CLIFFORD RUSSELL, JR. AND JEANENE RUSSELL APPELLANTS
JOHNSON & JOHNSON, INC.; BIOSENSE WEBSTER, INC.; JOHNSON & JOHNSON CONSUMER COMPANIES, INC.; JOHNSON & JOHNSON INNOVATION JJDC, INC.; AND BAPTIST HEALTH LEXINGTON ASC OF BAPTIST HEALTHCARE SYSTEM, INC. APPELLEES
APPEALS FROM FAYETTE CIRCUIT COURT HONORABLE JAMES D.
ISHMAEL, JR., JUDGE ACTION NO. 16-CI-02180.
FOR APPELLANTS: Jennifer L. Lawrence Anne L. Gilday
Covington, Kentucky Kevin C. Burke Jamie K. Neal Louisville,
FOR APPELLEES: JOHNSON & JOHNSON, INC.; BIOSENSE WEBSTER,
INC.; JOHNSON & JOHNSON CONSUMER COMPANIES, INC.; AND
JOHNSON & JOHNSON INNOVATION JJDC, INC.: James F.
Murdica, pro hac vice Chicago, Illinois Lori E. Hammond Jason
P. Renzlemann Louisville, Kentucky.
BAPTIST HEALTH LEXINGTON ASC OF BAPTIST HEALTHCARE SYSTEM,
INC. No brief filed.
BEFORE: JOHNSON, MAZE AND NICKELL, JUDGES.
Russell, Jr. ("Clifford") and his wife, Jeanene
(collectively "Russell"), appeal from two rulings
entered by the Fayette Circuit Court in a products liability
case stemming from testing of an experimental heart catheter.
The first opinion and order, entered May 9, 2017, dismissed
all claims with prejudice and granted Biosense judgment on
the pleadings under CR 12.03 after finding all claims were
preempted by federal law. 21 U.S.C.A. § 360k(a)(1). A
second opinion and order, entered January 29, 2018, denied a
CR 60.02(b) motion filed by Russell. Deeming the desired
evidence-adverse events suffered by other patients and a
voluntary recall of specific catheters-to be neither new nor
material, and finding no compelling reason to grant
extraordinary relief, the trial court declined to set aside
the prior judgment, allow Russell to try to amend the
complaint to allege a parallel state claim, or conduct
discovery. Following a thorough review of the record, briefs
and law, we affirm.
AND PROCEDURAL BACKGROUND
November 5, 2004, Biosense received approval of the
THERMOCOOL® catheter via the PMA process. Approval was
based in part on reasonable assurance from Biosense to the
FDA the catheter was both safe and effective. 21 U.S.C.
§ 360e(d)(2). On June 2, 2015, the FDA approved use of
the THERMOCOOL® SMARTTOUCH® SF Catheter under the
Investigational Device Exemption
("IDE") to the Medical Device Amendments of 1976
("MDA"). Approval under the IDE paved the way for a
clinical trial to evaluate this catheter's safety in
treating paroxysmal atrial fibrillation ("PAF")-a
type of irregular heartbeat.
from PAF, Clifford was a candidate for cardiac ablation using
the Class III IDE. On June 24, 2015, Clifford executed
"Consent to Take Part in a Research
Study" of the catheter. That same day, he
voluntarily underwent the typically outpatient procedure.
Unexpectedly, his heart sustained a tear resulting in the
ablation being aborted and emergency surgery to repair the
tear. Clifford claims health issues from the aborted
13, 2016, Russell filed suit against Biosense alleging
Clifford was seriously injured by use of the catheter they
described as "unreasonably dangerous and defective"
due to its design, testing, warnings, labeling and
instructions. Seeking both compensatory and punitive damages,
Russell alleged strict liability, negligence, lack of
informed consent, failure to warn, breach of both express and
implied warranties, fraud and fraudulent concealment, unjust
enrichment, loss of consortium, and violation of the KCPA.
