Thursday, October 02, 2008

Learned Intermediary Rule 201

We’ve discussed the learned intermediary rule on this blog many times before – such as here, here, and here. One of the things that everybody on our side of the “v.” appreciates – and those on the other side despise – is what the rule does to warnings and warning causation. Rather than a plaintiff’s usually complete lack of knowledge of medical matters and self-serving testimony that “if I had known that, I never would have taken the stuff,” we have the testimony of a physician who: (1) is a well-trained medical professional, and (2) is not (usually, at least) in cahoots with the plaintiff. Our side wins a lot of cases that way, as we discussed earlier this year. We’ve also gave our readers a general run down of our favorite learned intermediary warning causation cases here.

What we want to do today is examine the rule, and also warnings and warning causation in a little more depth. All defense lawyers know and can easily recognize the “big three” warning causation win situations: (1) the doctor already knew everything that a supposedly “adequate” warning would have said; (2) the doctor didn’t read our warnings at all, so a different warning wouldn’t have changed anything; and (3) the doctor testifies that, knowing everything then that he does now, he would have treated the plaintiff the same way. Similarly counsel can identify the big winner on adequacy as a matter of law - a specific mention and detailed description of the precise risk that the plaintiff suffered. Today we’re going to examine some situations that arise when we don’t quite have the ideal set of facts.

First hypothetical: The doc says I would have prescribed the drug anyway, but I might have done something else different, such as “monitoring the situation” more closely or telling the patient something different. First thing, know the jurisdiction’s law. Some states close the causation question at the “I would still prescribe” stage. E.g., Thomas v. Hoffman-LaRoche, Inc., 949 F.2d 806, 812 (5th Cir.1992) (“to create a jury question, the evidence introduced must be of sufficient weight to establish. . .some reasonable likelihood that an adequate warning would have prevented the plaintiff from receiving the drug”) (applying Mississippi law); Demmler v. SmithKline Beecham Corp., 671 A.2d 1151, 1155 (Pa. Super. 1996) (following Thomas’ phrasing); Edgar v. Danek Medical, Inc., 1999 WL 1054864, *6 (M.D. Fla. Mar. 31, 1999) (“plaintiff must show that the physician would not have used the device in question if he or she had been warned by the manufacturer of its risks”). Thus, it might be that the “but” in “I would have prescribed, but….” doesn’t even matter.

Assuming it does, it’s essential that defense counsel know the facts of the case well enough to keep pushing. Just because the doctor might have done something a little different doesn’t mean that the difference would produce a causal difference. If the testimony is “I would have told the plaintiff something different,” remember that the plaintiff has to make him/herself look ridiculous in order to turn this into something causal. The other side’s proposition has to be that the plaintiff, knowing whatever “more” there would have been, would have disobeyed medical advice and refused to take a drug that the doctor wanted to prescribe anyway. The doc will probably testify, if asked, that this never happens, even now, when he tells patients whatever’s at issue. Lots of plaintiffs routinely go along with medical advice despite learning about more common or more serious risks. So, if the plaintiff’s going to go this route, s/he is going to lose a lot of credibility in trying to fend off a causation summary judgment.

And, then again, the plaintiff might not avoid summary judgment at all. There are some cases that say monitoring is the doc’s job, not anybody else’s. E.g., Olvera v. Merck & Co., 2006 WL 3302574, at *3 & n.2 (S. D. Tex. Nov. 13, 2006); In re Rezulin Products Liability Litigation, 133 F. Supp.2d 272, 289, 295 (S.D.N.Y. 2001); Morgan v. Wal-Mart Stores, Inc., 30 S.W.3d 455, 463 (Tex. App. 2000); Walker v. Jack Eckerd Corp., 434 S.E.2d 63, 67-68 (Ga. App. 1993); Pysz v. Henry’s Drug Store, 457 So.2d 561, 562 (Fla. App. 1984). The key is to keep pushing. Would additional “monitoring” or warnings have done any good on the facts at hand? Was the plaintiff already being monitored? Was this particular physician in a position to do that monitoring?

