Here is the article link:
http://online.wsj.com/article/BT-CO-20090415-716238.html?mod=dist_smartbrief
Nothing outside this statement can be farther from the truth about pre-emption:
""Nothing chases away advanced medical device innovation like uncertainty" about whether a company is going to get sued for its product, said Stephen J. Ubl, AdvaMed's president."
What is innovation?
For one, it has nothing to do with the fear of being sued. That would be "AdvaMed-artifically-generated-phobia".
Here is what the paragon of truthisms, Wikipedia has to say on innovation:
"The term innovation means a new way of doing something. It may refer to incremental, radical, and revolutionary changes in thinking, products ..."
Reference: en.wikipedia.org/wiki/Innovation
Innovation would be saying, "Let's not start another drug eluting stent company, only to lay off 111 out of 121 folks after a few years. Let's either prove that drug eluting stents work or let's find a new way to cure disease."
Innovation could also be innovation in cost restructuring, outside of keeping the devilishly under-performing CEO, handing him out bonuses and laying off 20% of your workforce (amounts to 4,300 employees. Very hard to find out which "innovative" company I am talking about).
Innovation could be steps taken in shorter time to establish Design Validation, better designs, better manufacturing, Design for Manufacturability and so on.
What else could innovation be?
Surprisingly, it could be some of this:
1. When patients die because of your device, report them, promptly! No "the dog ate my adverse reaction reports".
2. When patients' hips start squeaking and their ICD batteries die out, start investigating.
3. When your product is the result of some bad "fitting round pegs into square holes", apologize - no medical device company has done that before. It would count as one heck of an innovation!
4. Do post-market follow up, not because the FDA weakly grunts about it, but because it is something you ought to do!
5. Stop subscribing to AdvaMed and it's opinion pieces.
Are innovation and torts related?
Absolutely not. Here is how a typical medical device gets to market:
1. Doctor and couple of engineers get together in a garage. They sit on the device for a while, think of and do all kinds of crazy things. They then double mortgage their house and go present in West this conference and East that conference.
2. After several failures and crazy ideas, some random thing works. Then a couple of years down the line they get funding and muck about sleeplessly for a few more.
3. They start selling the first generation, possibly first-in-class device. They are about to hit the IPO.
4. Really fat company rolls (lumbers and sometimes huffs and puffs) in and purchases them. Wants to impose it's "culture". Brings strange looking aliens (managers, change agents, transfer managers and such are their taxonomic guises) who want to change everything from the coffee machine to the CAD program.
5. All the "good" folks leave or are kicked out. The people who are left are still well meaning people staring at designs they don't understand. New people replace yet another layer of skimmed off people. Eventually, no one knows what's going on where.
6. The second in class device based on "marketing driven product development" and other wonders of nature gets to market.
7. Hips squeak, leads break, stents fail, meters dole out improper readings and patients, of course, die or become otherwise greviously injured!
In this whole mess innovation can only possibly happen from step 1 to 3. Torts happen after step 7. The FDA is a thematic black comedy that spans all these steps, but really doesn't affect anything, at least positively.
So, are torts and innovation related? No!
But don't we still need pre-emption?
Nope.
First of all, the Supreme Court Judges are acting like a bunch of txting teenagers. On the one hand they say that devices are subjected to pre-emption but on the other hand they say that the same iconic government agency (I mean the F, D and A) is ill-equipped to regulate drugs pre-emptively.
What gives?
Secondly, "the fear of lawsuits is the mother of many things". If these companies walked off on a permanent basis from responsibility (helped by the likes of the Federal Judge "Kyle" from Minnesota), then consumers, in this case patients, dead, dying or a loved one, have absolutely no respite.
A parting word for AdvaMed
So, let's not abuse the word innovation please. Let's start with listing your "donors" and "Corporate Members" somewhere easily accessible on the home page. That would make it so much easy for us to separate reality from Kool Aid and find out who really is going to be chased away from innovation and if that indeed is an ironic oxymoron...
