PORTLAND, Ore. (CN) - A woman who blames a painkiller pump for the near-total loss of movement in her shoulder can get a new negligence trial, the 9th Circuit ruled.
Christina McClellan sued in 2007 over injuries she attributes to her use of the PainBuster device, manufactured by I-Flow Corp. and distributed by DJO LLC and DJO Inc., when she needed continuous infusion of painkillers after two surgical procedures on her shoulder.
McClellan says the PainBuster caused a loss of articular cartilage, which led to the ball and socket of her shoulder fusing to form a single bone. She says she can only move her shoulder a few degrees and cannot move the joint.
The case went on to trial before a federal jury in Oregon, but the presiding judge shot down some of McClellan's requested jury instructions for state claims as pre-empted by federal law.
Because the 9th Circuit found no conflict between the requested jury instructions and the Medical Device Amendments to the federal Food, Drug & Cosmetics Act, however, it reversed and awarded McClellan a new trial Friday.
The lower court had based its decision on the 2001 Supreme Court case Buckman Co. v. Plaintiffs' Legal Comm., which involved state-law claims for fraud involving a company's claims to the Food and Drug Administration. In Buckman, the Supreme Court deemed those claims pre-empted because they conflicted with the MDA.
But McClellan did not allege any fraud on the FDA, the court found.
"There is no suggestion that Congress intended to displace traditional tort law by making all policing of medical labels and warnings the exclusive province of the FDA," Judge Alfred Goodwin wrote for a three-member panel.
The court saw no reason to heed the companies' concern that a jury's consideration of the MDA would create an obstacle to accomplishing the goals Congress envisioned in passing the MDA.
"I-Flow's and DJO's attempts to characterize McClellan's claims as torts in form only are poorly explained and unpersuasive," Goodwin wrote.
Finding that the withholding of the disputed jury instructions was not a harmless error, the federal appeals court vacated the judgment and remanding for a new trial.
Judges Harry Pregerson and Morgan Christen concurred.
Read the Top 8
Sign up for the Top 8, a roundup of the day's top stories delivered directly to your inbox Monday through Friday.