In October 2016 federal regulators announced that 12 U.S. hospitals, including well-known medical centers in Los Angeles, Boston and New York, failed to promptly report patient deaths or injuries linked to medical devices.
Following that announcement and amid growing scrutiny regarding their ability to identify device-related dangers and protect patients from harm, the FDA then followed with a violations in inspections report that named many well known medical facilities across the country.
Now, according to a recent story in the Wall Street Journal, the FDA will meet formally to discuss and develop ways to improve the reporting system. The agency realizes that it is critical they know when medical devices cause serious injuries or deaths, but they have been hampered because hospitals often don’t file the required reports.
Under federal rules hospitals have 10 days to report serious injuries potentially caused by devices to the manufacturer and notify both the manufacturer and the FDA about any deaths that may have resulted. Manufacturers are required to file reports to the FDA within 30 days of learning about an injury or death that may have been caused by a device. For the most serious problems that would require immediate action to prevent major public health harm, companies have five days to report them to FDA.
The lack of accurate medical reports has long raised alarm with the agency. Their most recent concern has been their failure in being able to flag a hysterectomy device’s potentially deadly risk.
The laparoscopic power morcellator is used in minimally invasive surgeries and often used to remove the uterus. The tool has rapidly spinning blades that cut tissue into small pieces that can be removed from the body through small slits made during surgery. But it has been discovered that when the morcellator is used in women with undetected cancers, during removal of the uterus malignant cells are sprayed around the abdomen and can actually speed the progression of the disease.
In November 2014, the FDA issued a statement saying that morcellator should no longer be used in “the vast majority” of women. However, the device was left on the market. Several major insurance companies then announced they would stop covering routine use of the power morcellator. That decision came on the heels of an FDA announcement earlier that year warning that women undergoing fibroid surgery have an estimated 1 in 350 risk of harboring the cancers called sarcomas, which was a much higher rate than had been generally realized.
What is alarming to me is that hospitals were aware of problems caused by the power morcellator, yet not a single report was made to the FDA until after the morcellator problems became publicized. As far back as 2006 doctors had begun raising concerns to Ethicon, the manufacturer of the device, about the potential for the morcellators to spread undetected cancer but the company never reported any of those concerns to the FDA. That lack of reporting was a direct violation of federal law, which requires all adverse events be reported to the agency.
As the FDA meets to discuss how to improve the reporting system on dangerous and defective medical devices, it is especially worth noting that Johnson & Johnson once again appears at the heart of the controversy. J&J is the parent company of Ethicon, makers of the power morcellator, and is responsible for some of the worst medical device failures in history. Only recently they have paid billions to settle claims over their flawed Pinnacle and ASR metal-on-metal hip replacements and the company facing thousands of lawsuits over surgical mesh devices they manufactured. Johnson & Johnson has a long, long history of concealing damaging information regarding its products, and its actions regarding the power morcellator seem to follow that pattern of behavior.
At Saunders & Walker we have a long history of representing patrons harmed by dangerous and defective medical devices. If you or a loved one has been harmed or had any adverse complications you believe were caused by a medical device, please contact us for a free consultation.