Friday, July 06, 2007

In Defense of the Learned Intermediary Rule

We’ve already deplored the recent decision of the West Virginia Supreme Court rejecting the learned intermediary rule outright, State ex rel. Johnson & Johnson Corp. v. Karl, ___ S.E.2d ___, 2007 W. Va. Lexis 57 (W. Va. June 27, 2007) (“Karl”). However, the more we’ve thought about it, the more we’re convinced that the proper response to this (we fervently hope) aberration has to be more than just self-righteous criticism.

In one way or another, we’ve helped convince supreme courts in six states either to adopt or to reaffirm the learned intermediary rule. See Larkin v. Pfizer, Inc., 153 S.W.3d 758, 761 (Ky. 2004); McCombs v. Synthes (U.S.A.), 587 S.E.2d 594, 595 (Ga. 2003); Vitanza v. Upjohn Co., 778 A.2d 829, 836-38 (Conn. 2001); Coyle v. Richardson-Merrell, Inc., 584 A.2d 1383, 1385 (Pa. 1991); Niemiera v. Schneider, 555 A.2d 1112, 1117 (N.J. 1989); and White v. Wyeth Laboratories, Inc., 533 N.E.2d 748, 755 (Ohio 1988). So we like to think that by this time we’re familiar with all the arguments, pro and con. It also makes us feel old, looking at dates like 1988, 1989, and 1991. That means we’ve been at this for a good twenty years now.

Now, we have to roll the boulder up the hill again.

Briefly put, we think the learned intermediary rule is a good idea.

We’re hardly alone. The rule has gained extraordinarily wide acceptance – we previously listed precedent for the rule in 47 states and two other American jurisdictions. To us, this alone demonstrates that the learned intermediary rule fills an important role in the law. It ensures harmonious operation of state product liability law with the “unique system used to distribute prescription [products].” Pittman v. Upjohn Co., 890 S.W.2d 425, 429 (Tenn. 1994).

There are several reasons why almost every other jurisdiction doesn’t share the West Virginia view that’s on display in Karl. First and foremost, the learned intermediary rule makes sense because it reflects what goes on in the real world. Ever since the FDA started regulating prescription drugs in the 1930s, those drugs and (more recently) prescription medical devices have only been available to the public after doctors have decided that they are appropriate for the treatment of particular patients. Thus the rule reflects how prescription drugs and medical devices are actually distributed. These mandatory federal restrictions on distribution are why prescription medical products are most definitely not just the same as a “lawnmower,” to use the concurring opinion’s example. Karl, 2007 W. Va. Lexis 57, at *59. Anybody can go down to the hardware store and buy a lawnmower for any reason (or no reason) at all. You can't do that – legally anyway – with prescription medical products.

Moreover, these FDA requirements are motivated by longstanding safety concerns. The FDA defines “[p]rescription drug” as “any drug (including any bio­logical product . . .) required by Federal law. . .to be dispensed only by a prescription.” 21 C.F.R. §203.3(y). All drugs are prescription drugs unless the FDA “finds such requirements are not necessary for the protection of the public health by reason of the drug’s toxicity or other potentiality for harmful effect.” 21 C.F.R. §310.200(b). Similarly a “prescription device” is “[a] device which, because of any potentiality for harmful effect. . .is not safe except under the supervision of a practitioner licensed by law to direct [its] use.” 21 C.F.R. §801.109.

Federal limitations upon distribution of prescription medical products are thus explicitly based upon their inherent safety risks. We’d support a learned intermediary rule for cars or guns (or lawnmowers) if they were subject to a similar regulatory regime. But nobody's out there telling purchasers of such products that they can't have them unless they first go to a government-licensed professional and obtain pre-certification that the purchase is necessary.

