Stengel v. Medtronic and Failure to Warn
by: Jonathan Knoll, Attorney
On January 10, 2013, the United States Court of Appeals for the Ninth Circuit sitting en banc found that the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetic Act (“FDCA”) did not preempt a plaintiff’s state-law failure to warn claim when the state-law duty “parallels” a manufacturer’s duty under federal law. In doing so, the Ninth Circuit reversed an earlier decision by a panel of the Court that had upheld the district court’s holding that the plaintiff’s claims were preempted by the MDA.
In Stengel v. Medtronic, the medical device at issue was a SynchroMed EL Pump and Catheter manufactured by Medtronic. Medtronic’s pain pump and catheter was a Class III medical device. A Class III medical device is subject to the FDA’s “rigorous” pre-market approval process. This means that before a Class III medical device is approved by the FDA, the “FDA performs a risk-benefit assessment of the device and determines the adequacy of the manufacturer’s proposed label.” The FDA then gives approval of the device, denies approval of the device, or gives approval of the device with conditions on how the device is marketed, distributed, or sold. Once the FDA approves the device, “the manufacturer is required to report any information that reasonably suggests that the device (1) ‘[m]ay have caused or contributed to a death or serious injury’ or (2) ‘[h]as malfunctioned’ and that any recurring malfunction ‘would be likely to cause or contribute to a death or serious injury.'”
In 2000, the plaintiff had Medtronic’s SynchroMed EL Pump and Catheter surgically implanted in his abdomen. In 2005, the plaintiff collapsed at home and was diagnosed with ascending paralysis in his lower body. Medtronic’s device had rendered the plaintiff permanently paraplegic. Before the plaintiff was paralyzed, Medtronic became aware of certain risks of harm associated with its device. However, even though Medtronic was required to warn the FDA of those risks under federal law, Medtronic failed to warn of those risks. Specifically, the plaintiff’s proposed amended complaint alleged that:
1. Medtronic had a continuing duty to monitor its device “and to discover and report to the FDA any complaints about the product’s performance and any adverse health consequences of which it became aware and that are or may be attributable” to the device;
2. Medtronic breached its duty under federal law by failing to warn the FDA of such risks; and
3. Because Medtronic breached its duty to warn under federal law, it breached its “duty to use reasonable case” under the applicable state law, which in Stengel was Arizona law.
The Ninth Circuit noted that under Arizona law, a warning to a third party such as the FDA satisfies a manufacturer’s duty to warn “if, given the nature of the warning and the relationship of the third party, there is ‘reasonable assurance that the information will reach those who safety depends on their having it.'” As the plaintiff’s state law claim “rest[ed] on a state-law duty that parallels a federal-law duty under the MDA” the plaintiff’s claim was not preempted.
The Ninth Circuit’s decision in Stengel reinforces the rule arising from decisions by the United States Supreme Court “that the MDA does not preempt a state-law claim for violating a state-law duty that parallels a federal-law under the MDA.” It is also consistent with opinions by the Courts of Appeal for the Fifth and Seventh Circuits which reached the same conclusion. As a result, this decision further underscores a medical device manufacturer’s duty to warn of the risks of harm associated with their products before it is too late to help users and consumers of those products.