ObTape Lawsuit Against Mentor in Florida

In Christenson v. Mentor Corp, the plaintiff filed a lawsuit in the seventeenth Judicial Circuit, in Broward County, Florida. The core of the action is a strict liability for injuries the Plaintiff suffered from the surgical implant of a device called ObTape, a prescription-only medical device sold by defendant Mentor Corporation. ObTape is a synthetic suburethral sling that was designed to help woman with stress urinary incontinence (“SUI”). Approximately 35,000 women in the United States used the Mentor ObTape between 2003 and 2006 for stress urinary incontinence.

The essence of the ObTape product liability case is that Mentor ObTape did not have a mesh design, which would have allowed the OBTape sling to breathe and get nutrients to the body’s tissue. Accordingly, the ObTape sling failed to allow the tissue where the sling is attached to heal, unlike other vaginal slings on the market. These ObTape problems became clear in a study in the fall of 2006 in the Journal of Urology which found that of the 67 women who had been implanted with the Mentor ObTape Vaginal Sling, more than 13% developed vaginal extrusions. Others patients had chronic vaginal discharge, and one patient developed an abscess that led to complications. It was telling that in the control group of 56 women who used another type of vaginal sling, none experienced the complications seen with the Mentor ObTape Vaginal Sling.

In Christenson v. Mentor Corp, the Plaintiff’s ObTape lawyer also brought a claim against the Cleveland Clinic (its West Palm Beach facility) alleging that it is in the chain for Plaintiff’s strict liability claim. Mentor sought to remove, relying on Porter v. Rosenberg, 650 So.2d 79 (Fla. Dist. Ct. App. 1995) – another case involving Mentor – for the proposition that strict product liability does not apply to health care providers when (1) the medical services provided could not have been rendered without utilizing the product at issue, and (2) the “predominant purpose of the transaction” was the provision of medical services.

The U.S. District Court Judge for Southern Florida William J. Zloch ruled there is no evidence that the Cleveland Clinic is the hospital where Plaintiff’s surgery took place and that the medical services could not have been rendered without utilizing the ObTape. Accordingly, although the Mentor is correct on the law, it assumes facts not in evidence because there is “no evidence offered that the Plaintiff’s surgery was performed at the Cleveland Clinic and that it did not sell the ObTape directly to Plaintiff, but rather used it as part of the procedure performed there.”
This outcome is a victory for the Plaintiff; her ObTape lawyers obviously believe that she is best served in Florida state court. Accordingly, this is a good outcome but not one that should be expected to be frequently replicated in most products liability cases, because most products cases will not have facts that get plaintiffs past the test for whether a health care provider is in the chain of distribution for purpose of a products liability lawsuit.

If you or someone you care about has been injured by this sling and would like to learn more about the vaginal mesh lawsuits that are pending around the country, call 800-553-8082.

  • Vaginal mesh lawsuits: 2013 update