Showing posts with label Charles Riegel. Show all posts
Showing posts with label Charles Riegel. Show all posts
Thursday, April 16, 2009
Friday, May 16, 2008
Irressistable to post: Hollywood Meets Riegel, Drugmakers and FDA: uninformed and uncompensated lab rats
[Click on Post Title for Link to External Article]
I don't care what you think of me, I don't know who Dennis Quaid is. But, I like his Hollywood style. Though brazen and "filmy", I completely agree. There is a problem with pre-emption. The FDA becomes judge and jury. In any democratic legal system that is a debacle.
We all know the effects of that. One has to only look at how the USPTO "regulates" or until recently tried to "regulate" itself and all of its customers, leaving a very bad taste in the mouths of several lifescience companies.
However, some of them are now trying to hide behind an anologous federal agency pre-emption situation.
Why wouldn't pre-emption benefit all of the industry? Very simple. Let's say your competitor is really selling a terrible product. And, unlike the present times when the FDA is displaying unparalleled levels of leadership, if said leadership were to degrade in quality at a future point in time!, neither you nor said company's unhappy customers have a reprieve.
All that needs to happen is, the FDA can take a look at boiling hearts and squeaking hips and say, "Bah, that was expected. It was not the manufacturer's fault. That is our decision. Of course, the investigation is closed and we won't tell you what happened". While this disastrous drooping of levels in the FDA is next to impossible, this is not just an unhappy customer's headache.
On the other end of the stick, is a problem where this happy state of squeaky hips, burned catheters and other quirks pile up for a while and then an appalled Congress picks up from there and over-regulates the industry. Getting a 510 (k) approval is tough enough, who wants new headaches?
Doubt it will happen? Tell that to the folks trying to end Sarbanes-Oxley.
From these two perspectives it becomes very important that Riegel should not have gone down the way it did. And it did. So now we are in trouble!
It is binding on any society that expects quality in service to create and maintain a system of checks and balances. Otherwise trust, efficiency, creativity and all other elegances will disappear into nothingness...
In face of this, it is important that Congress listen AND understand AND exercise an appropriate system of checks and balances.
Lets see if we succeed or wait till other Hollywood, YouTube, FaceBook and "Can you act stupider and sillier than a 2nd grade child" stars also show up screaming at Capitol Hill....
I don't care what you think of me, I don't know who Dennis Quaid is. But, I like his Hollywood style. Though brazen and "filmy", I completely agree. There is a problem with pre-emption. The FDA becomes judge and jury. In any democratic legal system that is a debacle.
We all know the effects of that. One has to only look at how the USPTO "regulates" or until recently tried to "regulate" itself and all of its customers, leaving a very bad taste in the mouths of several lifescience companies.
However, some of them are now trying to hide behind an anologous federal agency pre-emption situation.
Why wouldn't pre-emption benefit all of the industry? Very simple. Let's say your competitor is really selling a terrible product. And, unlike the present times when the FDA is displaying unparalleled levels of leadership, if said leadership were to degrade in quality at a future point in time!, neither you nor said company's unhappy customers have a reprieve.
All that needs to happen is, the FDA can take a look at boiling hearts and squeaking hips and say, "Bah, that was expected. It was not the manufacturer's fault. That is our decision. Of course, the investigation is closed and we won't tell you what happened". While this disastrous drooping of levels in the FDA is next to impossible, this is not just an unhappy customer's headache.
On the other end of the stick, is a problem where this happy state of squeaky hips, burned catheters and other quirks pile up for a while and then an appalled Congress picks up from there and over-regulates the industry. Getting a 510 (k) approval is tough enough, who wants new headaches?
Doubt it will happen? Tell that to the folks trying to end Sarbanes-Oxley.
From these two perspectives it becomes very important that Riegel should not have gone down the way it did. And it did. So now we are in trouble!
It is binding on any society that expects quality in service to create and maintain a system of checks and balances. Otherwise trust, efficiency, creativity and all other elegances will disappear into nothingness...
In face of this, it is important that Congress listen AND understand AND exercise an appropriate system of checks and balances.
Lets see if we succeed or wait till other Hollywood, YouTube, FaceBook and "Can you act stupider and sillier than a 2nd grade child" stars also show up screaming at Capitol Hill....
Tuesday, December 18, 2007
Addendum to Provenge Label: Warning! Might expose FDA inefficiences..
