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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.

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.”

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

“Implants can fail for many reasons, but if only a small percentage of them fail prematurely because they are substandard, the costs to taxpayers, policyholders and patients can run into the tens of millions
of dollars each year, health care experts estimate.”

You get into your car and place your child in the back seat and wrap the seatbelt around your child. You wrap the seatbelt around you child in case you are involved in an accident. Unfortunately you are in an accident and in that moment in time the seatbelt fails, throwing your child through the window and killing him. This seat belt was required by Federal Law and had to meet minimum design standards.

You later discovered that this seat belt had a recall because of a 4% failure rate. You also learn that this seat belt had an earlier recall with a smaller subset of that model of seat belts.

Unfortunately you can not sue because of a Supreme Court ruling for pre-emption protecting the automobile industry from lawsuits. The Supreme Court argued that allowing fifty states to sue would be imposing fifty different requirements on the auto industry.

Sorry you are out of luck.

Do I hear this Texas congressman talking about states rights. I do not believe I see him on the list of co-signers of the Medical Device Act to overturn the Supreme Court ruling restricting states rights.

“The existing process in some way thwarts innovation. By definition, the 510K approval is designated for substantial equivalence. That is, the device must do something in the same way as an existing device that was previously approved.”

“The U.S. Chamber supports health courts and other medical liability reforms that ensure fair damage awards”

Is this just smoke and mirrors? If the U.S. Chamber supports “fair damage awards” then why to they continue to NOT support the Medical Device Safety Act of 2009 preventing anyone from going to court to determine if a person is entitled to “fair damage awards” or to hold a company accountable for there actions if their was gross negligence?

Have we all forgotten the words of the Pledge of Allegiance? So we want “one nation under God, indivisible, with liberty” but not “justice for all.”

“I pledge allegiance to the flag of the United States of America and to the republic for which it stands: one nation under God, indivisible, with liberty and justice for all.”

This pledge is something that I said everyday in school. It had value to society or I would not have had to repeat those words. I was not given the choice of which words I repeated.

Do those words have any value to society, do they mean something, are they the foundation of this country?

Is it “justice for all” with the deepest pockets. Is justice for sale? Is the U.S. Chamber about a fair fight or only when it benefits business.

We must remember the primary objective of the Chamber of Commerce, to promote commerce.

“To advance human progress through an economic, political and social system based on individual freedom, incentive, initiative, opportunity, and responsibility.”

What are the obligations of corporations? Are corporations not obligated to be responsible as much so as individuals?

Are corporations an ingenious device for obtaining individual profit without individual responsibility?

Does not equality of opportunity mean equity of responsibility?

Or is the Chamber of Commerce like a baby, “A load noise at one end and no sense of responsibility at the other”?

“Liberty means responsibility. That is why most men dread it. “
-Shaw, George Bernard

“The liability for an act and the obligation to repair any damage caused by that act; in criminal law, a person’s mental capacity to understand and answer in court for her or his actions; guilt.”

Without the Medical Device Safety Act of 2009 how is a corporation to be held accountable for their actions?

There is much talk these days from conservatives about liberty and big government.

Maybe a refresher on the definition of “liberty” is important before we get started.


n. pl. lib·er·ties


         a. The condition of being free from restriction or control.

         b. The right and power to act, believe, or express oneself in a manner of one’s own choosing.

         c. The condition of being physically and legally free from confinement, servitude, or forced labor.

    2. Freedom from unjust or undue governmental control.

    3. A right or immunity to engage in certain actions without control or interference: the liberties protected by the Bill of Rights.

Those liberties are the “freedom from unjust or undue governmental control” and “the liberties protected by the Bill of Rights”.

One of those liberties in the Bill of Rights is the seventh amendment.

Seventh Amendment (Amendment VII)

In Suits at common law, where the value in controversy shall exceed twenty dollars, the right of trial by jury shall be preserved, and no fact tried by a jury, shall be otherwise re-examined in any Court of the United States, than according to the rules of the common law.

The Reigel v. Medtronic Supreme Court decision tells me I can not sue because the politically controlled FDA has approved a medical device but yet anyone can sue a driver, licensed by a state, that has killed my son through negligent behavior.

Is that what my son is worth, less then 842.63?

I also keep hearing much talk from the Republican party.

