DIXIE LESLIE, Administratrix Isabelle Stanley, Deceased v. CINCINNATI SUB-ZERO PRODUCTS, INC.
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RENDERED:
January 30, 1998; 10:00 a.m.
TO BE PUBLISHED
96-CA-1753-MR
DIXIE LESLIE, Administratrix
of the Estate of
Isabelle Stanley, Deceased
v.
APPELLANT
APPEAL FROM FAYETTE CIRCUIT COURT
HONORABLE GARY D. PAYNE, JUDGE
CIVIL ACTION NO. 91-CI-2513
CINCINNATI SUB-ZERO PRODUCTS, INC.
APPELLEE
OPINION
REVERSING AND REMANDING
* * * * * * * * * * * * * * * * * * * *
BEFORE:
BUCKINGHAM, COMBS, and EMBERTON, Judges.
BUCKINGHAM, JUDGE.
Dixie Leslie (Leslie), administratrix of the
estate of Isabelle Stanley (Stanley), appeals from an order of
the Fayette Circuit Court granting summary judgment to Cincinnati
Sub-Zero Products, Inc. (CSZ). For the reasons set forth
hereinafter, we reverse and remand.
Stanley underwent coronary bypass surgery at Central
Baptist Hospital in Lexington in 1990.
During the operation, a
heating/cooling blanket, commonly known as a thermal unit, was
utilized to regulate Stanley's body temperature.
The thermal
unit was manufactured by CSZ and sold under the brand name
"Blanketrol Hypo-Hyperthermia System, Model 200."
The unit is
designed so that it can be used in either automatic or manual
mode.
If the automatic mode is selected, a temperature probe
must be placed in or near the patient's body so that the unit can
adjust its temperature level in correlation to the patient's body
temperature.
The unit was placed in the automatic mode during
Stanley's surgery, but no temperature probe was utilized.
Two
safety switches designed to prevent the unit from reaching unsafe
temperatures failed to do so, causing Stanley to suffer severe
burns over approximately thirty-five percent of her body.
She
died of complications related to the burns eleven days later.
Suit was filed on behalf of Stanley's estate in 1991,
in which it was alleged that the thermal unit was in a defective
condition and unreasonably dangerous at the time of its
manufacture.
The complaint also alleged that the safety switches
were improperly designed and that CSZ failed to post adequate
warnings of reasonably foreseeable dangers that might arise from
the use or misuse of the unit and which were not apparent to
those who used it.
Following extensive discovery, the trial
court entered an order granting CSZ's summary judgment motion,
and this appeal resulted.1
1
Suit was also filed against Central Baptist Hospital, Good
Samaritan Hospital, and PSICOR (whose employee operated the
thermal unit). The claims against those defendants were settled
(continued...)
-2-
In the order granting summary judgment in favor of CSZ
on Leslie's claims, the circuit court ruled that the claims are
preempted by the Medical Device Amendments to the Federal Food,
Drug and Cosmetic Act and that even if the claims are not
preempted, the Kentucky Product Liability Act bars the claims.
Leslie contends that the circuit court erred with both rulings,
and we agree.2
In 1976, Congress enacted the Medical Device Amendments
of 1976 (MDA) to the Federal Food, Drug and Cosmetic Act of 19383
in response to consumer and regulatory concern.
v. Lohr, 116 S.Ct. 2240, 2246 (1996).
Medtronic, Inc.
The MDA classifies medical
devices into three categories based on the device's risk to the
public.
Class I devices are deemed to have the least risk factor
and thus are subject to minimal regulation.
2246.
Lohr, supra, at
Class III devices pose a far greater risk or are used to
support or sustain human life and thus are widely regulated.
Id.
Class II devices are not subject to the more stringent standards
of Class III devices but are required to comply with federal
1
(...continued)
by the parties.
2
Other than to rule in the manner stated above, the circuit
court did not further explain or elaborate on its ruling. It is
not required to make specific findings, however. Rule of Civil
Procedure (CR) 52.01; Wilson v. Southward Inv. Co. #1, Ky. App.,
675 S.W.2d 10, 13 (1984).
3
21 U.S.C. § 301-395.
-3-
performance regulations known as "special controls."
Id.
The
thermal unit has been classified as a Class II device.
21 C.F.R. § 870.5900 (1997).
The section of MDA which is at the root of the
preemption question is 21 U.S.C. § 360k(a) (1994 ed.).
That
statute states:
Except as provided in subsection (b) of
this section, no State or political
subdivision of a State may establish or
continue in effect with respect to a device
intended for human use any requirement-(1) which is different from, or
in addition to, any requirement
applicable under this chapter to
the device, and
(2) which relates to the safety
or effectiveness of the device or
to any other matter included in a
requirement applicable to the
device under this chapter.