Biosense answered the complaint arguing all claims were
preempted by 21 U.S.C.A. 360k(a)(1) and seeking dismissal
under CR 12.02. In response to the defense motion to dismiss,
Russell sought leave under CR 15.03 to amend the complaint to
allege state law claims paralleling federal violations and to
proceed with discovery.
heavily on Riegel v. Medtronic, Inc., 552 U.S. 312,
317, 128 S.Ct. 999, 1003, 169 L.Ed.2d 892 (2008)-the latest
pronouncement from the United States Supreme Court on federal
preemption of state tort claims against manufacturers of
Class III medical devices granted an IDE-the trial court
dismissed the complaint with prejudice after finding
Russell's alleged claims were preempted by operation of
21 U.S.C.A. § 360k(a)(1). The trial court specifically
found Biosense was correct in arguing the catheter used
during Clifford's procedure was part of an FDA-approved
IDE clinical trial and subject to federally-imposed
requirements regarding "the investigational plan,
design, manufacturing techniques, clinical protocol, warning
or consent form which could potentially affect clinical
subjects." The trial court concluded the claims were
preempted because the IDE and PMA processes impose
device-specific requirements pertaining to safety and
effectiveness and the complaint attempted to impose different
or additional state law requirements contrary to 21 U.S.C.A.
§ 360k(a). The trial court denied as "futile"
Russell's request to amend the complaint and pursue
discovery, noting when asked at oral argument, Russell could
identify no violation of federal law and no corresponding
parallel state law claim. Russell filed a timely notice of
appeal from judgment on the pleadings.
September 6, 2017, Biosense announced a voluntary recall of
various catheters including the same model used on
Clifford, but different lot
numbers. Via CR 60.02 motion, Russell asked the
trial court to set aside the prior dismissal, allow amendment
of the complaint to assert a parallel state claim, and permit
discovery. The trial court again found Russell could assert
no parallel state claim and the extraordinary relief provided
by CR 60.02 was unavailable because the recall did not
include the catheter used during Clifford's procedure.
Furthermore, the trial court found granting relief based on
the voluntary recall- which occurred after entry of
judgment-would vitiate the concept of finality. West Vale
Homeowners' Ass'n, Inc. v. Small, 367 S.W.3d
623, 628 (Ky. App. 2012). Finally, the trial court noted,
despite adverse event reports and the voluntary recall-all of
which were documented on the FDA's public
website and available to Russell-the FDA still
granted the catheter full PMA on August 11, 2016, ultimately
deeming it safe and effective for the treatment of PAF.
Russell again filed timely notice of appeal. Pursuant to
Russell's unopposed motion, we have consolidated the two
appeals for treatment in a single opinion. We affirm both
trial court rulings.
1960s and 1970s saw an increase in the marketing of medical
devices with mixed results-some devices worked; others-like
the Dalkon Shield intrauterine device-failed.
Riegel, 552 U.S. at 316, 128 S.Ct. at 1003.
Regulation of the devices was generally left to the states
until 1976, when Congress adopted the MDA to the Federal
Food, Drug and Cosmetic Act of 1938. From that point forward,
the FDA was authorized to approve and regulate medical
devices under 21 U.S.C.A. § 371(a). States were
thereafter prohibited from imposing different or additional
requirements relating to safety, effectiveness or any other
federally-regulated attribute of a medical device.
Riegel, 552 U.S. at 316, 128 S.Ct. at 1003. 21
U.S.C.A. § 360k(a) recites the general rule:
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.
preemption, as explained in Cipollone v. Liggett Group,
Inc., 505 U.S. 504, 516, 112 S.Ct. 2608, 2617, 120
L.Ed.2d 407 (1992), is rooted in our nation's Supremacy
Article VI of the Constitution provides that the laws of the
United States "shall be the supreme Law of the Land; . .
. any Thing in the Constitution or Laws of any state to the
Contrary notwithstanding." Art. VI, cl. 2. Thus, since
our decision in M'Culloch v. Maryland, 17 U.S.
(4 Wheat.) 316, 427, 4 L.Ed. 579 (1819), it has been settled
that state law that conflicts with federal law is
"without effect." Maryland v. Louisiana,
451 U.S. 725, 746, 101 S.Ct. 2114, 2128, 68 L.Ed.2d 576
(1981). Consideration of issues arising under the Supremacy
Clause "start[s] with the assumption that the historic
police powers of the States [are] not to be superseded by . .
