647 S.E.2d 899
CHIEF JUSTICE DAVIS delivered the Opinion of the Court.
JUSTICES ALBRIGHT AND BENJAMIN dissent and reserve the right to file
dissenting opinions.
JUSTICES STARCHER AND MAYNARD concur and reserve the right to file
concurring opinions.
Davis, Chief Justice:
In this action invoking the original jurisdiction of this Court in prohibition, a
drug manufacturer asks this Court to adopt the learned intermediary doctrine as an exception
to the general duty of manufacturers to warn consumers of the dangerous propensities of their
products. (See footnote 1) After thorough consideration of the learned intermediary doctrine in light of the
current state of the prescription drug industry and physician/patient relationships, we decline
to adopt this doctrine. Accordingly, the requested writ of prohibition is denied.
“In determining whether to entertain and issue the writ of
prohibition for cases not involving an absence of jurisdiction but
only where it is claimed that the lower tribunal exceeded its
legitimate powers, this Court will examine five factors: (1)
whether the party seeking the writ has no other adequate means,
such as direct appeal, to obtain the desired relief; (2) whether the
petitioner will be damaged or prejudiced in a way that is not
correctable on appeal; (3) whether the lower tribunal's order is
clearly erroneous as a matter of law; (4) whether the lower
tribunal's order is an oft repeated error or manifests persistent
disregard for either procedural or substantive law; and (5)
whether the lower tribunal's order raises new and important
problems or issues of law of first impression. These factors are
general guidelines that serve as a useful starting point for
determining whether a discretionary writ of prohibition should
issue. Although all five factors need not be satisfied, it is clear
that the third factor, the existence of clear error as a matter of
law, should be given substantial weight.” Syllabus point 4, State
ex rel. Hoover v. Berger, 199 W. Va. 12, 483 S.E.2d 12 (1996).
Syl. pt. 2, State ex rel. Caton v. Sanders, 215 W. Va. 755, 601 S.E.2d 75. See also Syl. pt.
3, id., (“'In determining whether to grant a rule to show cause in prohibition when a court is
not acting in excess of its jurisdiction, this Court will look to the adequacy of other available
remedies such as appeal and to the over-all economy of effort and money among litigants,
lawyers and courts; however, this Court will use prohibition in this discretionary way to
correct only substantial, clear-cut, legal errors plainly in contravention of a clear statutory,
constitutional, or common law mandate which may be resolved independently of any
disputed facts and only in cases where there is a high probability that the trial will be
completely reversed if the error is not corrected in advance.' Syllabus point 1, Hinkle v.
Black, 164 W. Va. 112, 262 S.E.2d 744 (1979).”). We will now proceed to apply this
standard to review the lower court's ruling.
a drug “manufacturer is excused from warning each patient who receives the product when the manufacturer properly warns the prescribing physician of the product's dangers.” See Porterfield v. Ethicon, Inc., 183 F.3d 464, 467-68 (5th Cir. 1999) (citing Alm v. Aluminum Co. of America, 717 S.W.2d 588, 591-92 (Tex. 1986)). Hence, a drug manufacturer's duty to warn consumers about the dangers of its prescription drugs extends only to the prescribing physician or healthcare provider, who acts as a “learned intermediary” between the manufacturer and the ultimate consumer and assumes responsibility for advising individual patients of the risks associated with the drug.
In re Norplant, 215 F. Supp. 2d at 803 (additional citation omitted).
Some authorities have suggested that the number of jurisdictions having
adopted the doctrine is an overwhelming majority, but those authorities have either included
lower court decisions, or have included jurisdictions where federal circuit courts applying
state law have concluded that the doctrine would be adopted. See, e.g., In re Norplant, 215
F. Supp. 2d at 806-09 (including lower state court and federal circuit court cases to conclude
that forty-eight states, District of Columbia and Puerto Rico have either applied or
recognized learned intermediary doctrine, and providing chart reflecting the same); Vitanza
v. Upjohn Co., 257 Conn. 365, 379 n.11, 778 A.2d 829, 838 n.11 (2001) (finding that forty-
four jurisdictions have adopted learned intermediary doctrine, and including lower state
courts and federal courts applying state law in that number); Larkin v. Pfizer, Inc., 153
S.W.3d 758, 768 n.4 and accompanying text (Ky. 2004) (observing that thirty-four states
have specifically adopted learned intermediary doctrine, but relying on decisions of some
lower state courts).
