#13
Ending the Performance Enhancing Drug Epidemic:
Let’s Stop the Problem Where It Starts ~ Imposing Liability on Drug Manufacturers
I.
Introduction
"I started taking anabolic steroids in 1969 and never stopped.
It was addicting, mentally addicting. Now I'm sick, and I'm
scared. Ninety per cent of the athletes I know are on the stuff.
We're not born to be 300lbs or jump 30ft. But all the time I
was taking steroids, I knew they were making me play better.
I became very violent on the field and off it. I did things only
crazy people do. Once a guy sideswiped my car and I beat the
hell out of him. Now look at me. My hair's gone, I wobble
when I walk and have to hold on to someone for support,
and I have trouble remembering things. My last wish?
That no one else ever dies this way."1
-Lyle Alzado, former NFL Lineman,
during his pain racked final days.
Alzado died of brain cancer attributable to excessive hGH and anabolic steroid use.2
Unfortunately, Lyle Alzado is not alone. Performance enhancing drug use has hit epidemic
levels3 in today’s society. From high school athletes to professionals, death resulting from such
use is all too common.
Sport is touted as a “bridge between cultures,” a “celebration of humanity.”4 It brings
individuals together, acting as a universally spoken language. The competitive nature that is the
very spirit of athletics provokes a desire in athletes to continually strive to enhance their
performance.5 Sports today are plagued by the reality6 that the desire for superior performance
inspires athletes to use and sometimes abuse legal drugs for performance enhancing purposes.7
“Drug use has a ‘snowball effect’ on athletes.”8 Use of performance enhancing drugs renders an
unbalanced competition, which in turn encourages those that are drug-free to become users
1
Memorial to Lyle Alzado, available at http://www.geocities.com/bigcory94533/alzado.html (last visited October
18, 2005).
2
Steroid Substitutes, No. FDA 93-1207 (July 1993), available at
http://www.openseason.com/annex/library/cic/X0081_ster_sub.txt.html (last visited October 18, 2005).
3
Steroids and Kids, (December 20, 2004), available at http://sev.prnewswire.com/publishing-informationservices/20041212/NYSU01012122004-1.html (last visited February 27, 2006).
4
Australian Sports Drug Agency: Anti-Doping Forum, (December 2004), available at
http://www.asda.org.au/_docs/Adforum_Sydney_Dec04.pdf (last viewed October 18, 2005).
5
The EPO Epidemic in Sport, available at http://www.bloodline.net/stories/storyReader$3144 (last visited March 3,
2006).
6
Who will win the drugs race?: Catching drug cheats is essential if sports are to be conducted on a level playing
field – and if deleterious health effects are to be avoided, available at www.science.org.au/nova/055/055key.htm
(last visited February 20, 2006).
7
The EPO Epidemic in Sport, supra note 5.
8
Id.
2
themselves, in an effort to remain competitive.9 For example, studies have shown that use of
Erythropoietin, a peptide hormone,10 can potentially enhance aerobic capacity by ten percent.11
“At the top level of athletics, that is the difference between worst and first.”12 While these drugs
can be used to enhance an athlete’s performance, they are potentially fatal.13 It is a grand risk for
an athlete to take, as he/she has no way of knowing exactly how the drug will affect his/her body
prior to using it for the first time.14
Use of performance enhancing drugs has become so rampant that we can rarely turn on
the television, read a newspaper, or surf the web without learning about another athlete’s stellar
performance being called into question. Canadian sprinter Ben Johnson,15 NFL lineman Lyle
Alzado,16 Major League Baseball player Jason Giambi,17 Chinese swimmer Yuan Yuan,18 an
entire cycling team in the 1998 Tour de France19; the list goes on and on. The 2006 Winter
Olympic Games in Torino had merely begun when eight cross-country skiers were making
headlines around the world.20 Athletes were suspended from the games for five days when
allegations of performance enhancing drug use surfaced, and tests revealed excessive
9
Id.
The dope on banned drugs: Drug Dictionary, available at
http://www.cbc.ca/sports/indepth/drugs/glossary/dictionary.html (last viewed January 4, 2006).
11
Athletes and Drug Use, available at http://www.globalpinoy.com/pinoyhealth/ph_fitness/FI120103.htm (last
viewed February 9, 2006).
12
Id.
13
Quantum ABC Television: EPO, (March 30, 2000) available at www.abc.net.au/quantum/stories/s112234.htm
(last viewed February 9, 2006).
14
Steroid Dangers May Outweigh Performance Boost, (December 13, 2004), available at
http://12.31.13.113/healthnews/HealthNewsFeature/hnf121304.htm, (last viewed January 4, 2006).
15
Steroids and Sports are a Losing Combination, (June 1, 1995) available at
http://www.fda.gov/bbs/topics/CONSUMER/CON00107.html (last visited January 4, 2006).
16
Steroid Substitutes: No-win Situation for Athletes, No. FDA 93-1207 (July 1993), available at
http://www.openseason.com/annex/library/cic/X0081_ster_sub.txt.html (last visited October 18, 2005).
17
Steroid Dangers May Outweigh Performance Boost, Id. note 14.
18
CBC Sports Online, 10 Drug Scandals, (January 19, 2003) available at
http://www.cbc.ca/sports/indepth/drugs/stories/top10.html (last viewed February 9, 2006).
19
Scientists raise spectre of gene-modified athletes, (November 30, 2001), available at
http://www.newscientist.com/news/news.jsp?id=ns99991627 (last viewed February 9, 2006).
20
Scandal brewing? Eight XC skiers suspended for excessive hemoglobin, (February 9, 2006), available at
http://sportsillustrated.cnn.com/2006/olympics/2006/02/09/bc.oly.xxc.hemoglobinsu.ap/?section=cnn_mostpopular
(last viewed March 2, 2006).
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hemoglobin levels.21 These reports center around athlete reprimand. After all, they are the ones
making the choice to use the drug, right? New methods of drug testing22 are proposed and Acts23
promulgated in an effort to curtail the use of these substances. In actuality, these athletes are
sick; they have an addiction. Studies indicate that athletes are so driven to win, they get caught
up in the fantasy that what they are doing is not wrong, and if it is only a risk to personal safety,
they are willing to take that risk.24
This article suggests that the sole focus of liability on the athlete is misplaced. While an
athlete should be responsible for his/her actions, if we truly desire to stop this epidemic,
responsibility and liability should also be placed elsewhere. As opposed to merely seeking to
strengthen drug testing programs, and promulgating “Acts” to regulate Sport, some responsibility
and liability should rest with the very entity that creates the drug. It is imperative to stop the
problem where it starts. Part I of this article provides an overview of the performance enhancing
drug epidemic our world currently faces. Part II discusses the three most commonly used
performance enhancing drugs, their FDA approved use, and the reasons athletes choose to use
them. Part III traces societal trends in tort litigation, and proposes that we place liability on the
manufacturer of these drugs when they should know, or do in fact know that the distributors they
are providing these drugs to, are disseminating the drugs for an improper purpose. Part IV
summarizes the legal framework that should be applied in negligence claims against drug
21
Id.