Fundamentally, the learned intermediary rule is “based on the principle that prescribing physicians act as ‘learned intermediaries’ between a manufacturer and consumer and, therefore, stand in the best position to evaluate a patient’s needs and assess the risks and benefits of a particular course of treatment.” Vitanza, 778 A.2d at 836-37. “When the purchase of the product is recommended or prescribed by an intermediary who is a professional, the adequacy of the instructions must be judged in relationship to that professional.” Mampe v. Ayerst Laboratories, 548 A.2d 798, 802 n.6 (D.C. 1988). The rule is legal recognition of something that is as true today as ever: prescription medical products are not available to the public at large precisely because the FDA has determined that such products have inherent, unavoidable risks of sufficient gravity to require a doctor’s evaluation before anyone can use them.
[A] prescription drug [is] a product whose distribution is limited precisely because its benefits and risks are to be assessed only by licensed physicians acting on behalf of particular patients whose individual physical condition and circumstances are known to them.
Coyle, 584 A.2d at 1387.

The entire system of drug distribution in America is set up so as to place the responsibility of distribution and use upon professional people. The laws and regulations prevent prescription type drugs from being purchased by individuals without the advice, guidance and consent of licensed physicians and pharmacists. These professionals are in the best position to evaluate the warnings put out by the drug industry.
Larkin, 153 S.W.3d at 763. The Rule’s consistency with overarching federal regulation of prescription medical products has been repeatedly recognized. E.g., Ellis v. C.R. Bard. Inc., 311 F.3d 1272, 1287 (11th Cir. 2002) (applying Georgia law); Fane v. Zimmer, Inc., 927 F.2d 124, 129 (2d Cir. 1991) (applying New York law); Phelps v. Sherwood Medical Industries, 836 F.2d 296, 298-99 (7th Cir. 1987) (applying Indiana law).

That’s how the FDA has the system set up. The warnings in the package insert are designed for doctors, not laypeople, to read. Don’t take our word for it. See for yourself. Go get a package insert from your own prescription medication. If you’re young, healthy, and/or lucky enough not to need any prescription medical products, type “package insert” into Google and go read one.

These documents are chock full of terms like “treatment-emergent hyperglycemia-related adverse events,” “mean (SD) pharmacokinetic parameters,” “agranulocytosis,” and “glomerular filtration rates” – to take random things that we saw in the first four package inserts that the Google search generated. We don’t know what this stuff means, and unless you’re a doctor, chances are that you don’t either.

But we’re pretty sure of one thing – that kind of jargon has very precise medical meaning to the people who do understand what’s in these package inserts. We’d like to keep it that way. Somehow, we think it’s more valuable to tell a doctor to watch for “interstitial nephritis” than to tell a patient to be careful if s/he’s “feeling out of it and not able to pee right.” In this country, we’ve always thought it best to have doctors to break things down to their patients in one-on-one conversations rather than having patients try to read package inserts.

Last time we looked, West Virginia recognized the doctrine of informed consent, requiring doctors to do just that. E.g., Cross v. Trapp, 294 S.E.2d 446, 454-56 (W. Va. 1982). Thus, at best, Karl has just created a regime of redundant and overlapping liability with the patients stuck in the middle – not knowing whom to believe if doctors and drug companies say different things.

The learned intermediary rule thus makes sound practical sense. An accurate description of the risks and benefits of prescription medical products requires precise medical terminology not easily understood by lay patients. Such warnings are “designed for the physician and not the patient.” Oksenholt v. Lederle Laboratories, 656 P.2d 293, 297 (Or. 1982). The rule ensures scientific precision, by allowing prescription medical product manufacturers to draft their warnings to be read by doctors, rather than patients:

Warnings for prescription drugs are intended for the physician, whose duty it is to balance the risks against the benefits of various drugs and treatments and to prescribe them and supervise their effects. The physician acts as an “informed intermediary” between the manufacturer and the patient; and, thus, the manufacturer’s duty to caution against a drug’s side effects is fulfilled by giving adequate warning through the prescribing physician, not directly to the patient.
Martin v. Hacker, 628 N.E.2d 1308, 1311 (N.Y. 1993). Doctors simply cannot be cut out of the drug distribution system in favor of direct patient warnings without endangering precisely those patients who need their advice the most:

Prescription drugs are likely to be complex medicines, esoteric in formula and varied in effect. As a medical expert, the prescribing physician can 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) (applying Texas law). Accord, e.g., Freeman v. Hoffman-La Roche, Inc., 618 N.W.2d 827, 841-42 (Neb. 2000) (following Reyes a quarter century later).

