

         FACTUAL BACKGROUND

         Viewed in the light most favorable to the Lucianos, the record reveals the following. Juana Luciano sought treatment from Dr. Stanley Kraus for stress urinary incontinence. Dr. Kraus advised Mrs. Luciano to undergo an ObTape implant procedure, and he implanted Mrs. Luciano with ObTape on June 21, 2004. Dr. Kraus does not recall receiving any literature or training regarding ObTape. Kraus Dep. 23:8-15, 36:13-22, ECF No. 39-4. Dr. Kraus could not identify any specific statements Mentor made that played a role in his decision to implant Mrs. Luciano with ObTape, and he does not recall reading the ObTape product insert data sheet. Id. at 36:23-3, 69:23-70:25. But Dr. Kraus did recall that he spoke with a Mentor sales representative about ObTape's pore size. Id. at 22:10-23:7. Although Dr. Kraus did not remember the specifics of his discussion with the Mentor representative regarding ObTape's pore size, he did understand that it was important for a mesh product to have large pores. Id. at 22:23-23:15. Dr. Kraus also testified that if he had known that ObTape had a greater risk of erosion (a complication associated with smaller pore size) than other slings, that information could have altered his decision to use ObTape to treat Mrs. Luciano.[1] Id. at 116:18-117:15.

         DISCUSSION

         The Lucianos filed this action in the United States District Court for the District of Massachusetts on July 8, 2014, and the Judicial Panel on Multidistrict Litigation transferred the case to this multidistrict litigation proceeding for pretrial proceedings. The parties agree that Massachusetts law applies to this case because Mrs. Luciano was a Massachusetts resident when her ObTape was implanted, and all of her ObTape-related treatment took place in Massachusetts.

         Under Massachusetts law, a prescription medical device manufacturer must adequately inform a patient's physician of the foreseeable risks associated with the device. E.g., Albright v. Boston Sci. Corp., 58 N.E.3d 360, 368 (Mass. App. Ct. 2016). Here, Mentor argues that Mrs. Luciano cannot establish causation on her pre-implant failure to warn claim because she did not present enough evidence to show that (1) Dr. Kraus relied on any representations from Mentor when he selected ObTape for Mrs. Luciano and (2) Dr. Kraus would not have recommended ObTape for Mrs. Luciano had he received a different warning from Mentor. But, as discussed above, Mrs. Luciano pointed to evidence that Dr. Kraus discussed ObTape-including its pore size-with a Mentor representative and that if Dr. Kraus had known that ObTape had a greater risk of erosion (a complication associated with smaller pore size) than other slings, that information could have altered his decision to use ObTape to treat Mrs. Luciano. Based on this evidence, the Court finds that there is a genuine fact dispute on Mrs. Luciano's pre-implant failure to warn claim, and Mentor's summary judgment motion on this claims is denied.

         CONCLUSION

         As discussed above, Mentor's partial summary judgment motion (ECF No. 38 in 4:14-cv-207) is granted as to Mrs. Luciano's strict liability, breach of express warranty, continuing duty to warn, and punitive damages claims. The motion is denied as to Mrs. Luciano's pre-implant failure to warn claims. That claim, along with the following claims, remain pending for trial: Mrs. Luciano's claims for negligence and breach of implied warranty and Mr. Luciano's loss of consortium claim.

         SUGGESTION OF REMAND

         This action is ready for trial. Given that Mentor has not elected to waive venue under Lexecon Inc. v. Milberg Weiss Bershad Hynes & Lerach, 523 U.S. 26 (1998) since Phase IV-1, the Court finds it appropriate to suggest that this action be remanded to the transferor court, the U.S. District Court for the District of Massachusetts. For the convenience of that court, the appendix to this Order contains a brief chronicle of the coordinated proceedings, as well as a list of significant filings and orders in MDL No. 2004.

         The Clerk of Court is directed to provide a copy of this Order to the Clerk of the Judicial Panel on Multidistrict Litigation.

         IT IS SO ORDERED.

         APPENDIX

         I. Brief Background of the Mentor ObTape MDL

         Mentor Worldwide LLC manufactured and sold a polypropylene mesh suburethral sling product called ObTape Transobturator Tape, which was used to treat women with stress urinary incontinence. The United States Food and Drug Administration cleared ObTape for sale in 2003 via its 510(k) regulatory process, and ObTape remained on the market in the United States until March 2006.

         Nearly ten years ago, women who had been surgically implanted with ObTape began filing lawsuits against Mentor, alleging that they had been injured by ObTape-primarily that they suffered infections caused by ObTape and that they were injured when ObTape eroded through their bodily tissues. In December 2008, the Judicial Panel on Multidistrict Litigation created MDL No. 2004 and transferred seventeen actions involving alleged injuries resulting from ObTape to this Court for consolidated and coordinated pretrial proceedings. See In re Mentor Corp. ObTape Transobturator Sling Products Liability Litigation, 588 F.Supp.2d 1374 (J.P.M.L. 2008). After pretrial proceedings and a bellwether trial that settled mid-trial, the original cases and approximately forty additional tag-along cases transferred to this Court were resolved through settlement. Since then, MDL No. 2004 has grown to include more than 800 additional tag-along cases, more than eighty of which remain open. The litigation was divided into phases, and cases from phases IV-8 through IV-10 are still pending. In 2013, the Court tried a Phase III bellwether case to verdict. In 2016, the Court tried a Phase IV-1 bellwether case to verdict.

         II. Significant Filings in MDL No. 2004

         These filings are, for the most part, evidentiary rulings that were made in the context of the bellwether cases that were tried in this Court; these issues may arise again.

         1. Order Denying Motion to Disqualify Expert Witness Dr. Catherine Ortuno, Apr. 1, 2010. ECF No. 231 in 4:08-md-2004; 2010 WL 1416548.

Summary: Mentor sought to exclude the testimony of Dr. Catherine Ortuno, who was an employee of a French Mentor subsidiary called Porges. While she was employed by Porges, Dr. Ortuno and a colleague developed concerns about the safety of ObTape and ultimately recommended that sales of ObTape be stopped. The Court concluded that Dr. Ortuno would be permitted to serve as an expert witness for Plaintiffs but that she would not be permitted to offer any testimony that would divulge privileged, attorney-client communications.

         2. Order on Phase I Summary Judgment Motions and Admissibility of Plaintiffs' Experts, Apr. 22, 2010. ECF No. 241 ...


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