In jurisdictions where “more monitoring” or “more warnings” testimony makes a difference, all that happens is that the causation analysis extends one step further – it doesn’t mean that the toothpaste’s automatically out of the tube. Hypothetical changes in medical care, without causation evidence, don’t get the plaintiff very far. In Eck v. Parke, Davis & Co., 256 F.3d 1013 (10th Cir. 2001) (already one of our favorite warning causation cases), the defendant won summary judgment despite both “I would have monitored more closely” and a heeding presumption because defense counsel didn’t give up. Testimony established that “better” monitoring by that particular doctor wouldn’t have mattered a hill of beans – before there was any change in the plaintiff’s condition that monitoring could have discovered, the plaintiff had switched doctors. Id. at 1020. That’s just one case-specific factual quirk, but it’s indicative of the type of testimony defendants need to go out and get once they are confronted with “I would still prescribe, but” testimony.

Here’s another example. In Vanderwerf v. SmithKlineBeecham Corp. (another of our warning causation favorites) the prescriber testified that he would still have prescribed a drug, notwithstanding a different warning, but would have “watch[ed plaintiff] considerably closer” for suicidal thoughts (“ideation,” in the medical jargon). 529 F. Supp.2d 1294, 1312 (D. Kan. 2008). But, again, our side kept pushing and established that “more monitoring” wouldn’t have made a difference. There was Eck-style testimony that the plaintiff was no longer seeing this doctor (that seems to happen a lot with plaintiffs – they don’t get along with doctors any more than they do with drug companies). Id. at 1313. Not only that, but the plaintiff also couldn’t prove either that too little suicide monitoring actually occurred or that “more” monitoring would have prevented the suicide. Id. (“[n]othing in the record, however, suggests that [the physician failed to carefully monitor . . . or that any level of further monitoring would have prevented [the] suicide”).

Most recently there’s the nifty Reece v. Astrazeneca Pharmaceuticals, LP, 500 F.Supp.2d 736 (S.D. Ohio 2007), decision about statins and muscle/kidney damage. Again, a prescriber testified that he would have “run more tests.” That wasn’t enough to stop summary judgment because plaintiff couldn’t point to anything that additional testing would have accomplished:


There is not a scintilla of competent evidence in the record to support a finding that baseline and periodic [tests] would be of any benefit to patients taking [the drug]. There is likewise no competent evidence to support plaintiff’s position that baseline and periodic [tests] would have alerted her physician to the presence of [her condition] in a sufficiently timely manner to prevent [injury].
Id. at 751.

So the takeaway from the first hypo is that, if defense counsel gets wishy-washy “I still would have prescribed, but” testimony from a prescriber, counsel needs to know the case well enough to find the fall-back positions that will still establish that whatever the prescriber might have done differently, it wouldn’t have changed the outcome in a particular case.

Second Hypothetical: This is more an adequacy than a causation issue, anthough some courts treat it as both. The manufacturer warned about whatever happened to the plaintiff, but plaintiff criticizes the warnings anyway because they didn’t tell the docs how to detect/treat/etc. the condition, or because the warning didn’t recount all the bad things that could happen to the plaintiff if he came down with that particular condition.

The basic response to this type of argument is that there’s no obligation to tell docs how to practice medicine. At the bottom of this slippery slope lies drug warnings that read like first-year medical school textbooks. Courts have rightly looked upon such arguments with skepticism.

In the weirdly named Meridia Products Liability Litigation v. Abbott Laboratories, 447 F.3d 861, 867 (5th Cir. 2006), the court blew out this type of claim, finding the defendant’s warning about high blood pressure sufficient and that there was no need to go further ant tell doctors about what high blood pressure itself can cause. “Physicians are well aware of the scope of the risks associated with increased blood pressure and do not need specifics regarding the possible consequences of blood pressure increases.” Id. at 867 (quoting district court).

The same thing happened in Stahl v. Novartis Pharmaceuticals Corp., 283 F.3d 254, 266-68 (5th Cir. 2002), where the court didn’t let the plaintiff get away with arguing that there should have been a warning about “liver failure” and “death” in addition to “hepatitis.” The warnings went to doctors, who could be expected to know this. “[B]ecause liver failure and resulting death are widely recognized to be possible outcomes in a severe case of hepatitis, those risks are adequately addressed by the warnings already provided.” Id. at 268.

[T]here is no duty to warn of obvious risks. In the context of warnings addressed to a physician acting as learned intermediary, this court has interpreted this “obvious risk” exception to exclude any duty to warn of risks that are within the knowledge of or obvious to the average learned intermediary.

Id.

