Source: https://www.druganddevicelawblog.com/2007/07/in-defense-of-learned-intermediary-rule.html
Timestamp: 2019-04-25 03:48:37+00:00

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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.
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.
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.
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.
(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.
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.
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.
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?
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).

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