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In re Mentor Corp. Obtape Transobturator Sling Products Liability Litigation

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

October 20, 2017

IN RE MENTOR CORP. OBTAPE TRANSOBTURATOR SLING PRODUCTS LIABILITY LITIGATION

          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 Paula Kwiatkowski was implanted with ObTape and asserts that she suffered injuries caused by ObTape. Kwiatkowski brought a product liability action against Mentor, contending that ObTape had design and manufacturing defects that proximately caused her injuries. Kwiatkowski also asserts that Mentor did not adequately warn her physicians about the risks associated with ObTape.

         The parties agree that Minnesota law applies to Kwiatkowski's claims because Kwiatkowski is a Minnesota resident whose ObTape-related treatment occurred in Minnesota. The parties further agree that the statute of limitations for Kwiatkowski's strict liability claims is four years, and the statute of limitations for her negligence claims is six years. See Minn. Stat. § 541.05 subd. 2 (“[A]ny action based on the strict liability of the defendant and arising from the manufacture, sale, use or consumption of a product shall be commenced within four years.”); Minn. Stat. § 541.05 subd. 1(5) (establishing six-year limitation period for personal injury claims not arising in contract or strict liability). The parties do not, however, agree on when a personal injury claim based on injuries allegedly caused by a defective implantable medical device accrues under Minnesota law. Mentor moved to certify the question to the Minnesota Supreme Court.

         Under Minnesota law, the Minnesota Supreme Court “may answer a question of law certified to it by a court of the United States . . . if the answer may be determinative of an issue in pending litigation in the certifying court and there is no controlling appellate decision, constitutional provision, or statute of this state.” Minn. Stat. Ann. § 480.065 Subd. 3. Mentor's request for certification has some superficial appeal because there is no controlling precedent from the Minnesota Supreme Court on the proper standard for accrual of product-based personal injury claims under Minnesota law. The Court has found this issue to be determinative in many other cases in this multidistrict litigation proceeding. But resolution of a summary judgment motion in this action does not turn on the proper accrual standard. Rather, it turns on the facts. Because it appears from the present record that the Court would deny summary judgment even under the strict accrual standard advocated by Mentor, the motion to certify (ECF No. 12) is denied.

         FACTUAL BACKGROUND

         Mentor did not file a summary judgment motion, but Mentor did submit a statement of relevant facts in support of its motion to certify, and Kwiatkowski responded with her own statement of facts. Both sides supported their fact statements with evidentiary submissions. The Court has reviewed the fact statements and citations to the record as it would review a similar record on a summary judgment motion: viewed in the light most favorable to Kwiatkowski. The present record reveals the following.

         Plaintiff Paula Kwiatkowski is a Minnesota resident who suffered from stress urinary incontinence. On July 12, 2004, Kwiatkowski was surgically implanted with ObTape, a synthetic mesh sling device, to treat her stress urinary incontinence. Pl.'s Am. Fact Sheet ¶ 2, ECF No. 12-6 in 4:16-cv-048. Kwiatkowski's implant surgery and other ObTape-related treatment took place in Minnesota. ObTape is a non-woven, thermally bonded polypropylene mesh tape, and Kwiatkowski asserts that its physical properties cause ObTape to admit bacteria, hinder immune cells, and fail to achieve tissue in-growth. Due to these and other issues, ObTape is susceptible to complications like infections and erosion of the ObTape through a patient's bodily tissues. Although erosion and infection are risks of any sling product, Kwiatkowski asserts that the risk is higher with ObTape but that Mentor failed to warn her physicians about the true risks of ObTape. She also asserts that she suffered from complications that were caused by defects in ObTape.

         Shortly after her implant surgery, Kwiatkowski's doctor twice diagnosed her with a vaginal dehiscence, which means that Kwiatkowski's surgical incision reopened. Ashford Dep. 87:14-23, ECF No. 13-2 in 4:16-cv-48. Although Kwiatkowski understood that she needed to have a revision surgery to fix the problem when it happened in August 2004 and again in November 2004, neither she nor her doctor concluded that ObTape caused the incision to reopen. Id. at 90:19-25 (“Well, in her case, because it looked like . . . this was probably not a mesh problem, but I was looking at this as a regular incision dehiscence problem. So I didn't think of it as a repair of a mesh erosion at the time. I was thinking her incision opened for some reason that had nothing to do with the [mesh].”). Based on this evidence, a reasonable juror could conclude that Kwiatkowski did not suffer an injury caused by ObTape in 2004.

