Health Law Daily No ‘failure to warn’ liability where doctor would not have taken different course of action even if warned of risks
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Thursday, July 22, 2021

No ‘failure to warn’ liability where doctor would not have taken different course of action even if warned of risks

By Jeffrey H. Brochin, J.D.

Where uncontroverted evidence established that surgeon would have informed patient of additional risks if he were warned of them, but would not have treated the product differently, patient’s strict liability—failure to warn claim failed.

A federal district court in Washington has granted the Motion for Summary Judgment filed by Ethicon, Inc. (Ethicon or manufacturer) as to a patient’s strict liability—failure to warn claim arising out of a vaginal mesh implant where the surgeon would not have used a different product even if warned of the risks. However, the court denied Ethicon’s Motion for Summary Judgment as to her design defect claim based on her expert witness’ testimony that her complications were the result of the characteristics of the polypropylene mesh (Ellis v. Ethicon Inc., July 14, 2021, Settle, B.).

Complications following implant. A patient who suffered from stress urinary incontinence (SUI) was implanted with Ethicon’s TVT vaginal mesh, and subsequently experienced complications of chronic sharp pelvic pain, nerve pain/neuropathy in her legs and feet, and a systemic immune system reaction, including a rash all over her body. She further stated that she experienced extremely painful intercourse and suffered from depression as a result of her inability to do many activities. She filed suit under Washington’s Product Liability Act (WPLA) claiming strict liability due to failure to warn, and strict liability based on design defect, among other claims. Ethicon moved for summary judgment, which, for the reason cited below, the court granted in part and denied in part.

Surgeon’s knowledge of risks. The patient’s surgeon testified that he had implanted approximately 400 to 500 polypropylene mesh midurethal slings, such as TVT, for the treatment of SUI, and that he was trained to use pelvic mesh implants during his residency and not by Ethicon. He had previously attended educational symposiums on the use of pelvic mesh implants, and he kept himself informed on mesh products by attending professional meetings, and reading medical journals.

He testified that if any additional risks were disclosed to him within any literature, such as patient brochures, he would have passed the information on to the patient, and although he had previously read the TVT instructions for use (IFU) he did not read the IFUs when he performed the patient’s surgery. He additionally testified that he believed that the TVT was the best surgical option for treating her SUI at that time.

Warning would not have altered treatment. The court found that although the surgeon testified that he would like to know "if something was unsafe for use in humans," that statement alone did not create an issue of material fact about whether he would have taken a different course of action. Although the patient speculated as to what the surgeon would have done if he was given additional warnings, the uncontroverted evidence established that the surgeon would have informed her of the additional risks, but not that he would have treated the product differently and avoided the harm.

The court concluded that even assuming Ethicon’s warnings were inadequate, the patient did not establish the requisite proximate cause under the WPLA, and they therefore granted Ethicon’s Motion for Summary judgment as to the Strict Liability – Failure to Warn claim.

Strict liability—Design Defect. The court next turned to the issue of whether the product suffered from a design defect. The WPLA also allows for recovery if harm was proximately caused by the negligence of the manufacturer in that the product was not reasonably safe as designed. To prevail in a WPLA claim for design defect, the patient needed to show that (1) a manufacturer’s product (2) was not reasonably safe as designed (3) caused harm to the patient. Ethicon again argued that the patient could not establish proximate causation under this claim, however, the court considered the patient’s expert witness’ testimony as to design defect. The expert witness testified that it was his opinion, to a reasonable degree of medical certainty, that the characteristics (i.e., heavy weight, deformation, small pores, degrading over time) of the old construction mechanical cut polypropylene mesh, directly caused the complications suffered by the patient.

Unlike with other mesh cases that the court had recently ruled on, this expert explicitly connected the patient’s injuries to specific design defects. The court accordingly denied Ethicon’s Motion for Summary Judgment as to the Design Defect claim.

The case is No. 3:20-cv-05692-BHS.

Attorneys: Kevin Kauffman (Wagstaff & Cartmell LLP) for Margo Ellis and Beau Ellis. Angelo J. Calfo (Calfo Eakes LLP) for Ethicon Inc. and Johnson & Johnson.

Companies: Ethicon Inc.; Johnson & Johnson

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