Edward H. Jurith & Mark W. Beddoes, The United States’ and International Response to the Problem of Doping
in Sports, 12 FORDHAM INTELLECTUAL PROPERTY MEDIA & ENTERTAINMENT L.J. 461 (2002) (arguing for Federal
Anti-Doping programs in the United States, following the lead of other countries such as Australia and Canada.
23
Anabolic Steroid Controlled Substances Acts have been promulgated as needed over the years to reclassify drugs
based on prominence and use in society. The most recent was the Anabolic Steroid Control Act of 2004 which
amended the Controlled Substances Act of 1990.
24
Mannie, Ken, Performance-Enhancing Drug Abuse, 2000 SCHOLASTIC INC., January 1, 2000, at No. 6, Vol. 69,
Pg. 42.
22
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manufacturers. Finally, Part V concludes the article, proposing that we make it more difficult for
athletes to obtain performance enhancing drugs bringing an end to the epidemic.
II. The Basics: Commonly-Used Performance Enhancing Drugs
The 1950s brought about the use of hormones by athletes in an effort to increase their
strength and power. 25 Because hormones are important in organ and tissue development, they
continue today as the basis of most performance enhancing drugs.26 As regulations are
effectuated, and drug testing methods created, athletes are turning to prescription drugs, in an
effort to avoid detection and punishment. The current trend is for athletes to use drugs intended
to treat diseases like cancer and anemia, for an unintended purpose such as improvement of their
aerobic capacity27 and to build muscle mass and strength.28
Three of the most commonly used performance enhancing drugs among athletes are
Erythropoietin (EPO), Human Growth Hormone (hGH), and Anabolic Steroids.29 EPO, hGH,
and Anabolic steroids are all hormones – “naturally occurring chemical messengers that regulate
many of the body’s functions.”30 The FDA has approved each of these hormones for specific
medicinal purposes.31 None of the drugs, however, are approved for the purpose of performance
enhancement. Athletes, therefore, are using these legal drugs, for an illegal purpose.
25
Doping in Cycling, supra note 21.
Who will win the race?, supra note 6.
27
Scientists raise spectre of gene-modified athletes, (November 30, 2001), available at
http://www.newscientist.com/news/news.jsp?id+ns99991627 (last viewed February 2, 2006).
28
How Performance-Enhancing Drugs Work, available at http:// www.howstuffworks.com/athletic-drug-test.htm
(last viewed February 2, 2006).
29
Which drugs are commonly used by elite athletes?, available at http://www.jaconline.com.au/legaloutcomes/hottopics/005-price-of-gold/which-drugs.html (last viewed December 11, 2005).
30
Who will win the race?, Id. note 24.
31
See generally, http://www.fda.gov.
26
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A. Erythropoietin (EPO)
Erythropoietin is a protein hormone that is found naturally in our body.32 It is secreted
by the kidneys,33 and stimulates the bone marrow in order to increase red blood cell production.34
Increased red blood cell production in turn, increases the amount of oxygen the blood can carry
to the muscles.35 EPO was initially approved by the FDA in June of 1989, to treat anemia.36 It is
now approved for use in treatment of patients with AIDS or AIDS-related conditions.37 When
used for its intended purpose, EPO has relatively few side effects, such as fever, headaches, and
fatigue.38
Amgen, Inc. based in Thousand Oaks, California, and Ortho Pharmaceutical Corporation,
in Raritan, New Jersey are the two FDA approved manufacturers of EPO.39 Amgen markets the
product using the trade name Epogen, while Ortho Pharmaceutical’s trade name is Procrit.40
EPO is commonly used by athletes because the stimulation of red blood cells “increases
an athlete’s aerobic capacity and muscle endurance.”41 Sports most associated with the use of
EPO are cycling, cross-country skiing, and long distance marathons.42 “The same effect that
improves endurance performance also risks the safety of the user.”43 “EPO can cause the blood
to become viscous and more prone to clotting.”44 Relatively insignificant side effects for the
32
How Performance-Enhancing Drugs Work, supra note 26.
Id.
34
EPO: Illegal, Effective, and Deadly, (2004), available at www.copacabanarunners.net (last viewed October 18,
2005).
35
Australian Sports Drug Agency: Prohibited Substances and Methods, (January 1, 2004), available at
http://www.asda.org.au/athletes/banned.htm (last viewed December 11, 2005).
36
EPO for AIDs Related Condition: Food and Drug Administration, (January 2, 1991), available at www.fda.gov
(last viewed January 4, 2006).
37
Id.
38
Id.
39
Id.
40
Id.
41
The dope on banned drugs: Drug Dictionary, supra note 10.
42
Id.
43
EPO: Illegal, Effective, and Deadly, supra note 32.
44
Id.
33
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unintended user are headache, nausea, vomiting, diarrhea, and rash.45 The side effects for the
unintended user can, however, be quite severe.46 “Unnaturally high red-blood cell levels
increase the risk of heart attack, stroke, and pulmonary embolism. The risk is exacerbated by
dehydration, which often occurs during endurance exercise.”47
Johannes Draaijer, a young Dutch cyclist, suffered the fatal consequences of using EPO
as a performance enhancing drug.48 Six months after finishing twentieth in the 1989 Tour de
France, cycling’s most grueling event, Draaijer’s heart ceased beating.49 He was dead at twentyseven, leaving behind a young wife.50 She spoke out about her husband’s death, warning his
fellow competitors of the fatal consequences of performance enhancing drugs.51 According to
his wife, Draaijer became sick after using the performance enhancing drug, Erythropoietin
(EPO).52
Johannes Draaijer is one of many deaths linked to performance enhancing drugs.53 In
1987, along with the availability of EPO, came sudden unexplained deaths among elite cyclists.54
In 1987,
“five Dutch cyclists died, followed by two more
Dutch riders and a Belgian in 1988, five Dutch
cyclists in 1989, and two Dutch and three Belgian
riders in 1990. All were regarded as fit and healthy
athletes before heart failure or related causes ended
their lives.”55
45
Gale Encyclopedia of Medicine, Erythropoietin test, (December 2002), available at
http://www.healthatoz.com/healthatoz/Atoz/ency/erythropoietin_test.jsp (last viewed February 27, 2006).
46
Id.
47
Australian Sports Drug Agency: Prohibited Substances and Methods, supra note 33.
48
James Deacon & Paul Gains, A Phantom Killer, Maclean Hunter Limited, Nov. 27, 1995, at 58.
49
Id.
50
Id.
51
Id.
52
Id.
