One of the more recent problems with a medical device involves stents used to treat weakened blood vessels. Two types have come under scrutiny -- drug-eluting stents made by Boston Scientific Corp. and Johnson & Johnson and the Ancure endograft, whose sales have already been halted by manufacturer Endovascular Technologies.
Some physicians and studies estimate that the widely used drug-coated stents may kill more than 2,000 Americans a year. The Ancure endograft has produced more than 2,600 complaints and has been linked to at least 28 deaths.
(Also:learn about unnecessary stent procedures performed on patients.)
Millions of patients already have the stents, which give off a drug to prevent cell growth that could close arteries. However, it is believed the stents also increase the chance of blood clots that block arteries, potentially causing heart attacks.
A story by NBC News put it this way: "Millions of Americans could be walking around with tiny time bombs in their hearts." (Read the article.)
Boston Scientific on Sept. 7, 2006 reported that its own analysis of clinical data revealed an increased risk of blood clots among patients who used the company’s drug-coated cardiac stent. Concern over such incidents of late thrombosis had been a major issue at the earlier World Congress of Cardiology conference, where studies were cited that drug-eluting stents might carry a higher risk of potentially fatal blood clots than bare metal stents. Nearly six million patients worldwide have received drug-coated stents in recent years and the product’s market value is estimated at more than $5 billion a year. (Read an article about drug-coated stents and blood clots.)
In addition, a recent study showed that drug-eluting stents may have an adverse effect on collateral artery function, the body’s ability to create new blood vessels to make up for those that are blocked. The study, conducted in Switzerland and released in December 2006, found that patients treated with drug-eluting stents had less collateral function than those treated with bare metal stents and that this could result in increased mortality.
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The company that produced the Ancure endograft device, 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. (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.
Kline & Specter, PC, with more than 40 attorneys (several of whom are also doctors), has had excellent results with lawsuits involving defective medical devices and other defective products, especially those filed in Pennsylvania, New Jersey and Delaware but also others across the nation. (See our Major Victories.)
At this time, Kline & Specter is not accepting cases involving injuries from drug coated stents.