This post is not from the Dechert side of the Blog.
We exchanged e-mails today with one of our first mentors, many years retired. With this long-ago colleague, we tried our first prescription drug cases when we were fresh out of law school, creating some of the fondest memories of our decades-long legal career. Back
New Hampshire has always marched to its own flinty tune. It was the first colony to establish a government independent of British authority. It holds the first presidential primary every four years, insisting that candidates visit waffle shops and bloviate to the amused Yankee locals. You’ve probably seen New Hampshire license plates with the “Live Free or Die” motto. That motto supplied the title for episodes of both The Sopranos and Breaking Bad. What other state can make that boast? And what other state with such a small population can list among its offspring such eloquent luminaries as “Go West Young Man” editor Horace Greeley, “Liberty and Union, now and forever, one and inseparable” Senator Daniel Webster, “And miles to go before I sleep” poet Robert Frost, and we-can’t-think-of-a-quote President Franklin Pierce?
New Hampshire has played a significant role in American legal history. Daniel Webster won a case against the Devil. One of the early major U.S. Supreme Court cases involved Dartmouth College. We cannot remember what the case was about, though we think it had something to do with Delta House being put on double secret probation. The Bartlett v Mutual product liability case gave rise to some awful rulings in the New Hampshire federal court before the Supreme Court set things right in what might be our favorite case of the last five years.
In today’s case, Murray v. Hogan, #226-2013-CV-00600 (New Hampshire App. Ct. Feb. 2, 2015), a New Hampshire court addresses Riegel preemption, as well as the dreaded parallel claim exception. As far as we can tell, it is the first such decision from the Granite State. (We gratefully tip our cyber cap to David Ferrara at Nutter McClennen for sending the case our way.) The plaintiffs in Murray brought negligence and products liability claims claiming injuries from a knee replacement gone wrong. The plaintiffs sued several defendants, including the manufacturer of the artificial knee, as well as the sale rep who was in the operating room and assisted in preparing the artificial knee for insertion. The artificial knee was a class III medical device, so it comes as no shock that the company moved for summary judgment against all of the plaintiffs’ claims as being preempted by federal law. Even less of a surprise, the plaintiffs disagreed, arguing that federal preemption does not apply because: (1) the artificial knee did not meet federal regulations, (2) the plaintiffs would like to have some discovery, please, and (3) the company is vicariously liable for the conduct of the sales rep.
Well, the First Circuit just had its bluff called. In Bartlett v. Mutual Pharmaceutical Co., 678 F.3d 30 (1st Cir. 2012), it essentially dared the Supreme Court to take the case and close off what Bartlett viewed as the plaintiff’s last option – a “pure” design defect claim, with no alternative design offered, explicitly
amounting to a claim that – under state law − an FDA-approved product should have been pulled from the market.
The Supreme Court has obliged. Most fundamentally, from our perspective, it has definitively killed off (for all federally-regulated products everywhere, we believe) the facile “stop-selling” argument that conflict-based preemption can be avoided because a defendant can simply remove its product from the market. That’s a red herring we remember from all the way back to airbag preemption days:
The Court of Appeals’ solution − that [defendant] should simply have pulled [the drug] from the market in order to comply with both state and federal law − is no solution. Rather, adopting the Court of Appeals’ stop-selling rationale would render impossibility pre-emption a dead letter and work a revolution in this Court’s pre-emption case law.
Mutual Pharmaceutical Co. v. Bartlett, No. 12–142, slip op. at 2 (U.S. June 24, 2013).
Good riddance. We’re happy to announce that one of our earlier #1 worst annual decisions list toppers, Wimbush v. Wyeth, 619 F.3d 632 (6th Cir. 2010), is no longer good law for the proposition that earned it that ranking. The Supreme Court wasn’t buying “stop-selling.”
Our initial post about Bartlett v. Mutual Pharmaceutical Co., ___ F.3d ___, 2012 WL 1522004 (1st Cir. May 2, 2012), was more or less a crie de coeur over what we saw as an essentially absurd result: that while a simple warning claim involving a generic drug is indisputably preempted under PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), a claim much more fundamentally in conflict with FDA approval of generic drugs – that state tort law can impose liability for not removing an FDA-approved product off the market entirely – supposedly is not.
Plain and simple, the preemption result in Bartlett makes no sense.
Today we take a closer look at the Bartlett opinion and the reasoning, if it can be called that, that brought the court to its highly questionable result.