It would not just be burdensome, but dangerous, for the law to demand the “dumbing down” of technical medical product information. Putting aside practicality, patients should follow doctor’s orders – and should not be conducting possibly ill-informed self-evaluations of their own prescribed medical treatments. Perez v. Wyeth Laboratories Inc., 734 A.2d 1245, 1254 (N.J. 1999); Dyer v. Best Pharmacal, 577 P.2d 1084, 1088 (Ariz. App. 1978); In re Norplant Contraceptive Products Liability Litigation, 215 F. Supp.2d 795, 815 (E.D. Tex. 2002).

The rule further reflects reality by recognizing that doctors make most prescribing decisions for their patients – in the context of a physician/patient relationship in which patients rely upon their doctors to explain treatment decisions, and do not rely upon their own reading of product labeling. See, e.g., West v. Searle & Co., 806 S.W.2d 608, 613 (Ark. 1991); Humes v. Clinton, 792 P.2d 1032, 1039 (Kan. 1990); Williams v. American Medical Systems, 548 S.E.2d 371, 375 (Ga. App. 2001); Reaves v. Ortho Pharmaceutical Corp., 765 F. Supp. 1287, 1289 (E.D. Mich. 1991).

Thus, “[i]t is. . .the duty of the physician to advise the patient of any dangers or side effects associated with the use of the drug as well as how and when to take the drug.” Coyle, 584 A.2d at 1385. “Education of the physician, on the one hand, and communication to the patient, on the other, are distinct processes, and the manufacturer’s duty involves only the former.” Harwell v. American Medical Systems, Inc., 803 F. Supp. 1287, 1299 (M.D. Tenn. 1992). If the product requires a doctor’s prescription, and a doctor in fact prescribed it, the Rule properly applies:

Whether [the] learned intermediary rule applies in a given case is not based on to whom a warning must be given to make a drug or device safe. Instead, the applicability of that rule depends on the type of drug or device at issue and whether there exists a learned intermediary.

Ellis, 311 F.3d at 1282.

Conversely, a tort system that requires manufacturers to bypass doctors and warn patients directly would disrupt the physician/patient relationship. “[I]mposition of a generalized duty to warn would unnecessarily interfere with the relationship between physician and patient.” Morgan v. Wal-Mart Stores, Inc., 30 S.W.3d 455, 467 (Tex. App. 2000). “When the physician-patient relationship does exist. . .we hesitate to encourage, much less require, a drug manufacturer to intervene in it.” Swayze v. McNeil Laboratories, Inc., 807 F.2d 464, 471 (5th Cir. 1987) (applying Mississippi law).

Doctors are highly trained, with their own professional and legal obligations to their patients. Among other things, they keep those patients from overreacting to the many warnings (often directed to limited situations or patient populations) that the FDA requires product labeling to include.

[S]ince the typical manufacturer's warning provides a list with scores of potential side effects, no matter how minute the possibility of occurrence, the lay consumer might overreact to such warnings and forego beneficial, or even vital, medical treatment.

Larkin, 153 S.W.3d at 764. Thus, the learned intermediary rule keeps doctors where they should be – front and center as the primary source of patient information about medical treatment.

The rule ensures that, once a manufacturer has warned a doctor, it “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, 876 (Ohio 1991). “[F]ailure[of medical personnel] to perform their duties from that point forward do[es] not operate to create, or to extend, a manufacturer’s duty to warn third-party fam­ly members, bystanders, or any persons other than the learned intermediary.” Ellis, 311 F.3d at 1283.

One in a serious medical condition. . .as a general matter faces unwanted, unsettling and potentially harmful risks if advice, almost inevitably in­volved and longwinded, from non-physicians, contrary to what the doctor of his choice has decided should be done, must be supplied to him during the already stressful period shortly before his trip to the operating room.

