Document 71358

Overdosed and Contaminated: A Critical
Examination of The FDA and Drug
Industry's Role in Drug Safety in the
Context of the Heparin Catastrophe
Caidin E. Fleming*
L
Introduction
At some point in your life, a medical mistake will affect you.
More people die from medical errors than in car accidents or
from breast cancer.' In fact, just under 100,000 people die every
year from medical errors.2 These numbers are the equivalent of
a jumbo jet crashing every day. In light of these statistics, the
question arises: how many of these errors are preventable?
In November 2007, a medical error involving the drug Heparin received national attention. Twins Thomas Boone and Zoe
Grace were born premature, but seemingly healthy.' Eleven
* Candidate forJuris Doctorate, 2010. I would like to acknowledge the members
of the Quinnipiac Health Law Journal for their editing support and insightful comments. I would also like to thank my family, in particular, Chris Berich, for his love and
support throughout the writing of this Note. Finally, this Note is dedicated in loving
memory to my grandmother, Roberta A. O'Dea, whose passing took place prior to the
written completion of this note. May she rest in peace knowing that the Wyeth decision
will enable us to continue her struggle against the drug manufacturer that harmed her
in the final years of her life.
IOprah: Medical Mistakes (ABC television broadcast Mar. 10, 2009) [hereinafter
Oprah] (notes on file with the author); see also COMMITTEE ON QUALITY OF HEALTH CARE
IN AMERICA, INSTITUTE OF MEDICINE, To ERR IS HUMAN: BUILDING A SAFER HEALTH SYSTEM 1 (Linda T. Kohn et al. eds., 2000) [hereinafter To ERR ISHUMAN] (suggesting that
the number of people who die each year as a result of in hospital medical errors exceeds the number of deaths from auto accidents, breast cancer, or AIDS).
2 Oprah, supra note 1. Many studies indicate high rates of adverse events. See
Troyen A. Brennan et al., Incidence of Adverse Events and Negligence in HospitalizedPatients:
Results of the HarvardMedical Practice Study 1, 324 NEw ENG. J. MED. 370, 370 (1991)
(showing that adverse events occurred in 3.7 percent of hospitalizations); see also To
ERR IS HUMAN, supra note 1, at 29-31 (studying healthcare accidents in Utah and Colorado and finding that adverse events occurred in 2.9 percent of hospitalizations). In the
Harvard study as much as 13.6 percent of events led to death while 6.6 percent of the
events led to death in the Utah-Colorado study. To ERR IS HUMAN, supra note 1, at 30.
With a total of 33.6 million hospital admissions in the United States in 1997, these
studies suggested that between 44,000 and 98,000 people die each year as a result of inhospital medical errors. Id. at 1.
3 Should the fDA Drug and Medical Device Regulation Bar State Liability Claims?:Hearing Before the H. Comm. On Oversight and Government Reform, 110th Cong. 1 (2008) (state-
QUINNIPIAC HEALTH LAW
[Vol. 13:117
days after their birth, the newborns developed skin irritations, so
their parents, actor Dennis Quaid and wife Kimberly, took them
to the doctor.4 The doctor sent the Quaids to Cedars-Sinai Medical Center in Los Angeles, California for a more thorough examination, and there the babies were diagnosed with a staph
infection. 5 Treatment required the babies to be on a constant
intravenous (IV) drip of antibiotics. 6 After the first dose of antibiotics, Thomas Boone and Zoe Grace had their lVs flushed
with a blood thinner, so they could begin the next dose of antibiotics.' As their parents looked on, the tiny newborns were administered a potentially lethal dose of Heparin, approximately
one thousand times the recommended dosage.8 Within eight
hours, they were again given the same lethal dosage of Heparin. 9
At this time, it was clear something was wrong. Quaid stated
that the babies "were [ ] bleeding profusely and severely bruised
from internal bleeding."1 Quaid further stated that "doctors
tried to clamp shut a bleeding wound in the remnants of TBoone's umbilical cord, [and] blood spurted six feet across the
room and splattered on the wall."" Hospital staff explained to
the Quaids that the babies were inadvertently given a higher
concentrated dosage of the medicine because of the similarity
between the labels of two different concentrations of Heparin.1 2
Fortunately for the Quaid family, the overdose of Heparin did
not prove fatal; today, Thomas Boone and Zoe Grace are healthy
babies.' 3
Despite the heavy media coverage of the overdose incident,
the Quaid family was not the first family to be harmed by the
ment of Dennis Quaid and Kimberly Quaid), available at http://www.gminjurylaw.com/
Quaid-Testimony.pdf [hereinafter Statement of Dennis Quaid].
4 Id.
5 Id.
6 Id.
7 Id. at 2.
8 Statement of Dennis Quaid, supra note 3, at 2.
9 Id.
10 Id. at 3.
11 Id.
12 Id. After interviewing doctors and nurses the Quaids found out that the labels
on the bottle of 10-units of Hep-Lock and the 10,000-unit bottle of Heparin, "were
deadly similar in labeling and size;" "[t]he 10,000-unit label is dark blue, and the 10unit bottle is light blue." Id.
13 See, e.g., Dennis Quaid is a CalmerDad, CELEBToTs, Jul. 27, 2009, http://www.
celebtots.com/2009/07/27/dennis-quaid-is-a-calmer-dad/.
2009]
OVERDOSED AND CONTAMINATED
119
similarity between the labels of the different vials of Heparin. In
Indiana, six children were administered multiple adult doses of
the drug; three children survived but three others did not. 4 In
Texas, medical providers gave overdoses of Heparin to fourteen
newborns in the last year. 5
The difficulty distinguishing between the labels for the
adult and child doses of Heparin was not the only issue with the
drug. About a month after the Quaid children were overdosed,
on December 19, 2007, Bonnie Hubley passed away with her
family and husband of forty-eight years at her side. 6 Three days
earlier, the Ohio Hospital administered Heparin to Bonnie during a hemodialysis session.1 7 She suffered from a genetic disease
known as polycystic kidney disease (PKD) whereby cysts grow in
the kidneys; if they grow too numerous or too large in size, the
kidneys become damaged." Bonnie received a kidney transplant in 1995, but in 2007, her body began to reject the kidney,
and she required hemodialysis to treat her condition." While
on dialysis in December of 2007, Bonnie began to experience
severe diarrhea, vomiting and rapid heartbeat.2 0 During and after her last dialysis session, Bonnie experienced chest and abdomen pain, a drop in her blood pressure, and difficulty
breathing. 2' Bonnie was put on a breathing tube, but her condition declined dramatically. 22 Her family was faced with the unthinkable task of following her physician's recommendation to
14 14 Preemies Given Blood Thinner Overdose: Babies At Texas Hospital Given Too
Much Heparin; Mistake Probed, Children Being Monitored, CBS NEWS, Jul. 8, 2008,
http://www.cbsnews.com/stories/2008/07/08/health/main4240519.shtml?source=rel
ated-story [hereinafter 14 Preemies]; Steve Kroft, Dennis Quaid Recounts Twins' Drug
Ordeal: Actor Tells 60 Minutes' Steve Kroft Medical Errors Kill Thousands, 60 MINUTES, Mar.
16, 2008, http://www.cbsnews.com/stories/2008/03/13/60minutes/main393641 2
page2.shtml?tag=contentMain;contentBody.
15 14 Preemies, supra note 14.
16 The Heparin Disaster: Chinese Counterfeits and American Failures. HearingBefore the
Subcomm. on Oversight and Investigations of the H. Comm. on Energy and Commerce, I10th
Cong. 2 (2008) (statement of Leroy Hubley), available at http://energycommerce.
house.gov/images/stories/Documents/Hearings/PDF/I 10-oi-hrg.042908.LeroyHuble
y-testimony.pdf [hereinafter Statement of Leroy Hubley].
