FDA Medical Device Approval Process Flawed

Wyeth Lawsuit Supreme Court Ruling March 2009
Wyeth Lawsuit Supreme Ruling March 2009
According to a January 15, 2009 GAO (Government Accountability Office) report, the FDA’s process for reviewing and approving the sales of medical devices is severely flawed. In reviewing potential medical devices for market here in the US, the FDA uses an antiquated process that dates back to 1976, which categorized medical devices into three groups or tiers depending upon their risk level to consumers.
Between 2003 and 2007 228 medical devices were found to have passed through an insufficient medical review process including about 24 high-risk devices such as heart defibrillators, artificial hip joints and electrodes for pacemakers, according to the government report.
In spite of the flawed FDA system, the Supreme Court denied consumers the right to sue medical device manufacturers for faulty and dangerous medical devices, arguing that if the device received FDA approval, the device company was immune from product liability lawsuits in state courts.
Wyeth Pharmaceuticals, one of the country’s largest manufacturers of prescription and over-the-counter drugs, has brought suit in order to extend this same legal protection for drug manufacturers. Last November, the case was brought before the Supreme Court. If the Court extends this benefit to drug companies, it will prove to be another loss for consumers.