Public Citizens, a consumer watchdog group, along with a former U.S. Food and Drug Administration (FDA) official, are asking the federal government to withdraw a Stryker medical device. This is not the first time Public Citizen made this request.
On January 28, 2013, Public Citizen filed a letter “in response” for FDA to reconsider its August 8, 2012 denial of the group’s petition asking the FDA to withdraw its approval for the Wingspan stent. Public Citizen’s original petition had urged the withdrawal of the approval for and recall of Stryker Corporation’s Wingspan Stent System with Gateway PTA Balloon Catheter (Wingspan Stent) used to treat narrowing of the blood vessels in the brain.
The National Institute of Health (NIH) funded a recent study, which revealed a 2.5 fold increase in stroke or death with the Wingspan stent system, which is actually designed to prevent stroke by clearing the blood flow to the brain.
The group presented a petition co-signed by a former executive from the FDA’s device division, asking the FDA to remove the device from the market.
“I can see no reason why this device should continue to be available,” stated Larry Kessler, in a letter accompanying the petition. Kessler, professor of health science at University of Washington, has spent more than 12 years in the FDA’s device division.
In 2005, the FDA approved the device under a special program that grants quick approval to devices for rare diseases and conditions. Stryker recently acquired the stent from its original manufacturer, Boston Scientific. The Wingspan consists of a small mesh tube that is braced into place through an inflatable tube. This encourages blood flow through the arteries to the brain. This device was cleared for patients who have had one stroke and are at risk for additional strokes.
A study involving 158 patients who experienced a stroke and received the Wingspan was published in the September New England Journal of Medicine. These patients were followed for six months. Their results were then compared with those of a separate group of patients who only received drug therapy. The study revealed that the patients who were treated with the device were more likely to suffer a second stroke or die within 30 days, compared to patients who were treated with a combination of blood-thinning medications.
Public Citizen’s petition argues that the FDA should immediately remove the device from the market and suggests that it never should have been approved in the first place. However, under the FDA’s “Humanitarian Device Exemption Program,” (HDE) medical implants and devices can be cleared based on preliminary evidence, as long as there is “reasonable basis” to show that the device’s benefits outweigh the risks. Under an HDE, the FDA authorizes the marketing of a humanitarian use device that treats (or diagnoses) a disease that affects less than 4,000 people in the U.S. annually.
Dr. Sidney Wolfe, of Public Citizen, writes that with this program, Boston Scientific “was able to gain marketing approval based on a single, uncontrolled trial of just 45 patients that was not designed to demonstrate whether the device was more effective or even safer than medical treatment alone.”
Although any consumer or group may petition the FDA to remove a product from the market based on safety, economic or environmental reasons, the FDA usually takes months, sometimes years, to deliver a decision on such requests.
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