Thursday, June 11, 2009

The Learned Intermediary Rule And Expert Witnesses

Quite some time ago (at least a month) a reader asked us to comment on how the learned intermediary rule affects the need for expert testimony to prove the adequacy of warnings pertaining to drugs and medical devices. Well, that request wasn't the kind of thing that had any time urgency on it, so we’re only now getting around to it.

We hope it’s better late than never.

The question of expert witnesses and warnings comes up because the learned intermediary rule only requires warnings to medical professionals – and not to ordinary people like plaintiffs/patients. In the law, when one is dealing with the requirements of a profession (such as medicine, but any profession, really) those requirements are typically proven through the testimony of an expert witness who is a member of that profession, and thus is competent to offer an opinion as to what those professional requirements are.

It's not a controversial point.

So the context of the learned intermediary rule, the adequacy inquiry becomes: Since the warning must be adequate as to the physician, is it necessary for a plaintiff (since the plaintiff bears the burden of proving a warning is inadequate) to present the testimony of a physician with an opinion that the warning wasn’t good enough to alert doctors to the full extent of the risk?

From what we can tell, most courts to consider the issue have required such expert testimony.
The most recent decisions we’ve found addressing this question are Montagnon v. Pfizer, Inc., 584 F. Supp.2d 459, 463 (D. Conn. 2008), and Colville v. Pharmacia & Upjohn Co., 565 F. Supp.2d 1314, 1321 (N.D. Fla. 2008). Coincidentally, both involve the same drug, Depo-Provera, a contraceptive alleged to reduce bone density (there’s considerable doubt whether that’s even a compensable injury, but that’s an issue for another post).

Colville dealt with the more common situation – where the plaintiff didn’t have any expert who purported to opine on the adequacy of the warning as to the medical profession. The first question was whether the issue was one of substantive state law (the state of Florida), or a procedural matter under the Federal Rules of Civil Procedure. The court considered it substantive, and looked to the Florida Supreme Court:

The manufacturer's duty to warn of the drug’s dangerous side effects is directed to the physician rather than the patient. Therefore, the adequacy or inadequacy of the warning to inform a physician must, except in the more obvious situations, be proved by expert testimony.

Upjohn Co. v. MacMurdo, 562 So.2d 680, 683 (Fla. 1990) (cited in Colville, 565 F. Supp.2d at 1321). Plaintiff offered the testimony of three doctors, but not one of them had an opinion on adequacy. 565 F. Supp.2d at 1321. The court therefore concluded that the warning was adequate, and the defendant entitled to summary judgment due to the plaintiff’s failure to offer expert proof. Id. (also following Paparo v. Ortho-McNeil Pharmaceutical, 2007 WL 121149, at *4 (S.D. Fla. Jan. 11, 2007)).

Montagnon was the same, but different. Again, the plaintiff’s expert “testified at his deposition that he was unable to offer an opinion as to the adequacy of the warnings.” 584 F. Supp.2d at 462. But this plaintiff’s counsel was a little more resourceful – or at least tried to be. Plaintiff claimed that, even in the absence of an outright expert opinion, certain studies established inadequacy of the warning. Id. at 463. But the studies were: (1) equivocal in their language, and (2) arguably rebutted by other studies. Thus, the court held that plaintiff’s warning claim failed in the absence of expert testimony:


[T]here is no expert evidence with which the jury could assess the link between the warnings and the injuries suffered by the consumer. . . . [N]either the Court nor a lay jury is capable of assessing the credibility of [the studies] . . . or comparing the results of these studies with other studies that came to contrary conclusions. . . . Even if expert testimony were not required as a matter of law, the Court finds that no jury of laymen, on the basis of two studies alone . . . could reasonably decide that [defendant]should have rewritten its warnings.
Id. at 463 (discussion of FDA role omitted).

These two cases exemplify the clear weight of the law. The Florida Supreme Court in MacMurdo cited the following precedent as supporting the expert testimony requirement: Wyeth Laboratories, Inc. v. Fortenberry, 530 So.2d 688, 692 (Miss.1988); Hill v. E.R. Squibb & Sons, 592 P.2d 1383, 1388 (Mont. 1979), and Dion v. Graduate Hospital, 520 A.2d 876, 880 (Pa. Super. 1987).

Does it?

Does it ever. Fortenberry held:

The adequacy of a warning addressed to the medical community may fall into the category of issues requiring expert testimony. Prescription drugs are likely to be complex medicines, esoteric in formula and varied in effect. The terms and applications of a warning on such a drug, in order to have meaning, must be explained to the jury. This is a subject so distinctively related to some science, profession, business or occupation as to be beyond the ken of the average layman.

