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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

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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

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

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

STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS — (Senate – March 05, 2009)

“Moreover, there is very little FDA oversight once a device reaches doctors and patients. In fact, even the best designed and most reliable clinical studies by their very nature cannot duplicate all aspects and hazards of everyday use. Moreover, while manufacturers are supposed to report defects and injuries, the FDA has admitted that there is ‘severe underreporting” of defects and injuries.

Given the FDA’s limitations, it is crucial that an individual have a right to seek redress. When defective medical devices reach the market, whether or not approved by the FDA, patients are often injured. Those injured are often left temporarily unable to work or to enjoy normal lives, and in many cases never fully recover. State tort law provides the only relief for patients injured by defective medical devices and should not be foreclosed.

Not only does access to State court mean that a person injured can receive fair compensation, but there are other advantages. Such suits aid in exposing dangers and serve as a catalyst to address their consequences. Through discovery, litigation can help uncover previously unavailable information on adverse effects of products that might not have been caught during the regulatory system. Litigants can demand documents and information on product risks that might not have been shared with the FDA. In this way, the public as a whole is alerted to dangers in medical products…”

http://thomas.loc.gov/cgi-bin/query/F?r111:9:./temp/~r111RtwMfs:e199102:

“The people killed, shocked, or injured by these medical devices have no place to turn for help.”

Currently, the medical device industry enjoys complete immunity for their class III medical devices, even when the devices are found to be defective and dangerous, and have even been recalled. This immunity was granted to device manufacturers following the Supreme Court’s decision in Riegel v. Medtronic last year. Prior to that decision, lawsuits served as a strong deterrent to the release of dangerous and defective medical devices. ”

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more about “Investigators: Detecting The Dangers“, posted with vodpod

So what happened? Was the FDA influenced by politics? Was the Bush administration telling the FDA to back off so that we could have more innovation? So what happens next presidential election if a President gets in that thinks we have to much regulation or the Republicans want to cut government funding?