failing to warn in the context of rare side effects Download

Morris Dweck*
The act of Choice that can be determined by pure Reason, constitutes the act of Free-will. That act which is determinable only by
Inclination as a sensuous impulse or stimulus would be irrational
brute Choice (arbitriumbrutum).... The Freedom of the act of volitional Choice, is its independence of being determined by sensuous
impulses or stimuli. This forms the negative conception of the Freewill. The positive Conception of Freedom is given by the fact that the
Will is the capability of Pure Reason to be practical of itself.'
INTRODUCTION ..............................................
Balancing the Risks and the Benefits ..............
The General Duty to Warn .....................
i. Rarity of Occurrence and the Duty to Warn...
ii. Adverse Reaction Reports .....................
A. Exceptions to the Learned Intermediary Doctrine .....
III. A DOCTOR'S DUTY TO WARN ........................
A. The Standardof Review in the Medical Profession.... 440
i. The New York Standard ...................
B. Plaintiffs Burden of Proofin an Informed Consent
...... 442
RARE SIDE EFFECTS ..................................
A. The Affect Heuristic ...............................
B. The StatisticalLiability Scale....................... 453
CONCLUSION .................................................
* J.D. Candidate, 2014, Benjamin N. Cardozo School of Law; Notes Editor, Cardozo Public Law, Policy & Ethics journal; B.A., 2010, Macaulay Honors College, Brooklyn College.
Thank you to Professor Ekow Yankah for his guidance in writing this Note.
PRINCIPLES OF JURISPRUDENCE AS THE SCIENCE OF RIGHT 13, (William Hastie trans., Edinburgh, T. & T. Clark 1887), available at FakeAQAAMAAJ
[Vol. 12:423
Combining the multidimensionality of modern medicine with the
sophistication of the human body it is amazing that basic medical training is only four years. However, after four years of medical school, a
physician cannot practice on her own before completing years of residency. The amount of training attests to the complexity of the profession. Due in part to this complexity and sophistication, one of a
physician's primary roles is to explain the intricacies involved to her
patients to allow them to make informed decisions. A physician acts as
the bridge between the sophistication of medical knowledge and an informative yet simple disclosure delivered to a patient. As the middleman, a physician is in the best position to weed out the overly
cumbersome details involved in medical treatments and side effects and
deliver to a patient a readily digestible account of the disease and its
Even if a physician could disclose the entirety of information about
the risks and benefits associated with different treatments, such a comprehensive disclosure would not necessarily promote patient self-determination.2 Prescription drugs are commonly associated with a "legion
of potential side effects, many being of low incidence or highly technical
in nature." 3 For example, requiring a doctor to warn a patient about the
approximately 180 potential adverse events listed in the physician package insert for Videx, an HIV therapy, would be far from informative or
beneficial. On the contrary, it would likely confound and complicate a
patient's decision.' It would be similarly burdensome to list the risks
from having blood drawn; as the California Supreme Court described
"the risks . . . are said to include hematoma, dermatitis, cellulitis, ab-
scess, osteomyelitis, septicemia, endocarditis, thrombophlebitis, pulmonary embolism and death, to mention a few." 6 Yet, it is clear that a
2 Lars Noah, Informed Consent and the Elusive Dichotomy Between Standardand Experimental Therapy, 28 Am. J.L. & MED. 361, 367 (2002); see also Canterbury v. Spence, 464 F.2d 772,
786 (D.C. Cir. 1972) ("It seems obviously prohibitive and unrealistic to expect physicians to
discuss with their patients every risk of proposed treatment-no matter how small or remote-and
generally unnecessary from the patient's viewpoint as well. Indeed, the cases speaking in terms of
"full" disclosure appear to envision something less than total disclosure, leaving unanswered the
question of just how much.").
3 Nancy K. Plant, The Learned Intermediary Doctrine: Some New Medicine for an Old Ailment, 81 IoWA L. REv. 1007, 1039 (1996).
4 Id.
5 Id.
6 Cobbs v. Grant, 8 Cal.3d 229, 244 n.2 (1972).
doctor must provide her patients with information regarding their treatment so that patients can make informed decisions.
Notwithstanding that full disclosure is not required, courts have
failed to detail clear limits on what must be disclosed; rather the determination is made on a case-by-case basis.7 Consequently, from a theoretical perspective, "no physician can absolutely avoid liability under the
informed consent laws unless she discloses every known risk."8 As the
California Supreme Court stated, a physician "cannot know with certainty whether a consent is valid until a lawsuit has been filed and
In clearly delineating the bounds of a legally required disclosure, a
patient can be given the best chance to make an informed decision.
Dedication to securing informed consent reflects a commitment to patient autonomy and self-determination.10 As a person, a man or woman
is not to be valued merely as a means, but as ends in themselves, exalted
above any price." Informed consent allows people to exist as ends in
making their own medical decisions; empowering patients with freedom
to choose the treatment they see fit. In addition to the philosophical
import, a clear delineation of the bounds of informed consent can aid in
the reduction of litigation and the expenses that come with it by reducing insurance premiums. Reducing litigation in the field of medical
malpractice is a significant goal in keeping health care costs manageable.
Given the importance of supporting patient autonomy the question becomes how far must a physician go in informing her patients? A
clear demarcation must be drawn between useful and harmful information; between too much and too little information; between information
that a physician has a legal duty to disclose and information a physician
may use her discretion in disclosing. The specific question this Note
will look to answer is must a physician inform a patient of a drug's side
effects where the chance of occurrence is extremely rare? Having delved
into the area of uncommon side effects, this note will argue that due to
the existence of a number of statistical biases, a statistical liability scale
should be created. The scale would create a liability boundary: the failJon F. Merz, An EmpiricalAnalysis of the Medical Infrrmed Consent Doctrine: The Search
for a "Standard"of Disclosure, 2 RISK 27, 42 (1991).
8 Id.
9 Moore v. Regents of the Univ. of Cal., 51 Cal.3d 120, 165 n.41 (1990).
10 Noah, supra note 2, at 364.
11 IMMANUEL KANT, THE METAPHYSICS OF MoImLs 223, 237-38, 434-35 (Mary Gregor
trans., Cambridge Univ. Press 1991) (1797).
V 12:423
ure to warn of risks falling below the boundary being non-actionable
against a doctor under a claim of lack of informed consent.
This Note will follow the progression of a drug from a manufacturer to a patient and discuss the duties owed along the way. 1 2 Part I of
this Note will discuss the extent of a drug manufacturer's duty to disclose risks. In Part II this Note will discuss the Learned Intermediary
Doctrine in how a doctor acts as the medium between a drug manufacturer and a patient. Part III will deal with a physician's general duty to
warn. Part IV will discuss the current case law regarding a doctor's duty
to relate the rare side effects of a drug to her patient's. Part V of this
Note will briefly take up the difficulties encountered in understanding
statistics on the rarity of side effects and propose a legal baseline under
which a doctor should not be liable for failing to warn her patients.
Balancingthe Risks and the Benefits
Legal scholars have long recognized that the law of civil liability for
the sale of defective or mislabeled prescription medications presented a
policy tension.13 On the one hand, courts have placed the fullest liability exposure upon manufacturers and sellers, the goal being to protect
unassuming patients from the subtle dangers of defective drugs that can
often be lethal. 1 4 On the other hand, courts and legislatures have taken
an extraordinarily careful and protective approach in crafting liability
rules associated with the sale of prescription products in order to get
them to the market in a timely fashion.1 5 Lawmakers recognized that
certain treatments carry with them an inherent danger, but the benefits
may outweigh the risks involved in these treatments.' In many states,
this legal attentiveness in crafting liability rules has taken the form of a
negligence safe harbor for drug manufacturers that have developed and
produced products that are sold in as safe a condition as scientific and
12 This comprehensive approach has been chosen in order to show the problems with the
current system. Currently, drug manufacturers are required to warn of more risks than doctors.
Though a doctor need not warn of all the risks provided by the drug manufacturer, the potential
for liability in failing to warn for any of these risks still exists. It is thus important to study
exactly which risks a drug manufacturer is required to provide. Merz, supra note 7, at 41-42.
M. Stuart Madden, The EnduringParadoxofProducts Liability Law Relating to Prescription
Pharnaceuticals,21 PACE L. REv. 313, 314 (2001).
15 Id
medical knowledge permits.17 This negligence standard is comparatively relaxed when weighed against the strict liability standard applied
to other products.
In order to market inherently dangerous drugs19 while at the same
time keep the public safe and informed, a manufacturer's liability, if
any, is directly related to the adequacy of the warning it provides. 2 0 The
extent of the warning becomes the key factor in a drug products liability
suit because prescription drugs are inescapably unsafe products.2 1 As
explained in the Second Restatement of Torts (hereinafter "Restatement"), when an inherently unsafe product is properly prepared and
accompanied by appropriate directions and warnings, it is not defective,
nor is it unduly dangerous.2 2 Medical research and knowledge justifies
the marketing and use of prescription drugs despite their inherent risk
may sometimes be lethal.2 3 A drug manufacturer should not be held
strictly liable for unfortunate results that are an intrinsic part of a drug's
use. 2 4
It is readily apparent that the application of a strict products liability standard, like that of § 402A of the Restatement, to prescription
drugs would create a number of tensions between health and liability
17 Id.
19 Drugs are generally considered inherently dangerous because of the inevitability of side
effects, which are not readily ascertainable to the common consumer. However, when the risks
of marketed drugs are outweighed by their benefits the drugs are determined to be of value to
the general community. Wolfgruber v. Upjohn Co., 72 A.D.2d 59, 61 (App. Div. 4th Dept.
