From do scandals disturb you to which scandal disturbs you? - The Pharma Industry comes of age.....

[No external article links on title this time...all links are below.]

Should you choose to accept the mission, your choices are:

1. Avandia - GSK, A Physician and the Senate

2. Lipitor - The Senate, Pfizer and a Doctor who doesn't actually practice

3. Vytorin - Two large Pharmas, The Senate, and ... well some more baggage,

or, here is the bonus

4. The FDA, and the number of centuries it will actually take them to complete inspections, should they choose to follow their own rules for once!!!!

Here are some links to guide you through the sorrow:

Avandia

Vytorin

Lipitor and Jarvik (this one's from yours truly!)

And the FDA

Whatever the heck happened to this industry? Why is there no permanent learning and adoption from old debacles?

It is proudly announced that the very presence of the FDA in the '60s saved many children from cancer and death through suspicious drugs that were sold like aspirin in Europe.

However, the very FDA now seems to be this megalolith that can barely move due its own weight. Among other things, people are now questioning the FDA's role in each of the individual debacles surrounding the pharmaceutical industry. Plus, the FDA's very functioning is now in question....

In the midst of all this the White House and the Solicitor-General actually dared defend FDA's status via federal preemption to be the most effective "overseer" of all things food, drug or device related.

How they can achieve this, suddenly or gradually, I cannot sense! And so cannot most people. Plus, the Congress seems to be the weakest link in the chain...

Without worrying about the completely useless patent "reforms", they should seize the opportunity to find out, among other things,

1. Why, despite Congress and the press raising enough doubts about the Lipitor ads, does Pfizer seem to play them fearlessly anyway..?

2. Do the investigations made by various Senators, Committees and other Capitol Hill-related odds and ends, actually have any meaning, purpose and consequence, given how company after company seems to be steeped in scandal...?

And, we the people, have to sit and wonder, given FDA's stringent regulations in the US, if we see so many failures, what of the "emerging" markets and all the development work that goes on there?

As if this was not enough, here is what UCSF is suggesting for medical devices. "Regulate them seeking more information like you would do for pharmas". Given the FDA's success with pharma, the irony almost makes the article humorous:

UCSF Article

Ironies aside, the article and what UCSF suggests, is accurate by the letter...!!! But is the FDA the right organization to do it?

So what you say? Everybody recognizes problems - what is your contribution? Here is my simple solution:

Make the different divisions in the FDA more entrepreneurial, punish them for their "slips" and provide them with more money and power...oh, before that, throw the existing structure and the dinosaurs in the FDA's office files out....



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Update: Its Riegel, Riegel and more Riegel at the Supreme Court, on blogs and everywhere else...

[Click on Post Title for Link to External Article]

[According to the WSJ, The Drug And Device Law Blog is the best. I will let you make your own conclusions :), but it is a true blog, in that they posted a written report by a third party and their comments on the proceedings]

So Riegel is everywhere. Everybody who thinks they are some kind of a journalist, a legal expert or a medical devices expert is writing about it, no matter how little they are adding in terms of new information or value. How, but how could I leave myself out of this? I want to feel important to..by way of some n'th association...

Anyway, coming back to reality, it appears that Medtronic, not surprisingly, is set to win this one. Federal pre-emption is set to win anyway. I am guessing this will be my pre-final update on the Riegel case..

All said, I would hope this doesn't open a bleeding wound whereby, jury trials become harder and harder to obtain against drug and device makers, societally speaking.

More or less folklore, it is not uncommon that State Regulations tend to be stricter than Federal Regulations, atleast in some of the "activist" states. This has led to better regulations at the Federal level and the Federal Justice System should not become "a path of least resistance" for the real wrongdoers [Medtronic, not being one of them] to "get away with it".



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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.
[ http://chaaraka.blogspot.com/2007/09/new-and-ironic-twist-in-riegel-case.html ]

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:

http://brodyhooked.blogspot.com/2007/12/are-devices-different-from-drugs.html

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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Are Medtronic and Pfizer bringing home new trouble for medical device and biotech companies?

[Click on Post Title for Link to External Article]

Follow the link for the law blog that details in a simple way what the supreme court has agreed to review for Medtronic and Pfizer. There are two separate lawsuits that aim to hold Medtronic and Pfizer responsible for damages arising out of their products. Both lawsuits were filed at the state level and both companies probably have legal teams that think Civics 101 is enough to get rid of the lawsuits.

Well, maybe, maybe not.

If it is, good for both companies. And maybe for other medical device companies, some, which may also use it tactfully to abdicate responsibility.

What if it is not?

What if the federal pre-emption is narrowed down by the Supreme Court?

What if the Supreme Court says that the FDA is not equipped to deal with such lawsuits?

That would be fun now, wouldn't it?

The premise here is that it is tough enough to innovate and make something work, and work ever so safely in the human body. Medical Device companies and Biotech companies have it hard enough with this challenge (yes, its a beaten, dead horse, but it still needs to be beaten over and over to get it into some people's heads).

I am not at all suggesting that victims should not sue companies anymore. They will continue to do so and sooner or later they will prevail. It would behoove companies like Medtronic and Pfizer to settle such cases instead of trying to pull a "Law and Order: Corporate Intent" on the rest of us.

I have nothing against either firm, but I think they might be risking passing on their bad luck to smaller medical device firms who may soon need to be looking for deeper pockets to keep paying their legal fees.

Would federal regulations work? I don't think so. It only seems to be a way to avoid lawsuits at the state level without actually framing a legal network that avails victims of what they deserve. Plus the FDA is barely functional, trying to live up to its current mandates. 100 years of existance have still not prepared the organization to run smoothly.

And, oh well, even if the Supreme Court favors Medtronic and Pfizer it doesn't look pretty for the victims. And, that again, is why, huge corporate firms "that put their customers first" should really try to do that...




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