[Drug and Device Law] SDNY Sinks "Circumstantial Case for Products Liability"
We're constantly reminded of what self-centered creatures we are. Both at work and on the home front, it is hard to dwell too long on something without wondering what's in it for us. Just a little while ago we sent out one of those "Can anybody recommend a litigator in X?" emails and were greeted with thunderous silence (except for the one or two kindly souls who always offer some sort of suggestion). Meanwhile, the Drug and Device Law heirs furnish constant proofs of the solipsism of youth. To be sure, it is not as if we are immune. At least once or twice we have instantaneously deleted those sad "Help me" emails even though, with a little thought, we might have come up with a name. Moreover, who was it on Sunday night who entered into the evening television cocoon, watching the moving pictures and waiting for them to jiggle our neurons in pleasing ways? As the French (more on that later) would say, "L'idiot c'est moi." And all of this (including this post) took place after we read that piece in the weekend Wall Street Journal about how people talk too much about television.
Even ardent fans of Mad Men have been complaining about how dull it has been this season. At least part of that complaint stems from how other shows, such as The Americans, have been pouring on thrills. It is fine for Don Draper to gavotte in gabardine infidelity, reading and living Dante's Inferno. But here is what we get in the first ten minutes of Game of Thrones: fiery trial by combat, a dead man coming back to life, a nice dollop of HBO nudity, and gore galore. Even when GoT3 slows down to mere, old lady palace intrigue, the old lady doing the intriguing is Diana Rigg, who in the late 1960s donned a catsuit in the British television show The Avengers and escorted teen lad viewers (Bexis no doubt among them) through puberty. How can a drama about a boozing, philandering ad executive compete with swordplay and dragons and Cersei's incest-twitchy eyebrows?
And yet, just when we were achingly close to giving up on Matt Weiner's manipulations, the most recent episode of Mad Men, called "The Flood," brought us back to the show by bringing us back to ourselves. We were reminded of the relentless madness of 1968, and how a traumatic public event affects people's lives and brings out personal truths. We know of at least one eight year old boy who had nightmares about assassinations and riots. In the show an even younger boy reacted with surprising empathy. That last bit made Don Draper's "heart explode," after years of his faking parental love. Maybe there is a word for feeling shame and exhilaration at the same time, but it escapes us. The episode is called "The Flood" in reference to a character's observation that in times of catastrophe God's creatures need to pair off and carry on. Most of the people in the show aren't so good at that. Draper ends the episode standing alone on a balcony (perhaps a cruel echo, or perhaps Jon Hamm pretending to be both Frank Sinatra and Batman), while "Love is Blue" -- a French (!) instrumental that became an improbable #1 hit in the Spring of 1968 -- plays. As any ad executive knows, when people say "it's all about me," they are only half-kidding.
And yet, just when we were achingly close to giving up on Matt Weiner's manipulations, the most recent episode of Mad Men, called "The Flood," brought us back to the show by bringing us back to ourselves. We were reminded of the relentless madness of 1968, and how a traumatic public event affects people's lives and brings out personal truths. We know of at least one eight year old boy who had nightmares about assassinations and riots. In the show an even younger boy reacted with surprising empathy. That last bit made Don Draper's "heart explode," after years of his faking parental love. Maybe there is a word for feeling shame and exhilaration at the same time, but it escapes us. The episode is called "The Flood" in reference to a character's observation that in times of catastrophe God's creatures need to pair off and carry on. Most of the people in the show aren't so good at that. Draper ends the episode standing alone on a balcony (perhaps a cruel echo, or perhaps Jon Hamm pretending to be both Frank Sinatra and Batman), while "Love is Blue" -- a French (!) instrumental that became an improbable #1 hit in the Spring of 1968 -- plays. As any ad executive knows, when people say "it's all about me," they are only half-kidding.
Last week a case came across the LexisNexis transom that, while not fascinating in its own right, arrested our attention because it covered issues that were front and center in our practice. We have been working on a product liability case in New York where there was precisely zero evidence that the product was defective in any way – except that the plaintiff was injured after the procedure. Where is the product defect? Where is the safer alternative? Where is the deviation from a manufacturing spec? New York law allows a case to proceed on the basis of "circumstantial evidence" if the plaintiff can eliminate all alternate causes. How seriously do courts take those requirements of eliminate and all?