53
Bob Ford, EPO Debate Heats Up Before Olympics, The Philadelphia Inquirer, June 11, 2000, at K7533.
54
Ann Westmore, Lack of Volunteers Hampers Drug Research, Canberra Times (Australia), Aug. 11, 1998, at Part
A, pg. 7.
55
Westmore, supra note 52.
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The trend in usage has not subsided, even as a result of these deaths. As recently as
2003, four more professional cyclists died from heart attacks, attributable to use of EPO as a
performance enhancing drug.56
B. Human Growth Hormone (hGH)
Human Growth Hormone is a peptide hormone57 produced in the anterior section of the
pituitary gland.58 It has been used since the 1950s59 to aid growth and development in adolescent
children.60 Side effects associated with hGH are gigantism,61 heart disease, and increased oil
gland production.62
The FDA approved Protropin, a recombinant hGH manufactured by Genetch, Inc. in San
Francisco, California, in October 1985.63 Eli Lily is also a manufacturer of hGH, sold by the
trade name, Humatrope.64 It is manufactured in Indianapolis, Indiana, and was approved on
March 8, 1990, with its only then accepted use being the treatment of children who have stunted
growth due to an inadequate endogenous growth hormone.65 In August 1996, however, the FDA
extended their approval for use in adults to treat “somatotrophin deficiency syndrome.”66 Like
EPO, hGH is not approved as a performance enhancing drug.
56
John Black, Drug Cheats Off to Flying Start, Nationwide News Pty Limited Courier Mail (Australia), Nov. 24,
2004, at 21.
57
The dope on banned drugs, supra note 10.
58
Will Growth Hormone Prove to be the First “Anti-Aging” Medication?, available at
http://www.usdoctor.com/gh.htm (last viewed February 27, 2006).
59
Australian Sports Drug Agency: Prohibited Substances and Methods, supra note 45.
60
Which drugs are commonly used by elite athletes?, supra note 27.
61
Id. (The term [gigantism] means excessive growth.)
62
Australian Sports Drug Agency: Prohibited Substances and Methods, supra note 45.
63
FDA: Human Growth Hormone, (March 12, 1990), available at http://www.fda.gov. (last viewed January 4,
2006).
64
Id.
65
Id.
66
FDA approved HGH?, (October 7, 2003), available at http://www.hghnews.us/p/101%2C212.html (last viewed
March 2, 2006).
8
Human Growth Hormone is commonly used by athletes because it stimulates muscle
growth, and helps reduce body fat.67 Studies indicate that Insulin Growth Factor 1, a growth
hormone, can increase muscle strength by up to twenty-seven percent.68 hGH also aids in
recovery following strenuous training.69 It is most commonly used by swimmers,70 but has also
been used by athletes such as football players, to increase muscle mass and strength.71
The law prohibits distribution or possession with the intent to distribute hGH for human
use other than medically approved uses, pursuant to a physician’s order.72 Violation of this
statute is punishable by imprisonment and / or fines.73
C. Anabolic Steroids
Anabolic steroids are likely the most commonly known performance enhancing drug.
They are similar to the male hormone, testosterone,74 increasing muscle and strength.75
Physicians prescribe anabolic steroids to patients with wasting diseases, and to HIV infected
men.76
Athletes most commonly use anabolic steroids to “bulk up” and increase their strength.77
They are also used in an effort to reduce recovery time following an injury.78 Sports commonly
associated with use of anabolic steroids are football, sprinting, and bodybuilding.79 Athletes face
67
The dope on banned drugs, supra note 55.
Athletes and Drug Use, supra note 11.
69
Id.
70
The dope on banned drugs, supra note 55.
71
Steroid Substitutes, supra note 2.
72
Federal Food, Drug and Cosmetic Act, 21 U.S.C. §333(e) (2005).
73
Id.
74
FDA Consumer: Are Steroids and Growth Hormones Safe?, (April 1990 update), available at
http://www.cfsan.fda.gov/~dms/qa-nut10.html (last viewed March 3, 2006).
75
Which drugs are commonly used by elite athletes?, supra note 27.
76
The dope on banned drugs, supra note 55.
77
Which drugs are commonly used by elite athletes?, supra note 73.
78
Id.
79
Athletes and Drug Use, supra note 66.
68
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a variety of side effects by taking anabolic steroids, ranging from aggression and
“masculinizing” side affects,80 to harm to the liver, cardiovascular and reproductive systems.81
More than one hundred anabolic steroids are currently available.82 Regulated by the
Drug Enforcement Administration, anabolic steroids were placed on the Controlled Substances
Act's Schedule III by the Anabolic Steroids Act of 1990.83 The Anabolic Steroid Control Act of
2004 amended the previous Act, imposing increased penalties for steroid use.84 Unlawful
distribution and possession with the intent to distribute anabolic steroids is a federal crime,
punishable by up to five years in prison.85 Since penalties were enacted for steroid use, many
athletes have avoided anabolic steroids,86 turning to substitutes such as Erythropoietin and
Human Growth Hormone.
III. Societal Trends in Tort Litigation
Public policy is a driving force behind litigation. As society changes and evolves, so too
must American Jurisprudence. “Society subjects dangerous instrumentalities to regulatory
schemes that safeguard or compensate the public.”87 The imposition of tort liability is an
additional means for ensuring adherence to these regulations.88 Historically, tort liability has
been imposed in a variety of contexts and industries.
80
Who will win the drugs race?: Catching drug cheats is essential if sports are to be conducted on a level playing
field – and if deleterious health effects are to be avoided, supra note 6.
81
Doping in Cycling, supra note 23.
82
Steroid Types, available at http://www.steroids.com/types.asp (last viewed February 27, 2006).
83
FDA: U.S. Drug Abuse Regulation and Control Act of 1970, available at http://www.fda.gov (last viewed March
2, 2006).
84
Anabolic Steroid Control Act of 2004: 108th Congress, available at http://www.theorator.com/bills108/s2195.html
(last viewed December 11, 2005).
85
Food and Drugs, 21 U.S.C. §841 (2005).
86
Steroid Substitutes, supra note 2.
87
Joi Gardner Pearson, Make It, Market I, and You May Have to Pay for It: An Evaluation of Gun Manufacturer
Liability for the Criminal Use of Uniquely Dangerous Firearms in Light of In re 101 California Street, B.Y.U.L.
Rev. 131 (1997) (quoting Andrew J. McClurg, The Tortious Marketing of Handguns: Strict Liability is Dead, Long
Live Negligence, 19 SETON HALL LEGIS. J. 777 (1995).
88
Id.
