Read the Bills Act Coalition

Thursday, June 18, 2009

Veteran's Medical Care Under Attack: Oppose the Medical Device Safety Act (H.R. 1346 and S. 540)

Posted by MAXIMUS

The Veterans Affairs ("VA") Medical Centers are tough places to visit--even tougher places for folks to recuperate in after receiving battlefield injuries. With limited resources and staff, the VA does its best to deliver critical medical services to our nations finest. The VA medical centers seek to fix the mental and physical maladies that inflict our wounded warriors. This much is a given. The staff at VA, and the warriors admitted in their medical centers for treatment, should not have to suffer from an assault on the quality and affordability of care they provide and or receive. The Medical Device Safety Act (H.R. 1346 and S. 540) is the coming assault that will significantly impact Veterans medical care at VA Medical Centers across the United States.


In 1976, Congress enacted the Medical Device Amendments Act (MDA) to create a uniform national process for evaluating the safety and efficacy of medical devices. Prior to enactment of the MDA, medical device manufacturers were subject to at least 13 different states’ regulatory regimes and were frequently sued over alleged device failures in state courts around the country. Congress enacted the MDA and incorporated an express preemption provision in that statute in response to this hopelessly complex regulatory environment.

The MDA ensures intensive federal review of new and innovative medical devices and provides manufacturers with clear guidance from a single source – the Food and Drug Administration (FDA) – on the safety and efficacy standards applicable to new medical devices. Under the MDA’s uniform regulatory environment, medical innovation has thrived, and patients have received cutting-edge medical technologies like pacemakers, arterial stents, and heart valves.

Here's the rub: The Medical Device Safety Act of 2009, if passed, seeks to stifle innovation of new medical devices thus limiting the availability of lifesaving technologies. Under the current process, the Food and Drug Administration is able to weigh the costs and benefits of a particular device, and to assure that when the former are outweighed by the latter, the device reaches the market. Replacing expert regulators with jurors hand picked by polished money grubbing lawyers would result in inconsistent and even misguided regulation (through the courts!!!) and ultimately prevent important medical technologies from reaching the patients who need them.

Lastly, H.R. 1346 and S. 540 would impose significant additional costs on American business at a time of economic crisis. Many medical device manufacturers are relatively small companies without large research and development budgets. These companies rely on often-scarce, venture capital to fuel innovation – and cannot afford the risk of increased lawsuits. For more than 30 years, the United States has been a leader in the innovation of medical technology.
Now is not the time to threaten the viability of an important American industry – especially one that has saved countless American lives.

If H.R. 1346 and S. 540 pass Congress, costs will rise to treat the wounded warriors who are seeking treatment in VA Medical centers. Trial lawyers will be suing the manufacturers of new prosthetic devices, new pacemakers, artificial optical devices, etc. All newly developed medical devices meant to help wounded warriors who suffer from loss of limb or worse, will be be subject to new litigation. Many of these warriors have suffered from improvised explosive device attacks and benefit from the new medical devices to bring their bodies back to some sense of normalcy. Unfortunately, if Congress doesn't vote to stop these two new bills, the trial lawyers will ensure that VA medical care blows up in the face of Veterans. Increasing costs to the VA curtails their power to purchase proven medical devices for those who have truly sacrificed for our nation. Please contact Senator Webb and Warner and ask them to vote against H.R. 1346 and S. 540.

If these bills pass, devices for wounded warriors (like the one below) will be the victimized:


Anonymous said...

i used to think the same way but wait until a loved one gets seriously injured by a bad device and there is nothing you can do about it! besides the government has to pay for everything now instead of the people that should be liable. whats better increased taxes???

ccMAXIMUS said...

This is a bad bill....simple...its just a sop to the trial lawyers and will drive up costs on everybody else.

Anonymous said...

As the recipient of a defective hip replacement, the current legal environment results in my having no recourse. While there may be some inhibiting features embedded withn the proposed bill, the end result will be better products for those needing them in the future, and some relief for those suffering with poorly designed devices in the present.

jack parkin

Anonymous said...

Your article is very misleading. You fail to mention that the Medical Device Safety Act is the result of a Supreme Court case decided in 2008 (Riegel v. Medtronic)that granted immunity to device manufacturers who have received FDA approval. The authors of the original Medical Device Amendments (Kennedy, Waxman, Dingell) have stated clearly that the Supreme Court misinterpreted Congressional intent by granting this immunity, and that not having the added protection of state tort law is extremely dangerous for patients. This bill will only return the law to the way it was a year and a half ago.

Congressional hearings have been held, and there is no evidence whatsoever that innovation will be stifled by returning the law to the way it was. That is a threat the device manufacturers use - a scare tactic and quite disgusting considering you are misleading veterans.

There's plenty of evidence that these multibillion dollar companies skirt FDA regulations and continue selling dangerous products that should be recalled - as in the case of Medtronic's Sprint Fidelis lead. Why shouldn't they? They'll get off scott free. I ask you, who should pay the medical bills for the people injured by a defective device? Injured and now bankrupted because they cannot hold the corporation accountable.

This is unacceptable for patients, and our returning veterans deserve the safest medical devices possible. Do not do them this disservice by telling lies and half-truths.

I think many of us have hear about the Walter Reed doc who worked as a Medtronic consultant and faked a study on a bone growth substance that has now injured veterans. (See: You should be ashamed of yourself for endorsing this potential for harm to our veterans. Boo!