Products Liability Law Daily Patient’s diagnostic uncertainty as to cause of pain after hip replacement was a question for the jury
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Thursday, November 21, 2019

Patient’s diagnostic uncertainty as to cause of pain after hip replacement was a question for the jury

Jeffrey H. Brochin, J.D.

The trial court’s grant of summary judgment for the device manufacturer was inappropriate because genuine disputes remained as to when the patient discovered the cause of her injury and whether her design defect and failure to warn claims were time-barred.

The U.S. Court of Appeals for the Third Circuit has reversed and remanded a Pennsylvania federal court’s grant of summary judgment in favor of a manufacturer of hip implants after determining that genuine disputes of material fact existed on the question of when a hip implant patient reasonably should have discovered her injury. The central issue in the case was whether a jury could conclude that the patient reasonably did not discover her injury until February 12, 2015, when her surgeon apprised her of his intraoperative finding that her implant had deteriorated and emitted metal shards into her hip. The Third Circuit found that the district court wrongly concluded there could be no dispute that the information available to the patient in her preoperative visits would have put a reasonably diligent person on notice of her injury, prior to the doctor’s disclosure, as a matter of law (Adams v. Zimmer US, Inc., November 20, 2019, Scirica, J.).

Implant and complications from infection. On January 18, 2011, the patient’s surgeon implanted a hip device, manufactured by Zimmer, Inc., to resolve her hip pain caused by advanced degenerative arthritis. She had no further problems with her hip for roughly a year and a half, but in late 2012, she started experiencing severe pain. Her doctor described the cause of her problems as "unclear" and the diagnostic process as "difficult." After conducting various tests, he eventually diagnosed an infection, and although he advised her that the infection might require another surgery, he was able to treat it successfully in 2013 without surgery.

Need for revision surgery. The patient’s hip problems returned in November 2014 when she dislocated her hip while in Florida. Upon her return home, her doctor ordered various diagnostic tests, and an x-ray showed calcification around the implant. He later testified that he thought this abnormal result possibly could have been related to ongoing tissue reaction or a reaction to the actual dislocation event. He ordered a CT scan which showed a local adverse tissue reaction.

The patient underwent revision surgery for replacement of the metal femoral head of her hip implant on February 12, 2015. The records from her pre-operative visit on January 30, 2015 stated that she was suffering from "right total hip metallosis," which indicated that metal wear from the device was causing a reaction to the surrounding tissues. The patient testified that she did not recall hearing about metallosis, but she did remember being distraught over her upcoming surgery.

Surprise intraoperative findings. Although the surgeon expected to replace only components of the implant around the hip socket, what he discovered during the surgery called for a different—and much more drastic—revision. Upon opening the patient’s hip, he found her muscle had largely deteriorated and metal debris had taken over much of the area. He discovered a pseudotumor roughly the size of a baseball. Rather than replacing the socket and implant lining, which were in fact largely intact, he replaced all the main components of the implant hip that had been discharging excessive, and potentially toxic, metal debris into the hip. After the revision surgery, the doctor told the patient about his intraoperative findings. She continued to experience hip pain after the surgery, and on February 10, 2017, she brought a products liability action against Zimmer US, Inc., Zimmer Holdings, Inc., Zimmer, Inc., and Zimmer Surgical, Inc. (collectively, Zimmer), the manufacturers and suppliers of the hip implant.

Pennsylvania statute of limitations. In Pennsylvania, a patient has two years to bring a design defect claim such as the one in the current case. The two-year statute of limitations generally begins to run "when an injury is inflicted." However, when the injury or its cause is neither known nor reasonably ascertainable, the discovery rule tolls the statute of limitations. The rule is designed to protect a patient who is reasonably unaware of latent injuries or who suffers from injuries of unknown etiology.

Diagnostic uncertainty a question for the jury. The court of appeals noted that the central issue in the case was whether a jury could conclude that the patient reasonably did not discover her injury until February 12, 2015, when her surgeon informed her of his finding that her implant had deteriorated and emitted metal shards into her hip. The trial court had concluded that there could be no dispute that the information available to the patient in her preoperative visits would have put a reasonably diligent person on notice of her injury as a matter of law [see Products Liability Law Daily’s August 16, 2018 analysis].

The Third Circuit, however, disagreed, finding that because factual disputes on the issues of notice and knowledge remained as to assessing the application of Pennsylvania’s discovery rule, Pennsylvania law required that a jury must resolve the disputes. Under the Pennsylvania discovery rule, the "commencement of the limitations period is grounded on ‘inquiry notice’ that is tied to ‘actual or constructive knowledge of at least some form of significant harm and of a factual cause linked to another’s conduct, without the necessity of notice to the full extent of the injury, the fact of actual negligence, or precise cause.’" The appeals court cited precedent in its review of the lower court’s ruling, noting that at summary judgment, it was required to view the record and draw inferences in a light most favorable to the patient as the non-moving party.

The patient had maintained that she acted with reasonable diligence but did not discover her injury until February 2015. Her claim was that she did not know the nature of her injury or that it was the deterioration of the Zimmer implant, rather than her reaction to the implant, that was the cause. Pennsylvania’s discovery rule asks only when the patient knew she was injured and that her injury was caused by another. Zimmer did not dispute that the patient investigated her claim in coordination with her doctor. A factfinder reasonably could determine that the patient had exercised reasonable diligence, which the appellate court found "strongly counsel[ed] against determining notice as a matter of law." Pursuant to Pennsylvania Supreme Court precedent, a patient does not have to have "a precise medical diagnosis" to start the statute of limitations. Rather, "a lay person is only charged with the knowledge communicated to him or her by the medical professionals who provided treatment and diagnosis." The patient’s physician did not know the cause of the patient’s injury until he was in the middle of operating on her hip in February 2015. Although Zimmer argued that the patient had constructive or actual knowledge of her injury, the evidence supporting this contention were facts that were relevant to a jury’s determination of knowledge and reasonable diligence. This evidence, however, did not "support imputing knowledge as a matter of law," the Third Circuit said.

Accordingly, the court of appeals could not conclude that summary judgment was appropriate. The question of whether the patient should have acted with greater diligence to investigate or otherwise should have known of her injury earlier was an issue of fact for the jury. Therefore, because factual disputes remained concerning application of the discovery rule, the Third Circuit reversed and remanded the case for further proceedings.

The case is No. 18-3011.

Attorneys: Charles L. Becker (Kline & Specter, PC) for Marilyn Adams. Dana E. Becker (Morgan Lewis & Bockius) for Zimmer US, Inc.; Zimmer Holdings, Inc.; Zimmer, Inc.; Zimmer Surgical, Inc.

Companies: Zimmer US, Inc.; Zimmer Holdings, Inc.; Zimmer, Inc.; Zimmer Surgical, Inc.

MainStory: TopStory SofLReposeNews MedicalDevicesNews DelawareNews NewJerseyNews PennsylvaniaNews VirginIslandsNews

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