Health Law Daily Manufacturer warning not defective if improved warning would not change outcome
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Friday, March 9, 2018

Manufacturer warning not defective if improved warning would not change outcome

By Rebecca Mayo, J.D.

A claim against a manufacturer for a defective warning will fail where there is no evidence that the outcome would be any different with an improved warning. The Seventh Circuit affirmed a lower court’s decision granting summary judgement to a knee-implant manufacturer where the patient could not show that he would have avoided injury with an improved warning (In Re: Zimmer, March 8, 2018, Sykes, D.).

Background. In 2008 a patient had knee-replacement surgery and his surgeon used a Zimmer NexGen Flex implant. After three years, the patient began to feel pain in his new knee and tests revealed that the bond between the bone and the implant had weakened and the patient needed revision surgery. The patient then sued the implant manufacturer for defective design, manufacture, and warning. After a judge entered summary judgement for the manufacturer rejecting all claims, the patient appealed the summary judgment decision as to his claim based on defective warning (see All claims dismissed in one of the Zimmer knee replacement cases, October 24, 2016).

Duty to warn patient. The learned intermediary doctrine holds that the manufacturer of a prescription drug or medical device fulfills its duty to warn of the product’s risk by informing the prescribing physician of those risks. Although neither the Wisconsin Supreme Court nor the state’s intermediate appellate courts have addressed the doctrine, the court here determined that given the opportunity, the state high court would adopt the doctrine and it should apply in this case. Therefore, to the extent that the patient’s defective warning claim is based on the manufacturer’s duty to warn him, it is foreclosed by the learned intermediary doctrine.

Additionally, while manufacturers owe a duty to warn consumers of dangers associated with the proper use of its product, the patient has not identified any danger that the manufacturer should have warned him about. The patient also failed to present evidence to support causation by showing that if properly warned, he would have altered behavior and avoided injury. The surgeon picked the implant, not the patient, and the surgeon based his decision on his own past experience, not on marketing materials or information provided by the manufacturer.

Duty to warn surgeon. The patient presented expert testimony that two bags of cement should have been used to properly bond the knee implant and the surgeon who performed that patient’s knee-replacement surgery only used one. The patient claimed that the manufacturer failed to issue an adequate warning to his surgeon about the amount of cement needed to properly bond the knee implant. However, there was no evidence to support the contention that it was the manufacturer’s responsibility to instruct surgeons about the amount of cement they should use in an implant surgery. Surgeons are primarily guided in their implant technique by their basic medical training. Further, the surgeon testified that he did not even read the instructions that accompanied the knee implant, so even with an improved warning, the surgeon would not have altered his behavior and avoided injury.

The case is No. 16-3957.

Attorneys: Paul J. Pennock (Weitz & Luxenberg, PC) for Theodore F. Joas. Andrea Roberts Pierson (Faegre Baker Daniels LLP) for Zimmer, Inc.

Companies: Zimmer, Inc.

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