Brooks v. Medtronic, Inc., 750 F.2d 1227, 1232 (4th Cir. 1984) (applying South Carolina law). Thus, manufacturers are not “advisors” to physicians during the informed consent process, Polley v. Ciba-Geigy Corp., 658 F. Supp. 420, 421 (D. Alaska 1987), nor are they responsible for how physicians conduct their business. Ellis, 311 F.3d at 1283; Prohaska v. Sofamor, S.N.C., 138 F. Supp.2d 422, 444 (W.D.N.Y. 2001).

An additional practicality consideration buttresses the Rule. “[T]he treating physician is in a better position to warn the patient than the manufacturer.” McCombs, 587 S.E.2d at 595. It’s unrealistic to depend upon pharmacies to take up the slack, as they don’t usually dispense prescription medical products to patients with full warnings. Tracy, 569 N.E.2d at 880. Thus, it’s frequently impractical, or even impossible, for manufacturers to provide direct warnings to unknown patients, particularly in a medical emergency. West, 806 S.W.2d at 613; Cunningham v. Charles Pfizer & Co., 532 P.2d 1377, 1381 (Okla. 1974); Talley v. Danek Medical, Inc., 179 F.3d 154, 163 (4th Cir. 1999) (applying Virginia law).

For these reasons, the American Law Institute – not exactly a knee-jerk pro-defense group, as some of our previous posts here, here, and here have made clear – agrees whole-heartedly with us on the learned intermediary rule. As described in the ALI’s Restatement (Third) of Torts: Products Liability, the learned intermediary rule has three factual prerequisites: (1) the claim being brought must involve “instructions or warnings”; (2) the product at issue must be available only by the “prescription” of a licensed physician, and (3) a doctor must actually be “in a position” to have an actual physician/patient relationship.

A prescription drug or medical device is not reasonably safe due to inadequate instructions or warnings if reasonable instructions or warnings regarding foreseeable risks of harm are not provided to:
(1) prescribing and other health-care providers who are in a posi­tion to reduce the risks of harm in accordance with the instructions or warnings, or
(2) the patient when the manufacturer knows or has reason to know that health-care providers will not be in a position to reduce the risks of harm in accordance with the instructions or warnings.

Restatement (Third) of Torts: Products Liability §6(d) (1998). If that’s “tepid,” Karl, 2007 W. Va. Lexis 57, at *45, we’ll take it. It’s been sufficient endorsement of the rule to convince a dozen other state supreme courts since its adoption.

Perhaps the principal justification in Karl for rejecting the learned intermediary rule is that the rule was “not a modern doctrine,” and thus was “largely outdated and unpersuasive.” 2007 W. Va. Lexis 57, at *25. The Karl court observed that the rule has “origins” going back to 1925, id., even though it goes on to state that the rule was first applied in 1948, and was not even named until 1966. Id. at *26-28 & n.11.

Sorry, but if we’re to be jettisoning as “outdated” every legal doctrine carrying this sort of pedigree, there’s not going to be very much law left.

Consider strict liability, for example. It’s “origins” go back to at least 1916 and the case of MacPherson v. Buick Motor Co., 111 N.E. 1050 (N.Y. 1916) (the one where the wheel fell off the car). “Strict liability” got its name in Greenman v. Yuba Power Products, Inc., 377 P.2d 897, 901 (Cal. 1963). Unlike the learned intermediary rule, strict liability had already been around long enough to qualify for its own section (402A) in the 1965 Restatement (Second) of Torts. Also unlike the learned intermediary rule, the ALI later found significant problems with strict liability and decided that the doctrine needed significant trimming in §2 of the Restatement (Third) of Torts.

If the learned intermediary rule is “outdated,” then strict liability is even moreso.

