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Tort/Negligence – Late Evidence Can’t Show Failure to Warn

By: Deborah Elkins//May 10, 2017

Tort/Negligence – Late Evidence Can’t Show Failure to Warn

By: Deborah Elkins//May 10, 2017

Carlson v. Boston Scientific Corp. (Lawyers Weekly No. 001-108-17, 10 pp.) (Thacker, J.) No. 15-2440, May 9, 2017; USDC at Statesville, N.C. (Voorhees, J.) 4th Cir.

Holding: Plaintiff, who alleged injuries from implantation of a transvaginal mesh device produced by defendant, failed to show that her injuries were due to reliance by her or her physician on inadequate warnings about the product, and the Multi-District Litigation court did not err in granting summary judgment to defendant, based on deposition testimony plaintiff failed to cite before the MDL court; the 4th Circuit also upholds the North Carolina district court’s denial of reconsideration of the summary judgment ruling on plaintiff’s failure to warn claim.

MDL Court Decision

This case is one of the tens of thousands of cases that have proceeded through Multi-District Litigation concerning transvaginal surgical mesh as treatment for pelvic organ prolapse and stress urinary incontinence. Plaintiff alleges that on July 16, 2010, a physician prescribed and implanted in plaintiff one of these mesh devices: the Uphold Vaginal Support System that defendant manufactured. As a result, plaintiff alleges the mesh caused injuries including pain, recurrent pelvic organ prolapse, bladder prolapse, incontinence and urinary and bowel problems. She brought a host of claims against defendant, including failure to warn of the dangers associated with the mesh, which is the only claim at issue in this appeal.

The MDL court dismissed plaintiff’s failure to warn claim, reasoning that because she did not present evidence that her doctor read or relied on the Directions for Use (DFU) accompanying the mesh, which contained the allegedly inadequate warnings, plaintiff could not prove that any alterations to those warnings could have impacted the doctor’s course of treatment. The MDL court awarded summary judgment to defendant.

After the case was transferred to a district court for trial on plaintiff’s remaining claims, she moved for reconsideration of the summary judgment award based on evidence that she failed to cite in the MDL court – purportedly showing that her doctor was familiar with and reviewed the DFU before implanting plaintiff’s mesh. The district court denied reconsideration, ruling that despite the additional evidence, plaintiff could not prove that any inadequate warnings proximately caused her injuries. Plaintiff now challenges that decision.

Failure to Warn

Under North Carolina law, even assuming the warnings in connection with the DFU were inadequate, defendant is only liable if such inadequate warnings proximately caused plaintiff’s injuries. Proof of proximate cause requires evidence that plaintiff or her treating physician relied on the DFU. Plaintiff cited zero evidence establishing that either she or her doctor so much as read the allegedly inadequate warning in the DFU. The portions of her doctor’s testimony to which she cited did not indicate that if the DFU included an adequate warning, the doctor would have read it.

In her motion for reconsideration, plaintiff cited to additional excerpts from the doctor’s deposition establishing that he had indeed read the DFU, among other sources, before concluding that plaintiff was an appropriate candidate for a mesh implant. Federal rules require parties to cite all evidence in support of their position at summary judgment, thus permitting a district court to limit its review to such cited materials. We cannot say the MDL court erred in its summary judgment ruling based on the evidence plaintiff cited in opposition to summary judgment.

Further, the district court did not abuse its discretion in denying reconsideration. The entirety of the doctor’s deposition testimony was available well before summary judgment briefing, and the additional portions of testimony plaintiff provided to the district court for “reconsideration” did not amount to the type of evidence constituting grounds for reconsideration.

Judgment affirmed.

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