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.


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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.


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This post comes from the non-Reed Smith side of this blog.

With some courts, the § 510(k) clearance of a medical device is not only insufficient to support preemption. It’s not probative enough to be discussed at trial.  The MDL court in the Boston Scientific Pelvic Repair System Products Liability Litigation is one such court, consistently excluding from trial evidence of 510(k) clearance of the pelvic mesh device.  According to a recent decision by one of the courts overseeing a trial on remand from the MDL, the MDL court read Medtronic v. Lohr to hold that § 510(k) clearance addresses only the device’s equivalence with an already marketed device, not safety.  Winebarger v. Boston Scientific Corp., 2015 U.S. Dist. LEXIS 126616, at *13-14 (W.D.N.C. Sept. 22, 20150) (describing the basis for the MDL court’s decision).

We’re not so convinced. The 510(k) process is not a complete abandonment of safety considerations.  And it certainly provides evidence of whether the manufacturer behaved reasonably.  Congress enacted the 510(k) process, in part, to enable quicker clearance for new devices that are equivalent to devices that have already been on the market and have accumulated some sort of safety and efficacy record.  Moreover, the 510(k) process is an inescapable reality for device manufacturers.  A discussion of the process, how it was followed, and the safety information that was provided or available through the marketing of equivalent devices is relevant to assessing the reasonableness of the manufacturer’s actions.  If plaintiffs want to minimize its importance, establish that it says nothing about safety, or show what the manufacturer failed to do, they are free to present such evidence.  The jury can then decide the relevance of this evidence.

Fortunately, the remand court, applying North Carolina law, got this right – sort of.  In North Carolina, a jury may consider the “extent to which the design or formulation [of the device] conformed to any applicable government standard.”  Winebarger, 2015 U.S. Dist. LEXIS, at *19 (quoting North Carolina’s Product Liability Act).  And so, unlike the MDL court, the remand court determined that evidence of § 510(k) clearance is admissible.  But introduction of that evidence will likely come with a fairly severe limiting instruction:

The fact that BSC followed the requisite 510(k) protocol – limited as it is – prior to marketing its Uphold device has minimal probative value regarding BSC’s efforts to adhere to FDA processes and procedure generally. . . .  Admissibility might depend upon a limiting instruction that 510(k) clearance is not to be considered as evidence that the FDA authorized the Uphold as safe and approved its intended use as such; that 510(k) clearance is not evidence that BSC satisfied any standard of care in designing the Uphold device.  For these reasons, the Court’s preliminary ruling on Plaintiff’s motion is that the 510(k) clearance process is admissible subject to a limiting instruction consistent with the terms of the instant Order.

Id. at *22-23.


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The test for determining whether a state law claim is impliedly preempted is whether or not the claim would exist in the absence of the FDCA.

Rarely do we drug and device law bloggers read such a pleasing sentence.  It’s lyrical.  It reads like romance language.  Well, at least to us it does.  The opening

Here’s a preemption case that we’ll likely have an opportunity continue to follow.  A magistrate in North Carolina federal court recently issued a report recommending dismissal, on the basis of preemption, of product liability claims concerning the product Gelfoam.  Bradley v. Baxter Healthcare Corp., 2013 U.S. Dist. LEXIS 158935 (W.D.N.C. Oct. 18, 2013).  Gelfoam

We talk a lot about the learned intermediary doctrine.  It’s rooted in the reality of the physician-patient relationship.  Patients gain access to prescription drugs only through doctors who have the expertise to understand and weigh the risks and benefits of the drugs.  The learned intermediary doctrine, accordingly, says that pharmaceutical companies’ duty is to warn

When Bexis got back from hiking the Milford Track and doing all sorts of other ridiculously strenuous things in New Zealand, a friend of his from the Tar Heel State had sent along a new decision by a local appellate court rejecting medical monitoring where the plaintiff had no present injury. Our readers know we