Sparks v. Oxy-Health, LLC (134 F. Supp. 3d 961, 2015)

ORDER

(UNDER SEAL)

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. (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”). 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-6 defective 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-5 inadequate 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 asphyxiation hazard 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.

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-6 claim, 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-5 failure 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 asphyxiation if air stopped flowing into the chamber, and further argue that causation is a disputed question of fact. 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.

Defendant replies in-kind to plaintiffs’ response without objection to plaintiffs’ various new legal theories, thereby constructively amending the complaint. 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. (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 chamber for the treatment of autism requires 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 chamber on June 10, 2011. Jarred was diagnosed with autism in 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 connectión 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 Golds-boro, 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 was in the room during the course of a 60 minute treatment session. (Id.; Kartzinel Dep. 57:16-58:14). During treatments at Creation’s Own two to three technicians were responsible for monitoring five hyperbaric chambers, (Bradstreet Dep. 36:5-16), and were checking on the patients in the chamber at least three times per hour. (See Kartzinel Dep. 74:19-75:12). In addition, during treatments, either Jarred’s father, Robert Sparks, or one of his siblings always accompanied him into the chamber. (Amy Sparks Dep. 96:3-13). Similarly, during Jarred’s treatments at A Small Miracle, one of the company’s employees would “come and go” throughout the duration of the treatment. (Id. 127:4-22).

Beginning in December 2006, for a period of approximately 10 months, the physician-owner of Creation’s Own, Jeff Bradstreet, allowed the Sparks family to borrow a Vitaeris 320 for temporary use in their home. (Amy Sparks Dep. 80:8-81:25). Bradstreet shipped the Vitaeris 320 . to the Sparkses in North Carolina. (Id.). However, Bradstreet did not include with the shipment any instructions on proper use of the chamber. (Id. 155:4-19). Despite not receiving any instructional material, the chamber was used. (See Robert Sparks Dep. 202:8-203:6).

On February 5, 2011, the Sparks family purchased the Chamber from A Small Miracle. (Agreement to Purchase). The Chamber was the same Vitaeris 320 Jarred had been using during his treatments at A Small Miracle, and had been purchased by A Small Miracle from a third party distributor, that in 2005 had purchased the Chamber from defendant. (Amy Sparks Dep. 123:16-24; Agreement between A Small Miracle and Vita 02; Patel Deck ¶ 15; see also Distributorship Agreement).

Prior to the purchase of the Chamber, the Sparks family had been planning to purchase a hyperbaric chamber for some time. (See Amy Sparks Dep. 137:1-11). In 2009, Amy Sparks attended a “Hope for Autism” conference in Charleston, South Carolina. (Amy Sparks Deck ¶ 4). At this conference, she met a representative, employed by defendant, who was touting the efficacy of HBOT, and in particular the efficacy of the Vitaeris 320, in treating the symptoms of autism. (See id. ¶ 5). The representative distributed an article entitled Autism and Its Growing Hyperbaric Movement, which represented that HBOT had beneficial effects for the autistic brain. (Id. ¶ 10). This experience affirmed the family’s desire, and specifically Amy Sparks’s desire, to purchase a hyperbaric chamber for Jarred’s use. (Amy Sparks Dep. 307:13-22, 314:14-315:13).

Prior to receiving the Chamber, Amy Sparks reached out to Kartzinel, who wrote Jarred the required prescription. (See Amy Sparks Dep. 137:1-11). On February 5, Jack Presson brought the Chamber to the Sparkses’s home and set it up in the upstairs. (Jack Presson Dep. 65:3-67:23; Amy Sparks Dep. 137:25-138:7). Given their experience with the Vitaeris 320 generally, the Pressons provided the Sparkses no training on how to use the Chamber, with the exception of the oxygen concentrator, an after-market component which the Sparkses had never used before. (Jack Presson Dep. 65:3-67:23; Amy Sparks Dep. 137:1-138:7). The oxygen concentrator was an external device that worked as the name implied, by increasing the oxygen concentration in the air inside the Chamber. (See Reference Manual at 36; see also Amy Sparks Dep. 83:7-24). The Pressons delivered with the chamber the Reference Manual, providing instructions on how to use the Chamber properly. (Amy Sparks Dep. 154:2-5). However, no member of the Sparks family ever read the manual. (See Amy Sparks Dep. 154:2-21; Robert Sparks Dep. 34:4-25; Dylan Sparks Dep. 64:19-65:5).

When using the Chamber, a consistent pattern was followed involving use at night, roughly every other day. (See Robert Sparks Dep. 202:8-23). On evenings when Jarred was to receive HBOT, the family would wait for him to go to bed and after a few hours would wake him up and guide him to the Chamber. (Id. 204:4-205:9). Treatments typically lasted 2-3 hours, but at times lasted up to 6 hours. (Id. 203:10-13, 205:3-6). Usually, the last person in the Sparks family to go to bed would wake Jarred up to get him out of the Chamber. (Id. 205:3-6). The Sparks-es never were told to limit the amount of time Jarred spent inside the Chamber explicitly. (Id. 203:20-204:1). Jarred always used the oxygen concentrator, (Amy Sparks Dep. 186:22-24), notwithstanding a label on the chamber body and FDA warning in the Reference Manual to the contrary. (See Concentrator Label; Reference Manual at 36). When the Chamber was in use, the release valves and air compressor could be heard downstairs, despite the Chamber’s location upstairs. (Robert Sparks Dep. 217:11-23; Dylan Sparks Dep. 109:8-14).

C. The Incident

Jarred’s body was discovered June 10, 2011, at approximately 3:00 a.m. (Dylan Sparks Dep. 93:2-9). Earlier that evening, at approximately 10:00 p.m., Jarred’s brother, Dylan, helped Jarred into the Chamber. (See id. 98:14-24, 104:6-10). Jarred laid in the Chamber and Dylan zipped him in. (Id. 104:6-10). At that time, the air compressor was attached to the Chamber and it was inflating properly. (Id. 104:6-19). After sealing Jarred in the chamber, Dylan turned the lights off, closed the door, and left the room. (Id. 91:22-92:8). Dylan had no trouble closing the door, (id. 112:24-113:2), and went to bed around 11:00 p.m. (Id. 91:22-92:8).

