Many thousands of patients have been injured over the years by medical devices that proved defective or problematic, devices ranging from pacemakers to hip replacements to breast implants. Sometimes a device-related injury, even death, can occur during an implant procedure. Sometimes it is not discovered until years later.
One of the more recent problems with a medical device involves a stent used to treat weakened blood vessels. The device, called the Ancure endograft, has produced more than 2,600 complaints and has been linked to at least 28 deaths.
The company that produced the device was hardly an innocent bystander - Endovascular Technologies, a subsidiary of Guidant Corp., pleaded guilty in June 2003 of concealing the vast majority of reported problems with its stent from the government. Guidant agreed to pay $92.4 million in criminal and civil penalties in the case. A few days later, the company stopped selling the device that had been used to prevent aneurysm.
Guidant, one of the country's largest medical device makers with 2003 sales of $3.7 billion, has since been the target of numerous lawsuits. The company has agreed to settlements with a number of victims. In October 2003 it settled - the amount was undisclosed - a suit filed by nine plaintiffs in California, including two whose family members had died.
Guidant faces more lawsuits from thousands of patients whose procedures did not go as planned. At one point, out of 7,632 devices sold, there were 2,628 reports of problems - more than one for every three Ancure stents implanted. But the company had only reported 172 instances of problems with the device to the U.S. Food and Drug Administration (FDA). (In all, a total of 18,000 were successfully implanted and those patients are not considered to be at risk.)
Most of the problems did not involve the stent itself, a woven plastic graft approved in 1999 to prevent abdominal aortic aneurysm by reinforcing weak spots in the major artery that runs from the heart through the abdomen. Problems occurred during implant procedures when equipment used to insert the stent through a small incision - avoiding invasive surgery - would become lodged. In some cases, surgery was needed to remove the equipment. In others, surgeons broke the equipment into pieces to be able to remove it, a technique devised not by doctors but by Guidant sales representatives.
Guidant first removed its stent from the market in March 2001 but, with FDA approval, made it available again five months later. It was not pulled for good until almost two years later. (Three other similar devices made by other companies are available as alternatives. Abdominal aortic aneurysm, which involves a ballooning of part of the blood vessel wall that can suddenly rupture, causes 15,000 deaths yearly in the United States.)
Patients who were injured during stent implant procedures could still be feeling the effects. One woman from Missouri, for example, suffered chronic pain and the loss of all sensation in her right foot after her 1998 implant procedure. She reached a confidential settlement with Guidant in late 2003.
If you or someone you know has suffered injury or death due to a defective medical device, please call the attorneys at Kline & Specter at 800-243-1100. We represent clients in defective medical device lawsuits nationwide.