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From Products Liability Law Daily, March 9, 2018

Knee implant manufacturer’s warning not defective if improved warning would not have changed outcome

By Rebecca Mayo, J.D.

An injured knee replacement patient’s defective warning claim against the implant manufacturer failed because there was no evidence that his injuries would have been avoided with an improved warning, the U.S. Court of Appeals for the Seventh Circuit ruled, affirming a lower court’s grant of summary judgment in favor of the knee implant manufacturer. Although his appeal raised unresolved issues in Wisconsin products liability law—specifically, the application of the learned intermediary doctrine, which the Wisconsin Supreme Court has not yet addressed—the court of appeals predicted that the state high court "would follow the lead of other states and adopt this doctrine" (In re: ZimmerNexGen Knee Implant Products Liability Litigation (Joas v. Zimmer, Inc.), March 8, 2018, Sykes, D.).

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. The patient’s suit is the second bellwether case in a multidistrict litigation concerning Zimmer NexGen Flex knee implants. The MDL plaintiffs allege that they have suffered pain and loss of movement because the NexGen Flex is prone to premature loosening. After the lower court entered summary judgement for the manufacturer rejecting all of the patient’s claims, the patient appealed the decision as to his claim based on defective warning [see Products Liability Law Daily’s October 24, 2016 analysis).

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 Seventh Circuit determined that given the opportunity, the state high court would adopt the doctrine and that it should apply in the case at bar. Therefore, to the extent that the patient’s defective warning claim was based on the manufacturer’s duty to warn him, it was foreclosed by the learned intermediary doctrine.

Additionally, while the device manufacturer owed a duty to the patient to warn him of dangers associated with the proper use of its product, the patient had not identified any danger that the manufacturer should have warned him about. The patient also failed to present causation evidence demonstrating that if properly warned, he would have altered his behavior. The patient argued that if Zimmer had warned him of a risk of early failure, he would have "heeded the warning and been inclined to choose an implant with a known greater longevity." However, the patient did not select the implant—his surgeon did. The surgeon based his decision on his own past experience, not on marketing materials or information provided by the manufacturer. Furthermore, the patient did not identify another implant known to have greater longevity that he would have selected if he had made the choice himself.

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 that 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.

In addition, the patient had argued at the summary judgment hearing that the trial court should allow his warning defect claim to go forward based on a "heeding presumption," which allows the factfinder to presume, absent proof, that a proper warning would have been read and heeded. However, the Wisconsin appellate courts have not addressed this doctrine, and the Seventh Circuit doubted that they would adopt it in this context. Rather the state court of appeals recently ruled that "[a] plaintiff who has established both a duty and a failure to warn must also establish causation by showing that, if properly warned, he or she would have altered behavior and avoided injury." The plaintiff in that case failed to show that the relevant actor "would have heeded a different warning," so summary judgment was upheld for the defendant. In the current case, the surgeon testified that he did not read the instructions that accompanied the knee implant. Therefore, even if the patient could establish that the manufacturer breached a duty to warn the surgeon, summary judgment was appropriate because the patient offered no evidence to show that if the doctor had been properly warned, he would have handled the patient’s condition differently or chosen a different implant device.

Finally, the appellate court declined the patient’s request to certify the questions on the learned intermediary doctrine and the heeding presumption to the Wisconsin Supreme Court. The court said that certification is appropriate if the court was "genuinely uncertain about a question of state law that is vital to a correct disposition of the case." However, no genuine uncertainty existed, according to the court of appeals.

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.

MainStory: TopStory WarningsNews MedicalDevicesNews ClassActLitigationNews IllinoisNews IndianaNews WisconsinNews

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