Health Law Daily Patient notice only if injury is sufficiently distinct from expected side-effects
Wednesday, August 29, 2018

Patient notice only if injury is sufficiently distinct from expected side-effects

By Rebecca Mayo, J.D.

There may not be sufficient notice to start the statute of limitations clock running when an injury is not distinct in some way from conditions naturally to be expected from both the patient’s condition and exposure to the product in question with some causal connection between the product and the injury. In an unpublished opinion, the Eleventh Circuit Court reversed a lower court ruling that the statute of limitations had run on a patient’s claim against the manufacturer of ObTape vaginal mesh. The court found that the question of whether the patient’s injuries were enough to put her on notice of the product’s defect was a question of fact for the jury (Perryman v. Mentor Worldwide LLC, August 28, 2018, Carnes, J.).

The complications. A patient had Mentor ObTape vaginal mesh "sling" surgically implanted to treat stress urinary incontinence. The patient’s doctor informed her that even if the mesh was properly implanted and even if there was nothing wrong with it, her body could reject the product, and the mesh could protrude through the vaginal wall or cause infection. After the surgery, the patient began experiencing pain and discomfort and on multiple occasions her doctor excised protruding mesh. A new doctor recommended removing the ObTape and replacing it with a natural product that was made with biological material that might be more likely to integrate with the human body than plastic synthetics like ObTape. The patient had the ObTape removed and replaced with the new product and her body reacted positively to the new product.

The notice. When the patient began experiencing symptoms after having the ObTape implanted, she assumed that she was having an allergy to the ObTape, her body was rejecting the product, or that she had an infection that was keeping it from healing properly. Because of the pre-surgical warning from her doctor, the patient believed the problems had something to do with her body not accepting the product rather than an inherent problem with the product itself. When her body reacted positively to the new product, she assumed it was because her body was accepting the new material better than it had accepted the ObTape. Eight years after initially having the ObTape implanted, the patient saw a television commercial about the defects and problems with the vaginal mesh.

Procedural history. After seeing the television commercials, the patient filed a lawsuit in federal court as part of a consolidated multi district litigation action against the manufacturer of ObTape. The manufacturer moved for summary judgment on the ground that the patient’s lawsuit was barred by Florida’s four-year products liability statute of limitations based on the date she had her ObTape implant removed. The district court granted summary judgment to the manufacturer and the patient appealed.

Statute of limitations. Under Florida law, the statute of limitations does not begin to run until "the date that the facts giving rise to the cause of action were discovered or should have been discovered with the exercise of due diligence." In a previous similar decision, the circuit court noted that when there is nothing about an injury that would communicate to a reasonable lay person that the injury is more likely a result of some failure of medical care than a natural occurrence that can arise in the absence of medical negligence, the knowledge of the injury itself does not necessarily trigger the running of the statute of limitations. Even medical treatment competently performed might cause new unpleasant symptoms, so the injury must be obviously unusual or sufficiently dramatic to provide notice.

Decision. The appellate court noted that the patient experienced symptoms that were acknowledged side effects of ObTape implants, mesh implants generally, and mesh implant surgery. Meaning, these symptoms could arise from a non defective mesh that had been implanted through surgery that was properly performed and were not sufficiently distinct from what might be expected after vaginal surgery to put her on notice of her cause of action as a matter of law. Therefore, the question of whether the patient’s claim had accrued when her ObTape implant was removed, is a question of fact for the jury. The court reversed the district court ruling.

The case is No. 16-16645.

Attorneys: Douglass A. Kreis (Aylstock, Witkin, Kreis & Overholtz, PLLC) for Patricia Perryman. John Q. Lewis (Tucker Ellis, LLP) for Mentor Worldwide LLC.

Companies: Mentor Worldwide LLC

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