Preemption - the legal defense that puts everyone at risk
Wednesday, January 30, 2008
Preemption has the ability to impact our health care system more than any other and it's barely being discussed. You can't turn on the news these days without hearing about the economy, the environment, the war and about health care but you've not heard about preemption and it is time for some public discussion about it. Preemption is a legal defense that the manufacturers of drugs and medical devices try to raise in lawsuits in order to shield themselves from any liability. Medical device and drug manufacturers frequently try to claim that the FDA's approval of a device or a drug grants them immunity, complete immunity, from being held accountable in cases when their products injured or kill people.
Riegel vs. Medtronic
A lot of the recent dialogue in legal circles about this revolves around a case that was recently argued before the United States Supreme Court called Riegel vs. Medtronic. Charles Riegel was a gentleman who underwent coronary angioplasty and during the procedure the balloon that was being used, the medical device, had ruptured, and he was seriously injured and had to go through all sorts of the emergency medical procedures. Riegel vs. Medtronic went all the way up to the United States Supreme Court and was argued before that court on December 4, 2007. The Riegels brought suit against Medtronic, the catheter’s manufacturer, claiming that the device was defective and that the labeling was inadequate. Medtronic moved to dismiss the case arguing that a piece of federal legislation called the Food Drug and Cosmetic Act preempted the case. In essence, they claim that they couldn't be sued because the FDA had previously approved the device.
There are a lot of problems with preemption and there are a lot of problems with that legal defense. The legal defense simply ignores the real world. It would be nice, of course, if we could rely upon the FDA to make sure that drugs and medical devices are safe before they’re marketed to the public. It would be nice if we could rely upon the FDA to make sure drugs and devices undergo sufficient research and development and sufficient testing before a manufacturer starts running television commercials about why people should buy them. It would be nice if we could rely upon the FDA for all those things and to make sure that all the information about the drug's risks or properly disclosed, but the truth is we can’t rely upon the FDA. The fact is, drugs and devices cause injury. Defective products and drugs kill people.
The FDA is the last government bureaucracy that's in a position to protect people. Why? Just take a look at this agency, they’re an absolute disaster. First, make no mistake about it the FDA is a bureaucratic government agency whose real purpose is to protect the pharmaceutical industry. They want to protect the industry’s objective to sell more drugs and make more profits, What they really are is a career path and a resume builder. If someone wants to ultimately go and work for the drug industry and pursue a career in the drug industry, then the FDA becomes a very desirable point along that person's career path. So why should we entrust the safety of our loved ones to an agency that has proven itself, over and over again, to be an incompetent safeguard for the American people?
Corruption in the FDA
The examples are endless. Lester Crawford, the former chief of the FDA, pleaded guilty several months ago to offenses that revolved around his lying about stock that he owned in companies that the FDA is supposed to be regulating. This is the very top of the agency and yet where do you think his allegiance went? He purchased stock in companies that he was supposed to be regulating, companies like Johnson & Johnson, Merck, Pfizer, Medtronic and Boston Scientific. The agency is supposed to be looking out for the American people not the business interests of the pharmaceutical industry. It's outrageous and takes away this agency's credibility while demonstrating they are incapable of protecting us from defective drugs and devices.
There was also the scandal over Vioxx, where evidence surfaced that the FDA knowingly approved, promoted and refused to recall a dangerous drug that caused large numbers of deaths. The evidence established in that particular instance, showed how Merck sought to a distort drug safety trials in order to hide evidence of heart disease and how the FDA refused to require further safety testing despite their being urged to do so.
Drug and device manufacturers want to hide behind the FDA, they want to shut courthouse doors on all of us, on people who were injured and whose loved ones were killed.
Why? - Because the agency is their best friend.
The FDA is an appendage to the drug industry and they don't see their job as protecting public health. That's what it's supposed to be, but they see their job as protecting the business interests of big pharma. When researchers want to speak out about the risks of a medication or against a particular drug they get censored.
At the FDA, it's all about pushing drugs and acting as a facilitator to drug companies. We should not entrust our lives to the FDA.This isn’t a legal issue nor just lawyer talk. An editorial published earlier this month in January 3, 2008 in the New England Journal of Medicine, a prestigious medical journal, the Riegal vs. Medtronic case and the preemption issue. It reads "Ultimately we believe that the pivotal question for the justices in Riegel vs. Medtronic resides in what is in the best interests of American society". Is it in people's interest to shield medical device companies from product liability claims? The editorial continues by asking if the FDA pre-marketing approval process is sufficiently rigorous and comprehensive to justify immunization of the industry against tort claims. It then goes on to say, if Congress later concludes that the Supreme Court has come to the wrong conclusion, one that is too restrictive of patients legal prerogatives and does not serve the public interest, Congress may then act to clarify the law and leave open the possibility that patients injured by devices or drugs can seek legal redress. But by rejecting Medtronic's plea for immunity the Supreme Court can act in now to protect patients. That's what this is all about - it's all about what do we do to protect patients. What do we do to protect patient safety and promote healthcare?
Preemption's Attack on Accountability
Accountability is one of the reasons why preemption is so dangerous. Preemption completely removes any accountability from these companies to the public. Our entire system of government including the inner workings of our judicial system is based on accountability. Accountability works. It works for the branches of government and it works in the private sector. When a defective product harms or kills someone the company that made that defective product must be held accountable, and it is completely unrealistic to rely on a biased bureaucratic government agency to protect the American people. A manufacturer should never be able to rely on a government agency to escape accountability when their product causes harm to others. Once you remove accountability you remove a person's ability to bring a company to court and hold them accountable for defects in their products. By doing that you remove a critical piece of the checks and balances system of our society. If you remove drug companies accountability people will die. Removing accountability and giving the drug manufacturers and the device manufactures complete immunity, through this defense of preemption, does not serve the public's interests.
Staying Informed is Protection
Let me remind you to stay informed. I am bringing attention to this issue because it has the potential to impact our public health system more than anything else. Find resources to give you objective information and stay informed. This isn't being discussed in mainstream media. Listen to shows like Ring of Fire on Air America, and find independent sources of information.
If the US Supreme Court comes down with decisions that strip away your rights and shut the courthouse doors on all of us, be prepared to reach out to your Congressman. Be prepared to talk about this, so that you can tell everyone that you deserve better from your legal and health care systems then immunity for the manufacturers of drugs and medical devices that unnecessarily injure and kill people.
Posted under: Dangerous Drugs • Medical Devices • Medtronic Sprint Fidelis Defibrillation Leads