We greeted the result in Bartlett v. Mutual – that a generic manufacturer could be tagged for $21 million in a product liability case, despite Mensing, on the theory that the manufacturer had the option not to sell the product at all – with derision and dismay. The decision was wrong, even subversive. It
In our two prior posts concerning Bartlett v. Mutual Pharmaceutical Co., 678 F.3d 30 (1st Cir. 2012), we first hoped that the defendant would “take it up” to the Supreme Court, and ended our second with our belief that Bartlett was worthy of summary reversal. Well, that happened earlier this week, and in the
We’ve just learned from our friends at Skadden that the plaintiffs attempt to obtain reconsideration of the Mensing preemption dismissals in the Darvocet MDL have come to naught. See In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, MDL No. 2226, slip op. (E.D. Ky. June 22, 2012). Here’s what the court had to
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.Continue Reading More Thoughts On Bartlett
The First Circuit decided Bartlett v. v. Mutual Pharmaceutical Co., No. 10-2277, slip op. (1st Cir. May 2, 2012) today – suggesting that it is the worst court of appeals in the country for defendants in prescription pharmaceutical product cases. There are various grounds for disliking the opinion, but the preemption ruling is probably
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).Continue Reading The Bartlett Saga Continues: Reversal Bait
Stop us if you’ve heard this one before. Actually, you mostly have, at least if you’ve been paying attention to our posts (here, here, and here) on the Bartlett v. Mutual Pharmaceuticals litigation. Judge LaPlante has issued a number of rulings, some of which we like, and some of which we’re not sure about, but all of which are well-written and thoughtful. Peter King in Sports Illustrated has a column called “Things I Think I Think.” We think we think Judge LaPlante’s latest Bartlett decision is pretty good.
By now we’re used to how middle-brow tv shows start with a “Previously on [Hill Street Blues or Weeds or Mad Men, etc].” So, here goes our “previously in Bartlett:” Plaintiff claimed she came down with Stevens Johnson Syndrome after taking a drug called Sulindac, an anti-inflammatory NSAID. Plaintiff’s complaint was chock-full of theories. Before trial, the court made some preemption rulings, which we viewed as a mixed bag. The court also granted summary judgment on some (but not all) of the claims. Of particular note, the court granted summary judgment on the failure to warn claims because the prescriber never read the label. Some failure to warn claims discussed items other than the label, such as the failure to issue a medication guide, Dear Doctor letter, black box warning, or educational materials. The court held that these non-label theories ran afoul of the learned intermediary rule or, more simply, were devoid of legal authority.
The case went to the jury, which found for plaintiff on strict liability design defect. After summary judgment and before trial, Plaintiff filed a brief in support of three negligence theories:
Like we said, you’ve heard this before. The court correctly concluded that Plaintiff was trying to “resurrect” her failure to warn theories, “in contravention of this court’s summary judgment ruling.” Bartlett v. Mutual Pharmaceutical Co., 2010 WL 3659789 at *1 (D. N.H. Sept. 14, 2010). Plaintiff was persistent, but not subtle. Sometimes losing parties (even if they win on something else) keep rearguing losing positions, hoping to wear the judge down. That apparently doesn’t work with Judge LaPlante.Continue Reading A Third Significant Decision in Bartlett v. Mutual Pharmaceutical
We have written several times before about the good and the bad pretrial rulings in Bartlett v. Mutual Pharmaceutical Co., No. 08-358 (D.N.H.). Faithful readers will recall that the plaintiff allegedly developed Stevens-Johnson Syndrome (SJS) after taking generic Sulindac, an NSAID. The court threw out the failure to warn claim because the provider never
In putting together yesterday’s post on second-guessing the FDA, we took a look at the Bartlett litigation in New Hampshire. Lo and behold, we discovered that, in the past couple of weeks the ever-thorough Judge Laplante has issued a slew of other opinions on in limine motions.
Scads of issues got decided (the trial’s probably
Remember what Wyeth v. Levine, 129 S. Ct. 1187 (2009), supposedly wasn’t about? We addressed this issue here shortly after the Levine decision. One thing that Levine wasn’t about (according to the majority, anyway) was a claim that the defendant failed to contraindicate an FDA approved use of the drug in question (Phenergan, in case you’ve forgotten). We observed:
In particular, the majority [in Levine] held that through the miracles of post-verdict review, the plaintiff’s trial attacks on the FDA and its approval of the IV-push indication disappeared. [129 S. Ct. at 1194.] It no longer mattered that the plaintiff had expressly argued that the drug should never be used for that indication (id.: plaintiff “offered evidence that the IV-push method should be contraindicated and that [the drug] should never be administered intravenously”), since the Vermont Supreme Court later declared that the verdict “established only” that the “warning was insufficient.” There were thus “any number of ways” – all unstated – for Wyeth to change its warnings. Id. In this way, Levine was no longer the “failure to contraindicate” case that we always considered it to be. Id. Allowing that kind of a claim couldn’t support a majority, so the plaintiff’s claim became something else.
We thought that change was significant, because the failure-to-contraindicate issue had been prominent in both the briefing and at oral argument. See here, here, and here. That the Levine majority went out its way to emphasize that it was not addressing a failure to contraindicate claim suggested – and still suggests – that there was no majority on the Court for a holding that preemption would not apply to a claim that essentially posited that an FDA-approved use should never be allowed.
Instead, as everyone following preemption knows, the Court held that a failure to warn claim didn’t present a conflict because manufacturers could revise their warnings immediately to take account of new information without FDA prior approval. Levine, 129 S. Ct. at 1197-98.
To put in starker terms, the majority in Levine shied away from allowing claims that state law could say “no” to a use of a drug to which the FDA had said “yes.” Except where FDA regulations (allegedly) by their own terms allowed modifications, there wasn’t a majority on the Court for letting the common law go there.Continue Reading On Second-Guessing the FDA