1979), affd, 52 N.Y.2d 768 (1980).
20 Id
§ 402A cmt. k (1979).
The risks and benefits of prescription drugs must be weighed against each other. Even
where a drug has a potential lethal side effect, its benefits may outweigh its risks depending upon
the rate of occurrence or conditions under which it is prescribed (possibly being a measure of last
resort). A good example is:
[T]he vaccine for the Pasteur treatment of rabies, which not uncommonly leads to
very serious and damaging consequences when it is injected. Since the disease itself
invariably leads to a dreadful death, both the marketing and the use of the vaccine are
fully justified, notwithstanding the unavoidable high degree of risk which they
Militrano ex rel. Militrano v. Lederle Labs, a Div. of Am. Cyanamid Co., 3 Misc. 3d 523, 529
(Sup. Ct. 2003), afd sub nom., Militrano v. Lederle Labs., 26 A.D.3d 475 (2d Dept. 2006).
24 RESTATEMENT (SECOND) OF TORTs § 402A cmt. k (1979). Once it is generally determined that a drug's benefits outweigh its risks as long as the prescribing physician administers
the drug under the proper conditions and a patient is fully informed, the patient takes the drug
subject to its known risks.
policy.2 5 First of all, there is general societal recognition of the public
health benefit in bringing potentially life-saving prescription drugs to
the market as expeditiously as possible, while giving proper consideration to their relative safety. 26 The policy importance placed on the development and marketing of new drugs "of which the use is attended by
an irreducible element of known or knowable risks, might be, in some
degree, thwarted by a strict liability rule that could have the consequence of making pharmaceutical manufacturers less likely to push for
early introduction and marketing of important new drugs." 2 7 Second,
because a strict liability rule would create a potentially greater breadth of
liability exposure than would fault-based liability, it could have an instantaneous and detrimental effect on the ability of drug manufacturers
to obtain affordable third-party liability insurance coverage.2 8 A third
reason is that manufacturers of many other products can evaluate the
engineering efficacy and the financial viability of alternative and potentially safer product designs. 2 9 However, in the context of prescription
drugs, a drug that is designed differently is no longer the same drug, but
rather a new one with new properties.3 0 Thus, the precautionary measures a manufacturer might undertake to reduce the risks of liability are
severely hampered, and the plaintiffs conventional prima facie showing
of an alternative feasible design is nearly impossible.
That being said, the duties of a drug manufacturer are far reaching,
for, at their ultimate end, they are focused on keeping patients safe and
informed. Without adequate warnings accompanying prescription
drugs they may be considered unreasonably dangerous and unsafe by
legal standards. 3 2 For this reason, the duty of a drug manufacturer is
bifurcated. The manufacturer of a prescription drug has a duty to warn
of all potential dangers, which it knows or should know, and a duty to
take such steps as are reasonably necessary to bring that knowledge to
Madden, supra note 13, at 318.
Madden, supra note 13, at 318-19.
Kirk v. Michael Reese Hosp. & Med. Ctr., 117 Ill. 2d 507, 517 (1987).
the attention of the medical profession.33 At focus in this Part is the
first of those duties, the duty to warn of all potential dangers.
The General Duty to Warn
The preparation for the duty to warn of all potential dangers begins with extensive premarket testing before a drug ever hits the market.35 As codified in the United States Code, new drugs require full
reports of investigation, which show whether or not they are safe and
effective.3 6 Once a drug is released to the public there is a continuing
duty upon a drug manufacturer to "keep abreast of knowledge of its
products through research, adverse reaction reports, scientific literature
and other available methods."3 7 Information discovered relating to a
drug's effects must be incorporated into its warning.3 8 Even a single
letter reporting an adverse event may be offered as evidence of a drug
33 Glucksman v. Halsey Drug Co., Inc., 160 A.D.2d 305, 307 (1990); see also Baker v. St.
Agnes Hosp., 70 A.D.2d 400, 406 (App. Div. 2d Dept. 1979) ("[T]he continuing obligation of
a drug manufacturer is two-fold. First, it must keep abreast of knowledge of its products as
gained through research, adverse reaction reports, scientific literature and other available methods. Second, and equally important, it must take such steps as are reasonably necessary to bring
that knowledge to the attention of the medical profession.").
34 The duty of a drug manufacturer to take such steps as are reasonably necessary to bring a
drug's hazards to the attention of the medical profession will not be discussed in this Note.
35 Kathleen H. Wilson, The Liability of PharmaceuticalManufacturersfor Unforeseen Adverse
Drug Reactions, 49 FoRDAM L. REv. 735, 749 (1981), available at http://ir.lawnet.fordham
36 21 U.S.C.A. § 355 (West 2013) ("No person shall introduce or deliver for introduction
into interstate commerce any new drug, unless . . . full reports of investigations [ ] have been
made to show whether or not such drug is safe for use and whether such drug is effective in
use."); see also Miller v. Pfizer Inc. (Roerig Div.), 196 F. Supp. 2d 1095, 1102 (D. Kan. 2002),
affd sub nom., Miller v. Pfizer, Inc., 356 F.3d 1326 (10th Cit. 2004) ("The FDA must reject a
NDA for particular use if it 'do[es] not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof; . . . the results of such tests show that the
drug is unsafe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof; . . . or . . . [the] labeling is false or misleading in any particular.'"
(quoting 21 U.S.C. § 355(d)).
37 Baker v. St. Agnes Hosp., 70 A.D.2d 400, 406 (App. Div. 2d Dept.1979). McEwen v.
Ortho Pharm. Corp., 270 Or. 375 (1974) discusses the continuous duty of a drug company.
The court described the drug manufacturer "as an expert in its particular field, and is under a
continuous duty to keep abreast of scientific developments touching upon the manufacturer's
product and to notify the medical profession of any additional side effects discovered from its
use." McEwen, 270 Or., at 386 (internal quotations omitted).
38 See Schenebeck v. Sterling Drug, Inc., 423 F.2d 919, 922 (8th Cir. 1970) (stating that
drug manufacturers have a "continuous duty cast upon the manufacturer of an ethical drug to
warn physicians of the dangers incident to prescribing the drug, to keep abreast of scientific
[Vol. 12:423
manufacturer's knowledge of a side effect.39 A manufacturer of prescription drugs "may be charged with the duty to warn even if the exact
nature of the adverse reaction is unknown."40
Still, a drug manufacturer's duty to warn corresponds not only
with its actual knowledge but also with its constructive knowledge as
measured by scientific literature and medical journals.4 Because of the
responsibility to be up to date on the latest medical knowledge, liability
may be imposed upon a manufacturer for information it was not aware
of but had a duty to be aware of.
Rarity of Occurrence and the Duty to Warn
It is clear that the scope of a drug manufacturer's duty is extensive.
But as one tries to define the edge of this duty, the line begins to blur.
As discussed in the introduction above, the proper balance must be
struck in warning patients in order to promote their ability to make
informed decisions. The frequency of occurrence is an important factor
in finding this balance. Where a side effect is very common it is an
obvious concern for a patient and consequently there is an obvious duty
to warn. With increasing rarity of occurrence comes the question of
whether there should exist a duty to disclose and liability for the failure
to disclose.
In the case of a drug manufacturer, liability may be incurred even
where in actuality the chance of occurrence of an adverse reaction is very
small or where causation has not been previously scientifically proven.
In Givens v. Lederle, a mother developed polio after a pediatrician administered the polio vaccine to her daughter.4 2 Lederle, the manufacturer of Sabin oral polio vaccine, was charged with the duty to warn
even though authorities estimated the risk of contracting polio from the
vaccine to be no more than one in three million.4 3 Additionally, it
could not be definitely established that any such case was due to the
vaccine strain and was not coincidental with infection due to naturally
occurring poliomyelitis.
developments touching upon the manufacturer's product and to notify the medical profession of
any additional side effects discovered from its use.").
39 Wilson, supra note 35.
McEwen, 270 Or. at 386.
Givens v. Lederle, 556 F.2d 1341, 1343 (5th Cir. 1977).
43 Id. at 1345.
The appellate court in New York has reached a similar holding. In
Bukowski v. CooperVision Incorporated,5 the court held that whether the
manufacturer was required to warn of a rare side effect was a question
for the jury. The defendant argued it had no duty to warn because the
risk of corneal ulceration was unknown or believed to be insignificant
prior to plaintiffs injury. 6 The defendant introduced evidence that the
reported incidence of corneal ulcers in the general population of contact
lens users was less than /1000% (or 1 out of 100,000)."
The court held:
[S]uch proof is insufficient to meet defendant's initial burden on the
motion for summary judgment. However, assuming such proof was
sufficient, the clinical reports, adverse effect abstracts and internal correspondence submitted by plaintiff in opposition to defendant's motion were sufficient to raise a question of fact as to whether defendant
knew or should have known of the risk that corneal ulcers posed for
extended wear contact lens users.4 8
In effect, the appellate division in Bukowski held that whether or not
there was a duty to warn of a side effect with an incidence of one out of
100,000 was a question for the jury, and not one properly dismissed by
summary judgment.
