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From Health Law Daily, March 22, 2017

$2.1M judgment against hip implant maker upheld

By Susan Engstrom

Wright Medical Technology, Inc. was not entitled to a new trial following an adverse jury verdict in the first bellwether trial against it for products liability and misrepresentation claims relating to the device maker’s Conserve® metal-on-metal hip implant device, the U.S. Court of Appeals for the Eleventh Circuit ruled, affirming the district court’s $2.1 million judgment against the company. Contrary to Wright’s assertion, the district court did not abuse its discretion in ordering the jury to continue deliberations after it had already begun to deliver its verdict. Nor did the district court err in its jury instructions on Utah’s products liability law regarding the unavoidably unsafe product defense (Christiansen v. Wright Medical Technology, Inc., March 20, 2017, Bartle, H.).

A patient who had surgery in 2006 to implant a Wright Conserve Hip Implant System later brought claims against the manufacturer for design defect (negligence and strict liability), fraudulent misrepresentation, negligent misrepresentation, and fraudulent concealment, alleging that the device had failed, causing severe pain and requiring revision surgery. The case was tried before a jury.

On the second day of deliberations, the jury announced that it had reached a unanimous verdict. On the verdict sheet, the jury had answered "No" to a question (Question 1A) asking whether Wright’s hip replacement device was defectively designed. Although the verdict sheet instructed the jury to stop and sign the form if their answer to Question 1A was "No," the jury made nine other findings, including that Wright was liable for negligent misrepresentation. After the deputy clerk read aloud the jury’s answer to Question 1A, the district court realized that the jury’s responses were inconsistent, and halted further reading of the verdict sheet. The court revised the jury sheet instructions to clarify that the jury should not complete the remainder of the sheet if it answered "No" to Question 1A, and then directed the jury to resume deliberations. The jury ultimately found that the hip implant device was defectively designed and that Wright was liable for negligent misrepresentation but not for fraudulent misrepresentation. The jury awarded the patient $1 million in compensatory damages and $10 million in punitive damages, which the district court later reduced to $1.1 million.

Jury responses. At the charge conference, the parties and the district court had agreed that the patient could prevail on her negligent misrepresentation claim only if the jury first found that there was a design defect. Thus, the original verdict sheet instructed the jurors to "stop, and sign and date this form" if they found no design defect. However, the jurors recorded on the original verdict sheet both that there was no design defect and that Wright had made a negligent misrepresentation. According to the Eleventh Circuit, those findings were inherently inconsistent because there was no rational, non-speculative way to reconcile them.

Wright urged the court to ignore the inconsistency on the ground that the jury’s response to Question 1A was controlling and any additional responses had no legal effect. However, it was apparent from the jury’s contradictory and irreconcilable responses that they did not understand the instructions on the original verdict sheet, the court determined.

The Eleventh Circuit also rejected Wright’s assertion that the district court erred in ordering further deliberations instead of a new trial. After recognizing the jury’s inconsistency, the district court—consistent with U.S. Supreme Court precedent—immediately stopped publication of the verdict and instructed the jury that an error had been made. At that point, only the finding as to the design defect had been announced. Contrary to the manufacturer’s argument, stopping at that moment did not bias further jury deliberations. To the contrary, the district court’s clarifying instruction emphasized that a finding of no design defect was legally permissible. Thus, the district court did not abuse its discretion in ordering the jury to continue deliberating.

Unavoidably unsafe product defense. In addition, the district court did not err in its jury instructions on Utah’s products liability law regarding the unavoidably unsafe product defense in Comment k of Section 402A of the Restatement (Second) of Torts. The jury instructions stated that in order to prove that defense, the manufacturer had to prove by a preponderance of the evidence that: (1) when the hip replacement device was made, it could not be made safe for its intended use even applying the best available testing and research; (2) the benefit of the device justified its risk; and (3) the device, properly manufactured, was accompanied by proper directions and warnings.

Wright contended that instead of instructing the jury to apply a case-by-case analysis that took into account whether the specific product at issue was properly manufactured and accompanied by proper directions and warnings, the district court should have instructed the jury that the defense was a categorical bar to liability if the jury found that the implant could not be made safe for its intended use and that the benefit justified the risk.

Although the Utah Supreme Court has adopted the categorical bar against strict liability for pharmaceutical drugs that have been approved by the FDA, it emphasized that "[n]o other class of products is subject to such special restrictions or protections in our society." And, even if the state high court were to extend the bar against strict liability to FDA-approved medical devices, it would not extend it to the hip replacement device at issue here, the Eleventh Circuit predicted, because the record was silent as to whether the implant had obtained FDA approval. Wright conceded that it had not presented any evidence at trial as to whether the device was FDA-approved and, thus, the manufacturer failed to prove that this affirmative defense applied to its implant. On that record, any categorical bar to liability for an unavoidably unsafe product was not available to the manufacturer under Utah law.

Accordingly, the Eleventh Circuit affirmed the district court’s denial of Wright’s motion for judgment as a matter of law or for a new trial, and upheld the judgment in favor of the patient for $2,100,000.

The case is No. 16-12162.

Attorneys: Michael L. McGlamry (Pope McGlamry Kilpatrick Morrison & Norwood, PC) for Robyn Christiansen and Gene Christiansen. Dana Jeffrey Ash (Duane Morris, LLP) for Wright Medical Technology Inc.

Companies: Wright Medical Technology Inc.

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