While Dylan was helping Jarred get into the chamber and thereafter, plaintiff Amy Sparks, a teacher, was downstairs filling out report cards for her students. (Amy Sparks Dep. 202:4-18). Robert Sparks was out of town, in Raleigh. (Dylan Sparks Dep. 96:16-25). Sometime after Dylan had gone to bed, plaintiff Amy Sparks fell asleep while working. (Amy Sparks Dep. 202:21-24). When she woke up, plaintiff Amy Sparks, concerned for Jarred, went upstairs to check on him. (Id. 202:24-203:11). She found the Chamber partially deflated despite the fact that the air compressor, which should have been providing fresh air into the chamber, was running. (Id.). At that time, plaintiff Amy Sparks discovered Jarred. (Id.).

Plaintiff Amy Sparks cried for Dylan, waking him up. (Dylan Sparks Dep. 92:9-18). Immediately thereafter, Dylan called 911 to request an ambulance. (Id.). While on the phone, the 911 operator instructed Dylan to pull Jarred’s body out of the Chamber and perform CPR. (Id. 92:9-93:1). Dylan stopped performing CPR only when emergency medical assistance arrived a few minutes later. (Id.). Dylan did not notice whether the quick disconnect valve was attached to the Chamber at that time. (See id. 141:7-142:18).

At around 5:30 a.m., officers from the Cumberland County, North Carolina, Sheriffs Department arrived. (See Sheriffs Report). The officers were the first people to point out that the quick disconnect valve had become disengaged from the Chamber. (Dylan Sparks Dep. 141:7-142:18; Amy Sparks Dep. 245:22-246:11). At approximately 8:15 a.m., detectives from the Sheriffs Department asked Dylan to set up the Chamber as he had the night before. (Sheriffs Report at 7). When the Chamber was inflated, the quick disconnect button, the feature that disengages the quick disconnect valve, was pressed against a book shelf near the head of the Chamber. (Id.). Upon closer inspection, a detective discovered that the book shelf had depressed the button and that the hose would become fully disengaged with only a slight disturbance. (Id.). Specifically, when the detective touched the hose it “fell to the floor and the [C]hamber started deflating.” (Id.). Earlier in the evening, other investigators observed that when the hose was disconnected from the Chamber, the hissing noise produced by the hose sounded similar to the hissing noise of the properly functioning chamber, and that the hose being disconnected made the air compressor much louder. (Id. at 8-4). After the investigators left, several of the family’s friends removed the Chamber from their home. (Amy Sparks Dep. 245:11-28). Based on the investigators event recreation, the Sparks family believes Jarred shifted while in his sleep, pressing the quick disconnect button against the book shelf and dislodging the quick disconnect valve. (See id. 247:7-15).

D. Defendant’s Relationship with HTI

HTI manufactured the Vitaeris 320. (Patel Decl. ¶ 3). Defendant was the exclusive distributor of certain hyperbaric chambers manufactured by HTI, including the Vitaeris 320, from 1999 until 2009. (See Distributorship Agreement; Patel Decl. ¶¶ 3, 6). There was no corporate overlap between the companies. (Patel Dep. ¶ 7).

Defendant, in its capacity as distributor, received certain chamber “bladders,” representing the portion of the Vitaeris 320 into which the patient is placed during the course of HBOT, in bulk and repackaged those bladders, along with other components including an air compressor, as a unified product sold as the Vitaeris 320. (See Patel Decl. ¶ 10). The air compressors shipped by defendant under the Oxy-Health brand were shipped to defendant by Brenner-Fielder, a third party, at the direction of HTI. (Lewis Dep. 34:17-35:11). During the course of repackaging the bladders, defendant’s employees inflated them to ensure that the exterior was clean and wiped them down if necessary. (Patel Dep. 13:15-14:1).

Under the Distributorship Agreement between defendant and HTI, defendant was given certain discretionary authority. Of note, the Distributorship Agreement gave defendant the right to consent to any changes HTI made to the Vitaeris 320. (Distributorship Agreement § 3.3). In addition, in the position of exclusive distributor, defendant relayed to HTI customer complaints and its own suggestions regarding the chamber’s design. (See Oxy-Health Dep. 227:21-230:18; Lewis Dep. 55:1-56:24; Change Notice). HTI incorporated into the Vitaeris 320’s design certain changes requested or initiated by defendant. (See Oxy-Health Dep. 227:21-230:18; Lewis Dep. 55:1-56:24; Change Notice). Among these changes were the addition of a “Made in the USA” label, (Lewis Dep. 55:19-23), as well as a new hose which would connect the air compressor to the chamber. (Id. 54:3-9; Change Notice). Defendant also made substantial recommendations regarding the content of the Reference Manual, specifically requesting that HTI implement a manual with pictures and detailed explanations as to how the Vitaeris 320 should be operated. (Oxy-Health Dep. 115:11-25).

Despite defendant’s limited role in the design and manufacture of the Vitaeris 320, defendant held itself out to be the chamber’s manufacturer. (See Reference Manual, passim; Janet Presson Dep. 161:24-162:3; Oxy-Health Dep. 84:11-24). In particular, defendant marketed the Vi-taeris 320 to consumers, including the parents of autistic children, as its own product at various trade shows. (Oxy-Health Dep. 25:12-39:24). Further, defendant represented to potential customers in various videos and promotional material widely available on the internet that it actively selected the materials incorporated into the Vitaeris 320. (Workman Report at 8). When a consumer purchased the chamber, it was delivered in a box bearing defendant’s trade name, “Oxy-Health.” (Patel Dep. 24:5-10). In addition, after purchase, defendant represented to consumers that it was the exclusive point of contact for all questions and necessary repairs, including those repairs performed pursuant to defendant’s “manufacturer’s warranty,” (Oxy-Health Dep. 84:11-24), which instructed customers to return the Vitaeris 320 to defendant in the event of a malfunction or defect. (Reference Manual at 35-36).

