Medical Device Maker Lobbied for FDA Approval
Supporters of the 2008 Supreme Court ruling that granted device makers immunity from medical injury lawsuits brought on by FDA approved devices, should rethink their position. According to the Wall Street Journal, a knee device maker engaged in unethical lobbying to obtain U.S. Food and Drug Administration (FDA) approval for its new device.
The approval for Menaflex implants, which are used to help knee injury patients, was given overriding objections by FDA scientists. According to FDA correspondents, several senior staff members of the agency complained that ReGen Biologics Inc., the company that manufactures Menaflex, pressured the agency to approve the device. Lawmakers have since gotten involved in the controversy with Senator Chuck Grassley sending letters to the agency as well as the device maker, calling for more information about interactions between the two. According to Senator Grassley, his investigation is based on emails that suggest the agency was overenthusiastic in its readiness to ‘’accommodate the company.’’ Menaflex received approval under the agency's fast track rules, in which clinical trials are not necessary.
It is not only ReGen Biologics Inc. and the safety, or lack of it, of Menaflex in question here. At the crux of the matter are the reliability and integrity of FDA approval processes. Email correspondence between staff members at the agency indicate that they removed certain lines from emails that could indicate ‘’special treatment for the device maker.’’ FDA critics are concerned about what they call the agency’s tendency to bow to device companies. The fast track process, in particular, has come under intense scrutiny. The process allows scientists to bypass clinical trials only when reviewing devices similar to existing ones. There is no explanation forthcoming about why Menaflex was approved under the fast track process considering it is the only device of its kind in the market. With the FDA behaving more like a corrupt government than the country's premier drug safety agency, it is fair to assume that medical injury lawyers will be kept busy for a while.
Defective Medical Device Lawsuits
Medical devices that are rushed through approval processes or approved through lobbying efforts may come with risks that can pose potential dangers to patients. These devices may not have had stringent review guidelines applied to them, which means their safety may not be thoroughly verified.
If you've been injured by the use of a defective medical device, and want to know if you are eligible for compensation, contact an experienced medical injury lawyer at Arnold & Itkin LLP.
