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From Health Law Daily, January 27, 2017

Physician’s failure to warn patient undercuts claim against manufacturer

By Patricia Hammond, J.D.

The decision of a physician, as a learned intermediary, not to inform the patient of the risks of using a medical device severed the required causal connection between an alleged failure to warn and an injury sustained by the patient, held the Southern District of New York. Furthermore, because the patient and her husband failed to identify any defect in the medical device, product defect, breach of implied warranty, and breach of express warranty claims failed (Tomaselli v. Zimmer, Inc., January 20, 2017, Netburn, S.).

GTR device. The GTR device consists of two components: the Integral Short Greater Trochanteric Reattachment Device ("plate" or "claw") and two 1.8 mm cables. Pioneer Surgical Technology, Inc. (manufacturer) is responsible for the assembly, quality control, inspection, labeling, and packaging of the device. Zimmer, Inc., and Zimmer Holdings, Inc., (distributor) distributes and sells the device. Each GTR device contains instructions for use titled "IMPORTANT PRODUCT INFORMATION," which referred to adverse effects, including: "fraying, kinking, loosening, or breakage of the cables securing the device, or disassembly of any of the components"; early or late loosening of the cables securing the device"; and "loosening, disassembly or breakage of the cables."

Pain following hip replacement surgery. After experiencing pain following a hip replacement surgery, the patient’s physician informed her that the fracture was caused by the hip replacement being placed too close to the bone and that, while the fracture would not heal on its own, she could avoid surgery if she walked with a cane. At the same appointment, the physician explained the implantation procedure and told the patient there was a five percent chance that the fracture would not heal even after the surgery and raised the possibility that implanting the plate could cause irritation and pain in the area over the plate. The physician did not discuss the risk of cable breakage, and the parties dispute whether the physician was aware of such a risk.

The patient chose to have the device implanted, and seven months after the implantation surgery the patient complained of sensitivities in the area over the plate. The physician told her there was nothing that could be done at the time, but that the device could be removed after the fracture or nonunion fully healed and if the pain persisted. Fourteen months after the surgery, an x-ray revealed that one of the cables in the GTR device had broken. The physician did not recommend removing the cable, as it had stayed in place. He advised that if the cable changed position, they would discuss moving the device. The patient expressed concern that the cable would migrate. At a follow-up appointment, the physician determined that the broken cable had not moved and that removing the cable would not eliminate the tenderness the patient felt over the area. He advised that the only way to eliminate the pain was to remove the plate, but the patient indicated she did not want to remove the plate.

A year later, the patient had not seen a physician for her hip since her last appointment with the physician. She was not seeking physical therapy and occasionally took over-the-counter pain medication for her hip pain. She was able to drive and shop for groceries and swam for exercise at least one a week. She testified that stretching and taking a few steps could relieve any pain. The patient and her husband filed suit against Pioneer and Zimmer for negligence, strict products liability, breach of implied warranty of merchantability, breach of implied warranty of fitness for purposes intended, and breach of express warranty. The couple also filed a derivative action for loss of consortium. Both parties moved for summary judgment.

Failure to warn. To succeed in a failure to warn claim against a manufacturer, the patient must show that (1) the manufacturer failed to satisfy its duty to the prescribing physician to provide a clear and adequate warning; and (2) this failure to provide an adequate warning to the physician was a proximate cause of the patient’s injuries. For medical devices that require a prescription (such as the GTR device) the duty runs to the prescribing physician, and not the patient, as the physician acts as an informed intermediary between the manufacturer and the patient. A warning is adequate as a matter of law if it is "accurate, clear, consistent on its face, and . . . portrays with sufficient intensity the risk involved." Even if the warning was somehow lacking, the patient must show that the failure to provide a sufficient warning to the prescribing physician was the proximate case of the patient’s injury.

The physician testified that he was aware of the potential cable breakage because, even though he did not read the warnings, he was aware of the risks and benefits of the device from his education, medical training, and clinical experience. He stated he did not need to review the warning to understand the risks. The physician also admitted at his deposition that he did not inform the patient of the risk of cable breakage. The court held that the physician’s failure to advise the patient of the potential adverse effect, given his knowledge of the risk, constituted an intervening cause, severing the required causal connection between the alleged failure to warn and the injury to the patient. Accordingly, the court held that the patient and her husband failed to demonstrate that the manufacturer and distributor of the device did not satisfy their duty to provide an adequate warning to the physician and that such inadequacy of the warning was a proximate cause of the patient’s injury. Thus, the court granted the motion for summary judgment as to the failure to warn claim in favor of the manufacturer and distributor.

Remaining claims. The court granted summary judgment as to the product defect claims in favor of the manufacturer and distributor, as the patient and her husband did not identify any product defect. Because there was no evidence that the device was defective, the court also concluded that the breach of implied and express warranty claims failed.

The case is No. 14-CV-04474 (RA)(SN).

Attorneys: James K. Riley (O'Connell & Riley) for Mary Tomaselli. Judi Curry (Harris Beach, PLLC) for Zimmer, Inc., Zimmer Holdings, Inc. and Pioneer Surgical Technology, Inc.

Companies: Zimmer, Inc.; Zimmer Holdings, Inc.; Pioneer Surgical Technology, Inc.

MainStory: TopStory CaseDecisions MDeviceNews PLDeviceNews SafetyNews NewYorkNews

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