Federal Appellate Court Affirms Summary Judgment For Johnson & Johnson In Pelvic Mesh Case

The United States Court of Appeals for the Seventh Circuit (“Federal Appellate Court”) stated in its June 15, 2022 decision involving an allegedly defective pelvic mesh case filed against Johnson & Johnson and its subsidiary Ethicon, Inc.: “Dianne M. Donaldson and her husband appeal from the grant of summary judgment entered in favor of the makers of surgically implanted medical devices that she contended injured her due to non-specific defects. Although there is no doubt that Donaldson suffered severe and painful complications after these devices were implanted, she failed to produce sufficient evidence to avoid summary judgment in her case for non-specific defects under Illinois product liability law, and we therefore affirm.”

The Underlying Facts

Diane M. Donaldson (“Donaldson”) sought treatment for stress urinary incontinence and anterior pelvic organ prolapse. On May 24, 2010, in an attempt to remedy these conditions, Dr. Michael Schultheis surgically implanted in Donaldson two transvaginal polypropylene mesh medical devices—a TVT-Secur to treat her incontinence, and a Prosima to treat the prolapse. Both devices were manufactured by Ethicon, Inc., a subsidiary of Johnson & Johnson. In 2014, Donaldson sought treatment for injuries resulting from erosion of the mesh into her bladder, vagina and adjacent tissues, causing scarring, bladder stones and abdominal pain, among other problems.

Information sheets packaged with the devices warned of the risks of erosion but Donaldson never saw the warnings and contends that Dr. Schultheis did not inform her of these risks. At his deposition, Dr. Schultheis testified that he was aware of the possible complications, and that at the time of the operation, he believed that the benefits of the devices outweighed the risks. He also testified that, in implanting the devices, he followed all of the instructions that the manufacturer presented in writing and in a course that he attended. He opined that the devices were both safe and effective at the time of the surgery. He had placed hundreds of the devices in other patients and stood by his decision to recommend the devices to Donaldson.

The district court granted the defendants summary judgment, finding that Donaldson failed to produce sufficient evidence to create a genuine issue of material fact on two of the Tweedy factors (an Illinois case setting forth a manner of proof that resembles the common law doctrine of res ipsa loquitor in products liability cases), namely, the absence of reasonable secondary causes or whether the devices failed to perform as reasonably expected.

The Federal Appellate Court stated: “Because Dr. Nayak [the plaintiff’s urologist expert] disclaimed any opinion on the TVT-Secur device, there is no evidence in the record eliminating abnormal use or secondary causes, and no evidence that the device failed to perform as expected. As for the Prosima device, Donaldson presented no medical evidence that the secondary causes offered by the defendants’ experts were not the likely source of her injuries, or that the device did not perform as reasonably expected in light of its intended purpose. Summary judgment was therefore appropriate under Tweedy.”

Source Donaldson v. Johnson & Johnson and Ethicon, Inc., No. 21-2028.

If you or a family member were implanted with pelvic mesh or other surgical mesh and suffered complications, injuries, or chronic pain afterwards, you should find a mesh claim lawyer in your U.S. state who may investigate your mesh claim for you and represent you or your family member in a claim against the manufacturer, distributor, and/or supplier of the mesh, if appropriate.

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