Stent Recall (Drug Coated/Eluting Stent)

Studies link Drug Eluting Stents to blood-clotting (thrombosis) and heart attacks.

Drug eluting stents (also “drug coated stents”) such as the Cypher stent from Cordis Corporation and Taxus stent from Boston Scientific Corporation are marketed as more effective than bare-metal stents in reducing the risk of restenosis or reclotting of the artery.  Stents are used to prop open blood vessels after blockages have been cleared, such as after a balloon angioplasty procedure.  Drug eluting or drug coated stents  have a special polymer coating and contain drugs in the coating that are released over time to reduce the chance of the artery becoming blocked again.  The belief is that these stents reduce the need for a second surgery more than bare-metal stents.

However, in November 2006, The American Journal of Medicine published the findings of a study indicating that patients with drug eluting stents were four or five times more likely to suffer from a stent thrombosis, or late forming blood clots, which can lead to heart attack or death.

Recent studies have linked drug eluting stents or medicated stents with side effects such as blood clotting (thrombosis) and the need for costly long term blood thinning medication to prevent thrombosis. The studies also found that drug eluting stents may result in a higher death rate due to cardiac events such as heart attack when compared to bare metal stents without a drug coating.

Increased rate of death & heart attack in patients with drug eluting stents

On September 14, 2006, the U.S. Food & Drug Administration released a statement on coronary drug eluting stents in response to inquiries asking for the FDA's position on adverse events related to Coronary Drug Eluting Stents (DES). The FDA confirmed that it was aware of recent data suggesting a significant increase in the rate of death and myocardial infarction (heart attack) possibly due to stent thrombosis (a blood clot in the stent) in patients treated with drug eluting stents.  And then on March 6, 2007, the chairman of the House Oversight and Government Reform Committee asked the two medical device companies for documents as part of an investigation into product safety and marketing practices.

Injured by a Drug Eluting Stent?

If you or a loved one has been injured following the implantation of a drug eluting stent, you may be entitled to compensation from those responsible for your injury.  If a loved one has died, the surviving spouse or other family members may be entitled to bring a wrongful death action against the responsible parties.

Arnold & Itkin LLP is pursuing litigation against Cordis Corporation, a Johnson & Johnson company, and Boston Scientific Corporation, both makers of drug eluting stents. At Arnold & Itkin LLP, our attorneys have the knowledge and experience to take on large medical device manufacturers like Cordis and Boston Scientific and hold them accountable for their actions.

Drug Eluting Stents in the News

Top doc urges restraint in adopting new technology

Reuters.com – Oct 4, 2007

Dr. Steven Nissen, head of cardiovascular medicine at the Cleveland Clinic, expressed caution about widespread adoption of drug eluting stents.  Nissen was among the first people to warn about heart risks posed by the use of the painkiller Vioxx, and later also the diabetes drug Avandia.  Among his concerns, the article quotes Dr. Nissen saying, “"If you adopt a technology too quickly, there may not be an incentive for manufactures to do the necessary trials.”

Johnson & Johnson’s Risky Tactic Fails in Patent Fight

NYTimes.com – Sep 25, 2007

“Johnson & Johnson was rebuffed yesterday in an attempt to gain the upper hand in a patent case in which its lawyers tried a high-risk tactic: highlighting safety concerns about the company’s own product. The lawyers hoped to persuade a federal judge in Delaware that because Johnson & Johnson’s drug-coated Cypher stent had been linked in clinical studies to blood clots, it fell outside the safety profile of a Boston Scientific patent.”

Heart attack victims do worse on drug stents: study

Reuters.com - Sep 5, 2007

“Patients given drug-coated stents after an acute heart attack are nearly five times more likely to die six months to two years later than those with bare metal forms of the arterial scaffolding...”.  This strong statement introduces the article about a two-year analysis of 2,300 patients in 14 countries focused on the safety of drug eluting stents made by Boston Scientific and Johnson & Johnson (Cordis Corporation).

Lawmaker seeks data from J&J on FDA stent warning

Reuters.com – Aug 14 2007

U.S. Representative John Dingell, chairman of the House Committee on Energy and Commerce, asked Johnson & Johnson for records related to the FDA's 2004 warning letter from U.S. regulators concerning manufacturing and quality processes used in the manufacture of the Cypher stent.  The request for records was made as part of an investigation into the ability of the FDA to protect consumers from the risks of using certain products it regulates, like the Cypher drug eluting stent manufactured by Johnson & Johnson (Cordis Corporation).

Cypher® stent is a registered trademark of Cordis Corporation.
Taxus® stent is a registered trademark of Boston Scientific Corporation.