The Medical Device Safety Act & Physicians Payment Sunshine Act

The Medical Device Safety Act -- Track the progress at http://www.govtrack.us/congress/bill.xpd?bill=s111-540 Check out who supports and opposes this bill, and contact your representatives.

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. This leaves the door open for recklessness with NO accountability! And this includes ALL medical devices approved through this avenue. Not just Synvisc.

"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=76834Manufacturers 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.


The Physicians Payment Sunshine Act 2009 would require transparency between pharmaceutical companies and physicians. YOU should know who "owns" you physician's decisions and opinions. Track it here http://www.govtrack.us/congress/bill.xpd?bill=s111-301 and contact your representatives to support this Act.