The interpretation of this statute varied widely from court to
court (see Lohr, supra, at 2250 n.6), which caused the U.S.
Supreme Court to take up the issue of interpreting the level of
preemption afforded by § 360k(a).
The Kentucky Supreme Court has
also recently taken up the preemption issue in Niehoff v.
Surgidev Corp., Ky., 950 S.W.2d 816 (1997).
We must, therefore,
determine whether Leslie's claims are preempted using the
guidance of Lohr and Niehoff, neither of which had been rendered
when the trial court entered its summary judgment in favor of
CSZ.
-4-
Lohr involved the preemption of a claim under Florida
law involving a Class III device (pacemaker).
The U.S. Supreme
Court was deeply divided on the issue, with the end result being
that only parts I, II, III, V, and VII of the majority opinion
gained the requisite five votes.
The Court did not rule out the
possibility that state tort claims would ever be preempted by the
MDA.
Lohr, supra, at 2257.
However, the Court stated that the
MDA's "overarching concern [is] that preemption occur only where
a particular state requirement threatens to interfere with a
specific federal interest.
State requirements must be 'with
respect to' medical devices and 'different from, or in addition
to' federal requirements."
Id.
In addition, relying upon
administrative regulations promulgated by the Food and Drug
Administration (FDA), the Court ruled that "state requirements of
'general applicability' are not pre-empted except where they have
'the effect of establishing a substantive requirement for a
specific device.'"
Id.4
4
The regulation upon which the Court relied is 21 C.F.R.
§ 808.1(d) (1997), which states in part that
(d) State or local requirements are
preempted only when the Food and Drug
Administration has established specific
counterpart regulations or there are other
specific requirements applicable to a
particular device under the act, thereby
making any existing divergent State or local
requirements applicable to the device
different from, or in addition to, the
specific Food and Drug Administration
(continued...)
-5-
Underpinning the Court's rationale were the FDA
regulations providing that state requirements would be preempted
"'only' when the FDA has established 'specific counterpart
regulations or . . . other specific requirements applicable to a
particular device.'
2258.
21 C.F.R. § 808.1(d)(1)."
Lohr, supra, at
The Court concluded, therefore, that federal requirements
and the allegedly preempted state requirements must be carefully
compared "to determine whether they fall within the intended preemptive scope of the statute and regulations."
Id. at 2257-58.
The Court went on to rule that the general state common-law
requirements in question were not preempted by the MDA.
2254-59.
Id. at
It classified the federal labeling and manufacturing
requirements as "reflect[ing] important but entirely generic
concerns about device regulation generally, not the sorts of
concerns regarding a specific device or field of device
regulation which the statute or regulations were designed to
protect from potentially contradictory state requirements."
Id.
at 2258.
The Niehoff case involved a preemption claim concerning
an artificial lens placed in an eye following cataract surgery.
4
(...continued)
requirements. There are other State or local
requirements that affect devices that are not
preempted by section 521(a) of the act
because they are not "requirements applicable
to a device" within the meaning of section
521(a) of the act.
-6-
The Kentucky Supreme Court stated in that case that it was
"highly influenced by the decision of Lohr and the analysis we
give it."
Niehoff, supra, at 819.
It interpreted the Lohr case
to stand for the proposition that the "medical device amendments
of 1976 do not preempt state law unless a specific state
requirement contravenes a specific [federal] regulation."
Id.
The court also made clear that "[t]here is a presumption against
preemption and a deference to the FDA determination of
preemption."
Id. at 820.
Classifying Justice Breyer's concurring opinion in Lohr
as "critical[,]" the court in Niehoff apparently endorsed
Breyer's view that § 360k(a) "would not preempt a state court
decision based on a finding by a jury under the common law,
unless it directly contravened a specific federal regulation
applicable to a specific device."
Id. at 821.
The court further
stated that the MDA did not preempt the plaintiff's strict
liability claim (including failure to warn) as "Kentucky's strict
liability case law and statutes are laws of general applicability
to all products and fall beyond the scope of the federal
preemption under § 360k."
Id. at 822.
CSZ argues that the specificity requirements set forth
by the FDA at 21 C.F.R. § 808.1(d) are "unwarranted attempt[s] to
narrow the federal statute."
(CSZ's brief, p. 8.)
CSZ further
argues that the regulations imposed on it by the MDA, such as
good manufacturing requirements and "highly detailed labeling
-7-
requirements,"5 are specific enough so that any common-law
products liability decision against it would "serve to add to the
requirements imposed by the FDA."
