Saturday, October 31, 2009

The Stryker Brouhaha: How the FDA demonstrates that it was never loved as a child...

If you have not heard about Stryker's (latest) legal problems, the FDA is charging Stryker and a random collection of expendable Stryker executives with off-the-label marketing.

I will link one of the many reporting stories available on the issue at the bottom, and you can read for yourself as to how, apparently, Stryker executives knowingly promoted a cement approved with stringent restrictions on marketing for humanitarian use, for off-label use. They even provided Doctors with highly suggestive recipes and concoctions on how to use the cements.

As with most of Orthopedic products that have been riddled with poor design, kickback scheme accusations and marketing attitudes, a lot of patients suffered.

So, the FDA finally jumped in!

The charges and the possible punishment

And it has accused a total of 8 Stryker folks, half of whom are classed as "former" and include, among others a former president and a sales executive.

At the outset, this all seems like "action". The charges include "wire fraud, conspiracy, misbranding, and making false statements."

Take a closer look. What does it entail as an eventual form of punishment?

Nothing, er, next to nothing in the following order: Something, Nothing, Next to Nothing.

If convicted, Stryker will face the following extremely debilitating actions taken against it:

1. As quoted: "fines for Stryker of at least $500,000 for each count"

2. "Exclusion from federal and state healthcare programs".

Okay, you read it, now say it loud with me, "Are you joking"?

Is the FDA Joking?

With you, one who is not charged by the FDA, yes.

How far does $500,000 go in 2009?

For large companies, $500,000 is chuck change. Heck, it is lesser than any of the following:

1. The amount such companies pay for their lawyers (which didn't work for Pepsi whose lazy lawyers missed a court date and are now scrambling to get a $1.2bn charge dismissed) to simply go out and harass, among others, federal agencies, smaller companies, individuals (Charles Riegel anyone?) and such.

2. The amount medical device and pharma companies pay in a quarter to lobby Congress to forget patients and pass laws that will make sure the right amounts of donations are made to individual campaign funds.

3. The amount these companies spend in a year using weak patents and other methods to harass smaller companies.

4. The amount these companies pay their executives in a month!

5. The amount that will be spent in lawyers fees defending the current charges by the FDA!!

6. The amount device companies are paying to lobby against healthcare reform of any kind!!!

And, of course I can go on and on...

This clearly demonstrates something. The FDA is obviously out of touch with reality, somewhat like a bad parent in need of love from their children at all costs.

What should be the punishment?

You may even wonder if punishment is necessary. See a lot of these brazen executives move from company to company and take their despicable attitudes with them. They do not change, because there is nothing that makes it necessary. They then proudly promulgate and breed more such "executives".

Punishment needs to be debilitating.

Punishment should invoke shame.

Large organizations thrive on corporate image across several industries. Not so in medical devices. Take Orthrocare or Stryker for example - such companies have been involved in all kinds of lawsuits. They pay cursory fines and get away with anything. Many such companies then turn around and lobby against healthcare reform!

Punishment should invoke the need for attitude change.

The punishment needs to be proportional to the crime. It is one thing for Hollywood to make disturbingly emotional movies where one soldier, one victim is important and a whole town, a whole army rallies around them.

It is another, for companies to be let go for a small fine when they kill and otherwise disable patients with obvious disregard for law and ethics.

Growing up to the times

The meter-maids, not FDA, are supposed to hand out parking tickets. Companies need to be punished proportional to their crime. Crime, among medical device companies is systemic:

1. The entire Orthopedic industry (well, the 4 companies controlling 95% of the industry) was implicated in wonderfully disgusting "kick-back schemes". Nothing came of it, except minor fines.

2. Companies like Stryker have been abhorrent at clinical research (read my squeaky hips post linked below) or at respecting patents, and systematically get involved in lawsuits. As a result of the fact that every federal agency, including the judiciary system is filled with ineptitude to mete out the right amount of judicial punishment, they keep on, keeping on.

Sending the wrong message

With the current listness and a lack of any form of seriousness, the FDA is sending the following message: As long as you hang back and reserve a few million dollars in lawyer fees and a few hundred thousand dollars in fines for the FDA, you can get away with anything you want - cooking data, promoting off-label use, anything.

At this rate, you should soon see the bigger device companies to sell 5-hour energy pills, phallic extension pills and fake weight-loss drugs.

Heck, why not? Right?

Hope and Change

If Obama and Margaret Hamburg really want change, they need to start setting examples. As I stated above, the industry does have it's fair share of fearless, lying crooks. By cowering to the fact that these companies are large and fearless, the Government is doing no better than the previous administration, and is really not bringing about any form of measurable change.

When companies such as Stryker are brought to court based on real evidence of crime, they should be made to pay. There should be no room for such companies to express "disappointed with this action and still hopes to be able to reach a fair and just resolution of this matter".

They should instead be "ashamed", rue the day they decided that bending the law was "cool", and should be forced to gouge themselves of their present attitudes.

If this is not what the Obama administration wants to do, then there will be no change, and soon the hope will whither away.

Grandma will have no insurance because that was lobbied against.

Grandma will get a squeaky hip that won't work and embarass her to no end.

Grandma will also get dysfunctional cements, stents and ICDs in her body.

And, instead of looking forward to their one hour of daily exercise, such "executives" will keep popping champaigne bottles everywhere...


1. On the charges against Stryker: Click here

2. On Stryker's squeaky hips:

3. On Acumed Vs Stryker:

4. On Stryker's previous kickback settlements:

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