Our own research has yielded a markedly different result. Considering
decisions of only the highest state courts, we find that a mere twenty-one states have
expressly adopted the learned intermediary doctrine. (See footnote 6) In one additional state, North Carolina,
the doctrine has been adopted by statute. See N.C. Gen. Stat. § 99B-5(c) (1995). (See footnote 7) Thus, the
total number of jurisdictions recognizing the learned intermediary doctrine, either by decision
of the highest court or by statute, is only twenty-two.
The highest courts of six other states have either referred to the doctrine
favorably in dicta, or have adopted it in a context other than prescription drugs; but, they
have not expressly adopted it with respect to prescription drugs. (See footnote 8)
On the other hand, the highest courts of the remaining twenty-two states,
Arizona, Colorado, Idaho, Indiana, Iowa, Louisiana, Maine, Maryland, Michigan, Minnesota,
Nevada, New Hampshire, New Mexico, North Dakota, Rhode Island, South Carolina, South
Dakota, Vermont, Wisconsin, West Virginia, and Wyoming, have not adopted the learned
intermediary doctrine. Likewise, the District of Columbia Court of Appeals and the Supreme
Court of Puerto Rico have not adopted the learned intermediary doctrine. Thus, while the
doctrine is widely applied among lower courts, the number of high courts who have followed
suit and expressly adopted the doctrine, while admittedly in the majority, do not make up the overwhelming majority that has often been suggested by courts and commentators.
Among the primary justifications that have been advanced for the learned intermediary doctrine are (1) the difficulty manufacturers would encounter in attempting to provide warnings to the ultimate users of prescription drugs; (2) patients' reliance on their treating physicians' judgment in selecting appropriate prescription drugs; (3) the fact that it is physicians who exercise their professional judgment in selecting appropriate drugs; (4) the belief that physicians are in the best position to provide appropriate warnings to their patients; and (5) the concern that direct warnings to ultimate users would interfere with doctor/patient relationships. For example, the Supreme Court of Washington has explained that
[t]he reasons for this rule should be obvious. Where a product is available only on prescription or through the services of a physician, the physician acts as a “learned intermediary” between the manufacturer or seller and the patient. It is his duty to inform himself of the qualities and characteristics of those products which he prescribes for or administers to or uses on his patients, and to exercise an independent judgment, taking into account his knowledge of the patient as well as the product. The patient is expected to and, it can be presumed, does place primary reliance upon that judgment. The physician decides what facts should be told to the patient. Thus, if the product is properly labeled and carries the necessary instructions and warnings to fully apprise the physician of the proper procedures for use and the dangers involved, the manufacturer may reasonably assume that the physician will exercise the informed judgment thereby gained in conjunction with his own independent learning, in the best interest of the patient. It has also been suggested that the rule is made necessary by the fact that it is ordinarily difficult for the manufacturer to communicate directly with the consumer.
Terhune v. A. H. Robins Co., 90 Wash. 2d 9, 14, 577 P.2d 975, 978 (1978) (footnote
omitted). (See footnote 9)
We find these justifications for the learned intermediary doctrine to be largely outdated and unpersuasive. At the outset, we note that the learned intermediary doctrine is not a modern doctrine. Rather, its origins may be traced as far back as 1925.
One of the first intimations that the manufacturer's duty to the
ultimate consumer would be limited in the case of prescription
drugs is found in Hruska v. Parke, Davis & Co., 6 F.2d 536 (8th
Cir. 1925). The court, while holding that the manufacturer was
liable to the consumer despite lack of privity, stated
“The defendant deals with the public to be treated
with its preparations and drugs, not on an equal
footing, but with the understanding the public will
trust to the superior intelligence and general
knowledge of defendant, its agents and
employees, in the manufacture and preparation of
its products; also, when its compounds, drugs, and
preparations are placed on the market, that they
are safe, harmless and beneficial in use. In other
words, the public relies on the truth of such
statements employed in advertising by the
defendant, and does not seek expert advice from
others regarding the propriety of the use of the
commodities defendant has manufactured and
placed on the market.”
Id. at 538 (emphasis added). . . .
Odgers v. Ortho Pharm. Corp., 609 F. Supp. 867, 873 n.12 (E.D. Mich. 1985).