17 Id. at 1-2; See also Bill Powell, Heparin'sDeadly Side Effects, TIME, Nov. 13, 2008,
http://www.time.com/time/magazine/article/0,9171,1858870-1,00.html [hereinafter
Heparin'sDeadly Side Effects].
18 Statement of Leroy Hubley, supra note 16, at 1.
19 Id.
20 Id.; see also Heparin'sDeadly Side Effects, supra note 17.
21 Statement of Leroy Hubley, supra note 16, at 1-2.
22 Id.
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end her suffering by removing her breathing tube.2 3
Bonnie's death was only the beginning of the suffering for
the Hubley family. A month later, on January 15, 2008, Bonnie's
son Randy passed away after being administered Heparin.2 4
Randy also had PKD and required hemodialysis sessions. 2 1 With
the help of his wife Colleen, a registered nurse, Randy was able
to undergo hemodialysis sessions in the comfort of his own
home; however, after a surgery, Randy needed to start 'in center
dialysis' at the same facility where his mother was treated.2 6
When he arrived home from dialysis on Friday, January 11, 2008,
he began experiencing symptoms such as low blood pressure
and severe diarrhea, which lasted throughout the weekend.2 7
On Monday, Randy awoke during the night, grabbed his chest
and ultimately collapsed. 21 Colleen administered CPR to Randy,
but to no avail. 29 In her testimony before the House Subcommittee on Oversight and Investigations, Colleen stated: "As a nurse,
I thought I would be there to save my husband from any [medical] errors, but I guess I was naive. I never thought that the lifesaving medication we were relying on might be contaminated."3
These Heparin-related tragedies were accompanied by some
remedial efforts, and in the case of the Heparin label mix-up, a
failed preventative effort by Baxter Healthcare Corporation
(Baxter). In February 2007, eight months before the Quaid incident, Baxter issued a warning letter urging medical professionals
to carefully read Heparin drug labels and alerting hospitals
about the potential for fatal mix-ups.3 1 After a number of new23 Id. at 2.
24 The Heparin Disaster: Chinese Countefeits and American Failures. Hearing Before the
Subcomm. on Oversight and Investigations of the H. Comm. on Energy and Commerce, 1I0th
Cong. 2 (2008) (statement of Colleen Hubley), available at http://energycommerce.
house.gov/images/stories/Documents/Hearings/PDF/1 10-oi-hrg.042908.ColleenHub
ley-testimony.pdf [hereinafter Statement of Colleen Hubley]; See also Heparin's Deadly
Side Effects, supra note 17.
25 Statement of Leroy Hubley, supra note 16, at 2.
26 Statement of Colleen Hubley, supra note 24 at 1-2.
27
28
29
30
31
Id. at 2.
Id.
Id.
Id. at 3.
See generally BAXTER, IMPORTANT MEDICATION SAFEY ALERT: BAXTER HEPARIN SO-
DIUM INJECTION 10,000 UNITS/ML AND HEP-LOCK U/P 10 UNITS/ML (2007), http://
www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuman
MedicalProducts/UCM154539.pdf; see also Statement of Dennis Quaid, supra note 3, at
4.
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OVERDOSED AND CONTAMINATED
born overdoses, Baxter also redesigned the drug labels to make
it easier to distinguish between adult Heparin drug vials and
child Heparin drug vials by enlarging the font and changing the
color of the label.3 2 However, Baxter did not recall the vials of
Heparin that were still on the market or those already stocked in
hospitals ready for use; if it had, Baxter could have prevented
the misfortune that befell the Quaid family nine months after
the corporation's initial warning.3 3
In the wake of the Hubley family tragedy, in January 2008,
Baxter announced a voluntary recall of Heparin and stopped
manufacturing the drug.3 4 Baxter and United States Food and
Drug Administration (FDA) officials launched an investigation
into the potential contamination of the drug, ultimately finding
one: oversulfated chondroitin sulfate. 5 The investigation revealed that the site of contamination was the Scientific Protein
Laboratories (SPL) facility in China, 36 which Baxter inspected
five months prior to this discovery and found adequate.
The
FDA had not inspected the facility,3 8 even though FDA officials
later admitted that their failure to conduct an inspection was a
mistake.3 9 The investigation concluded that the contaminant
was introduced during the raw material state in "a deliberate
scheme to adulterate a life-saving medication."40
32 Statement of Dennis Quaid, supra note 3, at 4.
33 Id.
34 Baxter Healthcare, Heparin Sodium Injection: 2008 Heparin Information, http://
www.baxter.com/products/biopharmaceuticals/heparin_2008.html
(last visited Dec.
13, 2009) [hereinafter Heparin Sodium Injection].
35 Id.; see also The HeparinDisaster: Chinese Counterfeits and American Failures. Hearing
Before the Subcomm. on Oversight and Investigationsof the H. Comm. on Energy and Commerce,
110th Cong. 2 (2008) (statement of Janet Woodcock, M.D.), available at http://
energycommerce.house.gov/images/stories/Documents/Hearings/PDF/110-oi-hrg.04
2908.Woodcock-Testimony.pdf [hereinafter Statement of Janet Woodcock]; see generally
Takashi Kei Kishimoto et. al., ContaminatedHeparin Associated with Adverse Clinical Events
and Activation of the Contact System, 358 NEw ENG. J. MED. 2457 (2008).
36 Families Tell U.S. Lawmakers of Heparin Deaths, REUTERS, Apr. 29, 2008, http://
www.reuters.com/article/idUSN29333077 [hereinafter Families Tell U.S. Lawmakers].
SPL has two facilities: one in Wisconsin and another in China. Heparin Sodium Injection,
supra note 34.
37 Families Tell U.S. Lawmakers, supra note 36.
38 Id.
39 Gardiner Harris, Heparin Contamination May Have Been Deliberate, FD.A. Says,
N.Y. TIMES, Apr. 30, 2008, available at http://www.nytimes.com/2008/04/30/health/
policy/30heparin.html?em&ex=1209700800&en=2c7flb380ee3057e&ei=5087%OA
[hereinafter Harris].
40 Heparin Sodium Injection, supra note 34.
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As a result of the Heparin catastrophe, families such as the
Quaids and the Hubleys must fight for compensation from drug
manufacturers so they can pick up the pieces of their lives and
work to prevent such tragedies in the future. Unfortunately,
many victims seeking a remedy have found it extremely difficult
to do so. The FDA, with the support of drug manufacturers,
contends that state common law tort claims, such as failure to
warn of the risks associated with a drug, are preempted when the
FDA approved the drug at issue. 4 ' Under this theory of liability,
victims like the Quaids and the Hubleys are unable to sue Baxter
because the FDA approved Heparin. Drug manufacturers called
into court have asserted the preemption defense and the lawsuits
against them have been dismissed.4 2
This note addresses two distinct issues that have arisen from
the Heparin controversy: the drug labeling dilemma and the
FDA's regulatory authority to oversee foreign drug manufacturers. This note first argues that the United States Supreme Court
correctly decided Wyeth v. Levine by holding that drug labeling
regulations promulgated by the FDA do not preempt state tort
law claims because state tort law claims supplement the federal
regulations and provide appropriate avenues, if not the only avenues, for injured parties to seek redress. Secondly, this note argues that the FDA is ill-equipped to enforce regulations already
in place that are necessary to protect consumers.