         After the dehiscence repairs in 2004, Kwiatkowski's incontinence improved for a while, but it got worse again in 2006. By 2008, Kwiatkowski was concerned that the ObTape was not working correctly. And in 2010, Kwiatkowski underwent a second sling procedure; her doctor removed those portions of the ObTape that were not embedded, and he implanted a different sling. There is no evidence in the present record that ObTape was causing adverse symptoms, such as pain or discharge. There is also no evidence in the present record that ObTape caused Kwiatkowski's recurrent stress urinary incontinence or that its partial removal as part of the 2010 sling placement was necessary to correct some problem caused by ObTape.

         DISCUSSION

         The Minnesota Supreme Court “may answer a question of law certified to it by a court of the United States . . . if the answer may be determinative of an issue in pending litigation in the certifying court and there is no controlling appellate decision, constitutional provision, or statute of this state.” Minn. Stat. Ann. § 480.065 Subd. 3 (emphasis added). Mentor is correct that there is no controlling Minnesota authority on the proper accrual standard for a personal injury claim based on an alleged product defect. But, at a minimum, Minnesota law requires that “two elements must be satisfied before a cause of action accrues in cases involving injuries caused by a defective product: ‘(1) a cognizable physical manifestation of the disease or injury, and (2) evidence of a causal connection between the injury or disease and the defendant's product, act, or omission.'” Rogers v. Mentor Corp., 682 Fed.Appx. 701, 709 (11th Cir. 2017) (quoting Klempka v. G.D. Searle & Co., 963 F.2d 168, 170 (8th Cir. 1992)) (applying Minnesota law).[1]

         Here, there is no evidence in the present record that Kwiatkowski suffered an injury that she knew or had reason to know was caused by ObTape more than four years before she filed this action. There is no evidence that the two revision procedures in 2004 were necessitated by an erosion or infection of the ObTape as opposed to some other surgical complication that caused Kwiatkowski's incision to reopen. A genuine factual dispute exists as to whether ObTape was the mechanism that contributed to the complications Kwiatkowski suffered almost immediately after the implant surgery. A reasonable jury could, perhaps, conclude that ObTape caused the incision to reopen. But Mentor did not point to sufficient evidence for the Court to exclude the reasonable possibility that the incision issues were unrelated to the ObTape, or that the surgical procedure itself contributed to the problems Kwiatkowski suffered. And, although Mentor appears to suggest that Kwiatkowski undisputedly suffered injuries caused by ObTape when she had a second sling procedure in 2010, there is no evidence in the present record that ObTape caused Kwiatkowski's recurrent stress urinary incontinence or that its partial removal as part of the 2010 sling placement was necessary to correct some problem caused by ObTape. For all of these reasons, a genuine factual dispute exists as to when Kwiatkowski suffered an ObTape-related physical injury that would commence the running of the statute of limitations under Minnesota law, even under the strict standard advocated by Mentor.

         CONCLUSION

         In light of the interpretation of Minnesota law by a panel of the Eleventh Circuit Court of Appeals, this Court would welcome guidance from the Minnesota Supreme Court on the proper standard for accrual of product-based personal injury claims under Minnesota law. But the Court cannot certify the question to the Minnesota Supreme Court in this case because the answer to the question would not make a difference in the outcome. As discussed above, even if the standard advocated by Mentor applies, there is a genuine fact dispute on when Kwiatkowski suffered an injury caused by ObTape, and it is not clear as a matter of law that she knew or had reason to know that she suffered an injury caused by ObTape more than four years before she filed this action. Because it appears from the present record that the Court would deny summary judgment even under the accrual standard advocated by Mentor, the motion to certify (ECF No. 12) is denied.

         TRANSFER OF ACTION

         Kwiatkowski filed this action pursuant to the Court's Direct Filing Order in MDL No. 2004. See Order Regarding Direct Filing § II(A), ECF No. 446 in 4:08-md-2004 (permitting plaintiffs from outside the Middle District of Georgia whose cases “would be subject to transfer to MDL No. 2004” to file their cases “directly in the MDL proceedings in the Middle District of Georgia”). The action was “filed in MDL No. 2004 for pretrial proceedings only, consistent with the Judicial Panel on Multidistrict Litigation's December 3, 2008, Transfer Order.” Id. § II(B). All discovery has been completed, and this case 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 early 2016, the Court finds it appropriate to transfer this action to the court where venue is proper, the U.S. District Court for the District of Minnesota. See Compl. ¶ 5, ECF No. 1 (stating that Kwiatkowski would have filed this action in Minnesota had she not filed it in this Court under the direct filing order). 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.

         About 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, although only a few remain open. The litigation was divided into phases, and cases from phase 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 ...


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