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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


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.”

I believe many electrical devices are UL approved in the same manner devices are approved by the FDA. Yet, Medtronic believes it should not be sued because of a faulty medical device approved by the politically controlled FDA as the Supreme Court ruled in Reigel v. Medtronic. Are their two standards here? I suppose, as Senator Hatch said of trial lawyers, some creative corporate lawyer will find some sort of neat logic to defend these two opposing legal arguments. If we allow this to happen would we not be imposing “fifty” different requirements on Petco. How do these frivolous lawsuits ever make it to court? Is “stuff” more important then a human being.

“’The defendant negligently failed to provide Plaintiffs with reasonable warnings of defects and hazards which it knew or should have known were present in the aquarium heater described herein, which negligence was a direct and proximate cause of the fire and damages,, the suit claims.

Medtronic contends that because the heater was defective, Petco should be liable for the damage that resulted from the fire.”

The following is from Sidley Austin LLP presented to the Advanced Medical Technology Association.

Setting the Stage – A Supreme Court Friendly to Business?

  • Supreme Court has increased the business cases on its docket, especially in the areas of patent, antitrust, preemption, and securities law.
  • Nearly all of the Court’s rulings on business cases have been in favor of he business.
  • February 20, 2008: “quite a hat trick” three pro-business decisions (including Riegel) in one day, comments Robin Conrad of the U.S. Chamber of Commerce. Tony Mauro, The Majority Flexes Its Muscles, Legal Times, Feb. 25, 2008.
  • Ms. Conrad earlier remarked that the 2006-07 term was the strongest showing for the business community in the past 30.
  • Justice Alito, most notably, “has taken bullets for business in the term just ended.” Tony Mauro, Roberts Court Takes a Pro-Business Stance, N.Y.
    Law Journal, July 5, 2007.
  • “The business docket is a very rich part of the docket and one in which the
    Roberts court to date has proven very sympathetic to the concerns of
    corporate defendants.” U.S. Solicitor General Paul D. Clement.

“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?

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