Part II of this note provides background information on the
key players in the Heparin controversy: the FDA, Heparin and
Baxter Healthcare Corporation. Part III addresses the drug la41 See Requirements on Content and Format of Labeling for Human Prescription
Drug and Biological Products, 71 Fed. Reg. 3922, 3934 Uan. 24, 2006) (to be codified at
21 C.F.R_ pts. 201, 314, 601) [hereinafter Physician's Labeling Rule] (noting the Department ofJustice "ha[d] filed a number of amicus briefs" on the FDA's behalf). These
briefs suggested that FDA approval of labeling preempts conflicting or contrary state
law. Id.
42 See Statement of Dennis Quaid, supra note 3, at 6 (stating that Baxter moved to
dismiss the Quaid's lawsuit on the basis of preemption); see also Morris v. Wyeth, Inc.,
582 F. Supp. 2d 861 (W.D. Ky. 2008) (holding that drug consumer's state law claim
against drug manufacturer was preempted); see also Demahy v. Wyeth, Inc., 586 F. Supp.
2d 642 (E.D. La. 2008) (drug manufacturer moved to dismiss consumer's state failure
to warn claim, asserting preemption as a defense); see also Knipe v. SmithKline
Beecham, 583 F. Supp. 2d 553 (E.D. Pa. 2008) (drug manufacturer asserted preemption defense after survivors of patient brought state failure to warn claim); Colacicco v.
Apotex, Inc., 521 F.3d 253 (3d Cir. 2008) (affirming dismissal of the consumers' state
failure to warn claims on the basis of preemption).
2009]
OVERDOSED AND CONTAMINATED
beling conundrum, in particular, the FDA's oversight of drug labeling, the doctrine of federal preemption, the United States
Supreme Court's decision in Wyeth v. Levine and the post-Wyeth
federal drug labeling regime. Part III also provides general recommendations for interested parties as to how to prevent future
medical errors involving inadequate drug labeling. Part IV examines the FDA's regulatory power abroad, and provides an
analysis of the FDA's ability to address foreign drug manufacturing issues in the context of the Heparin contamination. Part IV
also provides general recommendations to prevent similar drug
manufacturing errors and to improve post market drug safety.
II.
Background
A.
The Food, Drug and Cosmetic Act and the Food and Drug
Administration
i.
Establishing the FDA
Congress enacted the Federal Food, Drug, and Cosmetic
Act (FDCA)4" in 1938 "for the purposes of safeguarding the public health, [and] preventing deceit upon the purchasing public."4 4 The FDCA delegated authority to the FDA to regulate the
safety of food, drugs and cosmetics.4"
The FDA is one of the oldest consumer regulatory agencies
in the government. It is organized as part of the United States
Department of Health and Human Services and consists of nine
centers or offices.46 It is a scientific, regulatory and public
health agency that oversees many things, including most food
products (excluding meat and poultry), human and animal
drugs, biological products, medical devices; radiation-emitting
consumer products, cosmetics, and animal feed.4 7 The FDA also
"monitors the manufacture, import, transport, storage, and sale
of about" one trillion dollars of products; the annual cost to tax43 Federal Food, Drug and Cosmetics Act of 1938, 52 Stat. 1040, 1052 (1938)
(codified as amended by 21 U.S.C. §§ 301-392 (2009)) [hereinafter FDCA of 1938].
44 H.R. REP. No. 75-2139, at 3 (1938).
45 21 U.S.C. § 393 (2008).
46 U.S. Food and Drug Admin., Centers & Offices, http://www.fda.gov/AboutFDA/
CentersOffices/default.htm (last visited Nov. 15, 2008).
47 Id.; see also John P. Swan, Ph.D., U.S. Food and Drug Admin., FDA's Origin,
http://www.fda.gov/AboutFDA/WhatWeDo/History/Origin/ucm124403.htm (last visited Nov. 27, 2009) [hereinafter FDA's Origin].
124
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payers is approximately three dollars per person.4 8
The FDCA imposed new regulations on cosmetics and medical devices, and "it required that drugs be labeled with adequate
directions for safe use."4 9 A fundamental provision of the FDCA
prohibits misbranding or adulteration of drugs, and the introduction, delivery for introduction, sale or receipt of any drug
into interstate commerce that is adulterated or misbranded.5 °
The Act requires drug manufacturers to submit to federal
safety review before marketing new drugs. 5' The pre-market approval process is rigorous; "[a] manufacturer must submit what
is typically a multivolume application. '5 2 For example, a drug
manufacturer is required to file a new drug application prior to
the drug's approval, which includes "as a part of the application. . . 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. '53 The Secretary can deny the application on a finding that "the investigations... do 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....
FDA scientists evaluate applications for, among other
things, new drugs, biologics and complex medical devices.55
Within the FDA, the Center for Drug Evaluation and Research
(CDER) evaluates drugs before they can be marketed, verifying
that the drugs have effective labeled instructions and provide
benefits that outweigh risks.5 6
When Heparin was approved in 1939, the FDCA prohibited
selling a new drug, unless an application was filed and put into
48
Id.
49 U.S. Food and Drug Admin., FDA History - Part II:The 1938 Food, Drug, and
Cosmetic Act, http://www.fda.gov/AboutFDA/WhatWeDo/History/Origin/ucm54826.
htm (last visited Nov. 27. 2009) [hereinafter FDA History - Part 1I].
50 21 U.S.C. §§ 331(a)-(c) (2008).
51 FDA History - Part II, supra note 49; see also 21 U.S.C. § 355 (b) (2009).
52 Riegel v. Medtronic, Inc,, 128 S. Ct. 999, 1004 (2008).
53 21 U.S.C. § 355(b) (2009).
54 21 U.S.C. § 355(d).
55 FDA's Origin, supra note 47.
56 U.S. Food and Drug Admin., CDER"The Consumer Watchdog for Safe and Effective
Drugs, http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucml43462.htm (last
visited Dec. 13, 2009).
OVERDOSED AND CONTAMINATED
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effect. 7 Applicants had to submit reports of many things, including investigations and other materials "to show whether or
not such drug [was] safe for use, '"" and they had to provide
"specimens of the labeling proposed to be used for such drug."5 9
If the FDA failed to act, the application became effective sixty
days after filing.6" The FDCA provided for judicial review of "an
order of the Secretary refusing to permit the [drug] application
to become effective or suspending the effectiveness of the application" under section 505, but it did not permit judicial review of
an effective drug application. 6 ' In fact, "Congress has never authorized judicial review of FDA approval of a new-drug
application."6 2
ii.
The Ever Expanding and ContractingPower of the FDA
Over time, Congress has both contracted and expanded the
FDA's power through the passage of various amendments to the
FDCA. For example, when Congress passed the Drug Amendments of 1962, it expanded FDA power by requiring that "new
drugs meet an additional test of 'effectiveness' in addition to the
existing test of 'safety,"'63 and by requiring the FDA to approve
new drug applications, doing away with the previous procedure
whereby a new drug could become affective if the FDA failed to
act for 60 days.6 4 However, Congress limited FDA power by including a savings clause in the 1962 Amendments that stated,
"Nothing in the amendments made by this Act to the [FDCA]
shall be construed as invalidating any provision of State law
which would be valid in the absence of such amendments unless
there is a direct and positive conflict between such amendments
57 FDCA of 1938, supra note 43, § 355(a). Section 505(a) of the FDCA, provides
that "[n]o person shall introduce or deliver for introduction into interstate commerce
any new drug, unless an approval of an application filed [with the Food and Drug Administration] . . . is effective with respect to such drug." Id. § 355(a).