Rep. Spencer Bachus talked about the power of the individual. Rep. Judy Biggert talks about bipartisanship. Rep. Frank Lucas talks about “faceless bureaucrats”, and Rep. Michelle Bachman talks about “politically connected friends”

Rep. Adam Putnam in talking about the recent debate on financial regulation that “what this gives us is a bigger government bureaucracy”

Rep. Randy Neugebauer talks about the wisdom of the people: “I still have faith in the American people…” or “The American people are smart enough  to make their own decisions

Rep. Jeb Hensarling said that as “the economy gets more political it will depend more on who you know in government” and “you flip a switch and take care of your political supporters”

Rep. Scott Gerret is not going to sign the financial overhaul bill because “the bill has an expansion of government… we are allowing the Treasury Secretary, a political appointee, to decide which bank fails or not”

Michelle Bachmann said this about the current health reform bill,  “government will take control of the life and death of every citizen.. if you believe in liberty and if you reject tyranny… who will be the decision maker, what about rationing…”

The recurring theme with Republicans is the ingenuity of the American people and the faith they have in the “people” and how government is getting to big and controlling our lives more and more.

So Rep. Neugebauer do you have “faith in the American people” or only when they do not serve on a jury? Are the American people “smart enough to make their own decisions”? Are they smart enough to spot a frivolous lawsuit?

And Rep. Bachman, who will be the decision maker of the value of my son’s life? Will it be your “politically connected friends”? Will the FDA “take control of the life and death” of the citizens. Will you expand the power of the federal government with tort reform, basically regulating what the American people can and can not do by restricting access to the courts through caps?

Will “faceless bureaucrats” decide for society what is safe and what is not or how much a person is worth? Will you allow “freedom from unjust or undue governmental control” and not allow the Supreme Court to tell states what they can and can not do? Will you allow “freedom from unjust or undue governmental control” and not impose caps on what “we the people” decide is just or will you impose your definition of justice on the people?

So what are conservative values? The Republican party still has caps in their “national” health care plan and not one Republican has co-signed the Medical Device Act of 2009. Do conservative values only have meaning when they do not pose a burden on you?

There are millions of soldiers that died for the constitution and thousands fighting and dying this day. I served this country for four years to protect the constitution nearly losing my life and now you want to take away my rights, my responsibility as a father, to protect and fight for my child. Is this not what You have asked me to do as a father? I have served my country and I have lived up to my duties as a father.

What price are you willing to pay for the values embodied in the constitution? What is your price for selling out the constitution? Do you really have faith in the American people?

Why do you want to regulate the very institution where the common man with limited resources can seek justice in this world?

Who defines negligence or due diligence? Is not government the realm of legality, and society the realm of conscience. Is it not up to society to define negligence and due diligence? Is not society the source of moral or ethical judgment?

Irving Kristol has this to say about Democracy:

“Democracy does not guarantee equality of conditions – it only guarantees equality of opportunity.”

I am only asking for equality of opportunity. An opportunity to determine if their was negligence in the death of my son, to seek justice if justice is to be found. Is this not the responsibility of a father? Is this to much of a burden to ask of my country?

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.”
September 24, 2009

Some quick facts regarding medical malpractice issues.

This report is from the Institute of Medicine, a member of the National Academies  ( National Academy of Science, National Academy of Engineering, Institute of Medicine, and National Research Council)

“Medication errors are among the most common medical errors, harming at least 1.5 million people every year, says a new report from the Institute of Medicine of the National Academies.  The extra medical costs of treating drug-related injuries occurring in hospitals alone conservatively amount to $3.5 billion a year, and this estimate does not take into account lost wages and  productivity or additional health care costs, the report says.”

Could it be the return on investments that drives med mal premiums?

“Insurance premiums and claims for doctors both have dropped significantly in recent years, while the medical malpractice insurance industry is enjoying "remarkable profits" in light of the global economic collapse, a study released by Americans for Insurance Reform finds. The report concludes that further limiting the liability of negligent doctors and unsafe hospitals is not only unjustified, but also would have almost no impact lowering this country’s overall health care expenditures.”

John F. Kennedy had this to say.

For a nation that is afraid to let its people judge the truth and falsehood in an open market is a nation that is afraid of its people.

So have we become a nation that is afraid of its people? The Supreme Court and the Republican party believes this to be the case as is evidence by the Reigel v. Medtronic ruling and the Republican lack of co-sponsorship of the Medical Device Act of 2009.

Do we substitute government tyranny with corporate tyranny? It appears that we have both. A politically controlled and influenced FDA and corporate immunity.

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