To criticize the learned intermediary rule as “outdated” might make more sense if the rule hadn’t been used much lately, or if there were a general trend away from it. That just hasn’t happened. The rule is as routinely followed now as in prior years. So far, in 2007 the rule has been chugging along at a clip of better than a case a month. See Ethicon Endo-Surgery, Inc. v. Meyer, ___ S.W.3d ___, 2007 WL 1095552, at *2 (Tex. App. April 12, 2007); Bodie v. Purdue Pharma LP, ___ F.3d ___, 2007 WL 1577964, at *5-6, 11 (11th Cir. June 1, 2007) (applying Alabama law); Stilwell v. Smith & Nephew, Inc., 482 F.3d 1187, 1194 (9th Cir. 2007) (applying Arizona law); In re Zyprexa Products Liability Litigation v. Eli Lilly & Co., ___ F. Supp. 2d ___, 2007 WL 1678078, at *28 (E.D.N.Y. June 11, 2007) (applying Pennsylvania, North Carolina and Florida law); Soufflas v. Zimmer, Inc., 474 F. Supp.2d 737, 751 (E.D. Pa. 2007); Madsen v. American Home Products Corp., 477 F. Supp.2d 1025, 1033 (E.D. Mo. 2007) (applying Iowa law); Cowley v. Abbott Laboratories, 476 F. Supp.2d 1053, 1060 (W.D. Wis. 2007) (applying North Carolina law); Hill v. Wyeth, Inc., 2007 WL 674251, at *3-4 (E.D. Mo. Feb. 28, 2007); Saraney v. Tap Pharmaceutical Products, 2007 WL 148845, at *6 (N.D. Ohio Jan. 16, 2007); Paparo v. Ortho McNeil Pharmaceuticals, 2007 WL 121149, at *3 (S.D. Fla. Jan. 10, 2007).

Karl states that “only” four state supreme courts have adopted the learned intermediary rule since direct-to-consumer (“DTC”) drug advertising “proliferate[ed]” in 1997. 2007 W. Va. Lexis 57, at *35 (ironically, by Karl’s own stats, DTC advertising increased almost fifty-fold before 1997 and only five-fold thereafter). However no courts – other than Karl – rejected the rule during that (or any other) period. Nor does Karl acknowledge the additional seventeen high court opinions from twelve other states that reaffirmed the learned intermediary rule during this same period. For a complete roster of high court learned intermediary rule opinions, go here.

Indeed, Karl doesn’t cite a single other opinion that outright rejects the Rule. That’s because there aren’t any – or at least weren’t any until now. Remarkably, the court relied upon the silence of the highest courts in twenty-two states (some of which are erroneously included) as precedent for rejecting the rule. 2007 W. Va. Lexis 57, at *21. The “old, outdated” law argument in Karl is such a stretch that it strikes us as more of an excuse than a justification.

The Karl majority also makes a big deal out of DTC advertising. Id. at *31-43. Why, we’re not entirely sure. We’ve read both the opinion, and the concurrence, through several times. There’s nothing in either of them to suggest that this defendant (Janssen) ever engaged in DTC advertising about this drug (Propulsid). We can’t say for sure whether it did or it didn’t, only that the court doesn’t cite any record evidence to indicate that it happened here – and it’s the kind of thing we’d expect to see mentioned if it existed.

Why should anyone care about that? Well, everyone should care because courts are supposed to be in the business of deciding cases and controversies. They’re not legislatures, and they’re not executive agencies. Courts, and particularly appellate courts, are not familiar with anything that’s outside the four corners of the record of the cases that come before them. They can’t be expected to do their own research independent of the adversarial system. The lack of any factual tie to DTC advertising in this case, suggests that it’s entirely possible that the Karl court went off on its own tangent, without benefit of adversarial briefing on the DTC subject to provide an adequate foundation for what the court said.

Maybe that’s why it reached an outcome that can’t help but bring about results wildly at odds with what the Karl court’s criticism of DTC advertising. Karl quotes a law review note, for the proposition that:

Studies show that DTC advertising generates an increased patient load and often causes physicians to spend more time reviewing the benefits and risks of a specific brand with each patient.

2007 W. Va. Lexis 57, at *37. OK – so DTC advertising gets more people in to see their doctors. Conversely, it also prompts doctors to spend more time going over risks and benefits with their better-informed patients. What’s so bad about that? Maybe it’s just us, but we’re leary of arguments taking the position that people should be kept in the dark (often by suppressing truthful advertising) for their own good.

