RENDERED: OCTOBER 29, 2020 TO BE PUBLISHED
Supreme Court of Kentucky 2019-SC-0118-DG
CLIFFORD RUSSELL, SR. AND APPELLANTS JEANENE RUSSELL
ON REVIEW FROM COURT OF APPEALS V. NOS. 2017-CA-0866 AND 2018-CA-0195 FAYETTE CIRCUIT COURT NO. 16-CI-02180
JOHNSON & JOHNSON, INC., BIOSENSE APPELLEES WEBSTER, INC., JOHNSON & JOHNSON CONSUMER COMPANIES, INC., JOHNSON & JOHNSON INNOVATION JJDC, INC. F/K/A JOHNSON & JOHNSON DEVELOPMENT CORPORATION, AND BAPTIST HEALTH LEXINGTON ASC OF BAPTIST HEALTHCARE SYSTEM, INC.
OPINION OF THE COURT BY JUSTICE WRIGHT
REVERSING AND REMANDING
Appellants, Clifford Russell and his wife Jeanene, filed suit against
Appellees, Biosense,1 alleging state tort claims due to injuries caused by a
Class III medical device. Biosense moved for judgment on the pleadings based
on federal preemption of all claims. The trial court granted the motion, and
Court of Appeals affirmed. We reverse due to the Kentucky Rules of Civil
Procedure as detailed below.
1 “Biosense” collectively refers to Johnson & Johnson, Inc.; Biosense Webster, Inc.; Johnson & Johnson Consumer Companies, Inc.; and Johnson & Johnson Innovation JJDC, Inc. I. BACKGROUND
The Medical Device Amendments of 1976 (“MDA”) to the Federal Food,
Drug, and Cosmetic Act classifies medical devices among three categories
depending on their risk levels. 21 U.S.C. § 360(a)(1). Of relevance to this
appeal, a Class III medical device has the most potential for danger and “(I) is
purported or represented to be for a use in supporting or sustaining human life
or for a use which is of substantial importance in preventing impairment of
human health, or (II) presents a potential unreasonable risk of illness or
injury.” Id. § 360(a)(1)(C)(ii).
Class III medical devices have the most oversight and must generally
receive premarket approval from the Food & Drug Administration (“FDA”),
which is a rigorous process. See Riegel v. Medtronic, Inc., 552 U.S. 312, 315-17
(2008). “Manufacturers must submit detailed information regarding the safety
and efficacy of their devices, which the FDA then reviews, spending an average
of 1,200 hours on each submission.” Medtronic, Inc. v. Lohr, 518 U.S. 470, 477
(1996). Importantly, the MDA contains a limited preemption2 clause:
Except as provided in subsection (b), 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 Act 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 Act.
2 “Preemption” is correctly spelled both with and without a hyphen. We have chosen the unhyphenated version of the word in our opinion, however quotes herein from other courts often use the hyphenated version. Both are equally correct.
2 21 U.S.C. § 360(k)(a) (emphasis added).
This limited preemption clause only applies to state “requirements,”
meaning state standards and regulations—not state claims and causes of
action. The definition of “preemption” provides further guidance: “The principle
(derived from the Supremacy Clause) that a federal law can supersede or
supplant any inconsistent state law or regulation.” PREEMPTION, Black's Law
Dictionary (11th ed. 2019).
Therefore, when this preemption clause applies, it only preempts the
state regulations that apply to the medical device. This preemption is not a
blanket federal preemption of state causes of action; rather, it allows state
claims that seek to impose parallel standards on the medical device. Those
state standards cannot be more stringent than the federal standards that are
“applicable to the [specific medical] device.” The federal regulations must be
specific to the device in order to preempt state standards that are the basis for
state causes of action.