The first instance in which a court actually concluded that a manufacturer's
duty to warn was satisfied by providing warnings to a prescribing physician is the 1948 case
of Marcus v. Specific Pharms., 191 Misc. 285, 77 N.Y.S.2d 508 (N.Y. Sup. Ct. 1948). (See footnote 10) Marcus involved an action against a pharmaceutical company to recover for the death of a
thirteen-month-old child who had been administered a larger-than-recommended dose of a
prescription suppository manufactured by the defendant, Specific Pharmaceuticals, Inc. In
granting the defendant drug company's motion to dismiss the complaint, the Marcus court
stated:
[I]t is difficult to see on what basis this defendant can be liable
to plaintiff. It made no representation to plaintiff, nor did it hold
out its product to plaintiff as having any properties whatsoever.
To physicians it did make representations. And should any of
these be false it might be claimed with propriety that they were
made for the benefit of the ultimate consumers. But there is no
such claim. The sole claim is not misrepresentation or even
concealment, but a negligent failure to give adequate
information, and in some instances a failure to use adequate
means to call attention to the information given. It may be
safely conceded that these allegations would be sufficient if the
product were sold to the public generally as a drug for which no
physician's prescription was necessary. The situation alleged is
materially different. There is no reason to believe that a
physician would care to disregard his own knowledge of the
effects of drugs and hence of the quantity to be administered,
and substitute for his own judgment that of a drug manufacturer.
Nor is there any reason to expect that if a doctor did choose to
rely on the information given by the manufacturer he would
prescribe without knowing what that information was. In the
absence of any such grounds for belief there would be no
negligence.
191 Misc. at 287, 77 N.Y.S.2d at 509-10. (See footnote 11) The Marcus court clearly found significance in
the fact that no representations had been made directly to the plaintiff by the defendant drug
manufacturer. To a large degree, in a world where prescription medicine is widely
advertised, such a situation is becoming increasingly rare.
We note the lengthy history of the learned intermediary doctrine because the
very age of the doctrine requires us to pause and engage in a thorough examination, even
though the doctrine has been widely accepted. Significant changes in the drug industry have
post-dated the adoption of the learned intermediary doctrine in the majority of states in which
it is followed. We refer specifically to the initiation and intense proliferation of direct-to-
consumer advertising, along with its impact on the physician/patient relationship, and the
development of the internet as a common method of dispensing and obtaining prescription
drug information. (See footnote 12)
When the learned intermediary doctrine was developed, direct-to-consumer
advertising of prescription drugs was utterly unknown. “Historically, prescription drug
advertising in the United States was directed primarily to prescribers, who were once the sole
decision-makers when choosing prescription medications.” Francis B. Palumbo & C. Daniel
Mullins, The Development of Direct-to-Consumer Prescription Drug Advertising Regulation,
57 Food & Drug L.J., 422, 424 (2002). See also Ozlem A. Bordes, The Learned
Intermediary Doctrine and Direct-to-Consumer Advertising: Should the Pharmaceutical
Manufacturer Be Shielded from Liability?, 81 U. Det. Mercy L. Rev. 267, 274-75 (Spring
2004) (“Originally, pharmaceutical manufacturers advertised to physicians directly via
medical journals or pharmaceutical representatives. The general public was less aware of
what name brand drugs were on the market.”). As one court has aptly observed,
[o]ur medical-legal jurisprudence is based on images of health care that no longer exist. At an earlier time, medical advice was received in the doctor's office from a physician who most likely made house calls if needed. The patient usually paid a small sum of money to the doctor. Neighborhood pharmacists compounded prescribed medicines. Without being pejorative, it is safe to say that the prevailing attitude of law and medicine was that the “doctor knows best.” Logan v. Greenwich Hosp. Ass'n, 191 Conn. 282, [290,] 465 A.2d 294, 299 (1983).
Pharmaceutical manufacturers never advertised their products to patients, but rather directed all sales efforts at physicians. In this comforting setting, the law created an exception to the traditional duty of manufacturers to warn consumers directly of risks associated with the product as long as they warned health-care providers of those risks.
For good or ill, that has all changed. Medical services are
in large measure provided by managed care organizations.
