A federal appellate court upheld an award of summary judgment to Boston Scientific Corp. on a failure to warn claim in a transvaginal mesh action, finding the plaintiff failed to provide evidence that her implanting physician was inadequately warned of the risks, according to Harris Martin.
In a May 9 opinion, the 4th Circuit U.S. Court of Appeals explained that the plaintiff failed to establish that either she or her implanting physician actually read the alleged inadequate warning in the device’s Directions For Use (DFU).
Martha Carlson was implanted with a BSC Uphold Vaginal Support System to treat her pelvic organ prolapse. She later filed the instant action in the U.S. District Court for the Western District of North Carolina, alleging the mesh eroded and caused her to suffer pain, recurrent pelvic organ prolapse, incontinence, and urinary and bowel problems. She asserted various claims against BSC, including strict liability failure to warn.
In her opposition to BSC’s motion for summary judgment, Carlson submitted an affidavit stating she would not have used the mesh had she known of its risks. Carlson also provided excerpts of Dr. Kennelly’s deposition testimony in an attempt to show that additional information regarding risks could have impacted his decision to implant the Uphold device. However, Carlson failed to present evidence establishing that either she or Dr. Kennelly read the allegedly inadequate warning in the DFU, the appellate court noted.
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