In the context of rare side effects it is obvious that not all side
effects were created equally. Common sense as well as the law dictates
that the greater the potential hazard of a drug the more extensive a manufacturer's efforts to make that hazard known to the medical profession
must be.49 In Reyes v. Wyeth Laboratories,50 defendant marketed and
produced trivalent oral polio vaccine. The court noted:
Bukowski v. CooperVision Inc., 185 A.D.2d 31 (App. Div. 3rd Dept. 1993).
Id. at 33.
Id. at 33-34 (citations omitted).
49 "It is basic that a warning must be commensurate with the risk involved in the ordinary
use of the product." Martin v. Hacker, 83 N.Y.2d 1, 11 (1993); see also Baker v. St. Agnes
Hosp., 70 A.D.2d 400, 407 (App. Div. 2d Dept. 1979) ("The potential danger of Dicumarol is
extremely grave. It can cause the death of a fetus in utero and can leave a newborn with severe
and lifelong injury. In view of the seriousness of these hazards, we decline to hold that, as a
matter of law, Lilly's decision to limit its warning to its package inserts was reasonable and
therefore sufficient.").
50 Reyes v. Wyeth Labs., 498 F.2d 1264 (5th Cir. 1974), cert. denied (1974), 419 U.S.
[Vol. 12:423
When . .. the risk qualitatively (e.g., death or major disability) as well
as quantitatively, on balance with the end sought to be achieved, is
such as to call for a true choice judgment, medical or personal, the
warning must be given."1
In spite of the fact that the court in Reyes classified the quantitative risk
as "minute," because the qualitative risk was great the court concluded
that defendant owed a duty to warn. 5 2 On a similar note, once the
potential hazard is fatal, a warning is required according to the Code of
Federal Regulations.53
However, where there is clearly no evidence of scientific proof, the
Appellate Division, First Department, has held that there can be no
failure to warn on behalf of the manufacturer.14 In Heckstall v. Pincus55
a patient died after ingesting Bupropion, a prescribed smoking cessation
aid. 56 The affidavits of defendants' experts showed that there was no
evidence whatsoever that Bupropion causes arrhythmia or can aggravate
coronary artery disease. 57 The court held that such evidence warranted
the granting of summary judgment in favor of defendants unless plaintiff submitted scientific evidence sufficient to raise an issue of fact as to
whether plaintiffs theory of causation had gained general acceptance in
the scientific community." Reports of adverse cardiovascular effects
found in the Canadian Adverse Drug Reaction Letter, reports from the
British Regulatory Body Medicines Control Agency, and reports from
the Center for Drug Evaluation and Research for the improved Bupropion package insert were classified by the court as unverified listings and
reporting of adverse reactions. 5 9 The court noted that such observational studies and case reports are not generally accepted in the scientific
community on questions of causation.6 0 Based solely on such evidence,
the defendant owed no duty to warn.
Id. at 1294 (quoting Davis v. Wyeth Labs. Inc., 399 F.2d 121, 129-130 (9th Cir. 1968)).
Reyes, 498 F.2d at 1294 ("Here, the qualitative risk was great, the quantitative risk
53 21 C.F.R. § 2 01. 8 0(g)(3) (2013) ("The 'Warnings' section of the labeling or, if appropriate, the 'Contraindications' section of the labeling shall identify any potentially fatal adverse
54 Heckstall v. Pincus, 19 A.D.3d 203, 205 (App. Div. 1st Dept. 2005).
Id. at 203.
Id. at 205.
60 Heckstall v. Pincus, 19 A.D.3d 203, 205 (App. Div. 1st Dept. 2005).
In any case, it is important to keep in mind that the manufacturer's
duty to warn is owed to the medical community, and not directly to the
patient."1 Accordingly, a manufacturer can protect itself from a failureto-warn claim by showing that it adequately informed physicians of the
risk associated with a prescription drug.62 If a manufacturer satisfies this
duty, it can then rely on the prescribing physician to pass along the
warning to consumers. In this way a physician is able to aid a patient
in making an informed choice. ,6 5 Again, recognizing that: (1) the
duty of a manufacturer is so extensive; (2) that a physician's duty should
not be as extensive, and; (3) that a physician is on notice of all the risks
furnished to her by a drug manufacturer, it is all the more important to
clearly delineate which risks a physician may be held liable for in failing
to warn.66
Adverse Reaction Reports
As a bit of a side point, this section will define the term Adverse
Reaction Reports. As mentioned above the court in Baker held that a
drug manufacturer must keep abreast of knowledge of its products as
discovered through "adverse reaction reports."6 7 The term "adverse reaction reports" needs a precise definition in order to clearly demarcate
Glucksman v. Halsey Drug Co., Inc., 160 A.D.2d 305, 307 (App. Div. 1st Dept. 1990)
("Where the warning given to the physician, through the Physician's Desk Reference, and
through package inserts and/or other literature, gives specific detailed information on the risks of
the drug, the manufacturer may be absolved from liability."); see also Andre v. Mecta Corp., 186
A.D.2d 1 (App. Div. 1st Dept. 1992) (holding that the physician's role as a responsible intermediary broke the chain of proximate cause and insulated defendant drug manufacturer from liability to plaintiff); Wolfgruber v. Upjohn Co., 72 A.D.2d 59, 61-62 (App. Div. 4th Dept. 1979),
affd, 52 N.Y.2d 768 (1980) ("Where the warning given to the prescribing physician by the
manufacturer through the Physician's Desk Reference (PDR), package inserts and other literature gives specific detailed information on the risks of the drug, the manufacturer has been held
absolved from liability as a matter of law.").
62 Stephens v. Hook-SupeRx, 359 F. App'x 648, 649 (7th Cit. 2009).
Schenebeck v. Sterling Drug, Inc., 423 F.2d 919, 922 (8th Cir. 1970).
It should be noted that the duty of a manufacturer is not congruent to that of a prescribing physician, but does constitute an important part of a prescribing physician's decision. All of
the information that a drug manufacturer furnishes to a prescribing physician becomes part of
the basis for the physician. The physician must then decide what information to pass on to her
patient, as discussed in the following Parts.
66 Michael Imbroscio & Gabriel Bell, Adequate Drug Warnings in the Face of Uncertain Causality: The LearnedIntermediary Doctrine and the Needfor Clarity, 107 W. VA. L. REV. 847, 849
67 Baker v. St. Agnes Hosp., 70 A.D.2d 400, 406 (App. Div. 2d Dept. 1979).
[Vol. 12:423
between occurrences that are rare enough to not require inclusion in
drug warnings and those that are rare but nonetheless require listing in
drug warnings. 8
The meaning of the term as used by the court in Baker is somewhat ambiguous. In general, adverse reaction reports may refer to observational studies or case reports which are not generally accepted in
the scientific community on questions of causation. 9 On the other
hand, it may refer to reports that require reporting of adverse events by
sponsors.70 In Baker the term was used in conjunction with the terms
research, scientific literature and other available methods. 7 ' The term
"research" refers to research done by the drug manufacturer itself, 72 USUally describing clinical trials and the like. 73
Conversely, scientific literature is a source gathered from the general medical community and not the drug manufacturer itself. Scientific
literature, being a general term, may include clinical trials as well as
If adverse reaction reports refers to observational studies or case reports, then according to
Baker a drug manufacturer would be liable for constructive knowledge of side effects available
through such reports. This would include rare side effects that have been discovered through
observational studies and case reports. If this were the case, the Appellate Division, Second
Department in Baker would appear to be at odds with the First Department's holding in Heckstall. Heckstall v. Pincus, 19 A.D.3d 203, 205 (App. Div. 1st Dept. 2005). Conversely, if the
term refers to reports discussed by 21 C.F.R. %§ 312.32 and 201.80, which call for a revised
warning label as soon as there is reasonable evidence of an association of a serious hazard with a
drug, the two appellate division decisions could be in agreement with one another.
69 Because these reports are not generally accepted on questions of causation their findings
are not required to be included in drug warnings as held by the court in Heckstall. The court
stated, "other cardiovascular adverse effects found in the Canadian Adverse Drug Reaction Letter, reports of the British Regulatory Body MCA and the Center for Drug Evaluation and
Research for the improved Bupropion package insert, as well as other searches submitted by
plaintiffs counsel, must be classified as unverified listings and reporting of adverse reactions.
Courts have recognized that such observational studies or case reports are not generally accepted
in the scientific community on questions of causation." Heckstall, 19 A.D.3d at 205.
70 See 21 C.F.R. § 312.32 (2013). See also 21 C.F.R. § 201.80(e) (2013) (requiring the
findings from adverse reaction reports to be included in drug warnings: "Warnings. Under this
section heading, the labeling shall describe serious adverse reactions and potential safety hazards,
limitations in use imposed by them, and steps that should be taken if they occur. The labeling
shall be revised to include a warning as soon as there is reasonable evidence of an association of a
serious hazard with a drug; a causal relationship need not have been proved.").