By 2006, defendant was working hand-in-hand with HTI to develop a new hyper-baric chamber for which the two companies were going to apply for a patent. (See Bruce Memo; Design Input Proposal). Although the specifies are unclear, generally the new product was to incorporate a third zipper into the bladder, an improvement over the Vitaeris 320 which only had two zippers, (See Chamber Brochure); inflatable exterior ribbing; and an improved ability to withstand higher pressures. (See Design Input Proposal). By summer of 2006 the companies were developing a prototype. (See Bruce Memo). In addition, defendant had taken steps independent of HTI to improve upon the air compressors shipped with the Vitaeris 320. Again in 2006, defendant was working closely with Gast, a third party compressor manufacturer, to develop “enclosures” for the pumps shipped with the Vitaeris 320. (Patel Email). However it is unclear whether defendant actually successfully implemented these enclosures into a completed Vitaeris 320, because HTI was responsible for approving the change. (See Oxy-Health Dep. 67:14-24; Lewis Dep. 58:24-60:6, 120:14-17).

COURT’S DISCUSSION

A. Standard of Review

Summary judgment is appropriate where “the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed.R.Civ.P. 56(a). The party seeking summary judgment bears the initial burden of demonstrating the absence of any genuine issue of material fact. Celotex Corp. v. Catrett, 477 U.S. 317, 323, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). Once the moving party has met its burden, the nonmoving party then must affirmatively demonstrate with specific evidence that there exists a genuine issue of material fact requiring trial. Matsushita Elec. Indus. Co. Ltd. v. Zenith Radio Corp., 475 U.S. 574, 586-87,106 S.Ct. 1348, 89 L.Ed.2d 538 (1986). Only disputes between the parties over facts that might affect the outcome of the case properly preclude the entry of summary judgment. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247-48, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986).

“[A]t the summary judgment stage the [court’s] function is not [itself] to weigh the evidence and determine the truth of the matter but to determine whether there is a genuine issue for trial.” Id. at 249, 106 S.Ct. 2505. Similarly, “[c]redibility determinations ... are jury functions, not those of a judge.” Id. at 255, 106 S.Ct. 2505. In determining whether there is a genuine issue for trial, “evidence of the non-movant is to be believed, and all justifiable inferences are to be drawn in [non-movant’s] favor.” Id.; see United States v. Diebold, Inc., 369 U.S. 654, 655, 82 S.Ct. 993, 8 L.Ed.2d 176 (1962) (“On summary judgment the inferences to be drawn from the underlying facts contained in [affidavits, attached exhibits, and depositions] must be viewed in the light most favorable to the party opposing the motion.”).

Nevertheless, “permissible inferences must still be within the range of reasonable probability, ... and it is the duty of the court to withdraw the case from the jury when the necessary inference is so tenuous that it rests merely upon speculation and conjecture.” Lovelace v. Sherwin-Williams Co., 681 F.2d 230, 241 (4th Cir.1982) (quotations omitted). Thus, judgment as a matter of law is warranted where “a reasonable jury could reach only one conclusion based on the evidence,” or when “the verdict in favor of the non-moving party would necessarily be based on speculation and conjecture.” Myrick v. Prime Ins. Syndicate, Inc., 395 F.3d 485, 489 (4th Cir.2005). By contrast, when “the evidence as a whole is susceptible of more than one reasonable inference, a jury issue is created,” and judgment as a matter of law should be denied. Id. at 489-90.

B. Analysis

1. Defendant as a “Manufacturer” under § 99B-1(2)

Defendant first contends that it is not the Vitaeris 320’s “manufacturer,” as that term is used in Chapter 99B. Defendant’s argument merits separate address, because if defendant is not the Chamber’s “manufacturer” that determination reasonably moots the Estate’s defective design claim, as well as plaintiffs’ negligence and NIED claims. See generally, N.C. Gen. Stat. §§ 99B-1(3) & 99B-6. Plaintiffs advance two divergent theories under which defendant potentially could be considered a “manufacturer.” First, plaintiffs suggest that defendant manufactured the “bladder,” which includes only the inflatable portion of the Vitaeris 320 into which a patient would be placed during HBOT. Alternatively, plaintiffs contend defendant “manufactured” the Vitaeris 320 as a whole. The court addresses each argument in turn and, as determined below, finds each without merit.

a. Defendant as Manufacturer of the Chamber Bladder

Plaintiffs suggest defendant acted as the “manufacturer” of the bladder in two relevant respects. First, plaintiffs contend defendant “designed” the bladder. In the alternative, plaintiffs contend defendant “assembled” the bladder. See generally, N.C. Gen.Stat. § 99B-1(2) (defining “manufacturer” as “a person or entity who designs, assembles, fabricates, produces, constructs or otherwise prepares a product or component part of a product”). In support of their argument, plaintiffs point to a contract between defendant and HTI that grants defendant the power to “consent” to any changes HTI proposes in the chamber’s “design, materials or color,” (see Distributorship Agreement § 3.3), as well as testimony of defendant’s president, Samir Patel, wherein he states that defendant “assembled” or “set up” the chamber bladder after receiving it from HTI. In response, defendant argues it did not “design” the bladder, because its limited authority to impact the product’s design falls outside the scope of Chapter 99B. In addition, defendant contends it did not “assemble” the bladder, and argues that plaintiffs’ assertions to the contrary are based in mischaracterization of Patel’s testimony. In support of its position, defendant points to the testimony of Peter Lewis, the president of HTI, and Patel, which provides that defendant only had the right to distribute the chamber, and that HTI actually controlled its design, as well as Patel’s testimony addressing defendant’s role in “assembling” the product.

Drawing all inferences in plaintiffs’ favor, defendant’s conduct still falls outside the scope of “design” as that term is used in the statute. The power to accept or reject changes made by a third party, without more, falls short of the degree of autonomy necessary to constitute the ability to “design.” The evidence shows that defendant did not have unrestrained power to decide on the bladder’s look and function.