Hill stated:


In matters with respect to which a layman can have no knowledge at all, the court and jury must be dependent on expert evidence. The adequacy of a warning directed to physicians is such a matter. This conclusion is consistent with the only other case we have found where on similar facts an attempt was made to reach the jury without expert testimony that the warning was inadequate.
And Dion agreed:

[W]e find that in the instant case the trial court properly concluded that expert testimony was necessary. Without expert testimony, there is a complete absence of evidence to show that the warning was inadequate. Thus, a conclusion that the product was defective could not reasonably or properly be reached by the jury. . . . Frequently, the jury, or the court trying a case without a jury, is confronted with issues which require scientific or specialized knowledge or experience in order to be properly understood. Certain questions cannot be determined intelligently merely from the deductions made and inferences drawn from practical experience and common sense. On such issues, the testimony of one possessing special knowledge or skill is required in order to arrive at an intelligent conclusion. . . . Prescription drugs are likely to be complex medicines, esoteric in formula and varied in effect. The terms and applications of a warning on such a drug, in order to have meaning, must be explained to the jury. This is a subject so distinctively related to some science, profession, business or occupation as to be beyond the ken of the average layman. Thus, we hold that in a complex products liability action such as this, expert testimony is required to determine whether the drug manufacturer's warning to the medical community is adequate.
As for the follow-on point of whether the expert has to have special training, or can simply be a practicing physician, the decisions we’ve seen have held that more or less any doctor’s opinion will suffice – but we caution that all this precedent is at least a quarter century old. See Mauldin v. Upjohn Co., 697 F.2d 644, 648 (5th Cir. 1983); Mahr v. G.D. Searle & Co., 390 N.E.2d 1214, 1237-38 (Ill. App. 1979); Ortho Pharmaceutical Co. v. Chapman, 388 N.E.2d 541, 553-54 (Ind. App. 1979).

While we think that these cases suffice to illustrate both the general proposition that the learned intermediary rule requires expert testimony that drug/device warnings are adequate as to physicians – and the limitations to that rule – we rather suspect that the initial request that we address the topic was made at least in part with the intent to induce another of our state-by-state surveys. Being gluttons for punishment, we will oblige.

Here is a list of all the cases we know of that require expert testimony to establish adequacy of warnings for products governed by the learned intermediary rule:

Connecticut: Montagnon, supra.

District of Columbia: McNeil Pharmaceutical v. Hawkins, 686 A.2d 567, 583-84 (D.C. 1996) (“persuaded by” Northern Trust v. Upjohn (see Illinois)).

Florida: MacMurdo, supra; Colville, supra; Beale v. Biomet, Inc., 492 F. Supp.2d 1360, 1369-70 (S.D. Fla. 2007); Paparo, supra; Timmons v. Purdue Pharma Co., 2006 WL 263602, at *3 n.6 (M.D. Fla. Feb. 2, 2006); Bogle v. Sofamor Danek Group, Inc., 1999 WL 1132313, at *4 (S.D. Fla. April 9, 1999); Broderick v. Danek Medical, Inc., 1999 WL 1062135, at *3 (S.D. Fla. April 9, 1999); McDaniel v. Sofamor Danek Group, Inc., 1999 WL 1062136, at 3 (S.D. Fla. April 9, 1999); Barrow v. Bristol-Myers Squibb, 1998 WL 812318, at 30 (M.D. Fla. Oct. 29, 1998), aff’d, 190 F.3d 541 (11th Cir. 1999) (table); Haggerty v. Upjohn Co., 950 F. Supp. 1160, 1168 (S.D. Fla. 1996), aff’d, 158 F.3d 588 (11th Cir. 1998) (table).

Illinois: Northern Trust Co. v. Upjohn Co., 572 N.E.2d 1030, 1035-36 (Ill. App. 1991) (“such a requirement is the logical extension of the fact that a prescription drug manufacturer's duty to warn is directed to the prescribing physician. For that reason, only a physician or someone with specialized knowledge would be qualified to determine whether the warning was inadequate”); Schrott v. Bristol-Myers Squibb Co., 2003 WL 22425009, at *6 n.3 (N.D. Ill. Oct. 23, 2003) (“failure to present expert testimony independently dooms her negligent failure to warn claim”), aff’d, 403 F.3d 940 (7th Cir. 2005); Woodbury v. Janssen Pharmaceutica, Inc., 1997 WL 201571, at *9 (N.D. Ill. April 10, 1997) (“in order to prove inadequate warnings, plaintiff must show that the expert testimony is admissible”); Langer v. Dista Products Co., 1996 WL 526763, at *2 (N.D. Ill. Sept. 12, 1996); Koncz v. Burroughs Wellcome Co., 1994 WL 178320, at *4 (N.D. Ill. May 9, 1994); Martinkovic v. Wyeth Laboratories, Inc., 669 F. Supp. 212, 215 (N.D. Ill. 1987).

