[Drug and Device Law] Befuddled Plaintiffs Get Second Chance
This post is from the non-Reed Smith side of the blog.
We are going to begin this post by breaking the third person rule for a minute because Plaintiffs (really their counsel) in today’s case remind me of my third-grader. Generally speaking she’s a great kid, a handful at times – but then again who isn’t? But almost every day we go through the same evening routine. She gets out her homework, glances at it and immediately announces: “It’s too hard. I don’t know what to do!” To which I respond: “Did you try?” Of course she hasn’t. But the rule in our house is, you have to try on your own first – really try. If I see effort – real effort – and she’s still struggling, then I’m only too happy to help. More times than not, no assistance is needed other than some quick proofing. She just didn’t want to put in the effort. I don’t think this is that uncommon of a scenario for a grade-schooler. But when plaintiffs’ counsel try to pull the same nonsense, well that’s just *&#$%^@.
And that is just what happened in Marion v. Smith & Nephew, Inc., 2015 U.S. Dist. LEXIS 161681 (D. Utah Dec. 1, 2015). Plaintiff underwent hip repair surgery during which defendant’s hip resurfacing device was implanted. Six years later the system failed and had to be surgically removed. Id. at *1-2. Plaintiff filed a complaint alleging twelve state law causes of action against the device’s manufacturer. Id. at *6. The device, however, was pre-market approved by the FDA. That means, for any claim to survive preemption, it would need to impose a duty on defendant that was “narrower than or equal to” the federal device-specific PMA requirements (a parallel claim) and the state law duty has to “predate the federal statutory scheme” (no private right of action for FDCA violations) Id. at *5. That’s the “narrow gap” between Riegel and Buckman preemption.
It has been seven years since the Supreme Court’s Riegel decision and it has been fourteen years since Buckman. Yet nowhere in their twelve causes of action did plaintiffs even attempt to plead a parallel claim. And apparently their only argument in response to defendant’s motion to dismiss was “it’s too hard.” (While reading this, please add in the appropriate level of whininess that that comment deserves.) Plaintiffs argued that the law was uncertain, divergent, and disparate making it “difficult” for them to know how to plead their claims. This from counsel practicing in the Tenth Circuit where Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. 2015) makes it pretty clear you have to at least plead a parallel claim. If “I don’t know how” doesn’t work for an 8-year old, it surely shouldn’t work for plaintiffs’ counsel.
The court held that plaintiffs’ “too difficult” argument while not a proper legal basis to allow their claims to proceed, was enough to give them a chance to amend their complaint. Marion, at *6. But rather than sending them back to their desks with the admonition that they “really” try this time, the court decided to give them a helping hand and spell out the pleadings requirements for them:
· Specify the specific federal requirements that parallel the state law claims. A blanket citation to the FDCA is insufficient. Id. at *7. The court must be able to determine from the pleadings if the specific requirement applies to the device at issue and whether the duty parallels the state law duty. The court also mentions pleading “upon information and belief” if plaintiffs think a requirement is solely in the knowledge and possession of the defendant. We don’t see how that would be likely and we don’t particularly like creating “soft-edges” around this pleadings requirement, but we agree with specificity being the standard.
· Specify the state law duties. Again, passing mention of state law is not sufficient to allow the court to conduct a proper preemption analysis. The pleadings must also clearly demonstrate that the state law duty pre-dates and “exists independently” of the federal requirements. Id. at *8. It sounds like plaintiffs’ were trying to make out a negligence per se claim in opposition to the motion to dismiss, but the court shut that down as preempted by Buckman. Id. at *9.
· Finally, specify facts establishing entitlement to relief. Id. That is to say, plaintiffs can’t focus exclusively on preemption. If any claim survives preemption, it “must also be supported by sufficient factual allegations to make [it] plausible on [its] face.” Id. at *5-6. So, plaintiffs can’t overlook things like causation and expect to make it out of the pleadings stage.
Personally, we think the court gave plaintiffs’ more help than they deserved. Not even attempting to plead a parallel claim in a PMA medical device case is beyond shoddy drafting – it is inexcusable. You can’t practice medical device products liability law without being well-versed in Lohr, Riegel, and Buckman. Courts may differ in the margins, but the core principles are applied fairly uniformly. Certainly the law is clear enough that “I don’t understand” should be as unacceptable for plaintiffs’ counsel drafting a complaint as it is for a third-grader trying to figure out how many apples a farmer will harvest if he harvests 83 sacks of apples a day for 6 days.
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Posted By Michelle Yeary to Drug and Device Law at 12/08/2015 03:57:00 PM --
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