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.
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.
However, the defense got a big break when the prescriber testified that he never read that allegedly inadequate warning and that it made no difference in his treatment of the plaintiff:
- He never read either the defendant’s warnings of those with the brand name product, with respect to the condition plaintiff suffered. Id.
- Nothing in the label influenced his prescription of the drug. Id.
- He already knew, from medical training that all NSAIDs had some risk of SJS, but “it was not his usual practice” to discuss that risk with patients. Id.
- He still prescribes the drug “on rare occasions” even knowing what happened to plaintiff. Id.
So, while the plaintiff had a decent argument on the adequacy of the warning, the defendant had a much better argument on causation – that nothing wrong with the label made any difference to plaintiff’s prescriber.
Anyway, we’d been watching the Bartlett litigation ever since that case produced a major preemption decision back in September of last year. We didn’t say much about it then – we’re a defense oriented blog and we make no bones about that – but Bartlett v. Mutual Pharmaceutical Co., 659 F. Supp.2d 279 (D.N.H. 2009) (“Bartlett I”), was the first decision that systematically addressed the significant arguments that plaintiffs had developed to counter generic-drug-specific preemption arguments. It’s no secret that, since Bartlett I, generic drug manufacturers have taken their preemption lumps in a number of decisions. We chronicle the gory details in our drug/vaccine preemption scorecard.
It was that first Bartlett decision that led us to compare Judge Laplante in our minds to the late Hon. Edward R. Becker, from our neck of the woods (the one-time chief judge of the Third Circuit here in Philadelphia). Even though Bartlett I reached an anti-preemption result in the generic drug context, it was notably thorough and tightly reasoned opinion. Ed. Becker’s opinions were the same way – long and thorough – but at least in the type of tort cases we litigated – usually pro plaintiff. Unfortunately, Judge Becker rarely met a novel cause of action (such as medical monitoring or recovery of purely economic loss, to name two) that he didn’t like. We wondered whether Judge Laplante, in addition to sharing Judge Becker’s notable intellect and work ethic, might also have his tendency to lean towards the plaintiff side in tort cases.
Well we’re happy to report, based upon that most recent Bartlett opinion, that this fear appears unfounded. Unlike Bartlett I, Bartlett II isn’t entirely pear shaped – not hardly.
It is pretty darn thorough, though – just like Bartlett I.
The court first addresses whether the warning could be held adequate as a matter of law. On the one hand, it didn’t mention SJS, but on the other hand it expressly warned of potentially fatal “severe skin reactions.” The court conceded that the defendant had the better of the legal argument based upon prior precedent, but ultimately found a jury question as to adequacy in light of the intervening medical journal article mentioned above, which it held raised the salience of SJS beyond what the older cases had addressed. 2010 WL 2765358, at *4.
But we can’t groan too much because the defendant still won summary judgment on the warning claim. Bartlett II aligned itself with the majority view that a prescriber’s failure to read an allegedly inadequate warning severs the causal link to the purportedly inadequate information. Basically, a doctor has to read a warning for it to affect his/her treatment.
[The prescriber] made clear that he never reviewed [the] label before treating [plaintiff] and that nothing about it influenced his decision to prescribe the drug or what he told her about it. . . . Thus, even assuming arguendo that [defendant] had a duty to strengthen [its warning language], that stronger warning would not have affected [the prescriber’s] decision or prevented [plaintiff’s] injuries. [M]ost courts will find an absence of causation as a matter of law where the physician testifies that he or she never read the warnings given.
2010 WL 2765358, at *5 (citations and quotation marks omitted). Bravo! While that’s certainly the majority rule, it’s not universal, and there was no prior New Hampshire law case on the point. Bartlett II thus becomes the second case this month to reject warning causation as a matter of law on a “prescriber did not read” rationale. See also Phillippi v. Stryker Corp., 2010 WL 2650596, at *3 (E.D. Cal. July 1, 2010).
But Judge Laplante, being hyper-thorough, covered a number of interesting sub-arguments that we think defense counsel might find interesting. For one thing, the prescriber’s testimony about ever reading the brand-name (as opposed to the generic product actually taken by plaintiff) label was a little squishy. Branded involvement in...
