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Recall that the Pinto’s design met all government standards of the time. Had compliance with federal standards been a complete defense of vehicle safety, Ford could not have been held accountable for the many burn victims that the company was later shown to have anticipated.

So why are medical devices different? Why is it that the politically controlled FDA’s approval and standards preempt the medical device industry from accountability? Should the Supreme Court take this argument to drug companies or any type of company that is regulated by the government such as the auto industry? How would you feel if your sixteen year old son were killed in a Ford Pinto? What would you do if you were not able to sue Ford to discover what happened, to discover what Ford knew and hid?

How Our Cars Got Safer

This is how the Republicans/conservatives define “We the people…” Do not let them sue when the politically controlled FDA “approves” a device because “we the people…” are not smart on enough on a jury in a court room in our local backyard to make decisions as to how we want to orient society.

http://pagingdrgupta.blogs.cnn.com/2011/02/14/testing-was-lacking-in-most-recalled-medical-devices/?hpt=Sbin

I will be the first to admit that our justice system is not perfect nor is it efficient but what other system is there that each of us has access to out our very backdoor. There is no other system closer to us then our courts; a system that is a core value of what it means to be an American living in this Democracy. The jury system is part of the soul of America. It is a system with the beauty of simplicity and the power of the wisdom of ordinary people. It is this same wisdom that Rep. Spencer Bachus talked about in his recent debate about health care reform. The simple beauty of juries involves the following.

The system has a lawyer for the plaintiff and a lawyer or lawyers for the defendant. There is one judge, the referee, and twelve citizens called the jury. Each side tells their story and presents their facts. When each side has completed their arguments and presented all of their facts the judge tells the jury the laws that must be applied when deciding the case. The jury then moves to deliberate the case in private amongst themselves.

It is the jury that the Republicans, the US Chamber of Commerce and big business are really complaining about, the common man, you and I. Do they not believe we are not capable of making decisions about how to live our lives, that we are not capable of governing ourselves, that we are not capable as fully informed citizens to make decisions about the conscience of our community? Is this what we believe? I would argue otherwise.

Our Founding Fathers recognized the collective wisdom and judgment of its citizens and also understood that each of us unconsciously seeks those bits of information that confirm our underlying intuition. This is why the founding fathers gave us a system that allows for dissent. This confrontation forces us, the majority, to interrogate our own positions more seriously.

Yes, the jury system is not perfect, but neither is any institution that man creates and participates in because we ourselves are fallible. Given all of its imperfections the jury system is a microcosm of the very Democracy that men and woman have died for through our history. Yes, again I will say the jury system is not perfect but it is ours.

  • A jury is made up of local citizens who are in the best position to evaluate how the conduct at issue compares with the standards of the community in which they live.
  • The jury system is spontaneous, it is not known in advance preventing any undue influence on the members of the jury.
  • Jurors are not paid by either side.
  • Jurors complete their service and return to their private lives when the trial has ended. Judges are often on the bench for many years leaving them vulnerable to influence.
  • While it may be easy to find one judge that is out of touch with the community, it is much harder to find a jury of citizens that will come to an outrageous result.

So I ask you, what other place is there to better discover the truth and render justice? What other institution in this country does the common man have access to then a court out his backdoor?

The Founding fathers wanted to create a framework that would allow society to orient itself through dictates of conscience. This framework forces each of us into a communal process of finding the truth, an approach to truth that is experienced. An approach to truth that is more than dogmatic belief or a truth inferred from logical arguments. Are these principles and values something that we truly believe in our hearts as the best approach to society?

America is a nation formed by a set of ideals. America is composed of ideas of freedom, liberty, independent thought, independent conscience, self-reliance, hard work, and above all justice. It is a country that was formed from the injustices thrust upon the people and yet we want to deny ourselves the opportunity to seek justice, to seek the truth.

That is the strength of our Democracy, the people and our access to the courts out our backdoors. The ultimate power of the people can be found as close as the nearest court house. If our laws start to deny society this process of truth then the law is in danger of becoming no less a tyrant. Our founding fathers understood this which is why they gave us this tool of Democracy, the jury system. Are we to deny the wisdom of our fathers?

Is society ready to deny this father? When does it become OK when the life of another is more important than my son? I am told that allowing people to sue medical device manufacturers would harm innovation, innovation that would allow someone to live a better more productive life. My son is not living any life, better or productive. Is this my price for society’s innovation? Who makes that decision? Is it the politically influenced FDA commissioner or maybe the political appointment of Supreme Court Justices?

I will conclude with a quote from Thomas Jefferson, a powerful statement about the soul of America. “I know of no safe repository of the ultimate power of society but people. And if we think them not enlightened enough, the remedy is not to take the power from them, but to inform them by education.”

An interesting article. Medical device manufacturers just keep on giving. These days it is all about the sale.

