Campbell v. Boston Scientific Corp.

882 F.3d 70 (4th Cir. 2018)

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Nature of the Case

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Facts

Boston (D) manufactured a transvaginal mesh prescription medical device called the Obtryx Transobturator Mid-Urethral Sling System. It was designed to be permanently implanted as a treatment for severe stress urinary incontinence. The FDA approved the Obtryx in 2004. The FDA found the Obtryx to be 'substantially equivalent' to a device already legally on the market, and thus did not require clinical trials of the Obtryx before it was marketed. The Obtryx is made of Marlex polypropylene. Marlex polypropylene's manufacturer included a caution on its Material Safety Data Sheet (MSDS) stating that it should not be used 'in medical applications involving permanent implantation in the human body.' Ps sued D in product liability. Ps’ experts testified at trial that Marlex can degrade when implanted transvaginally and that it can elicit scar tissue that causes the mesh to shrink. D objected to the introduction of the cautionary warning by Marlex about its raw materials. D was found liable and appealed in part based on the admission of the MSDS Caution evidence.