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Guest Post - Design Defect Preemption - It’s as Simple as One, Two, Three
This guest post is from Richard Dean at Tucker Ellis. We're both greatly interested in extending impossibility preemption beyond generic drugs, particularly in the context of design defect claims, so when Dick saw this case, he both sent it to us (he's very good about that) and was willing to write it up. As always with guest posts, the author deserves all the credit and gets assigned any blame for the contents of what follows.
*********************
Courts are starting to "get" the design defect preemption argument. That makes sense because the argument is simple. Any major changes in the design of a drug or a medical device require the prior approval or permission of the FDA. And if FDA approval or permission is required, PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011), requires implied preemption.
Last Friday's post regarding Batoh v. McNeil-PPC., Inc., No. 3:14-cv-01462 (MPS), 2016 WL 922779 (D. Conn. Mar. 10, 2016), is followed only a few days later by this report on Barcal v. EMD Serono, Inc., No. 5:14-cv-01709-MHH, 2016 WL 1086028 (Mar. 21, N.D. Ala. 2016). Barcal involved alleged heart birth defects from a fertility drug – Serophene. The drug's labeling included a statement about congenital heart defects being observed in children of mothers whose pregnancies had been induced by the drug, but the plaintiff claimed the risk was higher than indicated. Before discovery commenced, the defendant filed a motion to dismiss. The plaintiff filed a Rule 56(d) request saying she needed to have discovery to respond to the motion. As to some parts of the motion – the failure to warn claim – the court denied the motion and agreed that the plaintiff was entitled to discovery, but the court disagreed as to the design defect claims and entered judgment on behalf of the defendants. The court held that the design claims were both preempted under the Supremacy Clause—the focus of today's post—and barred by Alabama's Extended Manufacturer's Liability Doctrine (AEMLD) under the principles of comment k.
This case is significant procedurally, as well as substantively, because the preemption motion was granted at the preliminary pleading stage – not at the end of years of litigation as in Yates v. Ortho-McNeil Pharm., Inc., 808 F.3d 281 (6th Cir 2015). Yates was this blog's leading defense decision of 2015.
Barcal is notable for its succinctness and clarity on the preemption issue. It dispenses with preemption in three short paragraphs. The first paragraph repeats the core holding of Mensing: that the question for impossibility "is whether the private party could independently do under federal law what state law requires of it." 131 S.Ct. at 2579. The reference to a "private party" is key; the court did not refer to a "generic pharmaceutical company." This is the building block of the design preemption argument. In Barcal, there is not even a discussion of whether Mensing applies beyond generics. It is assumed given the broad language of Mensing.
The second paragraph cites the key sentence from Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 2466 (2013), noting that "once a drug – whether generic or brand name – is approved, the manufacturer is prohibited from making any major changes to the . . . active ingredients." Id. at 2471. The opinion then notes that under the state tort scheme, a finding for the plaintiff would require a redesign of the product. But having to ask for approval for such a change is at odds with independent action test in in Mensing.
The third and final paragraph simply notes that Wyeth v. Levine, 555 U.S. 555 (2009) "is not to the contrary." That is of course precisely the language Justice Thomas used to distinguish Wyeth in Mensing. 131 S.Ct at 2581. Wyeth found no preemption on a failure to warn claim against a brand name manufacturer because the CBE process existed. Barcal correctly found that because no such process exists for design changes, Wyeth is inapplicable. (Note that not all parts of the label are subject to the CBE provisions; for example, the Mechanism of Action section of the label requires prior approval. Indeed, the general presumption of the statutory scheme is that prior approval is required for label changes. In re Celexa & Lexapro Marketing & Sales Practices Litig., 779 F.3d 34, 37 (1st Cir. 2015)). [Editorial note: see here for a post about various forms of FDCA "major" changes.]
So that's it. A short one-two-three punch: Mensing, Bartlett, and Wyeth. When it's simple, you don't have to write much.