58 Id. § 355 (b) (1) (A).
59 Id. §§ 355(b)(1)(F), (d)(6).
60 Id. § 355(c).
61 Id. § 355(h).
62 Brief for Appellee-Respondent at 5, Wyeth v. Levine, 944 A.2d 179 (Vt. Nov. 3,
2008), available at http://www.abanet.org/publiced/preview/briefs/pdfs/07-08/061249-Respondent.pdf [hereinafter Brief for Appellee].
63 Id. at 5-6; See alsoDrug Amendments of 1962, Pub. L. No. 87-781, §102(a) (2), 76
Stat. 780 (1962) [hereinafter Drug Amendments of 1962].
64 See Brief for Appellee, supra note 62, at 5-6; see also Drug Amendments of 1962,
supra note 63, §§ 102(d), 104.
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and such provision of State law."6 5
Generally, the FDA's power is limited in the drug labeling
industry. Once a drug is approved, the FDA lacks the authority
to compel manufacturers to make labeling changes.6 6 Under
the FDCA, drug manufacturers are encouraged to update their
drug labels,6 7 and under the 'changes being effected' (CBE) regulation, 68 drug manufacturers can make changes to a label, without prior FDA approval, "[t]o add or strengthen a
contraindication, warning, precaution, or adverse reaction,"69 or
" [t] o add or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug
product. ' 7° Such changes to a drug's label can be implemented
immediately upon the FDA's mere receipt of the supplemental
application 7 ' rather than after a thirty-day waiting period. 72 The
FDA has required manufacturers to revise drug labeling "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. ' 7' The CBE regulation is in keeping with a "central premise of federal drug regulation" that drug
manufacturers traditionally bear ultimate responsibility for the
content of drug labels."
In a significant addition to FDA authority, former President
George W. Bush signed the Food and Drug Administration
65 Brief for Appellee, supra note 62, at 6; see also Drug Amendments of 1962, supra
note 63, § 202.
66 Brief for Appellee supra note 62, at 8 (citing FDA's DrugApproval Process: Up to the
Challenge?: HearingBefore the Subcomm. On Health Education, Labor and Pensions, 109th
Cong. 5 (2005) (testimony of Sandra Kweder, M.D., Deputy Dir., Off. of New Drugs,
U.S. Food and Drug Admin.), available at http://help.senate.gov/Hearings/2005_
03_01/kweder.pdf ("FDA may ask the manufacturer to revise the labeling to add information on adverse reactions not previously listed.")
67 See Brief for Appellee, supra note 62, at 7; see also Werner v. Upjohn, Co., Inc.,
628 F.2d 848, 860 (4th Cir. 1980) ("FDA's regulations and policies encourage early
unilateral action by the drug companies to improve their warnings").
68 See Brief for Appellee, supra note 62, at 7; see also Wyeth v. Levine, 129 S. Ct.
1187, 1196 (2009). Congress, in 2007, for the first time granted the FDA authority to
require certain post-market drug labeling changes. Wyeth, 129 S. Ct. at 1196. Generally,
a drug manufacturer may only make changes to a drug's label after FDA approval, but
there is a regulation that permits them to do so before it. Id.
69 21 C.F.R. § 314.70(c)(6)(iii)(A) (2009). See also Wyeth, 129 S. Ct. at 1196.
70 21 C.F.R. § 314.70(c)(6)(iii) (C) (2009). See also Wyeth, 129 S. Ct. at 1196.
71 21 C.F.R. § 314.70(c) (6) (2009).
72 21 C.F.R. § 314.70(c) (4) (2009); see also 21 C.F.R. § 314.70(c) (6) (2009).
73 21 C.F.R. § 201.80(e) (2009).
74 Wyeth, 129 S. Ct. at 1197-98.
OVERDOSED AND CONTAMINATED
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127
Amendments Act of 2007 (FDAAA) into law on September 27,
2007. 7 ' The Act provides the FDA with authority and resources
to oversee pre-market and post-market drug safety. 76 Notably,
the Act provides the FDA with new, albeit limited, authority to
require certain drug safety labeling changes. However, the FDA
must first attempt to negotiate with the drug manufacturer
before it can order changes to be made to a drug label. 77 The
Act also includes a provision that allows the FDA to collect fees
from drug companies to help fund the review of new drugs. 78
The Act further allows for shorter review times of new drug applications while maintaining the quality of the reviews. 7' Finally,
the Act provides the FDA with some authority to require drug
manufacturers to participate in post-market drug safety studies.8 "
iii.
GlobalizationAct of 2009
Another law that would expand FDA authority is the proposed Globalization Act of 2009.1 The Globalization Act out75 U.S. Food and Drug Admin., Food and Drug Administration Amendments Act
(1DAAA) of 2007, http://www.fda.gov/Regulatorylnformation/Legislation/FederalFoo
dDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FoodandDrugAd
ministrationAmendmentsActof2007/default.htm (last visited Nov. 10, 2009).
76 U.S. Food and Drug Admin., FDAAA Implementation: Highlights One Year after Enactment, http://www.fda.gov/Regulatorylnformation/Legislation/FederalFoodDrugan
dCosmeicActFDCAct/SignificantAmendmentstotheFDCAct/FoodandDrugAdministra
tionAmendmentsActof2007/ucm083161.htm (last visited Dec. 13, 2009).
77 U.S. Food and Drug Admin. Amendments Act of 2007, Pub. L. No. 110-85, 121
Stat. 823, 841 (2007) (requiring the Secretary to "hold discussions"); See also INST. OF
MED. COMM. ON ASSESSMENT OF U.S. DRUG SAFETY Sys., BD. ON Pop. HEALTH & PUB.
HEALTH PRAc., THE FUTURE OF DRUG SAFETY: PROMOTING AND PROTECTING THE HEALTH
OF THE PUBLIC 157 (Alina Baciu et al. eds., 2007) [hereinafter FUTURE OF DRUG SAFETY]
("Currently, most actions involve softer remedies negotiated with a drug sponsor; FDA
cannot unilaterally compel label changes, addition of boxed warnings, or fulfillment of
postmarketing study commitments. Nor can it unilaterally restrict marketing, change
the content of a package insert (including Medication Guides), or change the content
of other documents intended for the public.").
78 U.S. Food and Drug Admin., Renewed Legislation Improves Safety of FDA-Regulated
Products, http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm61229.htm (last
visited Nov. 10, 2009).
79 Id.
80 FDA's Role in Identifying and Communicating Drug Safety Issues: HearingBefore the H.
Comm. On Veteran's Affairs, 110th Cong. (statement of Paul Seligman, M.D., M.P.H.,
Assoc. Dir. of Safety Policy and Commc'n, CDER, FDA), available at http://veterans.
house.gov/hearings/Testimony.aspx?TID=45155&Newsid=270&Name=%2OPaul%20%
20Seligman,%20M.D.,%20M.P.H [hereinafter Statement of Paul Seligman].
81 See generally Discussion Draft of the 'Food and Drug Administration Globalization Act'
Legislation: Drug Safety: Hearing Before the Subcomm. On Health of the H. Comm. On Energy
and Commerce, 110th Cong. (2008), available at http://www.govtrack.us/congress/bill
text.xpd?bill=H 111-759 [hereinafter Globalization Act]. See infta Part IV.
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[Vol. 13:117
lines proposed amendments to the FDCA, such as authorization
for the imposition of a registration fee on drug manufacturers
who are already required to register each year with the FDA. 2
The Act proposes to utilize the collected registration fees for the
purpose of funding increased inspections of drug manufacturing
facilities.8 3 The Globalization Act will also require all drug manufacturing facilities to be inspected before a drug manufactured
in the facility is introduced into interstate commerce.8 4 The Act
authorizes
a civil penalty of up to $100,000 for each violation of
85
the Act.
