[Drug and Device Law] Mark Marcum Down as a Not-So-Good Case on Preemption and TwIqbal

2 views

Skip to first unread message

Steve McConnell

unread,

May 15, 2013, 8:15:20 AM5/15/13

to drug-and-...@googlegroups.com

We are looking forward to this week’s DRI Drug and Medical Device Seminar and the opportunity to get together with so many old friends. We'll learn some new things, relearn too many old things, maybe learn some wrong things, and listen to judges tell us how we should be able to work out most of our disputes with plaintiffs. When lawyers congregate, they waste liters of vodka and oxygen bragging about their latest wins. By contrast, plaintiff lawyers are content merely to show off the proofs of their successes, in the form of Porsches, Patek Phillippes, and pinky rings. It is passing strange how we lawyers feel the imperative to tell war stories where we always emerge as winners. That impulse is possibly understandable, but it is not particularly useful. The medical profession has a much sounder practice of focusing on cases gone kablooey. The periodic mortality and morbidity meetings at hospitals discuss errors and ways to avoid them. Everyone says that you can learn more from defeats than victories. But while lawyers just say it, doctors practice it. Wouldn't it be great to see a lineup of litigation stars ruminating on "My Biggest Blunders"? Moreover, if there was a judicial panel on that topic, it would be a must see. The conference planners could plant that program at the end, on Friday afternoon, and the speakers for once wouldn't be drowned out by the sound of fleeing rollaboards.

Today we will discuss a case that did not turn out so well for the good guys. Normally in this blog we focus on defense wins. After all, we do not relish the idea of doing the plaintiffs’ work for them. But today we will conduct a mortality and morbidity meeting on the case of Marcum v. DePuy Orthopedics, Inc., 2013 U.S. Dist. LEXIS 62875 (S.D. Ohio May 2, 2013), and see if there is any wisdom to be gained from it. We will not exactly be performing a dissection, but there are definitely a few grisly bits to hold up and examine. We’re not saying there was any discernible error or fumble – no legal-doctrinal equivalent of a sponge left in the chest cavity. But the court’s failure to consign the case to the dustbin of history was eminently predictable.

Marcum is not an entirely bad case. The medical device in issue was a ceramic femoral head component for hip replacement, as opposed to all those metal-on-metal devices that gave rise to so much litigation. Because this is a product liability case, something went wrong. The component broke four years after the plaintiff’s hip replacement surgery and there had to be a revision surgery. Consequently, the plaintiff filed an action alleging every cause of action in sight. Those causes of action include strict liability (defective manufacturing, defective design, and nonconformance with representations), common law negligence, breach of express warranty, breach of implied warranty, and negligent misrepresentation. None of this is surprising. Our system seems to encourage the transformation of ignorance about what really happened into allegations that everything bad happened. It is also not surprising that the plaintiff sought punitive damages in her prayer for relief, even though there was no reason to believe that the defendant did anything particularly terrible or malicious. Again, our system of litigation prompts allegations of the most and the worst. When you think of it, that process evinces a scurvy view of human nature. And it's not as if it is especially logical or inevitable. But it's what we've got.

The defendant did the right thing and tried to clean up this mess of a complaint by cutting away unnecessary underbrush. The initial question was the extent to which the various product liability claims were subsumed or abrogated by the Ohio Product Liability Act. That matters, if only because if this thing goes to trial any defendant would prefer that fewer causes of action linger in front of the jury. There is always the danger that the jury might arrive at some silly compromise that latches onto a seemingly-throw-away count. Less is not more; less is less. Less is good. The plaintiff did not contest that the negligence, breach of express warranty, and breach of implied warranty causes of action were abrogated by the Ohio Product Liability Act. [So why file them?] But the plaintiff argued that her negligent misrepresentation claim was not abrogated because it implicated a more general duty not to deceive rather than a duty to warn. Oh, that argument. It usually does not work. It did not work here. The court correctly held that however the plaintiff dressed up the misrepresentation claim, the fundamental beef was failure to warn, and that is covered by the Ohio statute.

At this point, the case has become a little less clunky, and that's a good thing. But here is where the defendant might have gotten just a tad too ambitious. There's something to be said for quitting while you're ahead. Mind you, we know only what we read in the opinion. It is possible that the court's discussion does not do justice to the defense arguments and is looking to make their rejection seem as inevitable as possible by making the arguments seem as weightless as possible. For this case, we have no inside skinny. We are helplessly dependent on the judge's account of things.

