Photo of Bexis

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 going on as we speak) – we’ll just give you what we think are the highlights. This is not a complete list.

Adverse Event Reports:  Admissible only to prove “notice” – that’s a big deal in Bartlett because of the defendant’s failure to survey medical literature.  Bartlett v. Mutual Pharmaceutical Co., 2010 WL 3092649, at *1 (D.N.H. August 2, 2010).  Plaintiff has to establish that AERs are “reasonably relied upon” before her experts can use them to form opinions.  Id.  We generally agree, since the FDA has repeatedly made clear  that AERs can’t validly be used to reach conclusions about causation.

Subsequent Label Changes:  In a ruling we disagree with the court let some of these in because they were “mandated” by the FDA, and supposedly the rule excluding subsequent remedial measures “applies only” to “voluntary” changes.  2010 WL 3092649, at *2-3.  We’ve addressed that elsewhere, and pointed out that FDA-“mandated” changes are routinely excluded on this basis.  We note that the opinion itself is internally inconsistent, stating at one point that an FDA “recommendation” can come in.  Id. at *2.  A “recommendation” is not a “mandate” – even if there is such a thing as a “mandated” exception.

Contra-Factual “Hypothetical” FDA Actions:  In rulings we whole-heartedly support, the court precluded either side from speculating what the FDA might have done, had this or that circumstance been different.  2010 WL 3092649, at *5; Bartlett v. Mutual Pharmaceutical Co., 2010 WL 3156555, at *3 (D.N.H. July 26, 2010); Bartlett v. Mutual Pharmaceutical Co., 2010 WL 2889114, at *3, 14 (D.N.H. July 22, 2010).  Claims that the FDA might have done something different encourage the jury to ignore what the FDA actually did, which we consider pernicious.

Legal Opinions by Experts:  The court barred either side’s experts from offering opinions about what FDA regulations meant or about whether X, Y, or Z was “negligent” or “broke the law.”  2010 WL 3092649, at *5; 2010 WL 2889114, at *2-4, *12.  The latter opinion includes one of the best discussions we’ve seen of this issue in an FDA-related case.  E.g.:

Since it is the judge’s role, not a witness’s, to instruct the jury on the law, this court has broad discretion to exclude expert opinion evidence about the law that would impinge on the roles of the judge and the jury or would cause “jury confusion.” Indeed, expert testimony proffered solely to establish the meaning of a law is presumptively improper.

2010 WL 2889114, at *2.  Industry practices, if divorced from opinions on the law, are all right.  Id. at *3 (“customs and practices of an industry are proper subjects for expert testimony”).

If [plaintiff] wants the jury to know what relevant FDA regulations require, she can propose appropriate jury instructions. And if she wants to show the jury that [defendant] violated them, she may do so by introducing evidence of [defendant’s] acts or failures to act, rather than conclusory opinions from her experts . . . .

[The ultimate issue rule is not] a carte blanche for experts to substitute their views for matters well within the ken of the jury. Courts have generally prohibited experts from using the term “negligent” to describe the defendant’s conduct in a negligence case where the opposing party objects to it.

2010 WL 2889114, at *12

We generally like this result, even though we’ve frequently had our FDA experts push the envelope, too.  All in all, we’d rather have everybody’s experts stick to professional opinions and leave legal ones to the judge.

Subsequent Medical Literature:  It’s not admissible for notice, because that’s a “chronological impossibility,” 2010 WL 3092649, at *6, but might be admissible on risk/utility if “it does not stray far afield from the pre-purchase information, either in time or content.”  Id. at *6, n.6.  We’re not exactly sure what that last comment means, because these other possible uses weren’t cleanly teed-up, but we’d point out that the state of the art defense is a major issue here.

Withdrawal from the Market:  Plaintiff can’t claim that anything requires withdrawal, but can point out if similar drugs were withdrawn (this being relevant to the peculiar risk/utility theory under which the case is being tried, which was the subject of our second-guessing post). 2010 WL 3092649, at *7.  Plaintiff cannot argue a state-law failure to recall claim because it doesn’t exist, so uses of such evidence have to be limited. Id. at *8.

Collateral Sources:  The court excludes write offs by medical practitioners (that is, that they took less than the amount they nominally billed), as covered by the collateral source rule.  Bartlett v. Mutual Pharmaceutical Co., 2010 WL 2990816, at *2 (D.N.H. July 23, 2010).  We don’t like giving plaintiffs money that they never, in fact, had to pay to anyone, and lots of other courts – most notably our home state of Pennsylvania – say that’s an abuse of the policies behind the collateral source rule.  Moorhead v. Crozer Chester Medical Center, 765 A.2d 786, 789-90 (Pa. 2001).  We point it out because it’s a pretty big issue these days, with states all over the place.  At some point the federal courts ought to certify the question to the New Hampshire Supreme Court.

Number of NSAID Users: The court allows this testimony.  2010 WL 2889114, at *5-6.  We agree. A numerator without a denominator is useless.  Adverse events have to be considered in the context of how many people actually use the drug (or class of drugs).