There are exceptions to the premarket approval process, such as the
investigational device exemption at issue in this case. 21 U.S.C. § 360j(g). The
investigational device exemption “permits a device that otherwise would be
required to comply with a performance standard or to have premarket approval
to be shipped lawfully for the purpose of conducting investigations of that
device.” 21 C.F.R. § 812.1. Its purpose is to allow medical devices without
premarket approval—“to the extent consistent with the protection of public
3 health and safety and with ethical standards,” Id.,—to be used in human trials
“as early in the device development process as possible.” 21 C.F.R. § 812.36(a).
The FDA approved the ThermoCool SmartTouch SF Catheter (“SF
Catheter”), a Class III medical device, under the investigational device
exemption for human trials. The SF Catheter was developed, manufactured,
and marketed by Biosense. Less than a month after approval, Mr. Russell
underwent a cardiac ablation procedure to treat his heart condition, and the
SF Catheter was used. During the ablation procedure, electrical energy was
delivered through the SF Catheter to the heart tissue, which resulted in
burning and destroying heart tissue to achieve the desired result. If the device
were to burn the heart or vein in the wrong location or deeper than intended,
then it could result in severe damage to the heart or vein.
Unfortunately, the SF Catheter perforated Mr. Russell’s pulmonary vein,
which resulted in numerous life-threatening events. Approximately fourteen-
months after Mr. Russell’s surgery, the SF Catheter received full premarket
approval, but importantly the SF Catheter was only at the investigational
device exemption stage at the time of the surgery.
Mr. Russell and his wife Jeanene, filed suit against Biosense, asserting
claims for strict liability, negligence, lack of informed consent, failure to warn,
breach of express and implied warranties, fraud, unjust enrichment, and
violation of Kentucky’s Consumer Protection Act. Biosense answered and
moved for judgment on the pleadings based upon federal preemption of all
claims.
4 The trial court held a hearing on the motion and granted Biosense’s
motion for judgment on the pleadings, which dismissed all Appellants’ claims;
the Court of Appeals affirmed. Appellants then filed a motion for discretionary
review to this Court, which we granted. We now reverse the Court of Appeals.
A. Standard of Review
Judgment on the pleadings is a question “of law and requires an
examination of the pleadings.” Archer v. Citizens Fidelity Bank & Trust Co., 365
S.W.2d 727, 729 (Ky. 1962). Therefore, we conduct a de novo review. See
Schultz v. Gen. Elec. Healthcare Fin. Servs., Inc., 360 S.W.3d 171, 177 (Ky.
2012).
B. Preemption and Parallel State Claims
From the outset, we note that even if a device has received FDA
premarket approval and federal preemption applies, parallel state claims are
allowed to proceed in state court. Specifically, the Supreme Court of the
United States stated “the MDA expressly pre-empts only state requirements
‘different from, or in addition to, any requirement applicable . . . to the device’
under federal law.” Riegel, 552 U.S. at 321 (quoting 21 U.S.C. § 360K(a)(1)).
Importantly, the first time the Riegels “argue[d] that their lawsuit raise[d]
parallel claims” was at the United States Supreme Court, and “they made no
such contention in their briefs before the Second Circuit, nor did they raise
[the] argument in their petition for certiorari.” Id. at 330. Therefore, the
Supreme Court “decline[d] to address that argument” but noted the trial court
“recognized that parallel claims would not be pre-empted.” Id. at 330.
5 As the United States Court of Appeals for the Tenth Circuit clarified:
To the extent the state law duty is narrower than or equal to the federal duty it survives, through what seems a sort of Venn diagram approach to preemption. Still, even if the state claim fails that test because it would impose a “broader” duty than can be found in federal law, it appears we may not find the claim preempted just because it conflicts with “any” federal requirement. Instead, we may find the state law claim preempted only if there exists a device-specific federal requirement
Caplinger v. Medtronic, Inc., 784 F.3d 1335, 1340 (10th Cir. 2015).
