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Russell v. Johnson & Johnson, Inc.

Court of Appeals of Kentucky

November 9, 2018



          BRIEFS FOR APPELLANTS: Jennifer L. Lawrence Anne L. Gilday Covington, Kentucky Kevin C. Burke Jamie K. Neal Louisville, Kentucky.

          BRIEFS 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.




          NICKELL, JUDGE.

         Clifford 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[2] 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.


         On 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[3] under the Investigational Device Exemption ("IDE")[4] 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.

         Suffering from PAF, Clifford was a candidate for cardiac ablation using the Class III[5] IDE. On June 24, 2015, Clifford executed "Consent to Take Part in a Research Study"[6] 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 procedure persist.

         On June 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.

         Relying 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.

         On September 6, 2017, Biosense announced a voluntary recall of various catheters including the same model used on Clifford, but different lot numbers.[7] 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[8] 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.


         The 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.

         Federal 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 Clause.

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).

         Whether 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).


         Riegel 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.

         While 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 procedure.

         Russell 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, 2009).

         In 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 ...

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