A woman underwent two surgeries to repair her shoulder. After each surgery, she was prescribed continuous infusion of a painkiller, delivered through a continuous infusion pump device, known as a pain pump. The pain pump contained a portable medication reservoir attached to a catheter that delivered the medication to the site. After the woman’s surgeries the pain pump delivered medication to her shoulder joint.
During her recovery from the second surgery, the woman’s physician diagnosed her with chondrolysis of the shoulder. The woman suffered the loss of articular cartilage in her main shoulder joints, which provided a slick surface allowing bones to move easily. The woman suffered complete loss of articular cartilage, resulting in a spontaneous fusion of her shoulder due to the ball and socket growing together into a single bone. She had no motion in the joint and could move her shoulder only a few degrees. The woman’s condition was not treatable.
The woman sued the manufacturer and distributors of the pain pump for negligence and strict products liability. The complaint alleged that the manufacturer negligently failed to warn that its pain pump should not be used in intra-articular spaces such as the shoulder joints and that the manufacturer was strictly liable for selling a product that was unreasonably dangerous due to a lack of adequate warnings.
The pain pump was regulated under the Medical Device Amendments of 1976 (MDA) to the Food, Drug & Cosmetics Act (FDCA), which requires devices to comply with the federal premarket approval process conducted by the FDA. The United States District Court for the District of Oregon refused to instruct the jury on simple negligence reasoning that the MDA preempted state law negligence claims. Following a jury verdict, the district court entered judgment in favor of the manufacturer and distributors of the pain pump.
The Ninth Circuit United States Court of Appeals vacated and remanded for a new trial. The court held that the woman’s state law claims for negligent failure to warn and strict liability based on lack of adequate warnings were not preempted by the MDA and the district court’s erroneous refusal to instruct the jury that a violation of the MDA by the manufacturer and distributors of the pain pump amounted to negligence per se was not harmless error.
The woman’s state law claims for negligent failure to warn and strict liability based on lack of adequate warnings were not preempted by the MDA. The court explained that “conflict preemption” arises when (1) compliance with both federal and state regulations is a physical impossibility, or (2) when state law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress. In evaluating whether federal law has preempted state law, a court must (1) look to the purpose of Congress as the ultimate touchstone, while also (2) starting with the assumption that the historic police powers of the States were not to be superseded unless that was the clear and manifest purpose of Congress. The court found that, even though the state-law claims were premised on the manufacturer’s violation of the MDA, the woman’s requested negligence per se jury instruction did not conflict with the congressional intent behind the MDA. The woman’s claims were not fraud-on-the-FDA claims. The failure to warn claims did not arise solely by virtue of the MDA. The woman’s requested instructions would not usurp the exclusive federal enforcement power over the MDA. The allegations at issue occurred outside the context of the regulatory process. The court reasoned that using federal law to establish the standard of care was not an attempt to enforce the underlying federal provisions.
The district court’s erroneous refusal to instruct the jury that a violation of the MDA by the manufacturer and distributors of the pain pump amounted to negligence per se was not harmless error. The court reasoned that although the district court instructed the jury that it could consider the federal law discussed during the trial, the instruction given was far weaker than the requested negligence per se instruction.
The Ninth Circuit United States Court of Appeals vacated the district court’s entry of judgment, following the jury verdict, in favor of the manufacturer and distributors of the pain pump and remanded for a new trial.
See: McClellan v. I-Flow Corp., 2015 WL 294292 (C.A.9 (Or.), January 23, 2015) (not designated for publication).
See also Medical Law Perspectives, June 2014 Report: Physician and Manufacturer Risks for Pain Pump Injuries: Malpractice, Negligence, and Products Liability