Products Liability Law Reporter

A federal district court has held that a plaintiff may proceed on failure to warn and negligence claims against Coloplast Corp., a marketer and distributor of surgical mesh products.

Here, Marilyn Carlen was implanted with the Aris Transobturator Tape System (“Aris System”), a medical device used for treating pelvic organ prolapse and stress urinary incontinence. After the surgery, she experienced debilitating pain, necessitating another surgery to remove the Aris System. Carlen sued Coloplast Corp., which marketed and distributed the Aris System, alleging the defendant had failed to warn or provide information about the product’s unreasonably high failure rate and tendency to cause infection, vaginal erosion, and chronic pain. The plaintiff also alleged that the defendant failed to exercise reasonable care in the advertising and sale of its products. The defendant moved to dismiss.

Denying the motion, the district court noted that to prove a failure-to-warn claim, a plaintiff must prove that a manufacturer did not disclose an unreasonably dangerous condition or instruct on a product’s proper usage. Here, the court said, the plaintiff alleges that the defendant failed to warn both her physician and her about complications of its surgical mesh product. Moreover, the plaintiff alleges that after receiving notice of multiple bodily injuries resulting from the defendant’s products, the defendant had failed to provide post-marketing or post-sale warnings or instructions. Citing an Illinois high court holding that a manufacturer of a prescription medical device has a duty to warn the prescribing physician or health care provider of the product’s known dangerous propensities, the court held that the plaintiff may therefore pursue her post-sale allegations as she had presented facts suggesting that the defendant had a continuing duty to warn.

Citation: Carlen v. Coloplast Corp., 2020 WL 5645308 (S.D. Ill. Sept. 22, 2020).

Plaintiff counsel: AAJ member Kenneth B. Moll, Rebecca Fredona, and Stephen M. Cady, all of Chicago; and Daniel C. Burke, Port Washington, N.Y.