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Drugs, used for performance enhancing purposes rather than for their medicinally
approved use, are dangerous instrumentalities. These drugs are not only dangerous to the
athletes that choose to use them; they also pose a danger to society. Drugs alter personalities;
they alter the competitive balance in sports, and can potentially lead to death.89 Because
performance enhancing drugs are so prevalent in today’s society and increasingly easy to obtain,
imposing a legal duty on those who introduce the drugs into the stream of commerce will compel
regulation of distribution, thereby reducing the unintended use of these substances. The most
compelling tort claims to assert against drug manufacturers are negligence claims. Based on the
legal framework in comparable contexts, negligent distribution is the most viable claim to assert
against drug manufacturers. Negligent marketing and negligent entrustment are potentially
viable claims as well.
A.
A Claim Based on Negligence: The Basics
Negligence is “conduct which falls below the standard established by law for the
protection of others against unreasonable risk of harm.”90 Common Law Negligence consists of
three elements: (1) a legal duty owed by one person to another; (2) a breach of that duty; and (3)
damages proximately resulting from the breach.91
Establishing that the manufacturer has a duty is the cornerstone of establishing a prima
facie case in negligence.92 Duty is the care a reasonable person would take under the same or
similar circumstances.93 It is sourced in “existing social values and customs.”94 Though there is
no standard equation for establishing a duty, “the most commonly applied test used to determine
89
The dope on banned drugs: Drug Dictionary, supra note 10.
RESTATEMENT (THIRD) OF TORTS §282 (2005).
91
84 AM. JUR. Trials §105 (2005).
92
Christie, George C. & James E. Meeks, et. al., Cases and Materials on The Law of Torts 234 (West Publishing Co.
1997) (1938).
93
Dobbs, Dan B., The Law of Torts, Hornbook Series, § 115 (2000).
94
Mullins v. Pine Manor College, 389 Mass. 47, N.E. 2d 331 (1983) (quoting Schofield v. Merrill, 386 Mass. 244,
435 N.E. 2d 339 (1982)).
90
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whether a legal duty exists is the ‘foreseeability’ standard.”95 This standard turns on whether the
harm caused was a “reasonably foreseeable” consequence of the actor’s actions.96 The
foreseeability standard was enunciated in the landmark decision, Palsgraph v. Long Island
Railroad Co.97 Merely the result must be foreseeable, the manner in which the incident occurs
need not be.98 Foreseeability, however, is not the only factor to consider. Other relevant factors
in determining whether a duty exists are the “morality and justice of imposing liability, and
society’s ideology of where to direct the loss.”99
Moreover, the existence of a third party complicates the finding of a duty to exist. As a
general rule, the defendant has no duty to control third party actions.100 The rule ceases to apply,
however, when a “special relationship” exists between the parties.101 A special relationship may
exist by means of a contract, or may exist solely because of the kinship between the parties. 102
When a special relationship exists between the actor and the third person, the law of torts
imposes a duty on the actor to exhibit control over the third person’s conduct.103
The determination of whether a duty exists, and the extent and scope of this duty are
questions of law for the court.104 Duty is typically established either by statute promulgated by
the Legislature, or by the court where “clearly supported by public policy.”105 When establishing
a duty based on public policy, courts consider factors such as:
“the foreseeability of harm to the plaintiff, the degree
95
Pearson, supra note 85, at 153.
Lavo v. Medlin, 705 S.W. 2d 562 (1986).
97
Doug Morgan, What in the Wide, Wide World of Torts is Going on? First Tobacco, Now Guns: An Examination
of Hamilton v. Accu-Tek and the Cities’ Lawsuits Against the Gun Industry, 69 MISS L.J. 521 (1999).
98
St. John Bank & Trust Co. v. City of St. John, 679 S.W. 2d 399 (1984) (quoting Prosser & Keeton, Torts §44 at
317).
99
Morgan, id. note 95, at 543.
100
Greater Houston Transportation Co. v. Kurt Steven Phillips, 801 S.W. 2d 523 (1990).
101
Hergenrether v. East, 61 Cal. 2d 440, 393 P.2d 164, 39 Cal. Rptr. 4 (1964).
102
California Civil Practice: Torts §1.2 (2005).
103
See Greater Houston Transportation Co., 801 S.W. 2d at 525.
104
Merrill v. Navegar, 26 Cal. 4th 465, 28 P.3d 116, 110 Cal. Rptr. 2d 370 (2001).
105
Id.
96
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of certainty that the plaintiff suffered injury, the
closeness of the connection between the defendant’s
conduct and the injury suffered, the moral blame
attached to the defendant’s conduct, the policy of
preventing future harm, the extent of the burden to
the defendant and consequences to the community
of imposing a duty to exercise care with resulting
liability for breach, and the availability, cost, and
prevalence of insurance for the risk involved.”106
B.
Remaining Elements of Negligence
To determine whether the defendant breached the duty of care owed to the plaintiff,
“the magnitude of the harm likely to result from
[a] defendant’s conduct must be balanced against
the social value of the interest which he is seeking to
advance, and the ease with which he may take
precautions to avoid the risk of harm to plaintiff.”107
Finally, establishing a prima facie case in negligence requires proof of causation.108
Causation can be broken down into two prongs: (1) Causation in fact; and (2) Proximate
Cause.109 “Causation in fact” requires that the defendant’s conduct caused the plaintiff’s harm or
injury.110 Sine qua non is the test most often employed to establish causation.111 This means,
“but for” the act of the defendant, the plaintiff would not have been injured.112 When this
rigorous standard is not met, if it can be proven that the defendant’s act was the “substantial
cause or causes” of the event that occurred, then in most jurisdictions causation will be met.113
Proximate cause is the test for legal cause the judge uses in deciding whether the plaintiff
is within the scope of foreseeable harm that the defendant’s actions created. Proximate cause
concerns itself with policy, asking “the larger, more abstract question: Should the defendant be
106
See Merrill, 26 Cal. 4th at 477.
Ileto v. Glock, Inc., 349 F.3d 1191 (Ninth Cir.) (2003).
108
Christie, George C. & James E. Meeks, et. al., supra note 89, at 234.
109
Id.
110
See id. at 235.
111
Id.
112
Id.
113
Id.
107
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held responsible for negligently causing the plaintiff’s injury?”114 The judge will consider
whether the act was foreseeable, and whether intervening or superceding causes were instead the
reason for the plaintiff’s harm. In some jurisdictions, proximate cause requires the cause of harm
to be substantial; it need not be the sole cause of the harm, however.115 Other jurisdictions
employ a stricter standard and require proof that the defendant’s action (or inaction) was a
probable cause of the harm.116 As with establishing the existence of a duty, intervening factors
such as third party actors, do not necessarily bar the defendant’s liability.117 Rather, as long as
the intervening force is foreseeable, it is within the scope of the defendant’s negligence.118
C.
