Source: https://www.druganddevicelawblog.com/2018/01/no-old-kentucky-home-for-parallel-fdca-based-tort-claims.html
Timestamp: 2019-07-24 09:05:56
Document Index: 672342668

Matched Legal Cases: ['§446', '§1983', '§446', '§446', '§446', '§446', '§446', '§446', '§446']

No Old Kentucky Home for Parallel FDCA-Based Tort Claims | Drug & Device Law
Home » No Old Kentucky Home for Parallel FDCA-Based Tort Claims
Our only other encounter with Kentucky FDCA-based negligence per se claims involved a misbegotten case that held such a claim wasn’t preempted, but didn’t address the claim’s viability under state law. See Steiden v. Genzyme BioSurgery, 2012 WL 2923225 (W.D. Ky. July 18, 2012)
We thought we’d look at this issue more closely. Here is what’s going on. The earlier of these cases, T & M, involved a peculiar state statute that “codifies the doctrine of negligence per se in Kentucky.” 189 S.W.3d at 530. That statute provides:
Ky. Rev. Stat. §446.070. In determining the scope of this statute, T & M construed it in pari materia (that’s legal Latin for “in conjunction with other provisions about the same subject”) with the rest of that chapter, pointing out that “numerous provisions in KRS Chapter 446 refer to ‘the statute laws of this state,’ and also repeatedly refer to acts or intent of ‘the General Assembly.’” 189 S.W.3d at 530 (footnotes containing citations omitted). Against that legislative background, the Kentucky Supreme Court concluded that plaintiffs claiming “injur[y] by the violation of any statute” in Kentucky were limited to asserting violations of Kentucky – not federal (or other state) – statutes:
Thus “any statute” in KRS 446.070 has been held to be limited to Kentucky statutes and not to federal statutes or local ordinances. The Kentucky General Assembly did not intend for KRS 446.070 to embrace the whole of federal laws and the laws of other states and thereby confer a private civil remedy for such a vast array of violations.
189 S.W.3d at 530 (footnotes containing citations omitted).
That limitation has been the law of Kentucky ever since. In St. Luke Hospital, Inc. v. Straub, 354 S.W.3d 529 (Ky. 2011), a case involving (state) constitutional civil rights litigation, the Kentucky high court reiterated this holding while rejecting the plaintiff’s state-law analogy to 42 U.S.C. §1983:
Precedent acknowledges some restrictions on the applicability of KRS 446.070. The “any statute” language used applies to Kentucky statutes. Our courts have considered the application of the statute to federal laws and regulations. . . . Violations of federal laws and regulations . . . do not create a cause of action based on KRS 446.070.
354 S.W.3d at 534 & nn.10, 14 (citing T & M). Other Kentucky courts continue to follow these holdings that plaintiffs claiming injuries from statutory/regulatory violations under Kentucky law cannot assert violations of federal enactments. Harrison Memorial Hospital, Inc. v. Wellcare Health Insurance Co., 509 S.W.3d 69, 75 (Ky. App. 2016) (no negligence per se or other private recovery for alleged Medicaid reimbursement violations), review denied (Ky. Feb. 9, 2017); Brock v. Bennett, 2015 WL 136330, at *4 (Ky. App. Jan. 9, 2015) (no negligence per se based on alleged violation of Federal Building Code), review denied (Ky. Sept. 16, 2015); Jackson v. JB Hunt Transportation, Inc., 384 S.W.3d 177, 182-83 (Ky. App. 2012), review denied (Ky. Dec. 12, 2012) (no negligence per se based on alleged violation of federal trucking regulations); Gordon v. Turner, 2016 WL 3636073, at *7-8 (E.D. Ky. June 29, 2016) (same as Jackson); Gonzalez v. City of Owensboro, 2015 WL 4594505, at *8 (W.D. Ky. July 30, 2015) (no negligence per se based on alleged violation of National Electrical Code); Wise v. Pine Tree Villa, LLC, 2015 WL 1611804, at *3 (W.D. Ky. April 10, 2015) (no negligence per se based on alleged violation of federal regulations governing certification of long-term care facilities); Halcomb v. Britthaven, Inc., 2015 WL 998560, at *4 (E.D. Ky. March 5, 2015) (same as Wise); Vanhook v. Somerset Health Facilities, LP, 67 F. Supp.3d 810, 817-18 (E.D. Ky. 2014) (no negligence per se based on alleged violation of federal Social Security regulations); Kelter v. Wasp, Inc., 2014 WL 4639914, at *8 (W.D. Ky. Sept. 16, 2014) (no negligence per se based on alleged violation of federal OSHA regulations); McCarty v. Covol Fuels No. 2, LLC, 978 F. Supp.2d 799, 808-09 (W.D. Ky. 2013) (no negligence per se based on alleged violation of federal mine safety regulations); Pace v. Medco Franklin RE, LLC, 2013 WL 3233469, at *2 (W.D. Ky. June 25, 2013) (same as Wise); Cummins v. BIC USA, Inc., 2011 WL 1399768, at *3 (W.D. Ky. April 13, 2011) (no negligence per se based on alleged violation of federal childproofing regulation).
