S. 3398, The Medical Device Safety Act of 2008

  • This item is from the 110th Congress (2007-2008) and is no longer current. Comments, voting, and wiki editing have been disabled, and the cost/savings estimate has been frozen.
  • This bill, or a similar bill, was reintroduced in the current Congress as S. 1455, The Recovery Enhancement for Addiction Treatment Act.

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August 5, 2008, 11:14pm (report abuse)

I don't need the government to take away another choice. If this is passed, the small business owner making bath and body products will suffer greatly. There are many of us that cannot or do not want to use chemicals on our bodies. Do NOT let this pass! It's just another nail in our freedom coffin.


September 8, 2008, 8:22pm (report abuse)

This Act is to prevent people from dying because of faulty medical devices. This overrules a deeply flawed Supreme Court decision to allow the DEFENDANT in a case where a balloon catheter burst inside a patient and killed him, to avoid all responsibility for the tragedy even though their faulty product caused this outcome.

Medtronic vs Riegel. brought by Riegel (survivor)with Public Citizen.

US Supreme Court ruled WITH THE DEFENDANT, Medtronics. Immediately Congress then passed the Medical Device Safety Act of 2008, to address and reverse this glaringly flawed decision by the Court.

This directly addresses a freedom that over-rides any corporate "freedom of choice". This addresses the freedom to live, and to not be killed by shoddy medical devices.



September 14, 2008, 11:42am (report abuse)

When people are hurt or maimed by products, whether or not they are approved by the FDA, they need the ability to hold the manufacturer accountable. The ruling of the Supreme Court Judiciaries is ludicrous, and opens the door for manufacturers to be lax in the areas of safety. Manufacturers propose upgrades to devices with little or no long term clinical studies. Further more, when the proposal for “upgraded devices” is proposed, one must wonder what was wrong with the original device to mandate that the manufacturer make improvements.

The FDA stated in a letter to me, “One or two well-documented case reports may provide an early signal of unexpected problems and lead to additional evaluation. This may result in FDA regulatory actions that improve the safety of the products used in patient care each day.” This is bogus. I know of many adverse event reports filed against Gynecare for its TVT device, and nothing is being done.


September 15, 2008, 12:25am (report abuse)

This is about accountability. I am accountable for my actions at work, and so should the device manufacturers. It is beyond my comprehension why they should be exempted from responsibility in the first place. Passage of this bill will make things safer for us patients. I just wish this same committee would go a step further and establish a Superfund, paid for by the device manufacturers and drug companies, to take care of patients when one of their drugs or devices cause harm.


November 23, 2008, 12:27pm (report abuse)

I know someone very dear to me, who had a faulty device. She was for lack of a better word, attacked by this device. This idea that a company wont stand by its product, to me, seems like scam. Make a product that costs thousands of dollars and maybe it kills you. This product is supposed to keep you alive. Just like if you went into surgery, you would expect to wake up not die on the operating table. Someone should step forward for this, and the government should make sure that this never happens again.

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