Roeder v. Am. Med. Sys.
| Decision Date | 15 October 2021 |
| Docket Number | 20-1051-JWB |
| Parties | CLEMENTINA ROEDER and RONALD ROEDER, JR., Plaintiffs, v. AMERICAN MEDICAL SYSTEMS, INC., Defendant. |
| Court | U.S. District Court — District of Kansas |
This matter comes before the court on Defendant's motion for summary judgment (Doc. 85). The motion has been fully briefed and the court is prepared to rule. (Docs. 86, 91, 98.) For the reasons stated herein, Defendant's motion is GRANTED IN PART and DENIED IN PART.
This is a products liability action filed by Plaintiff Clementina Roeder (individually, “Plaintiff”) and her husband Ronald Roeder, Jr. (together with Plaintiff hereinafter referred to as “Plaintiffs”) involving injuries allegedly sustained by Plaintiffs due to Defendant's products. On September 2, 2015, Plaintiffs filed a short form complaint against Defendant in an MDL action involving Defendant. See In re: American Medical Systems, Inc., Pelvic Repair Systems Products Liability Litigation, Case No. 12-MD-2325 (“MDL”). In that action and as raised in the pretrial order in this case Plaintiffs seek damages on the basis that Plaintiff suffered significant injuries due to the implantation of Defendant's products.
The following facts are uncontroverted for the purpose of this motion. On January 6, 2011, Plaintiff complained to her physician Dr. Darrell Werth of stress incontinence and discomfort.
Plaintiff had previously suffered from stress urinary incontinence (“SUI”) and pelvic organ prolapse (“POP”). Plaintiff was diagnosed with a large cystocele (bladder prolapse) with associated uterine prolapse and urethral hypermobility. Dr. Werth recommended a hysterectomy with anterior mesh cystocele repair and sling suspension of the bladder neck. The proposed treatment involved implanting two vaginal mesh products (“the products”), the MiniArc Precise (“MiniArc”) for SUI and the Elevate Anterior Apical System with IntePro Lite (“Elevate”) for POP. Defendant American Medical Systems, Inc., manufactured and sold the products. (Docs. 66 at 3-5; 86 at 8-9; 91 at 7.) Dr. Werth testified that he believed that the products were the best options for Plaintiff at the time of treatment. (Doc. 86-2 at 58:23-59:1.)
At the time of treatment, Dr. Werth had implanted over 100 mesh devices for the treatment of POP and over 500 mesh slings. Dr. Werth testified that he was aware at the time of Plaintiff's procedure of risks of infection, chronic pain, vaginal bleeding, dyspareunia (pain with intercourse), and continued incontinence. (Doc. 86-2 at 24:23-27:8, 30:2-24.) Both products have Instructions for Use (“IFUs”) that include associated risks with the products. Dr. Werth does not recall relying on the IFUs but he was aware of the risks listed in the IFUs prior to Plaintiff's procedure. Dr. Werth testified that he did not tell Plaintiff about the possibility of painful sex and that she could experience chronic pain after implantation of the products. (Doc. 91-2 at 73:21-74:13.)
Plaintiff told Dr. Werth that she did not want to be implanted with a product that would be “faulty later on.” (Doc. 91-1 at 102:22-103:1.) Plaintiff did some internet research on mesh implants and found that some women were having trouble but Plaintiff did not see any evidence of lawsuits regarding the mesh. (Id. at 102:11-17.) Dr. Werth allegedly told Plaintiff that he implanted the mesh into his wife, so it was safe. (Id. at 103:6-9.) This information resulted in Plaintiff deciding to go ahead with the implant procedure. (Id.) Plaintiff signed an informed consent form stating that she understood that the procedure involved some risks including pain or difficulty with sexual intercourse. (Id. at 95:6-96:9.)
The facts surrounding the communication by Dr. Werth of the risks of the mesh to Plaintiff are in dispute here. Although Dr. Werth testified that his routine is to provide a patient with the pamphlet with the risks, which was provided by Defendant, Dr. Werth didn't document this in Plaintiff's case and Plaintiff disputes that she was provided with pamphlets regarding the mesh. (Id. at 93:19-21; 86-2 at 19:9-24.) Dr. Werth has also testified that he reviewed the risks of the procedure and the potential for mesh erosion, infection, and bleeding with Plaintiff. (Doc. 86-2 at 18:23-19:8.) Plaintiff has testified, however, that she was not informed of the risks or complications associated with the mesh but that she was only told about the risks associated with surgery. (Doc. 91-1 at 92:21-93:11.) Plaintiff further testified that had she been told that the products would make her more susceptible to urinary tract infections, bleeding, and pain during intercourse, she would not have consented to the procedure. (Id. at 132:22-133:10.)