The court in Goldin v. Smith & Nephew, Inc., 2013 U.S. Dist. LEXIS 58811 (S.D.N.Y. April 24, 2013), took those requirements very seriously. The case involved a hip replacement device. The plaintiff underwent right total hip replacement in July 2009. In May 2010, the plaintiff underwent revision and exchange of the metal components with metal and polyethylene components. A month later, the plaintiff had revision surgery utilizing the product at issue, a Smith & Nephew Constrained Liner, which was recommended to the plaintiff by her surgeon. The plaintiff seemed to be making good progress toward regaining her range of motion, ambulation, and overall function. But on August 12, 2010, the plaintiff was taking a shower when she experienced excruciating pain in her right hip. X-rays revealed that the right femoral head had become dislodged from the polyethylene liner. Smith & Nephew issued a voluntary recall of the constrained liners, warning of the risk of intra-operative and post-operative dislocation. The plaintiff filed a complaint in New York state court alleging causes of action for strict products liability under manufacturing defect, design defect, and failure to warn theories of liability, breach of implied warranty, breach of express warranty, negligence, and violations of New York's consumer protection statute. The defendant removed the case to federal court and then filed a motion to dismiss.
The defendant argued that the plaintiff failed to allege any facts regarding the manufacturing process. "The Complaint says nothing about a mishap in the manufacturing process, improper workmanship, or use of defective materials." Goldin, 2013 U.S. Dist. LEXIS 58811 at *7-8. The plaintiff argued that her Complaint "nonetheless should survive because she has alleged facts suggesting that the product did not perform as intended and by excluding all other causes for the product's failure." Id. at *8-9. There is that theory of circumstantial case for products liability, which is especially pertinent where, as in Goldin, the plaintiff no longer remains in possession of the disputed product. The plaintiff argued that several possible causes have been excluded and that her surgeon concluded that "the problem was with the constrained liner." Id. at *9. Admittedly, that opinion by the surgeon is pretty strong stuff. But it is not strong enough. The plaintiff did not allege that "her surgeon viewed the problem with the constrained liner as a manufacturing defect, that the only possible cause of her injury was such a defect in the product, or, most importantly, that the circumstantial case supports the conclusion that this otherwise adequately designed product must have suffered from a manufacturing defect of the sort described above. If plaintiff is going to rely on the circumstantial theory of liability described in New York case law, she must allege more facts to nudge her claim above the level of speculation and into the realm of the plausible." Id. at 9-10.
The insight of the Goldin court is that a product can fail without there being a defect. It is strange how many courts just do not get that, and are content to wave the case along to the jury. Their reasoning is defective. It is as if some judges insist upon vaguely mis-recalling the doctrine of res ipsa loquitur. But the Goldin court gets it right. It also dismissed the design defect claim, because the plaintiff did not allege "any facts to demonstrate that the product as designed posed a substantial likelihood of harm or that it was feasible to design the product in a safer manner that would have prevented Plaintiff's injuries." Id. at *11. Now, just as the plaintiff had a pretty good fact in the surgeon's opinion that the device failed, the plaintiff had another pretty good fact in the product recall. But the "bare fact of the voluntary recall does not suffice to prove a design defect." Id. at *12. The plaintiff asked the court to take judicial notice of the fact that most hip implants do not dislocate during revision surgery, but the Goldin court correctly ruled that such fact was beside the point. The real question for a design defect claim is "whether a safer alternative design for this product existed." Id. The plaintiff did not allege that fact in her complaint.
The failure to warn claim fared no better. The plaintiff did "not identify the promotional materials upon which she and her surgeon allegedly relied, nor does she explain what warnings those materials contained and how those materials breached a legal obligation. Standing alone, the bare fact that Plaintiff suffered an injury after using a product that had been promoted for patients in her situation does not render the warnings inadequate. " Id. at *14. And now all the other claims fall like dominoes:
- The implied warranty claim requires a product defect, and that hasn't been alleged.
- The express warranty claim requires a promise that is, um, express, and there isn't one of those in sight.
- The negligence claim requires a showing that the defendant knew the constrained liner was defective which, again (aren't you paying attention?), is not sufficiently alleged.
- The action under New York General Business Law §349 was premised on allegations that the defendant "failed to adequately warn consumers and the medical community of the safety risks associated with the R3 Constrained Acetabular Liner" and made "false and misleading representations and omissions of material facts regarding the safety and potential risks of the R3 Constrained Acetabular Liner," but those allegations are as empty as Don Draper's soul.
The Goldin story is not yet completely over (though, unlike the remainder of Mad Men season 6 and 1968, we hope it ends peaceably). The court gave leave to amend, and part of the reason for that was that "[t]he Complaint was drafted as part of a state court filing, but is now subject to the higher pleading standards applicable in federal court." Id. at * 19. So the hero of this story is not a knight, wizard, imp, ad executive, or Batman, but, rather, TwIqbal. Again. Whether the Goldin complaint can be resurrected remains to be seen.
And since we have a very similar case, we will be tuning in even more attentively than usual. After all, it's all about us.
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Posted By Steve McConnell to Drug and Device Law at 5/01/2013 07:30:00 AM --
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