Profits Over Safety?
The plaintiff alleges that Atrium was aware of the fact that the C-Qur was not compatible with human tissue, and yet worked to convince medical professionals to purchase the device and recommend it for their patients. He claims that the company was indifferent to the suffering of the plaintiff and placed profits over his health.
In December 2013, the man underwent a procedure involving the C-Qur after being diagnosed with an umbilical hernia. Within a few months, he began to suffer from severe pain in his abdomen. He learned in 2015 that the mesh could have been the cause of his discomfort, and he had it removed in January 2016. However, he said he still has pain in the area.
After the removal procedure, according to the plaintiff, the report showed he had suffered a severe cell reaction to the mesh. This resulted in the formation of scar tissue around the device. He alleges that not only did Atrium know that implantation of the C-Qur could lead to this type of reaction, but it also lied to the U.S. Food and Drug Administration (FDA) regarding changes it had made to the design of the device.
The plaintiff alleges that Atrium tried to dismiss the possibility that the C-Qur could cause severe – and potentially fatal – reactions in patients with fish allergies (the device is reportedly coated with fish oil). He says the company failed to notify the FDA of changes it made to the manner in which the device was coated with the oil.
In addition, the plaintiff alleges Atrium failed to either investigate or disclose reports of adverse reactions to the agency, and also recalled multiple models of the C-Qur without notifying the FDA, patients or doctors.