I-Flow, a subsidiary of Kimberly Clark, lost a bid for a summary judgement in a mass tort case. The lawsuit accuses the company of improper marketing practices and failure to warn healthcare providers of the risks associated with On-Q Painbuster, a continuous infusion medication pump.
According to details from the case, plaintiff Gilbert Placencia first accused Breg Inc., a subsidiary of Orthofix, and I-Flow of developing unsafe pain pumps. According to Placencia, continuous infusion pain pumps developed by the companies had manufacturing defects that caused over-delivery of medication. High doses of anesthetic medications led to severe pain and cartilage loss for Placencia.
The case against both companies was sparked by an incident in April of 2005. At this time, Placencia received an I-Flow pump after a surgical operation. A few months later, he also received a Breg pump. According to statements from the plaintiff, the device caused him to “experience pain, immobility and lack of function in [the] shoulder.”
By the end of 2009, Placencia had also been diagnosed with chondrolysis. Chondrolysis is indicated with severe or complete cartilage loss. Tissue surrounding the pain pump injection site showed severe cartilage degradation.
To date, Placencia has undergone a shoulder arthroplasty to replace the shoulder joint. He will also require additional procedures.
According to court documents, I-Flow has requested a summary judgement in the case since "the alleged risk of chondrolysis was unknown at the time of Gilbert's surgery, and a medical device cannot be defective unless physicians would not prescribe the device for any class of patients."