[Click on Post Title for Link to External Article]
Okay, so the first two Congressmen started expressing their "Provenge" displeasure and I thought, oh well, what is two Congressmen. After all, under President Bush, most federal agencies have weathered an entire Congress!
And then one more added himself to the list and Three's Company of course, so I thought, might as well roll out my cynical red carpet...
The gist of the story is that the panel that reviewed Provenge had atleast one guy working for a competing company, Novacea. How did he get to sit on the panel anyway? Apart from violating fundamental ethics, was he also able to access sensitive data on Provenge? Is the FDA performing the dual function of being unethical and destroying competitiveness?
So, in the future everytime the FDA rejects a drug, are we to spend immense time and energy investigating and/or lamenting over whether or not the rejection was appropriate?
Heck, it atleast gets a few Congressmen to do something..anything!
However, now let's take a step back into this month's favorite cliche: Riegel (with all respect to the deceased).
So, the FDA, the attorney general and anyone who considers themselves an expert (including the lawyer who doesn't believe in juries) went in front of the Supreme Court or blogorama as they saw fit, to argue in favor of federal pre-emption.
But we go back to the age old question that Will Smith asked in that spy movie, "Who watches those who watch us?"
And if we claim that the FDA knows better than the jury because it employs a "panel of experts" who are somehow better than 12 high school educated folks, how would you explain all the hullaboo surrounding Provenge?
Even 12 year olds know thats not the right thing to do!
IMO, by taking up the Riegel case, the Supreme Court has snatched itself a nice little commonsense vacuum. With low funding, low morale and definitely lower ethics, the FDA is now an aging dinosaur - just refer back to my post on the "new" DES rules..
All our friendly, neighborhood Supreme Court Justices run the risk of stepping on some 'caca' for suggesting that the FDA is above "torts" and has its own "experts" who will keep us all safe....a very dubious and unbelievable statement indeed.
Meanwhile, do you have any hope for some good to come out of the potential Provenge investigation? Do Congressional investigations actually result in any good?
I have a suggestion: Try to make the panel immaculate (not religiously, and this is the season when Discovery Channel tries to show through reruns that nothing can happen immaculately! - sorry for the spoiler!!!). That is, there should not be folks with conflicts in the panel. If you had a prostate cancer panel of 14 guys, none of them should be working on ANY prostate cancer drugs, maybe even cancer drugs.
Am I suggesting that 14 such folks can be found among a population of 300 million (and counting)?
Yes!
Whenever that's not possible: Pick rotating panels of experts from the FDA. Let them keep serving their commercial masters. But come time for applications (which the FDA can set starting from 3 - 6 months prior to the actual review date), the FDA should set a period where it decrees that the panelists should stop any conflicting work which might include accruing current benefits (like salary, bonuses etc). They can pick up conflicting businesses once the decision is made. Given the potential "upping" to the resume that serving on FDA panels brings, I doubt if many will protest this with vigor.
Then again, don't blame it entirely on the panel. This is where the irony of the FDA's argument in Riegel sets in. The Provenge panel did recommend an approval. The panel is support to be the expert..and a 13-4 vote is not contentious. So, who then got to decide to screw Provenge over?
What would be the point of arguing that panels know better than juries and then not listening to panels? We might as well do a TV program where out-of-work parttime bartenders could review drug applications...
So, is an investigation necessary? Yes.
Is there a better way for the FDA to function? Yes
Transparency somehow appears to be a potential keyword in this business...so does commonsense!
But hey, why listen to me..after all the FDA has its own experts!!!
Add to Onlywire
Okay, so the first two Congressmen started expressing their "Provenge" displeasure and I thought, oh well, what is two Congressmen. After all, under President Bush, most federal agencies have weathered an entire Congress!
And then one more added himself to the list and Three's Company of course, so I thought, might as well roll out my cynical red carpet...
The gist of the story is that the panel that reviewed Provenge had atleast one guy working for a competing company, Novacea. How did he get to sit on the panel anyway? Apart from violating fundamental ethics, was he also able to access sensitive data on Provenge? Is the FDA performing the dual function of being unethical and destroying competitiveness?
So, in the future everytime the FDA rejects a drug, are we to spend immense time and energy investigating and/or lamenting over whether or not the rejection was appropriate?
