Sparks v. Oxy-Health, LLC

• Decision Date: 15 September 2015
• Docket Number: No. 5:13–CV–649–FL.,5:13–CV–649–FL.
• Citation: 134 F.Supp.3d 961
• Court: U.S. District Court — Eastern District of North Carolina
• Parties: Amy SPARKS, individually, and Robert D. Sparks, as Personal Representative of the Estate of Jarred B. Sparks, Plaintiffs, v. OXY–HEALTH, LLC and Oxy–Health Corporation, Defendants.

134 F.Supp.3d 961

Amy SPARKS, individually, and Robert D. Sparks, as Personal Representative of the Estate of Jarred B. Sparks, Plaintiffs,

v.OXY–HEALTH, LLC and Oxy–Health Corporation, Defendants.

No. 5:13–CV–649–FL.

United States District Court, E.D. North Carolina, Western Division.

Signed Sept. 15, 2015.

Justin D. Bice, Bice Law LLC, Fort Mill, SC, Thomas David Hoyle, William Christopher Swett, Motley Rice LLC, Mt. Pleasant, SC, for Plaintiffs.

Douglas W. Rennie, Timothy C. Ammer, Montgomery Rennie & Jonson, Cincinnati, OH, Kevin Lee Chignell, Melanie Black Dubis, Parker, Poe, Adams & Bernstein, LLP, Raleigh, NC, for Defendants.

ORDER

(UNDER SEAL)¹

LOUISE W. FLANAGAN, District Judge.

This matter is before the court on the motion for summary judgment of defendants Oxy–Health, LLC and Oxy–Health Corporation (collectively "defendant"), made pursuant to Federal Rule of Civil Procedure 56.² (DE 39). The issues raised have been briefed fully, and in this posture are ripe for ruling. For the reasons that follow defendant's motion for summary judgment is granted.

STATEMENT OF THE CASE

Plaintiff Robert Sparks is the administrator of the Estate of his son, Jarred Sparks. Together with his wife and Jarred's mother, Amy Sparks, plaintiffs filed this product liability action on September 12, 2013. Plaintiffs contend that defendant, the alleged manufacturer of the Vitaeris 320 Hyperbaric Oxygen Therapy Chamber System, ("Chamber" when used in reference to the specific product at issue in this case, otherwise "Vitaeris 320" or "chamber"), negligently designed the Vitaeris 320 and provided insufficient warning about the potential risk of asphyxiation, resulting in Jarred's death. The Estate asserts statutory claims for inadequate design, in violation of N.C. Gen.Stat. § 99B–6; inadequate warning, in violation of N.C. Gen.Stat. § 99B–5; breach of the implied warranty of merchantability, in violation of North Carolina's Uniform Commercial Code (the "UCC"), N.C. Gen.Stat. § 25–2–314; breach of express warranty, in violation of the UCC, N.C. Gen.Stat. § 25–2–313; and violation of the North Carolina Unfair and Deceptive Practices Act ("UDPA"), N.C. Gen.Stat. § 75–1.1, as well as common law claims for negligence and negligent failure to warn. In addition, plaintiff Amy Sparks, suing in her individual capacity, brings a common law claim for negligent infliction of emotional distress, ("NIED").³ Plaintiffs seek compensatory and punitive damages, as well as attorney's fees.

After a period of discovery, defendant filed the instant motion for summary judgment on all claims asserted by plaintiffs. Defendant argues the Estate's § 99B–6defective design claim fails because defendant did not manufacture the Vitaeris 320, did not breach the manufacturer's standard of care, and, in any case, the Estate has not adduced sufficient evidence to survive summary judgment on the issue of proximate cause. Defendant further argues that the Estate's § 99B–5inadequate warning claim fails because the Chamber's alleged defects were matters of common knowledge requiring no warning, or, in all events, any failure to warn was irrelevant because defendant had no knowledge of the particular asphyxiationhazard and the Estate cannot establish proximate cause. In addition, defendant contends both the Estate's various negligence claims, as well as plaintiff Amy Sparks's NIED claim, all are "product liability" claims under § 99B–1(3), and argues summary judgment also is warranted on each of those claims because plaintiffs cannot establish causation.

With regard to the Estate's UDPA claim, defendant argues that none of the bases asserted by plaintiffs qualify as "unfair or deceptive practices." In addition, defendant contends the Estate has forecast insufficient evidence to show that defendant was the proximate cause of Jarred's death. Finally, in opposition to plaintiffs' punitive damages claim, defendant contends that plaintiffs failed to submit evidence supporting the alleged willful nature of its conduct.⁴

In response plaintiffs attempt to undermine defendant's arguments, as well as raise a number of new theories supporting the Estate's claims previously not developed by the pleadings. In particular, plaintiffs argue defendant is not entitled to summary judgment on the Estate's § 99B–6claim, as a jury reasonably could conclude from the evidence that defendant was the Chamber's "manufacturer" because defendant either designed or assembled the Vitaeris 320, or was its "apparent manufacturer." In addition, plaintiffs contend they have submitted ample evidence of causation. With respect to the Estate's § 99B–5failure to warn claim, plaintiffs argue that summary judgment is inappropriate because, even if defendant merely acted as the Vitaeris 320's distributor, defendant failed to warn customer about the known risk of asphyxiationif air stopped flowing into the chamber, and further argue that causation is a disputed question of fact.⁵ In opposition to defendant's motion for summary judgment attacking the Estate's UDPA claim, plaintiffs contend that defendant engaged in conduct that amounted to a deceptive "misrepresentation," and that factual questions exist as to the required causative element. Plaintiffs also contend that defendant's motion for summary judgment on their punitive damages claim is unfounded.⁶

Defendant replies in-kind to plaintiffs' response without objection to plaintiffs' various new legal theories, thereby constructively amending the complaint.⁷ Defendant argues that the "apparent manufacturer" doctrine is inapplicable to the instant matter and further maintains its strenuous objection to the causative element of each of the Estate's substantive product liability and UDPA claims.