We think it’s notable that only one other jurisdiction even recognizes an exception to the learned intermediary rule for DTC advertised products. Perez, 734 A.2d at 1256. Perez was decided eight years ago, and until now, every other state had declined to follow New Jersey down Perez’s slippery slope. Norplant, 215 F. Supp.2d at 812 (“New Jersey law is in direct conflict with the law of every other jurisdiction in the United States”); see also, Colacicco v. Apotex, Inc., 432 F. Supp.2d 514, 547 n.30 (E.D. Pa. 2006); In re Meridia Products Liability Litigation, 328 F. Supp.2d 791, 812 n.19 (N.D. Ohio 2004), aff’d, 447 F.3d 861 (6th Cir. 2006); Larkin, 153 S.W.3d at 766; Eady v. Lansford, 92 S.W.3d 57, 60-61 (Ark. 2002); Allen v. G.D. Searle & Co., 708 F. Supp. 1142, 1148 (D. Or. 1989) (rejecting similar argument before Perez was decided).

Now Karl has slid all the way down to the bottom of that slippery slope. As much as we don’t like Perez (DTC or no DTC, only doctors can make the necessary prescription decisions, and thus exercise professional medical judgment), it at least imposed a rational set of carrots and sticks – if a company engaged in DTC advertising, it faced a penalty in terms of the learned intermediary rule. Other things being equal, that penalty would tend to reduce the prevalence of such activity.

Karl did just the opposite. By abrogating the learned intermediary rule altogether – supposedly based upon its critique of DTC advertising – it virtually forces every prescription medical product manufacturer to engage (even for drugs and devices haven’t been the subject of DTC advertising before) in precisely the DTC conduct about which the decision so loudly complains. How else is a company supposed to satisfy this new duty to convey warnings about prescription medical products directly to the general public, bypassing the doctor altogether?

The answer will inevitably be more DTC advertising, not less. Drug companies aren’t stupid. They use DTC advertising because it’s an effective way to reach the public. Assuming that (like any other form of warning) a DTC drug warning must be “adequate,” the thrust of the law will essentially force manufacturers to utilize the most effective medium for reaching the public as a whole. Thus, by demanding that all prescription product manufacturers – whether or not they engage in DTC advertising – now provide DTC warnings, Karl virtually ensures the increased presence of exactly what the opinion otherwise condemns at great length.

Be careful what you ask for, you just might get it….

The final justification that Karl gave for rejecting the learned intermediary rule was that the rule comes with a “plethora” of exceptions – so many that the rule itself has “no benefit.” 2007 W. Va. Lexis 57, at *50-51. That’s just not so, and the only widely recognized exceptions to the rule are perfectly in accordance with the rule's legal prerequisites.

As the Rule is founded on the required involvement of a doctor before the product can be obtained, over-the-counter drugs available without a prescription are excluded. E.g., Pittman, 890 S.W.2d at 429; Stone v. Smith, Kline & French Laboratories, 447 So.2d 1301, 1305 (Ala. 1984); Torsiello v. Whitehall Laboratories, 398 A.2d 132, 138 (N.J. Super. App. Div. 1979); Plummer v. Lederle Laboratories, 819 F.2d 349, 355-56 (2d Cir. 1987) (applying California law); In re Rezulin Products Liability Litigation, 133 F. Supp.2d 272, 282 (S.D.N.Y. 2001) (applying Mississippi law). But OTC drugs represent a very discrete exception, easy to determine, and not one that comes up very often.

Likewise, the learned intermediary rule is inapplicable “where no individualized medical judgment intervenes between the manufacturer of a prescription drug and the ultimate consumer” – as when prescrip­tion vaccines were distributed to all comers at mass immunizations. Reyes, 498 F.2d at 1276; accord Mazur v. Merck & Co., 964 F.2d 1348, 1355 (3d Cir. 1992) (applying Pennsylvania law); Stanback v. Parke, Davis & Co., 657 F.2d 642, 647 (4th Cir. 1981) (applying Virginia law); Davis v. Wyeth Laboratories, 399 F.2d 121, 131 (9th Cir. 1968) (applying Montana law). This is also a rather limited exception. These days, how many prescription medical products are given out on a mass basis, without any doctor present to prescribe them?

