Williams v. Quest Diagnostics, Inc.

• Decision Date: 18 October 2018
• Docket Number: C/A No. 3:16-cv-00972-MBS
• Citation: 353 F.Supp.3d 432
• Parties: Amy Elizabeth WILLIAMS as the Personal Representative of the Estate for [Redacted], and Amy Elizabeth Williams, Individually, Plaintiffs, v. QUEST DIAGNOSTICS, INC., Athena Diagnostics, Inc., and ADI Holdings Inc., Defendants.
• Court: U.S. District Court — District of South Carolina

353 F.Supp.3d 432

Amy Elizabeth WILLIAMS as the Personal Representative of the Estate for [Redacted], and Amy Elizabeth Williams, Individually, Plaintiffs,

v.QUEST DIAGNOSTICS, INC., Athena Diagnostics, Inc., and ADI Holdings Inc., Defendants.

C/A No. 3:16-cv-00972-MBS

United States District Court, D. South Carolina, Columbia Division.

Signed October 18, 2018

Bradford William Cranshaw, Grier Cox and Cranshaw, James M. Ervin, Matthew M. McGuire, Ervin and McGuire Law Firm, Columbia, SC, for Plaintiffs.

Alice W. Parham Casey, John C. Moylan, III, Wyche Law Office, Columbia, SC, Wade S. Kolb, III, Wallace K. Lightsey, Wyche Law Office, Greenville, SC, for Defendants.

OPINION AND ORDER

Margaret B. Seymour, Senior United States District Judge

Plaintiff Amy Elizabeth Williams, as both Personal Representative of the Estate of [Redacted] and individually, (hereinafter collectively, "Plaintiff"), brought the within action against Defendants Quest Diagnostics, Inc. ("Quest"); Athena Diagnostics, Inc. ("Athena"); and ADI Holdings Inc. ("ADI") (hereinafter collectively, "Defendants") in the Court of Common Pleas for Richland County, South Carolina. The action was removed to this court on March 28, 2016. Plaintiff alleges that Defendants negligently performed diagnostic testing on her son ("Decedent"), and that the negligent acts or omissions give rise to claims for wrongful death, a survivorship action, negligent misrepresentation, constructive fraud, civil conspiracy, and violation of South Carolina's Unfair Trade Practices Act.

This matter is before the court on Defendants' motion to dismiss pursuant to Fed. R. Civ. P. 12(b)(6) filed on June 24, 2016, ECF No. 25. Plaintiff filed an opposition to Defendants' motion on July 25, 2016, ECF No. 28, to which Defendants filed a reply on August 11, 2016. ECF No. 31.

I. FACTUAL BACKGROUND

Decedent was born on August 23, 2005. When he was four months old, he began suffering from febrile focal motor seizures

. Decedent's treating clinical geneticists, John McKinley Shoffner, M.D. and Frances Dougherty Kendall, M.D., diagnosed him with probable mitochondrial encephalomyopathy. ECF No. 24 at ¶ 15. Decedent's physicians extracted Deoxyribonucleic acid ("DNA") from a blood sample and provided the DNA to Athena's lab for a SCN1A DNA Sequencing Clinical Diagnostic Test so as to confirm or deny the diagnosis. Id. at ¶ 17. Athena issued a SCN1A DNA Sequencing Clinical Diagnostic Report on June 30, 2007 (the "2007 Report"), which indicated Decedent possessed a DNA mutation in the SCN1A gene classified as a "variant of unknown significance." Id. at ¶ 19. The glossary included in the 2007 Report defined variant of unknown significance as, "DNA sequence variants that are detected reproducibly, but have not been correlated with clinical presentation and/or pathology in the current literature, nor do they result in a readily predictable effect upon protein structure and function." Id. at ¶ 21. In a section entitled "Interpretation," the 2007 Report provided the following information: "This individual possesses a DNA sequence variant or combination of variants in the SCN1A gene whose significance is unknown (missense variant of unknown significance). Testing of the biological parents is strongly recommended to resolve the uncertainty of these test results." ECF No. 24-1 at 7. In a section entitled "Comments," the 2007 Report further stated: "[T]he results of this analysis cannot be definitively interpreted ..."; "Testing of the biological parents is strongly recommended (for no additional charge) to help resolve the uncertainty of this sequent variant's pathogenicity and the uncertainty of the predicted phenotype"; "Most mutations that cause SMEI are de novo, or sporadic (arise in the affected individual rather than being inherited) an inheritance pattern that can be confirmed by testing of parents"; "In order to provide a more comprehensive interpretation of this patient's SCN1A results, Athena Diagnostics is requesting samples from the biological parents of this patient"; and "Athena will perform a target analysis on these samples for variant(s) identified in gene SCN1A only and use the findings to help interpret the patient's SCN1A result(s) at no additional charge." Id. at 7, 8, 12. Drs. Shoffner and Kendall and Decedent's treating neurologist, Timothy Scott Livingston, M.D., relied on the classification to administer treatment to Decedent appropriate for epileptic seizures

not caused by Dravet Syndrome. ECF No. 24 at ¶ 34.

