We have been following the issue of potential product liability for software, including in connection with medical devices, for a while. Much of our attention, predictably, has been on FDA regulation of device software, including issues related to resistance to hacking to obtain information or cause harm. Like here, here, here, and
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.Continue Reading Summary Judgment Win Unsealed
A couple of cases we’ve posted about recently started us thinking – a dangerous turn of events, we know. There was that Beaumont Hospital case involving allegations about delivery of an incorrect free sample of a device. If somebody – anybody – at the hospital had simply looked at the thing, either when it was
As far as pharmaceutical mass torts go, the fen-phen litigation has been around for as long as any. But just because it’s mature litigation doesn’t mean that the old dog can’t do new tricks. Last month a fen-phen case produced the first post-Levine decision recognizing implied preemption, as we discussed here. This month
It’s an unfortunate fact of life that there are a lot of prescription drugs out there that people can also use to get high. We’re not just talking about cocaine, barbiturates, and methamphetamines, or even the long lists of drugs found at 21 U.S.C.A. §812. The truth of the matter is that just about any