The other interesting thing about Barcal is that it does not cite Yates, the only Circuit court decision to address this issue. Nor does it cite any of a number of district court opinions on design defect preemption decided before and after Yates. The preemption discussion cites nothing other than Supreme Court cases. [Editorial note: our cheat sheet on drug preemption collects all the relevant cases].
It should be mentioned that only major changes in drugs and medical devices must be approved or permitted by the FDA before taking effect. So one does have to compare the alleged defect against those regulations. Suffice it to say that in regard to a drug, a change in the "molecule" clearly suffices. In a medical device case, plaintiffs do sometimes point to a specific defect which then must be evaluated against the regulations.
The major rationale used by lower courts to reject this argument is a claim that Mensing applies only to generic pharmaceutical companies. See, e.g., In re Tylenol Marketing, 2:12-cv-07263, 2015 WL 7075949 (E.D. Pa. Nov. 13, 2015). That conclusion flies in the face of a straightforward sentence in Mensing, not to mention the Bartlett language also quoted above. It is a claim rejected directly in Yates and implicitly in In re Celexa. This subject is generally discussed at length in Dean & Larimer, "Between a Regulatory Rock and a Hard Place: Does Preemption Provide an Escape?" DRI In House Defense Quarterly (Fall 2014).
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[DK GreenRoots] The chance the Birdie missed (but is still within grasp of a reusable mug)
I've been trying to think of these primaries in some sort of a useful eco context, and the Birdie event finally sparked something for me...
http://www.dailykos.com/stories/2016/3/30/1508103/-The-chance-the-Birdie-missed-but-is-still-within-grasp-of-a-reusable-mug
Cheers,
Sven
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First Circuit Upholds Defense Verdict in Diet Drug Case
Happy Birthday, Eric Clapton. (Today is also the birthday of painters Goya and Van Gogh. Is there something about March 30 that breeds people who turn their blues into art?) Clapton has been around so long it is easy to take him for granted. He has built up a formidable body of musicianship. He is the only three-time inductee in the Rock and Roll Hall of Fame, for his solo work as well as his stints with the Yardbirds and Cream. We remember how, in the late 1960s, one of our sisters would scribble on her school notebooks that "Clapton is God." That sister later married a very nice, very hip guy, who was also a Clapton fan. A couple of years ago Clapton's autobiography came out. Our brother-in-law summarized the book thusly: "I made a lot of music, took a lot of drugs, caused a lot of damage to relationships and health, but in the end, everything was pretty cool." Just so.
In the early 1990s, we were working at a law firm representing the Robert Stigwood Organization (RSO). You might remember RSO as the force behind the soundtracks for Grease and Saturday Night Fever. RSO also managed the careers of the Bee Gees, Andy Gibb, Yvonne Elliman, and Clapton. In our case, RSO, along with Eric Clapton, was being sued by Jim Gordon, the drummer in the short-lived rock group Derek and the Dominos. Gordon claimed he had been denied writing credit and money for the long piano coda in the all-time great song, "Layla." By the time he filed the lawsuit, Gordon was a resident of the Atascadero Prison for the criminally insane. Somewhere along the way, Gordon had started hearing a voice. That voice told him to kill his mother. With a hammer and butcher knife. He obeyed that voice. Needless to say, the deposition of Gordon behind prison walls was odd. Earlier in the case, our firm sent a representative to London to meet with our co-defendant, Mr. Clapton. That assignment went to another associate - one who didn't even like Clapton's music that much - certainly not as much as we did. Our bitterness and envy were complete. We insisted that the lucky associate (a close friend of ours, but his musical tastes ran more toward c&w and happy pop than toward guitar gods) relay a message to Clapton that, of all the versions of "After Midnight," the best was the slow one that ran on the Michelob beer commercials. Imagine our delight when we were told that after Clapton listened to that opinion, he paused thoughtfully, nodded, and gently assented: "Yes. That one is the most soulful."
