Manufacturer Agrees to Pay $74 Million

The civil complaint concerned the distribution in 1998 of a premounted coronary stent delivery system called the NIR' ON' Ranger' with SOX, which was sold to hospital catheterization laboratories throughout the country. Cardiologists used the stent system to clear coronary artery blockages known as percutaneous transluminal coronary angioplasty. The system consisted of a stainless steel mesh sheath called a “stent” mounted on a balloon catheter. Physicians used the balloon catheter to deliver the stent to the proper location in a patient's artery. Once in the proper location, the stent was expanded by inflating the balloon with high pressure bursts of saline solution, which simultaneously expanded the diameter of the stent. Once the stent was deployed, the physician would then deflate the balloon and withdraw the catheter, leaving the stent in the artery wall to provide arterial support and prevent reclosure of the artery.

The stents themselves were not the subject of the complaint; rather, the “delivery system” was what was allegedly wrong with the devices. U.S. Attorney Michael J. Sullivan explained, “This case does not involve any risk to those patients who had one of these stents implanted in their bodies. The issue is not, and was never, whether the stent performed properly. Rather, the issues raised in the complaint concern the functioning of the balloon used to deploy the stent in the NIR ON Ranger with SOX device, the fact that the balloon failed to perform at the pressures indicated on the devices' labels, and the fact that Boston Scientific, while undertaking an internal investigation and consulting with outside regulatory counsel, did not take sufficient steps to ensure that these devices never reached the marketplace.”

The United States alleged that Boston Scientific began shipping the NIR ON Ranger with SOX device on Aug. 12, 1998. Within days, the company began receiving reports from hospitals that the balloons that were used to deploy the stents in the patients' bodies were prematurely failing by leaking or bursting at pressures below the maximum pressures stated on the device labels. Such failures potentially could allow the pressurized saline solution used to inflate the balloon to spray out of the balloon and cause tears in the walls of the patients' arteries.

On Aug. 28, 1998, engineers at Boston Scientific's subsidiary, Scimed, conducted an internal investigation to determine the extent of any problem or defect in the devices that were in the company's finished goods inventory and awaiting shipment. Preliminary test results conducted on the most popular size of the device revealed that 19 of 90 (21.1%) of the devices tested had balloons that were failing prematurely. As a direct result of this dramatic and unexpected level of failures, the engineers immediately shut down manufacture of that size device and forwarded the test results to corporate management. By Aug. 30, 1998, internal testing of devices pulled from finished goods inventory was completed. The testing confirmed the preliminary results and showed that the balloons were failing prematurely at rates between 2.9% and 12.6%, depending on the size of the device. As a result, the engineers shut down manufacturing of the entire NIR ON Ranger with SOX product line and communicated the test results to corporate management. At that point in time, the decision whether to continue shipping the devices became the responsibility of Boston Scientific corporate management.

The Complaint

The United States' complaint alleged that on Sept. 2, 1998, Boston Scientific convened an internal Field Action Committee to review the situation and determine whether the company should continue shipping the device. As of that date, the company had received only 39 complaints relating to premature balloon failures out of an estimated 6500 devices used and had received reports of four devices causing patient injury or complications. The Field Action Committee concluded that commercial distribution should continue.

After continued internal investigations, the company was unable to determine the root cause and could not develop a screening test to be used during manufacturing to identify those devices with balloons that would fail. The company also could not work out how to screen the mechanisms to segregate those defective devices already in finished goods inventory awaiting commercial distribution from the non-defective products. Despite this inability to solve the problem and identify problem devices, the company, after consulting with outside counsel and with a leading cardiologist, continued commercial shipments.

FDA Concerns Ignored

Boston Scientific participated in a conference call with representatives from the FDA in mid-September 1998, during which they discussed the fact that the company was continuing to ship the devices despite not knowing the cause of the problem or having developed a test procedure to screen for defective devices. Two subsequent calls between an FDA representative and a member of Boston Scientific's management team, in which the manager was told the FDA had serious concerns about the company's continued shipment of the stent system, brought no action from the company until Oct. 5, 1998, when the devices were recalled. Because of Boston Scientific's delayed action in remedying the situation, the FDA opened an investigation, which led to the filing of the civil suit. “This case represents a failure by Boston Scientific to take the most appropriate steps in a timely manner to ensure that the devices it was distributing to hospitals nationwide performed properly,” said U.S. Attorney Michael J. Sullivan in a release. “The company identified the problem through its own internal testing and took a risk that those same problems would not occur in the marketplace. This type of behavior by a major medical device manufacturer is unacceptable.”

Margaret Glavin, Associate Commissioner for Regulatory Affairs at the FDA, said.”[W]e and the U.S. Department of Justice will vigorously enforce the laws that ensure safe and effective devices. This successful outcome should send a clear signal that device companies, and the other industries FDA regulates, must take all necessary steps to market only products that meet our high standards. The American people demand and deserve no less.”

Natick, MA-based Boston Scientific Corp. has agreed to pay $74 million to the United States to resolve an ongoing investigation concerning its 1998 distribution and subsequent recall of one of its coronary stent delivery systems. In agreeing to the settlement, the company did not admit to any wrongdoing.

