Sunday, December 02, 2007

Riegel Update, Can States Regulate Medical Devices?, Are Devices and Drugs related? and how "stupid" juries are...

[Click on Post Title for Link to External Article]

Typically, struggles in a field ensue because a bubble burst...morbidly, in this case a balloon burst. That is how Medtronic's struggles started with Charles Riegel and his family. Thence followed a series of "interesting" events -

1. Charles Riegel himself did not die from the incident. However, he did manage to sue Medtronic for "alleging design and manufacturing defects and inadequate labeling with the device."

2. He then passed on and his wife continued the lawsuit. At one point in the recent past the case was in the danger of being dismissed based on a technicality - the lawyer acting on behalf of the Riegels displayed the maturity of a 5 year old.
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3. Somehow the case seems to have survived, and will be heard by the Supreme Court this month. Against this backdrop, here are some interesting things that have come to view...

a. The basic argument by medical device makers is that they are already regulated by the FDA, a federal agency, which supersedes any state regulation and thus should not have to answer to a state. Fair enough, after all, we do need to invoke the constitution whenever it benefits us. Only, the FDA regulates how a manufacturer makes and labels a device - it does not punish the manufacturer for causing harms to patients by awarding penalties. This is one of the essentials of the legal system.

The "national standards" argument is very weak - given how several states have time and again demonstrated the ability to exceed politically motivated federal standards that are generally lower.

b. Here is the Soliciter General's Office expressing their "expert" opinion:
"Subjecting a manufacturer to liability for not departing from an FDA-approved design or label would interfere with FDA's ability to protect public health by balancing the risks and benefits of a particular design or label," the brief states.

- Call me naive, but doesn't the statement sound like "Bring it on"? It is almost asking the people to sue the FDA instead. Exactly how does a lawsuit in a state interfere with the public's duty? The suit will follow the approval usually, not precede it. They seem to be claiming an extraordinary amount of defense, almost as if saying they are infallible.

c. Here is the clincher:

"I think you should put this in the hands of an expert federal agency, which sets up one set of standards that applies nationally," said Mark Herrmann, a partner at the law firm Jones Day, who has followed the Riegel case closely. "Having a jury of 12 people, with an average of a high school education and in the presence of an injured person in the courtroom, decide whether or not the medical device company did things that were right or wrong is a bad situation for society," he said.

- If you are thinking, "Geez, are they handing out law degrees at the county fair?", you are not alone. Sometimes, they suggest, if you cannot say something nice, just say nothing. This guy could have done himself the favor.

Let's extend his argument. What do a bunch of lawyers who read books for three years to get a degree know about medical devices? All they do is argue, "He says, she says".

Juries of 12 people have gone on for a few hundred years around the world, making judgement calls on hundreds of thousands of cases. Yes, they do make mistakes, but so do the "experts". And that is what is being argued out in the Riegel case, that is if it gets past the point of State Vs. Federal statutes.

Who would have known insulting the intelligence of juries, high school education and the general practice of law is considered a cogent argument by some? I am thanking my stars I am not a lawyer. To believe this guy would be a peer just makes me shudder...

Believe me I have nothing against Medtronic or other device makers. The Riegel case makes an important judgement call on the volume of legal troubles device makers will see in the future. It is a very serious situation, and what happens to Medtronic will reflect on the entire industry.

So, for their own good, and for the rest of the device makers, lets hope Medtronic has a better argument (they seem to have a good lawyer, who won a case based on thin air) than that of the Solicitor General and the genius lawyer who didn't believe in juries.

On a slightly different note, here is something Howard Brody raises, "Are devices different from drugs?". Read the blog here:

Now, visualize if the Riegel case is part of a rather larger, more troublesome issue of coercion than basic legality and ethics. Because, if device makers are indeed dodging the law in Minnesota and elsewhere based on influence, it is bound to run out one day and bring what would seem like a house of cards down. One would hope, they decide to take the high road... so that the rest of us in the devices industry stay safe and employed!

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1 comment:

laura said...

This is a link to a blog that clearly explains the flawed reasoning that medical device and drug preemption advocates are dealing with. Far from being an all knowing, faultless administration, the FDA is actually fraught with corruption,lack of funds, overwork, and the inability to fully investigate and follow up on products they have approved for market. Should the public be expected to bow to the FDA's decisions and be left with no recourse when, by the FDA's own admission, they are a flawed administration?