The statute provides no definition of the word “design” and the court has found no case bearing on its interpretation. “Undefined words are accorded their ordinary meaning, for which [the court] may look to a dictionary.” Stark ex rel. Jacobsen v. Ford Motor Co., 365 N.C. 468, 476-77, 723 S.E.2d 753 (2012) (defining “party” as used in N.C. Gen.Stat. § 99B-6). As defined by the Oxford English Eictionary, the term “design,” means to “[d]ecide upon the look and functioning of [an object].” “Design,” Oxford English Dictionary, available at http://www.oxforddictionaries. com/us/definition/american_english/design (last accessed August 18, 2015). In the case at bar, because plaintiffs forecast evidence showing only that defendant had final approval authority over design changes made by HTI, defendant’s conduct commonly would not be understood to fall within the definition of “design.”

Plaintiffs contend defendant “designed” the bladder because HTI incorporated into the bladder several changes requested by defendant, including a “Made in the USA label” and different variety of hose, which connected the air compressor to the chamber. (See Lewis Dep. 54:3-59:9). The term “design,” as it is used in statute, is not so broad as to encompass non-binding recommendations bearing on the physical appearance or functionality of a product. To hold otherwise unnecessarily would expand “manufacturer” liability under Chapter 99B to any customer, where the customer makes a recommendation about the design of a product that eventually is adopted by its manufacturer. Defendant’s requests fall short of the autonomy inherent in the “design” of a product. Plaintiffs have submitted no evidence from which the court can infer that HTI was obligated to comply with defendant’s requested changes. Rather, the evidence shows that the changes were made in response to customer “feedback” provided by defendant, (id. at 58:24-60:6), but that defendant was “not involved in the design choice of materials, [or the] fabrication processes of the [bladder].” (Id. 120:14-17).

The remaining pieces of evidence upon which plaintiffs rest their “design” theory fare no better. Plaintiffs cite two internal correspondences that suggest defendant and HTI, in 2006, were working together on a prototype chamber, (See Bruce Memo; Design Input Proposal), as well as a 2008 email, wherein an HTI employee requests authority to perform certain repairs on a bladder that had been returned to defendant pursuant to its manufacturer’s warranty. (Darmofal Email). The chamber at issue was sent to defendant by a customer to take advantage of defendant’s “manufacturer’s warranty,” and then was sent to HTI for repair. (See Darmofal Email, Invoice, Janet Presson Dep. 161:4-14).

Addressing first the internal correspondences, these documents, viewed in the light most favorable to plaintiffs, do not tend to show that defendant designed the Vitaeris 320. Rather, these documents show only that HTI and defendant were working together on a new hyperbaric chamber that they intended to patent. (See Design Input Proposal; see also Bruce Memo (“Keep in mind that once we submit the patent application in a week or so, we can use the patent pending, but it will have to have the third zipper. Let’s start building a lot of 25 now to see if there is any potential problems both here or with Oxy-Health.”)). That defendant and HTI were working on a new product is apparent based on the references to a three-zipper design, where the Vitaeris 320 only had two zippers. (See Chamber Brochure). With respect to the Darmofal Email, even though defendant required HTI to obtain its approval to make repairs to products already in the market place, it does not follow that defendant designed the bladder.

In any event, defendant also did not “assemble” the bladder. As before, “assemble” is not defined in the relevant case law or statutes. Thus, the court looks to a dictionary to assist in defining that term. See Jacobsen, 365 N.C. at 476-77, 723 S.E.2d 753. To “assemble” is to “fit together the separate component parts of (a machine or other object),” “Assemble,” Oxford English Dictionary, available at http://www.oxforddictionaries.com/ definition/english/assemble (last accessed August 18, 2015), or “to fit together parts.” “Assemble,” Merriamr-Webster, available at http://www.merriam-webster.com/ dictionary/assemble (last accessed August 18, 2015).

The undisputed facts show that defendant did not “assemble” the bladder within that word’s common meaning. Patel testified that defendant’s employees “assembled” the bladder only inasmuch as they “[h]ooked up a pump [to the bladder], zipfped] it up, inflate[d] it, [and inspected it to] see if it’s clean.” (Patel Dep. 13:20-21, 14:22-24). The extent of any employee’s interaction with the bladder involved only “wipfing] [it] down, if necessary, [and examining the bladder to] see if it’s still under pressure.” (Id. 13:23-25). Despite plaintiffs’ suggestion to the contrary, Patel’s non-judicious use of the word “assemble” is insufficient to convert defendant into the bladder’s manufacturer in light of the remainder of his testimony bearing on defendant’s employees’ actual interaction with the bladder. Thus, defendant is not the “manufacturer” of the bladder, and cannot be liable for its design. See N.C. GemStat. §§ 99B-1(2) and 99B-6.

b. Defendant as Manufacturer of the Oxy-Health Vitaeris 320

Notwithstanding the court’s holding addressing defendant as the manufacturer of the bladder, plaintiffs also contend defendant “manufactured” the Vitaeris 320, as the product was marketed to consumers, by purchasing the bladder and thereafter assembling or “otherwise preparing” the chamber by packaging the bladder with an air compressor. In addition, plaintiffs argue defendant “designed” the Vitaeris 320 because it had the power to select the air compressor shipped with the product.

Defendant neither assembled nor otherwise prepared the chamber. “Assembly” connotes at least some amount of fitting products together, not merely packaging them together for sale. See “Assemble,” Oxford English Dictionary, supra. Here, defendant only packaged multiple products together into one box. In addition, the phrase “otherwise prepared” is not so broad as to encompass defendant’s actions, considered in light of the other words used to define “manufacturer.” See N.C. Gen.Stat. § 99B-1(2).

