You are currently browsing the monthly archive for July 2010.

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

An interesting discussion on “loser pays”. For all the talk of reducing lawsuits I have to ask two questions that I have not found an answer to?

  1. What is the definition of a frivolous lawsuit? Is this in the eye of the beholder?
  2. What percentage of all lawsuits are frivolous? If this is a small amount than why would we want to make it harder for the middle class to protect themselves?

http://newtalk.org/2008/08/would-loser-pays-eliminate-fri.php

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

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.”

http://www.tradingmarkets.com/.site/news/Stock%20News/2188586/

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