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Lawmakers Looking for Ways to Step in Against FDA’s Ineffective Monitoring of Dangerous Drugs and Medical Devices

February 29, 2016  ·  By HM&M

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Originally developed to protect consumers, the U.S. Food and Drug Administration is responsible for monitoring and investigating the safety, efficacy, and security of drugs and medical equipment used and prescribed in the United States. But patient advocates, federal auditors, and health-policy experts have been voicing concerns over the FDA’s monitoring and surveillance systems since the 1990s. Now, with the number of defective drug and medical equipment injuries and deaths mounting, lawmakers are looking for a way to step in and take over.

FDA’s Concerning Failures Exposed

Over the years, the FDA has been cited for a number of failures in the way they approve and oversee the drugs and equipment they are responsible for monitoring. Part of the problem relates to outdated or inaccurate data. The system’s self-reporting reliance is another. All lead to one very concerning conclusion: their shortcomings are causing injuries and deaths to innocent people.

In December, the Government Accountability Office released a report that indicated tracking inefficiencies and missing data in the FDA’s drug monitoring system. Then, in January, Senator Patty Murray brought attention to the nationwide spread of antibiotic resistant ‘superbugs’ from gastrointestinal scopes in which nearly 200 patients were sickened from 2012 to 2015.

Despite the widespread investigation, the FDA allegedly took 17 months to investigate the issue before finally issuing a warning on the medical scopes responsible for the infections. During that time, seven more hospitals reported outbreaks, and 68 patients developed dangerous infections. Every additional infection could have been prevented, had the organization issued an immediate warning.

A Complete Overhaul?

Senator Murray wants a complete overhaul to prevent problems like this from happening again. Unfortunately, most solutions would be time and cost intensive, which leaves even more people subject to injury or death while the new programs or provisions are put into place. Of course, there are also lawmakers who feel that the expensive changes are both unnecessary and unreasonable. With enough push-back, they could prevent any form of reform altogether.

Even Federal Regulators Should Be Held Responsible

Oftentimes, medical malpractice cases, such as those that may stem from the defective medical scopes, are multi-faceted with multiple responsible parties. Because of those complexities, malpractice victims are encouraged to seek competent and experienced legal counsel. However, it is important to ensure you are choosing the right attorney for your case.

With more than 75 years of combined experience, the attorneys of Hurley, McKenna & Mertz possess the investigatory, medical-specific experience needed to build a strong case against all responsible parties. Committed to receiving justice for victims, we can ensure your rights are protected and will work hard at getting you and your loved ones full and fair compensation. Schedule your free initial consultation with a Chicago liability lawyer today by calling 312-553-4900.


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