A manufacturer “designs, assembles, fabricates, produces, constructs or otherwise prepares a product.” Id. The phrase “otherwise prepares” is an ejusdem generis term, also known as a “catch all.” See Meyer v. Walls, 347 N.C. 97, 106, 489 S.E.2d 880 (1997) (holding phrase “all other departments, institutions, and agencies” was an ejusdem generis term where statute listed several specific agencies); State v. Gamble, 56 N.C.App. 55, 57, 286 S.E.2d 804 (1982) (holding phrase “any other structure” following a statute defining “building” as “dwelling, dwelling house, uninhabited house, building under construction, building within the curtilage of a dwelling house” to be ejusdem generis term). Under the principle of ejusdem generis, “[w]here words of general enumeration follow those of specific classification, the general words will be interpreted to fall within the same category as those previously designated.” Meyer, 347 N.C. at 106, 489 S.E.2d 880.

This principle of statutory construction informs the court’s interpretation of the term “manufacturer,” particularly the actions that make one a “manufacturer.” All of the actions a “manufacturer” might perform connote an active role in either the planning or building of a finished product. See, e.g., “Design,” Merriam-Webster, supra; “Assemble,” Oxford English Dictionary, supra; “Construct,” Oxford English Dictionary, available at www.oxford dictionaries.com/us/definition/american_ english/construct (“Build or erect (something, typically a building, road, or machine.”); “Produce,” Oxford English Dictionary, available at http://www.oxford dictionaries.com/us/defínition/ameriean_ english/produce (“Make ... from components or raw material”); id. (“Make (something) using creative or mental skills.”); “Fabricate,” Oxford English Dictionary, available at http://www.oxford dictionaries.com/us/defínition/american_ english/fabricate (“Construct ... (something, especially an industrial product), especially from prepared components.”). Here, defendant performed no action that involved the “fitting” of component parts together as one unified product prior to shipment. Rather, the evidence indicates that defendant merely repackaged multiple products into one box. Accordingly, defendant did not “otherwise prepare” the chamber, within the meaning of that phrase, and is not the “manufacturer.”

Nevertheless, plaintiffs also suggest defendant “designed” the chamber because defendant was allowed to select the air compressor shipped with the it. However, defendant only “recommend[ed]” compressors to HTI for inclusion with the Vitaeris 320, (Oxy-Health Dep. 67:21-24), demonstrating that defendant lacked power in the design of the chamber, beyond the mere power of suggestion. Without evidence showing HTI was required to comply with defendant’s recommendations, the evidence before the court is insufficient to hold defendant liable as the bladder’s “manufacturer.”

Plaintiffs make much of an email exchange between Patel and Lewis in which Patel indicated that defendant was working closely with a third corporation, Gast, to develop a certain “enclosures” for compressors shipped with the chamber. (Patel Email). However, these emails do no demonstrate defendant’s control over the chamber’s design. Rather, the emails only demonstrates that defendant and Gast were collaborating on a design potentially to be implemented in the future, not that a final design actually was implemented. In addition, the record is bereft of evidence to suggest that defendant was involved in the selection of the air compressor actually sold with the chamber. (See Invoice).

2. Defendant as the “Apparent Manufacturer.”

Plaintiffs also contend that defendant properly may be considered the “apparent manufacturer” of the chamber, because it provided a “manufacturer’s warranty” for the chamber, was the point of contact for all repairs, and actively marketed the chamber, (See Lewis Dep. 26:22-29:6; Distributorship Agreement § 2.1; Janet Presson Dep. 55:1-9, 161:4—164:17; Reference Manual, passim; Oxy-Health Dep. 84:19-24). See Warzynski v. Empire Comfort Systems, Inc., 102 N.C.App. 222, 401 S.E.2d 801 (1991) (establishing apparent manufacturer doctrine). Defendant disagrees and argues that the apparent manufacturer doctrine applies only in cases where the defendant seller asserts the “sealed container” defense, see generally N.C. Gen.Stat. § 99B-2(a), and in any event, the “apparent manufacturer” doctrine cannot apply here because HTI’s name appears on the bladder. (See Manufacturer Label) (depicting a label reading displaying HTI’s name on the Chamber). Although this presents a close question, the court agrees with plaintiffs.

In the usual case,

A retailer who purchases from a reputable manufacturer and sells the product under circumstances where he is a mere conduit of the product is under no affirmative duty to inspect or test for a latent defect, and, therefore, liability cannot be based on a failure to inspect or test in order to discovery such defect and warn against it.

Cockerham v. Ward, 44 N.C.App. 615, 623, 262 S.E.2d 651, disc. rev. denied, 300 N.C. 195, 269 S.E.2d 622 (1980) (internal quotations omitted). However, in a narrow range of cases, North Carolina courts have applied § 400 of the Restatement (Second) of Torts, which imposes liability on the seller of a product as if it were the product’s manufacturer, where the seller “puts out [the product] as his own.” Restatement (Second) Torts, § 400. See generally, Rulane Gas Co. v. Montgomery Ward & Co., 231 N.C. 270, 275, 56 S.E.2d 689 (1949); Haymore v. Thew Shovel Co., 116 N.C.App. 40, 43-44, 446 S.E.2d 865 (1994); Warzynski, 102 N.C.App. at 225-28, 401 S.E.2d 801. The facts before the court indicate that this may be such a case.

In Warzynski, defendant Empire Comfort Systems, Inc., (“Empire”), distributed a gas heater, manufactured by Safel-Inel-sa Orbaiceta, S.A., (“Safel”), a Spanish company. Warzynski 102 N.C.App. at 224, 401 S.E.2d 801. Empire was Safel’s exclusive U.S. distributor and purchased, in connection with Safel, commercial advertising for the heater. Id. Empire serviced the heaters, which came with an “Empire Heating Appliance Limited Warranty.” Id. at 228, 401 S.E.2d 801. In addition, the advertising insinuated Empire manufactured the heaters. Id. (“One of Empire’s promotional flyers for dealers and wholesalers called the Empire Corcho ‘America’s best made and best-selling un-vented gas wall furnace.’ ”). The only indication that Empire was not the heater’s manufacturer was a label indicating that the heater was “made in Spain.” Id. At summary judgment, - Empire asserted a sealed container defense under N.C. Gen. Stat. § 99B-2, arguing that it received the heaters in sealed containers and was nothing more than a “conduit.” Id. at 225, 401 S.E.2d 801.