On June 9, 2011, Plaintiff underwent the implant procedure in which the Elevate and MiniArc mesh products were implanted by Dr. Werth to treat Plaintiff's conditions. Immediately after, Plaintiff complained of pain, vaginal bleeding, and worsening incontinence. (Docs. 86 at 4; 91 at 5.) Plaintiff also noticed dyspareunia upon resuming intercourse. Plaintiff also experienced four to five urinary tract infections per year following the implant procedure. (Docs. 86 at 10; 91 at 9-10.)
On August 15, 2011, Plaintiff had a follow-up appointment with Dr. Werth. Plaintiff's medical records show that she reported that she had good bladder control and no discomfort. (Doc. 91-4 at 2.) Her pelvic examination on that date showed good suspension of her cystocele and bladder neck and no sign of mesh erosion. (Id.)
On November 1, 2012, Plaintiff had a follow-up appointment with Dr. Werth. The medical records note that Plaintiff had seen advertisements on television regarding mesh repairs. (Doc. 91-5 at 2.) Plaintiff testified that at the time she believed something was wrong with her mesh. (Doc. 91-1 at 125:6-9.) She also testified that she didn't know if there was a problem at that time. (Id. at 100:25-101:6.) Plaintiff wanted Dr. Werth to check out the mesh to make sure it was healing okay because she didn't think it was. (Id.) Dr. Werth testified that he told Plaintiff that her mesh was doing fine and healing properly. He noted in her records that she had “good support” and no “signs of erosion.” (Docs. 91-2 at 49:21-50:2; 91-5 at 2.) The medical records note that Dr. Werth (Doc. 91-5 at 2.) After November 2012, Plaintiff did not see Dr. Werth as a provider.
On July 1, 2015, Plaintiff saw Dr. Brian Flynn and complained of constant vaginal pain and burning, painful sexual intercourse, bleeding, infections, and frequent/urgent urination. Dr. Flynn diagnosed Plaintiff with SUI, cystocele, urinary tract infections, dyspareunia, and complication of genitourinary device. (Doc. 91-6 at 3.) Dr. Flynn believed that Plaintiff's mesh exposure was the cause of her pain and dyspareunia and advised Plaintiff to undergo a near total mesh explant due to her chronic exposure to the mesh and his concern that the mesh was contaminated because bacteria was growing on the mesh. (Doc. 91-7 at 76:23-78:16.) Plaintiff testified that it was at this appointment when she first attributed her pain and other symptoms to the mesh. (Doc. 91-1 at 133:24-134:3.)
The material used in the products, polypropylene mesh, was recommended by its manufacturer for use in carpet backing, ropes, and cordage products. Plaintiff has offered evidence from the manufacturer, Total Petrochemicals, and Dr. Rosenzweig, her expert, that this material is unsuitable for permanent human implantation. Defendant disputes this and has offered its own expert who has opined that the mesh is a safe treatment option. (Docs. 91 at 13; 98 at 7.) Dr. Werth testified that he did not know that Total Petrochemicals wrote a letter dated June 29, 2010, stating that its product is not suitable for human implants. (Doc. 91 at 13; 98 at 7.) He further testified that he does not know whether polypropylene would have a different effect in the abdomen compared to the vagina and would want to know if there were detrimental effects to implanting mesh in the vagina. If there were detrimental effects in implanting polypropylene in the vagina, Dr. Werth would not use those products. (Doc. 91-2 at 81:2-82:1.) Further, Dr. Werth testified that he would want to know if polypropylene mesh was not inert and, as a result, could have detrimental effects on a body. His concern would be toxicity. (Id. at 83:6-9.)
Dr. Rosenzweig has opined that the mesh is not inert in that it will degrade over time and that this leads to long term complications. (Doc. 91-10 at 17-22.) Defendants dispute Dr. Rosenzweig's opinions and assert that the mesh is safe for implantation and that all risks were communicated to implanting physicians. (Doc. 98 at 8.) Although this fact is disputed, Plaintiffs contend that the IFUs do not adequately communicate to the user the frequency and severity of the risks disclosed and the safety and effectiveness of the products.
Defendant now moves for summary judgment on the basis that Plaintiffs' claims are barred by the statute of limitations and, alternatively, that her claim under the Kansas Product Liability Act (“KPLA”) fails as a matter of law.
Summary judgment is appropriate if the moving party demonstrates that there is no genuine dispute as to any material fact....
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