Iowa: Benedict v. Zimmer, Inc., 405 F.Supp.2d 1026, 1033 (N.D. Iowa 2005) (“to show the device was defective because of inadequate instructions or warnings requires expert testimony”).

Louisiana: Sheridan v. Merck & Co., 2003 WL 22902622, at *3 (E.D. La. Dec. 8, 2003); Hornbeck v. Danek Medical, Inc., 1999 WL 1117107, at *3 (W.D. La. Aug. 5, 1999) (summary judgment granted because “plaintiff offered no expert evidence to refute the adequacy of the package insert”); Doucet v. Danek Medical, Inc., 1999 WL 1129648, at *2 (W.D. La. June 28, 1999) (same).

Mississippi: Fortenberry, supra.

Montana: Hill, supra.

New Jersey: Prince v. Garruto, Galex & Cantor, 787 A.2d 245, 252 n.2 (N.J. Super. A.D. 2001) (“expert testimony must address . . . what a qualified and practicing physician would have understood”); Grobelny v. Baxter Healthcare Corp., 2008 WL 2186417, at *2 (D.N.J. May 23, 2008) (“testimony of a physician would be necessary for the trier of fact to understand whether the warning was adequate”).

New York: Mulhall v. Hannafin, 841 N.Y.S.2d 282, 286-87 (N.Y.A.D. 2007) (defendant entitled to summary judgment where plaintiff’s warning expert report was impermissibly “conclusory”).

Ohio: Jones v. Roche Laboratories, 616 N.E.2d 545, 548 (Ohio App. 1992) (“A drug manufacturer's primary responsibility is to provide adequate warnings concerning its product to prescribing physicians. . . . [E]xpert opinion evidence is necessary for that showing”); Graham v. American Cyanamid Co., 350 F.3d 496, 514 (9th Cir. 2003) (“When a plaintiff alleges that the warning given to a prescribing physician is inadequate, the plaintiff must prove his claim through expert medical testimony”); Saraney v. TAP Pharmaceutical Products, Inc., 2007 WL 148845, at*6 n.3 (N.D. Ohio Jan. 16, 2007); Yanovich v. Sulzer Orthopedics, Inc., 2006 WL 3716812, at *12 (N.D. Ohio Dec. 14, 2006), aff’d, 255 Fed. Appx. 957 (6th Cir. 2007).

Pennsylvania: Demmler v. SmithKline Beecham Corp., 671 A.2d 1151, 1154 (1996) (“expert medical testimony is required to determine whether the drug manufacturer's warning to the medical community is adequate”); Dion, supra; Soufflas v. Zimmer, Inc., 474 F. Supp.2d 737, 751 (E.D. Pa. 2007) (“the adequacy of a warning in prescription medical device cases must be proven by expert testimony”); Burton v. Danek Medical, Inc., 1999 WL 118020, at *8 (E.D. Pa. March 1, 1999); Taylor v. Danek Medical, Inc., 1998 WL 962062, at *13 (E.D. Pa. Dec. 29, 1998).

South Dakota: Carlsen v. Javurek, 526 F.2d 202, 206 n.5 (8th Cir. 1975 (“plaintiff was not prepared to pursue this issue by offering any expert testimony to support a theory of inadequacy of warning”).

What? Only thirteen states? Are you guys slipping?

Maybe, but this post doesn't prove it. Those are simply the only states that have expressly looked at the issue. At least that we know of. If anybody's got additional cites, well you know how we are.... Send 'em along.


On the other hand, there’s next to no precedent holding that plaintiffs can establish the adequacy of drug/device warnings to doctors without the opinion of a physician who is a member of the class to whom these types of warnings are directed.

3 comments:

ashcraft said...

What if the pharmaceutical company markets directly to the consumer?

Andrew Oh-Willeke said...

Impressive. You're going to put Am Jur out of business with posts like these.

Beck/Herrmann said...

No matter how much DTC marketing a drug manufacturer may do, the consumer may not obtain the drug without a physician's prescription. The physician at all times has his/her own professional obligation to evaluate a patient's own particular medical risks and needs.

So as far as we're concerned, DTC marketing is irrelevant to the application of the learned intermediary rule.