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Burningham v. Wright Medical Group, Inc.

United States District Court, D. Utah

February 15, 2018

DALE BURNINGHAM and LANA BURNINGHAM, Plaintiffs,
v.
WRIGHT MEDICAL GROUP, INC., WRIGHT MEDICAL TECHNOLOGY, INC., HARLAN C. AMSTUTZ, M.D., a California corporation, and HARLAN C. AMSTUTZ, M.D., an individual, Defendants.

          ORDER CERTIFYING QUESTIONS TO THE UTAH SUPREME COURT

          Jill N. Parrish United States District Court Judge.

         Pursuant to Rule 41 of the Utah Rules of Appellate Procedure, the United States District Court for the District of Utah requests that the Utah Supreme Court answer the following questions of law:

1. Under Utah law, does the unavoidably unsafe exception to strict products liability in design defect claims recognized in Comment k to Section 402A of the Restatement (Second) of Torts apply to implanted medical devices?
2. If the answer to Question 1 is in the affirmative, does the exception apply categorically to all implanted medical devices, or does the exception apply only to some devices on a case-by-case basis?
3. If the exception applies on a case-by-case basis, what is the proper analysis to determine whether the exception applies?
4. If the answer to Question 1 is in the affirmative, does the exception require a showing that such devices were cleared for market through the FDA's premarket approval process as opposed to the § 510(k) clearance process?

         These issues are controlling in this matter and “there appears to be no controlling Utah law.” Utah R. App. P. 41(c)(1). The court acknowledges that the Utah Supreme Court may reformulate these questions. See In re W. Side Prop. Assocs., 13 P.3d 168, 170-71 (Utah 2000).

         I. FACTUAL AND PROCEDURAL BACKGROUND

         Plaintiffs Dale and Lana Burningham brought suit alleging that Mr. Burningham sustained injuries from implanted hip devices designed, manufactured, marketed, and sold by Defendants. The complaint alleges three causes of action involving the failure of three Class III medical devices, all of which were cleared by the Food and Drug Administration (FDA) pursuant to the Section 510(k) premarket notification process: (1) a Profemur Modular Neck implanted in Mr. Burningham's left hip, fractured on February 3, 2012 and revised on February 6, 2012; (2) a metal-on-metal failure of Conserve Components implanted in Mr. Burningham's right hip, revised on February 6, 2012; and (3) a metal-on-metal failure of Conserve Components implanted in Mr. Burningham's left hip, revised on March 27, 2013. Each of Plaintiffs' three causes of action alleges design defect claims arising under a theory of strict liability.

         On April 24, 2017, Defendants filed a motion to dismiss, in which they argued, among other things, that the court should dismiss Plaintiffs' claims for strict liability design defect. Regarding the design defect claims, Defendants argued that the Profemur Modular Neck and the Conserve Components implanted in Mr. Burningham's hips are “unavoidably unsafe” products and are therefore categorically barred from strict liability design defect claims under the relevant exception to strict products liability set forth in Comment k to section 402A of the Restatement (Second) of Torts.

         Comment k recognizes that “[t]here are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use.” But despite their dangerous nature, they are tremendously beneficial and should not be held to a strict liability standard. Comment k gives the example of the rabies vaccine, which can lead to “very serious and damaging consequences when it is injected.” But untreated rabies “invariably leads to a dreadful death, ” so “the marketing and the use of the vaccine are fully justified, notwithstanding the unavoidable high degree of risk which they involve.” Restatement (Second) of Torts § 402A cmt. k (Am. Law Inst. 1965).

         The Utah Supreme Court addressed the Comment k exception in Grundberg v. Upjohn Co., 813 P.2d 89 (Utah 1991). There, the court “characterize[ed] all FDA-approved prescription medications as ‘unavoidably safe, ' . . . [thereby] expanding the literal interpretation of comment k.” Id. at 90. Specifically, the court held that “a drug approved by the [FDA], properly prepared, compounded, packaged, and distributed, cannot as a matter of law be ‘defective' in the absence of proof of inaccurate, incomplete, misleading, or fraudulent information furnished by the manufacturer in connection with FDA approval.” Id.

         In their motion to dismiss, Defendants argued that the doctrine regarding unavoidably unsafe products “applies equally to medical devices like the Profemur Modular Neck and Conserve Components at issue.” But Defendants did not cite any Utah authority suggesting that Utah applies the unavoidably unsafe doctrine in any context other than FDA-approved prescription drugs. Plaintiffs objected that Utah courts had never applied the unavoidably unsafe doctrine of Comment k to implanted medical devices and argued that Utah law clearly limited that doctrine's application to FDA-approved drugs.

         After reviewing the relevant memoranda, the court noted that whether Comment k's unavoidably unsafe exception should apply to implanted medical devices appeared to be an issue of first impression in Utah. Consequently, on September 27, 2017, the court notified the parties that it was considering certifying the question to the Utah Supreme Court and requested additional briefing. Both parties strongly opposed certification, but neither party cited Utah law that resolved the question. Instead, Plaintiffs insisted that, because no Utah court had applied the doctrine to medical devices, no Utah court would do so in the future. On the other hand, Defendants argued that the Utah Supreme Court's decision in Grundberg answered the question, even though neither Grundberg nor Comment k mentions medical devices, and despite Grundberg&#39 ...


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