United States District Court, D. Utah
ORDER CERTIFYING QUESTIONS TO THE UTAH SUPREME
N. Parrish United States District Court Judge.
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
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?
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).
FACTUAL AND PROCEDURAL BACKGROUND
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.
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.
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).
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
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
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