Theories of Negligence
Negligent Distribution, Negligent Marketing, and Negligent Entrustment are viable
claims to assert against a drug manufacturer. While negligent distribution and negligent
marketing claims are often asserted in tandem, and even confused, it is necessary to accurately
distinguish between these theories of negligence. The rationale behind the theories is for
individuals to avoid foreseeable risks of harm to others by using reasonable care.119
Negligent Distribution
A manufacturer is liable for “negligent distribution” when it fails to use “reasonable
means” to regulate the sale of its product.120
Negligent Marketing
A manufacturer is liable for “negligent marketing” when it markets its product in a
manner that increases a product’s inherent risk to consumers and third parties.121 There are
114
Evan v. Hughson United Methodist Church, 8 Cal. App. 4th 828, 10 Cal. Rptr. 2d 748 (1992).
See Iteto, 349 F. 3d at 1206.
116
Scafidi v. Seiler, 119 N.J. 93, 574 A.2d 398, (1990).
117
Id.
118
Tenney v. Atlantic Associates, 594 N.W. 2d 11 (1999) (quoting RESTATEMENT (SECOND) OF TORTS §449, cmt. b,
(2005)).
119
Morgan, supra note 95, at 6.
120
See Ileto, 349 F. 3d at 1197.
115
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currently three aspects of negligent marketing claims: (1) negligent marketing of unusually
dangerous weapons; (2) negligent advertising of handguns to criminal consumers; and (3)
negligence in the failure to take “reasonable precautions to minimize the risk of handguns being
sold to those likely to misuse them.”122
Negligent Entrustment
A manufacturer is liable for “negligent entrustment” when it entrusts its product to a
distributor with the knowledge that the product is likely to be used in an improper or dangerous
fashion. 123
D. Liability in Comparable Contexts
To establish a legal framework for drug manufacturer liability, it is necessary to examine
manufacturer liability in comparable contexts. This article suggests a legal framework based on
similarities and persuasively distinguishable characteristics in liability imposed on manufacturers
of guns, pesticides & fungicides, chemicals, and slingshots.
Imposition of liability on drug manufacturers may arise in different contexts, depending
on the drug involved, and penalties associated with its unintended use. For example, the
Controlled Substances Act of 1990 placed anabolic steroids on the Schedule III list of controlled
substances, thereby imposing a criminal penalty on individuals distributing steroids for
unintended uses.124 Distribution and subsequent acquisition of drugs carrying criminal penalties
can be analogized to the manufacture and distribution of guns to illegal purchasers.
121
Richard C. Ausness, Tort Liability for the Sale of Non-defective Products: An Analysis and Critique of the
Concept of Negligent Marketing, 53 S.C. L. Rev. 907 (2002).
122
Andrew Jay McClurg, Symposium: Triggering Liability: Should Manufacturers, Distributors, and Dealers Be
Held Accountable for the Harm Caused by Guns?: The Tortious Marketing of Handguns: Strict Liability is Dead,
Long Live Negligence, 19 SETON HALL LEGIS. J. 777 (1995).
123
National Association for the Advancement of Colored People v. Acusport, Inc., 271 F. Supp. 435 (2003).
124
FDA: U.S. Drug Abuse Regulation and Control Act of 1970, supra note 81.
15
Today, the gun industry is at the forefront of tort litigation.125 The 1980s brought about
the theory of negligent marketing as a possible basis for recovery in gun manufacturer liability
cases.126 Negligent distribution and negligent entrustment claims were often asserted in tandem
with the negligent marketing claim. Early cases proposing these theories were not well accepted
by courts, as they found no duty owed by manufacturers, thereby precluding a prima facie case in
negligence.127 The late 1990s brought about a seemingly changing attitude in the New York and
California court systems, however this came to a screeching halt in the early 2000s when
decisions in Hamilton v. Accu-Tek and Merrill v. Navegar were overturned.128 Perhaps the
attitude is again on the rebound as illustrated by Ileto v. Glock.129 Courts are at least allowing the
claims to withstand the biggest hurdle of establishing that manufacturers have a duty.
Liability was established in Ileto v. Glock, when Lilian Ileto, decedent’s mother, joined
with four minors shot in a Jewish Community Center by a deranged gunman (prohibited from
gun possession130), and was allowed to bring suit against gun manufacturers, distributors, and
dealers. 131 Plaintiffs asserted public nuisance and negligence claims against the defendants.
The negligence claim is based on the argument that “through their distribution scheme,
defendants created an illegal secondary market for guns targeted at illegal users.”132 In reversing
the lower court’s dismissal of the negligence claim against defendant, Glock, Inc., the Court of
Appeal found that the plaintiffs sufficiently alleged “reasonable foreseeability,” and proved the
causal connection between the manufacturers’ negligence and the harm suffered.133
125
Andrew M. Dansicker, The Next Big Thing For Litigators, 37-AUG MD. B.J. 12 (2004).
Ausness, supra note 119, at 918.
127
Id.
128
Id.
129
Ileto v. Glock, 349 F. 3d. 1191 (2003).
130
Id. at 1204.
131
Id. at 1196.
132
Id. at 1201.
133
See Ileto, 349 F. 3d at 1203.
126
16
Reasonable foreseeability was established by plaintiff’s allegations that Glock, a gun
manufacturer, targeted states that have less stringent gun laws so that guns will be sold there,
then distributed to the neighboring states with more stringent laws.134 Reasonable foreseeability
was further established by evidence that the harm suffered by the plaintiffs “is the kind of harm
that is reasonably foreseeable when a person who is forbidden under federal law from purchasing
guns is able to purchase an arsenal as a result of the manufacturer’s distribution system.”135
The court found a duty to exist, and that duty was thereby breached because the
defendants continued to supply distributors they knew distributed in crime-ridden areas, and
because defendants failed to contract with the distributors to prohibit sales in areas of crime.136
Further, manufacturers failed to provide training so that distributors would avoid selling to illegal
purchasers.137 Taking public policy into consideration, the court found a duty to exist, because
the “social value of this practice to the defendants is outweighed by the health and safety interest
of potential victims of gun violence at the hands of prohibited purchasers.”138
The court concluded causation was met because Glock could have prevented the harm.139
“The key … is that the defendant’s relationship with either the tortfeasor or the plaintiff places
the defendant in the best position to protect against the risk of harm.”140 Defendants argued that
an intervening act by the gunman should absolve manufacturer liability.141 The court disagreed,
and held that the intervening act was foreseeable because Glock’s negligent distribution and
marketing targeted people like the gunman.142 Plaintiffs therefore, established a prima facie case
134
Id. at 1197.
Id. at 1205.
136
Id.
137
Id.
138
Id. at 1206.
139
Id. at 1207.
140
See Ileto, 349 F. 3d at 1207.
141
Id. at 1209.
142
Id.
