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FAILING TO WARN IN THE CONTEXT OF RARE SIDE EFFECTS 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 .............................................. I. THE DUTY OF A DRUG MANUFACTURER .............. A. B. Balancing the Risks and the Benefits .............. The General Duty to Warn ..................... i. Rarity of Occurrence and the Duty to Warn... ii. Adverse Reaction Reports ..................... 424 426 426 429 430 433 II. THE LEARNED INTERMEDIARY DOCTRINE ............. 436 A. Exceptions to the Learned Intermediary Doctrine ..... 438 III. A DOCTOR'S DUTY TO WARN ........................ 439 A. The Standardof Review in the Medical Profession.... 440 i. The New York Standard ................... 441 B. Plaintiffs Burden of Proofin an Informed Consent ...... 442 ........................ Claim... IV. CURRENT CASE LAW IN NEW YORK DEALING WITH 443 RARE SIDE EFFECTS .................................. V. INTERPRETING STATISTICS AND CREATING A LIABILITY SCALE................................................ 449 A. The Affect Heuristic ............................... 450 B. The StatisticalLiability Scale....................... 453 CONCLUSION ................................................. 456 * 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. 1 IMMANUEL KANT, THE PHILOSOPHY OF LAW: AN EXPOSITION OF THE FUNDAMENTAL PRINCIPLES OF JURISPRUDENCE AS THE SCIENCE OF RIGHT 13, (William Hastie trans., Edinburgh, T. & T. Clark 1887), available at http://books.google.com/books?id= FakeAQAAMAAJ &printsec=frontcover&source=gbsge-summary-r&cad=0#v=onepage&q&f=false. 423 424 CARDOZO PUB. LAW POLICY & ETHICS J [Vol. 12:423 INTRODUCTION 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 management. 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). 2014] FAILING TO WARN 425 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 resolved."9 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 7 trans., Cambridge Univ. Press 1991) (1797). 426 CARDOZO PUB. LAW POLICY & ETHICSJ. V 12:423 [Vol. 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. I. THE A. DUTY OF A DRUG MANUFACTURER 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. 13 M. Stuart Madden, The EnduringParadoxofProducts Liability Law Relating to Prescription Pharnaceuticals,21 PACE L. REv. 313, 314 (2001). 14 Id 15 Id 16 Id 2014] FAILING TO WARN 427 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. 18 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 21 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 involve. 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. 22 RESTATEMENT (SECOND) OF TORTS 23 428 CARDOZO PUB. LAW POLICY 6- ETHICSJ. [ 12:423 [Vol. 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 25 26 27 28 29 30 31 32 Id Madden, supra note 13, at 318. Id Id Id Id Madden, supra note 13, at 318-19. Kirk v. Michael Reese Hosp. & Med. Ctr., 117 Ill. 2d 507, 517 (1987). FAILING TO WARN 2014] 429 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. B. 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 .edulflr/vol49/iss5/4. 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 CARDOZO PUB. LAW POLICY &'ETHICS J 430 [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. i. 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. 40 Id McEwen, 270 Or. at 386. Givens v. Lederle, 556 F.2d 1341, 1343 (5th Cir. 1977). 43 Id. at 1345. 41 42 44 Id. 2014] FAILING TO WARN 431 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: 45 Bukowski v. CooperVision Inc., 185 A.D.2d 31 (App. Div. 3rd Dept. 1993). 46 47 Id. at 33. Id. 48 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. 1096. CARDOZO PUB. LAW POLICY & ETHICS J. 432 [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 minute."). 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 reaction."). 54 Heckstall v. Pincus, 19 A.D.3d 203, 205 (App. Div. 1st Dept. 2005). 51 52 55 Id. 56 Id. at 203. Id. at 205. 57 58 59 Id. Id 60 Heckstall v. Pincus, 19 A.D.3d 203, 205 (App. Div. 1st Dept. 2005). FAILING TO WARN 2014] 433 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 ii. 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). 61 63 Id. 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 (2005). 67 Baker v. St. Agnes Hosp., 70 A.D.2d 400, 406 (App. Div. 2d Dept. 1979). 64 65 434 CARDOZO PUB. LAW POLICY 6- ETHICS J. [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 methods."). 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. 68 2014] FAILING TO WARN 435 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). 74 75 76 436 CARDOZO PUB. LAW POLICY & ETHICS . [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 II. THE LEARNED INTERMEDIARY DOCTRINE 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. 82 2014] FAILING TO WARN 437 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. 92 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 NYPRAC. 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. 438 CARDOZO PUB. LAW POLICY & ETHICS J1 A. [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 102 Plant, supra note 3, at 1016. 103 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. Id 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). 106 107 FAILING TO WARN 2014] 439 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. III. A DOCTOR'S DuTY TO WARN 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 decisions. 