According to the Supreme Court, NO . There is no recourse:
http://www.newsinferno.com/archives/4787
An excerpt from the article follows:
From a year ago:
According to The New York Times, both Waxman and Pallone have criticized the Riegel decision. For his part, Pallone said he expects the House Energy and Commerce Committee to hold hearings this session to question whether the FDA. process for approving devices is adequate.
Many consumer advocates also decry the ruling because of the FDA’s poor track record of policing medical device, something that has been well-documented in recent months.
In fact, last month the Government Accountability Office issued a report that criticized the agency for failing to conduct appropriate medical device reviews. Around the same time of FDA scientists wrote then President-elect Obama imploring him to reform the agency, which they characterized as corrupt.
The letter explained that that FDA’s regulation of medical devices was “corrupted and distorted by current FDA managers, thereby placing the American people at risk.” The letter also provided specifics about how scientists who differed in opinion from FDA management were threatened with disciplinary action.
“Consumers face the worse of all possible worlds,” David C. Vladeck, a professor at Georgetown University Law Center and a medical industry watchdog, told the Times.
“The FDA has shown itself incapable of keeping dangerous products off the market, and now the Supreme Court has said patients can’t sue companies for redress.”
http://www.nytimes.com/2008/02/21/washington/21device.html
Your child, mother, father, or grandparents could literally have a known defective lead from a Medtronics implantable defibrillator and die or be severely injured from the defect device and you have no recourse.
This is a travesty and the law MUST BE CHANGED!
Medtronic and the Bush Administration asserted that allowing state personal injury lawsuits against the makers of defective medical devices amounts to a state “requirement” different from FDA requirements because such complaints are based on state laws. Eight members of the high court agreed with Medtronic. The Court recently heard another case, Wyeth vs. Levine, that could extend a similar lawsuit shield to drug makers.
There is renewed effort to overturn one of the Bush era tragedies (his staunch support that medical device manufacturers cannot be sued), please read here:
http://www.yourlawyer.com/articles/read/16018
I have no affiliation with the website above and used it only for the purpose of displaying the updated information regarding efforts to overturn the law.
Some in Congress are seeking to do just that. According to The Minneapolis Star Tribune, Rep. Henry Waxman, D- Calif. and Rep. Frank Pallone Jr., D-N.J., plan to introduce legislation that would ov turn the Supreme Court's Riegel ruling. The Supreme Court decision "left consumers without any ability to get compensation for injuries caused by certain defective medical devices,'' Waxman said in a statement to the Star Tribune.
"The Supreme Court assumed that FDA approval ensures medical devices are safe, but the many recent stories of patients harmed by faulty devices have proven that assumption false."
According to the Star Tribune, the Supreme Court ruling covers Class III medical devices, such as implantable defibrillators, which are theoretically subject to the greatest level of scrutiny by the FDA before they are approved.
But lawyers representing Sprint Fidelis victims argue that the lead was not subjected to the same level of clinical scrutiny as other Class III devices because its application piggybacked an earlier Medtronic lead approved by the agency, the Star Tribune said.
It does not stop there, the FDA is rife with corruption! From the New York Times in mid-January, excerpts from the article are below:
http://www.nytimes.com/2009/01/28/us/28fda.html?_r=1&emc=tnt&tntemail0=y
But the accountability investigators found that the agency still allowed manufacturers of most Class III devices to gain approval without conducting extensive testing. Part of the reason may be that some Class III devices should be reclassified as Class II devices, while other such devices simply should be tested more.Critics have long bemoaned the agency’s device approval process, which allows most devices to be approved with minimal testing. Manufacturers say the agency is already overly restrictive.
Of course they (manufacturers) feel they are "over regulated", they want these devices on the market as soon as possible to make MONEY, they don't care about the safety of the public at large, only the money going in their coffers!!
For these reasons, in the quote above, people are dying, being treated as guinea pigs, seriously injured or even being scarred for life by cosmetic devices that went to market in less than a year!!!!
Here is an excellent editorial written by Dr. Dr. Amy Newburger (published in the Archives of Dermatology/VOL 142, FEB 2006) warning of rush to market medical devices and FDA regulation:
http://www.dcwderm.com/arch.pdf
What can you do? WRITE YOUR CONGRESSMAN!
Find contact information for all members of Congress here:
http://www.conservativeusa.org/mega-cong.htm
Sign this petition to Congress to protect yourself, family and friends:
http://www.rallycongress.com/revamp-the-fda/1546/call-to-congress-to-overhaul-fda-medical-device-approval/
To read the stories of those damaged by these FDA approved devices, please visit the support forum:
http://iplandlaserdamagesupport.prophpbb.com/
