Thursday, April 19, 2007

“If Only My Expert Had Treated Me”: “Reasonable” Physicians Don’t Prove Warning Causation

We have to admire the creativity of plaintiffs’ lawyers in learned intermediary rule cases, even while we shake our heads at their frequent departures from not just the law but fundamental logic as well. Take warning causation, for instance – we do all the time. The prescriber testifies unequivocally that I’m a responsible doc. I keep up on medical controversies in my field, and I knew all about the risk involved in the case. Because of plaintiff X’s condition, I would have used this drug (or device) anyway, in the same way, and I’d still make that decision today.

Summary judgment city, right? There are dozens of cases that say where an additional warning would not have changed the prescriber’s decision, then as a matter of law there’s no causation, and any claim based upon inadequate warnings fails. Just look in Bexis’ book, for one thing. There’s a footnote almost four pages long – in that tiny print that we old guys can't read anymore – with nothing but cases in which this kind of evidence has defeated causation.

“Wait a minute,” says the plaintiffs’ lawyer. “I’ve got the best expert money can buy – he’s even a medical doctor. He’s going to testify that, no matter what this prescriber says, a ‘reasonable physician’ would never have prescribed the drug had there been a proper warning. That creates an issue of fact.”

We beg to differ. If the plaintiff is going to accuse his or her prescriber of acting unreasonably, then that’s an entirely different kind of litigation, and it doesn’t involve our client. Warning causation – whether or not a “better” warning would have made a difference – is inextricably linked to the facts of the particular case. The only difference the learned intermediary rule makes is to change who evaluates the risk, and thus who’s knowledge is important.

Aside from the identity of the actor, the knowledgeable prescriber creates the same situation as the plaintiff’s decedent who, after saying “hold my beer and watch this,” goes out and wins him/herself a Darwin Award. A plaintiff’s decision to disregard a known risk defeats causation in a “normal” product liability case. The plaintiff can’t defeat summary judgment by bringing in, say a driving expert, to testify that a “reasonable” person wouldn’t have done what the plaintiff did, and therefore the plaintiff can recover because the fence in front of the cliff didn’t have a big enough “Danger” sign on it. Contrafactual “expert” physician testimony – testimony that the prescriber shouldn’t have done what s/he did – is no different.

“Reasonable physician” evidence has nothing to do with establishing causation in a particular case. The learned intermediary rule requires plaintiffs to prove to the jury that their own prescribing physicians – not some nonexistent “reasonable prescriber” who never treated them – would have altered their behavior and not prescribed if there had been “adequate” warnings.

The learned intermediary rule doesn’t operate in the abstract. The “failure of [the prescribers] to perform their duties from that point forward does not operate to create, or to extend, a manufacturer’s duty.” Ellis v. C.R. Bard, Inc., 311 F.3d 1272, 1283 (11th Cir. 2002). A manufacturer “may reasonably assume that the physician will exercise his informed judgment in the patient’s best interests,” Tracy v. Merrell Dow Pharmaceuticals, Inc., 569 N.E.2d 875, 878-79 (Ohio 1991). It is the physician’s responsibility to:
take into account the propensities of the drug, as well as the susceptibilities of his patient. His is the task of weighing the benefits of any medication against its potential dangers. The choice he makes is an informed one, an individualized medical judgment bottomed on a knowledge of both patient and palliative.
Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1276 (5th Cir. 1974) (emphasis supplied). We could cite lots more cases like these, but why beat a dead horse?

Because the learned intermediary rule is predicated upon “individualized medical judgment” that involves weighing “potential dangers” against patient “susceptibilities,” the law rightly requires that causation be proven individually within each plaintiff’s physician/patient relationship.


[T]he important issue is whether [the prescriber] would have done anything different. . .after reading an adequate [warning]. If she would not have changed her conduct. . .the causal chain is broken, and [defendant] is absolved of liability.
Mazur v. Merck & Co., 742 F.Supp. 239, 262 (E.D. Pa. 1990).

