Medical Companies Sued Over Product Deficiency in Medical Mesh

A lawsuit against a group of medical suppliers was removed on Wednesday by the defendants to the New Mexico District Court. The plaintiff, Susan Candelaria claimed that she sustained injuries due to the defendants’ AMS Monarc Hammock product. 

The defendants, American Medical Systems, Inc., American Medical System Holdings, Inc., Endo Pharmaceuticals, Inc., and Endo Pharmaceuticals Holdings, Inc., were accused of being responsible for the plaintiffs’ injury which was “a result of having transvaginal mesh manufactured by American Medical Systems, Inc. implanted into her vaginal area.”

In 2016, Candelaria was diagnosed with a medical condition known as stress urinary incontinence. Her doctor-recommended course of treatment was to implant the AMS Monarc Hammock, for which she received surgery on March 18, 2016. The complaint described that the plaintiff began experiencing incomplete bladder emptying, urinary retention, intra-abdominal and pelvic swelling, and urinary tract infections “shortly after the procedure.” The transvaginal mesh implanted into the plaintiff’s vaginal area was produced by the defendant.

The defendants design, patent, manufacture, label, market, sell, and distribute a line of “pelvic mesh products.” They produced the FDA- approved AMS Monarc Hammock that was implanted in the Plaintiff and allegedly harmed her. That product is designed to treat “urinary incontinence and pelvic organ prolapse.” 

The complaint noted that an FDA Safety Communication said that the benefits of using transvaginal mesh products did not outweigh the associated risks. The defendants were allegedly aware of this, yet did not disclose it in consumer advertising.

The complaint explained that the “Defendants omitted the risks, dangers, defects, and disadvantages of the AMS Monarc Hammock, and advertised, promoted, marketed, sold, and distributed them as safe medical devices,” knowing they had the potential to cause catastrophic injuries. Polypropylene is a material used in the mesh, which is scientifically evidenced to be “biologically incompatible with human tissue and promotes a negative immune response in a large subset of the population,” the filing explained.

Due to the side effects, Candelaria had revision surgery on July 2, 2018 where a doctor removed the AMS Monarc Hammock. The surgery caused the doctor to note that Candelaria had “intraurethral erosion of synthetic mesh.” Candelaria asserted that due to the product, she was forced to undergo additional surgery and assume the risks once again of general anesthesia.

The complaint cited negligence, strict liability – design defect, fraud, a violation of the unfair trade practices act, and estoppel and tolling of statute of limitations. These charges have led Candelaria to seek compensatory, economic, and punitive damages, unjust enrichment, restitution and disgorgement of profits, reasonable attorney’s fees, and other relief deemed just by the Court.

The plaintiff is represented by Montes Law Group PC, while the defendants are represented by O’Brien & Padilla.