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AP Investigation Shows Thousands of Unsafe Devices Cleared by FDA Through Streamlined Pathway


According to an extensive investigation and report conducted by the Associated Press — you can click here to view the full article, posted on November 27th, 2018 — the Food and Drug Administration (FDA) has been rushing medical device review processes, allowing unsafe devices to reach the market in the thousands. Based on the FDA’s own declarations, it aims to be the first source of medical device approval across the globe, which may have paved the way for expedited review processes. Critics of the FDA say it is acting less for the safety of the people and more for medical device manufacturers.

With the direction of Dr. Jeffrey Shuren, the current acting Director of the FDA Center for Devices and Radiological Health, the number of device approvals has tripled in recent years. On the other hand, the number of warnings and reprimands sent to medical device manufacturers have plummeted by about 80% in the same time period. In response to the AP investigation, the FDA claimed it would begin making changes to the “streamlined system” that would require device manufacturers to use better materials and technologies in their devices.

Investigation Examines 80,000+ Deaths Linked to Medical Devices in Past Decade

According to a CNN report — which you can view in full by clicking here — another investigation from the International Consortium of Investigative Journalists (ICIJ) seems to coincide with the AP’s investigation. According to their findings based upon the review of 8 million device-related health records, close to 83,000 deaths and 1.7 million injuries in the United States occurring between 2008 and 2018 can be traced back to defective medical devices. The FDA was quick to deny any correlation or connection between the ICIJ report and its decision to revamp its medical device review process.

The ICIJ report also pointed to a recent history of massive payouts from medical device manufacturing giants. More than $1.5 billion in settlements have been fulfilled by these companies in the last 10 years. Some of the charges of regulatory violations included global corruption and fraud charges.

Analysis: Medical Devices Deemed Unsafe in Other Countries Can Be Sold in the U.S.

Lastly, a recent NBC News report — which can be seen in full by clicking here — brought light to the lack of quality checks between countries. A medical device deemed unsafe in one nation can still be placed on shelves in another. Every country has its own system and administration for reviewing and approving medical devices, inadvertently drawing a regulatory curtain at international borders. While the FDA claimed it works alongside regulators from other countries, it did not provide any immediate records or evidence to show its thoroughness in this process.

Call Kentucky Medical Malpractice, Medical Device and Drug Lawyer – (502) 242-8877

Brett Oppenheimer has been fighting for the rights of people wrongfully injured by defective medical devices and medical malpractice for decades. Throughout his career, he has been able to secure multiple multimillion dollar settlements and verdicts for his clients, building his reputation as one of the go-to Kentucky attorney for medical device claims. When you need a real legal champion on your side, come to Brett H. Oppenheimer, PLLC and arrange a free initial consultation with Brett today.

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