District of Columbia
Ascent usurped one of Biosense’s functions as a manufacturer – the function of providing instructions to customers – when Ascent replaced Biosense’s instructions for use with Ascent’s own. Thus, if [plaintiff’s] claim depended on an argument that Biosense negligently failed to include certain warnings in its instructions for use, [that claim] would fail for lack of causation: [plaintiff’s] damages could not have been caused by the omission of a warning from Biosense’s instructions for use, because Ascent replaced Biosense’s instructions with its own, and thus Biosense’s instructions did not accompany the catheter that injured [plaintiff].2011 WL 4470701, at *23. That’s actually a variant of the failure-to-read argument when you think about it, because the manufacturer’s instructions weren’t with the product any longer, and thus weren’t available to be read by anyone.
The fact that Ascent, in reprocessing the catheters, also became a manufacturer in some respects does not change the fact that Biosense was the catheters’ original manufacturer and sold the catheters to doctors. The Court therefore finds – at least for the sake of argument – that Biosense had a duty to warn doctors of the risk of mitral-valve entrapment.Kapps, 2011 WL 4470701, at *23.
There’s also an FDA “draft guidance” about Dear Doctor letters – something utterly without binding legal effect – that states that the FDA "should" be "consulted" about whether to send a Dear Doctor letter and what it should say. Again, not all that helpful in litigation (other than as the basis for an expert opinion). But that draft does tell us this: Dear Doctor letters are for “important new information” – they’re not for rehashing something that doctors already should know:
[A] DHCP letter is used to inform health care practitioners about important new information about a drug. In most cases, the new information is about an important new safety concern that could affect the decision to use a drug or require some change in behavior by health care practitioners, patients, or caregivers to reduce the potential for harm from a drug. In some cases, the new information is about how to improve the effectiveness of a drug.Draft guidance at 3 (emphasis added). New. New. New. New. Moreover, Dear Doctor letters should “avoid discussion of non-critical information that could obscure the more important information.” Id. at 4. The only other FDA-recognized use for a Dear Doctor letter is “to correct misinformation in advertising or other types of prescription drug promotion.” Id. at 3.
[I] it seems reasonable to expect [plaintiff] to show that Biosense could have sent out the type of “Dear Doctor” letter that [plaintiff] calls for without violating those [unknown FDA] regulations. But neither party has discussed the regulations covering “Dear Doctor” letters. The Court therefore will assume, for the sake of argument, that Biosense could have issued the warning advocated by [plaintiff].Kapps, 2011 WL 4470701, at *24.
Causation on the most fundament level.
Would the hypothetical letter have done any good in the plaintiff’s case? No. “[Plaintiff] cannot show that either [physician] would have done anything differently if Biosense had sent out the “Dear Doctor” letter proposed.” 2011 WL 4470701, at *24. In short, the court found no evidence that Superman would have been able to save the day.
Would a doctor who is manipulating a catheter inside a patient’s heart near the mitral valve become more careful if he read a warning saying, “Be careful not to get this catheter trapped in the mitral valve”? Surely doctors know, based both on their training and on common sense, that they must be “very careful” when manipulating an instrument inside a human heart.Id. Well, duh.
What is presumed under the heeding presumption is that the omitted warning would have been heeded, not that the heeding of the omitted warning would have prevented the plaintiff's injury. . . . Biosense is being faulted for not warning [the physician] to “be very careful” in manipulating the [using the device]. But there is no reason to believe that [he] was not being very careful. Put differently, there is no evidence that, if [he] had heeded the warning to be very careful, he would have done something differently – and thus there is no evidence that the absence of that warning caused [plaintiff’s] injuries.Kapps, 2011 WL 4470701, at *25 n.22.
- Is a Dear Doctor letter within the scope of the defendant’s duty to warn? If the prescription medical product is not the defendant’s own product, unlike Kapps, where that was an important point, then probably not. That’s why a Dear Doctor letter shouldn’t help a generic-only plaintiff against the branded manufacturer. If the branded product isn’t being sold anymore – generally, or to this particular physician, or to this particular patient’s health plan – there shouldn’t be any duty to send such a letter.
