Hermann and Beck's clever Drug and Device Law Blog recently praised, as a panacea of defense positions, the benefits of federal preemption in defective products cases. The blog was clearly written to influence the upcoming Supreme Court opinion in Riegel v. Medtronic.
First off, give credit where credit is due: Medtronic defense attorneys have created the state of the art medical device defense practice relying on federal preemption to stick it to injured people across the United States.
So, you ask, “What is my beef?” Here is my beef. While these guys are self laudatory about the "cool-ness" of federal preemption, they fail to take into account the real life affect of defective products. At a legal/theoretical level, the theory of federal preemption sounds like a good thing. In the real world, however, defective products hurt people. Defective products kill people. Defective products create life changing problems for people. Not theoretical people. Not names on an appellate brief. Real people. Live human beings. Flesh and blood. Commonly referred to as families, children, parents.
When a defective product harms one of those real people the company that made the defective product must be held accountable. To rely on an over worked, under paid, bureaucratic government worker to determine if there is a latent product defect is simply unrealistic. Further to permit the company to be exempt from liability because that government inspector places a "stamp of approval" on the product is ridiculous. It is ridiculous regardless of whether that government stamp was a PMA or a 510(k) review. The company should never be able to rely on government approval to escape from their responsibilities especially when the company product’s harm human beings.
Sure, these guys blather on and on about how tough it is to gain FDA approval. They believe a strong FDA can make our world safe. This is simply not true. The government is not as efficient or as strong as a free market tempered by the right of individuals to sue for their damages when a product defect harms them or a loved one. The checks and balances of our present capitalistic system work. If they didn’t work Medtronic, Bristol Myers Squibb, Purdue Pharma, GlaxoSmithKline, Stryker, Ferno and all the rest of the big medical players would be bankrupt from paying spurious lawsuits.
Are they bust? I don’t think so. In fact, the opposite is true. These companies pay huge fines and penalties to the government, pay off huge litigation bills and lawsuits and still pay their upper management millions of dollars per year for keeping them in the multi-millions of annual profitability. Why in the world do they need federal preemption?
Granted, meritless product liability cases are filed every year. Those cases are disposed of with pre-trial motions from a capable defense bar, like Hermann’s or Beck’s firms. They also know that there are far more valid cases filed than the few meritless matters that make their way into their offices to defend. Federal preemption is like throwing the baby, the family and the bathroom all out with the bathwater. It simply goes too far.
There is also the “mindless American lack of juror intelligence” argument within the Drug and Device Law Blog. The fact that the American public is ill equipped to handle the hard technical issues within a medical device case is another theme in the argument for federal preemption. That is a pretty typical white shoe/big firm analysis. It goes like this “We are all trained at the best schools and we have a hard time understanding this stuff, your lowly jurors certainly can’t fairly judge this case, you don’t have the training or expertise.” The American juror is by and large pretty bright. Certainly the group dynamic allows jurors to rise to the occasion and make a fair determination of whether the product was or was not defective. Juror’s also have the assistance of numerous experts presented by both sides at a products liability case. Therefore, the stupid juror argument simply doesn’t fly. Americans deserve better from their legal system.
Corporate America does not fear government. The government has a lot on its plate. Is it possible that all the Iraq war money and effort is having an effect on the amount of money, time and manpower the government puts into examining medical products, food and dairy and every other thing the government reviews? Without a doubt. The public has heard nothing but cut backs from this administration over the past 7 years for everything not military. The American people can not rely on big government to save them from greedy corporate citizens, especially if those corporate citizens only need federal approval to sell crappy products.
So, what saves us from an onslaught of defective products?
Sounds crazy but it is true.
Here is the really crazy part: Republicans stand for small government. Traditionally Republicans want the citizenry to take care of their own problems so government can stay as small as possible. Small government means less regulation, less oversight and less taxes (Yeah! We all like less taxes!).
Democrats, on the other hand, believe government can be trusted to take care of the people. Government can regulate business, oversee business and make business safer for America. This creates bigger government, more regulations and higher taxes. So, why is it, when we are talking about lawsuits the Republicans and Democrats switch hats? Republicans believe in creating government oversight allegedly to protect the people. Democrats want to keep product liability in the realm of private attorneys bringing private actions all without government oversight or involvement (read less regulations, less taxes),
The Drug and Device Blog artfully notes that companies are presently using the 510(k) approval more then the PMA system even though the 510(k) absolutely does not have a preemption exemption. That analysis is flawed because it assumes there is an actual 100% preemption under a PMA system. This may or may not be in the future, but prospectively, you simply can't judge the corporate behaviors pretending that preemption existed in the past. I would bet that if PMA did grant 100% right to preemption more companies would use it more often.
These guys claim that they are doing this because they truly believe that preemption is a great system for everything except product manufacturing defects. Well isn’t that nice. I would bet the tune would change if it was their child or spouse that was injured by a defective product. Not just a defect in manufacturing, but an actual product that simply was not doing what it said it would do but was OK’d by the feds. When it happens to you the rules change. I have people in my office every single day say “I am not a sue happy person, but what happened to me… XYZ, was just wrong.” Everyone’s personal experience is the exception to the “you are just a sue happy malingering worthless Plaintiff” analysis.
Don’t buy into the fancy lawyer arguments that the FDA is here to save us. It is not. It can only help to stem the tide of ever flowing dangerous products into our market.
Getting off the soapbox.