Still plaintiffs try. There are a fair number of cases where courts have had to grapple with testimony from a paid plaintiff’s expert that what actually happened should be ignored because a “reasonable physician” would have done it differently. Most recently, in Stafford v. Wyeth, 411 F. Supp. 2d 1318 (W.D. Okla. 2006) “reasonable physician” testimony was rejected as irrelevant:


Likewise irrelevant is plaintiff’s argument regarding what a reasonable physician would do. The question in the learned intermediary context is not what an objective physician would decide, but rather what plaintiff's doctor would determine based on his knowledge of the drug in question and the plaintiff's risk factors.

Id. at 1322.

Offering expert “reasonable physician” testimony seems to be fairly common (if not very successful) in fen-phen litigation. Stafford was a fen-phen case, as were several recent trial court decisions in Philadelphia that likewise gave such testimony the back of the judicial hand:

Contrary to [plaintiff’s] assertions, the affidavit of [an expert], attesting to what a “reasonable doctor” would have done had a different warning been supplied is insufficient evidence to create a material issue of fact and satisfy her burden on proximate causation. As [the law] makes clear, the evidence required to establish a reasonable likelihood is evidence that the learned intermediary. . ., and only [him], would provide to the effect that he. . .would have altered his behavior. Accordingly, an affidavit or testimony of [an expert] as to what a “reasonable doctor” would have done with appropriate knowledge is not admissible, is irrelevant and is contrary to the legal standard long established.

Gronniger v. American Home Products Corp., 2005 WL 3766685, at *5 (C.P. Philadelphia Co. Oct. 21, 2005); accord Anderson v. Wyeth, 2005 WL 1383174, at *5-6 (C.P. Philadelphia Co. June 7, 2005); Leffler v. American Home Products Corp., 2005 WL 2999712, at *5 (C.P. Philadelphia Co. Oct. 21, 2005).

Stafford relied on an earlier case that pointed out the “curious” effect of “reasonable physician” opinions is to ignore what the actual prescriber actually did:

[T]he court [would be] required to take the rather curious action of ignoring what the treating physician says he would have done given a certain factual setting for no other reason than the fact that he is not an “objective” physician, i.e., any physician other than the actual physician who diagnosed, treated and prescribed medication to the patient. . . . The court does not believe this construction. . .is supported by [state] case law.

Woulfe v. Eli Lilly & Co., 965 F. Supp. 1478, 1484 (E.D. Okla. 1997). See also Fraley v. American Cyanamid Co., 589 F. Supp. 826, 828 (D. Colo. 1984) (“The acts of the treating physician, not the average or ‘reasonable’ physician, are the acts relevant to proximate cause.”); Dyer v. Danek Medical, Inc., 115 F. Supp. 2d 732, 742 (N.D. Tex. 2000) (rejecting “objective” learned intermediary causation standard where contrary to actual conduct of prescriber). What a hypothetical physician who never actually treated plaintiff might have done is irrelevant and immaterial. Causation under the learned intermediary rule turns solely on what the actual prescriber did or would have done in light of additional warnings.

The only fly in the ointment (isn’t there always something) is dictum in Thomas v. Hoffman-LaRoche, Inc., 949 F.2d 806 (5th Cir. 1992). Thomas did deign to consider expert testimony of this nature – but ultimately found that the expert opinion did not establish any factual question and affirmed summary judgment for the defendant because the plaintiff had not established any basis for concluding that a different warning would have changed the result. Id. at 812 (“the plaintiff must establish that an adequate warning would have convinced the treating physician not to prescribe the product”). The Thomas court held a “reasonable physician” expert opinion was insufficient to defeat summary judgment because “the possibility that [the prescriber] would have changed his decision if he had been warned. . .is too remote to create a genuine issue of fact with respect to warning causation.” Id. at 817.

Thus, while “reasonable physician” evidence has its place in learned intermediary rule litigation, that place is solely in determining the adequacy of the warning. The causative effect of a warning, by contrast, is inherently case specific, as it makes no sense to ignore what actually happened in favor of a nonexistent hypothetical.

But after saying all this, we don’t expect the plaintiffs to stop trying. We just expect the defendants to go on winning the point because not only the law, but logic as well, are on our side.

1 comment:

Family practice jobs said...

Not all physicians are like that though....