. Federal Act unless that [is] the clear and manifest purpose
of Congress." Rice v. Santa Fe Elevator Corp.,
331 U.S. 218, 230, 67 S.Ct. 1146, 1152, 91 L.Ed. 1447 (1947).
Accordingly, "'[t]he purpose of Congress is the
ultimate touchstone'" of pre-emption analysis.
Malone v. White Motor Corp., 435 U.S. 497, 504, 98
S.Ct. 1185, 1189, 55 L.Ed.2d 443 (1978) (quoting Retail
Clerks v. Schermerhorn, 375 U.S. 96, 103, 84 S.Ct. 219,
222, 11 L.Ed.2d 179 (1963)).
Congress' intent may be "explicitly stated in the
statute's language or implicitly contained in its
structure and purpose." Jones v. Rath Packing
Co., 430 U.S. 519, 525, 97 S.Ct. 1305, 1309, 51 L.Ed.2d
604 (1977). In the absence of an express congressional
command, state law is pre-empted if that law actually
conflicts with federal law, see Pacific Gas & Elec.
Co. v. State Energy Resources Conservation and Development
Comm'n, 461 U.S. 190, 204, 103 S.Ct. 1713, 1722, 75
L.Ed.2d 752 (1983), or if federal law so thoroughly occupies
a legislative field "'as to make reasonable the
inference that Congress left no room for the States to
supplement it.'" Fidelity Fed. Sav. & Loan
Assn. v. De la Cuesta, 458 U.S. 141, 153, 102 S.Ct.
3014, 3022, 73 L.Ed.2d 664 (1982) (quoting Rice v. Santa
Fe Elevator Corp., 331 U.S., at 230, 67 S.Ct., at 1152).
Congressional intent is express or implied, preemption is
mandatory when the intention exists and a state regulation
conflicts therewith. State Farm Bank v.
Reardon, 539 F.3d 336, 342 (6th Cir. 2008).
was a product liability suit filed after a heart catheter
ruptured when inflated beyond the pressure recommended by the
FDA-approved label. Riegel claimed the catheter was defective
under New York state law. The United States Supreme Court
held Riegel's claims were expressly preempted by the MDA
because New York's common law attempted to impose tougher
safety requirements than those imposed by the FDA.
similar in some respects to the facts we review today,
Riegel is not a mirror image of our case. The Class
III catheter at the heart of Riegel received PMA
from the FDA prior to its challenged use. In
contrast, the catheter used during Clifford's procedure
was approved for clinical testing as an IDE at the time of
use and received full PMA after Clifford's
urges us to discount Riegel because the catheter did
not have PMA at the time of Clifford's procedure. While
Russell has seized upon a distinction between this case and
Riegel, we follow the lead of some federal
courts-albeit in unpublished decisions-finding the timing of
a grant of PMA to a device previously approved for clinical
testing under an IDE, to be immaterial. Dorsey v.
Allergan, Inc., 3:08-0731, 2009 WL 703290, at *5 (M.D.
Tenn. Mar. 11, 2009) (whether PMA follows IDE for human
testing is "distinction without a difference.").
See also Williams v. Allergan USA, Inc.,
CV-09-1160-PHX-GMS, 2009 WL 3294873, at *4 (D. Ariz. Oct. 14,
another unpublished case, a different federal court found
approval of IDE devices to be synonymous with PMA, writing:
[b]ecause IDE devices are subject to a level of FDA oversight
and control that is, for the purpose of a preemption
analysis, identical to that governing PMA devices, the body
of preemption law governing PMA devices applies equally to
the IDE device at issue in this case. See Martin v.
Telectronics Pacing Sys., Inc., 105 F.3d 1090 (6th
Cir.1997) (applying PMA preemption analysis to IDE
regulations); Becker [v. Optical Radiation
Corp., 66 F.3d 18, 21 (2d Cir.1995)] (applying PMA line
of cases to optical device subject to regulations effectively
identical to IDE regulations); Ber ...