Medicated Stent Lawsuits - Dangerous Devices

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New data indicate that medicated stents may cause 4,500 heart attacks every year, up to 2,000 of them fatal. This increased risk, moreover, could persist for a lifetime, requiring patients to take blood thinners for the rest of their lives, thereby facing the sometimes fatal side effects of those drugs.

Update: Schmidt & Clark is no longer accepting Heart Stent cases.

The Alarming Truth About Medicated Stents

The medicated, drug-coated or drug-eluting stent is a miracle of medical engineering. The tiny, stainless-steel mesh tube, less than 4 millimeters wide, relieves the crushing chest pain that occurs when the heart is starved of blood. Covered in a chemical that keeps the artery from closing, the stent slides into a blocked vessel in a simple, not very invasive procedure and stays there, propping it open. After it hit the market in April 2003, cardiologists implanted the new stent in 350,000 people in eleven months, though it costs nearly three times as much as older, noncoated versions.

Since then medicated stents from Johnson & Johnson (J&J), Boston Scientific and Guidant have been inserted into the arteries of 4 million people. The breakthrough medical devices generate $5 billion a year in sales from a million patients.

You might figure that, being federally regulated, these devices were approved only after the manufacturers established both their safety and their efficacy. But that's true only up to a point. It turns out that the teensy tubular scaffolds have never been shown to prevent heart attacks or save lives; their human trials were smaller, of shorter duration and more narrowly focused than trials for many new drugs; and half of all applications involve "off-label" uses, deploying stents in ways that weren't studied at all in clinical testing.

Now new data indicate that the heart stents, because of their supposedly miraculous medicated coating, may cause 4,500 heart attacks every year, up to 2,000 of them fatal.

This increased risk, moreover, could persist for a lifetime, requiring patients to take blood thinners for the rest of their lives, thereby facing the sometimes fatal side effects of those drugs.

"There's so much evidence" of the new danger, says Spencer King, the Piedmont Hospital cardiologist who in 1987 implanted the first heart stent in North America. He says up to 30% of patients who get medicated stents would fare better with bare metal, avoiding extra heart attack risk; some probably didn't need a stent procedure at all. "Everybody agrees this is real," he says.

Patients with medicated stents get clots at the rate of 1 per 500 patients per year, to judge from outside analyses of the company's trial results. J&J, Boston Scientific and Guidant will be running trials of tens of thousands of patients to better understand the blood-clot risk, but results won't be available for years.

FDA Approved - Medical Device Manufacturer Loophole - FDA 510(k)

It's appalling that the manufacturers of heart/cardiac stents brought a product to market that has been implanted into more than 4 million people without ever performing proper clinical trials. As previously stated, the trials that J&J and Boston Scientific ran in connection to the currently available medicated stents were smaller, of shorter in duration and more narrowly focused than FDA required trials for any new drugs brought to market.

Why Were These Devices Approved By The FDA In The First Place?

The medical device industry was barely regulated until 1976, when Congress empowered the FDA to ensure devices were safe, effective and well made. But the new law included a loophole called 510(k) that remains today: A device can be approved with few or no clinical trials if it is deemed "substantially equivalent" to a gadget that existed before 1976. Most of the thousands of devices in use today were cleared under this easy passage.