The same thing happened in Plenger v. Alza Corp., 13 Cal.Rptr.2d 811, 819 (Cal. App. 1992), where it wasn’t necessary to warn that “pelvic infection” (warned about), if untreated, could be fatal. “[T]he risk of death from any untreated infection was a matter of general and elemental medical knowledge.” Id. at 819. The court also slammed the claim on causation grounds. “[I]f the risk of death from untreated infection is universally known in the medical profession, [which the court had just held it was] the failure to warn the physician of that risk cannot be the legal cause of the decedent's death.” Id. Note to opponents: most doctors are familiar with the germ theory of disease, and if not in your case, you're suing the wrong defendant.

In Guevara v. Dorsey Laboratories, 845 F.2d 364, 367-68 (1st Cir. 1988), the question was whether a warning about “allergic reactions” included that the patient might come down with a skin rash. Nah, the court said. The record “indicates that the warning actually provided was sufficient to alert a general practitioner with the ordinary knowledge common to the medical community, that [the drug] could cause a dermal reaction.” In effect, the court refused to hold that doctors don’t know how to practice medicine.

A similar claim was rejected in Nichols v. Clare Community Hospital, 476 N.W.2d 493 (Mich. App. 1991). The court held that it was enough to warn against a risk of herpes, and no further warning about how to go about diagnosing the disease was needed for adequacy. “A manufacturer fulfills its duty to the medical community when it warns of the risk inherent in use of the drug. There is no requirement that the warning apprise the doctor of how to properly diagnose the condition that renders use dangerous.” Id. at 495.

In Ames v. Apothecon, Inc., 431 F.Supp.2d 566 (D. Md. 2006), the question was a little different. The plaintiff claimed that, in addition to discussing the risk, the manufacturer had to tell physicians now widespread it was. That argument, too, got the bum’s rush – and a reminder about the intended audience for drug warnings. “One must also bear in mind that the warnings are intended to be read by learned intermediaries who are presumed to have considerable medical training as well as the ability to access the medical literature if they require additional information.” Id. at 573.

Nor do drug warnings have to provide basic sex education. In Gerber v. Hoffmann-La Roche Inc., 392 F.Supp.2d 907, 919 (S.D. Tex. 2005), involving a drug that was a known teratogen, the court held that, once doctors were warned that their patients should use birth control, there was no further need to warn physician that contraceptives don’t always work. That “concern[ed] facts doctors should already know as learned intermediaries.” In Banner v. Hoffmann-La Roche Inc., 891 A.2d 1229 (N.J. Super. A.D. 2006), the court had the same reaction to a proposed warning that abstinence is not effective birth control if the person is not, in fact, abstinent. “It is certainly “ordinary knowledge” that a married woman of child-bearing age may not remain abstinent and may become pregnant after engaging in sexual relations without the use of contraception.” Id. at 1239-40. And in Brumley v. Pfizer, Inc., 149 F.Supp.2d 305 (S.D. Tex. 2001), involving Viagra, a warning that already cautioned against use by people with heart disease had no reason to also warn against “strenuous activity.”

A physician who is aware of his patient’s heart disease is cognizant that the patient is at risk both during sexual intercourse and during any other strenuous exercise. . . . both the original precaution and the second warning merely alert physicians to a risk of which they already should be aware-the danger that strenuous physical activity poses to patients with heart disease.
Id. at 312.

We kid you not – all these claims were actually brought, litigated by opposed motion, and sometimes even appealed. Jeez, we’re not even doctors, and we know this stuff. What planet do these plaintiffs – and their lawyers – come from? Men are from Mars, women are from Venus, and plaintiffs are from…. We’ll stop there; you figure it out.

The take away from this hypothetical is, if defense counsel or the defense medical expert's first reaction is to roll their eyes, and the first response upon reading the other side’s argument is, “well, duh,” then this line of cases is for you.

Third Hypothetical: Back to causation, this time. The doc testifies that s/he’s heard of the controversy about the risk in question, but considered it trivial, or had some independent treatment-related reason for not warning about it. It’s a variant of standard win situation #3 that we mentioned – “I wouldn’t do anything different even now” – but grounded more firmly in medical specifics than in the general orneriness of some physicians.