If it passes, the Globalization Act is likely to increase FDA
initiatives overseas. Currently, the Office of International Programs coordinates the FDA's international activities." The FDA
is responsible for monitoring products within its jurisdiction that
are imported to the United States. 8 7 To facilitate the process,
the FDA requires foreign drug manufacturers to register with
the FDA and provide the name and address of its United States
agent.8 8 However, the FDA lacks the resources to inspect imports arriving from over one hundred and fifty countries.8 9 To
compensate for this lack, the FDA, among other things, imposes
high public health standards that imports must meet,9" and inspects hundreds of foreign facilities each year.9 1 In conjunction
82 Id. § 736C(a).
83 Id.
84 Id. § 202(a) (2) (A).
85 Id. § 211(a) (2).
86 U.S. Food and Drug Admin., Office of International Programs, http://www.
fda.gov/AboutFDA/CentersOffices/OC/OfficeoflnternationalPrograms/ucm 119564.
htm (last visited Nov. 10, 2009).
87 Drug Safety: Preliminary Findings Suggest Weakness in FDA's Programfor Inspecting
ForeignDrug Manufacturers: HearingBefore the Subcomm. On Oversight and Investigations of
H. Comm. On Energy and Commerce, 109th Cong. 4 (2007) (testimony of Marci Crosse,
Dir., Health Care, U.S. Gov't Accountability Off.), available at http://www.gao.gov/
new.items/d08224t.pdf [hereinafter Statement of Marcia Crosse 1] ("FDA is responsible for overseeing the safety and effectiveness of human drugs that are marketed in the
United States, whether they are manufactured in foreign or domestic establishments.").
88 21 C.F.R. § 207.40(c); see also 21 U.S.C. § 360(h) (i) (2009).
89 Kristen E. Schleiter, Court Support for FDA Regulation of Drug Importation, 11(7)
Am. Med. Assoc. J. Ethics 521, 523 (2009) ("The United States imports products from
more than 150 countries, with India and China accounting for more than half of these
imports.").
90 Id. at 522 ("The FDA inspects foreign or domestic manufacturing facilities to
ensure they meet the same manufacturing standards for quality, purity, potency, safety,
and efficacy required of domestic establishments.").
91 Discussion Draft of the Tood and Drug Administration Globalization Act' Legislation:
DrugSafety: HearingBefore the Subcomm. On Health of the H. Comm. On Energy and Commerce,
OVERDOSED AND CONTAMINATED
2009]
with its foreign inspections, the FDA educates regulatory counterparts in other countries on United States public health standards, and on how to comply with the FDA's Good
Manufacturing Practices.9 2 The FDA has also been an advocate
for raising international health safety standards and for harmonizing the standards amongst different countries.9 3 Thus, by
providing for increased resources for inspection of drug manufacturing facilities that import products to the United States, the
Globalization Act would assist the FDA with its current initiatives
and in its role of protecting the public health.
iv.
Changes in the FDA's Landscape
In the last twenty years, political pressure, consumer activism, and industry involvement have incited rapid changes in the
nature of the FDA's work.9 4 For example, "patient advocacy
groups ... played a role in the agency's development of accelerated techniques for drug approval." 5 Also, a law was passed
which requires the "industry to reimburse the FDA for review of
drugs and biologics to speed up the agency's evaluations. '"" Despite these changes, the overall expansion of the agency's regulatory authority has left the agency strained and unable to
adequately fulfill its stated purpose.
These strains have manifested into infrequent drug label
updates and inadequate (or sometimes, non-existent) drug manufacturing facility inspections. As a result, the FDA has left the
public exposed to new dangers. However, patients injured by
dangerous drugs have successfully brought state law failure-towarn claims against drug manufacturers. 7 Aware of those state
110th Cong. (2008) (statement of Andrew C. von Eschenbach, M.D., Comm'r of Food
and Drugs, U.S. Dep't of Health and Hum. Res.), available at http://www.fda.gov/
NewsEvents/Testimony/ucm109676.htm
[hereinafter Statement of Andrew von
Eschenbach].
92 U.S. Food and Drug Admin., Overview: Office of InternationalPrograms, http://
www.fda.gov/AboutFDA/CentersOffices/OC/OfficeoflnternationalPrograms/ucm 116
397.htm [hereinafter Overview: Office of InternationalPrograms].
" Id.
94 U.S. Food and Drug Admin., FDA History - Part V Trends in the Last QuarterCentury, http://www.fda.gov/AboutFDA/WhatWeDo/History/Origin/ucm125632.htm
(last visited Dec. 13, 2009).
95 Id.
96 Id
97 See, e.g., Levine v. Wyeth, 183 Vt. 76 (2006); Demahy v. Wyeth, Inc., 586 F. Supp.
2d 642 (E.D. La. 2008); Brochu v. Ortho Pharm. Corp., 642 F.2d 652 (lst Cir. 1981).
QUINNIPIAC HEALTH LAW
[Vol. 13:117
law remedies, Congress has not included an express preemption
provision for prescription drugs in various amendments to the
FDCA despite having done so for medical devices.9" The FDCA,
as originally drafted, "included a federal private right of action
for injured consumers."9 However, witnesses testified that the
provision was unnecessary because state law remedies adequately
protected consumers injured by dangerous drugs; thus, the provision was omitted from the Act.'0 0 Until recently, the FDA
viewed such state law claims as complementing federal
regulation. 101
B.
Heparin
Heparin, an anti-coagulant or blood thinner that helps prevent the formation of blood clots in the veins, arteries, lungs or
heart,' 0 2 was discovered in 1916 and was approved by the FDA in
1939.03 The drug is used to prevent blood clotting during
open-heart surgery, during dialysis 0 4 and in patients who are
confined to bed.' 5 Heparin is also often considered the drug of
choice for anti-coagulation in pregnancy.' 016 It is available by
prescription only.'0 7
Heparin is usually made from pig intestine enzymes, 10 8 and
consists of a long series of complex sugar molecules.' 0 9 There
are generally two types of Heparin: unfractionated Heparin and
low molecular weight Heparin." ° Unfractionated Heparin is
composed of many different sizes of sugar compounds.1 1 ' The
98 Wyeth, 129 S. Ct. at 1200.
99 Brief for Appellee supra note 62, at 4.
100 Id.
101 Id. at 1.
102 Heparin Injection, DRUG DIGEST, May 1, 2009, http://www.drugdigest.org/wps/
portal/ddigest (search for "heparin injection") [hereinafter Heparin Injection].
103 INDIANA
MEDICAID
THERAPEUTICS
COMMIrrEE,
THERAPEUTICS
CLASS
REVIEW
1 (2008), http://www.indianapbm.com/Doc%2021/Hematologic%20Agents
/Heparin%20and%2ORelatedES%2003-08.pdf [hereinafter HEPARIN THERAPEUTICS].
SUMMARY
104 Id.
105
HeparinInjection, supra note 102.
106 HEPARIN THERAPEUTICS,
supra note 103.
HeparinInjection, supra note 102.
108 Scientists Unravel Heparin Death Mystery, SCIENCE DAILY, Apr. 24, 2008, http://
www.sciencedaily.com/releases/2008/04/080423171529.htm.
109 Id.; see also What is Heparin?, http://www.anticoagulation-advisor.com/ckshop.
php?category=7 (last visited Oct. 18, 2008) [hereinafter What is Heparinf].