- Is the defendant allowed by FDA regulations to send a Dear Doctor letter concerning the risk at issue? From what little we’ve been able to discover in a few minutes on the FDA’s website, we’d have to say that the kind of “reminder” letters, "consistent" with existing labels, mentioned in some of the generic cases aren’t likely to pass muster.
- Is there evidence that Dear Doctor letters in general are likely to influence the plaintiff’s prescriber’s behavior? How many such letters does he get? Does s/he read them? What kind of information actually changes prescribing behavior? Examples? Here, it would really help if either the defendant or, even better, the prescriber, had software installed that kept track of the prescriber’s receipt of and opening of Dear Doctor letters.
- Is there evidence that this particular proposed Dear Doctor letter would have changed the outcome of this particular case? Other causation evidence – failure to read warnings; prior knowledge of the risk; “I wouldn’t do anything differently” testimony – will help here. So would information that the same physician received Dear Doctor letters about other, equally or more serious, risks and still uses those products in the same way. Again, software that keeps track of this kind of thing would be most useful.
So that’s Kapps. On the other side of the ledger is Winter v. Novartis Pharmaceuticals Corp., 2011 WL 5008008, slip op. (W.D. Mo. Oct. 20, 2011). Winter let a Superman-type warning claim (maybe a Dear Doctor letter; maybe something else – the opinion isn't entirely clear) save the day for the plaintiff. Winter is a blatant failure-to-read case. The prescriber wasn’t just ignorant – he was loudly ignorant. He testified that he didn’t ever read any of the defendant’s drug labeling because the lot of it was “useless”:
[The prescriber] cannot recall a patient with [cancer] to whom he did not prescribe [the drug] prior to that point. [The prescriber] has testified that he never read the package inserts for [drug] while practicing . . ., but that this was because [the defendant] produced them in a way that made them useless to a practitioner.
Id. at *1.
[Defendant] highlighted these latest changes in a Dear Doctor letter dated September 24, 2004, but the parties dispute whether [the prescriber] ever received this letter.Winter, 2011 WL 5008008, at *1. The same doctors who don’t read drug labels, probably don’t read anything else either – but when caught, they plead ignorance, and ta-da, that’s a “dispute.” Here’s another example of a problem needing a technological fix. Paper Dear Doctor letters leave no paper trail, unfortunately. Software does. Sending Dear Doctor letters by email means that a doctor who, as in Winter “ma[kes] himself ignorant,” id. at *2, won’t be able to hide behind that ignorance any longer.
Get modern - win cases.
But even assuming [defendant’s] claims are true, [plaintiff] has still shown that genuine issues of material fact exist as to causation on her claims. First, [the prescriber] has testified that he did not read the package inserts for [the drug] medication because [defendant] produced these inserts in a way that made them useless to practitioners.
2011 WL 5008008, at *2. Okay, but there’s not a scrap of affirmative evidence of causation in that statement. How could anything different in an insert that’s “useless” change this doctor’s treatment? No idea. And if it’s inherent in how the FDA requires inserts to be drafted, then it would be afirmatively impossible.
But to us this sort of rank “could have” speculation doesn’t cut it – not where the plaintiff has the burden of showing causation. There’s no mention of any evidence that this doctor – who didn’t read drug warnings, and couldn’t say if he’d even received Dear Doctor letters – read articles, let alone changed his practice in reliance on them. Nor is there evidence that this doctor ever did anything in reliance on “communications,” either via Dear Doctor letters or in person via sales representatives. If such evidence existed, we’d expect to see some mention of it in the Winter opinion, but we’re left scratching our heads.
Id. There's Superman. Something, who knows what, saying exactly the right thing at exactly the right time. What “communications”? Could it be a Superman Dear Doctor letters – timed, of course, just right so that Superman can save the day? Stay tuned.Further, [plaintiff] has argued that [defendant] had a duty to reflect the known side effects of its medication in articles and communications through sales representatives, both of which could have reached [the prescriber] and changed the course of events despite his not reading package inserts.