135
17
in negligence with regard to defendant, Glock. The case was remanded to the lower court for
further proceedings.143
The court recently employed a similar rationale in District of Columbia v. Beretta.144
Nine plaintiffs in the instant action appealed the dismissal of their suit against gun manufacturers
and distributors.145 Plaintiffs sued on several theories, one of which was negligence.146 They
argued that defendants should be held criminally liable because misuse of defendant’s guns led
to their injury, or to the death of a family member.147 Similar to Ileto, plaintiffs allege that
defendants failed to enter their product into the market in a manner that would prohibit the guns
from reaching the hands of criminal users.148
Dissimilar to Ileto however, the court declined to find the requisite elements met in order
to allow plaintiffs’ action.149 It reasoned that in the case of third party intervention, a special
relationship must exist to establish that defendant had a duty.150 It then declined to extend the
special relationship distinction because plaintiffs failed to suggest a “reasonable way that gun
manufacturers could screen the purchasers of their guns to prevent criminal misuse.”151
Additionally, it found the chain of causation to be too attenuated.152
Drug manufacturers’ act of negligently distributing their product is analogous to the
negligent distribution of guns. Just as the distribution scheme in the gun industry leads to an
illegal secondary market targeted at illegal users,153 the lack of regulation and haphazard
143
Id. at 1217.
District of Columbia v. Beretta, 872 A.2d 633 (2005).
145
Id. at 638.
146
Id. at 637.
147
Id. at 638.
148
Id. at 638.
149
Id. at 641.
150
Id. at 640.
151
Id.
152
Id. at 644.
153
Id. at 1202.
144
18
distribution of prescription drugs leads to acquisition of these drugs by unintended users, thereby
fueling the performance enhancing drug epidemic. In both contexts, the manufacturers continue
to supply their product with the knowledge that the distribution will likely, or in fact does, cause
their product to fall into the hands of misusers. Moreover, the Ileto court imposed a duty on gun
manufacturers because of the value that their decision would bring to society. 154 Imposing a duty
on drug manufacturers would similarly render benefit to today’s society. In holding drug
manufacturers responsible for their distribution scheme, society would derive value from more
restricted access to drugs for non-prescription uses. This would in turn reduce the number of
individuals able to easily access the drugs, thereby causing less misuse and fewer fatalities. It
too will reinstill the value of hard work, competition, and true heroism in sports by causing
athletes to strive for excellence merely through physical performance and stamina rather than
relying on drugs for enhanced performance. It will eliminate the competitive imbalance caused
by the use of these drugs, and in turn reinstate the legitimacy of sport.
Dissimilar to the harm caused by the manufacturer’s actions in the drug industry, in the
gun context the injured party, estate, or even a city is typically suing the gun manufacturer
because of the actions of a third party shooter, who used the gun to injure the victim. The drug
context is distinguishable because the injured athlete or the athlete’s estate if deceased, is not
suing the drug manufacturer because of the unlawful actions the third party distributor took
against the athlete. If the act of the distributor was in fact unlawful, it was at the request of the
athlete, as opposed to the athlete being an unknowing third party victim as is the case with gun
plaintiffs. Moreover, the malicious act of loading a bullet into a gun and shooting another
individual with the intent to harm is extremely different from risking your own personal health
and safety by using a drug to enhance your performance in a sporting event. This distinction
154
Id. at 1205, 1206.
19
obviates the obstacle faced by the court in establishing “reasonable” foreseeability sufficient to
impose a duty on defendant manufacturers in District of Columbia v. Beretta.
Further, the court struggles with the question of where liability ever ends in the gun
context, because the chain of causation is so attenuated.155 It is difficult to establish a duty, and
hold a gun manufacturer liable for distribution because there are so many intervening factors in
the chain. Guns are sold, and re-sold making it nearly impossible to track the exchanges between
owners once the product actually enters the stream of commerce. Again this is distinguishable
from the drug industry. To obtain performance enhancing drugs, the athlete either seeks a
physician’s assistance or finds an Internet website selling drugs. The latter is the more likely
source being that it is incredibly simple to purchase over the Internet. With either means of
purchase, however, the chain of causation is far less attenuated in the drug context because once
purchased, the drugs are consumed, as opposed to being sold and re-sold like guns. The less
attenuated chain of causation makes it easier to track the drug distribution back to the
manufacturer, thereby obviating the difficulty the courts faced in linking gun manufacturers to
the negligent distribution of guns. Moreover, the ability to purchase hGH and certain anabolic
steroids on the Internet makes tracing distribution back to specific manufacturers relatively
simple. The websites used to order these drugs often list the manufacturers that distribute to
them. In such instances, there is no uncertainty as to what manufacturer initiated the negligent
act of distributing their product to known unintended users. Negligence therefore ensues when
the manufacturer fails to take adequate precautions in distributing their drugs to pharmacists and
physicians who in turn provide drugs to athletes to enhance their performance rather than
prescribing the drug for its FDA approved purpose.
155
Hamilton v. Beretta, 96 N.Y. 2d 222, 750 N.E. 2d 1055, 727 N.Y.S. 2d. 7 (2001).
20
Courts also must walk a fine line in not impeding individual rights with regulations in the
gun industry. The court must balance the right to bear arms under the Second Amendment with
the desire to keep such dangerous instrumentalities out of the hands of criminals, so as not to
cause harm to disinterested third parties. A similar concern is simply not present in the drug
industry. Restrictions on distribution will not infringe on personal rights, and it will not hinder
intended users from obtaining drugs necessary for treatment of their disease. Rather, regulation
in the drug industry will serve to curb unintended use, benefiting society, as opposed to
inhibiting personal liberties.
Because of the distinguishing characteristics of the drug industry, an alternative and
perhaps stronger argument for imposing liability on drug manufacturers is to argue that a chain
of negligence stemming from the manufacturer’s initial negligent act, absent a third party
criminal act, is responsible for the plaintiff’s injury. This theory is plausible regardless of
whether the negligence led to a subsequent act criminal in nature. The manufacturer remains
liable for his initial negligent act as long as the subsequent negligent acts were foreseeable to him
at the time his negligence ensued.156
Claims based on negligent distribution theories are relatively few in number. While
establishing liability based on negligence in the face of an intervening criminal act has only
recently prevailed as evidenced in Ileto, negligent distribution claims without the intervening
third party criminal element have proven even more successful over the years. Absent third
party action, negligence takes one of two forms. The negligent act of the manufacturer may lead
to a violation of some law or statute. In the alternative, the negligence need not lead to a
subsequent illegal act for the original negligent manufacturer to be held liable.
156
Christie, George C. & James E. Meeks, et. al., supra note 106, at 329.
