Products Liability Law Daily Lack of proximate cause plagues vaginal mesh failure-to-warn case
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Thursday, May 11, 2017

Lack of proximate cause plagues vaginal mesh failure-to-warn case

By Sheila Lynch-Afryl, J.D., M.A.

A patient’s failure-to-warn claims against a manufacturer of transvaginal mesh could not proceed because she "woefully failed" to meet her burden in opposition to the manufacturer’s motion for summary judgment. There was no evidence that either the patient or her treating physician read the directions for use accompanying the mesh, which was necessary to establish proximate cause (Carlson v. Boston Scientific Corp., May 9, 2017, Thacker, S.).

Summary judgment. The patient sued Boston Scientific Corp. alleging that transvaginal surgical mesh prescribed and implanted as treatment for pelvic organ relapse stress urinary incontinence caused injuries. A multi-district litigation (MDL) court granted Boston Scientific summary judgment on the failure to warn claim because the patient did not present evidence that inadequate warnings caused her injuries. After the case was transferred to a district court for trial on the remaining claims, she sought reconsideration of the summary judgment order based on evidence she failed to submit to the MDL court. The district court denied the motion and she was ultimately unsuccessful at trial.

Proximate cause. The court did not err in granting summary judgment and denying the motion for reconsideration because there was no evidence that the alleged failure to warn was the proximate cause of the patient’s injuries. Proof of proximate cause requires evidence that the patient or her treating physician relied on the directions for use accompanying the mesh.

The patient submitted an affidavit stating that she would not have used the mesh if she had known of the risks. She also cited excerpts of her doctor’s deposition testimony in an attempt to demonstrate that additional information regarding the risks could have affected his decision as an implanting surgeon. The patient, however, cited no evidence establishing that either she or her doctor had read the allegedly inadequate warning in the directions for use.

Motion to reconsider. Nor did the district court err by denying the patient’s motion to reconsider despite her citation to additional excerpts of her doctor’s deposition establishing that he reviewed and was familiar with the directions for use. The entirety of this testimony was available before the summary judgment briefing, and the additional portions provided for reconsideration was not the type of evidence constituting grounds for a valid motion for reconsideration.

The case is No. 15-2440.

Attorneys: William Louis Hurlock (Mueller Law, LLC) for Martha Carlson. Leslie C. Packer (Ellis & Winters, LLP) and Daniel Brandon Rogers (Shook Hardy & Bacon LLP) for Boston Scientific Corp.

Companies: Boston Scientific Corp.

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