Today is sort of a twofer Tuesday.  We have two cases, but only one issue.  So, maybe it’s more of a two-for-one deal.  There is also one general takeaway – it pays to look at state-specific defenses to state-specific claims.  For example, the privity requirements in North Carolina make it extremely difficult to bring a

Here are some things you probably will not hear very often, if at all:  1) a fervent supporter of a defeated political candidate agreeing that the winning elected official has done a good job, regardless of economic growth, infrastructure projects, public health progress, or some other measure of good government; 2) a fervent supporter of

We have promised ourselves that we will stream this week’s “This Is Us” episode when we finish this blog post.  We love this series beyond reason, and we dread its imminent demise, notwithstanding the title’s grammatical transgression.  (We generally condition any sort of allegiance on correct use of predicate nominatives.)  We are struck, over and

Now comes the pathos of social distance. As with many of you, we are working remotely. The pantry shelves are groaning under the weight of so many soup cans. Our only reliable encounter with other humans is with the UPS delivery driver, through a door-glass darkly.

Per our Spring Break plans, right now we should

Put a New Yorker and a Californian in a room together and the debate will begin almost immediately. Hollywood v. Broadway. Atlantic v. Pacific. Dodgers v. Yankees or Giants v. Forty-Niners. Shake Shack v. In-N-Out (or is Five Guys overtaking both?). And more generally speaking that east coast/west coast divide extends beyond those two urban

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

This post comes from the Cozen O’Connor side of the blog.

To those of us who were unable to find a slide in anything that Chase Utley did Saturday night, it made a whole lot of sense to suspend him for two games.  The wisdom of the suspension does not only lie in the fact that, at least as we’ve seen it done and done it ourselves, sliding involves an actual slide across the ground in front of the base, not airborne hurtling above the base toward a fielder’s exposed leg.  It lies at least as much in the practical decision not to allow Utley to trot to the foul line, walk to the plate, jog to his position, or do anything at Citi Field tonight.  Because that might be dangerous.  It shouldn’t be.  But it might be.  Whether you think his play was bush league or clean [the correct answer: “bush league”], there’s no denying that New York now has a palpable dislike for him, one based as much on his getting away with it as his doing it.  And, by telling Utley, “no Citi Field for you,” MLB can defuse the situation.  It was a sensible and practical decision, whether the suspension is supported by the language of the rulebook or not [the correct answer: “it is”].

So too was the Court’s decision in Carlton v. Boston Scientific Corp., 2015 U.S. Dist. LEXIS 132675 (W.D.N.C. Sep. 30, 2015).  [That’s what we call a segue.]  North Carolina has codified the learned intermediary doctrine, but its codification mentions only prescription drugs, not medical devices:

[N]o manufacturer or seller of a prescription drug shall be liable in a products liability action for failing to provide a warning or instruction directly to a consumer if an adequate warning or instruction has been provided to the physician or other legally authorized person who prescribes or dispenses that prescription drug for the claimant unless the United States Food and Drug Administration requires such direct consumer warning or instruction to ac-company the product.

N.C. Gen. Stat. § 99B-5(c).  The learned intermediary doctrine is based on a real-world construct, however, in which patients gain access to certain medical products only through doctors, educated professionals who can understand and interpret the risks and benefits of medical products and describe them to patients.  And that construct applies equally to medical devices and prescription drugs.

Continue Reading Court Interprets North Carolina Law to Apply the Learned Intermediary Doctrine to Medical Device Cases