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Medical System
Costs of Litigousness
By: David K. Every
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Article
May 05,2003
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 here are many unexpected consequences for everything we do. For every action, there is an opposite reaction. In life, unlike physics, it isn't always an equal and opposite reaction; but there is a reaction.
Today I hear about the costs of healthcare, and issues in healthcare and so on. Rarely the discussion ever goes into some of the truer costs or issues. The more I've looked into it, the deeper the root causes go. One huge eye-opener was from first hand experience at Baxter-Edwards while making a medical instrument.
One of the biggest issues in any biomed organization is liability. It can literally make or break organizations. I don't think the public fully realizes the impacts of this on their healthcare costs, the quality of care they get (towards the negative), and so on. Companies have to do gymnastics to avoid liability and to cover their asses. This was driven home when I first started at Baxter Edwards. I basically was hired into pandemonium.
        
 The division I joined made infusion pumps; intelligent devices that infused drugs into a patient at particular rate, with all sorts of features about delays, mixtures, ramp-up and ramp-down speeds, and so on; basically an intelligent IV line.
Well, if you know software, you can guess what happened. One day, on leap year, whether the stars aligned just wrong, and a drug had a certain rate, and a name was a certain size, they overflowed a buffer, wrapped something to zero; and the pump decided to dump its load. This killed the patient.
Now THAT is a software bug. The company had gone through multiple auditing processes, done months or years of testing, and the machine had been in use for 10 years, all before these certain stars aligned incorrectly, and all hell broke loose. So the company had done everything reasonable to protect human life; but does any of that matter? Not when lawyers and money are involved.
There was a serious risk that the lawsuit would have put the entire organization, out of business. Our ridiculous attitudes towards liability awards are such that a single event can wipe out a decade of profits or an entire organization. A device that helped saved 10's of thousands of lives, could be taken off the market, because of a "good faith" mistake and a .01% failure rate. Think about those implications to society.
When I got there, the company was running around pulling every device off the market, and retrofitting them because of this newly discovered bug. No one will factor in the costs of patients NOT having those devices. Many only see an opportunity to win the dead-relative lotto.
Ironically, Baxter (Edwards) was saved, not because of their efforts in all this; that doesn't matter in the real world of liability. What saved Baxter was that the Hospital had ONCE had this particular infusion pump serviced by a non-Baxter authorized support person (his authorization had expired), so all liability was transferred to the Hospital because of a non-authorized servicing. Hurray! A company was saved for all the wrong reasons.
       
 So a year or so goes by. There I was, at Baxter, working on a new medical instrument as one of their Human Interface Designers and implementers, and just general do everything kind of guy. My new instrument measured many parameters of the heart (SaO2: Arterial Oxygen Saturation, SvO2 : Venous Oxygen Saturation , CCO : Continuous Cardiac Output), and did most of this through a catheter inserted into the heart itself. These parameters are important for diagnosing what is going on; before, during and after surgery. And I noticed a problem.
The catheter was actually pretty smart, it had a small computer module, as well as a removable and disposable part that you inserted into patients; and then threw away when done. The money in the business was in selling these catheters (disposables). However, each time you plugged one of these devices in, you need to calibrate it, and enter many different numbers (say 5 different 10-digit numbers). This was because the light going through the catheter varied in manufacturing, or other issues (variances and tolerance corrections).
Whenever you moved the catheter, you had to manually reenter the calibration values for the device, and if you entered any of it wrong, then it could cause mistakes in information, that could lead to misdiagnosis and harm or death for a patient. Which as I've expressed, is a bad thing.
To aggravate the problem, you aren't just plugging in a patient once, and leaving them. There could be many stages. You set things up in a prep-room (one instrument), then move them to the OR (Operating Room) and do the procedure. Then move them intensive care, and then to a final recovery. Each of these places might have their own instrument, and require moving the catheter. And each of them required re-entering the calibration numbers.
 
I looked at that processes and thought, "there has to be a better way". And with a minor epiphany, I had a solution. I crunched over a weekend, and created a working prototype; and demonstrated it to some higher ups (board members) to show them what we had.
My solution was that they pushed a button "transfer patient", which downloaded all the calibration numbers to the catheter. When you plugged the catheter in, it did some fancy data validation, brought in the calibration numbers, and even recalibrated itself a little (to verify that things were correct). It had a safety timeout, so transfers had to be within a few minutes, and I had checksums so that you couldn't have stale data on the catheter, and so on. I put in many fail-safes that made it much, much, much safer for the patient than the old way.
Management was impressed; I'd taken the initiative on my own and single-handedly reduced the steps and complexity involved, and created a process that would save lives. They would talk it over and get back to me.
I was around for some of the discussions, and saw what happened. It ended something like this; "Thank you for your initiative, this would increase productivity and save lives - but we can never use it". The reason? Well, when the nurses were forced to enter that information, if anything went wrong, then it was the Hospital (nurses) fault. In my system, while it was much, much less likely to ever have a mistake in the process (the saving lives part), and it was much faster and easier to use, the problem was that we'd shifted liability from the Hospital to the Manufacturer. We couldn't say "they just entered the information wrong" and get out of lawsuits. So we couldn't use the far better solution that would save lives and make a better product, because of product liability. The Insurance companies would get mad at them for taking on that liability, and a single bad lawsuit could bankrupt the company. They had an obligation to the stockholders and organization not to take that risk; and recent events had made them very sensitive to such things.
In the end, they stayed with the old process. There are probably very few lives ever lost because of that; but most importantly, there is far less liability on Baxter. You can't blame just Baxter for that decisions; sometimes that's the way things work in the real world. All companies are forced to make decisions that cost us lives because of costs and risks; think of that next time you hear of a big liability award - I know I do. Think of all the companies that have gone out of business, and the lives lost because of drugs they don't make. Think of the delays in bringing life saving drugs or instruments to market because of liability. Think of the fact that the FDA keeps things off the market up to a decade more than necessary for the sake of bureaucracy. Or think about the facts that if a drug isn't going to make billions of dollars, then it is too expensive to develop, so few can afford to do it; and many die waiting for those things that are well within our technological reach, but well about the financial risk/reward balance. And you can't just blame companies for not risking their livelihoods or those of their employees and stockholders. Start comparing those lives lost, to the few saved due to quackery, and you have an idea of just some of the problem.
Many would vilify Baxter, or any company, for doing such self-preservation techniques. But the facts are the facts; they did what was in their best interests. If you want to look at the root cause of the problem it wasn't one bad management decision; it was a litigious environment that makes companies react in such ways. Baxter was being overly sensitive; but they had reasons to. They had just gone through a particularly nasty lawsuit that could have bankrupted the company. They were wisely not going to risk another.
The truth is that I think we need tort reform, and caps on liability far more importantly than we need medical reform. It would have broader implications, and affect our lives in many more positive ways. It is just that most of the savings and costs are currently hidden, and most people would rather vilify the evil large corporations than think of the costs and consequences of their vilification and lawsuits. I've always strongly suspected (after researching it) that eliminating the FDA would save more lives than it costs. There are many complex tradeoffs, but many are only looking at one side of the equations.
I think as a society and culture we need to mature. Punish those that aren't taking life seriously, but not swing to the other extreme and punish those that are. We need to find a balance, and sadly, we have a long way to swing back (from our anti-business vilifications) before we're even close.
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