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[Drug and Device Law] A Civil Discussion

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This week sees the annual ACI Drug and Medical Device Litigation get-together in New York. Here's a shameless plug: we will take part in a panel discussion on civility, diversity, and ethics. We were assigned the dreaded end-of-conference Friday afternoon slot, so we are prepared to bellow over the din of retreating rollaboards. Always a good time. Rumor has it that some plaintiff lawyers are showing up. The panel will devote a few minutes to discussing how nice it is to be nice. We might also devote a few minutes to challenging that assumption.

Not that we have anything against conviviality, especially this time of year.

Conviviality is good in itself, but it can also serve a purpose. Recently we attended an MDL hearing. Part of the festivities included a cocktail party, complete with defense hacks, plaintiff lawyer pursuers of justice (in the form of wire transfers), and court staff. Talk about civility! Several times we were treated to an odd bit of theater where a lawyer would snicker about how something weird and wonderful happened, but how it dare not yet be revealed. Then, two or three sips later, that same lawyer would whisper out of a mouth corner something like, "Okay, here's how it went down." Most of what we learned was silly or possibly wrong. But we gathered at least one useful tidbit.

So it really can be nice to be nice.

But we also learned something from a colleague that made us feel not so nice. One of our early law firm boss-hero-mentors, Jim Lyons of Skadden Arps, passed away earlier this year. He was way too young. Lyons was one of the best litigators who walked the planet. He was also one of the fiercest. (We have worked with two lawyers named Lyons. Fittingly, both were courageous, ferocious litigators.) If you worked with Jim Lyons, odds are that the case was high-stakes and high-pressure. And Jim had the highest standards. If you were a young associate, Jim could be intimidating. After you wrote something up, such as a memo or a brief, he would instruct you to come to his office. Then he would interrogate you about your research. Did you look at A? Did you think of B? He would keep asking until you confessed that, No, you had not considered that. What followed was not pleasant. Jim let you know that your failure was not acceptable. Go back and do it right. And then the process would recycle. After you turned in what you thought was a new and improved paper, the interrogation would resume. Did you look at C? Did you think of D?   Inevitably, Jim would name something you missed, and you felt awful. Fix it! But here's the thing: eventually the final product would be much, much better.   Moreover, eventually you would learn how to do thorough, creative research in the first place so that you could answer Jim's questions the right way. Yes. Yes. Yes, damn it. It's all in there. Jim made you a better lawyer. He trained you. In fact, the other litigation partners insisted that young associates work with Jim first, so that associate work product would always be complete and reliable.

After surviving the Lyons meat-grinder, then practicing better law and climbing the ranks over the years, you entered into a different relationship with Jim. Sure, he was still senior to you.   He was still a better lawyer than you were. But as he started to treat you more like a peer, you discovered that he was a kind, funny (though still driven) guy. For some reason, we remember a prolonged debate between Jim and another partner about whether the best steaks ended up on plates in Kansas City or New York. Lyons was from Missouri, but went to law school and began his career in NewYork. Thus, his pronouncements on the subject were authoritative. Anyway, all of that terrifying of young associates was intentional, and the intention was honorable. It was a way of protecting clients. It was also a way of turning whiners into winners.

Nowadays, that tough love approach is hard to find in law firms. We get the impression that associates now expect to be handled with kid gloves. Maybe that is better. But there is a price to all those participation trophies. And now we will reluctantly admit to something that makes us feel ashamed. There have been a few occasions when, after receiving an inferior draft, rather than tell the young lawyer how deficient the draft was, we uttered insincere thanks, shooed them on their way, and then closed the door and rewrote the document. It is possible that we seethed a bit. Perhaps we also congratulated ourselves on our relentless niceness. But were we really being nice? Isn't it better to be honest? Isn't it better to help people be better, even if that requires a few awkward or even unpleasant moments? We are still not half the lawyer and mentor that Lyons was.

It turns out that civility and niceness are more complicated than one might think.   Let's agree that we want professionalism in our profession and will do our best to figure out what exactly that means, while being as decent to each other as we can.

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Posted By Steve McConnell to Drug and Device Law at 12/02/2015 07:30:00 AM

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[DK GreenRoots] Paris: What if they threw a COP and Nobody Came?

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Paris: Dec. 2: What if they threw a COP and nobody came?

Sample Tweet:

Paris: Dec. 2: What if they threw a COP and nobody came?

What's it all about? #COP21 What if they threw a COP and nobody came? http://goo.gl/YI3MGM #COP21Paris

Deborah Phelan

Executive Director, 2050kids

"Tomorrow belongs to the people who prepare for it today." African Proverb

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[Drug and Device Law] A Funky Preemption Decision from California

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Based on that title, we’re guessing you don’t know if we are talking about a defense win or a defense loss. “Funk” is a contronym – a word that has contradictory meanings. Some examples: continue can be used to mean keep doing an action or to suspend an action; you can use overlook to mean supervise or to mean neglect; and transparent can mean both invisible and obvious. The word funk originally – and still does – refer to a strong odor. A half-eaten, week old ham & cheese sandwich that has been rotting in a ten-year old’s backpack is funky (trust me!). But somewhere along the way, funk moved from just meaning stink, to also meaning stank – a term used by jazz musicians in the early twentieth century that is still used by musicians today to mean a dirty or gritty sound – but in a good way.