In Caplinger, the medical device completed “the premarket approval
process,” so the Court held “[t]here’s no dispute . . . device specific federal
requirements apply.” (emphasis added). Thus, the state claims were not
preempted as long as the “federal requirements impose duties that are at least
as broad as those [the plaintiff] seeks to vindicate through state law.” Id. at
1340.
The United States “Supreme Court has twice addressed the limited
scope of this preemption provision.” Bausch v. Stryker Corp., 630 F.3d 546,
550 (7th Cir. 2010) (emphasis added). The Seventh Circuit analyzed both
cases—Riegel and Lohr—and clarified “[n]either case held that state lawsuits
premised on violations of federal law are preempted under section 360k(a). In
fact, the Court’s opinions in Lohr and Riegel expressly left the door open for
state law claims based on violations of federal law.” Id. at 550.
The Ninth Circuit has held “the MDA does not preempt a state-law claim
for violating a state-law duty that parallels a federal-law duty under the MDA.”
Stengel v. Medtronic Inc., 704 F.3d 1224, 1228 (9th Cir. 2013). As to specific
6 parallel claims, the Fifth Circuit has held “claims for negligent failure to warn
or negligent manufacturing of a device are not preempted, provided that such
claims are premised entirely on violation of the applicable federal
requirements.” Hughes v. Boston Scientific Corp., 631 F.3d 762, 770 (5th Cir.
2011). Further, Hughes “conclude[d] that invoking the negligence per se
doctrine to support a negligence claim that is otherwise parallel to federal
requirements is not expressly preempted.” Id. at 772.
Here, in contrast to the above cases, the SF Catheter had not received
FDA premarket approval and only had investigational device exemption status.
Although the SF Catheter ultimately received FDA premarket approval, it was
approximately fourteen-months after Mr. Russell’s surgery. Even if we assume
medical devices with the investigational device exemption are able to qualify for
federal preemption, Kentucky’s parallel tort claims are allowed; the federal
preemption would only restrict the state standard that applies to the device.
None of the above-cited cases stand for the proposition that parallel tort
claims cannot be filed in state courts. Instead, the cases make clear the
limited federal preemption only applies to the extent Kentucky’s parallel tort
claims seek to impose a higher standard than federal law; our claims must be
in harmony with the federal regulations.
Justice Ginsburg’s Riegel dissent provides insight; she quoted “the
former chief counsel to the FDA” as stating “that FDA product approval and
state tort liability usually operate independently, each providing a significant,
yet distinct, layer of consumer protection. . . . . Preemption of all such
7 claims would result in the loss of a significant layer of consumer protection . . .
.” 552 U.S. at 337-38 (emphasis added). We agree and reiterate that
Kentucky’s parallel tort claims are not preempted by federal law.
If a state tort standard imposes a higher duty than federal regulations,
the state standard is only preempted to the extent it imposes a more stringent
duty; as long as the state cause of action seeks to vindicate a claim within the
boundaries of the federal regulation, it survives. Further, even with a fully
premarket approved device, if a state claim is premised on a violation of a
federal regulation, it is not a federally preempted claim. Last, we note “[t]he
medical device amendments does not preempt state punitive damage
remedies.” Niehoff v. Surgidev Corp., 950 S.W.2d 816, 822 (Ky. 1997).
As a precursor, it was necessary for us to clarify these principles. We
now turn to the Kentucky Rules of Civil Procedure, upon which the outcome of
this case turns.
C. Judgment on the Pleadings
Under Kentucky Civil Rule 12.03, “[a]fter the pleadings are closed but
within such time as not to delay the trial, any party may move for judgment on
the pleadings.” The moving party “admits for the purposes of his motion not
only the truth of all his adversary’s well-pleaded allegations of fact and fair
inferences therefrom, but also the untruth of all his own allegations which have
been denied by his adversary.” Pioneer Vill. v. Bullitt Cnty., 104 S.W.3d 757,
759 (Ky. 2003) (citing Archer, 365 S.W.2d 727). Importantly, a motion for
judgment on the pleadings should never be granted unless “it appears beyond
8 doubt that the nonmoving party cannot prove any set of facts that would entitle
him/her to relief.” Id. (citing Spencer v. Woods, 282 S.W.2d 851 (Ky. 1955)).