Under these facts, the North Carolina Court of Appeals adopted § 400 of the Restatement and held that the sealed container defense was inapplicable. Id. at 226-28, 401 S.E.2d 801. Quoting from the restatement, the court reasoned “The mere fact that the goods are marked with such additional words as ‘made for’ the seller, or describe [the seller] as a distributor, particularly in the absence of a clear and distinctive designation of the real manufacturer ... is not sufficient to make inapplicable the [apparent manufacturer rule].” Id. at 226-27, 401 S.E.2d 801.

The facts of the ease at bar nearly are indistinguishable from those of Warzynski. Defendant distributed the Vitaeris 320 in boxes labeled as its own. Inside the box, the chamber was packaged with an “operating and reference” manual that is rife with examples insinuating that defendant was the chamber’s manufacturer. In particular, the “Oxy-Health” branded Reference Manual refers to “chambers manufactured after 2002,” (Reference Manual at 13-14); discusses the chamber’s FDA 510(k) clearance, without ever indicating that defendant was not involved in obtaining that clearance, (id. at 32); and indicates that defendant provides consumers with a “manufacturer’s warranty,” which requires the product be shipped directly to defendant for service. (Id. at 35). Moreover, defendant made a number of statements in videos provided on its website that may lead reasonable people to believe defendant hand selected the materials from which the chamber was made. (See Workman Report at 8). The evidence suggests that defendant alone manufactured the chamber. (Agreement § 2.1; Lewis Dep. 26:22-29:6). Based on this evidence, there are genuine issues of material fact about whether defendant was the chamber’s “apparent manufacturer.”

Defendant contends Warzynski is inapplicable for two reasons. First, defendant highlights a factual distinction, the fact that HTI’s name appears on the chamber, whereas in Warzynski, Safel was not named on the heater. Second, defendant argues that, notwithstanding the facts of Warzynski, the “apparent manufacturer” doctrine may apply only when a seller asserts a sealed container defense. The court is not persuaded.

Turning first to defendant’s attempt to distinguish Warzynski on its facts, defendant’s argument falls short. Defendant contends the Warzynski court attached special significance to the fact that Safel was named nowhere either on the product or in its advertising. Although the court did mention the absence of Safel’s name, Warzynski 102 N.C.App. at 228, 401 S.E.2d 801 (“The decal did not refer to Safel at all.”), there is no indication that the presence of Safel’s name would have been determinative in the outcome of the case. In addition, the commentary to § 400 counsels against finding the presence of HTI’s name ■ determinative of the issue. Comment d provides that there can be no “apparent manufacturer” liability, “where the real manufacturer or packer is clearly and accurately identified on the label ... and it is also clearly stated that another who is also named has nothing to do with the goods except to distribute or sell them.” Restatement, supra § 400 cmt. d; see also Carney v. Sears, Roebuck & Co., 309 F.2d 300, 304 (4th Cir.1962) (applying “apparent manufacturer” doctrine); Swift & Co. v. Blackwell, 84 F.2d 130, 132 (4th Cir.1936) (holding defendant could be liable under “apparent manufacturer” doctrine where defendant stated it was the product’s “distributor” in “type quite small when compared with the wordfs] ... elsewhere displayed”); Bilenky v. Ryobi Techs., Inc., 115 F.Supp.3d 661, 669-72, 2015 WL 3946612, at *6-8 (E.D.Va.2015) (relying on Swift in applying “apparent manufacturer” doctrine). Defendant cites no evidence showing that it ever clearly indicated it was nothing more than a distributer or seller.

Defendant’s second argument also misses the mark. There is nothing in the case law that indicates the “apparent manufacturer” doctrine only may apply in cases where the statutory sealed container defense is asserted. See generally N.C. Gen. Stat. § 99B-2 (establishing “sealed container” defense). Rather, courts generally apply the “apparent manufacturer” doctrine to impose upon the seller of a chattel vicarious liability commensurate with that which could be imposed on the manufacturer. See, e.g., Swift, 84 F.2d at 132; Kennedy v. Guess, Inc., 806 N.E.2d 776, 785-86 (Ind.2004) (holding seller held to same standard of care as manufacturer); Stones v. Sears, Roebuck & Co., 251 Neb. 560, 564-65, 558 N.W.2d 540 (1997) (holding purpose of doctrine is to impose liability on “the party whose actions effectively conceal the true manufacturer’s identity”); Forry v. Gulf Oil Corp., 428 Pa. 334, 343-44, 237 A.2d 593 (1968); Media Prod. Consultants, Inc. v. Mercedes-Benz of N. Am., Inc., 262 La. 80, 89-90, 262 So.2d 377 (1972) (“We hold, therefore, that the liability of MBNA to the American consumer is that of the manufacturer of a defective vehicle.”); Burkhardt v. Armour & Co., 115 Conn. 249, 161 A. 385, 391 (1932) (holding one who holds itself out as a manufacturer is estopped from denying its identity as a manufacturer), overrule on other grounds Porpora v. City of New Haven, 122 Conn. 80, 187 A. 668 (1936), overruled on other grounds Foran v. Carangelo, 153 Conn. 356, 216 A.2d 638 (1966); Martin v. Schoonover, 13 Wash.App. 48, 54, 533 P.2d 438 (1975).