21
If the drug used for performance enhancing purposes is a Schedule III drug, criminal
penalty will be imposed for unintended distribution.157 Therefore, in the absence of an
intervening third party, when the manufacturer’s negligent action leads to illegal distribution and
use of the drug, the legal framework in Suchomajcz v. Hummel Chemical Co.158 should be
applied. The Suchomajcz court held that distribution of a chemical to a foreseeable misuser of
the product was sufficient grounds for a negligent distribution claim.159
In Suchomajcz v. Hummel Chemical Company, plaintiffs alleged chemical manufacturer,
Hummel, “knew or should have known” that the company they were distributing chemical
components to intended to use the chemicals to manufacture and sell firecracker assembly kits.160
These firecracker kits were illegal.161 The Suchomajcz Court based its decision partially on
policy.162 It reasoned that the manufacturer knew that the distributor intended to misuse the
chemicals.163 Moreover, the “social utility of knowingly selling chemicals for illegal use is
minimal; the social consequences of such sales may be devastating.”164 Based on this
foreseeable misuse, a duty to warn arose.165 Hummel’s knowledge and inaction was sufficient
ground for the negligent distribution claim to prevail.166
Alternatively, distribution and use of drugs, such as EPO, are not Schedule III drugs, thus
not carrying a criminal penalty. Drugs such as EPO, therefore should follow the legal
framework established in E.I. Du Pont De Nemours & Co. v. Aquamar S.A.167 In Du Pont, a Du
157
Food and Drugs, supra note 83.
Suchomajcz v. Hummel Chemical Company, 524 F. 2d 19 (Third Cir.) (1975).
159
Id. at 28, 29.
160
See Suchomajcz, 524 F. 2d at 26.
161
Id.
162
Id.
163
Id.
164
Id.
165
Id. at 28.
166
Id.
167
E.I. Du Pont De Nemours and Company v. Aquamar S.A, 881 So. 2d 1 (2004).
158
22
Pont manufactured fungicide, Benlate, was applied to banana farms to prevent the spread of
Black Sigatoka, a disease, in Ecuador.168 Neighboring shrimp farms began to suffer loss of their
shrimp because they relied on river water, which was being contaminated by the Benlate.169
Plaintiffs sued Du Pont for negligently distributing Benlate.170 There were two reasons for
asserting this claim.171 Plaintiff alleged Du Pont “was negligent ‘in advising and instructing
Ecuadorians that Benlate should be widely applied in combination with the fungicides Tilt and
Calixin.’”172 Plaintiffs also alleged Du Pont acted or failed to act, following its notification of
the government that the fungicide was linked to the shrimp deaths.173 A jury awarded plaintiff
more than $12 million in damages for Du Pont’s negligent distribution of Benlate, however on
appeal, the court held plaintiff’s claims were preempted by the Federal Insecticide, Fungicide,
and Rodenticide Act.174
Regardless of whether the misuse is governed by criminal penalty, the courts apply a very
comparable rationale in the foregoing cases, indicating the cases turn on foreseeability,
causation, and public policy. Similar to Hummel Chemical Company and the Du Pont Fungicide
Manufacturer, drug manufacturers should be held liable for distributing their drugs to distributors
that they “know or should have reason to know” intended to provide the drugs to unintended
users. Moreover, the distributor of Benlate in Du Pont was liable in part because the
manufacturer failed to properly notify the government once they had knowledge that their
product was causing death of shrimp in nearby waters.175 While the Du Pont case is
distinguishable because the banana farmers were legitimate users of Benlate, this distinction does
168
Id. at 2.
Id.
170
Id. at 3.
171
See E.I. Du Pont De Nemours and Company, 881 So. 2d at 3.
172
Id.
173
Id.
174
Id. at 2.
175
Id.
169
23
not preclude use of Du Pont as precedent in the drug manufacturer context, because Du Pont’s
negligence was predicated in part on their failure to act. Du Pont neglected to notify the
government once they had knowledge that the shrimp deaths were caused by their product.
Liability similarly should follow in drug manufacturer cases. It is simply not a viable
defense for manufacturers to argue that they don’t have knowledge of the performance
enhancing drug epidemic that our world currently faces. A manufacturer’s knowledge that their
drug is potentially being used for unintended purposes, should render a duty on the manufacturer
to track its sales, and ensure legitimacy of its distributors. Whether supplying a pharmacy, either
tangible or on-line, manufacturers should be responsible for directing their products to
distributors who will abide by FDA regulations, thereby precluding distribution to unintended
users. Regulation of distribution to legitimate distributors could be achieved by manufacturers
performing background checks on distributors prior to selling their product.
Further, the same policy considerations applicable in Suchomajcz are persuasive in the
drug context. The Suchomajcz court compared the “social utility” to the “social consequences”
of the manufacturer’s actions.176 In the drug context, the social utility of selling prescription
drugs to athletes to enhance their performance is negligible. The social consequences of these
sales, on the other hand, are devastating to society. Legitimacy of America’s favorite pastime is
being called into question; athletes are dying, and use of these drugs is extending to today’s
youth. The legal framework employed in these negligent distribution cases, therefore, should
also serve as the framework for holding drug manufacturers liable for their negligent distribution
of drugs used for performance enhancing purposes.
176
See Suchomajcz, 524 F. 2d at 25.
24
Negligent marketing and negligent entrustment are also viable claims to assert against a
drug manufacturer. Asserted in tandem with a negligent distribution claim, they are even
stronger, as the claims illustrate the full realm of the manufacturer’s negligence.
Moning v. Alfono177 provides a legal framework for negligent marketing and entrustment
claims. Nearly twenty years ago, the Moning Court was presented the legal question, whether a
manufacturer of slingshots can be held liable for negligent marketing.178 Considering this issue,
the court reasoned that the theory of common law negligence was established by judges, and it
was necessary for the court to consider this issue because in the absence of action by the
Legislature, the court must adjudicate, either developing or limiting governing law.179
The plaintiff in Moning, a twelve year old boy, was blinded when his playmate hit him in
the eye with a pellet from his slingshot.180 Plaintiff’s claim based on negligent marketing,
alleges the manufacturer, wholesaler, and retailer are liable for marketing the sale of slingshots
directly to children.181 The Moning court found a duty to exist, establishing that the
manufacturer and wholesaler of a product are liable “by marketing the product,” and “owe a
legal duty to those affected by its use.”182
Plaintiff also asserted a claim based on negligent entrustment.183 He argued,
“One who supplies directly or through a third person a
chattel for the use of another whom the supplier knows
or has reason to know to be likely because of his youth,
inexperience, or otherwise, to use it in a manner involving
unreasonable risk of physical harm to himself and others
whom the supplier should expect to share in or be endangered
by its use, is subject to liability for physical harm resulting
to them.”184
177
Moning v. Alfono, 400 Mich. 425, 254 N.W. 2d 759 (1977).
Id. at 432.
179
Id. at 436.
180
Id. at 432.
181
Id.
182
Id. at 433.
183
Id. at 444.