In any event, let's all agree that the allure of preemption is undeniable. It makes claims go away completely. No muss, no fuss. No need to worry about bad science, bad documents, or bad experts. So it is no marvel that the defendant sought dismissal of the case on grounds of preemption. But the ceramic femoral head is a Class II medical device. We lost that issue in Lohr years ago. So it is also no marvel that the court rejected the preemption argument, even if the court garbled the law in getting there. For instance, the court held that the plaintiff's strict liability claims "are not, at base, claims for violation of federal law." Marcum, 2013 U.S. Dist. LEXIS 62875 at *10. Okay. So what? Instead, "Plaintiff’s claims in question are that Defendant breached well-recognized state law duties owed to her through conduct that is also a violation of federal law, and these claims are therefore not preempted by Buckman." Id. We'll confess that we are not sure what the court means by that. Is this an invocation of the "parallel" claim exception, even though, like we said, this isn't a PMA device? That word nowhere appears in the decision. Look, there probably was not going to be preemption for this 510(k) cleared product anyway, but now we have some baffling, ugly language that will be cited in cases where there might actually be a vigorous preemption claim. We can think of arguing preemption in a case where a plaintiff is challenging the 510(k) status of a product, where the plaintiff argues that the clearance process is illegitimate, or that the manufacturer should have insisted on going the PMA route, or that the manufacturer should have engaged in testing above and beyond that required by the 510(k) clearance process. Otherwise, don't lead with your chin, not on a defense as precious as preemption. We'd like to think those valid preemption arguments are not foreclosed by the court's reasoning in Marcum, but we're not certain what that reasoning is or what argument by the defendant provoked such reasoning.

It looks like the defendant mounted a TwIqbal challenge to the complaint, and the court mushed together the manufacturing and design defect claims in a way that mystifies: "Plaintiff pleads and references good manufacturing practices that Defendant is required to maintain, including establishing and maintaining quality audits, quality testing, and process validation for the Articul/EZE ceramic femoral head, and that here, in their absence, the product was defective and failed, resulting in a fracture of the ceramic femoral head and injuries." Id. at *13. How precisely did the defendant depart from manufacturing specs or good practices? Dunno. Has the Marcum court just blessed a formula that will permit every manufacturing defect claim to survive via a blizzard of empty words? According to the Marcum court, such a blizzard is enough to blow away pleading requirements: "Specifically, Plaintiff pleads that Defendant designed, manufactured, sold, distributed and supplied the Articul/EZE ceramic femoral head into the stream of commerce, that it was defective when it left Defendant’s hands, and that it reached Plaintiff on November 12, 2007 when she underwent a left total hip replacement." Id. at *13-14. Check out that word "Specifically." That is what we in the biz call a howler.

The court also rejected the defendant's assertion that the plaintiffs claims were "inadequately pled because she does not currently have the device in question or because her surgeon's assembly of the hip implant device rendered the product substantially altered." Id. at *14-15. The court reasoned that the unavailability of a medical device is not fatal if there is circumstantial evidence of the alleged defect, and the alteration of the device was expected and intended and, thus, not a barrier to either design or manufacturing claims. Id. at *15. It is far from pellucid how any of this fits in with pleading issues, unless the idea is that the unavailability or alteration rendered the product liability claims implausible. It just might be that the court is not telling us what the defendant actually argued.

Similarly, we are never told exactly what the defendant's argument was against the claim for nonconformance with representations claim. What we are told is that the plaintiff "pleads that she and/or her physician justifiably relied on Defendant’s representations about the wear characteristics of Defendant’s product in choosing the Articul/EZE ceramic femoral head. Additionally, Plaintiff pleads that Defendant’s representations were false and the femoral head fractured inside her body. " Id. at *17. Again, those are rather empty allegations. Anyone could author them, untethered to a single fact. And what gives with the "she and/or her physician"? Shouldn't it just be the physician? As is so mind-numbingly often the case with these cases, it becomes enough for the plaintiff simply to say that the product failed. There's your proof of defect. There's your proof of a lie. Except it isn't.

Finally, the court says that the complaint adequately sets forth a request for punitive damages. Under Ohio law, punitive damages are precluded if the device was manufactured and labeled in conformance with Food and Drug Administration regulations. The Marcum court holds that "[a]though the fact that Defendant received marketing approval does not establish that Defendant’s product was actually manufactured and labeled in accordance with that approval, Plaintiff must allege facts to show a lack of the required compliance." Id. at *18. Hmmm. So we are talking about compliance with federal law, ay? And some jury in Ohio, as opposed to the FDA, will decide that, ay? Getting past that, how does the plaintiff allege lack of such compliance? Here's how: "Plaintiff pleads that, in conflict with the requirements of the 510(k) approval process, the Articul/EZE ceramic femoral head was adulterated because the product failed to meet performance standards, that Defendant failed to establish and maintain current good manufacturing practice with respect to quality audits, quality testing, and process validation, and that as a result of Defendant’s failure to maintain such standards as required by the 510(k) approval process, the device failed and caused Plaintiff’s injuries." Id. Hence, according to Marcum, a few vague generalities are enough to conjure up the threat of punitive damages.

As we said, all we can do is hold up the nasty parts of this opinion and gaze in distaste. We recommend using tweezers and rubber gloves.