110 What is Heparin?, supra note 109.
111 Id. See also David N. Leff, Heparins Oddest Ball Molecular Sequence Yields to MIT
107
OVERDOSED AND CONTAMINATED
2009]
dosage for this type of Heparin depends on results from a blood
clotting test, so frequent blood clotting tests are necessary to administer the drug appropriately.' 2 In contrast, low molecular
weight Heparin contains only one small size sugar compound
and the dosage depends on the patient's weight."' Both types
of Heparin are usually administered intravenously through an IV
bag, or subcutaneously, under the skin like an insulin shot." 4
The drug takes effect very quickly in patients; for example,
"peak plasma levels of heparin are achieved 2 to 4 hours following subcutaneous administration.""' 5 Heparin can lead to excessive bleeding, especially in patients who have recently
undergone surgery. 1 6 Heparin may also cause back pain, burning or itching of the feet, allergic reactions such as hives and
swelling of the face, feeling faint, coughing up blood, breathing
problems, stomach pain, nausea, vomiting and unusually low
blood pressure.' 17
C.
Baxter Healthcare Corporation
Baxter Healthcare Corporation has a longstanding history
of service to the healthcare industry; it was founded in the 1930s
"as the first manufacturer of commercially prepared intravenous
[] solutions.""' 8 Currently, "Baxter manufactures products in 26
countries and sells them in more than 100 countries."119 Sixty
percent of Baxter's sales come from outside the United States
and, in 2008, its worldwide sales totaled $12.3 billion. 2 0 To facilitate this magnitude of sales, Baxter has facilities located all over
Biotech Analytical Tool Formula, 11 BIOWORLD TODAY 1, 5 (2000), available at http://
web.mit.edu/tox/sasisekharan/downloads/bioworld.pdf (stating that if you imagine
putting heparin into a food blender, you would get sugar molecules) [hereinafter
BioWORLD].
112 What isHeparin, supra note 109.
113 Id.; See also BioWORLD, supra note 111, at 5.
114 Id.
1 (2008),
http://www.baxter.com/products/biopharmaceuticals/downloads/Heparinlmp_Safe
tyInformationHealthCareProf.pdf.
116 See BIOWORLD, supra note 111, at 5 (stating that bleeding is a risk associated with
Heparin).
117 Heparin Injection, supra note 102.
118 Baxter Healthcare Corp., History, http://www.baxter.com/about-baxter/com
pany-profile/sub/history.html (last visited Nov. 20, 2009).
119 Baxter Healthcare Corp., Company Profile, http://sustainability.baxter.com/
company-profile/index.html#worldwide (last visited Nov. 20, 2009).
1 15 BAXTER HEALTHCARE CORP., IMPORTANT HEPARIN SAFETY INFORMATION
120 Id.
132
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[Vol. 13:117
the world and in the United States, including Arkansas, California, Florida, Illinois, Indiana, Maryland, Mississippi, New Jersey,
and North Carolina. 12 1 Baxter's headquarters is located about
22
twenty miles north of Chicago, Illinois.'
For over thirty years, "Baxter, and its predecessor company
ESI Lederle (Wyeth), has been manufacturing heparin in a vial
form. 1 23 Together they supply fifty percent of the United States
market for Heparin.1 24 A factory owned by SPL in Chagzhou,
China produces the active ingredient for the drug, which is derived from a pig intestine enzyme.' 2 5 Baxter then "processes,
sterilizes and packages the finished product for distribution" in
the United States.1 2 6 Since Heparin was approved, Baxter is responsible for investigating and reporting to the FDA any adverse
drug event information associated with the drug that it receives
and periodically submitting any new or follow-up information to
the FDA that may call into question the FDA's previous conclu127
sions about the safety, effectiveness, or labeling of the drug.
The Drug Labeling Dilemma
Drug labeling is "[t] he centerpiece of risk management."128
The contents of drug labels have increased over the years, and
now include the container label, package insert, consumer medication information, a medication guide, a Highlights section and
patient counseling information.1 29 In 2006, the FDA promulgated the Physician's Labeling Rule, which was aimed at simplifying prescription drug labeling for medical practitioners." 0 The
III.
121 Baxter Healthcare Corp., Global Presence, http://www.baxter.com/about-bax
ter/company-profile/sub/globalpresence.html (last visited Nov. 15, 2008).
122 Id.
123 Testimony Of Baxter Int. CEO Before Subcommittee On Oversight And Investigations
Committee On Energy And Commerce U.S. House Of Representatives, MEDICAL NEws TODAY,
Apr. 29, 2008, http://www.medicalnewstoday.com/articles/ 105761.php [hereinafter
Testimony of Baxter CEO].
124 Heparin Sodium Injection, supra note 34.
125 Heparin Chinese Supplier Was Never Checked by Chinese Drug Regulators, MEDICAL
NEWS TODAY, Feb. 16, 2008, http://www.medicalnewstoday.com/articles/97598.php
[hereinafter Chinese SupplierNever Checked].
126 Id.
127 See 21 C.F.R. § 314.80(b) (2009).
128 Physician's Labeling Rule, supra note 41, at 3934.
129 IMPROVING PRESCRIPTION DRUG CONTAINER LABELING IN THE UNITED STATES: A
HEALTH LITERACY AND MEDICATION SAFETY INITIATIVE 24-25 (2007), http://foundation.
acponline.org/files/medlabel/acpfwhitepaper.pdf [hereinafter INIPROVING LABELING].
13O See Physician's Labeling Rule, supra note 41, at 3923.
OVERDOSED AND CONTAMINATED
2009]
133
FDA set specific requirements for what information must appear
on a prescription drug container label: the drug name, pharmacy name and address, serial number of the prescription, prescribing physician's name, patient name, and instructions for
use. 1 3 ' Oversight of drug labeling has always been a focus of the
FDA, and in 2006, the FDA attempted to adopt a policy of exclusive oversight of drug labeling through the doctrine of federal
32
preemption.
A.
Federal Law Preemption
i.
Generally
The United States Constitution establishes the three
branches of the government and lists their respective duties and
powers. The power of the Federal government consists of only
those powers enumerated in the text of the Constitution. The
Tenth Amendment to the Constitution reserves to the States the
powers not expressly granted to the federal government. 133 As a
result, '[t]he powers delegated . . . to the federal government,
are few and defined' and '[t]hose which are to remain in the
state governments, are numerous and indefinite. ' 1 34 The Supreme Court ruled
The Framers adopted this "'constitutionally mandated balance of power,"' to "reduce the risk of tyranny and abuse
from either front," because a "federalist structure ofjoint sovereigns preserves to the people numerous advantages," such
as "a decentralized government that will be more sensitive to
the diverse needs of a heterogeneous society".
[and] provide[ ] "a double security
to the rights of the
people".
135
However, when Congress chooses to exercise its power and create a federal law, the federal law may supersede a contrary state
law by operation of the supremacy clause. The supremacy clause
of the Constitution provides that federal law is "the supreme Law
131 IMPROVING LABELING, supra note 129, at 25.
132 See Physician's Labeling Rule, supra note 41, at 3934.
133 U.S. CONST. amend. X.
134 Wyeth, 129 S. Ct. at 1206 (Thomas, J., concurring) (citations omitted).
135 Id. at 1205 (citations omitted).
134
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of the Land."' 3 6 Thus, when a federal law and a state law conflict, federal law will preempt the state law.
A federal law can preempt a state law in three ways: by express statement (express preemption), by implied occupation of
the regulatory field (field preemption), or by implied preclusion
of conflicting state regulations (conflict preemption). 3 7 In the
case of express preemption, the only issue to consider "is
13
whether the state statute falls within the area preempted.""