(CSZ's brief, pp. 9-14).6
In Oja v. Howmedica, Inc., 111 F.3d 782 (10th Cir.
1997), the Tenth Circuit interpreted the Lohr decision to mean
that a court "must first determine whether the FDA imposed any
specific federal . . . requirement applicable to the [device]."
Oja, supra, at 789.
As CSZ has not pointed to any federal
regulation which pertains specifically to the thermal unit, it
has failed to meet the first half of the two-pronged preemption
test of the Lohr case as interpreted by the court in Oja.
The second part of the two-pronged test as stated in
Oja is whether the state requirement with respect to the medical
device is different from, or in addition to, the federal
requirement.
test.
Id. at 789.
CSZ's argument also fails under this
To prevail under a common-law strict liability claim in
Kentucky, one must meet the requirements of § 402A of the
5
The "detailed" label required by the FDA is, in its
entirety, "Caution: Federal law restricts this device to sale by
or on the order of a __________________________ [physician]." 21
C.F.R.
§ 801.109(b)(1) (1997).
6
CSZ's claim that the good manufacturing requirements
promulgated by the FDA are sufficient to preempt state law claims
is erroneous under Duvall v. Bristol-Myers-Squibb Co., 103 F.3d
324 (4th Cir. 1996). ("[S]tate-law claims pertaining to medical
devices subject only to the general controls imposed by the . . .
GMP's [good manufacturing practices], or labeling requirements
are not preempted.") Id. at 330.
-8-
Restatement (Second) of Torts (1965),
"which imposes strict
liability on one who sells any product in a defective condition
unreasonably dangerous to the user or consumer, even though the
seller has exercised all possible care in the preparation and
sale of the products."
Niehoff, supra, at 822.
These
requirements are in no way specifically directed to the thermal
unit, but rather are applicable to manufacturers of virtually any
product.7
Thus, the state requirements are not preempted
according to 21 C.F.R. § 808.1(d)(1), which excepts state
"requirements of general applicability" from federal preemption.
Furthermore, CSZ has not demonstrated a "careful comparison" of
how these general requirements are preempted by specific federal
requirements as required by Lohr, supra, at 2257-58.
In short, given the holdings of Lohr and Niehoff and
the fact that CSZ has not met its burden of showing which
specific federal requirement would preempt the general state
common-law requirements, the circuit court's ruling that state
law is preempted by the MDA is erroneous.
7
In addition, it appears that negligent design claims would
also not be preempted under Niehoff. ("A judgment by a Kentucky
court or a potential jury verdict that Surgidev [the manufacturer
of the device in question] failed to use ordinary care in its
design . . . would not diverge from any specific federal
regulation." Niehoff at 822.) See also Oja, supra, at 789 ("the
standard of care governing [a plaintiff's] failure to warn claim
is not the type of device-specific requirement that would
threaten the MDA's federal interests[.]")
-9-
The remaining issue is whether or not the circuit
court's alternative ground for granting summary judgment is
correct.
In addition to determining that Leslie's claims against
CSZ were preempted by federal law, the circuit court also
determined that CSZ was nonetheless entitled to summary judgment
on the claims even if the state law claims were not preempted.
The statute upon which CSZ relies for its contention
that Leslie's claims are barred by the Kentucky Product Liability
Act is Kentucky Revised Statute (KRS) 411.310.
That statute
states in its entirety:
(1) In any product liability action, it
shall be presumed, until rebutted by a
preponderance of the evidence to the
contrary, that the subject product was not
defective if the injury, death or property
damage occurred either more than five (5)
years after the date of sale to the first
consumer or more than eight (8) years after
the date of manufacture.
(2) In any product liability action, it
shall be presumed, until rebutted by a
preponderance of the evidence to the
contrary, that the product was not defective
if the design, methods of manufacture, and
testing conformed to the generally recognized
and prevailing standards or the state of the
art in existence at the time the design was
prepared, and the product was manufactured.
The statute clearly sets forth two presumptions that the product
was not defective which exist "until rebutted by a preponderance
of the evidence to the contrary[.]"
To overcome these
presumptions and have his or her strict liability claim submitted
to a jury, a plaintiff must "present something more than a
-10-
conclusion that it was theoretically probable that a different
design would have been feasible and would have prevented his
injury . . . ."
Ingersoll Rand Co. v. Rice, Ky. App., 775 S.W.2d
924, 929 (1988).
The statutory presumptions of KRS 411.310 do no more
than leave the burden of proof with Leslie to prove that the
thermal unit was defective.8
Contrary to what CSZ has suggested,
Leslie does not have to prove that the unit was not designed in
accordance with the 1980 "state of the art."
