Every day, patients in Ohio put their lives in the hands of doctors and hospitals. Legislators now want to make things safer for these patients by making doctors alert the U.S. Food and Drug Administration (FDA) to the potential risks of medical devices.
Medical Device Guardians Act
Lawmakers have proposed a bill, entitled “Medical Device Guardians Act of 2016,” to require doctors to report any potential risks connected with medical devices to the U.S. Food and Drug Administration (FDA).
If the bill goes into effect, the law will consider doctors and doctors’ offices mandated reporters.
This is a significant change from the current FDA law that merely encourages doctors to report deaths and injuries connected with medical devices. As of now, the law only requires hospitals and device manufacturers to report device-related deaths and injuries to the FDA’s database.
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Proposed Legislation Based on Faulty Morcellator Device
U.S. representatives Mike Fitzpatrick (Pa.) and Louise Slaughter (N.Y.) first introduced the bill to colleagues after an issue in 2014 involving laparoscopic power morcellators, a type of surgical tool used on women. Surgeons used this tool in thousands of minimally invasive surgeries across the country to remove fibroids.
What is the problem with the device?
That year, the FDA found that the device can potentially spread uterine cancer during hysterectomies and other surgeries. The cancer is hard to detect and doctors may mistake it for fibroids. Detecting the cancer before surgery is nearly impossible. As a result, the morcellator may spread diseased tissue unintentionally.
With this knowledge, the FDA insisted the device come with a “black box warning” which nearly halted usage completely. Johnson & Johnson stopped selling the device in April 2014 and withdrew it from the market three months later. The company has settled numerous lawsuits relating to the cancer-spreading nature of the device. Other companies are also facing lawsuits regarding their morcellator devices.
It turns out that numerous medical studies have addressed the risk since the 1990s when the device first came out. However, the FDA did not receive a report regarding the risk until 2013 when a doctor at a Boston hospital spoke out after her hysterectomy.
This delay in public awareness of the risks of the morcellator inspired lawmakers to make some changes to the current laws. Rather than place responsibility on the patients to get the attention of the FDA, lawmakers want to hold medical professionals responsible.
The morcellator issue also brought attention to the fact that there are problems with the United States’ methods of tracking device risks. The Brigham and Women’s Hospital in Boston, which treated both the doctor mentioned earlier in 2013 and another woman in 2012, did not report either incident to the FDA.
The hospital claimed that there was no need to report the incidents as the device functioned properly and doctors used it appropriately.
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Current Status
On June 8, 2016, after introduction, the bill was referred to the House Committee on Energy and Commerce. The committee has not yet taken action.
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How You Can Recover Compensation for Device-Related Injuries
If you sustained injury through the use of a dangerous or defective medical device, you may be entitled to damages to help cover medical costs, lost wages, and pain and suffering. Please contact David Bressman at (614) 538-1116 to schedule a free consultation.
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