Defective medical devices are ruining lives
According to a new report, medical devices approved by the U.S. Food and Drug Administration (FDA) have cost thousands their lives and injured millions in the United States. On November 27, 2018, a yearlong study of these devices, conducted by 250 journalists with The International Consortium of Investigative Journalists, revealed the disturbing facts.
In 2018, CNN reported the consortium’s research linked 83,000 deaths and more than 1.7 million injuries since 2008 in the U.S. to a range of implantable devices. The consortium’s journalists examined “more than 8 million device-related health records, including death and injury reports.” Their study covered “pacemakers, insulin pumps, breast implants, spinal cord stimulators and other surgically embedded appliances and materials.”
According to CNN’s report, “device manufacturers have paid out at least $1.6 billion to settle charges of regulatory violations, including corruption and fraud over the last decade.” The consortium’s research is supported by years of reports by major U.S. news agencies and medical journals about failing medical devices and the FDA’s lax approval process.
They include The Washington Post in 2011, The New York Times in 2011, ProPublica in 2012, The New York Times in 2015, Reuters in 2015, The New York Times in 2016, and Scientific American in 2016. Their reports cover a wide range of failing devices from hip and knee replacements to heart stents, IVC filters and numerous others.
In 2015, the Medical Daily, reported that all medical devices approved by the FDA” may not be safe” and “premarket studies” of the devices exhibit “bias and limitations.”In 2016, the Brookings Institution reported that surgically implanted devices in the U.S. are linked to “about 3,000 deaths per year.”
Can the FDA end the danger?
According to the University of Minnesota in 2017, the FDA “has long sought” to build a better “medical device surveillance system.” A 1976 federal law created its current approval process. The university reported that the FDA announced plans in 2012 to develop a better “national evaluation system for health technology (NEST).” In 2017, the FDA received a $3 million dollar grant to create a “coordinating center” for the new system.
Meanwhile, the medical device industry – a powerhouse worth an “estimated $156 billion in 2017” according to NBC News, is lobbying Congress to loosen federal regulations on its businesses. NBC reports that “10 of the largest publicly traded medical device companies in the U.S. have spent “more than $36.5 billion” to influence Congress. The industry’s lobbying resources far exceed those of consumer and patient advocates lobbying Congress for stiffer medical device regulations to stop the thousands of deaths and injuries.
Wayne Wright can represent those injured by the industry’s failing devices
Wayne Wright is one of America’s top trial lawyers. For 40 years, he has successfully represented those injured by the negligence of large corporations that fail to warn patients. His numerous, national legal honors are based on the large monetary amounts he has justifiably secured for clients who were hurt through no fault of their own. Calls and evaluations are free. There are no fees until a case is successfully concluded.