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). -~ 112 13 Id. Id Brumaghim v. Eckel, 94 A.D.3d 1391, 1394 (App. Div. 3d Dept. 2012). 114 Id. "15 116 Id Id 440 GARDOZO PUB. LAW POLICY 6'- ETHICSJ. A. [ 12:423 [Vol. 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 117 MELVIN ARON EISENBERG & JAMES D. Cox, CORPORATIONS AND OTHER BUSINESS ORGANIZATIONS 643 (Robert C. Clark et. al eds.,IOth ed. 2011). 118 Id 119 Spensieri v. Lasky, 94 N.Y.2d 231, 238 (1999). 120 Id. (internal citations omitted). 121 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 122 124 Id. 12 5 Id 126 Frantz, supra note 122, at 1008. FAILING TO WARN 2014]1 441 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 i. 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 4 128 Canterbury v. Spence, 464 F.2d 772, 784 (D.C. Cir. 1972). Noah, supra note 2, at 367. 129 Id 130 Id. 131 Id. 132 Id. at 367-68. 127 133 N.Y. Pub. Health Law 134 Id. § 2805-d(1) (West 2013) (emphasis added). 442 CARDOZO PUB. LAW POLICY 6ÐICSJ B. [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. 135 136 FAILING TO WARN 2014] 443 "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. IV. CURRENT CASE LAW IN NEW YORK DEALING WITH RARE SIDE EFFECTS 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 one. 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. 147 148 Id. Id. Id. 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. 149 444 CARDOZO PUB. LAW POLICY e&r ETHICS [ 12:423 [Vol. 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 1 153 Heckstall, 19 A.D.3d at 205. 154 Id. at 204. Id. at 205. 155 157 Id Id 158 McElroy v. Yousuf, 268 A.D.2d 733, 734 (App. Div. 3d Dept. 2000). '59 Id 156 160 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), http://www.thefreedictionary.com/infarct. 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. 2014] FAILING TO WARN 445 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 165 Marchione v. State, 194 A.D.2d 851, 854 (App. Div. 3d Dept. 1993). 166 Id. at 851. 167 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), http://www.webmd.com/erectile-dysfunc tion/erectile-dysfunction-priapism. 169 Marchione, 194 A.D.2d at 853. 170 Id. at 854. 168 172 Id. Id 173 Id. The Physicians' Desk Reference is a manual that categorizes drugs currently available 171 on the market. CARDOZO PUB. LAW POLICY 6- ETHICS J 446 [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 furnished. '74 Marchione, 194 A.D.2d at 854. 175 Id Id 176 177 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). JOHN's 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. 180 2014] FAILING TO WARN 447 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. 184 Id. 185 Id. at 1013. 186 Id. 188 Id Id. at 1013. 189 Id 187 190 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 http://jbjs.org/pdfaccess.ashx?ResourcelD=29236&PDFSource= 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), http://www.uptodate.com/con 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. 448 CARDOZO PUB. LAW POLICY & ETHICSJ. [[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, http://www.mayoclinic.com/health/gynecomastia/DS00850/ (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), http://blogs.wsj.com/health/2008/11/25/risperdal-can-have-troub ling-side-effects-in-boys/. 201 Schilling v. Ellis Hosp., 75 A.D.3d 1044, 1046 (App. Div. 3d Dept. 2010). FAILING TO WARN 2014] 449 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. V. INTERPRETING STATISTICS AND CREATING A LIABILITY SCALE 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 202 Id 203 See Murrayv. Maniatis, 21 A.D.3d 1012, 1012 (2nd Dept. 2005); Schilling, 75 A.D.3d at 1046. 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. HEALTH, 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). 205 206 207 208 Id Id Id. at 700. CARDOZO PUB. LAW POLICY & ETHICS J 450 [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 A. 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 209 Id. 210 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. 211 212 213 214 215 216 217 218 PSYCHOL. S35 (2005). 2014] FAILING TO WARN 451 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. 228 Id 229 Id. Id 230 OPERATIONAL REs. 1333, 1333- 452 CARDOZO PUB. LAW POLICY &' ETHICS J [Vol. 12:423 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 39 231 232 233 234 235 236 237 238 239 Hibbard & Peters, supra note 204, at 427. Id Id Lipkus, supra note 205, at 700. Id Id Hibbard & Peters, supra note 204, at 414. Lipkus, supra note 205, at 700. Id 2014] FAILING TO WARN 453 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 Id. 241 Jon F. Metz et al., Verbal Expressions of Probability in Infornned Consent Litigation, 11 240 MED. DECIS. MAKING 273, 277 (1991). 242 Metz, supra note 7, at 65, 73. 243 244 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. 454 CARDOZO PUB. LAW POLICY & ETHICS J.: [Vol. 12:423 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. 2014] FAILING TO WARN 455 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. 253 254 456 CARDOZO PUB. LAW POLICY &rETHICSJ. [[Vol. 12:423 CONCLUSION 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 WebMD.com, RxList.com, and Drugs.com, 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. 255 256 Hibbard & Peters, supra note 204, at 427. Id. at 429-30.