178
25
The Court of Appeal reversed the trial court’s directed verdict for the defendants, and
remanded the action based on its finding that the manufacturer owed a duty to its consumers.185
Breach of the duty remained a question for the jury. 186
The gun industry attempted to use Moning as precedent for establishing negligent
marketing in Caveny v. Raven Arms Co.187 The Caveny court found Moning distinguishable, and
disallowed its application.188 It reasoned that the class of misusers in Moning was “readily
identifiable” because they were children, as opposed to an unlimited class of “gun users”.189
Further, it reasoned that means for prohibiting distribution to the misusers was viable in
Moning,190 whereas applied to gun manufacturers, it is difficult to “conceive of a method of
distribution by which handgun manufacturers could avoid the sale of its product to all potential
misusers”.191
Unlike Caveny’s unsuccessful attempt to follow Moning’s precedent, based on the
Moning Court’s rationale, drug manufacturers will be more successful in asserting Moning as
precedent. A child’s naivety and “blindness” to the danger of the toy because of their desire to
use the toy is analogous to an athlete’s uninhibited use of performance enhancing drugs. A
slingshot is an object that is appealing to a child. The child fails to see the inherent danger of the
slingshot because of the child’s desire to play with the fun toy. Such is the case with the
professional athlete. The athlete fails to see the danger in misusing a drug because his/her focus
is on enhanced performance promised by use of the product. The user in each situation is
184
Id. quoting RESTATEMENT (SECOND) OF TORTS §390.
See Moning, 254 N.W. 2d at 432.
186
Id.
187
Caveny v. Raven Arms Co., 665 F. Supp. 530 (S.D Ohio, Western Division) (1987).
188
Id. at 533.
189
Id.
190
Id.
191
Id. at 534.
185
26
blinded of the product’s danger by his/her desire to use the product. The benefits of the drug
resonate in the athlete’s mind, drowning out the recognition of the drugs’ danger. The athlete is a
child; the performance enhancing drug, his toy.
IV. Bringing It All Together: The Framework for Liability
Foreseeability, causation, and public policy support imposing a duty on drug
manufacturers to responsibly distribute their drugs. News reports, personal testimonials of
athletes and their families, and even athlete deaths render misuse of drugs such as EPO, hGH,
and Anabolic steroids foreseeable to drug manufacturers. Further, causation is met, as drug
manufacturers are certainly a substantial factor in an athlete’s ability to obtain these drugs.
Finally, public policy supports imposition of liability on drug manufacturers. Athletes are dying
for their sport, legitimacy of world records are being called into question, and perhaps even more
tragic, this epidemic is spreading to today’s youth. Athletes are so blinded by their desire to be
the best that they fail to realize the grave consequences associated with their actions. Moreover,
drug manufacturers are in the best position to remedy this problem.
Athletes are being held accountable for their actions. Why should drug manufacturers
not be held accountable? This article suggests that a drug manufacturer’s fear of liability would
detour negligent conduct, thereby decreasing use of drugs for improper purposes. Only imposing
liability on the athlete by creating new drug tests and penalties merely encourages athletes to
search out new performance enhancing drugs, such as EPO and hGH that are extremely difficult
to detect. If instead of reprimanding the athlete and trying to regulate his/her conduct, we target
the drug manufacturer, athletes would have a much more difficult time obtaining the drug in the
first place. Lets stop the problem where it starts. We need to negate the ability for the athlete to
27
obtain the drug for a non-prescription purpose, rather than reprimanding the athlete once they are
determined a user.
The legal framework exhibited in comparable contexts illustrates that negligent
distribution is a viable claim against drug manufacturers. Negligent distribution is a widely
applicable concept in this industry, and should be asserted against manufacturers who fail to
monitor and regulate the distributors to whom they provide drugs. In order to prove successful
based on cases in related contexts, the manufacturer must have a duty. The court should have
little difficulty in finding such a duty to exist. A drug manufacturer has a duty to regulate
distribution because undoubtedly the manufacturers have knowledge of off-label uses of their
drugs. The latest scandal, announced in the 2006 Winter Olympics caused the performance
enhancing drug epidemic to re-emerge in news headlines around the world. The knowledge of
this misuse, and society’s need for regulation, not only for protecting the health of athletes, but
also to reinstill the value and legitimacy in sport, imposes a definite duty on drug manufacturers.
Arguably, because certain drugs such as EPO, hGH, and anabolic steroids are the drugs most
commonly abused, thus most frequently reported on in the news, manufacturers of these drugs
should have a heightened awareness and an even more compelling duty to protect their
consumers.
Though negligent distribution is likely the most viable claim to assert against drug
manufacturers, negligent marketing is also a potentially viable claim. Negligent marketing in the
drug context is proven when the manufacturer of a drug promotes that drug in a way that
encourages misuse. Evidence does not suggest that the original manufacturers of FDA approved
drugs such as Amgen and Ortho Pharmaceuticals market their drugs, targeting unintended users.
Advertisements and order forms easily accessible on the Internet, however, suggest that some
28
generic drug manufacturers target unintended users such as athletes, making it so simple to
obtain these drugs that once ordered, they can be delivered via Federal Express directly to your
doorstep.
Take for example the anabolic steroid, Deca-Durabolin, which is FDA approved to
increase bulk and muscle mass in cancer patients. When the patent expired on Deca, generic
makers swooned, and Deca is currently being manufactured by numerous generic companies.
Some manufacturers of generic versions of Deca should be held liable for negligent marketing
because they produce the generic drug under the guise that it is for a varied use, such as to
increase muscle mass in animals. From the picture on the label, however, to the usage
indications, the drug is tactically marketed to an athlete. These manufacturers should also be
held liable for negligent distribution. The websites selling these generic drugs are selling to
athletes. This is apparent by the pictures on the websites, the disclaimers, and the order
procedure. Moreover, some websites actually list the manufacturers supplying drugs to these
Internet distributors, therefore it is easy track the manufacturers and allocate liability.
Finally, negligent entrustment may also be asserted against manufacturers. Applying the
court’s rationale in Moning, a manufacturer should be held liable when they have knowledge that
the distributors they provide their drug to intend to negligently distribute to unintended users.
Failure of manufacturers to use diligence in conducting background checks on their purchasers
results in a chain reaction, saturating the market with drugs that are used for an unintended
purpose. The potential for manufacturers to be held liable for negligent entrustment would serve
as a deterrent to manufacturers, and cause manufacturers to be more selective in their
distribution. The manufacturer is in the best position to determine what distributors to entrust
29
their product to, and thoughtful entrustment will thereby eliminate the initial negligent act by the
manufacturer, relinquishing the manufacturer’s liability.
V.
Conclusion
Society has dictated the need for imposition of liability on drug manufacturers for their
negligent distribution, marketing, and entrustment of drugs used for performance enhancing
purposes. Imposition of liability on manufacturers will better society and reduce risks to athletes
by making it much more difficult to obtain prescription drugs for performance enhancement.
Holding manufacturers liable in addition to holding athletes responsible for their actions will
help to end the performance enhancing drug epidemic that plagues the world, by stopping the
problem where it starts.
30