It would be hard to list all of the great songs that Clapton worked on, but here is a start:
"For Your Love" (with the Yardbirds. Clapton hated the poppy-ness of the song and left the group just before the song climbed the charts)
"White Room" (listen to that solo and try arguing that the Drug and Device Law Sister was wrong all those years ago about deifying Clapton – go ahead, we dare you!)
"Sunshine of Your Love"
"Badge" (written with George Harrison. On the track credits, the rhythm guitarist is listed as L'Angelo Misterioso- that's Harrison, who couldn't use his real name for legal reasons. Damn lawyers.)
"Crossroads"
"While My Guitar Gently Weeps" (we read somewhere that John Lennon contemplated replacing Harrison with Clapton, but Clapton wasn't interested in becoming a Beatle)
"Layla" (the title song of rock's greatest double album. Like most of the songs on that magnum opus, it is about Clapton falling in love with Harrison's wife, Patti Boyd. Ms. Boyd, by the way, was one of the screaming, predatory schoolgirls in the Hard Day's Night movie)
"Why Does Love Got To Be So Sad"
"Bell Bottom Blues"
"I Shot The Sheriff" (Maybe the original version by Bob Marley is better, but Clapton's is also superb)
[The founder of this blog wants us to include "Wonderful Tonight" on our list of Clapton favorites. Who are we to refuse? But who knew there was a softer side of Bexis?]
Another one of Clapton's hits was "Cocaine." And thus we have an introduction to today's case, Tersigni v. Wyeth, 2016 U.S. App. LEXIS 5393 (1st Cir. March 23, 2016). Tersigni was a diet drug case, and the alleged injury was Primary Pulmonary Hypertension (PPH). PPH is a very bad disease. The claims were brought under Massachusetts law for negligent design and negligent failure to warn. The trial court dismissed the negligent design claim. The negligent failure to warn claim went to the jury, which returned a defense verdict. On appeal, the plaintiff raised these issues:
The negligent design defect claim should not have been dismissed
The court should not have admitted evidence at trial that the plaintiff had been incarcerated
- The court should not have admitted evidence at trial of the plaintiff's cocaine use
The First Circuit panel that reviewed the appeal included retired United States Supreme Court Justice David Souter. He did not author the opinion, but his presence on the panel must have been a thrill for the lawyers at oral argument. Souter was a bit of a puzzle while on the Supreme Court. To call him unpredictable would be an understatement. Republicans today talk of Souter the way they used to talk of Earl Warren and William Brennan (and, amazingly, some today even talk of C.J. John Roberts): as a mistake, as someone who went off the ideological rails. Democrats used to say something similar about Felix Frankfurter and Byron White. Souter definitely marched to his own drummer. We cannot recall any of his opinions off-hand, and we do not have any particular fix on his judicial philosophy, but there is something about Souter that we can't help loving: he writes with a fountain pen. Anyway, Souter retired from the high court in 2009, and is still only 76 years old. (That 'only' works only when talking about Article III judges, doesn't it?) Souter stays pretty active, hearing First Circuit cases.
[This ability of retired Supreme Court Justices to continue hearing appellate cases reminds us of when we began working on a law firm hiring committee and encountered a candidate who adorned his resume with a Potter Stewart clerkship. You had to look at the dates on the resume carefully to realize that the clerkship was after Stewart had stepped down from the Supreme Court. Stewart is probably most famous (to his regret) for saying this about obscenity, "I know it when I see it." Stewart, like Souter, kept active in retirement, occasionally sitting on Sixth Circuit panels. Getting that post-Supreme Court clerkship has simply got to be easier than getting one with an active Justice, but one couldn't help being impressed by the candidate's career ingenuity. We know a slick move when we see one.]
