United States: Eleventh Circuit Affirms A Very Unhappy Unverdict Against Hip Manufacturer

Last Updated: March 27 2017
Article by Steven Boranian

A funny thing happened on the way to a defense verdict last year—after the jury decided that the defendant's product was not defective, the MDL judge told the jurors that perhaps they did not "fully understand" and instructed them to try again. So the jury went back into the jury room, and having been duly admonished by the court, the jury changed its mind and returned a verdict for the plaintiff. We commented fully on the proceedings here, and while we will not repeat all the gory details, trust us, the proceedings were odd.

The Eleventh Circuit has now affirmed the plaintiff's verdict, and the defendant has valid reasons to be unhappy. Not only did the Eleventh Circuit place its stamp of approval on the do-over verdict, it applied a hopelessly muddled view of comment k.

The case is Christiansen v. Wright Medical Technology, Inc., No. 16-12162, 2017 WL 1046088 (11th Cir. Mar. 20, 2017). The plaintiff alleged that a defect in the defendant's metal-on-metal hip replacement device caused him an injury, and he asserted product liability claims governed by Utah law. Id. at *1. As luck would have it, the case was selected as a "bellwether" trial case in the Conserve Hip Implant MDL, and after a trial that lasted about a week, the jury returned a verdict finding that the product was not defectively designed. Id. The jury also found that the defendant had made negligent misrepresentations and awarded compensatory and punitive damages. Id.

Under Utah law, this is a defense verdict. The Utah Products Liability Statute covers all claims for injuries allegedly caused by defective products, and it requires proof of a product defect. As a result, once the jury found that the product was not defective, nothing else mattered. The defendant won. The court, however, ruled that the verdict was "inconsistent" because the jury found no defect on the one hand, but also found negligent misrepresentation on the other. Id. That is why the court re-instructed the jury, resulting in the second verdict finding a product defect. Id.

The Eleventh Circuit affirmed this result, and its opinion relies on the assumption that the first verdict was "inconsistent." Id. at **5-7. But what inconsistency? The jury made two core findings—no defect and negligent misrepresentation. Maybe the evidence supported those findings and maybe it did not, but it is very possible for a defendant to make a misrepresentation and also sell a product that is free from design defects. (There were no manufacturing or warning-based defect claims, in case you were wondering.) The finding of no defect makes the misrepresentation finding meaningless under Utah law. They are not "inconsistent." The former just deprives the latter of any legal consequence.

For whatever reason, the district judge saw an "inconsistency," and the Eleventh Circuit deferred. The Eleventh Circuit tries to explain the proceedings in the district court, but in the end, it really did not explain why the initial verdict called for further deliberation. It seems to have taken that for granted.

There is a second problem with the Eleventh Circuit's opinion—it declined to apply Utah's adoption of Comment k and gave a reason that simply does not hold up. Comment k to section 402A of the Restatement (Second) or Torts provides protection against strict liability claims involving "unavoidably unsafe products." Nearly all states have adopted some version of Comment k—some apply it on a case-by-case basis; some treat it as an affirmative defense; some apply Comment k as a matter of law in all cases involving prescription medical products, recognizing that all drugs and medical devices have both benefits and risks.

Utah has adopted Comment k, but has placed the burden on the defendant to prove certain elements to invoke Comment k as a defense. However, in cases involving prescription medical products, the Utah Supreme Court has "rejected the case-by-case approach and adopted Comment k as a categorical bar against strict liability." Id. at **7-8 (quoting Grundberg v. Upjohn Co., 813 P.2d 89 (Utah 1991)). Comment k therefore applies in Utah across the board, and the Defendant justifiably argued to the Eleventh Circuit that Comment k applied and that it should result in a judgment for the defense.

The Eleventh Circuit "predicted" Utah law differently. According to the Eleventh Circuit, the Utah Supreme Court applied Comment k to prescription drugs because they are FDA approved. Id. at *8. It therefore held that the Utah Supreme Court would not apply comment k categorically to medical devices. Id. at **8-9. It further held that, even if Comment k applied to "FDA-approved medical devices," the defendant had not carried its burden of proving that the product was FDA approved. Id. at **8-9.

There is so much wrong with this holding. To start, with the Utah Supreme Court having decided that Comment k applies to prescription drugs, there is no basis on which to predict that Utah law would be different for prescription medical devices. The rationale for applying Comment k is the same—no matter how you design a drug or medical device, there will always be risks. (See here for our research post on comment k, including a 50-state survey.) In addition, the Eleventh Circuit's fixation on FDA approval to distinguish prescription drugs from prescription medical devices ignores that the FDA regulates medical devices, too. It also ignores that drugs are approved for marketing in different ways—some through full-blown new drug applications, some under pre-NDA rules, some through a showing of substantial equivalence, etc. Comment K applies to all of them, and the Utah Supreme Court has never drawn a distinction. There is no reason to believe it would draw a distinction between drugs and medical devices because of their respective regulatory pathways either.

Finally, the Eleventh Circuit held that Comment k would not help the defendant in any event because the defendant did not prove that the product was approved by the FDA. This is wrong. Utah's version of Comment k requires the defendant to prove certain elements, but FDA approval is not one of them. Neither the Utah pattern jury instruction nor the instruction given by the district court called for the defendant to prove FDA approval. Yet, the Eleventh Circuit based its opinion on this purported failure of proof.

We can't help but consider the possibility that this plaintiff's judgment had more staying power because it came out of an MDL "bellwether" trial. Maybe. Maybe not. It seems to us that if you assume that "bellwether" verdicts actually help the parties value other cases, a defense verdict is as useful as a plaintiff's verdict. Both have dollar amounts attached to them, and the number attached to the defense verdict is zero, plus the defendant's costs. That should have been the result in Christiansen.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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