Furthermore, as our predecessor Court stated, if “the pleadings raise any issue
of material fact,” then a judgment on the pleadings “should be denied.” La
Vielle v. Seay, 412 S.W.2d 587, 590 (Ky. 1966).
1. Kentucky Pleading Standard
“Kentucky is a notice pleading jurisdiction, where the ‘central purpose of
pleadings remains notice of claims and defenses.’” Pete v. Anderson, 413
S.W.3d 291, 301 (Ky. 2013) (citing Hoke v. Cullinan, 914 S.W.2d 335, 339 (Ky.
1995)). In accordance with Kentucky Civil Rule 8.01(1), “[a] pleading which
sets forth a claim for relief . . . shall contain (a) a short and plain statement of
the claim showing that the pleader is entitled to relief and (b) a demand for
judgment for the relief to which he deems himself entitled.” As interpreted by
this Court, “[i]t is not necessary to state a claim with technical precision under
this rule, as long as a complaint gives a defendant fair notice and identifies the
claim.” Grand Aerie Fraternal Order of Eagles v. Carneyhan, 169 S.W. 3d 840,
844 (Ky. 2005) (citing Cincinnati, Newport, & Covington Transp. Co. v. Fischer,
357 S.W.2d 870, 872 (Ky. 1962)).
Importantly, “[w]e no longer approach pleadings searching for a flaw, a
technicality upon which to strike down a claim or defense, as was formerly the
case at common law.” Smith v. Isaacs, 777 S.W.2d 912, 915 (Ky. 1989). When
reviewing a complaint to determine whether it states a cause of action, it
“should be liberally construed.” Morgan v. O’Neil, 652 S.W.2d 83, 85 (Ky.
9 1983). Our liberal pleading standard was recently demonstrated when we held
that a complaint “couched in general and conclusory terms, complied with CR
8.01(1).” KentuckyOne Health, Inc. v. Reid, 522 S.W.3d 193, 197 (Ky. 2017).
Applying Kentucky’s well-established notice pleading principles, we hold
Appellant’s complaint alleged a sufficient cause of action to survive a motion
for judgment on the pleadings. We refuse to mandate a heightened pleading
standard and, therefore, reiterate Kentucky’s requirement of bare-bones, notice
pleading.
Here, Biosense asserts a complaint must include the specific federal
regulations violated in order to survive a judgment on the pleadings; we
disagree. Although Biosense appears to cite federal cases supporting this
position, those cases were evaluated under the more stringent, federal pleading
standard. Biosense does not cite any Kentucky cases on our pleading
standard; and notably, Kentucky’s pleading standard is more lenient. See
Combs v. ICG Hazard, LLC, 934 F. Supp. 2d 915, 923 (E.D. Ky. 2013). Combs
clarified “the [United States Supreme Court] altered the federal pleading
standard by making it more stringent for plaintiffs,” and held “Kentucky’s
pleading standard is more lenient than the federal rules.” Id.
As we have held, “[t]he federal rules of procedure . . . are applicable to
the proceedings in federal court and are not to be applied to practice or
procedure in state courts.” Steelvest, Inc. v. Scansteel Serv. Ctr., Inc., 807
S.W.2d 476, 483 (Ky. 1991). In Kentucky, “[i]t is vital that we not sever
10 litigants from their right of trial, if they do in fact have valid issues to try, just
for the sake of efficiency and expediency.” Id.
Biosense’s counsel asserted the Russells conceded they were not alleging
parallel claims to the trial court. However, that assertion is inaccurate. At the
hearing on the motion for judgment on the pleadings, the Russells repeatedly
informed the trial court they were alleging parallel claims under Kentucky law.
