When it came time for trial in McClellan v. I-Flow Corp., the district court refused to give certain jury instructions pertaining to Oregon state law (where the trial was held), finding that because the device was regulated by the federal Medical Device Amendments of 1976 (MDA), federal law pre-empted state law and such instructions were barred. Jurors issued a verdict favorable to defendants, but on appeal, the appellate panel ruled the failure to offer requested jury instructions was improper and not harmless to plaintiff.
The case was remanded for a new trial.
Our South Florida defective medical device lawyers recognize the significance of this finding in that it could mean more stringent state standards might be applied in certain cases, so long as the instructions offered do not conflict with the congressional intent behind MDA. This is important because we are seeing an increase in the number of lawsuits filed against pain pump manufacturers by patients who have developed chondrolysis. These lawsuits have been filed primarily at the federal level, as was the McClellan case, before the U.S. Court of Appeals for the Ninth Circuit.
Lawsuits followed an initially mysterious number of “medical mysteries,” as surgeons across the U.S. started to report once-active young patients suddenly developed the condition – a relatively rare condition in which joint cartilage dies, leaving bone grinding on bone – after surgery. Some high school and college athletes were forced to end their athletic ambitions. In some cases, it has meant total joint replacement. Most sufferers are staring down a lifetime of disability and pain.
It now seems the “mystery” is solved, and the culprit, say hundreds of plaintiffs, is a postsurgical pain pump used to delivery local painkillers to certain areas through a plastic tube.
Pain pumps gained in popularity in the late 1990s, with orthopedic surgeons convinced it was an alternative to longer hospital stays. It was also seen as a safer alternative to prescribing narcotic painkillers, where doses were controlled by the patient.
But many now say that when areas of the body are exposed to those medications for up to 72 hours, otherwise harmless drugs become toxins. In 2009, the U.S. Food & Drug Administration issued a warning regarding pain pump use in joints, and manufacturers were instructed to alter labels and discourage doctors from longer-term use. This was after a number of studies had been conducted indicating the pain pumps were likely causing the chondrolysis.
I-Flow is one of the top manufacturers of the device, and the company has vowed to “vigorously defend” against liability claims.
In the McClellan case, plaintiff asserted her chondrolysis diagnosis in her shoulder was a direct result of receiving an infusion of a painkiller through defendant’s infusion pump device, known as the “Pain Buster.” As a result, she has no motion in the joint and can only move her shoulder a few degrees. Her condition is not treatable, doctors say, meaning she will suffer lifelong disability.
Her lawsuit alleged two theories of liability: Manufacturer negligently failed to warn that the pump shouldn’t be used in intra-articular spaces (such as the glenohumeral joint where hers was placed), and that manufacturer was strictly liable for selling an unreasonably dangerous product that lacked adequate warnings.
District court denied plaintiff’s request to give certain state-statute instructions to jurors, reasoning they were pre-empted by federal law. It found the requested instructions would run afoul of MDA premption, based on the U.S. Supreme Court findings in Buckman Co. v. Plaintiffs’ Legal Comm. in 2001.
Jurors decided in defendant’s favor.
The federal appellate court reversed, however, finding Buckman was not controlling. Further, there was nothing in the requested instructions that conflicted with the congressional intent behind federal law.
If you have been injured by a defective medical product, contact the Hollander Law Firm at 888-751-7777 for a free and confidential consultation. There is no fee unless we win.
McClellan v. I-Flow Corp., Jan. 23, 2015, U.S. Court of Appeals for the Ninth Circuit
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