71 Baker, 70 A.D.2d at 406 (1979) (a drug manufacturer must "keep abreast of knowledge
of its products through research, adverse reaction reports, scientific literature and other available
72 If not, the term research would be superfluous with "scientific literature."
73 Under 21 U.S.C.A. § 355 (West 2013), research must include full reports of investigations, which have been made to show whether or not such drug is safe for use and whether such
drug is effective in use.
other non-causational type studies.7 4 Since Baker refers to adverse reaction reports in the context of "research" as well as "scientific literature,"
at first glance, it is unclear if adverse reaction reports are of the nature of
clinical research trials or of the nature of observational accounts from
general sources of medical literature.7 5
Fortunately, the term becomes clear through an examination of the
Baker Court's source for the term in the Supreme Court of Oregon
decision of McEwen v. Ortho PharmaceuticalCorporation.7 6 The Court
in McEwen stated "[t]he drug manufacturer's duty to warn is, therefore,
commensurate not only with its actual knowledge gained from research
and adverse reaction reports but also with its constructive knowledge as
measured by scientific literature and other available means of communication."7 7 The Court clearly distinguishes between sources derived from
the drug manufacturer itself (i.e., research and adverse reaction reports),
and sources derived from the medical community at large (i.e., scientific
literature and other available means of communication). Thus, adverse
reaction reports are those that a drug manufacturer is required to submit
to the federal government based on its own research. 78
As evinced by the discussion above, particularly the decision in
Heckstall, a drug manufacturer is under no duty to warn where there is
no concrete evidence to prove causation.79 However, the line between
no evidence and slight evidence is a fine one. According to the C.F.R. a
label must be revised "to include a warning as soon as there is reasonable
evidence of an association of a serious hazard with a drug; a causal relationship need not have been proved.""o It is clear from the regulations
that a drug manufacturer should include a warning even where a causal
relationship has not been established."' Yet, the extent of a drug manufacturer's liability, as opposed to duty, under these circumstances is less
clear. The New York case law discussed above indicates that even where
the rate of occurrence is extremely small, questions of failure to warn
Heckstall, 19 A.D.3d at 205.
Baker, 70 A.D.2d at 406.
McEwen v. Ortho Pharm. Corp., 270 Or. 375, 386 (1974).
77 Id
78 Thus, the courts are referring to the adverse reaction reports dealt with by the C.F.R. See
21 C.F.R. § 201.80 (2013) (requiring a revised label to describe serious adverse reactions as soon
as there is reasonable evidence of an association of a serious hazard with a drug).
79 Heckstall, 19 A.D.3d at 205.
80 21 C.F.R. § 201.80 (2013).
81 Id. See also Tucker v.SmithKline Beechum Corp., 596 F.Supp.2d 1225, 1228,
2008 WL 2788505 (S.D. Ind. 2008).
[Vol. 12:423
will proceed to a jury,8 2 as opposed to where the evidence of causation is
not concrete and not generally accepted in the scientific community.83
The language used by the C.F.R. of cases of reasonable evidence where
"a causal relationship need not have been proved" seems to fall somewhere in the grey area between the two.8 4
In general, warnings serve two purposes; to inform product users of
risks so that they may decide whether or not to use a product, and to
assist product users in reducing any dangers associated with using a
product.8 For these reasons, the common law rule for warnings, as set
forth in the Restatement, is that a manufacturer must warn the foreseeable ultimate user of the risks and dangers associated with its products. 6
However, because prescription drugs are likely to be complex
medicines, obscure in formula and varied in effect,87 the method of conveying a warning for a drug differs from what is practicable for other
consumer products. 8 Courts generally recognize that even if patients
directly receive warnings about a prescription drug from the manufacturer, they would be unable to fully comprehend or appreciate those
warnings.89 Therefore, the majority of states have adopted the learned
intermediary doctrine. 90
Under the learned intermediary doctrine, a pharmaceutical manufacturer provides warnings directly to prescribing physicians, who then
In Givens, the rate of occurrence was measured at about one in three million, in Bukowski,
at around one in one hundred thousand and in Cunningham v. Charles Pfizer dr Co., Inc.,
discussed in Part II, at a rate between four and seven in a million. Givens v. Lederle, 556 F.2d
1341, 1345 (5th Cir. 1977); Bukowski v. CooperVision Inc., 185 A.D.2d 31, 33 (3d Dept.
1993); Cunningham v. Charles Pfizer & Co., Inc., 532 P.2d 1377, 1380-81 (1974).
83 Heckstall, 19 A.D.3d at 205.
84 21 C.F.R. § 201.80 (2013).
85 Plant, supra note 3, at 1013.
86 See Restatement (Second) of Torts § 388 (1979) ("One who supplies directly or through a
third person a chattel for another to use is subject to liability to those whom the supplier should
expect to use the chattel with the consent of the other or to be endangered by its probable use,
for physical harm caused by the use of the chattel in the manner for which and by a person for
whose use it is supplied.").
87 Kirk v. Michael Reese Hosp. & Med. Ctr., 117 Ill. 2d 507, 518 (1987); Wolfgruber v.
Upjohn Co., 72 A.D.2d 59, 60-61 (App. Div. 4th Dept. 1979), affd, 52 N.Y.2d 768 (1980).
88 Imbroscio, supra note 66, at 849.
89 Plant, supra note 3, at 1013.
90 Imbroscio, supra note 66, at 849.
relay a simpler warning to their patients. 9' Drug manufacturers are
shielded from liability for failure to warn consumers as long as they
provide the prescribing physicians with an "adequate warning. "92 In
this way, a prescribing physician is able to balance the risks and benefits
of various drugs and treatments, taking into account the various properties of the drugs and the susceptibilities of patients." The prescribing
physician, as the informed intermediary, is in a better position to make
an informed choice via her "individual medical judgment bottomed on
a knowledge of both patient and palliative."'
The primary rationale for the learned intermediary doctrine is to
assume a proper balance of responsibility between the doctor, who interacts with patients on an individual basis, and the manufacturer, which
produces the drugs." The manufacturer, who is required to have an
intimate knowledge of all aspects of a drug, is in the best position to
keep updated on a drug's side effects.96 The prescribing physician,
equipped with the information supplied by the drug manufacturer, is in
the proper position to furnish the patient with a simpler, less complicated warning specifically tailored to the patient and her condition.
Additionally, many courts have chosen to apply the learned intermediary doctrine in the case of prescription drugs" because federal law conventionally requires drug warnings to be provided to the medical
community and not directly to the individual consumer.99 Consumers
of prescription drugs also have no option but to obtain such drugs from
their physicians.oo For the above reasons, part of a physician's professional duty to patients is to provide them with information and counseling concerning the risks and benefits associated with treatments. This,
of course, includes pharmacological treatment.'
9' Id.
93 Martin v. Hacker, 83 N.Y.2d 1, 9 (1993).
94 Kirk v. Michael Reese Hosp. & Med. Ctr., 117 Ill. 2d 507, 518 (1987) (quoting Reyes v.
Wyeth Labs., 498 F.2d 1264, 1276 (5th Cir. 1974), cert. denied (1974), 419 U.S. 1096).
95 Imbroscio, supra note 66, at 849.
96 Id
97 Id
98 LEE S. KREINDLER ET AL., NEW YORK LAw OF TORTs § 16:25, available at Wesdaw
99 Wolfgruber v. Upjohn Co., 72 A.D.2d 59, 61 (App. Div. 4th Dept. 1979), affd, 52
N.Y.2d 768 (1980).
100 KREINDLER ET AL., supra note 98.
101 Id.
[Vol. 12:423
Exceptions to the Learned Intermediary Doctrine
Although the learned intermediary doctrine has gained popularity,
there are a few situations where the doctrine is not commonly applied.
Courts have typically not allowed manufacturers to invoke the doctrine
as a defense where one of the traditional assumptions underlying the
doctrine was not present.10 2 For example, instances in which no true
physician-intermediary relationship exists, the archetypical circumstance
being a vaccine that is supplied directly from a manufacturer to a patient. 103 Because the vaccines are dispensed "without an individualized
balancing by a physician of the risks involved ... it is the responsibility
of the manufacturer to see that the warnings reach the consumer."10 4
Even when courts do not apply the learned intermediary doctrine,
they apply the same standards for warnings, requiring a manufacturer to
warn of all risks of which it is or should have been aware. An example
of such a case is Samuels v. American Cyanamid Company, where the
court found the learned intermediary doctrine inapplicable where travel
vaccines were administered in a company clinic.' 0 5 The court held the
manufacturer had a duty to warn of "all potential dangers of which it
knows or should know."106
Similarly, a manufacturer is responsible to directly warn patients
even where the risks are low. In Odgers v. Ortho PharmaceuticalCorporation, the court held that the manufacturer owed a duty to warn the
patient even though a physician's affidavit estimated the patient's risk to
about one in two thousand.1 07 Likewise, the manufacturer in Cunningham v. Charles Pfizer & Company, Inc. was required to warn the consumer where evidence indicated the incidence of paralytic polio from all
three types of polio was between four and seven per million. 0 8 The
court noted that "[a] duty to warn of known potential risks of drugs had
Plant, supra note 3, at 1016.
See, e.g., Samuels v. Am. Cyanamid Co., 495 N.Y.S.2d 1006 (Sup. Ct. 1985) (involving
travel vaccines routinely administered in company clinic); Davis v. Wyeth Labs., Inc., 399 F.2d
121, 122 (9th Cir. 1968) (concerning the contraction of polio from a polio vaccine at a mass
immunization clinic); Reyes v. Wyeth Labs., 498 F.2d 1264, 1269 (5th Cir. 1974), cert. denied,
419 U.S. 1096 (1974) (defendant was liable for failing to market its unavoidably unsafe vaccine
in such a way as to warrant parents of unreasonably dangerous condition).