More complex issues arise when the federal statute is unclear
about its intended impact on state laws. When the law is ambiguous, it is often necessary to examine Congressional intent and
the legislative history of the federal law in order to determine if
Congress intended the law to have preemptive effect. Ordinary
principles of field preemption establish that a federal law will
preempt state law if the "scheme of federal regulation is 'so pervasive as to make reasonable the inference that Congress left no
room for the States to supplement it.I"
39
Ordinary principles of
conflict preemption establish that a federal law preempts a state
law if "the state requirement actually conflicts with the federal
requirement - either because compliance with both laws is impossible ...or because the state law 'stands as an obstacle to the
accomplishment and execution of the full purposes and objectives of Congress."" 4 Furthermore, "a federal agency acting
within the scope of its congressionally delegated authority" may
pass regulations that preempt state regulations.14 '
ii.
Reading Preemptive Intent into the Preamble
As one reporter succinctly stated, "The issue is increasingly
whether [agencies, and consequently, drug manufacturers] can
use broad preemption language in regulatory preambles to get"
lawsuits dismissed. 142 Arguably, one can view the preamble as
136 U.S. CONST. art. VI, cl. 2.
137 GERALD GUNTHER & KATHLEEN
M. SULLIVAN, CONSTITUTIONAL LAW 234-35 (16th
ed. 2007).
138 Id. at 234.
139 Medtronic, Inc. v. Lohr, 116 S. Ct. 2240, 2261 (1996) (Breyer, J., concurring)
(citation omitted).
140 Id. at 2261 (citations omitted).
141 City of New York v. F.C.C., 108 S. Ct. 1637, 1642 (1988).
142 Pete Yost, Bush Administration Rules Limit Lawsuits, USA TODAY, May 13, 2008,
http://www.usatoday.com/money/economy/2008-05-13-536172364_x.htm.
20091
OVERDOSED AND CONTAMINATED
"the agencies' interpretation of whether the federal regulatory
law permits preemption of lawsuits."143
The FDA's Physician's
Labeling Rule was accompanied by a preamble containing broad
preemptive language, suggesting that if the FDA approved a prescription drug, then state tort law claims are preempted. 144 The
"FDA believes that under existing preemption principles, FDA
approval of labeling under the act, whether it be in the old or
new format, preempts conflicting or contrary State law."14' 5
In particular, the FDA contemplated that at least the following claims would be preempted:
(1)
(2)
claims that a drug manufacturer breached an obligation
to warn by failing to include a statement in labeling or
advertising the substance of which the FDA has prohibited in labeling or advertising;
claims that a drug manufacturer breached an obligation
to warn by failing to include a statement in labeling or
advertising the substance of which has been proposed
by the FDA for inclusion in the labeling or advertising,
if such statement was not required by the FDA at the
time the plaintiff claims the sponsor had an obligation
to warn;
(3)
(4)
claims that a drug manufacturer breached an obligation
to warn by failing to include in the "Highlights" section
of the drug label, or otherwise emphasize, any information the substance of which is included in the label; and
claims that a drug manufacturer breached an obligation
to warn by failing to include contraindications or warnings that are not supported by evidence satisfying FDA
standards. 146
In an attempt to justify its position on preemption, the FDA
asserted in the preamble that it "is the expert federal public
health agency charged by Congress with ensuring that drugs are
safe and effective, and that their labeling adequately informs
users of the risks and benefits" associated with the product.14 7
A recent 2008 regulation reaffirmed the FDA's position on
143
Id.
144 Physician's Labeling Rule, supra note 41, at 3933-34.
145
146
147
Id. at 3934.
Id. at 3934-35.
Id. at 3934.
136
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[Vol. 13:117
preemption that it asserted in the Physician's Labeling Rule.' 4 '
Specifically, the FDA stated in the regulatory preamble that it
"does not believe that the absence of an express preemption provision with respect to drugs affects the application of the doctrine of implied preemption."' 4 9
On May 14, 2008, Randall W. Lutter, Deputy Commissioner
for Policy of the FDA testified before the House Committee on
Oversight and Government Reform about challenges to FDA determinations. Lutter stated that in order to "protect the public
health... state law claims are preempted if they challenge a design or labeling that FDA approved.' 150 Lutter generally believed that state courts should not second guess the FDA's
decisions "about the safety, efficacy, and labeling of medical
products." 15 1 Lutter further testified,
[The] FDA is concerned that state product liability lawsuits
that challenge [the] FDA's careful determination of safety, efficacy and appropriate labeling can have detrimental effects
to public health in a number of ways, including limiting patient and doctor choices and decreased patient access to beneficial products, and increased confusion over warnings or
statements that can
deter the use of [the most] beneficial
152
medical products.
Thus, through Lutter's testimony, the FDA clearly delineated its
attitudes about preemption.
B.
Preemption and State Tort Claims
The United States Supreme Court articulated a two-part
standard in Chevron, U.S.A., Inc. v. NR.D.C.1 53 - known as the
"Chevron deference" standard - in order to determine the level
148 See generally Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices, 73 Fed. Reg. 49603-01 (Aug. 22, 2008)
(to be codified at C.F.R. pts. 314, 601, and 814).
149 Id. at 49605.
150 Should FDA Drug and Medical Device Regulation BarState Liability Claims?: Before the
H. Comm. on Oversight and Govt. Reform, 110th Cong. (2008) (statement of Randall W.
Lutter, Deputy Comm'r for Policy, Assoc. Comm'r for Policy and Planning for the U.S.
Food and Drug Admin.), available at http://www.hhs.gov/asl/testify/2008/05/t20
080514b.html.
151
152
Id.
Id.
153
See generally Chevron, U.S.A., Inc. v. N.R.D.C., 104 S. Ct. 2778 (1984).
OVERDOSED AND CONTAMINATED
2009]
of deference given to an agency's interpretation of its own laws.
For example, the Chevron standard is applicable to determine the
deference due to the FDA's statement about preemption in the
preamble of the Physician's Labeling Rule. Accordingly, a Court
must first "question whether Congress has directly spoken to the
precise question at issue."' 5 4 If the intent of Congress is clear,
then the agency and the Court are obliged to give effect to the
unambiguous intent of Congress.15 5 If, however, the intent of
Congress is ambiguous, then the Court must decide "whether
the agency's answer is based on a permissible construction of the
156
statute."
The United States Supreme Court has used Chevron deference to preempt state tort claims. For example, in Geier v. American Honda Motor Co. the Supreme Court granted Chevron
deference to a rule promulgated by the Department of Transportation (DOT) .157 The DOT rule provided for a phase-in of a
mix of passive restraints instead of requiring air bags in all
cars.15 ' The plaintiff, Geier, drove her Honda into a tree, and
although she was wearing her seatbelt, she suffered serious injuries.159 As a result, she filed suit against Honda, alleging that it
had "designed its car negligently and defectively because it
lacked a driver's side airbag." 16' The Court determined that
Geier's claim, based on the car manufacturer's state duty to install air bags, was an obstacle to achieving "the variety and mix of
devices that the federal regulation sought.1 6 1 Ultimately, the
Supreme Court held that state tort claims premised on Honda's
failure to install air bags conflicted with a federal regulation that
did not require air bags, and therefore, state tort claims were
preempted. 162
The FDA has achieved mixed success in its attempt to preempt state tort law claims based on defective drugs and medical
devices. In Wysocki v. Reed, the plaintiffs husband suffered se154
Id.
at 2781.
155 Id.
156
157
158
159
Id. at 2782.
See generally Geier v. Am. Honda Motor Co., 120 S. Ct. 1913 (2000).
Id. at 1924.
Id. at 1917.
