647 S.E.2d 899
Rather than trying to enervate the near-majority of jurisdictions that have
already adopted the doctrine, the majority should have earnestly analyzed whether any of the
rationales which underlie the doctrine remain valid today. What the majority overlooks by
emphasizing the direct marketing of drugs to consumers is that the doctrine may still serve
a useful purpose for prescription drugs that are not heavily marketed and in those
circumstances where a physician's expertise is relied upon to make the all-important
selection of which particular drug(s) to prescribe; to interpret contraindicative information;
and to interpret the myriad of warning-related information distributed by a pharmaceutical
manufacturer.
As the Kentucky Supreme Court recently recognized in Larkin v. Pfizer,
Inc.,153 S.W.3d 758 (Ky. 2004),
Three basic rationales have been articulated to support the rule. The first and best rationale is that the prescribing physician is in a superior position to impart the warning and can provide an independent medical decision as to whether use of the drug is appropriate for treatment of a particular patient. . . . The second rationale for the rule is that manufacturers lack effective means to communicate directly with each patient. . . . The third rationale for the rule is that imposing a duty to warn upon the manufacturer would unduly interfere with the physician-patient relationship.
Id. at 763-64. After essentially deciding that advertising and communication changes have
attenuated or eliminated the second rationale stated above, (See footnote 2) the majority rejected any need
for the doctrine's adoption
Notwithstanding the widespread use of marketing efforts by pharmaceutical
companies aimed at the consumer, the need for a physician's involvement in the decision to
choose a specific drug remains. Just because a warning can be printed and advertised as part
of the marketing plan for a prescription drug does not mean that a consumer, especially one
not educated in medical jargon, can digest or comprehend the significance of that warning
in a useful fashion. And, in those cases, where a physician's expertise has been relied upon
to select a specific prescription drug, the learned intermediary doctrine, with the exceptions
identified by the Restatement (Third) of Torts, is a well-recognized and reasoned approach
to resolving the issue of the adequacy of the warnings issued by a pharmaceutical company
for its product.
Both the northern and southern federal district courts for this state predicted
that this Court, when presented with the issue, would choose to adopt the learned
intermediary doctrine. See Ashworth v. Albers Medical, Inc., 395 F.Supp.2d 395 (S.D.
W.Va. 2005); Pumphrey v. C.R. Bard, Inc., 906 F.Supp. 334 (N.D. W.Va. 1995). In Ashworth, the court described the doctrine as an “'understandable exception' to the general
rule that manufacturers must warn foreseeable end users about the dangers inherent in their
products.” 395 F.Supp.2d at 407 (quoting Walls v. Alpharma USPD, Inc., 887 So.2d 881,
883-84 (Ala. 2004)). “[T]he superior role of the physician in servicing the patient's medical
needs” was one of the litany of reasons the court in Ashworth relied upon in choosing to
extend the doctrine's reach to a pharmacy. 395 F.Supp.2d at 407. In addition to citing the
accepted rationale that “the determination of whether certain medications and medical
devices should be utilized in any given case requires an individualized medical judgment
which can be made only by the patient's physician with knowledge of the patient's
characteristics,” the northern district court looked to the fact that “West Virginia generally
follows the Restatement of Law in appropriate cases.” 906 F.Supp. at 338 (citing draft
provision of Restatement of the Law Third: Torts, Product Liability).
Finding the position taken by the Restatement (Third) of Law (See footnote 3) undeserving of
adoption, the majority essentially concludes that the learned intermediary doctrine is
unworkable because it would require the need for case-by-case consideration of its
application “through developing case law” and would also present a need for recognizing
exceptions to the rule. Johnson & Johnson, ___ W.Va. at ___, ___ S.E.2d at ___, No. 33211
(filed June 27, 2007) at slip. op 29 (quoting Restatement (Third) of Torts: Products Liability § 6 cmt. e, at 149). In my opinion, the Restatement position combined with the exceptions
recognized in comment e, (See footnote 4) introduce a balanced and fair approach that would allow this state
both to adopt the doctrine and to develop rules as to its application based on the factual and
legal variations of the cases in which the doctrine was applied.
Consistent with comment e to the Restatement (Third) of Torts, I would follow
the American Institute of Law's proposal that prescription drugs which are marketed via the
mass media should be treated as a distinct category. Because government regulations
already require that these heavily-marketed drugs must include appropriate risk-related
information as part of the advertising materials, there is an established procedure for
requiring that the manufacturers of such drugs disclose pertinent warning-related information
concurrent with the marketing of these pharmaceuticals. Where the need for the doctrine's
adoption is most clear is where the drugs at issue were not the subject of a massive
advertising campaign and/or where the physician did in fact assume the role of a “learned
intermediary” in advising and recommending that the plaintiff/patient use a particular drug.
And, in the case of a defective drug, the manufacturer should always be required to advise
both the pharmacies and all the direct purchasers of the drug at issue as to the nature of the
product concerns.
Because I believe that the issue of adequate pharmaceutical warnings is one
that will largely depend on the unique circumstances of the case, I think it was unwise to
completely cast aside the learned intermediary doctrine. Furthermore, by attaching undue
importance to the effects of direct marketing, the majority downplays the continuing and
vital role that a physician plays in the decision as to which prescription drugs are appropriate
for a given patient based upon that particular individual's specific medical needs. In those
circumstances where the physician has received extensive warning material regarding the
effects of a specific drug and makes an individualized decision to prescribe that medication
based on such information, there is a valid and continuing rationale for permitting the
learned intermediary doctrine to operate. Where on the other hand, a physician advises
against the use of a specific drug and the consumer insists on a particular medication based
on his or her exposure to a massive advertising campaign for a specific drug, the need for
the doctrine's application is arguably reduced. But to presume, as the majority appears to,
that the mere presence of pharmaceutical advertising in our society relegates the role of the
physician to a mere dispensary of prescriptions is simply not true. In those cases where the
medications are prescribed in a traditional fashion with the physician carefully weighing the
advantages and disadvantages of a given drug for a patient presenting with specific concerns,
to deny on an across-the-board basis the application of the learned intermediary doctrine _
a doctrine that has been applied throughout this country for years _ seems both precipitous
and unwarranted. Accordingly, I dissent.
I am authorized to state that Justice Benjamin joins this dissenting opinion.