The FDA’s failures leave Us with Dangerous Drugs
A review of the U.S. Food and Drug Administration’s performance for the last 10 years reveals dangerous loopholes in the way it operates. Statistics tell the story. Over the last decade, the FDA has approved products associated with “1.7 million injuries and more than 80,000 deaths,” according to The Washington Post, in early January 2019.
The paper cited serious examples of failing medical devices. It found 50% of the FDA approved artificial hip replacements made with cobalt – a hard metal used to make them last longer – failed within six years. The cobalt also poisoned some patients, damaging vital organs.
In 2011 a panel of experts urged the FDA to conduct a safety review of surgical mesh that was “cleared for use” in 2002 to repair transvaginal pelvic organ prolapse. It could cut into flesh and vital organs, causing infections and hemorrhages. In some cases, failing cardioverter defibrillators (ICDs) repeatedly shocked heart patients for no reason. The patients “risked electrocution and possible death” if the defibrillators were left in the body. But surgery to remove them can also be fatal.
The Washington Post’s article appeared on January 4, 2019 under this headline: “The FDA is still letting doctors implant untested devices into our bodies.” It began with story of a patient who nearly suffocated due to a small device implanted near the top of the spine. It was meant to stop pain, but it caused “airway obstruction, trouble swallowing and respiratory failure.” The device was cleared by the FDA in 2003 “without clinical testing in humans.”
Two other major news agencies published reports highly critical of the FDA in early January 2019. On the 4th of January, NBC News reported that tainted prescription drugs approved by the FDA are making “sick patients sicker.” On the 7th of January, ABC News reported that Fosamax – a drug to prevent osteoporosis – could cause serious bone fractures.
NBC’s story examined the FDA’s inspection process of plants that manufacture prescription drugs. It found “confusing regulatory terms and standards” that are “decades out of date,” are used to inspect these plants. That’s how a contaminated stool softener, routinely prescribed in hospitals, put a 1-year old heart transplant patient on a ventilator, perhaps for the rest of his life. The Florida plant that made it was inspected by the FDA. The stool softener was just one of the “thousands of medicines, including over the counter medicines like Aleve,” in FDA inspected plants, that also had to be recalled.
ABC’s story was about the more than 500 patients who were prescribed Fosamax for long periods to avoid bone fractures who ended up with serious breaks that happened during simple, every day activities. They say Merck, the drug’s manufacturer, knew there was “early evidence” of the side effect but they weren’t warned.The case is before the U.S. Supreme Court.
Wayne Wright has years of experience fighting drug companies
His national legal honors are based on the top dollar awards he wins for their victims. Wayne Wright is one of America’s top trial lawyers. He doesn’t charge by the hour. Clients only pay fees, agreed on in advance, when he wins their case. Calls and evaluations are free. Top notch legal service is only a phone call away if you are a victim of a drug or medical device that should not have been approved.
The FDA’s failures leave Us with Dangerous Drugs
A review of the U.S. Food and Drug Administration’s performance for the last 10 years reveals dangerous loopholes in the way it operates. Statistics tell the story. Over the last decade, the FDA has approved products associated with “1.7 million injuries and more than 80,000 deaths,” according to The Washington Post, in early January 2019.
The paper cited serious examples of failing medical devices. It found 50% of the FDA approved artificial hip replacements made with cobalt – a hard metal used to make them last longer – failed within six years. The cobalt also poisoned some patients, damaging vital organs.
In 2011 a panel of experts urged the FDA to conduct a safety review of surgical mesh that was “cleared for use” in 2002 to repair transvaginal pelvic organ prolapse. It could cut into flesh and vital organs, causing infections and hemorrhages. In some cases, failing cardioverter defibrillators (ICDs) repeatedly shocked heart patients for no reason. The patients “risked electrocution and possible death” if the defibrillators were left in the body. But surgery to remove them can also be fatal.
The Washington Post’s article appeared on January 4, 2019 under this headline: “The FDA is still letting doctors implant untested devices into our bodies.” It began with story of a patient who nearly suffocated due to a small device implanted near the top of the spine. It was meant to stop pain, but it caused “airway obstruction, trouble swallowing and respiratory failure.” The device was cleared by the FDA in 2003 “without clinical testing in humans.”
Two other major news agencies published reports highly critical of the FDA in early January 2019. On the 4th of January, NBC News reported that tainted prescription drugs approved by the FDA are making “sick patients sicker.” On the 7th of January, ABC News reported that Fosamax – a drug to prevent osteoporosis – could cause serious bone fractures.
NBC’s story examined the FDA’s inspection process of plants that manufacture prescription drugs. It found “confusing regulatory terms and standards” that are “decades out of date,” are used to inspect these plants. That’s how a contaminated stool softener, routinely prescribed in hospitals, put a 1-year old heart transplant patient on a ventilator, perhaps for the rest of his life. The Florida plant that made it was inspected by the FDA. The stool softener was just one of the “thousands of medicines, including over the counter medicines like Aleve,” in FDA inspected plants, that also had to be recalled.
ABC’s story was about the more than 500 patients who were prescribed Fosamax for long periods to avoid bone fractures who ended up with serious breaks that happened during simple, every day activities. They say Merck, the drug’s manufacturer, knew there was “early evidence” of the side effect but they weren’t warned.The case is before the U.S. Supreme Court.
Wayne Wright has years of experience fighting drug companies
His national legal honors are based on the top dollar awards he wins for their victims. Wayne Wright is one of America’s top trial lawyers. He doesn’t charge by the hour. Clients only pay fees, agreed on in advance, when he wins their case. Calls and evaluations are free. Top notch legal service is only a phone call away if you are a victim of a drug or medical device that should not have been approved.