By Gregory Kane, J.D., M.B.A.
Injured patient failed to establish that the mesh was defective.
In an action brought by a patient who suffered from bowel obstructions allegedly as a result of a defect in the mesh that was used during his hernia surgery, the federal district court in Idaho determined that the patient failed to produce evidence substantial enough for a reasonable trier of fact to find that the device was defective. As such, the mesh manufacturers’ motion for summary judgment was granted (Grunig v. Johnson & Johnson, December 16, 2019, Winmill, B.).
The defendants, Johnson & Johnson and Ethicon, Inc., manufacture and distribute Ethicon Proceed Surgical Mesh used in hernia repair surgery. The mesh is designed to be absorbed by the body after implantation. The patient at issue in this case underwent hernia repair surgery in 2010 using the mesh. In 2017, he was diagnosed with bowel obstruction, and subsequent surgery revealed that adhesions had formed in his abdomen. A portion of underlying mesh was removed. The patient then filed a complaint against the device makers alleging defective manufacture and design of the surgical mesh; failure to warn; and negligence in design, testing, inspection, manufacture, packaging, labeling, marketing, distribution, and warnings. Following discovery, the device makers moved for summary judgment arguing that the patient had failed to establish his claim. They also filed a motion to strike a portion of the patient’s affidavit as inadmissible hearsay.
Hearsay. The manufacturers moved to strike a portion of an affidavit in which the patient’s son alleged that he had spoken to the surgeon following the procedure and the surgeon believed the adhesions were caused by the mesh. The court found that the comments of the surgeon were inadmissible hearsay not subject to an exception. The conversation was not "nearly contemporaneous" with the surgery, and the statements were undermined by the surgeon’s own deposition, which included no such beliefs. Thus, the motion to strike was granted.
Defects. Under Idaho law, the patient had to prove that the mesh was defective and negate other causes for the injury. The question of whether the mesh was defective was complex to the point of requiring expert interpretation, which the patient did not provide. Circumstantial evidence alone would not allow a reasonable juror to conclude that the nature and extent of the adhesions were made more severe by the surgical mesh because the mesh contained a defect. The patient’s lone expert was not a medical expert, in contrast to the device makers’ two experts. In addition, the defendants’ expert testimony was supported by the surgeon who performed the 2010 hernia repair. The court stated that the patient also failed to negate other causes for the injury. Because the patient failed to raise a genuine issue of material fact that a reasonable trier of fact could find the mesh defective, the court granted the device makers’ motion for summary judgment.
The case is No. 18-cv-00111-BLW.
Attorneys: Sam Johnson (Johnson & Monteleone, LLP) for Ronald Grunig and Shannon Grunig. G Brian Jackson (Butler Snow LLP) for Johnson & Johnson, Inc. and Ethicon, Inc.
Companies: Johnson & Johnson, Inc; Ethicon, Inc.
MainStory: TopStory DesignManufacturingNews WarningsNews EvidentiaryNews MedicalDevicesNews IdahoNews
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