Medical Device Pre-emptive Protection by the US Supreme Court

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.

Warning to the Chemically Sensitive

Synvisc is billed as a viscosupplementation with limited localized adverse events [meaning in the injected joint], and little to no systemic adverse events [meaning on the whole body.] If you read the literature Genzyme, the makers of Synvisc, offers to their physicians and patients, you'd think the only exclusionary criteria would be if you have a known chicken, avian, feather, poultry, egg allergy. Genzyme, with the help of FDA, excludes listing or warning about the chemicals used in the cross-linking process allowed in permissible levels. These chemicals are formaldehyde and divinyl sulfone (DVS). Formaldehyde is a known neurotoxin and carcinogen. DVS is a by-product of mustard gas, and is more toxic.If you are hypersensitive to chemicals, do not let your physician inject this gel into your body.You will likely regret it.

More info will follow.

Take charge of your own health. There are other options.