Liability Standard For Defects In Complex Medical Devices

Medical Malpractice

In the case of Cavanaugh v. Stryker Corporation, Case Number 4D19-523 (Fla. 4th DCA October 7, 2020), Florida’s Fourth DCA held that complex medical devices are subject to a “risk utility test” as opposed to a “consumer expectations test” for product liability.

Underlying Medical Malpractice Case And Dispute over Jury Instructions

This case involved a very unfortunate incident during a surgical procedure where a high volume suction device was used on a passive drain line. The use of this device resulted in the patient’s death when the high volume suction device (to dispose of surgical fluid waste) was connected to that passive drain line following cardiac surgery. The patient’s heart shifted to the side of his chest as a result of the force of the suction.

The patient’s estate brought a medical malpractice case in addition to a product liability case. The surgeon took the position that he was not aware that the high volume suction device was not to be used on a passive chest line and that the suction device did not have a warning against doing so.

On appeal, one of the issues of contention was the jury instruction used to address the legal standard for product liability with a complex medical device.

Both sides proposed jury instructions. The judge went with Stryker’s proposed jury instruction, which was an iteration of the “risk utility test.” As such, the risk utility test (from the Third Restatement of Torts) concerns whether a “reasonable alternative design exists” and “whether the benefit of the product’s design outweighed any risks of injury or death caused by the design.”

On the other hand, the “consumer expectations test” requested by the plaintiff does not require a reasonable alternative design and merely a question of whether the product “at the time it leaves the seller’s hands [is] in a condition not contemplated by the ultimate consumer” and is hence “unreasonably dangerous.” This version of the test comes from the Second Restatement of Torts.

The Fourth DCA discussed that a surgical patient does not necessarily have expectations of a product used at some point during the surgery and that, for a complex medical device, the appropriate test is the risk utility test (along with all of the expert testimony that comes with it).

In essence, if you are going to complain about a medical device with a complex use, then you need expert testimony to show why the device was unreasonably dangerous to highly skilled and trained users (such as surgeons) and you need to show how such a complex device should have been designed differently.

Talk To A Florida Medical Malpractice Attorney

We offer a free consultation to determine whether what happened to you was medical malpractice. Please call Russo Law today if you would like to talk with a Florida medical malpractice attorney about your potential case.

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October 08, 2020