104 Davis, 399 F.2d at 131.
105 Samuels, 495 N.Y.S.2d at 1011.
Odgers v. Ortho Pharm. Corp., 609 F. Supp. 867, 880 (E.D. Mich. 1985).
108 Cunningham v. Charles Pfizer & Co., Inc., 532 P.2d 1377, 1380-81 (1974).
been found to exist even though the chances of the adverse reaction
occurring are statistically small." 09
As previously mentioned, the liability and duty to warn of a drug
manufacturer is far reaching, extending to extremely rare occurrences.
Although a drug manufacturer's liability extends to these extremely rare
side effects, implying a vast duty to inform doctors, a doctor's duty to
warn patients is not as extensive and is therefore dealt with separately in
the following section.
The relationship between a physician and her patient usually
comes into being because of the patient's need of the skill, learning, and
experience of the physician. But, however wise the physician may be,
she may not under ordinary circumstances impose her services upon
another without that person's consent.o Each person being the master
of her own body may choose to prohibit the performance of life-saving
surgery, or other medical treatment.'
While a doctor might well believe that an operation or form of treatment is necessary, she may not
substitute her own judgment for the will of her patient.' 1 2 It is the duty
of a physician to provide her patients with enough information so that
they may maintain control over their own bodies in making treatment
In general, a prescribing physician has a duty to know the characteristics of the drug she is prescribing as well as the proper dosage of the
drug." 3 The physician must inquire from the patient what other drugs
the patient is taking and properly prescribe various combinations of
drugs."' Patients should be warned of the dangers associated with taking drugs and a patient's dependence on the drugs should be monitored.' 15 A prescribing physician should also inform a patient as to
when and how to take the drugs she prescribes." 6
109 Id. at 1381. See also Plant, supra note 3, at 1040-44 (the duty even encompasses risks
within the range of one in one million to one in three million).
110 W. M. Moldoff, Malpractice:physician's duty to inform patient of nature and hazards of
disease or treatment, 79 A.L.R.2d 1028 (1961).
Brumaghim v. Eckel, 94 A.D.3d 1391, 1394 (App. Div. 3d Dept. 2012).
The Standard of Review in the Medical Profession
Two standards exist in almost all areas of law, a standard of conduct and a standard of review.11 7 In most areas these two standards are
identical. 1 ' Analyzing the standard of review is therefore a worthwhile
endeavor in defining the standard of conduct for a physician. The standard of review in medical malpractice claims is generally one that is
established by the profession itself,"' 9 meaning "[a] physician will usually be insulated from tort liability where there is evidence that he or she
conformed to accepted community standards of practice."1 2 0
In concert with this general standard, when measuring the extent
of a physician's duty to warn, courts have conventionally looked to the
custom of physicians practicing in the community in making the same
disclosure. 1 2 ' This standard is commonly known as the "professional
standard," due to its sole focus on the medical profession. Ultimately,
the professional standard came under criticism for its excessive paternalism and the effective immunity it granted physicians. 12 2
The professional standard does not guarantee any measure of protection to patients, rather it guarantees protection to the average physician. 123 Some argue that reliance on a general practice respecting the
average disclosure is inconsistent with the numerous variables involved
in particular cases. For one thing, the standard of disclosure exercised
by the medical community bears no inherent relationship to the amount
of knowledge a particular patient might require to make an informed
decision.124 The use of the professional standard circumvents an investigation into the actual importance that undisclosed information might
have had for a patient.12 5 The standard has also been regarded as undermining the basis of the informed consent theory in that a patient has the
right to be the final judge of her body and to do with her body as she
wills.126 A patient's right of self-determination in treatment demands a
ORGANIZATIONS 643 (Robert C. Clark et. al eds.,IOth ed. 2011).
118 Id
Spensieri v. Lasky, 94 N.Y.2d 231, 238 (1999).
Id. (internal citations omitted).
Canterbury v. Spence, 464 F.2d 772, 783 (D.C. Cir. 1972).
Laurent B. Frantz, Modern status of views as to general measure ofphysician's duty to inform
patient of risks ofproposed treatment, 88 A.L.R.3d 1008 § 3 (1978).
123 Id
12 5
Frantz, supra note 122, at 1008.
standard of review set by law rather than one which physicians may or
may not impose upon themselves. 1 2 7 As a result of these and other criticisms, many states have shifted to a "patient standard" of informed
consent. 128
Under the patient standard for assessing the adequacy of a warning,
many courts use an objective test, asking whether a reasonable person
would regard the information as important.12 9 Other courts use a more
subjective test, asking about the personal prior knowledge and preferences of the particular patient.13 0 Under either of the patient standard
tests, a plaintiff must evince expert testimony as to what a physician
should have known about the relative risks and benefits of the treatment.13 1 Yet, the patient does not need, as under the professional standard, testimony about what other physicians customarily would have
disclosed.13 2
The New York Standard
Under New York law a court must use a hybrid standard in determining the adequacy of a physician's disclosure. The New York Public
Health Law sets forth the meaning of informed consent:
Lack of informed consent means the failure of the person providing
the professional treatment or diagnosis to disclose to the patient such
alternatives thereto and the reasonably foreseeable risks and benefits
involved as a reasonable medical, dental or podiatricpractitionerunder
similar circumstances would have disclosed, in a mannerpermitting the
patient to make a knowledgeable evaluation. 3 3
The New York statute contains a provision that borrows from the professional standard asking whether a reasonable medical practitioner
under similar circumstances would have disclosed the same, as well as a
provision that borrows from the patient standard asking whether the
disclosure was in a manner permitting the patient to make a knowledgeable evaluation.13 4
Canterbury v. Spence, 464 F.2d 772, 784 (D.C. Cir. 1972).
Noah, supra note 2, at 367.
Id. at 367-68.
133 N.Y. Pub. Health Law
§ 2805-d(1) (West 2013) (emphasis added).
[Vol. 12:423
Plaintiffs Burden of Proofin an Informed Consent Claim
According to the New York Public Health Law, in order for a doctor to be found liable for failure to obtain a patient's informed consent,
a plaintiff must sustain the burden of proof on three issues.' 3 5 First, the
doctor must have failed to warn the plaintiff of a reasonably foreseeable
risk of the treatment. 1 3 6 Second, having been informed of the risks and
alternatives, the plaintiff must prove that a reasonable person in the
plaintiffs condition would have opted against such treatment. 1 3 7 Third,
the plaintiff must prove that the treatment was the proximate cause of
her injury.'13 The first two of these burdens are interrelated in that
both burdens use a measure of rarity in their analysis. Once a risk is
exceedingly rare it is more likely to be an unforeseeable risk and is more
likely to be a risk that is of no concern to a reasonable plaintiff. The
frequency of risk thus becomes an important factor in analyzing the
plaintiffs first two burdens of proof, as exemplified in Bernard v.
Block.1 39
In Bernard, plaintiff who was ultimately diagnosed with multiple
sclerosis, consulted with defendant doctors complaining of a back problem. Plaintiff was ordered a myelogram.'o She was informed "of the
purpose of the myelogram, that it causes pain, discomfort and sometimes allergic reactions, but that it was essential for her diagnosis." 14 '
Plaintiff signed a consent form.' 4 2 A second myelogram was ordered.
Plaintiff was informed of the reasons for the second myelogram and
consented to the procedure. 4 3 Plaintiffs condition subsequently degenerated and she lost the ability to use her legs.' 44 She argued that the
myelograms accelerated her disease causing her injury and that she
should have been warned in advance that the myelograms could worsen
her condition.' 4 5 Plaintiffs evidence as to the negative effects of myelograms on multiple sclerosis patients was limited to plaintiffs expert's
Id.; Bernard v. Block, 176 A.D.2d 843, 848 (App. Div. 2d Dept. 1991).
Pub. Health Law § 2805-d(3); Bernard, 176 A.D.2d at 848.
137 Pub. Health Law § 2805-d(3); Bernard, 176 A.D.2d at 848.
138 Bernard, 176 A.D.2d at 848.
139 Id
140 Bernard, 176 A.D.2d at 843. A myelogram is an x-ray of the spinal cord after an injection
with contrast material.
141 Id
142 Id
143 Id. at 844.
144 Id.
'45 Id at 849.
"somewhat conclusory and contradictory statements," and the fact that
plaintiff became substantially worse after the myelograms.1 4 6
The court first considered whether the evidence supported the
jury's finding that the myelograms posed a reasonably foreseeable risk to
plaintiff.14 7 Without any evidence as to how frequently multiple sclerosis patients were subjected to myelograms in 1982, how often they may
have suffered injury, or how permanent the injury suffered may have
been, the court found that no fair interpretation of the evidence justified
the jury's verdict that the risk to plaintiff was foreseeable.148 The court
also found that a reasonable person would have opted to incur the risk
under plaintiffs circumstances." 9
The court in Bernardused the same evidence as to the frequency of
paraplegia to analyze both the first and second burdens of proof.15 0
Thus, in order to properly evaluate the extent of a physician's duty to
disclose and a physician's liability for failure to disclose rare side effects,
a survey of the cases dealing with rare side effects is necessary.