Medicines are purchased in the pharmacy department of
supermarkets and often paid for by third-party providers. Drug
manufacturers now directly advertise products to consumers on
the radio, television, the Internet, billboards on public
transportation, and in magazines.
Perez v. Wyeth Labs. Inc., 161 N.J. 1, 4, 734 A.2d 1245, 1246-47 (1999).
Direct-to-consumer prescription drug advertising has been a fairly recent
development. “The first U.S. prescription drug print advertisement directed to the consumer
was issued in 1981.” Palumbo & Mullins, supra, 57 Food & Drug L.J. at 424. Thereafter,
[i]n 1997, the [Food & Drug Administration] issued draft guidelines intended to supplement the regulations regarding broadcast advertisements. These guidelines led to a rapid proliferation of a newer, more informative broadcast advertisement, allowing the manufacturers to include both the product name and indication. The guidelines recommended that drug manufacturers provide a means for consumers to obtain more information (e.g. an Internet Web page address).
Patrick Moore & Michael Newton, Prescription Drug Advertising on the Internet: A
Proposal for Regulation, 2 W. Va. J. L. & Tech. 1.1, ¶ 3 (Feb. 14, 1998) (emphasis added)
(footnote omitted). (See footnote 13) See also Palumbo & Mullins, supra, 57 Food & Drug L.J. at 423
(“[R]ecent changes . . . in the Food and Drug Administration's . . . guidance _ introduced in
1997 and finalized in 1999 _ have opened the door to a plethora of advertisements.”
(emphasis added)). (See footnote 14) Indeed, it has been observed that “drug manufacturers have spent more
money on direct-to-consumer advertising in the last few years than on advertising to
doctors.” Bordes, supra, 81 U. Det. Mercy L. Rev. at 268 (citing Paula C. Ohliger, DTC
Advertising and the Potential Liability of Manufacturers, Drug Benefit Trends, 11(8):39-40
(1999)).
Since the 1997 proliferation of drug advertising, only four high courts have
adopted the learned intermediary doctrine. See Vitanza v. Upjohn Co., 257 Conn. 365, 778
A.2d 829 (2001); McCombs v. Synthes, 277 Ga. 252, 587 S.E.2d 594 (2003); Larkin v. Pfizer,
Inc., 153 S.W.3d 758 (Ky. 2004); Freeman v. Hoffman-La Roche, Inc., 260 Neb. 552, 618
N.W.2d 827 (2000). In deciding to adopt the learned intermediary doctrine, none of those
courts gave thorough consideration to the changes that have occurred in the prescription drug
industry with respect to direct-to-consumer advertising. We, however, find such changes to
be a significant factor in deciding this issue, especially the impact direct-to-consumer
advertising has had on the physician/patient relationship. See Larkin v. Pfizer, Inc., 153
S.W.3d 758, 770-71 (Wintersheimer, J., dissenting) (“This Court should take notice of the
abundantly obvious fact that the development of direct to consumer pharmaceutical
advertising has indelibly changed the realities of physician/patient relationships. Anyone
who watches television is regularly bombarded with a variety of pharmaceutical products
which suggest that the ultimate consumer ask his physician to prescribe a particular
advertised product.”).
Opponents of direct-to-consumer advertising have made the following
arguments regarding the impact of such advertising on the physician/patient relationship:
[P]hysicians state that they are increasingly asked and pressured by their patients to prescribe drugs that the patient has seen advertised. For example, the diet drug combinations known as fen-phen was prescribed despite little hard scientific evidence of its potential side-effects. Physicians are under attack for prescribing the pills too often and too readily to inappropriate patients. Physicians argue that it is not their fault; rather, they claim pushy patients, prodded by DTC advertisements, pressed, wheedled, begged and berated them for quick treatments. . . . Physicians complain that it is impossible to compete with pharmaceutical companies' massive advertising budgets, and resign themselves to the fact that if consumers make enough noise, they will eventually relent to patient pressure.
Moreover, industry critics of DTC advertisements argue
that the advertisements distort doctor-patient relationships and
may actually increase the use of prescription drugs. They also
believe that drug advertisements are created to sell products and
thus are inadequate sources of information and poor substitutes
for medical advice. Critics also argue that the advertisements do
not discuss other medications, alternative treatments and the
wisdom of doing nothing. Furthermore, these advertisements
are unable to diagnose an ailment. All these factors may create
a misinformed patient whom the physician will have to educate.