Back to Tersigni. The analysis upholding the lower court's ruling was straightforward. Here is the skinny on how the court disposed of this diet drug case:
Is there a claim under Massachusetts law for negligent design of a prescription drug? The court below reasoned that the Massachusetts Supreme Court had adopted Restatement (Second) Torts, section 402A, comment K. As most of you know, comment K says that there are some useful products that are inherently incapable of being made safe, so application of strict liability would be crazy. But would this preclusion also apply to a claim for negligent, as opposed to strict, design liability? In the end, the First Circuit punted on the issue, holding that the claim failed because the plaintiff had failed to proffer evidence of a safer reasonable alternative. (For that same reason, the First Circuit also dodged deciding the defendant's preemption argument.) The plaintiff never suggested how some tinkering could have made the diet drug safer. Instead, the plaintiff discussed safer methods of weight control. But those alternatives would not be a safer product; they would be an entirely different product. As the Tersigni court pointed out, a motorcycle could be made safer by adding two additional wheels, but then it would no longer be a motorcycle.
At this point, the plaintiff attempted to escape the safer alternative requirement by suggesting that the Massachusetts courts would likely adopt the Third Restatement of Torts which, according to the plaintiff, would ease up on the safer alternative requirement, at least for prescription drugs. For anyone practicing in Pennsylvania, as we do, this argument is more than a little reminiscent of the 'will-they-or-won't-they' debate over whether courts will plump for the Third Restatement over the Second. The Pennsylvania state courts have not made the move, but some federal courts predicted they would. The First Circuit was not in the predicting business: "As a federal court applying Massachusetts law, we are bound to apply state law as it exists, not as it may become, or as the plaintiff wishes it to be." Speculating on the adoption of the Third Restatement was "a bridge too far, and we decline to cross it." The First Circuit, accordingly, upheld the dismissal of the negligent design claim.
Should the trial court have admitted evidence that the plaintiff had been incarcerated for failure to pay child support? The defendant argued that incarceration was a "stressful event" for the plaintiff, and might have contributed to his cardiopulmonary symptoms. The fact of incarceration came up four times during trial. The First Circuit concluded that it need not decide whether admission of this evidence was an abuse of discretion, because the evidence made no difference. Even if there was error, evidence of the plaintiff's incarceration was harmless. That conclusion is rooted in the jury's verdict, which decided that the defendant had not failed to warn the doctor of the relevant risks. The jury never reached the issue of medical causation, which was the issue for which the fact of incarceration had been introduced.
Should the trial court have admitted evidence of the plaintiff's cocaine use? The plaintiff had "occasionally" used cocaine several decades before the alleged injury. Again, the defendant wanted to cite this evidence as a possible alternative cause of the PPH. The trial court denied the plaintiff's motion in limine to exclude the evidence of cocaine use, pending evaluation of defense expert testimony connecting the cocaine dot with the PPH dot. Understandably, the plaintiff probably thought that would be too late. The jury would already have heard the damning evidence. Also understandably, the plaintiff at trial wanted to get out front on the issue. Consequently, the plaintiff's counsel mentioned cocaine in the opening statement and during direct exams of plaintiff witnesses. It was an effort to remove the sting of the damaging evidence. But there is SCOTUS and First Circuit authority that fronting bad evidence constitutes a waiver of the right to appeal admissibility of such evidence. The plaintiff pointed to a 2000 amendment to Federal Rule of Evidence 103 (on preserving claims of error), but the First Circuit held the amendment and Advisory Committee Note too unclear to dislodge existing authority. To our eyes, it looks like a close call. We could well imagine being on the other side of that thorny problem. But for now, we must applaud the defense lawyer for intelligence, foresight, and resistance to temptation. By not mentioning the cocaine use in the defense opening, by forcing the plaintiff to front the issue, the defense elicited a waiver of a viable appellate issue. Having strong evidence is one thing, but as for real trial mastery ... well, as per the title of another great Clapton song, "It's in the Way that You Use It."
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