The current case law on rare and uncommon side effects is sparse,
but there are a few revealing New York Appellate Division cases that
deal with the topic. Reviewing the New York case law will map out the
statistical boundaries of a physicians liability for failing to warn patients.
In this Part, I will briefly discuss five of the New York cases in increasing
order of frequency, from the more rare side effect to the more common
In the first case Heckstall v. Pincus,5 ' discussed above, plaintiff
brought a claim for lack of informed consent. 15 2 The defendant physician prescribed Bupropion to decedent to aid in her attempt to quit
146 Id. at 849.
150 1) Whether the doctor failed to warn the plaintiff of a reasonably foreseeable risk of the
treatment; 2) whether having been informed of the risks and alternatives a reasonable person in
the plaintiffs condition would have opted against such treatment. N.Y. Pub. Health Law
§ 2805-d(3) (West 2013); Bernard, 176 A.D.2d at 848.
151 Heckstall v. Pincus, 19 A.D.3d 203, 205 (App. Div. 1st Dept. 2005).
152 Heckstall involved two claims, one claim against Glaxo, a drug manufacturer, and one
against a physician. The claim against the drug manufacturer was discussed above in Part I.
The claim against the physician is discussed here.
smoking.1 3 Plaintiff claimed that Bupropion led to decedent's arrhythmia, which ultimately caused her death.1 4 The affidavits of defendants'
experts showed that there was no evidence whatsoever that Bupropion
causes arrhythmia or could aggravate coronary artery disease. 155 The
court held that reports of cardiovascular adverse effects found in the
Canadian Adverse Drug Reaction Letter, reports of the British Regulatory Body the Medicines Control Agency and the Center for Drug Evaluation and Research for the improved Bupropion package insert were
unverified listings and reports of adverse reactions.' 5 6 The court commented that such observational studies and case reports are not generally
accepted amongst the scientific community on questions of
causation. 157
The second case, McElroy v. Yousuf concerned plaintiff who consulted defendant, a cardiothoracic surgeon, regarding a spot on her chest
and lung.1 5 1 Plaintiff underwent chest surgery and while in recovery she
noticed she could not move her legs.15 9 A magnetic resonance imaging
test later showed a spinal infarct but no evidence of compression of the
spinal cord itself was found.1 6 0 Plaintiff never recovered use of her
legs.' 61 It was uncontroverted that defendant did not specifically advise
plaintiff of any risk concerning paraplegia. 1 6 2 The appellate court upheld a jury verdict finding no negligence on the part of defendant.' 63
Although the court commented that a physician is required to inform
her patient of all reasonably foreseeable risks relative to a certain medical
procedure, the jury accepted evidence which demonstrated that paraplegia would be extremely uncommon and an unexpected complication of
any chest surgery.16 1
Heckstall, 19 A.D.3d at 205.
Id. at 204.
Id. at 205.
McElroy v. Yousuf, 268 A.D.2d 733, 734 (App. Div. 3d Dept. 2000).
160 An infarct is an "area of tissue that undergoes necrosis as a result of obstruction of local
blood supply, as by a thrombus or embolus." Infarct, THE FREE DICTIONARY, (Mar. 18, 2014,
3:23 PM),
161 McElroy, 268 A.D.2d at 734.
162 Id. at 736.
163 Id. at 737.
164 Defendant's expert testified that given the unexpected nature of the type of complication,
defendant's failure to specifically advise plaintiff of this remote possibility did not constitute a
departure from the required standard of care. McElroy, 268 A.D.2d at 736.
The first two cases, Heckstall and McElroy, demonstrate that where
there is no proof of actual causation nor hard evidence of a causational
link, courts will not hold a physician liable for not warning her patients.
Due to the lack of causational evidence in these two cases no actual rate
of frequency for the side effects discussed was presented.
Marchione v. State, the third case, presents a quantifiable measurement for the rate of occurrence, i.e., two or three out of several million. 165 In Marchione plaintiff, a prison inmate, brought an action for
lack of informed consent.1 6 6 Plaintiff claimed that the prison physician
failed to inform him about the side effects of Minipress, a hypertension
drug.' 67 Subsequently, the inmate suffered permanent priapism,16 s
which ultimately led to permanent impotence. 6 9 The defendant's expert urologist testified that "it was exceedingly rare for priapism to be
associated with the use of Minipress and there was no established causal
link between the two."170 The defendant further argued that the two or
three cases reporting priapism as a result of Minipress was not enough
evidence to qualify priapism as a significant risk of which a patient must
be informed. 17 ' The defendant doctor claimed his duty to warn was
limited to severe or frequent side effects. 1 7 2
The appellate division upheld the trial court's determination that
the plaintiff did not establish a lack of informed consent. The court
reasoned that despite the fact that priapism was listed among the many
possible reactions associated with Minipress in the physician's desk reference (hereinafter "PDR"),1 7 3 it is apparent from the evidence that the
risk of Minipress-induced priapism is so rare that it is entirely reasonable
to find a physician bears no liability for failing to inform a patient of
Marchione v. State, 194 A.D.2d 851, 854 (App. Div. 3d Dept. 1993).
166 Id. at 851.
Id. at 853.
"Priapism is a persistent, usually painful, erection that lasts for more than four hours and
occurs without sexual stimulation. The condition develops when blood in the penis becomes
trapped and unable to drain. If the condition is not treated immediately, it can lead to scarring
and permanent erectile dysfunction." Erectile Dysfunction and Priapism, Erectile Dysfunction
Health Center, WEBMD, (Mar. 18, 2014, 3:27 PM),
169 Marchione, 194 A.D.2d at 853.
170 Id. at 854.
Id. The Physicians' Desk Reference is a manual that categorizes drugs currently available
on the market.
[Vol. 12:423
such a possibility.17 ' The court accepted the argument that a danger of
only two or three cases out of several million had too rare an incidence
to require disclosure.17 ' Despite the fact that the PDR listed priapism as
one of thirty-one reactions associated with Minipress, the prescribing
physician was not liable for failing to warn his patients of the dangers of
priapism.' 7 1
The court in Marchione essentially determined that a physician is
not required to disclose a laundry list of reactions and side effects to a
patient in delivering an adequate disclosure.17 7 Under the standard of
the Public Health Law,' 7 the appellate court upheld the lower court's
verdict finding that a reasonable person would not refuse to take
Minipress to control hypertension, a potentially dangerous condition,
even though Minipress carries with it a risk of priapism of about three in
several million.17 9 Although plaintiff stated he would not have agreed to
take Minipress if he was aware of the risk of priapism, the court considered the low risk of priapism in deciding it was not clear that a reasonable person would have avoided taking the medication under similar
circumstances. 8 0 The decision in Marchione demonstrates the dichotomy between the duty of a drug manufacturer to list priapism as a side
effect and the lack of liability for a doctor in not relaying the PDR listed
side effect to a patient. It also demonstrates that there is a quantifiable
cut off below which it is reasonable to find no warning need be
Marchione, 194 A.D.2d at 854.
177 Paula Walter, The Doctrine of Informed Consent: To Inform or Not To Infrn, 71 ST.
L. REV. 543, 577 (1997). In effect the court held that a full disclosure of all reactions
and possible side effects is not necessary in order to comply with the hybrid standard of N.Y.
Public Health Law § 2805-d § 1 (West 2013).
178 N.Y. PUB. HEALTH Law § 2805-d(3) (West 2013) ("For a cause of action therefore it
must also be established that a reasonably prudent person in the patient's position would not
have undergone the treatment or diagnosis if he had been fully informed and that the lack of
informed consent is a proximate cause of the injury or condition for which recovery is sought.")
(discussed above).
179 Marchione v. State, 194 A.D.2d 851, 854 (App. Div. 3d Dept. 1993).
Id. The court stated "it is not at all certain from the evidence that a reasonable person,
who had shown sensitivity to other medication, would refuse to take a drug to control hypertension, a potentially dangerous condition, simply because of the two or three cases of priapism that
occurred in a population of several million who were taking the drug." id.
The next two cases, Murray v. Maniatis81 and Schilling v. Ellis
Hospital, 18 2 push the boundary of liability even further. In the fourth
case, Murray v. Maniatis, the defendant physician treated plaintiff with
oral systemic steroids during the course of his treatment.18 3 After plaintiff developed avascular necrosis, a rare side effect of steroids, he was
forced to undergo two hip replacement surgeries and arthroscopy, and
arthroscopic surgery of his left shoulder.1 8 1 Plaintiff claimed lack of informed consent in that defendant failed to advise him of the risks and
dangers associated with taking oral steroids.185 The jury found in the
physician's favor, but the verdict was set aside and a new trial was
granted. "
The appellate court held that "the evidence did not so preponderate in the plaintiffs favor that the verdict could not have been reached
upon any fair interpretation of the evidence." 1 7 The disputed testimony of the parties and their medical experts presented issues for the
jury to resolve. 1 8 Thus, the verdict regarding informed consent, finding for the defendant physician, was not against the weight of the
evidence. 8 9
Although not discussed in the case, the rate of occurrence of avascular necrosis from steroids is around three percent.' 9 o In Murray this
rate was considered frequent enough in a question of informed consent
to proceed to the jury. At the same time the appellate division upheld a
jury verdict determining the side effect was rare enough that a reasona181 Murray v. Maniatis, 21 A.D.3d 1012 (App. Div. 2d Dept. 2005).
