Have You Read Your Package Inserts Lately?

This is just a quick update on a story I wrote a while back. A couple of years ago I wrote about a medical malpractice case in Connecticut involving the use of an LMA in a morbidly obese patient. It turned out to be not such a great idea as the patient suffered a severe aspiration and was left in a coma for 26 days and suffered long term medical complications. The anesthesia group wound up paying $10.5 million dollars to the plaintiffs for this incident.

Since the wheels of justice grinds ever so slowly, you probably wouldn't be surprised that this case has still been winding its way through the state court system for the past two years. A few weeks ago, the state's Court of Appeals upheld the judgement against the anesthesia group. This article has a lot more detail on the case and what happened during the trial.

What is so surprising is how much credence the courts gave the LMA package insert as evidence of a substandard level of care given by the anesthesia providers. One of the contraindications for using an LMA according to the manufacturer's insert was morbid obesity. This was taken by the plaintiff's lawyer and the court as setting a standard of care. Despite the defendant's expert witness stating that the use of an LMA was appropriate in obese patients when properly used, the jury obviously did not agree and rendered the multimillion dollar judgement against the anesthesia group.

This opens up a whole Pandora's box for doctors everywhere, not just anesthesiologists. As we all know, package inserts of medical devices and pharmaceuticals are written in tiny type with every possible risk and complication that's ever been recorded listed. This is more for preventing legal liability on the part of the manufacturer than as guidelines on how to use the product. However, if the courts start considering this as evidence of standard of care, there may be no complication too small for plaintiffs to consider medical malpractice.

How many anesthesiologists have read through those little pieces of paper and memorized the potential complications of propofol, or succinylcholine, or sevoflurane? What about the package insert of that IV catheter you're about to insert into the patient? Or the possibility of harming the patient with use of the IV pump? The risks are endless since those inserts are written by lawyers to cover their own butts. Should we start practicing medicine based on the legalese of some company lawyer? If the trial lawyers start using them as evidence of medical malpractice because we don't adhere to the letter on a product's proper use, and the judges agree with them, then we might as well just start writing out blank checks.