In a 9th Circuit decision handed down in January 2013, the court of appeals found that the Medical Device Amendments (MDA) to the Federal Food, Drug and Cosmetics Act were not a wedge to prevent a plaintiff from making a state negligence claim against Medtronic. In a series of previous cases dating back to 2008, defendants, manufacturers and distributors of medical devices were armed with preemption defenses as a result of the cases of Riegel v. Medtronic, Inc. and bolstered by Bell Atlantic Corp. v. Twombly and Ashcroft v. Iqbal. Because of the conflicts in the different U.S. Circuit Courts, there is a good possibility that the U.S. Supreme Court will take up these cases to clarify this litigation and rectify the conflict in the districts.
In the Stengel v. Medtronic case, the 9th Circuit held that the plaintiff’s claim of state law negligence for the defendant’s choosing not to report known risks of its product to the FDA, was not expressly nor impliedly preempted by the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act.
In the Stengel case, Stengel had a Medtronic pump implanted in his abdomen to control pain he had in his back. Unfortunately, an inflammatory mass formed at the tip of the pump’s catheter that caused permanent paraplegia.
According to the court of appeals’ analysis, before Stengel was paralyzed, Medtronic had known of the risk of paralysis, but chose not to inform the FDA, notwithstanding its obligations under the MDA to do that.
The risks associated with paralysis were known to Medtronic and one of its facilities, which had been inspected in late 2006 and early 2007. A “warning letter was sent to Medtronic in July 2007” stating that the company had misbranded its Class III device by concealing known risks. Medtronic sent a “medical device correction” letter to doctors in January 2008 and then recalled the pump a few months after that.
In a 5th Circuit case of Hughes v. Boston Scientific Corp., 631 F.3d at 762, 765-766, the plaintiff alleged that Boston Scientific had “failed to comply with the FDA’s medical device reporting (MDR) regulations, which require a manufacturer of a Class III device to report incidents in which the device may have caused or contributed to a death or serious injury, or malfunction in such a way that would likely cause or contribute to death or a serious injury if the malfunction recurred.” In that case, the plaintiff was severely burned when the Boston Scientific product leaked during a procedure.
Again, it was learned through discovery that there were reportable events that similarly caused injury to patients that had not been communicated to the FDA. In Hughes the discovery revealed that Boston Scientific had been previously directed by the FDA to change its reporting process and that when the change took place, a significant increase in the number of reported burn incidents was apparent.
In Hughes, the 6th Circuit found that the plaintiff’s failure to warn claim was not expressly preempted because the claim was “parallel” to the FDA requirements.
With these two court of appeals decisions, Stengel and Hughes, there is now an opening for injured patients by medical devices to avoid a preemption under certain circumstances. Because there is a split in the circuits, the Supreme Court may soon take up an appealedl case to resolve the conflict.
Stengel v. Medtronic, Inc., 704 F.3d 1224 (9th Cir. 2013).
Kreisman Law Offices has been handling medical device lawsuits, pharmaceutical defect cases and medical negligence for individuals and families who have been harmed, injured or died as a result of medical device defects and pharmaceutical defects for more than 37 years in and around Chicago, Cook County and its surrounding areas, including Chicago (Beverly, Washington Heights, Pullman, Lake Calumet, Washington Park, Bronzeville, West Loop), Bellwood, Hillside, Westchester, Villa Park, Western Springs and Palos Heights, Ill.
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