The mutation in Decedent's SCN1A gene "possessed the characteristics expected of a disease causing alteration," and had been reported and studied as a mutation associated with Dravet Syndrome. ECF No. 24 at ¶ 22. The 2007 Report correctly identified "the transversion

in question located on the correct SCN1A gene," but Athena had "simply [ ] mislabeled" the mutation. Id. at ¶ 24. Decedent subsequently passed away on January 5, 2008.

In September 2014, at the request of Plaintiff, Decedent's physicians contacted Athena and Quest to ask for a copy of the 2007 Report. ECF No. 24 at ¶ 43. Before that time Plaintiff had not seen or read the 2007 Report. Id. at ¶ 20. On January 30, 2015, Quest and Athena jointly produced a Revised Report ("2015 Report"). Id. at ¶ 43. The 2015 Report classified Decedent's DNA mutation correctly as a "known disease associated mutation" consistent with Dravet Syndrome. Id. Plaintiff alleges that, because of the error in the 2007 Report, Decedent was not provided with proper medication and treatment, and, in fact, the treatment he received exacerbated his seizures. Plaintiff alleges that Decedent lost his life as a proximate result of Athena's negligent laboratory practices.

At all times relevant to this lawsuit, Athena employed Narasimhan Naga, Ph.D. and Hui Zhu, Ph.D. as Directors of Genetics and Sat Dev Batish, Ph.D. as Chief Director of Genetics. ECF No. 24 at ¶¶ 7-9. The 2007 Report lists these individuals as those who reviewed the laboratory results and submitted the clinical information. ECF No. 24-1 at 17. Plaintiff alleges that at the time the 2007 Report was issued, Athena employed Joseph J. Higgins, M.D. as the Clinical Laboratory Improvement Amendments ("CLIA") Laboratory Director and license holder, and that Dr. Higgins signed the Report in that capacity. ECF No. 24 at ¶ 10. See ECF No. 24-1 at 17. CLIA refers to a "federal certification process for laboratories that perform clinical diagnostic tests on human specimens in the United States." ECF No. 24 at ¶ 27. ADI owns all outstanding shares of Athena. Id. at ¶ 6. In 2011, Quest purchased ADI and acquired all of that company's outstanding shares. Id.

II. PROCEDURAL HISTORY

Following the removal of this action to federal court, Plaintiff filed an amended complaint with the consent of Defendants.

ECF No. 19, 24.¹ Defendants thereafter filed a motion to dismiss, arguing inter alia that the amended complaint is barred by the six-year statute of repose applicable to actions brought against licensed health care providers, and that Athena qualifies as a "licensed health care provider," as described by S.C. Code Ann. § 38-79-410. ECF Nos. 25-1 at 18-22, 28 at 16-19. Plaintiff filed a Response, ECF No. 28, to which Defendants filed a reply, ECF No. 31. On January 4, 2017, the court heard oral argument on the motion and took the matter under advisement. ECF No. 34. The court subsequently indicated its inclination to certify to the South Carolina Supreme Court the question of whether diagnostic laboratories are considered health care providers pursuant to S.C. Code § 38-79-410, and heard limited argument from the parties on the topic during a telephone conference held March 2, 2017. ECF No. 36, 39. The court thereafter certified the following question to the South Carolina Supreme Court:

Is a federally licensed genetic testing laboratory acting as a "licensed health care provider" as defined by S.C. Code. Ann. § 38-79-410 when, at the request of a patient's treating physician, the laboratory performs genetic testing to detect an existing disease or disorder?

ECF No. 40.

On June 27, 2018, the South Carolina Supreme Court issued an opinion answering the certified question in the affirmative. ECF No. 59. The Court held that genetic testing laboratories such as Athena that perform testing at the request of a patient's treating physician for the purpose of assisting the treating physician in detecting an existing disease or disorder constitute licensed health care providers as contemplated by section 38-79-410. Id. The court thereafter granted the parties leave to file supplemental briefs addressing whether the amended complaint alleges medical malpractice or ordinary negligence. Plaintiff and Defendants filed their briefs on August 17 and August 24, 2018, respectively. ECF No. 58, 61.

III. LEGAL STANDARD

A Rule 12(b)(6) motion to dismiss for failure to state a claim upon which relief can be granted tests the legal sufficiency of a complaint. Schatz v. Rosenberg , 943 F.2d 485, 489 (4th Cir. 1991). While the complaint need not be minutely detailed, it must provide enough factual details to put the opposing party on fair notice of the claim and the grounds upon which it rests. Bell Atl. Corp. v. Twombly , 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) (citing Conley v. Gibson , 355 U.S. 41, 47, 78 S.Ct. 99, 2 L.Ed.2d 80 (1957) ). Additionally, a complaint must contain factual content that allows the court to reasonably infer the defendant is liable for the alleged misconduct. Ashcroft v. Iqbal , 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) ("A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged."). "Facts that are ‘merely consistent with’ liability do not establish a plausible claim to relief." United States ex rel. Nathan v. Takeda Pharms. N. Am., Inc. , 707 F.3d...