At first, the Russells stated they alleged parallel claims but not a violation of
FDA regulations, then the Russells clarified they were alleging Biosense
“violated FDA regulations” and “those violations under federal laws parallel
recognized claims under state law.” The Russells also informed the trial court
about their absence of FDA regulations due to lack of discovery; they attempted
to conduct discovery to gather more information. Biosense objected, refused to
answer every question, refused to produce documents, and then attempted to
block further discovery by filing a motion for judgment on the pleadings.
In Kentucky, our high standard necessary for granting a judgment on the
pleadings requires there be no possible way the opposing party can prevail.
This mitigates the concern of a party being shut out before resolving legitimate
claims in court. The denial of a judgment on the pleadings allows for discovery
on legitimate claims. We also find guidance from the Seventh Circuit, which
stated “courts must keep in mind that much of the product-specific
information about manufacturing needed to investigate such a claim fully is
kept confidential by federal law. Formal discovery is necessary before a
plaintiff can fairly be expected to provide a detailed statement of the specific
11 bases for her claim.” Bausch, 630 F.3d at 558 (emphasis added). We agree
with the Seventh Circuit and believe discovery is necessary. Before discovery,
plaintiffs simply don’t know what they don’t know.
Biosense asks this Court to determine whether “Plaintiffs have stated a
non-preempted cause of action.” This very question demonstrates the depth of
misunderstanding of this federal preemption issue. As noted, state claims and
causes of action are not federally preempted; only state standards that are
more stringent than device-specific federal regulations are federally preempted.
Further, a state claim based upon a violation of an applicable federal regulation
or parallel state standard can proceed in state court. Confusion can easily
result if the parties fail to differentiate between more stringent state standards,
which are preempted, and parallel state causes of action, which may proceed in
state court.
Among other viable claims, the Russells pleaded both negligence in
manufacturing and failing to inform/warn. As the Seventh Circuit already
clarified, those claims are not preempted as long as they are being used within
the boundaries of the applicable federal regulations. This Court agrees.
Further, the Russells expanded upon their claims by notifying the trial court
they were asserting parallel claims under Kentucky law because our claims
parallel “those violations under federal laws.” Therefore, under Kentucky’s
notice pleading standard, the Russells’ complaint sufficiently put Biosense on
notice of parallel claims that may not be preempted.
12 II. CONCLUSION
Under Kentucky’s notice pleading standards, the motion for judgment on
the pleadings should have been denied. Even if investigational medical devices
(such as the SF Catheter at the time it was used with Mr. Russell) qualify for
federal preemption, a party may pursue parallel state tort claims, and those
claims are not preempted under federal law. Here, under Kentucky’s notice
pleading standard, Biosense was properly put on notice of parallel claims. We
reverse the Court of Appeals, and this case is remanded to the trial court for
proceedings consistent with this opinion.
Minton, C.J.; Hughes, Keller, Lambert, and VanMeter, JJ., sitting. All
concur. Nickell, J., not sitting.
13 COUNSEL FOR APPELLANTS:
Kevin Crosby Burke Jamie Kristin Neal Burke Neal PLLC
Anne Louise Gilday Jennifer Lee Lawrence The Lawrence Law Firm
COUNSEL FOR APPELLEES JOHNSON & JOHNSON, INC., BIOSENSE WEBSTER, INC., JOHNSON & JOHNSON CONSUMER COMPANIES, INC., AND JOHNSON & JOHNSON INNOVATION JJDC, INC. F/K/A JOHNSON & JOHNSON DEVELOPMENT CORPORATION:
Lori Elizabeth Hammond Charles Martin Pritchett Jr. Jason Patrick Renzelmann Frost Brown Todd LLC
James F. Murdica Barnes & Thornburg, LLP
COUNSEL FOR APPELLEE BAPTIST HEALTH LEXINGTON ASC OF BAPTIST HEALTHCARE SYSTEM, INC.:
David T. Klapheke Boehl, Stopher & Graves, LLP