Pain pump maker I-Flow lost a bid for summary judgment in a patient injury lawsuit associated with its On-Q Painbuster continuous infusion drug pump.
Plaintiff Gilbert Placencia accused I-Flow and former Orthofix (NSDQ:OFIX) subsidiary Breg Inc. of developing pain pumps that delivered "dangerous doses" of anesthetic medication to his shoulder, leading to cartilage loss and pain.
In April 2005 Placencia was implanted with the I-Flow pump immediately after surgery and the Breg pump a few months after, following which he "experienced ongoing pain, immobility and lack of function in his shoulder," according to court documents.
In December 2009 Placencia was diagnosed with chondrolysis, a condition of complete or near complete cartilage loss in the shoulder. The condition is irreversible and extremely painful, according to the plaintiff’s complaint.
Placencia has already had 1 total shoulder arthroplasty to repair the joint and will require additional procedures, including total shoulder joint replacement, for which he blames the drug pumps and the devices maker behind them.
"Defendants did not warn plaintiff or his surgeon about the unreasonable risks and dangers of using the pain pumps and anesthetic medications in this manner," according to the plaintiff’s complaint. "The surgeon used the pain pumps in the manner instructed and directed by I-Flow, Breg, and DJO. If plaintiff’s surgeon had known the information known to the defendants, he would not have used pain pumps in either of the surgeries he performed on plaintiff."
I-Flow in 1998 won FDA clearance for its pain pump for use in an intra-operative site, later losing a bid to gain indication to use the devices in intra-articular and orthopedic indications. Breg won FDA clearance in 2001, similarly losing an FDA bid for expanded indication to include orthopedic indications.
I-Flow asked for summary judgment on the case on the grounds that "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," according to court documents.
"No one suspected a possible association between the use of pain pumps and chondrolysis and thus the risk was not known or knowable and testing was not required," according to I-Flow’s defense.
The Plaintiffs argued that the FDA’s refusal to accept expanded indication for I-Flow’s device into orthopedic uses indicates a known safety issue and cited research articles predating Placencia’s surgery which raised questions about the possibility that certain medical solutions may lead to cartilage damage. The Plaintiffs further allege that I-Flow was warned of possible connections between chondrolysis and pain pumps as far back as 2004.
The court ruled out the plaintiff’s claims that the device makers failed to provide proper warning on the devices as well as accusations of manufacturing defects, but upheld a question about the device maker’s responsibilities to pursuing additional clinical testing based on the information they had.
In August 2011 Breg, declared a victory in the 1st of a series of pain pump lawsuits after a jury deemed Breg blameless of charges that it manufactured and sold a pump found to be defective and unreasonably dangerous.
The jury determined that Breg’s pain pumps were unreasonably dangerous, but decided that the company was not at fault because the technology was "state of the art" when it hit the market.