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 and explaining formulary restrictions when patients request a brand that is outside the health plan's drug formulary. This may be a potential waste of time for both the patient and the physician, because their discussion will have little effect on formulary rules. The doctor-patient relationship may suffer when physicians must justify decisions to patients concerning which product they will prescribe. Physicians also believe that superficial and misleading advertisements create unreasonable or inappropriate patient expectations for product effectiveness and often lead patients to request inappropriate products for their medical needs.
Tamar V. Terzian, Note, Direct-to-Consumer Prescription Drug Advertising, 25 Am. J. L.
& Med. 149, 158 (1999) (footnotes omitted). See also Bordes, supra, 81 U. Det. Mercy L.
Rev. at 280-81 (“Today, doctors still argue that their relationship with patients is undermined
by direct-to-consumer advertising. They claim that patients demand a particular drug they
saw on television, or in a magazine. Additionally, the advertisements encourage lay people
to make self-diagnoses by listing symptoms and suggesting the viewer may have the
condition that the drug can treat. . . . [One doctor] says that direct-to-consumer advertising
'has created more conflict between the doctor and the patient where the doctor is seen as a
barrier to the drug the patient wants.' . . . [Another] says that if a doctor feels that the
requested prescription is not right for the patient, doctors find their credibility at issue, not
the manufacturer. She also adds that insurance companies may not cover the prescription
drug that the patient wants. The physician must then explain to the patient it is not covered
by the plan. The patient may ask the physician to petition the insurer to get the drug covered,
which can waste valuable time.” (footnotes omitted)).
In rejecting the application of the learned intermediary doctrine to drugs that
had been the subject of direct-to-consumer advertising, the Supreme Court of New Jersey
opined, and we agree, that such advertising obviates each of the premises upon which the
doctrine rests:
These premises: (1) reluctance to undermine the doctor patient-relationship; (2) absence in the era of “doctor knows best” of need for the patient's informed consent; (3) inability of drug manufacturer to communicate with patients; and (4) complexity of the subject; are all (with the possible exception of the last) absent in the direct-to-consumer advertising of prescription drugs.
First, with rare and wonderful exceptions, the “'Norman Rockwell' image of the family doctor no longer exists.” [Lars Noah, Advertising Prescription Drugs to Consumers: Assessing the Regulatory and Liability Issues, 32 Ga. L. Rev. 141, 180 n.78 (1997)] (citing Paul D. Rheingold, The Expanding Liability of the Drug Manufacturer to the Consumer, 40 Food Drug Cosm. L.J. 135, 136 (1985)). Informed consent requires a patient-based decision rather than the paternalistic approach of the 1970s. See Largey v. Rothman, 110 N.J. 204, 206, 540 A.2d 504 (1988) (discussing Canterbury v. Spence, 464 F.2d 772 (D.C. Cir.), cert. denied, 409 U.S. 1064, 93 S. Ct. 560, 34 L. Ed. 2d 518 (1972)). The decision to take a drug is “not exclusively a matter for medical judgment.” See Teresa Moran Schwartz, Consumer-Directed Prescription Drug Advertising and the Learned Intermediary Rule, 46 Food Drug Cosm. L.J. 829, 831 (1991) (citing Margaret Gilhooley, Learned Intermediaries, Prescription Drugs, and Patient Information, 30 St. Louis. U. L.J. 633, 652 (1986)).
Second, because managed care has reduced the time allotted per patient, physicians have considerably less time to inform patients of the risks and benefits of a drug. Sheryl Gay Stolberg, Faulty Warning Labels Add to Risk in Prescription Drugs, N.Y. Times, June 4, 1999, at A27. “In a 1997 survey of 1,000 patients, the F.D.A. found that only one-third had received information from their doctors about the dangerous side effects of drugs they were taking.” Ibid.
Third, having spent $1.3 billion on advertising in 1998, supra at 12-13, 734 A.2d at 1251-52, drug manufacturers can hardly be said to “lack effective means to communicate directly with patients,” Noah, supra, 32 Ga. L. Rev. at 158, when their advertising campaigns can pay off in close to billions in dividends.
Consumer-directed advertising of pharmaceuticals thus belies each of the premises on which the learned intermediary doctrine rests.