STATEMENT OF FACTS

A. Hyperbaric Chambers

"Portable mild hyperbaric chambers" are enclosures that are inflated and allow the occupant to experience higher than normal atmospheric pressure. (Patel Decl. ¶ 4). The Vitaeris 320 generally, and the Chamber specifically, is a "portable mild hyperbaric chamber," described as a "cylindrical, soft-shelled enclosure that receives continuous fresh air through a valve at one end." (Id. ¶¶ 4–5). The air is pumped through a hose, secured to the chamber body by a "quick disconnect" valve. (Id. ¶ 5). The valve itself is manufactured by Colder Products, a non-party, and is a "push button" disconnect, rather than a threaded-style connector. (Id.; see also Natoli Dep. 139:13–15). As fresh air continuously is forced into the chamber through one end, two valves at the opposite end expel carbon dioxide and excess fresh air ("release valves"). (See Patel Decl. ¶ 5). The Vitaeris 320 also ships with an air compressor to deliver air into the chamber. (See Lewis Memo at 4).

The quick disconnect valve is the only avenue through which fresh air is delivered into the otherwise air-tight enclosure. (See Oxy–Health Dep. 95:18–24, 104:11–105:4). In the event the quick disconnect valve becomes disengaged, or the air compressor supplying air to the occupant malfunctions, the release valves no longer expel excess carbon dioxide. (Id. 105:4–21; see also id. 108:5–10). In the event that occurs, carbon dioxide will build up in the Vitaeris 320 over time, as the occupant respires. (Id. 108:5–21). There is no alarm to alert the occupant to the accumulation of carbon dioxide. (Natoli Dep. 270:13–23).

In 2000, Hyperbaric Technologies, Inc. ("HTI"), the chamber's manufacturer, applied for and received market clearance for the Vitaeris 320 from the Food and Drug Administration ("FDA") through the FDA's § 510(k) clearance procedure.⁸

(FDA 510(k) Clearance; Patel Decl. ¶ 6). The Vitaeris 320 was cleared only for the treatment of "acute mountain sickness," a relatively rare condition that affects climbers who are exposed to altitudes in excess of 8,000 feet. (Patel Decl. ¶ 6; Workman Decl. ¶ 28). However, despite not being "cleared" for the treatment of autism, such use is a recognized "off-label use" in certain medical communities. (Kartzinel Dep. 33:4–34:14). Use of a hyperbaric chamberfor the treatment of autismrequires a prescription. (See id. 35:2–9).

B. The Sparks Family's Experience with Hyperbaric Oxygen Therapy

Plaintiffs are the mother and father of Jarred Sparks, a 19 year old autistic man who asphyxiated inside a hyperbaric chamberon June 10, 2011. Jarred was diagnosed with autismin 1994. (Amy Sparks Dep. 35:24–25). Sometime prior to November 2005, plaintiff Amy Sparks learned about the purported ability of hyperbaric oxygen therapy ("HBOT") to treat or reduce the symptoms of autism. (Id. 74:18–75:8). Sometime thereafter, in connection with a recommendation from Jarred's treating physician, Jerry Kartzinel, Jarred began HBOT at "Creation's Own," a clinic in Melbourne, Florida. (Amy Sparks Dep. 59:14–25, 69:13–25; Bradstreet Dep. 54:23–24). Jarred's treatments at Creation's Own were intermittent, ideally once every three to four weeks, but realistically once every few months. (Amy Sparks Dep. 77:4–12). During the treatments Jarred first used a Vitaeris 320, but later switched to a "hard sided" chamber. (Id. 126:1–6). Due to the distance between the family's home in North Carolina and the clinic, Jarred also began receiving treatment at A Small Miracle, a clinic in Goldsboro, North Carolina, offering certain services, including HBOT, to children and adults with special needs, owned by Jack and Janet Presson. (See Amy Sparks Dep. 77:14–21, 127:4–22; see also Agreement to Purchase). At A Small Miracle, Jarred was treated using a Vitaeris 320. (See Amy Sparks Dep. 123:16–21). Jarred's treatments at Creation's Own and A Small Miracle overlapped, but Jarred was last treated at Creation's Own on July 1, 2008. (Bradstreet Dep. 69:2–15).

During his treatments at Creation's Own, Jarred rarely was left alone while inside the hyperbaric chamber. Usually, plaintiff Amy Sparks remained in the room, (Amy Sparks Dep. 94:12–16), and a technician employed by Creation's Own frequently...