What most people think of as funk music dates back to the 1960s and a blending of soul, R&B and jazz. James Brown, Sly & the Family Stone, The Isley Brothers. Now we’re talking the good kind of funky. The kind you groove to. And we couldn’t be discussing funk without mentioning George Clinton and Parliament-Funkadelic – one of the most heavily sampled funk groups of all time. While we’re skipping over too many to name, we can’t not mention Bruno Mars. Backed up by his band (The Hooligans) that mixes rock guitar and bass with an amazing horn section, his live shows are a mix of 11 year-old girls who’ve never heard such funky beats and 65 year-old women re-living James Brown concerts. Either way, we’re glad funk is still going strong.

So, is today’s case sweaty gym socks funky or “Papa’s Got a Brand New Bag” funky? Well, first of all, it’s the name of the case – Funke v. Sorin Group USA, Inc., No. SACV-15-01182-CJC(ASx), slip op. (C.D. Cal. Nov. 24, 2015). Not to be confused with another preemption decision, Funk v. Stryker Corp., 631 F.3d 777 (5th Cir. 2011). Second, the decision is “Give up the Funk” funky. Or in legal speak – a preemption win.

Plaintiff underwent an aortic valve replacement with a valve manufactured by the defendant. Slip op. at 2. After 5 years, the valve failed and had to be replaced. Plaintiff’s complaint alleges claims for negligence, strict liability failure to warn, strict liability manufacturing defect, and negligent misrepresentation. Id.

The valve was Pre-Market Approved (“PMA”) by the FDA – making this one of those cases where plaintiff’s claims must fit through the “narrow gap” between express and implied preemption in order to survive. Id. at 6. A viable claim must parallel the federal regulations/requirements for the device (can’t impose different or additional obligations on the defendant) but must also be a claim recognized under state law; it can’t be solely a claim to enforce federal requirements. Plaintiff in Funke didn’t pass the test.

First up was strict liability failure to warn: “Allowing Mr. Funke to proceed on such a claim would impose requirements different from, or in addition to federal requirements.” Slip op. at 6-7. Plaintiff tried to argue that defendant’s labeling was false and that that triggered a requirement for the defendant to provide different warnings to plaintiff and his doctors. But as the court acknowledged, Mr. Funke missed the mark:

A plaintiff cannot escape preemption with regard to a device that has gone through the PMA process under the MDA by asserting that federal law does not prohibit additional warnings. A state law claim can only escape preemption if it is parallel to the federal law, meaning that the federal law itself affirmatively prohibits or requires the same conduct.

Id. at 8. Failure to warn plaintiff and his doctors is preempted.

That’s the positive funky part. The less groovy and more smelly part is that the case is in the Ninth Circuit and therefore, we have to deal with Stengel – failure to warn the FDA. Unfortunately, this court, like others, holds that California recognizes such a claim. Id. at 7. Fortunately, plaintiff didn’t plead his Stengel claim well enough to survive a motion to dismiss. Plaintiff alleged that because the FDA website did not list any adverse events before 2013, defendant failed to report adverse events before then. However, at defendant’s request, the court took judicial notice of the FDA’s online database (MAUDE) which showed adverse events back to 2008. Plaintiff also alleged that earlier adverse events could be found in literature, but they neglected to tell the court that those events occurred outside the United States and prior to PMA clearance of the valve, meaning defendant had no reporting obligation to the FDA for those events. So, while a Stengel claim may be possible, one of plaintiff’s allegations was factually refuted and the other legally refuted. Id. at 9-10. Plaintiff is being given an opportunity to re-plead his Stengel claim.

The next claim is strict liability manufacturing defect. Or is it? The court wasn’t sure because plaintiff’s briefing cited articles alleging a possible link between the valve’s design and device failure. Id. at 11. If plaintiff is alleging a design defect, the device’s design was approved by the FDA in the PMA process and that claim is preempted. If plaintiff is alleging that defendant failed to adhere to the approved design, that might be a manufacturing claim that survives preemption. Since the complaint is unclear, plaintiff is also being given a chance to re-plead his manufacturing defect claim.

Plaintiff also brought a general negligence claim which the court found essentially broke down into negligent design defect, negligent failure to warn, and negligent manufacturing defect. The design defect and warning claims suffered the same fate as their strict liability counterparts. For instance, the court found Mr. Funke’s “failure to test,” “failure to investigate,” and “failure to correct design” allegations to be “straightforward attack[s] on the product’s design” that are clearly preempted. Id. at 13. As with the other claims, plaintiff is getting a second shot at pleading.

Finally, on negligent misrepresentation the court found it was preempted for the same reasons plaintiff’s failure to warn claim was preempted – no federal regulation that imposes a duty on defendant to go beyond the product labeling and no allegation that defendant deviated from the product labeling. Plaintiff apparently alleged that defendant’s marketing materials were in accord with the approved product labeling. So we concur with the court that it is “difficult to understand how such representations could avoid preemption.” Id. at 15. They can’t.

Thanks to Matthew Marshall of Morris, Polich& Purdy LLP for bringing this decision to our attention and for helping us set up our playlist for the commute home … “It’s Your Thing,” “Family Affair,” “Atomic Dog” . . . .

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Posted By Michelle Yeary to Drug and Device Law at 12/01/2015 05:25:00 PM

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[Drug and Device Law] A Civil Discussion

[DK GreenRoots] Paris: What if they threw a COP and Nobody Came?

[Drug and Device Law] A Funky Preemption Decision from California

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