Heck, it atleast gets a few Congressmen to do something..anything!
However, now let's take a step back into this month's favorite cliche: Riegel (with all respect to the deceased).
So, the FDA, the attorney general and anyone who considers themselves an expert (including the lawyer who doesn't believe in juries) went in front of the Supreme Court or blogorama as they saw fit, to argue in favor of federal pre-emption.
But we go back to the age old question that Will Smith asked in that spy movie, "Who watches those who watch us?"
And if we claim that the FDA knows better than the jury because it employs a "panel of experts" who are somehow better than 12 high school educated folks, how would you explain all the hullaboo surrounding Provenge?
Even 12 year olds know thats not the right thing to do!
IMO, by taking up the Riegel case, the Supreme Court has snatched itself a nice little commonsense vacuum. With low funding, low morale and definitely lower ethics, the FDA is now an aging dinosaur - just refer back to my post on the "new" DES rules..
All our friendly, neighborhood Supreme Court Justices run the risk of stepping on some 'caca' for suggesting that the FDA is above "torts" and has its own "experts" who will keep us all safe....a very dubious and unbelievable statement indeed.
Meanwhile, do you have any hope for some good to come out of the potential Provenge investigation? Do Congressional investigations actually result in any good?
I have a suggestion: Try to make the panel immaculate (not religiously, and this is the season when Discovery Channel tries to show through reruns that nothing can happen immaculately! - sorry for the spoiler!!!). That is, there should not be folks with conflicts in the panel. If you had a prostate cancer panel of 14 guys, none of them should be working on ANY prostate cancer drugs, maybe even cancer drugs.
Am I suggesting that 14 such folks can be found among a population of 300 million (and counting)?
Yes!
Whenever that's not possible: Pick rotating panels of experts from the FDA. Let them keep serving their commercial masters. But come time for applications (which the FDA can set starting from 3 - 6 months prior to the actual review date), the FDA should set a period where it decrees that the panelists should stop any conflicting work which might include accruing current benefits (like salary, bonuses etc). They can pick up conflicting businesses once the decision is made. Given the potential "upping" to the resume that serving on FDA panels brings, I doubt if many will protest this with vigor.
Then again, don't blame it entirely on the panel. This is where the irony of the FDA's argument in Riegel sets in. The Provenge panel did recommend an approval. The panel is support to be the expert..and a 13-4 vote is not contentious. So, who then got to decide to screw Provenge over?
What would be the point of arguing that panels know better than juries and then not listening to panels? We might as well do a TV program where out-of-work parttime bartenders could review drug applications...
So, is an investigation necessary? Yes.
Is there a better way for the FDA to function? Yes
Transparency somehow appears to be a potential keyword in this business...so does commonsense!
But hey, why listen to me..after all the FDA has its own experts!!!
Add to Onlywire
Wednesday, December 05, 2007
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".
Add to Onlywire
[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".
Add to Onlywire
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.
[ 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!
Add to Onlywire
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!
Add to Onlywire
Saturday, September 29, 2007
New and Ironic twist in Riegel case....
[Click on Post Title for Link to External Article]
So, I was out all day and come back to read a long list of interesting medical device articles. And, hidden deep inside, I find this.
Read the blog and some very unsympathetic comments at the end of the article.
As some commentor on that blog pointed out, no one seems to care about the actual issue at hand, and everyone wants to pounce on the plaintiff's lawyer. Well, she does need pouncing on, but why are people stopping there?
It would be interesting to see if this case goes anywhere. Oh well, that's that, till some other case with lawyers atleast more competent than 4 year olds makes its way upto the Supreme Court again...
Add to Onlywire
So, I was out all day and come back to read a long list of interesting medical device articles. And, hidden deep inside, I find this.
Read the blog and some very unsympathetic comments at the end of the article.
As some commentor on that blog pointed out, no one seems to care about the actual issue at hand, and everyone wants to pounce on the plaintiff's lawyer. Well, she does need pouncing on, but why are people stopping there?
It would be interesting to see if this case goes anywhere. Oh well, that's that, till some other case with lawyers atleast more competent than 4 year olds makes its way upto the Supreme Court again...
Add to Onlywire
Friday, September 28, 2007
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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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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