Synvisc is classified as a class III “medical device.” It received FDA approval through the Pre-market Approval process. This classification and means of approval by the FDA means that the pharmaceutical company, Genzyme, is protected from virtually any liability if something goes wrong with the injection.
The “injected gel” that eventually ends up in your bloodstream DOES NOT have to follow the same stringent guidelines as a product classified as a “drug” by the FDA. Genzyme offers no data regarding the “systemic half-life” or the “metabolic pathway” or “how do you get this out of your system”…especially under life-threatening reactions.
We can thank the US Supreme Court whose decision on Feb 20, 2008 through RIEGEL v. MEDTRONIC, INC. which gave free range to the pharmaceutical industry to produce harmful medical devices with no accountability...oh, except through the FDA. The FDA has a history of approving many defective and deadly medical devices and drugs in recent years. Read
http://www.rd.com/your-america-inspiring-people-and-stories/fda-approves-harmful-antibiotic/article55526.html
The US Supreme court voted 8:1 to protect BIG MONEY (ie: manufacturer’s of medical devices) from any liability if the product causes harm to a patient.
http://www.supremecourtus.gov/opinions/07pdf/06-179.pdf
http://www.afj.org/check-the-facts/cases/medical-device-safety-act-2008.html
Contact your US Congressman regarding this ruling and support "The Medical Device Safety Act."
"This bill would overturn Riegel v. Medtronic, which held that the express preemption provision of Section 360k(a) of the Medical Device Amendment to the Food, Drug and Cosmetic Act preempts state-law claims seeking damages for injuries caused by medical devices that received pre-market approval from the FDA." [Read more about recent US Supreme Court decisions regarding Medical Devices.
Proposed Changes At FDA And Proposed Legislation Threaten Both Pharmaceutical And Medical Device Companies at http://www.mondaq.com/article.asp?articleid=76834
Manufacturers of drugs are also seeking pre-emeptive protection based on "Riegel vs Medtronic." If you think prescription drugs are dangerous now, wait until their is NO legal recourse.
Subscribe to:
Post Comments (Atom)
Seprafilm, an anti-adhession barrier, manufactured by Genzyme shares the same immunity as Synvisc. It has caused many very serious adverse reactions as well as several deaths and yet Genzyme is left with no accountability. Congress is currently debating whether the Medical Device Safety Act should be brought to vote.
ReplyDeleteSome Congressmen would have you believe that, if a medical device company commits fraud against the FDA by not properly reporting clinical trials and adverse events to the FDA, a lawsuit can proceed. (Preemption sounds a lot more palatable if there is a way to get around it.) From what I have read and been told, however, this is not the case. The Supreme Court's decisions in Riegel in 2008 along with Buckman in 2001, leaves medical device companies completely off the hook. Unless the Medical Device Safety Act of 2009 is passed, medical device companies will enjoy the unique privelage of facing no accoutability for the products they place on the market. Everyone must let their Congressmen and Senators know that this very important Act must be passed quickly.
The information I shared about Genzyme in the above post is based upon Genzyme's reports to the FDA's MAUDE database.
ReplyDeleteLaura,
ReplyDeleteThanks for your additional information. I was recently told that pharmacuetical companies are also seeking the same pre-emptive protection as medical devices. The people of America need to wake up and contact their congressmen and women. This is an outrage.
Thanks for stopping by.