Notably in Young v. Carran, 289 S.W.3d 586 (Ky. App. 2008), a plaintiff seeking to recover for purported HIPAA violations, after losing under Ky. Rev. Stat. §446.070, tried to maintain the same claim under some sort of residual “common law” negligence per se theory that supposedly survived the legislature’s action. That gossamer-thin attempted distinction also failed, with a unanimous court holding:
[Plaintiff] next contends that [HIPAA regulations] impose a duty of care on Appellees allowing for a Kentucky “common law” negligence per se claim. [plaintiff’s] reliance upon T & M . . . in support of her argument is misplaced. In that case, the Supreme Court of Kentucky used provisions of [a] federal [statute] to define a duty of care for purposes of a common law negligence action − not a KRS 446.070 negligence per se claim. Indeed, the Court expressly refused to apply the act in a negligence per se context. Therefore, her claim must be rejected.
Id. at 589 (citations omitted). There is thus no “lingering” common law out there. Sadler v. Advanced Bionics, Inc., 929 F. Supp.2d 670, 681 n.10 (W.D. Ky. 2013).
In drug/medical device litigation, Kentucky courts that have addressed the issue have held that Ky. Rev. Stat. §446.070 bars all negligence per se claims asserting violations of the FDCA or FDA regulations. Waltenburg v. St. Jude Medical, Inc., 33 F. Supp.3d 818, 837 (W.D. Ky. 2014); Sadler, 929 F. Supp.2d at 681.
We think that these cases, while correctly decided, do not do §446.070 justice. The statute isn’t limited to negligence per se, indeed the statute is not targeted against any particular cause of action. Rather, the legislature cast its statutory net much more broadly − the universe of claims covered by §446.070 extends to any “person injured by the violation of any statute.” That language reaches any supposed “parallel” claim, no matter how captioned. The recent decision, Moore v. Zydus Pharmaceuticals (USA), Inc., ___ F. Supp.3d ___, 2017 WL 4365162 (E.D. Ky. Sept. 29, 2017), involving generic drugs, rather than medical devices, thus took a step in the right direction in holding that §446.070 precluded any “negligence” claim, not merely one denominated “negligence per se.”
The Kentucky Supreme Court’s holding in T & M . . . offers binding and unequivocal precedent concerning the scope of KRS 446.070 and demonstrates that [plaintiff] does not have a state based right to sue for negligence in this matter.
Id. at *7. We think the same thing could be said for any “parallel” claim, whether purporting to sound in strict liability, warranty, or any other theory. As long as the claim is brought by a “person injured by the violation of any statute” – which parallel claims, by their nature, must be – then, quite apart from preemption, they may not be brought under Ky. Rev. Stat. §446.070. We also note that the same result could also be reached under implied preemption under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), since in §446.070 the Kentucky legislature abolished any “parallel” state-law action.
Tags: Kentucky, Negligence Per Se