Innovations in medical devices have been happening at hitherto unknown magnitudes of time and quality. The time for medical devices to join the banking sector in defrauding the American Public seems to have finally arrived! How, you say?
1. The FDA:
The Bush administration, in well measured tactical moves has rendered the FDA a nearly useless joke (except of course it's the dead Chimpanzee cartoon kinda joke - the kind that no sane person would laugh at). Want to know more?
Now, regulations both necessary and otherwise don't exist. You know what happens when there is less regulation?
More "innovation" in medical devices!
2. The Supreme Court:
Give a bunch of extremely old people with outdated ideas and
Last year, this was very helpful in creating something so entertaining that Tyler Perry, Stephen Colbert and their like have to kiss it's ass - this was called "Pre-emption".
With this tad bit of innovation, now you the patient cannot sue a company for a medical device that the FDA has already "approved". Yes, you are right, the very same FDA that is totally weak, engages in all kinds of unethical duty dodging...
Yes, you cannot sue if in fact the device malfunctioned, did not do what the labeling suggested it was going to do, or if in fact, the device killed you or a "loved one".
Who else laughed so hard that their stomachs hurt?
Careful there, your stomach ache medication may have side effects including death, permanent disability, loss of self esteem, feelings of suicide...
3. The Slapstick Entertainment Commission, er., SEC:
If you thought the FDA was a joke, wait till the SEC comes to investigate. You know, how in Hollywood movies the cops and the army always show up after the trouble is over (unless they caused it of course!), and the hero has tackled all the thieves, alien monsters and so on....who told you that was fiction?
4. More Tools to help innovation? - Democrat Nominees for HHS, FDA or any government position you can name
Let's see. There is this certain subspecies among humans. They love taxing you. Any excuse is enough. Are you rich? Are you wealthy? Are you a business? Are you none of the above?
Doesn't matter. They will tax you!
Except...they won't pay.
Come on, whoever followed what they preached?
Won't believe me? Go look up "Daschle", "Geithner", "The husband of a labor secretary nominee" on the Googles and see for yourself!
With friends like these in Government, who needs the GOP and their fear of comparative studies? (Yes, they don't like the idea!)
Meanwhile, if you are a medical device company looking to "innovate" alongside the aegis of "Art-No-Care" and others, here are a few tips:
1. Don't worry about the FDA. As long as you fill paper work, you will get a 510(k) - heck you might even get a PMA approval.
2. Tell your sales folks to ignore "approved uses". Tell them to sell the medical device for any use that pleases them. If convicted, only the sales guys go to prison. You can even take your company name out of the mention in court papers!
3. Hire lawyers whose dads work in the federal judiciary system. This way, you can use the son to get the dad to dismiss any cases, pre-emption or otherwise. The dad can always deny even knowing his son had a job!!
(See my previous blog post, if you can't believe your eyes and ears about 2 and 3).
4. When in doubt, be assured that pre-emption will protect you! Do you fear that the Obama administration will ever do something about it? Fear not!
How come you say? Well, for one, they are not very different from the Bush Administration - they just sided with them (and against your right to know) on White House emails. How different do you think they are going to be? Change is only for Washington - not much else.
For another, Obama will never appoint a HHS secretary. Or he may, and it would be too late anyway. Heck he hasn't responded to FDA scientists who lamented about the FDA and later pleaded that they were being persecuted.
5. Ignore audits, the SEC and other regulations. If anything, it will be years before the SEC investigates. By the time the agency would be busy with one of two possibilities - either the administration (and the party that administers said administration) would have changed, or the SEC itself would be re-branding, because the last name did not work out! And you would be far away.
Who cares if you have to re-state revenue figures for a whole decade in the past? As long as you can cook up the numbers for the next 90 days, it's good enough! Be practical.
Meanwhile - Yay! Innovation. Enjoy! There are absolutely no barriers or regulations or rules of law that will stand in your way.
Art-No-Care just proved it.....