In its final effort to distance this case from the apparent manufacturer doctrine, defendant argues that it should not apply here, where the Sparks family purchased the Chamber second hand and did not actually rely on defendant’s advertising or warranty in making the decision to purchase the Chamber. However, defendant’s argument must fail. Plaintiffs do not need to show any member of the Sparks family relied on defendant’s marketing of the Vitaeris 320 when the family decided to purchase the Chamber. Rather, the appropriate focus of the apparent manufacturer inquiry is the effect of defendant’s marketing on the public at large. Hebel v. Sherman Equip., 92 Ill.2d 368, 374, 65 Ill.Dec. 888, 442 N.E.2d 199 (1982) (“The primary rationale for imposing liability on the apparent manufacturer of a defective product is that it has induced the purchasing public to believe that it is the actual manufacturer, and to act on this belief — that is, to purchase the product in reliance on the apparent manufacturer’s reputation and skill in making it.”); see also Carney, 309 F.2d at 304-05; Kennedy, 806 N.E.2d at 784; Dudley Sports Co. v. Schmitt, 151 Ind.App. 217, 225, 279 N.E.2d 266 (1972) (“When a vendor puts his name exclusively on a product, in no way indicating that it is the product of another, the public is induced to believe that the vendor was the manufacturer of the product----When products are held out in this manner, the ultimate purchaser has no available means of ascertaining who is the true manufacturer.”). In light of defendant’s marketing, as discussed above, a reasonable juror could conclude defendant was the Chamber’s apparent manufacturer. Thus, the court now turns to the substance of plaintiffs’ claims.

3. Product Liability Claims

North Carolina by statute has adopted a specific structure for product liability actions. See generally N.C. Gen. Stat. ch. 99B. Unfortunately, this statute is not a model of clarity, and many judicial opinions interpreting it have done so piecemeal. As gleaned from the language of the statute, and relevant case law, all claims “brought for or on account of personal injury, death or property damage caused by or resulting from the manufacture, construction, design, formulation, development of standards, preparation, processing, assembly, testing, listing, certifying, warning, instructing, marketing, selling, advertising, packaging, or labeling of any product” properly are termed “product liability actions.” See N.C. Gen. Stat. § 99B-1(3). Recovery for a product liability action may be premised either on contract or tort principles. See DeWitt v. Eveready Battery Co., 355 N.C. 672, 682, 565 S.E.2d 140 (2002); Tetterton v. Long Mfg. Co., 314 N.C. 44, 50, 332 S.E.2d 67 (1985) (“On the face of this statute, it seems evident that this act ... was meant and intended to apply to manufacturers and retail sellers alike.”); Red Hill Hosiery Mill, Inc. v. MagneTek, Inc., 138 N.C.App. 70, 74-75, 530 S.E.2d 321 (2000).

In the usual case, where a product liability claim sounds in tort, as the parties suggest plaintiffs’ claims do here, the plaintiff must prove duty, breach, causation, and damages. Bryant v. Adams, 116 N.C.App. 448, 465, 448 S.E.2d 832 (1994); see also Yates v. Ford Motor Co., No. 5:12-CV-752, 2015 WL 2189774 (E.D.N.C. May 11, 2015); Durkee v. C.H. Robinson Worldwide, Inc., 765 F.Supp.2d 742, 748 (W.D.N.C.2011). Those elements are satisfied where the plaintiff demonstrates “(1) the product was defective at the time it left the control of the defendant, (2) the defect was the result of defendant’s negligence, and (3) the defect proximately caused plaintiff damage.” Red Hill, 138 N.C.App. at 75, 530 S.E.2d 321; see also Farrar & Farrar Farms v. Miller-St. Nazianz, Inc., 477 Fed.Appx. 981, 984 (4th Cir.2012).

The Estate may prove the first element, product defect, either by direct evidence, such as expert testimony, or by relying on the inference of negligence that arises upon a showing that the product malfunctioned after it was put to its ordinary use. See Bernick v. Jurden, 306 N.C. 435, 450, 293 S.E.2d 405 (1982); City of Thomasville v. Lease-Afex, Inc., 300 N.C. 651, 656, 268 S.E.2d 190 (1980); Red Hill, 138 N.C.App. at 76, 530 S.E.2d 321. However, if the Estate relies on inference to establish product defect, it must present direct evidence that the defect was a result of defendant’s negligence. See Red Hill, 138 N.C.App. at 77 n. 7, 530 S.E.2d 321; see also McLaurin v. E. Jordan Iron Works, Inc., 666 F.Supp.2d 590, 600 (E.D.N.C.2009) (noting that where there is no direct evidence of defect, plaintiff must “come forward with evidence that suggests what a reasonable person would do in similar circumstances”); Carlton v. Goodyear Tire & Rubber Co., 413 F.Supp.2d 583, 588 (M.D.N.C.2005) (“[A] plaintiff may not prove negligence by stacking inference upon inference.”). Thus, the Estate may not prevail on its claim if that claim solely rests on inferential evidence.

The product liability statute subjects all product liability claims to special statutory defenses. See N.C. Gen.Stat. §§ 99B-2 through -4. In addition, Chapter 99B theoretically imposes upon certain claims heightened proof requirements. See id. §§ 99B-5 & -6. Claims alleging inadequate warning or instruction, N.C. Gen. Stat. § 99B-5, or inadequate design or formulation, id. § 99B-6, require proof of additional statutory elements. See, e.g., Durkee, 765 F.Supp.2d at 748-49 (noting plaintiff must prove statutory factors in order to establish negligence). These sections, in theory, swallow up a large segment of potential product liability claims. However, they leave unaffected, for example, manufacturing defect claims, see generally, Restatement (Third) of Torts, Products Liability § 2 (defining “manufacturing defect” and contrasting that term with “design defect”), or claims alleging negligent assembly or inspection. See, Crews v. W.A. Brown & Son, Inc., 106 N.C.App. 324, 329-30, 416 S.E.2d 924 (1992) (addressing claims of negligent assembly, installation, and inspection).

Having stated the controlling principles of law, the court now turns its attention to the substance of defendant’s motion,

a. § 99B-6: Design Claim

Section 99B-6 provides:

No manufacturer of a product shall be held hable in any product liability action for the inadequate design or formulation of the product unless the claimant proves that at the time of its manufacture the manufacturer acted unreasonably in designing or formulating the product, [and] that this conduct was a proximate cause of the harm for which damages are sought.