The OTC and mass immunization situations are the only exceptions to the learned intermediary rule that are recognized in more than a handful of jurisdictions, and each is limited to a very specific fact pattern. As for others – well, we’ve already discussed the DTC exception being limited to New Jersey. At one time, some courts questioned the applicability of the rule to contraceptives, asserting that greater patient involvement in prescription decisions justified the tort system requiring direct-to-patient warnings. E.g., MacDonald v. Ortho Pharmaceutical Corp., 475 N.E.2d 65, 69-70 (Mass. 1985); Hill v. Searle Laboratories, 884 F.2d 1064, 1070-71 (8th Cir. 1989) (applying Arkansas law). That reasoning, however, has largely been discredited, and no jurisdiction has adopted this exception in almost twenty years:

While the physician does not make the final choice but leaves that to the patient, he advises the patient with respect to the advantages and disadvantages of various choices. . .and it is he who supplies [the product]. The fact that the patient makes the final choice among suggested contraceptives (or decides not to use any at all) does not constitute a distinction which makes the general rule inapplicable.

Terhune v. A.H. Robins Co., 577 P.2d 975, 978 (Wash. 1978). Accord, e.g., Humes, 792 P.2d at 1039-41; Martin v. Ortho Pharmaceutical Corp., 661 N.E.2d 352, 356-57 (Ill. 1996); West, 806 S.W.2d at 614 (Arkansas Supreme Court effectively overruling Hill); Lacy v. G.D. Searle & Co., 567 A.2d 398, 400-01 (Del. 1989); McKee v. Moore, 648 P.2d 21, 25 (Okla. 1982); Taylor v. Wyeth Laboratories, Inc., 362 N.W.2d 293, 297 & n.11 (Mich. App. 1984) (rejecting contrary federal court prediction of Michigan law); In re Norplant Contraceptive Products Litigation, 165 F.3d 374, 379 (5th Cir. 1999) (applying Texas law).

Another would-be exception to the rule, also typically asserted against contraceptives, would require direct patient warnings where required by FDA regulations – but far more jurisdictions have rejected this rationale than have accepted it. It was suggested in MacDonald, 475 N.E.2d at 69-71; Edwards v. Basel Pharmaceuticals, 933 P.2d 298, 303 (Okla. 1997); and Lukaszewicz v. Ortho Pharmaceutical Corp., 510 F. Supp. 961, 965 (E.D. Wis. 1981), mod., 532 F. Supp. 211 (E.D. Wis. 1981). Most courts have rejected it, finding it “puzzling” and “counterintuitive.” Norplant, 165 F.3d at 379. See West, 879 S.W.2d at 414; Lacy, 567 A.2d at 401; Martin, 661 N.E.2d at 356-57; Reaves, 765 F. Supp. at 1291; MacPherson v. Searle & Co., 775 F. Supp. 417, 425 (D.D.C. 1991); Zanzuri v. G.D. Searle & Co., 748 F. Supp 1511, 1515-16 (S.D. Fla. 1990); Spychala v. G.D. Searle & Co., 705 F. Supp. 1024, 1032-33 (D.N.J. 1988). The most recent of even the cases rejecting this exception is from 1999. It’s not even being argued anymore. This exception has fallen into the category of “a bad idea whose time has passed.”

Finally, if the learned intermediary rule really was so shot through with exceptions as to be virtually meaningless, we wouldn’t be spending so much time defending it – nor would the Karl case be considered such a big deal.

So those are the three supposed “pillars” of Karl: (1) an “outdated” rule; (2) enervated by DTC advertising; and (3) so full of exceptions as to be meaningless. As we hope we’ve demonstrated, none of them holds water.