First, the fact that manufacturers are advertising their drugs and devices to consumers suggests that consumers are active participants in their health care decisions, invalidating the concept that it is the doctor, not the patient, who decides whether a drug or device should be used. Second, it is illogical that requiring manufacturers to provide direct warnings to a consumer will undermine the patient-physician relationship, when, by its very nature, consumer-directed advertising encroaches on that relationship by encouraging consumers to ask for advertised products by name. Finally, consumer-directed advertising rebuts the notion that prescription drugs and devices and their potential adverse effects are too complex to be effectively communicated to lay consumers. Because the FDA requires that prescription drug and device advertising carry warnings, the consumer may reasonably presume that the advertiser guarantees the adequacy of its warnings. Thus, the common law duty to warn the ultimate consumer should apply.
[Susan A. Casey, Comment, Laying an Old Doctrine to Rest: Challenging the Wisdom of the Learned Intermediary Doctrine, 19 Wm. Mitchell L. Rev. 931, 956 (1993) (footnotes omitted).]
When all of its premises are absent, as when direct warnings to consumers are mandatory, the learned intermediary doctrine, “itself an exception to the manufacturer's traditional duty to warn consumers directly of the risk associated with any product, simply drops out of the calculus, leaving the duty of the manufacturer to be determined in accordance with general principles of tort law.” Edwards v. Basel Pharms., 116 F.3d 1341, 1343 (10th Cir. 1997) (discussing question of adequacy of nicotine patch warning under Texas law certified in Edwards v. Basel Pharms., 933 P.2d 298 (Okla.1997)). . . .
Perez v. Wyeth Labs. Inc., 161 N.J. 1, 18-19, 734 A.2d 1245, 1255-56. See also Patrick
Cohoon, Comment, An Answer to the Question Why the Time Has Come to Abrogate the
Learned Intermediary Rule in the Case of Direct-to-Consumer Advertising of Prescription
Drugs, 42 S. Tex. L. Rev. 1333, 1356-60 (Fall 2001) (explaining how each of the bases for
the learned intermediary doctrine no longer exist in light of direct-to-consumer advertising).
Many jurisdictions have addressed the shortcomings of the learned
intermediary doctrine by developing various exceptions.
[C]ourts have recognized exceptions [to the learned
intermediary doctrine] regarding: (1) vaccine inoculations; Davis v. Wyeth Laboratories, Inc., [399 F.2d 121, 131 (9th Cir.
1968)]; (2) oral contraceptives; MacDonald v. Ortho
Pharmaceutical Corp., 394 Mass. 131, 135-36, 475 N.E.2d 65,
cert. denied, 474 U.S. 920, 106 S. Ct. 250, 88 L. Ed. 2d 258
(1985); (3) contraceptive devices; Hill v. Searle Laboratories,
[884 F.2d 1064, 1070-71 (8th Cir. 1989)]; (4) drugs advertised
directly to consumers; Perez v. Wyeth Laboratories, Inc., [161
N.J. 1, 21, 734 A.2d 1245, 1257 (1999)]; (5) overpromoted
drugs; Proctor v. Davis, 291 Ill. App. 3d 265, 279-84, 225
Ill. Dec. 126, [136-40,] 682 N.E.2d 1203, [1212-16,] cert.
denied, 175 Ill. 2d 553, 228 Ill. Dec. 725, 689 N.E.2d 1146
(1997); and (6) drugs withdrawn from the market; Nichols v.
McNeilab, Inc., 850 F. Supp. 562, 565 ([E.D.] Mich. 1993).
Vitanza v. Upjohn Co., 257 Conn. at 393, 778 A.2d at 846-47. See also Bordes, supra, 81