182 Schilling v. Ellis Hosp., 75 A.D.3d 1044 (App. Div. 3d Dept. 2010).
183 Murray, 21 A.D.3d at 1012-13.
Id. at 1013.
186 Id.
Id. at 1013.
190 George Bradbury et al., Avascular necrosis of bone after cardiac transplantation:prevalence
and relationship to administrationand dosage ofsteroids, 76 J. BONE AND JOINT SURG. AM. 1385,
1385-88 (1994), available at 17
(although this study looked particularly at patients after cardiac transplantation they should not
differ in the rate of development from the general population); see also Lynne C. Jones, Osteonecrosis (avascularnecrosis ofbone), UPTODATE (Feb. 24, 2013),
tents/osteonecrosis-avascular-necrosis-of-bone. Murray was placed before Schilling although the
rate of occurrence is higher because the case didn't specifically quantify the rate of occurrence
and because the ruling in Schilling turns out slightly differently than the previous four cases.
[[Vol. 12:423
bly prudent person in the patient's position would have undergone the
treatment. 191
The fifth and last case, Schilling v. Ellis Hospital, involved Jordan
Howard, plaintiffs son, who was admitted to the psychiatric unit of
defendant Ellis Hospital due to manic behavior, a result of his bipolar
mania. 1 9 2 A psychiatrist at the hospital increased Jordan's dose of Risperdal, a psychotropic drug medication, from to two to eight milligrams
per day. 1 93 Jordan thereafter developed gynecomastia, 94 a rare side effect of Risperdal. 1 " Plaintiff contended that the defendants failed to
properly inform her that gynecomastia was a possible side effect of Risperdal before administering a higher dosage to her son. 196
Defendants' expert opined that given the rarity of gynecomastia
there was no deviation from the standard of care in not having warned
Plaintiff about the side effect. 197 Plaintiffs expert concluded that "given
the information provided in the manufacturer's insert stating that dosages of more than six milligrams had not been found to be more effective than lower doses," combined with the fact that the safety and
effectiveness of Risperdal in children had not been established, defendant should have warned plaintiff of all possible side effects.19 8 The
appellate court held that the denial of summary judgment was reasonable although the side effect plaintiff was not informed of was rare.1 9
Gynecomastia as a side effect of Risperdal is seen at a rate of 2.3%
in children and adolescents. 20 0 At this rate of occurrence gynecomastia
was considered a rare side effect by the court in Schilling.201' Nevertheless, whether there was a breach of informed consent by the prescribing
191 Murray, 21 A.D.3d at 1013.
192 Schilling v. Ellis Hosp., 75 A.D.3d 1044, 1044 (App. Div. 3d Dept. 2010).
193 Id. at 1045.
194 Gynecomastia is "swelling of the breast tissue in boys or men." Gynecomastia (enlarged
breasts in men), MAYO CLINic,
(last updated Jan. 2, 2014).
195 Schilling, 75 A.D.3d at 1044.
196 Id. at 1045.
197 Id
198 Schilling v. Ellis Hosp., 75 A.D.3d 1044, 1046 (App. Div. 3d Dept. 2010).
199 Id.
200 Alicia Mundy, Risperdal Can Have TroublingSide Effects In Boys, Health Blog, WALL ST. J.
(Nov. 25, 2008, 4:52 PM),
201 Schilling v. Ellis Hosp., 75 A.D.3d 1044, 1046 (App. Div. 3d Dept. 2010).
physician in failing to warn the plaintiff of the risks of gynecomastia was
considered a question for the jury.20 2
After reviewing the cases above it appears that the appellate division in New York considers the risk of a side effect with a likelihood of a
few in several million to be one that a doctor incurs no liability for in
not warning her patients. Furthermore, the second and third departments are in agreement that a frequency of occurrence of about zero to
three percent is considered rare and is one that properly proceeds to the
jury on questions of informed consent. 20 3 Being a question that proceeds to the jury, when the probability reaches around zero to five percent the outcome is much less predictable than greater or lesser
frequencies. As will be discussed in Part V, much of this unpredictability comes from the use of statistics themselves combined with the subject matter, i.e., rare medical side effects.
Low-probability information is important to many healthcare decisions, particularly in choosing among treatment options whose risks and
benefits vary in probability. 204 This probabilistic information is often
expressed using a number of different methods including numerical,
verbal, and visual formats.2 0 5 For example, a smoker can be told that
compared with nonsmokers, her chance of getting a disease is 20% compared with 10% (numerical), or is twice as likely (verbal), or the smoker
can be shown a histogram of the risk for smokers and nonsmokers (visual). 2 0 6 Although these three probabilities are equivalent they often
have different affects on decision-making. 207
A critical issue in assessing the use of statistics is whether providing
a person with "a numeric probability is understood sufficiently, especially in the context of unfamiliar health outcomes." 2 0 8 Many times a
See Murrayv. Maniatis, 21 A.D.3d 1012, 1012 (2nd Dept. 2005); Schilling, 75 A.D.3d at
204 Judith H. Hibbard & Ellen Peters, Supporting informed consumer health care decisions:
Datapresentation approaches thatfacilitate the use ofinformation in choice, 24 ANN. REV. OF PUB.
413, 413-14 (2003).
Isaac M. Lipkus, Numeric, verbal, and visual formats ofconveying health risks: suggestedbest
practicesand future recommendations, 27.5 MED. DECISION MAKING 696, 697 (2007).
Id. at 700.
[Vol. 12:423
statistic is provided to inform a patient about the chance of getting a
disease, e.g., one's absolute or lifetime risk of getting lung cancer is
3% .209 However, a single statistic may not be sufficient to convey valuable or adequate meaning, especially in the context of important healthcare decisions. 210
Appreciating the relevancy of numbers and probability of decisionmaking is easier said than done because of the role of affect, which is the
role that emotions play in decision-making. 2 11 Even people we take to
be intelligent have difficulty understanding the meaning of and properly
acting on measures or statistics pertaining to risk, unless these statistics
are imparted with affect.2 1 2 Thus, the methods of transmitting information that researchers assume to be meaningful may in fact be misleading
if they are infused with unanticipated emotional meaning.2 1 3 Information needs to be provided in a usable and readily digestible form in order
to be of benefit to patients. Otherwise patients can feel dissatisfied and
frustrated.21 4 Research on evaluability demonstrates that even if we understand the numbers used at some fundamental mathematical level, we
may not have an emotional or affective understanding of it.2 1 5 For example, although Medicare beneficiaries are given plenty of information,
they report being confused about the nature of their choices because too
much information is given and it is not presented in a readily understandable manner.2 1 6
The Affect Heuristic
The perception and integration of affective feelings into decisionmaking is theorized to be a kind of maximization process known as the
affect heuristic. 2 17 The affect heuristic is a mental shortcut, which enables people to quickly make rational decisions in many important situations, without going through a logical step-by-step analysis.2 1 8 It is the
Lipkus, supra note 205, at 700.
Paul Slovic et al., Affect, Risk, and Decision Making, 24.4S HEALTH
Id. at S39.
Id. at S35, S36.
Hibbard & Peters, supra note 204, at 414.
Slovic et al., supra note 211, at S35, S36.
Hibbard & Peters, supra note 204, at 414.
Id. at 417; see also Slovic et al., supra note 211, at S35, S36.
Slovic et al., supra note 211, at S36.
S35 (2005).
influence that current emotion or affect has on decisions.2 1 9 It works
best when past experiences enable an accurate anticipation of how we
will like the consequences of our decisions.22 0 Thus, without working
out the consequences in detail one can make a decision based on the
perceived consequences. 2 21 The heuristic fails when the consequences
turn out to be much different in character than anticipated. 2 2 When
information lacks emotional meaning, it lacks evaluability and is not
weighed properly in decision-making.2 2 3
Affect plays important roles in measuring consequences, specifically in measuring losses versus the perceived severity of losses. 2 2 4 This
may arise from persons acknowledging the statistical population likelihood but believing their individual likelihood to be different. 2 2 5 In
other words, people often feel that statistics don't apply to them or more
generally that group statistics do not apply to individuals.
In addition, statistics are not readily evaluable in that they have
various emotional effects based on their method of presentation. 22 6
This variation is most pronounced when working with low-probability
information. 2 27 Decision-makers do not optimally process small percentages (e.g., 2%) but are better able to process the same information
presented as a frequency (e.g., 2 out of 100).228 A prominent example
comes from a study conducted at the Harvard Medical School, which
found that the diagnostic judgments of faculty and students were greatly
improved by presenting information about diseases and symptoms in
the form of frequencies rather than as probabilities.22 9 On a similar
note, a study found that forensic psychiatrists and psychologists judged
a patient's risk of being violent as much greater when it was communicated as a frequency (e.g., 1 person in 10) as opposed to an equivalent
probability (e.g., 10%).230
219 Paul Slovic et al., The Affect Heuristic, 177.3 EUR. J. OF
35 (2007).
220 Id
221 Id
222 Id
223 Hibbard & Peters, supra note 204, at 420.
224 Lipkus, supra note 205, at 698.
225 Id
226 Hibbard & Peters, supra note 204, at 426-27.
227 Id. at 427.
REs. 1333, 1333-
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As exemplified above, research on statistics carried out with both
experts and the general public shows that information presented as frequencies rather than probabilities carries more affect and, as a result,
greater weight in decision-making. 23 1 Perhaps using percentages appears
as a more bland way of describing risk, whereas highlighting the number
of people who could be at risk appears to be a more vivid way of
describing risk, drawing attention to the actual number of people who
could be harmed and creating identification.2 3 2 Balancing the weight a
given statistic should carry when being presented to a patient or a jury
consequently becomes a challenging task.