Finally, there’s another intensely practical argument made by two justices in a concurring opinion:

Suppose Patient John Doe visits his small-town West Virginia doctor. Further suppose he is prescribed a drug by his doctor that causes him serious injury. Suppose that the drug is one that is heavily advertised. Patient Doe then sues his West Virginia doctor and the drug manufacturer for the injury caused by the drug. If this Court were to adopt the learned intermediary doctrine, the West Virginia doctor would remain in the lawsuit, but the drug manufacturer would not remain in
the suit and would not be liable for damages if the drug manufacturer could show that it warned the doctor of the risks of injury associated with the drug. Thus, a small-town West Virginia doctor would become solely responsible for the injury to Patient Doe while an out-of-state multi-million dollar drug manufacturer is off the hook. . . . This result simply would be unfair.

2007 W. Va. Lexis 57, at *55-56 (emphasis added).

Just why is this result “unfair”? The “out-of-state multi-million dollar drug manufacturer” can’t make a prescription drug that doesn’t have a significant risk of injury. If it did, the FDA wouldn’t have classified the product as a prescription drug to start with, and we wouldn’t be talking about the learned intermediary rule in the first place. So it’s not the fact that the product causes injury that makes anything unfair.

Nor is the result “unfair” due to an inadequate warning. The hypothetical provides that the doctor was warned. If the warning were inadequate, then the learned intermediary rule won’t preclude liability. If the “out-of-state multi-million dollar drug manufacturer” adequately warned the “small-town West Virginia doctor” about the inherent risks of its product, then what did it do that’s wrong?

[T]he fact that a particular drug might produce unfortunate side effects makes it “unavoidably unsafe” but not “ unreasonably dangerous”, and strict liability will not obtain if “proper warning is given, where the situation calls for it.”

Larkin, 153 S.W.3d at 761 (quoting Restatement (Second) of Torts §402A, comment k (1965)).

Suppose the “small-town West Virginia doctor” prescribed the hypothetical drug notwithstanding adequate warnings of the harm it caused his/her patient, or did so without telling the patient what could happen. Suppose there was malpractice, or perhaps a breach of that doctor’s informed consent duty. What business does the “out-of-state multi-million dollar drug manufacturer” have in the suit – except that it’s got deep pockets?

The “unfairness” being advanced as the basis for the concurrence’s hypothetical doesn’t seem tied to any tort concept of fault. Instead, the sole basis advanced for liability to an injured West Virginian is wealth (“multi-million dollar company”) and residence (“out-of-state”). To us, that attitude is not just wrongheaded but dangerous.

We think that this sort of “Robin Hood” mentality fundamentally misconstrues the proper role of courts, and indeed of the legal system as a whole. It’s perfectly proper (whether or not we out-of-staters like paying for it with our taxes) for a legislator like Senator Robert Byrd to use his or her clout to “bring home the bacon” for his constituents. That’s one of the things that legislators do.

But courts are supposed to be different. They’re supposed to be impartial – dispensers of justice, not earmarks.

It’s not just us – performing our usual role as shills for the defense – that say this. The notion of courts as the keepers of the scales of justice dates back at least to the ancient Greeks. Where the “multi-million dollar” corporation, or other “out-of-state” defendant, has not done anything wrong (that is, where it provided “adequate” warnings) it’s not a court’s job to impose what amounts to an extra-legislative tort tax in order to extract money (ultimately coming almost entirely from the pockets of other, out-of-state product users) for the benefit of local plaintiffs regardless of any concept of legal fault.

We know our clients, and we know how much they are dedicated to providing beneficial and often lifesaving products to everyone in this country. But the fact remains that they’re businesspeople as well. If the tort system prevents them from making a profit, then the goose stops laying the golden eggs. That’s exactly what happened with vaccines – until Congress intervened. It may be happening again with property insurance in some hurricane-vulnerable regions of our country. If West Virginia’s tort system ignores reality and opts for what amounts to absolute liability on our clients, then like it or not, they will inevitably have to consider whether the state’s relatively small market is worth serving. See Strahin v. Sullivan, ___ S.E.2d ___, 2007 WL 1891551, at *1 (W. Va. Feb. 21, 2007) (“West Virginia is now routinely called a ‘judicial hellhole’ with the ‘worst legal system in America’”) (Starcher, J, dissenting).

1 comment:

mdjd said...

thanks for the info regarding West Virginia. I have long suspected that the legislature in that state needs to return to the mother ship.