Washington, DCWe are just a few days beyond the one-year anniversary of the issuance, by the US Food and Drug Administration (FDA), of a Class 1 designation to the recall of the Fetch 2 Aspiration Catheter by medical device manufacturer Boston Scientific. The voluntary recall was triggered by the manufacturer the previous month, on March 22, 2016.
The recall cut a wide swath into the market, with no fewer than 21,155 of the allegedly problematic devices manufactured between June 11, 2011 and February 19, 2016.
The recall was serious, with the manufacturer noting reports of shaft breakage involving the catheter. The Class 1 designation holds that the use of the device exposes the patient to a reasonable chance of a serious adverse health consequence or death.
Such failure of manufactured goods is frustrating enough when an appliance or other manufactured product fails. Individual components can fail, rendering the entire appliance useless – or at the very least, less reliable. One can imagine, for example, the spinning tines of an egg beater failing at high speed and flying every which way throughout the kitchen.
When the failure of a medical device occurs within the human body, however, serious consequences may ensue. Fragments from the device can migrate to vital organs. Often, the failed devices or fragments cannot be removed, putting the patient into emotional and physical trauma while waiting for the other shoe to drop.
Boston Scientific noted, at the time of the recall a year ago, that there had been no reports of deaths or injury originating with its failed Fetch 2 catheters.
But patients have died when implanted devices have failed. The Dallas Morning News (10/01/16) reported on a heartbreaking story of a Texas woman who died last year at the age of 60 years. A catheter lawsuit against the hospital involved alleged medical malpractice surrounding the presence of an 8-inch fragment of a plastic tube from a catheter left inside Debra Wilson’s aorta during surgery in 2007. Hospital records show the large tube fragment was visible on X-rays conducted as early as November, 2007 but the Wilsons allege they were never told until Debra suffered a debilitating heart attack in August, 2016. She did not survive.
Pundits and health advocates wonder about where and how such devices are manufactured. Best practices surrounding the manufacture of implantable medical devices is of paramount importance, and more easily monitored when manufacturing occurs on American soil. However, more devices are manufactured offshore for the lower labor costs and efficiencies offshore manufacturing provides. Even devices manufactured domestically have been known to fail due to cost cutting for materials.
The FDA’s 510(k) Clearance program, which allows new devices “substantially equivalent” to existing devices to achieve approval without rigorous testing pre-market, has long been criticized. With the Trump Administration pledging to deregulate federal oversight by requiring the elimination of two policies for each new policy adopted, critics remain concerned the status quo will only get worse, not better.
There is a silver lining for plaintiffs, in that deregulation is expected to make it easier for plaintiffs to prove harm in Defective Catheters Causing injury lawsuits, for example – while making it more difficult for manufacturers to defend their products against litigation.
There are other devices similarly recalled, including the Shuttle Select Slip-Catheter, and the Beacon catheters.
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