“It is alleged that the deal Dr. Burnam, Burnam, and St. Jude struck was that Dr. Burnam would prescribe St. Jude defibrillators for his patients as a quid pro quo for hiring his son. Burnam also would receive commission points with a guaranteed floor of $200,000 per year. As part of the deal, it is alleged that the doctor would receive compensation for engagements and so-called research projects.”

http://www.qmed.com/news/22308/medical-device-company-cardiologist-and-salesman-son-accused-fraud-and-medical-malpractic

Why have companies behaved so badly this past decade? Was it cost cutting? Was it greed?

DC and the US Chamber are continuing their march to destroying all middle class protections. The next battle is to get generic drugs preempted from state tort laws because the politically controlled, conservatively underfunded FDA has approved the drug. This is the perfect situation that big business loves. They have the power and the influence to squeeze every ounce of profit out of life.

So who is going to protect the middle class? It is not the Democrats/liberals, Republicans/conservatives or libertarians. No one believes in the power of citizens to determine how they want to orient their society.  We have given up on juries in deciding how citizens want to orient their society. We have given up on ourselves. Maybe we really to need a king since we are not smart enough to determine what is important and what is not?

“Food and Drug Administration inspectors found in April that McNeil Consumer Healthcare, which has voluntarily recalled certain lots of its children’s and infants’ Tylenol products, knowingly used bacteria-contaminated materials to make them, a report posted Tuesday by the agency says”

http://www.usatoday.com/news/health/2010-05-04-tylenol-plant_N.htm?csp=34

A warning letter?! It is up to the manufacturer to provide information to the FDA. I also did not hear of any fine against Medtronic. What will force them to cleanup their act or is Medtronic to big of a ship to steer?

“It took almost two years from when the missing propellant was initially identified to conduct a recall.”

“In a statement, Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic said, quoted the Business Journal, “Medtronic remains committed to providing the highest quality products to our customers and is working with FDA to resolve all remaining issues as quickly as possible…”

“FDA is concerned with your failure to initiate a recall for devices affected by the propellant problem in a timely manner,” the warning letter, dated June 1, states. “It took almost two years from when the missing propellant was initially identified to conduct a recall.”

“According to the letter, training records indicated that the employee who evaluated MiniMed pump reports only had a high school diploma with some additional in-house training.”

http://www.newsinferno.com/archives/13953#more-13953

The Republicans are not on board to pass the Medical Device Safety Act because they say the industry is regulated by the FDA. Allowing people to sue will place 50 requirements on these device manufacturers and yet they will not fund the FDA.

You draw your own conclusions. If I was in charge I would not let this company sell drugs for one year. Of course with caps they can more easily calculate the cost of doing business unethically.

Diabetes Drug Maker Hid Test Data, Files Indicate

“I was first ignored, then pressured to change my scientific opinion, and when I refused to do that, I was intimidated and ultimately terminated,” he said in an interview. “And I’m going to tell the committee exactly that at this meeting.”

http://www.nytimes.com/2010/03/29/health/policy/29fda.html?pagewanted=2&partner=rss&emc=rss

So if one of the 24,000 late-model vehicles you purchased had a high failure rate and caused the death of your son what would you do? What would you do if you were not able to sue because the Department of Transportation approved the vehicle for sale?

And if you have one of these vehicles would you call to determine if your vehicle was part of the recall. Maybe my son would have been better off if Chrysler had manufactured his pacemaker.

Chrysler Group is recalling about 24,000 late-model Chrysler, Dodge and Jeep vehicles to fix a defective part that could cause sudden, unexpected brake failure.

Owners of these vehicles can contact NHTSA’s vehicle safety hotline at 888-327-4236 or Chrysler at 800-853-1403

http://money.cnn.com/2010/01/18/autos/chrysler_recall/

So Senator Hatch why should I trust the FDA? Senator Hatch will you give the FDA the needed funds to do their job?

“In one instance, it took the FDA 11 years to debar a doctor who had been convicted of 53 counts of criminal offense for, among other things, bribing an employee to conceal information about the attempted suicide of a clinical-trial patient and prescribing a drug without a license.

Types of misconduct that can get doctors debarred include submitting false information to the FDA, forging patient consent forms and not reporting when a patient has an adverse reaction to an experimental drug.”
http://online.wsj.com/article/SB125622345164801405.html

“Delfina Hernandez helped to carry out one of the most audacious drug research frauds in American history, but because federal drug regulators sent a legal notice years late and to the wrong address, she can legally continue to conduct research.”
http://www.nytimes.com/2009/10/22/health/policy/22fda.html
October 21, 2009

Given the fact that this has happened what has been put in place to prevent this from happening again?

“The agency’s scientific reviewers repeatedly and unanimously over many years decided that the device, known as Menaflex and manufactured by ReGen Biologics Inc., was unsafe because the device often failed, forcing patients to get another operation.

But after receiving what an F.D.A. report described as “extreme,” “unusual” and persistent pressure from four Democrats from New Jersey — Senators Robert Menendez and Frank R. Lautenberg and Representatives Frank Pallone Jr. and Steven R. Rothman — agency managers overruled the scientists and approved the device for sale in December.”
http://www.nytimes.com/2009/09/25/health/policy/25knee.html?pagewanted=1&_r=1&hp
September 24, 2009