On two scores, Fortune's World’s Most Admired Companies 2012 listee (No.3) Stryker Corp. had trouble at FDA in March.
Most serious, it received a second Warning Letter over quality issues at a manufacturing facility in Michigan responsible for its Neptune Waste Management System and also became the subject of an FDA statement announcing additional death and injury reports related to the Neptune 1 Silver Waste Management System and the Neptune 2 Ultra Waste Management System.
“The patient death and injury reports indicate that the high-flow, high-suction vacuum had been incorrectly applied and were associated with users of the device who had not been properly trained on how to use the device,” an agency safety update said.
In October 2012, FDA and the company was warned about patient injuries and one death associated with the device, which was later recalled (Class 1).
“Stryker and the FDA are particularly concerned about these cases, since a requirement for continuing to use these devices under the Certificate of Medical Necessity is to ensure that all users are adequately trained and have implemented the use of the Pre-use Checklist,” the update said. Stryker issued updated recall notifications last month reminding customers about the steps they need to take to continue using these devices.
The Warning Letter followed an FDA investigation of Stryker’s Portage, MI-facility last November. The investigation concerns quality system observations made during the inspection and cites Stryker for failing to notify FDA about a product recall, and for marketing devices, including the Neptune Waste Management System, without 510(k) clearance.
The letter reportedly acknowledged that Stryker has already submitted corrective action plans for the quality system and recall observations. The Portage facility was previously cited in a 2009 Warning Letter after an inspection found that the company was marketing its Stryker Custom Cranial Implant without having received FDA approval or clearance.
The Warning Letter said that the device was cleared in 2005 as a nonsterile device, but the FDA District Office determined there had been significant changes or modifications in design, components, method of manufacture, or intended use that require submission of a new premarket notification.
That Warning Letter also said that the company failed to include required information in the report of correction or removal submitted to FDA. In previous years, the company received numerous Warning Letters for quality violations at various manufacturing plants, and sales representatives have pleaded guilty to off-label marketing violations.
Less serious for the company, Public Citizen in March wrote to FDA challenging the agency’s August 2012 denial of its petition asking that FDA immediately withdraw approval of the Humanitarian Device Exemption for the Stryker Wingspan stent system and order a Class 1 recall for all unused systems.
Rather than withdraw the device, Public Citizen now says, FDA, “based on seriously flawed reasoning and a disregard for the best available scientific evidence assessing the safety and effectiveness of the Wingspan stent system, has approved new, narrowed labeling proposed by Stryker….”
The advocacy group says that despite FDA’s acknowledgement that the Wingspan system will not provide a benefit for most patients compared with the best available medical treatment alternatives, the agency has approved a new narrowed indication for the device without any evidence that the device confers any additional benefits to the intended patient population specified in the new labeling.
“Valid scientific evidence must always be the basis for FDA’s regulatory decision-making,” the response says, “and in this case the available scientific evidence overwhelmingly fails to support FDA’s regulatory decision to allow the Wingspan stent system to remain on the market, even for patients specified in the new labeling. The only way FDA can address the serious, ongoing safety risk posed to patients by the Wingspan stent system is by withdrawing approval of the HDE for this device.”
Public Citizen concludes by acknowledging the importance of maintaining patient access to safe and effective treatments for life-threatening conditions, particularly when treatment options are limited. But it says it finds “no patient benefit in exposing desperate patients to a dangerous and costly invasive procedure that has been demonstrated to be ineffective and to cause life-threatening injury and death. We believe that FDA’s standards for evaluating evidence should not be lowered where treatment options are limited and a disease is fatal, because patients with such conditions are even more vulnerable to false promises regarding treatments that do more harm than good.”