Two fundamental facts underlie Bartlett: First, the plaintiff had (at least in theory) lost her warning-based claim for lack of causation – the prescribing physician did not read or otherwise rely on the allegedly inadequate warning, rendering the warning non-causal. Second, for whatever reason, the defendant at trial made the strategic decision (which with the benefit of 20-20 hindsight now seems disastrous) not to offer any affirmative defense at all.
The plaintiff’s lack of a warning claim itself had two effects. One, plaintiff was damn lucky, because warning claims against generic drugs were precisely what the Supreme Court held to be preempted in Mensing. A verdict in Bartlett based upon a warning claim – the most common theory – would undoubtedly have been overturned before the First Circuit ever saw the case. Two, since both Mensing and Wyeth v. Levine, 555 U.S. 555 (2009), involved warning claims (again, they’re the most common), neither case was 100% on point.
Bartlett initially demonstrates why “design defect” simply doesn’t fit prescription drugs (some medical devices are different). As the First Circuit mentioned, you can’t change the “design” of something that “is a one-molecule drug; and the variations in [it] as sold consist of inactive ingredients that ordinarily do not have significant pharmacological effects.” 2012 WL 1522004, at *2. The ordinary constraint on design defect claims – that there be an alternative design – does not exist where the product is a chemical molecule, let alone one that would require FDA re-approval if it were changed in any way that affected its safety or efficacy.
The Monday curse continues! Another bad case that makes us feel so disappointed, so cheated, so sad, so … Monday.
We have blogged on the Bartlett case before. We did it here. And here. And here. And here. And that’s not all. It’s been the gift that keeps on giving. Though, as was the case over the holidays, some of those gifts were items we’d just as soon return. Make no mistake about it, Judge LaPlante works hard and writes lengthy, scholarly opinions. He seems thoughtful and diligent. Some of what he wrote we liked a lot. Some — not so much. Being thoughtful and diligent doesn’t always make you right. (And sometimes one can be thoughtless and lazy and still be utterly right. Every day we bank on that possibility.)
In the Bartlett case the plaintiff suffered truly horrific injuries, claiming they were the result of a generic anti-inflammatory drug called Sulindac. The details are in our earlier posts, so let’s get right to the bottom line: the jury returned a verdict of $21 million. The defendant filed a motion for judgment as a matter of law and, in the alternative for a new trial. Last week, Judge LaPlante denied those motions. Bartlett v. Mutual Pharmaceutical Co., 2010 WL 5494053 (D. N.H. Jan. 5, 2010).
The coverage we’ve seen so far of this decision emphasizes the defendant’s claims that the trial was unfair because the plaintiff lawyer inserted all sorts of prejudicial stuff (including putting up on the screen a precluded question about the company’s net sales — supposedly an accident due to a computer “glitch”) as well as the defendant’s claim that the judge seemed biased because he said a few things that defendant construed as rooting for the plaintiff, and also appeared to get teary-eyed during emotional testimony (the Judge told the jury the next day that it was only an allergy).
Last Friday we had a brief post about the new decision in Bartlett v. Mutual Pharmaceutical Co., 2010 WL 2765358 (D.N.H. July 12, 2010). That was a tickler; we promised you a more fulsome discussion of the opinion later.
Well, later is now, so here goes.
Briefly, the product involved in Bartlett is generic Sulindac, an anti-inflammatory NSAID. The plaintiff was prescribed Clinoral – the branded version of the drug – but in an increasingly common scenario, plaintiff’s pharmacist substituted generic Sulindac. 2010 WL 2765358, at *1. Plaintiff came down with Stevens-Johnson Syndrome (“SJS”), a nasty condition that among other things left her permanently blind.
Plaintiff sued, and we suppose in the course of discovery, discovered FDA-related issues with the generic manufacturer’s ongoing post-marketing research – like there wasn’t any. The following facts were taken as true for purposes of the defendant’s summary judgment motion:
More than a year before these events [that is, plaintiff’s prescription], an international medical journal published a study of the link between NSAIDs and [SJS]. The study revealed that . . . Sulindac had 89 reported cases of [SJS] . . . more than any other NSAID on the market and all but four drugs of any kind. [Defendant] was not aware of that study, however, because it had not been monitoring the medical literature for information about Sulindac’s safety risks. [It] believed that the manufacturer of Clinoril, the brand-name version of the drug, was responsible for such monitoring.
2010 WL 2765358, at *2.
At the time of the prescription, the defendant’s FDA-approved label didn’t mention SJS by name, instead describing it as “hypersensitivity” – albeit specifically mentioning “severe skin reactions” and “fatalities.” Id. Thus, the state of the labeling was something that, on the whole, tended to favor the plaintiff.