Personal Injury Law

FDA Testing for Cardiovascular Implants come under Scrutiny

By LaBovick Law

The Food and Drug Administration has come under fire for having insufficient scientific standards to for evaluating cardiovascular devices. This recently came to light from a report found in the Journal of the American Medical Association entitled "Strength of Study Evidence Examined by the FDA in Premarket Approval of Cardiovascular Devices".

In an Associated Press article, The New York Times reports finding from researchers at the University of California, San Francisco. This article shares alarming patterns of how the FDA frequently gave their seal of approval for heart devices based on foreign research in small groups of patients. In a further twist, common standards and protocols for device studies were lacking such as clear goals and randomization. One can't help but wonder, who is looking out for the American public, if the FDA's testing has such fundamental flaws.

Scientific American, author, Cynthia Graber states the following in her podcast transcript, in response to the JAMA article.

"We like to think that medical equipment implanted in our bodies undergoes rigorous testing before it's put inside a person

These recent turn of events, further underscores the need to pass the Medical Device Safety Act (MDSA), according to the American Association for Justice (AAJ). Since the hotly debated Supreme Court Decision in Riegel v. Medtronic, medical device product liability has been front and center in the debate on FDA approved devices and who should be held accountable.

AAJ President Anthony Tarricone eloquently states the following in support of the Medical Device Safety Act  (HR. 1346 / S. 540)

"Passage of the Medical Device Safety Act is critical for patient safety, especially when medical devices have not gone through rigorous premarket testing and post-market monitoring.'

Time will tell if the new studies shake things up at the FDA and ignite discussions on passing  the Medical Device Safety Act. Consumers are encouraged to join in the discussions with lawmakers that if the FDA approval process is flawed from the beginning, this loop hole must be closed to provide consumers safeguards and protections. 

Medical devices such as cardiovascular devices that are implanted inside a patient's body,  after a doctor shares that the device has been approved by the FDA.  The justice system is flawed, if the medical manufacturer knows the shortfalls of their device from the beginning, but hides it,  to secure the FDA seal of approval.  

Full post as published by LaBovick Injury Law Blog on January 06, 2010 (boomark / email).