Photo of Michelle Yeary

Two weeks ago we told you that an interesting decision was rendered in Sparks v. Oxy-Health, LLC, et al, Case No. 5:13-cv-649-FL, slip op. (E.D.N.C. Sept. 15, 2015), but we could not talk about it because the opinion had been sealed.  The parties have informed the court that no redactions were necessary and now the order has been unsealed and we are free to blog about it.

We want to start our post by acknowledging that the underlying circumstances of this case are tragic.  It is simply a sad story for the individuals involved.  For that reason, we are going to deal with the legal issues in a very straight forward manner.  From a legal perspective, plaintiffs did not have the evidence required to sustain a products liability or a consumer fraud case under North Carolina law.  It is the import of the judge’s reasoning and the precedential value of the case that we center on and bring to your attention.

The lawsuit was brought by parents on behalf of their deceased son.  Their son was 19 years old and autistic.  The medical device at issue is a portable mild hyperbaric chamber.  Hyperbaric chambers are designed to increase atmospheric pressure.  Sparks, slip op. at 6.  The one at issue in this case was §510k cleared by the FDA for the treatment of “acute mountain sickness” (condition that affects climbers who climb in excess of 8,000 feet).  Id. at 7-8.  In certain medical communities, a recognized off-label use for hyperbaric chambers is the treatment of autism.  Id. at 8.  A prescription is required for this treatment.  Id.  For several years, plaintiffs took their son to clinics where he would receive hyperbaric chamber treatments.  During clinic treatments, plaintiffs’ son was not left alone. Either a family member or a technician monitored and stayed with him throughout the treatment.  Id. at 9.   In 2011, plaintiffs decide to purchase a hyperbaric chamber from the clinic for in-home use.  Id.  The chamber had been in use in plaintiffs’ home for four months before their son’s death.  On the night of his death, decedent was placed in the chamber by his brother who left the room and went to bed.  Id. at 11-12.  Decedent’s father was not home that night and his mother fell asleep downstairs.  Id. at 12.  When she woke, she checked on her son and found the chamber had deflated and that her son had asphyxiated.  It was later discovered that the hose that pumps air into the chamber had become disconnected when a book shelf had depressed the disconnect button on the hose valve.  Id. at 12-13.

Plaintiffs filed suit alleging claims for design and warning defects, breach of express and implied warranties, consumer fraud, and negligence.  Id. at 2.    Plaintiffs’ claims center on allegations that the air hose valve should have been a threaded style and not a quick disconnect, that the chamber should have included an alarm to warn about carbon dioxide accumulation, and inadequate warnings. The court’s legal analysis starts with a lengthy discussion of whether the defendant could be held accountable as the manufacturer of the chamber.  Defendant was a distributor who was involved in actual assembly, packaging, and promotion of the device.  The court ultimately concluded, based on specific facts, that the defendant was the “apparent” manufacturer of the chamber.  The discussion can be found at pages 17-29 of the opinion.  We aren’t going to dwell on it here as it is a rather uncommon issue in typical drug and device cases, but we note it in case you want to read the analysis yourself.

North Carolina has a products liability statute, but as the court states, it is “not a model of clarity.”  Id. at 29.  On design defect, plaintiffs have to prove that the manufacturer acted unreasonably in designing the product.  Plaintiffs must also prove either a feasible alternative design or that the design was so unreasonable, a reasonable person would not have used the product.  Id. at 32.  And of course, plaintiffs must prove proximate cause.  In this case, the court found that plaintiff had presented evidence of a feasible alternative design – a threaded connector and an alarm; but failed to carry their burden on proximate cause.  The number of unaccounted for intervening factors is what the court found persuasive.

Plaintiffs argue that the quick disconnect button and lack of alarm were the cause of their son’s death.  Those, however, are “at best” but-for causes.  Id. at 36.  Defendant demonstrated and the court agreed that product misuse was an intervening event that rendered any causal nexus to the alleged defect too speculative.  Plaintiffs were not following the instructions (which were also consistent with their prior use experience) that came with the chamber regarding always having an attendant present while the chamber was in use. Id. at 36-37.  Further the evidence showed that when the hose became disconnected, it made a much louder than normal sound.  So, there is no way to know whether if the decedent had been attended and/or if his family had been awake that night, the problem would have been remedied and decedent would not have died.  Id. at 37.  “Without evidence tending to show that the same result would have occurred even [without misuse], the causal connection between the [alleged defect] and the harm suffered by [decedent] is too speculative.”  Id.

In response, Plaintiffs argued that it was foreseeable that users would not read the instructions manual.  But, as the court points out, foreseeability is about the harm suffered, and even if the injury was foreseeable, plaintiffs must also show that the foreseeable harm was caused by the product defect.  Id. at 38.  Plaintiffs next argued res ipsa loquitur – an inference of negligence.  First, the court found that res ipsa alone doesn’t get you to the jury:

Thus, in a product liability action the inference of defendant’s negligence, without more, does not carry the plaintiff’s claim to the jury.  Rather, the plaintiff much demonstrate a casual connection between the product itself and the harm suffered.

Id. at 40.  Second, res ispa only applies where the product was under the “defendant’s exclusive control.”  As described above and in more detail in the opinion, that was not the case here.  The design defect claim was dismissed in its entirety.

Moving on to warning defect, the analysis is complicated by the fact that the defendant is not the manufacturer but rather the apparent manufacturer, and so the court concludes that on warnings, the standard that applies to defendant is the one for a seller, not a manufacturer.  Id. at 43.  As the seller, defendant had a duty to warn of particular risks of which if had “actual or constructive knowledge.”  Particular is the key word.  While defendant may have had knowledge of the risk of asphyxiation generally, there was no evidence “that defendant knew the quick disconnect valve unintentionally would disengage with someone in the chamber, thus leading to asphyxiation.”  Id. at 44.  But even if there had been a duty to warn, plaintiffs’ warning claim also fails for lack of proximate cause.  Given failure to read and non-compliance with the warnings that were given, there was no evidence that plaintiffs would have acted differently if supplied with a different or additional warning.  Any suggestion otherwise is “inherently speculative.  Id. at 45.

Plaintiffs’ consumer fraud claim was premised on three alleged misrepresentations:  representing that the chamber was FDA approved for the treatment of autism; misrepresenting that the chamber was manufactured according to certain industry standards; and misrepresenting that the chamber was safe for in-home use without medical supervision.  Id. at 50.  But once again, plaintiffs lack the required causal connection. Misrepresentation claims require a showing of both actual and reasonable reliance.  Id. at 51.  For this, plaintiffs relied on an affidavit executed by plaintiff Amy Sparks detailing information she claims she was provided at a “Hope for Autism” conference and on which she claims she relied on in purchasing the chamber.  The contents of the affidavit, however, were in direct contradiction to plaintiff’s prior deposition testimony regarding what she relied on (conversations with nurse and tangible benefits she saw for her son, not marketing statements or materials).  So, under the “sham affidavit” rule, the court disregarded the affidavit – without which plaintiffs had no evidence of actual reliance.  Id. at 54.

Plaintiffs’ claims were dismissed in their entirety. As we said at the outset, the case is presented on tragic facts, there is no denying that.  But, tragedy does not create liability.  Plaintiffs were still required to make out a prima facie case and they could not.  Their own intervening misuse, failure to heed, and lack of reliance severed the causal connection between the injury and the alleged defect.  In checking the docket for the unsealed opinion, we learned that plaintiffs are appealing.  There are many legal issues at play, so we’ll keep a watch for further developments.