U. Det. Mercy L. Rev. at 270-74 (discussing exceptions to learned intermediary doctrine).
Even the version of the learned intermediary doctrine contained in the
Restatement (Third) of Torts incorporates the foregoing exceptions by including a general
exception to cover those circumstances where the manufacturer knows or should know that
a physician will not be in a position to provide an adequate warning:
(d) 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), at 145 (1998). (See footnote 15) In Comment e to §6, the American Law Institute discusses some circumstances under which direct warnings to patients may be warranted under subsection 6(d)(2). (See footnote 16) Ultimately, though, the Institute commented that it “leaves to developing case law whether exceptions to the learned intermediary rule in these or other situations should be recognized.” Restatement (Third) of Torts: Products Liability § 6 cmt. e, at 149. It has been observed that, “[o]ne commentator described the Restatement's approach as a 'tepid endorsement' of the learned intermediary doctrine.” Perez v. Wyeth Labs. Inc., 161 N.J. at 14-15, 734 A.2d at 1253 (quoting Charles J. Walsh et al., The Learned Intermediary Doctrine: The Correct Prescription for Drug Labeling, 48 Rutgers L. Rev. 821, 869 (1994)). (See footnote 17)
Given the plethora of exceptions to the learned intermediary doctrine, we ascertain no benefit in adopting a doctrine that would require the simultaneous adoption of numerous exceptions in order to be justly utilized. This is particularly so when our existing law of comparative contribution among joint tortfeasors is adequate to address issues of liability among physicians and drug companies in those cases where patients sue for injuries related to the use of prescription drugs. (See footnote 18)
Furthermore, we believe that if drug manufacturers are able to adequately
provide warnings to consumers under the numerous exceptions to the learned intermediary
doctrine, then they should experience no substantial impediment to providing adequate
warnings to consumers in general. “There is no question that pharmaceutical manufacturers
believe they have very effective methods to communicate directly with consumers.” Larkin
v. Pfizer, Inc., 153 S.W.3d at 771 (Wintersheimer, J., dissenting).
Finally, because it is the prescription drug manufacturers who benefit
financially from the sales of prescription drugs and possess the knowledge regarding
potential harms, and the ultimate consumers who bear the significant health risks of using
those drugs, it is not unreasonable that prescription drug manufacturers should provide
appropriate warnings to the ultimate users of their products.
Public policy dictates that the manufacturer should warn the
ultimate user of the harmful effects of its pharmaceuticals since
it involves a person's health. The knowledge of pharmaceutical
side effects goes well beyond the scope of the average
individual. The benefit in warning the consumer directly is far
outweighed by the costs. It is not as though the manufacturer
must incur costs to discover the risks as they are already known.
It is only a matter of adding the consumer to the list of who to
warn. . . .
. . . Since the early 1980's, direct-to-consumer
advertising has boomed into a very profitable venture for
pharmaceutical manufacturers. Yet, consumers' exposure to
harm has increased as a result. They are surrounded by various
prescription advertisements in all forms of print and broadcast
media. Advertisements directed to consumers, however, often
supply partial or incomplete information. Additionally,
self-diagnosis by the consumer has resulted from these
advertisements, as well as patient-demand for the brand-name
drugs. It is in the best interest of the general public that
manufacturers have a duty to warn the ultimate user of side
effects and risks. Courts are increasingly motivated to protect
the consumer, and require manufacturers to warn more than just
the physician.
. . . .
Pharmaceutical manufacturers spend millions to make
millions more. They are pushing their products onto the general
public like never before. Consequently, consumers need more
protection. As a response to the changing times, courts have
diminished the manufacturer's shield of the learned intermediary
doctrine. They have imposed a duty to warn the consumer in
addition to the physician. In doing so, the goal of product
liability to protect the ultimate user from harm, is more
attainable. In the end, the burden should be on the one
producing health care, not the one consuming it.
Bordes, supra, 81 U. Det. Mercy L. Rev. at 286-87 (emphasis added). West Virginia
physicians naturally have duties and responsibilities regarding their role in providing
prescription medicines to consumers. It would be unreasonable not to require the
manufacturers of those medicines to accept similar responsibilities.
Based upon the foregoing, we now hold that, under West Virginia products
liability law, manufacturers of prescription drugs are subject to the same duty to warn
consumers about the risks of their products as other manufacturers. We decline to adopt the
learned intermediary exception to this general rule.
[e]xisting West Virginia law permits the full development
of the claims and defenses as to the adequacy and method of
communicating warnings without adopting the Learned
Intermediary Doctrine.
. . . .
West Virginia's law as to comparative contribution
among tortfeasors will adequately address the issues of warnings
as between the manufacturer and Dr. Wilson, without adopting
a legal concept not yet embraced by the West Virginia Supreme
Court of Appeals.
We agree with the circuit court's conclusions and find no grounds upon which to grant the
requested writ of prohibition. Accordingly, Janssen's petition for writ of prohibition is
denied.