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Manufacturing Defect, Claims Will Proceed in Mesh Case


In 2004, a Georgia resident was diagnosed with stress urinary incontinence. On July 16, 2004, she was implanted with a Mentor transobturator sling. In December 2010, she began experiencing pain in her thigh and saw an orthopedic surgeon, who diagnosed her with a groin strain. In March 2011, she experienced severe pain in her right leg, along with vaginal discharge. She was diagnosed with an abscess due to an erosion of the Mentor transobturator sling. In April 2011, Dr. Mygayy and Dr. Kyburz performed an excision surgery to remedy the situation.

Lady JusticeIn September 2011, the plaintiff sued Mentor, the maker of the transobturator sling, in the Northern District of Georgia. The plaintiff asserted claims of duty to warn, manufacturing defect, misrepresentation and concealment. Mentor moved for summary judgment on the claims of duty to warn, manufacturing defect, misrepresentation and concealment.

Judge Land first addressed the manufacturing defect claim noting it is based on evidence that Mentor’s product specifically called for pores measuring between 40 and 100 microns, and tests of sling samples revealed “non-uniform pores, some of which are closed-ended pores and the vast majority of which are smaller than 40 microns.” As to the manufacturing defect claim, the Judge concluded that genuine issues of fact surround this claim and, as such, it should proceed.

In her misrepresentation and concealment claims, the plaintiff asserted that she elected to undergo the sling procedure after consulting with her doctor and that Mentor provided the doctor with materials that led him to recommend the transobturator sling to the plaintiff. The plaintiff asserts that those materials either misrepresented or concealed an accurate complication rate for sling, the severity of known transobturator sling (“ObTape”) complications, and true information about sling’s physical characteristic.

Mentor contended that the plaintiff cannot prove that she relied on any misrepresentation by Mentor because it is undisputed that it did not make any representation directly to the patient. Mentor communicated exclusively with her doctors. Judge Land concluded that a genuine fact dispute exists on the justifiable reliance element and as such, Mentor is not entitled to summary judgment on the misrepresentation and concealment claims.

The Judge held that: “In general, a fraudulent or negligent misrepresentation claim ‘must be based upon a misrepresentation made to the defrauded party, and relied upon by the defrauded party,'” the Judge stated. “Here, [Plaintiff] asserts that Mentor, intending to defraud her and induce her to undergo the ObTape procedure, made misrepresentations to Dr. Mygatt and induced him to recommend ObTape to [the plaintiff]. [The plaintiff] relied on Dr. Mygatt in deciding to proceed with the ObTape procedure.”

Therefore, the Judge denied the summary judgment as to the plaintiff’s manufacturing defect claim and her claims for fraudulent misrepresentation, fraudulent concealment and negligent misrepresentation.

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