Moreover, when it comes to making important healthcare decisions, individuals often prefer numeric information relative to other formats (e.g., verbal probabilities).2 3 3 The benefits of numbers are limited
though by their lack of sensitivity for adequately expressing intuitions as
well as problems people have understanding and applying mathematical
concepts.2 3 ' As an illustration:
[A]ccording to the ratio-bias phenomenon, expressing a ratio as 2
smaller numbers (e.g., 1 out of 10) leads to lower perceptions of event
likelihood than the same ratio incorporating larger numbers (e.g., 10
out of 100). Conveying a ratio using the latter format may increase
the perceived magnitude of risk.2 35
These problems are compounded when dealing with small
probabilities, i.e., probabilities less than one percent, for a number of
reasons. 2 36 Firstly, because these side effects are rare, people rarely experience them. The less familiar people are with experiences the harder it
is to evaluate them statistically. 2 3 7 Secondly, numbers close to zero will
at times be dismissed as representing no risk, in line with the idea that
group statistics do not apply to individuals.2 38 Thirdly, events that are
perceived as unlikely are perceived as less severe, creating another reason
why they may be more readily dismissed.2 39
Hibbard & Peters, supra note 204, at 427.
Lipkus, supra note 205, at 700.
Hibbard & Peters, supra note 204, at 414.
Lipkus, supra note 205, at 700.
Having previewed a few of the nuances in dealing with statistics
the possible issues with submitting data on rare side effects to a jury
become more apparent. Under certain circumstances, small probabilities are given more significance than would normally be expected. Yet,
under other circumstances people give small probabilities less significance. Lastly, it remains unclear at what point in the balancing process
people treat small probabilities as no risk. 2 4 0 For these reasons it might
be more efficient, under normal circumstances, to create a liability scale
for certain types of side effects.
B. The Statistical Liability Scale
One would think that frequency of risk would naturally play an
important role in determining jury outcomes.241 However, studies analyzing frequency of risk and jury outcomes found no significant relationship between the two. 2 42 Dr. Merz collected data from over 220
published informed consent cases, comprising predominantly appellate
decisions as well as 187 summaries of trial cases secured from Jury Verdict Research, Inc.24 3 He found an "increase in the probability of a
verdict for plaintiff as the mean jury verdict valuation of the consequences suffered increases." 244 In other words, Plaintiffs' verdicts increased with the severity of Plaintiffs' injuries.245 Dr. Merz found "no
clear demarcation . . . separating risks which must be disclosed from
those which need not be disclosed." 2 4 6 From analyzing the cases it was
not determinable how complete a disclosure should be to shield a physician from liability. 2 4 7 Although the study found no relationship between the two variables, Dr. Merz nonetheless hypothesized that an
approach to defining a standard for disclosure could be adopted with
the frequencies of occurrence and severity of consequences in mind.2 48
241 Jon F. Metz et al., Verbal Expressions of Probability in Infornned Consent Litigation, 11
MED. DECIS. MAKING 273, 277 (1991).
242 Metz, supra note 7, at 65, 73.
Id. at 46.
Id. at 62.
245 It is possible to explain part of Dr. Merz's findings based on the fact that as the severity of
the side effect increases the necessity for a warning increases. For a more detailed list of the
possible shortcomings of Dr. Merz's study, see Mez, supra note 7, at 69-71.
246 Id. at 71.
247 Id. at 71-72, 75.
248 Id. at 73.
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In a similar study analyzing frequency of occurrence based on verbal probability (e.g., high, very high, low, etc.), Merz et al., studying 95
cases, found that while plaintiff won a slightly higher percentage of high
frequency cases than low frequency cases, the difference was not
significant.2 49
Before discussing a liability scale it is important to keep in mind a
few principles of side effects. As discussed in Part I of this note, creating
a new drug is a balancing act.25 o While drugs are beneficial they are
very often harmful and therefore subjected to a battery of tests before
they reach the market. 2 5 1 That is not to say that drugs which carry
extreme side effects are never approved, but when they are approved it is
usually because of a net benefit. The severity of a given side effect will
usually mirror the severity of a disease. The less severe a given disease,
the less severe the side effects will usually be. The general consumer
would not be willing to consume a drug to treat a headache if the drug
carried with it harsh side effects.2 52 On the other hand, the reasonable
patient would be willing to forego the risks of even an extremely severe
side effect if the disease the drug is meant to treat is life threatening. In
a sense, it is a built in reasonableness test, in that the side effects of a
drug will vary directly in severity in comparison to the severity of the
disease the drug treats.
With the idea of balancing in mind, creating a statistical liability
scale would essentially be forming a number of liability baselines.
Under these baselines, a physician would not face liability in failing to
warn of a given side effect. For example, in dealing with a moderate
disease and a moderate side effect a liability baseline of about one percent could be established. This would mean that if the rate of occurrence of a moderate side effect were less than one percent, as a matter of
law a physician would not be liable in failing to warn her patient of the
side effect. Similar baselines could be made for varying levels of severity,
the more severe side effects having lower liability baselines. A physician
could thus avoid unnecessary litigation in having those claims whose
likelihood of risk fell under a liability baseline summarily dismissed.
249 Merz et al.,
supra note 240, at 277.
250 See supra text accompanying note 18.
251 Wilson, supra note 35, at 749.
252 That is, unless the given harsh side effect was so rare as to be practically non-existent. It
should be noted that there are cases which do not fall into this balancing framework. Consumers are at times willing to ignore side effects for results that are highly desired. Yet, a similar
balance can be found weighing desire against the severity of the side effect.
Unfortunately, because there is no concrete evidence that pinpoints
at what probability people treat unlikely risks as no risk at all it is difficult to clearly demarcate baselines for liability. However, the studies
implicate that this probability boundary is in the vicinity of one percent. 2 5 3 One percent was chosen as a preliminary baseline to protect the
rights of patients.25 4 Ultimately, the baseline should be above the point
at which people treat small risks as no risks. The baselines would optimally approach the level of rarity at which the reasonable patient would
clearly choose to risk being afflicted by a moderate side effect in favor of
receiving the benefits of a drug. Multiple baselines are proposed as a
way of dealing with varying levels of severity. More extreme side effects
would translate into lower statistical baselines for liability, for a reasonable person would tolerate as much. However, these baselines need not
vary too much because of the direct variation between a side effect's
severity and a drug's benefit, as discussed previously in this section.
Thus patients would be willing to risk more to receive greater benefits.
At first glance this system might appear to abrogate too much of a
patient's rights. Yet this system deals with liability and not with a physician's duty. A patient is certainly free to request further information on
the side effects of a given drug, as well as written material as to all of a
drug's potential side effects. This system would also further the compatibility of a doctor's duty and liability. A doctor is not required to
deliver a complete list of every side effect to her patients. It is therefore
quite reasonable that a physician should not be totally unsure of her
liability in not disclosing such a list.
An additional concern for patients could arise from a mistaken statistical reporting of a side effect. Hypothetically, a doctor might be free
of liability in failing to warn her patient of a risk that the patient should
have been warned of. Though, in such a case a drug manufacturer
would almost certainly be liable to a patient. Overall, the system of
using statistical liability baselines could potentially increase efficiency in
dealing with decisions that are likely difficult for juries to deal with,
while at the same time increasing physicians' security and maintaining
the rights or access to information of patients.
Lipkus, supra note 205, at 700.
If a patient treats risks around one percent as being no risk, a reasonable patient would
normally not consider the risk when making a determination as to what treatment to undergo.
[[Vol. 12:423
Having traced the duties owed to consumers of prescription drugs,
we end where we began, i.e., the drug manufacturer. The drug manufacturer, with the greatest access to information and the most financial
assets, is the best insurer of patients. Drug manufacturers are ultimately
required to provide reports of all the potential side effects of a drug. In
turn, patients can access this information even though a doctor has no
duty to provide it. Patients can avail themselves of information from
drug package inserts, websites such as,, and, and by asking doctors for additional information. With
limited time and resources, a doctor's office may not be the ideal venue
for a patient to gain access to all of the information a patient might
desire. A package insert is more detailed than a patient-doctor visit can
ever hope to be. Doctors, as the intermediaries, are imperative in delivering the most important information to patients in a comprehensible
form, not all of the information.
Currently, statistics are very likely to form an important part of a
doctor's warning. Research has "demonstrated conclusively that the way
a decision is framed strongly in?uences people's preferences, in some
cases resulting in complete reversals of preference." 2 5 5 Still, further research must be done in understanding how statistics are interpreted.2 5 6
One thing is clear: statistics should not be taken at face value. Low
frequency data in the context of potentially complicated pharmacological/medical decisions can easily create uncertainties. Unfortunately, the
entirety of this project could not be completed here. Further research is
needed to determine precisely at what frequency risks no longer play a
part in a patient's decision-making process. Creating a statistical liability scale will aid in a process of simplification, having the law reflect the
decision-making process of the objective reasonable patient and increasing efficiency in the court system.
Hibbard & Peters, supra note 204, at 427.
Id. at 429-30.