The complaint, filed in federal district court, alleged that Boston Scientific commercially distributed premounted coronary stents that had a manufacturing defect that resulted in random failures of the balloons used to deploy the stents; that the company failed to identify and segregate the defective devices to ensure that they were not distributed commercially; and that the company failed to establish proper internal procedures to identify the causes of the defects.

Background

The civil complaint concerned the distribution in 1998 of a premounted coronary stent delivery system called the NIR' ON' Ranger' with SOX, which was sold to hospital catheterization laboratories throughout the country. Cardiologists used the stent system to clear coronary artery blockages known as percutaneous transluminal coronary angioplasty. The system consisted of a stainless steel mesh sheath called a “stent” mounted on a balloon catheter. Physicians used the balloon catheter to deliver the stent to the proper location in a patient's artery. Once in the proper location, the stent was expanded by inflating the balloon with high pressure bursts of saline solution, which simultaneously expanded the diameter of the stent. Once the stent was deployed, the physician would then deflate the balloon and withdraw the catheter, leaving the stent in the artery wall to provide arterial support and prevent reclosure of the artery.

The stents themselves were not the subject of the complaint; rather, the “delivery system” was what was allegedly wrong with the devices. U.S. Attorney Michael J. Sullivan explained, “This case does not involve any risk to those patients who had one of these stents implanted in their bodies. The issue is not, and was never, whether the stent performed properly. Rather, the issues raised in the complaint concern the functioning of the balloon used to deploy the stent in the NIR ON Ranger with SOX device, the fact that the balloon failed to perform at the pressures indicated on the devices' labels, and the fact that Boston Scientific, while undertaking an internal investigation and consulting with outside regulatory counsel, did not take sufficient steps to ensure that these devices never reached the marketplace.”

The United States alleged that Boston Scientific began shipping the NIR ON Ranger with SOX device on Aug. 12, 1998. Within days, the company began receiving reports from hospitals that the balloons that were used to deploy the stents in the patients' bodies were prematurely failing by leaking or bursting at pressures below the maximum pressures stated on the device labels. Such failures potentially could allow the pressurized saline solution used to inflate the balloon to spray out of the balloon and cause tears in the walls of the patients' arteries.

On Aug. 28, 1998, engineers at Boston Scientific's subsidiary, Scimed, conducted an internal investigation to determine the extent of any problem or defect in the devices that were in the company's finished goods inventory and awaiting shipment. Preliminary test results conducted on the most popular size of the device revealed that 19 of 90 (21.1%) of the devices tested had balloons that were failing prematurely. As a direct result of this dramatic and unexpected level of failures, the engineers immediately shut down manufacture of that size device and forwarded the test results to corporate management. By Aug. 30, 1998, internal testing of devices pulled from finished goods inventory was completed. The testing confirmed the preliminary results and showed that the balloons were failing prematurely at rates between 2.9% and 12.6%, depending on the size of the device. As a result, the engineers shut down manufacturing of the entire NIR ON Ranger with SOX product line and communicated the test results to corporate management. At that point in time, the decision whether to continue shipping the devices became the responsibility of Boston Scientific corporate management.

The Complaint

The United States' complaint alleged that on Sept. 2, 1998, Boston Scientific convened an internal Field Action Committee to review the situation and determine whether the company should continue shipping the device. As of that date, the company had received only 39 complaints relating to premature balloon failures out of an estimated 6500 devices used and had received reports of four devices causing patient injury or complications. The Field Action Committee concluded that commercial distribution should continue.

After continued internal investigations, the company was unable to determine the root cause and could not develop a screening test to be used during manufacturing to identify those devices with balloons that would fail. The company also could not work out how to screen the mechanisms to segregate those defective devices already in finished goods inventory awaiting commercial distribution from the non-defective products. Despite this inability to solve the problem and identify problem devices, the company, after consulting with outside counsel and with a leading cardiologist, continued commercial shipments.

FDA Concerns Ignored

Boston Scientific participated in a conference call with representatives from the FDA in mid-September 1998, during which they discussed the fact that the company was continuing to ship the devices despite not knowing the cause of the problem or having developed a test procedure to screen for defective devices. Two subsequent calls between an FDA representative and a member of Boston Scientific's management team, in which the manager was told the FDA had serious concerns about the company's continued shipment of the stent system, brought no action from the company until Oct. 5, 1998, when the devices were recalled. Because of Boston Scientific's delayed action in remedying the situation, the FDA opened an investigation, which led to the filing of the civil suit. “This case represents a failure by Boston Scientific to take the most appropriate steps in a timely manner to ensure that the devices it was distributing to hospitals nationwide performed properly,” said U.S. Attorney Michael J. Sullivan in a release. “The company identified the problem through its own internal testing and took a risk that those same problems would not occur in the marketplace. This type of behavior by a major medical device manufacturer is unacceptable.”

Margaret Glavin, Associate Commissioner for Regulatory Affairs at the FDA, said.”[W]e and the U.S. Department of Justice will vigorously enforce the laws that ensure safe and effective devices. This successful outcome should send a clear signal that device companies, and the other industries FDA regulates, must take all necessary steps to market only products that meet our high standards. The American people demand and deserve no less.”