Justices Make It Tougher to Sue Medical Device Makers

The Supreme Court upheld a lower federal court's decision today (story) that limited a patient's right to sue a medical device manufacturer under state law. And I think this is good. Medical devices undergo rigorous scrutiny by the FDA before being approved for use in patients. The FDA knows much more about these things than any juror ever will. If FDA approval did not protect a manufacturer from lawsuits (in state courts) then we would have fewer life-saving technologies since manufacturers would be reluctant to push new innovations; the new innovations would take more time and money for unnecessary testing (cover-your-ass design); the devices would cost more because of increased liability. All that sounds acceptable if you are the very rare and unfortunate person who is harmed by a device. It is absurd for the rest of us who enjoy its benefits.

Unfortunately doctors don't have a FDA that protects them from lawsuits. Without a doubt medical negligence is unacceptable and should be punished (medical negligence is not simply making a mistake; it is making a mistake that is unacceptable or unreasonable when measured up to the standard of care practiced in that doctor's community). Bonafide cases of medical negligence are relatively rare. The bulk of medical malpractice lawsuits (whether or not they go to trial) fall into two types.

1. The first is when there is an unfavorable outcome according to the patient, although the doctor had followed community standards and had not nade a mistake at all. These are lawsuits driven by the media and malpractice attornies.
2. The second is when a doctor had made a decision that is deemed a mistake in retrospect but had been in accordance with community standards at the time. This is a medical error but not negligence.

Studies have shown that the doctors who tend to get sued are not the doctors who make poor decisions or make a technical error in the OR, but are the doctors with poor interpersonal skills, who refuse to accept responsibility for a bad outcome, or who don't apologize for their mistakes. It is more about how patients are treated than an objective medical outcome in other words. Although such a patient may be justified in feeling angry at their doctor, it is an abuse of our legal system to let patient/jury emotions play a role (a huge role) in determing whether a doctor is liable for a certain outcome.

The problem with our medical liability system in this country - [sigh] this is a huge topic - is that

• Juries decide cases that involve technical information beyond their understanding and experience - doctors, drug companies and device manucturers are not tried by a jury of their peers (I am not a mechanic and have absolutely no ability to determine if a mechanic has made a good or bad decision in fixing my car. It is more rational to defer to the opinion of a jury of mechanics.)
• The court room only represents cases of failure (harm), rather than cases of success, which are far and away more common, and so
• Rulings in favor of a patient have huge negative consequences for the rest of society at large, such as increased medical costs and physician shortages due to unreasonably expensive liability (these costs are ultimately passed down to the consumer, so although we may cheer the patient who was awarded $25 million, we are all going to pay for it)

The key to reforming the medico-legal landscape lies in creating a system that acurately and inexpensively identifies true medical negligence from frivolousness, and then awards generously in those cases. I don't how to do this, but eliminating incentives for malpractice attorneys to cook up lawsuits for prize money would probably be a key piece. Another piece would be rationalizing the system to ensure that frivolous complaints do not consume too many resources.

One idea is to get rid of juries in malpractice lawsuits. Such lawsuits are about technical errors, and so I don't see any role for a jury composed of laypeople. Even with expert witnesses it is unrealistic to expect a layperson to understand the complexities of medical decision making that requires years to learn and master. I know there are people who would say that doctors would form a cabal and protect themselves by never prosecuting each other. This could be true, but I think it is unlikely since the overwhelming majority of doctors I know are deeply upset about and ashamed of bad doctors; they give their profession a bad image, afterall. Furthermore, negligent doctors are dangerous and other doctors will be left with caring for patients harmed by their irresponsible care. However, it is safe to predict that a jury of doctors would be immune to the emotional arguments involved with frivolous lawsuits. And that is the point.

Tort reform is another proposed solution to the medical liablity problem. This would involve maintaining the current jury system but placing a limit on compensation for non-economic damages.

Although both proposals would limit the amount of money awarded in frivolous malpractice lawsuits, I am uncertain if either proposal would reduce the number of frivolous lawsuits. Most malpractice complaints are resolved out of court, but still cost the medical industry beaucoup bucks in legal defense fees. Reducing the huge awards, although an admirable goal, will probably not make a huge difference in overall liability costs.