Patient wins $5.475 million verdict in pain pump case

In the first verdict of its kind, a jury awarded $5.475 million to an Oregon man and his wife for the loss of his shoulder joint after a pain pump was inserted following surgery.

The outcome is a boost to more than 300 cases already on file against several pain pump manufacturers, especially given that many saw it as the defendants’ test case.

The claims against the defendant, pain pump maker I-Flow, are similar to allegations against other manufacturers: that they marketed the devices for an “off-label” use not approved by the Food and Drug Administration and failed to warn about the risks of cartilage damage.

After a request to consolidate the cases was denied, cases are now proceeding individually.

Tom Powers of Williams Love O’Leary & Powers in Portland, Ore., who helped try the case and has about 70 more pending, said this case shares common themes with others.

“There are three big strikes against all manufacturers. Every single one of them put the pain pump on the market without doing any research. All companies at various times tried to get approval and were denied or knew other companies with an identical product had been denied. And beginning in mid-2004 manufacturers started to see red flags from world-class orthopedic surgeons,” charged Powers.

Ironically, unlike other plaintiffs’ firms that are handling dozens of cases, this was the winning attorney’s first and only case.

The attorney, John Coletti of Paulson Coletti Trial Attorneys in Portland, Ore., said he took it on because his clients were a “nice family” whose case fit within his firm’s products liability and med-mal practice.

The verdict “sends a message that these are significant cases with serious injuries,” Coletti said.

Multiple FDA denials

The plaintiff, 35-year-old Matthew Beale, underwent surgery in 2005 for a shoulder injury suffered during a flag football game.

At that time, orthopedic surgeons were using a pain pump that they inserted post-surgery that released anesthesia over two to three days. When it was finished, the patient would pull out and discard the catheter.

“The problem is the continuous exposure of cartilage to local anesthesia causes chondrolysis, which just melts away the cartilage until the joint is literally bone on bone,” said Coletti.

During the two-week trial, Coletti demonstrated that the FDA had only approved the pain pump for use in the body for soft tissue surgery and had actually denied multiple requests by I-Flow to use it in joint surgery.

“First, I-Flow tried to get it approved for intra-articular surgery, and the FDA said no. Then they said proximal to the intra-articular space, and the FDA said no. Then they asked for approval in orthopedic surgery, and the FDA said no. Then they changed it to the synovial cavity, and the FDA said no. That’s four times total they were told no by the FDA,” Coletti said.

He argued that the company thwarted the FDA by marketing directly to doctors.

According to Coletti, doctors had been using a single injection of post-surgical anesthesia since the 1920s, and they had no idea that the pain pumps had not been approved for use in joints.

A string of doctors testified that had they known the pumps weren’t approved they never would have used them.

Coletti also called a sales rep for I-Flow who testified that he would not have marketed the pumps for use in joint surgery had he known about the FDA denials.

While the defendant claimed that the doctor was to blame, Coletti argued that it was the surgeons themselves who began to notice the mysterious condition among their young, otherwise healthy patients.

“Doctors had never seen chondrolysis in their entire careers until they started using pain pumps. And since they’ve quit using them, they have never had another case,” Coletti said.

He blamed the company for failing to investigate safety concerns even as renowned orthopedic surgeons discussed their concerns at conferences and began conducting their own studies.

“Doctors started to speak amongst themselves and write articles to each other saying, ‘We think it’s these pain pumps.’ The manufacturers were up in arms saying, ‘How can they accuse us?’ but they never did any studies themselves,” said Coletti.

In November 2009, the FDA issued a statement saying that the pumps had never been approved for joint surgery and requiring the makers of the device and of the drugs used in them to warn of the risks.

Defense attorneys Eric J. Neiman of Williams Kastner in Portland, Ore., and Maynard Kirpalani, a partner at Wilson Elser Moskowitz Edelman & Dicker in Boston, declined to comment, citing a policy against commenting on pending litigation.

Kay Jackson, a spokesperson for Kimberly Clark, which acquired I-Flow in October, said the company will appeal the verdict.

But Coletti said if the company appeals he will appeal a pre-trial motion that denied him the ability to ask for punitive damages and put on evidence of adverse events that the company knew about but didn’t report.

“They better be careful what they wish for,” said Powers. “They could get a remand for a new trial likely to include punitive damages.” MMLR

Questions or comments can be directed to the writer at: sylvia.hsieh@lawyersusaonline.com