The "sole question
in a products liability case," regardless of whether the case
involves failure to adequately warn, defective design, or other
products liability theories, is whether the product is defective.
Montgomery Elevator Co. v. McCullough, Ky., 676 S.W.2d 776, 782
(1984).
To attempt to prove that the thermal unit was defective
and to overcome the statutory presumptions of KRS 411.310, Leslie
relies on the deposition testimony of her expert witness, Dr.
William Campbell, who testified that the thermal unit's "first
deficiency" was its ability "to operate in any mode that could
8
See Rice, supra, at 928 (stating that the presumptions in
KRS 411.310 may "do nothing more than codify what the law has
always been" and that "the plaintiff must still prove by a
preponderance of the evidence that the product in question is
defective"); 2 Palmore, Kentucky Instructions to Juries, § 49.01
(1989), (the presumptions do "no more than to leave the burden of
proof, and the quantum of proof necessary to sustain it, exactly
where it was in the first place--with the plaintiff."). See also
Kentucky Rule of Evidence (KRE) 301.
-11-
produce injury to the patient" (i.e., usage in automatic mode
without a probe).
(Campbell deposition, p. 41.)
The heart of
Campbell's testimony is his assertion that the two safety
switches installed on the thermal unit were "redundant," meaning
that they would age and eventually fail at the same rate.
Campbell further testified that "fail-safe" technology regarding
different circuitry for the machine, which would have prevented
the thermal unit from overheating and burning Stanley, had
existed for over 60 years.
Campbell also testified that "[i]t doesn't matter
whether it [the thermal unit] was [properly] maintained or not"
because the thermal unit was "a product that had a built-in time
bomb [the redundant safety switches]."
According to Leslie,
therefore, the presumption in KRS 411.310 that the product was
not defective was overcome by Campbell's testimony that the
product was, in fact, defective and that standard circuitry
technology existed when the thermal unit in question was
manufactured which would have prevented Stanley's injuries and
death.
CSZ argues that Campbell was unable to state
authoritatively whether or not any medical devices manufactured
in 1980 used the valve/circuitry which Campbell alleges would
have prevented the accident.
Campbell did testify, however, that
at least one medical device (cystoscope) contains the safety
valves which he asserts should have been installed on the thermal
-12-
unit.
CSZ also asserts that Campbell admitted that he would not
be testifying at trial as to the state of the art for thermal
units in 1980.
Campbell stated in a deposition, however, that he
would testify as to the state of the art of the switches and
instruments in the thermal unit.
CSZ also contends that Leslie admitted that the thermal
unit was not maintained in accordance with CSZ's recommendations
by Central Baptist Hospital.
Campbell testified, however, that
proper use and maintenance would not have prevented Stanley's
injuries.
Furthermore, KRS 411.320(1), which stated that a
manufacturer would be held liable only for injury which would
have occurred if the product had been properly maintained, was
deemed to be repealed by the enactment of the comparative fault
statute (KRS 411.182) in Caterpillar, Inc. v. Brock, Ky., 915
S.W.2d 751, 753 (1996).
CSZ's argument that KRS 411.320(1) is
still in effect if product misuse is the sole cause of the injury
is irrelevant, as Campbell testified that Stanley's injuries
would have occurred whether or not the thermal unit was properly
maintained.
"The standard of review on appeal of a summary judgment
is whether the trial court correctly found that there were no
genuine issues as to any material fact and that the moving party
was entitled to judgment as a matter of law."
Ky. App., 916 S.W.2d 779, 781 (1996).
Scifres v. Kraft,
Furthermore, the trial
court must view the evidence in a light most favorable to the
-13-
party opposing the summary judgment motion, and summary judgment
should be granted only if it "appears impossible for the
nonmoving party to produce evidence at trial warranting a
judgment in his favor."
Steelvest, Inc. v. Scansteel Service
Center, Inc., Ky., 807 S.W.2d 476, 480-482 (1991).
Leslie
presented sufficient evidence through Campbell's testimony to
overcome CSZ's summary judgment motion.9
As Kentucky product liability law is not preempted by
the MDA, and as Leslie has presented sufficient evidence to
withstand CSZ's summary judgment motion, we conclude that the
trial court erred in granting summary judgment to CSZ.
The
judgment of the Fayette Circuit Court is reversed, and the case
is remanded for a jury trial.
ALL CONCUR.
9
This court is not required to defer to the determinations
of the trial court since factual findings are not at issue.
Scifres, supra, at 781.
-14-
BRIEFS FOR APPELLANT:
BRIEF FOR APPELLEE:
Gary L. Gardner
Anne Milton McMillan
Louisville, KY
B. Todd Thompson
Millicent A. Tanner
Louisville, KY
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