Texas learned intermediary medical device decision

The Texas Court of Appeals in Fort Worth reversed a jury verdict in favor of the plaintiff against Ethicon in late December on learned intermediary grounds.  Read case here.

The medical device at issue was a surgical stapler made by Ethicon and used during colon surgery on the plaintiff. The surgeon used the device to cut out a piece of bowel that needed to be removed, and then sewed the remaining ends of the bowel back together.  The surgeon testified that he tested to make sure that gas and fluid could pass through the opening, and that there was no leaking.  The bowel ends eventually came apart and caused a bad infection which required additional surgeries and hospitalization to correct.

Plaintiff brought a medical malpractice lawsuit and a product liability lawsuit against Ethicon.  She settled with all defendants except for Ethicon before trial. 

At trial, the jury awarded the plaintiff more than $500,000.

The appellate court reversed the verdict and held for Ethicon.  It came to this conclusion because there was no proof that if the warning which the plaintiff claims should have been given would have stopped the surgeon from using the stapler.  The surgeon testified that he was aware of the risks of using the stapler that plaintiff claims should have been given,.  Therefore, the court held that as a matter of law, the product warning could not be considered a competent producing cause of the injuries.

Plaintiff's expert claimed that there should have been warnings that even if properly applied, staples can come apart and cause the difficulties that the plaintiff had here.  The surgeon testified that he did not need Ethicon to tell him this because he knew it already, and that leaks can come from any number of reasons.  Even had Ethicon specifically told him this, he would not have stopped him from using the device. 

The rule articulated by this court is one that makes sense and that other jurisdictions use as well.  If a physician is aware of the risks of the use of a device, even if not specifically warned about by the company, then plaintiff has not been able to establish causation, one of the necessary elements of a claim.