A doctor might not think that the risk is serious enough to warrant a warning. That happened in Colville v. Pharmacia & Upjohn Co., 565 F. Supp.2d 1314, 1322 (N.D. Fla. 2008). The doc thought that the risk of bone loss with a drug was minimal. Id. at 1322. To the great benefit of the manufacturer, he continued to think that “even after [a] black box warning was added.” Id. The doc continued to prescribe the drug “in the same manner, without a specific conversation or warning about the potential for low bone density.” Id. The doctor’s independent assessment of the risk eliminated proximate cause:


[A]ny inadequacy in the drug warning could not have been the proximate cause of the injury in this case. . . . Because [the prescriber] was aware of the risk factor and did not have a specific conversation with [plaintiff] about it, [she] has failed to show that the inadequacy of the manufacturer’s warnings was a proximate cause of her [injury].
565 F. Supp.2d at 1322.

Suicide cases are an excellent source of this kind of fact pattern. Lots of psychiatrists don’t want to warn their patients about possible suicide risks in drugs, for fear that the warning will “plant seeds in the patient’s mind that suicide was an option.” Ackermann v. Wyeth Pharmaceuticals, 526 F.3d 203, 210-212 (5th Cir. 2008) (Texas law), which we discussed, here, because we were both involved in it. In Motus v. Pfizer Inc., 196 F. Supp.2d 984 (C.D. Cal. 2001) (another of our favorite causation cases), the prescribing physician believed that the plaintiff’s underlying depressed condition, not the drug, caused suicide. Thus the doc was “aware” of the claimed risk, but “discounted these claims based on his personal experience” because his “personal belief” was that the drug “did not cause” anybody to commit suicide. Id. at 989. In light of the physician’s disbelief and non-reliance there could be no causation:


[The prescriber] state[d] unequivocally that in making that decision, he did not rely either on any statements [defendant’s] representatives made to him nor any written materials they may have provided to him. . . . It follows that the inclusion of adequate warnings in that information would not have affected his decision.
Id. at 996. On appeal, the Ninth Circuit found “no conceivable causal connection” between any lack of a suicide warning “that accompanied the product and plaintiff’s injury.” Motus v. Pfizer Inc., 358 F.3d 659, 661 (9th Cir. 2004). As we’ve mentioned before, the plaintiff’s complete failure on the causation prong let the Ninth Circuit avoid a preemption question (Hah! You knew we’d work preemption in here somehow).

Finally, there’s Madsen v. American Home Products Corp., 477 F.Supp.2d 1025 (E.D. Mo. 2007) (another favorite), a fen-phen case, where prescriber believed that the risks of being overweight were worse than the risks of the drug. Thus the doc “questioned the relative risks of the adverse effects,” and from that it was “reasonable to infer” that he “would have continued to prescribe” to plaintiff no matter what the warning said. Id. at 1036.

The takeaway from this third line of learned intermediary cases is that, if it turns out that the prescriber still uses the drug (or wishes s/he could), there are probably good reasons for it. It can be very beneficial to the defense to get those reasons on the record and to explore whether they apply to the case in question.

As we’ve said quite often, there are lots of reasons for defense counsel to like the learned intermediary rule. Having exhausted the most important ones – and needing to feed the blog – we thought we’d pass along a few of our more esoteric reasons.

5 comments:

Supremacy Claus said...

Both the learned intermediary rule and the idea of informed consent have been swept away. The courts have yet to recognize this development.

They have been swept away by the doctrine of the Duty to Google.

Warnings, disclosures, informed consent do not work. The decay rate of knowledge is rapid. The sole way to inform oneself is by repetition. So, I am in pain. A surgeon whips out the Powerpoint and spends 3 hours on the proposed treatment, at the advanced residency level. Is that informed consent or learned intermediary territory. I am in pain. I would do anything to feel better. I am not even listening, never mind able to rationally consider the pros and cons.

It is only at home, repeatedly researching the treatment that I can come to understand it.

Here are some initial cases of the Duty to Google, not applicable to health law. Nevertheless, I anticipate rapid adoption of this correct defense by the courts.

http://www.ali-aba.org/doc/IFF0705.pdf

If other cases have taken place, I would appreciate them for my collection.

Supremacy Claus said...

Sorry. Here is another case.

http://www.abajournal.com/news/lawyer_to_use_google_search_stats_to_defend_obscenity_case

Soronel Haetir said...

The first couple links labelled "here" appear to be broken, They come back saying file not found.

Beck/Herrmann said...

The links are fixed.

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