N.C. Gen.Stat. § 99B-6(a). Further, a claim .under § 99B-6 requires a plaintiff prove that “[a]t the time the product left the control of the manufacturer,” either “the manufacturer unreasonably failed to adopt a safer, practical, feasible, and otherwise reasonable alternative design or formulation that could then have been reasonably adopted and that would have prevented or substantially reduced the risk of harm without substantially impairing the usefulness, practicality, or desirability of the product” or “the design or formulation of the product was so unreasonable that a reasonable person, aware of the relevant facts, would not use or consume a product of this design.” Id.

To determine whether a manufacturer has breached its duty, the statute supplies a list of relevant considerations including: the scope of the risks associated with the product’s design “in light of the intended and reasonably foreseeable uses, modifications, or alterations”; the likely awareness of users of the risks “whether [that awareness is] based on warnings, general knowledge, or otherwise”; design compliance with applicable government standards; extent to which labeling conformed to applicable government or private standards; utility of design; feasability of alternative designs at the time of manufacture; and the nature and magnitude of foreseeable risks. Id. § 99B-6(b).

Plaintiffs contend the Chamber contained two design defects, which form the basis of the Estate’s § 99B-6 claim. First, plaintiffs argue that using the “quick disconnect” valve to secure the sole means of delivering oxygen to the chamber was a design defect, because of the ease with which the valve could disconnect. Plaintiffs suggest the quick disconnect valve should have been replaced by a threaded connector. Second, plaintiffs argue that failure to incorporate an oxygen sensor (or as the alternative side of the coin, a carbon dioxide sensor) with an alarm was a design defect, because patients inside the chamber might not appreciate that oxygen levels were depleting if the quick-disconnect valve became disengaged.

Defendant argues that plaintiffs have failed to forecast any evidence supporting the statutorily enumerated factors contained in § 99B-6(a) or § 99B-6(b) with regard to either alleged design defect, or, in any event, that plaintiffs cannot present evidence to raise proximate cause above the speculative level. In response to defendant’s first argument, plaintiffs lay out their evidence on the § 99B-6 factors. In response to defendant’s proximate cause argument plaintiffs rely heavily on the testimony of their expert, Ron Natoli, as well as the Cumberland County Sheriffs Department’s Report detailing the agency’s investigation into Jarred’s death. In addition, plaintiffs contend that, even if Nato-li’s testimony and the Sheriffs Report are insufficient, the inference of negligence is sufficient to preclude summary judgment and carry this case to the jury. The court agrees with defendant. Plaintiffs have failed to adduce sufficient evidence of proximate cause.

Plaintiffs have presented sufficient evidence of the factors set out in § 99B-6(a) & (b). “A showing that a defendant acted unreasonably under section 99B-6(a)(l) requires evidence” in satisfaction of four separate factors. They are as follows:

• that the proposed alternative design or formulation was “a safer, practical, feasible, and otherwise reasonable” design or formulation;

• that the alternative desiign or formulation “could then have been reasonably adopted”;

• that the alternative design or formulation would have prevented or substantially reduced the risk of harm complained of; and

• that the alternative design or formulation would not have substantially impaired the usefulness, practicality, or desirability of the product.

See DeWitt v. Eveready Battery Co., 144 N.C.App. 143, 159, 550 S.E.2d 511 (2001) aff'd 355 N.C. 672, 565 S.E.2d 140 (2002); see also N.C. Gen.Stat. § 99B-6. Here, plaintiffs have satisfied these four factors with respect to both the threaded connector and alarming oxygen sensor. To support the feasibility of implementing a threaded disconnect valve and alarming oxygen sensor, plaintiffs rely on a competitor hyperbaric chamber, the SOS Hyper-lite, which possessed these features. (See SOS Hyperlite Brochure). Plaintiffs have submitted an expert report indicating that these features would have improved the Chamber’s safety. (See Natoli Report at 10-12). In addition, Natoli’s report suggests that these features were available in 2005, at the time the Chamber was manufactured. (See id.). Finally, Natoli’s report indicates that use of a threaded connector and alarming oxygen sensor could have prevented or reduced the likelihood of Jarred’s death without impairing the Chamber’s usefulness. (Id.).

In addition, plaintiffs have presented evidence bearing on a number of the factors set out in § 99B-6(b). This list of factors is non-exclusive and “[a] plaintiff is not required to present evidence on all of these factors in order to meet his burden of proving a defective design claim, as some of these factors may not be relevant to a particular plaintiffs claim.” DeWitt, 144 N.C.App. at 155, 550 S.E.2d 511. In particular, plaintiffs have shown that asphyxiation was a harm associated with the chamber as designed, (Oxy-Health Dep. 105:8-21, 108:5-109:15, 166:10-17); the utility of the chamber would not have been affected by plaintiffs’ proposed design changes, (Natoli Report 8-9, 16) (“The benefit[] of using a quick disconnect for the air supply connections on the [chamber] [is] the simplicity of not requiring a special tool and speed of setup.”); implementing the proposed design changes would have been feasible at the time the chamber left HTI, (SOS Hyperlite Brochure); the changes would have been economically feasible, (id.); and there were few risks associated with adding a threaded connector. (Natoli Dep. 219:24-220:5). This evidence, viewed in the light most favorable to plaintiffs, is sufficient to carry the Estate’s burden of showing that the chamber’s manufacturer, HTI, acted unreasonably. Thus, defendant may be liable because, when the evidence is viewed in the light most favorable to plaintiffs, defendant was the Chamber’s apparent manufacturer.

Next defendant argues the Estate’s design defect claim fails because there are too many factors unaccounted for that could have proximately caused Jarred’s death, rendering plaintiffs’ proof of causation speculative. The court agrees.

Typically, proximate cause is a question of fact. Ross v. Wash. Mut. Bank, 566 F.Supp.2d 468, 479 (E.D.N.C.2008), aff'd sub nom, Ross v. F.D.I.C., 625 F.3d 808 (4th Cir.2010). To survive summary judgment on the issue of proximate cause, a non-movant’s evidence must be fact-specific and not merely speculative. Id. Although the issue proximate cause usually should be submitted to the jury, where there are multipl