160 Id.
161 Id. at 1925.
120 S. Ct. at 881.
162 Geier,
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vere injuries as a result of an adverse reaction to Heparin, which
he received as treatment for phlebitis.16 Mr. Wysocki's right leg
was amputated below the knee, his right arm was paralyzed and
he experienced mental deterioration, loss of speech, memory
and self-control.1 6 4 The Heparin was manufactured by either
Upjohn Company or Wyeth Laboratories. 1 65 The Court, in determining whether the plaintiff could proceed with a legal malpractice claim against the attorneys who represented her in the
underlying products liability action, found that both Upjohn
and Wyeth were negligent toward Mr. Wysocki and could consequently be held liable. 1 66 The state tort claims were allowed.
Similarly, in Medtronic, Inc. v. Lohr, the Supreme Court held
that the Medical Device Amendments of 1976 (MDA) "does not
preempt state or local requirements that are equal to, or substantially identical to, requirements imposed under federal
law.' 6 7 In this case, Lohr depended on a pacemaker to keep
her heart functioning properly. 16 In 1987, Lohr received a
pacemaker from Medtronic; when it failed on December 30,
1990 Lohr was rushed into emergency surgery.' 6 9 She filed suit
as a result.
The MDA, which established federal oversight of medical
devices, also contained an express preemption clause whereby
the MDA preempted state law tort claims against medical device
manufacturers if the FDA approved the device. 170 However, the
Court in Lohr narrowed the scope of the provision, finding the
provisions of the pre-emptive MDA ambiguous. 171 In its reasoning, the Court applied two presumptions: first, the police powers
of the states are not to be superseded by federal law "unless that
was the clear and manifest purpose of Congress"; and second,
"'[t]he purpose of Congress is the ultimate touchstone' in every
163 Wysocki v. Reed, 222 Il. App. 3d 268, 270 (1991) (stating that "Wysocki allegedly suffered a severe adverse reaction to the heparin," which led to his total disability,
which in turn led to his death).
164 Id.
165 Id.
166 Id. at 279.
167 See generally Medtronic, 116 S. Ct. at 2240.
168 Id. at 2248.
169 Id.
170 Medical Device Amendments of 1976, §521, 90 Stat. 574 (codified as amended
by 21 U.S.C. 360k (a) (2009)).
171 Medtronic, 116 S. Ct. at 2252.
2009]
OVERDOSED AND CONTAMINATED
preemption case. 1 72 The Court determined that it was "difficult
to believe that Congress would, without comment, remove all
means of judicial recourse for those injured by illegal conduct"
in relation to medical devices.1 7 3 The Court went on to state that
the MDA's legislative history does not contain any evidence of
"fear that product liability actions would hamper the develop''
ment of medical devices.""4
Thus, Lohr's claim was successful.
In contrast, in Riegel v. Medtronic, Inc., the Supreme Court
held that the patient's state law claims of negligence, strict liability and implied warranty against the manufacturer of a medical
device were preempted. 7 5 In 1996, Charles Riegel suffered a
myocardial infarction and subsequently underwent coronary
angioplasty. 1 76 Riegel's doctor inserted a catheter, the medical
device at issue, into Riegel's coronary artery in an attempt to dilate the artery. 7 7 The label for the catheter warned that it
"should not be inflated beyond its rated burst pressure."' However, Riegel's doctor ignored the warning and the catheter ruptured.179 Riegel developed a blockage in his heart, "was placed
on life support, and underwent emergency coronary bypass surgery." ' Riegel alleged that Medtronic's catheter was designed,
labeled, and manufactured in violation of New York common
8
law.' '
The Riegel Court stated that general tort duties of care 'directly regulate' the medical device, including its design.1 82 However, the Court recognized the argument that "[s]tate
requirements are pre-empted under the MDA only to the extent
that they are 'different from, or in addition to' the requirements
imposed by federal law."'8 3 Thus, as in Lohr, the Court upheld
the determination that federal law would not "prevent a State
172 Id. at 2250 (citations omitted).
173 Id. at 2251.
174 Id.
175 See Riegel, 128 S. Ct. at 1009.
176 Id. at 1005.
177 Id.
178 Id.
179 Id.
180 Riegel, 128 S. Ct. at 1005.
181 Id. at 1005.
182 Id. at 1010.
183 Id. at 1011 (citing Medical Device Amendments of 1976 (MDA),
§ 360k(a) (1)).
21 U.S.C.
QUINNIPIAC HEALTH LAW
[Vol. 13:117
from providing a damages remedy for claims premised on a violation of FDA regulations."' 4
However, the doctrine of preemption as it applies to medical devices and the MDA is decidedly different from the doctrine's application to drug labeling. As previously mentioned,
the MDA contains an express preemption clause, but there is no
similar provision related to drug labeling. State courts traditionally litigated claims based on inadequate drug labeling, but increasingly, state courts have been reluctant to allow the claims
because of the FDA's statement in the preamble to the Physician's Labeling Rule and the Supreme Court's decision in Reigel.
C.
Wyeth v. Levine: The Supreme Court Weighs In
i.
Overview of the Arguments
On March 4, 2009, the United States Supreme Court decided Wyeth v. Levine. i" 5 The Wyeth Court affirmed the Supreme
Court of Vermont's decision, ultimately holding that state law
failure-to-warn claims are not preempted by FDA drug labeling
regulations. 8 6
Levine, a professional musician, 18 7 was suffering from a severe migraine. To treat her symptoms, she was injected with
Demerol for her pain and Phenergan, a drug manufactured by
Wyeth to treat nausea.' 8 8 Phenergan is administered in two ways:
"intramuscularly or. . . intravenously through either the 'IVpush' method. . . or the 'IV-drip' method."' 9 However, "[t]he
drug is corrosive and causes irreversible gangrene if it enters a
patient's artery."' 90
Levine's first injection of Phenergan was administered intramuscularly, but Levine's symptoms were not relieved, so she returned to her local clinic later in the day for additional
treatment.'
The second injection of the drug entered Levine's
184 Id.
185 WAlyeth v. Levine, 129 S. Ct. 1187, 1196 (2009); see also Levine v. Wyeth, 944 A.2d
179, 193-94 (Vt. 2006).
186 Levine, 944 A.2d at 193-94.
187 Wyeth, 129 S. Ct. at 1189.
188 Id. at 1191.
189 Id.
190 Id.
191 Id.
20091
OVERDOSED AND CONTAMINATED
artery, and a gangrene infection formed. As a result, Levine's
1 92
right hand, and eventually her entire forearm, was amputated.
Afterward, Levine initiated a state tort law action against Wyeth,
alleging that Wyeth was negligent because "[Phenergan's] labeling was defective [as] it failed to instruct clinicians to use the IVdrip method of intravenous administration instead of the higher
risk IV-push method."1 93 Furthermore, "she alleged that Phenergan is not reasonably safe for intravenous administration because the foreseeable risks of gangrene and loss of limb are great
194
in relation to the drug's therapeutic benefits."
In its defense, Wyeth argued that Levine's failure-to-warn
claims were preempted by federal law because "there was an 'actual conflict between a specific FDA order,' and Levine's failureto-warn action," ' 95 and because the FDA approved Wyeth's label.
The FDA first approved Phenergan in 1955.196 In 1987, "the
FDA suggested different warnings about the risk of arterial exposure" to Wyeth, and Wyeth submitted proposed revisions to
Phenergan's label in 1988.117 The FDA finally approved the label in 1998 and instructed that the "final printed label 'must be
identical' to the approved package insert." 9 '
ii.
The Lower Court Decisions
The trial court evaluated the "correspondence between Wyeth and the FDA [regarding] Phenergan's labeling and found
no evidence that Wyeth had 'earnestly attempted' to strengthen
the intra-arterial injection warning or that the FDA had 'specifically disallowed"' a stronger warning.' 9 9 The jury was instructed
that Wyeth's compliance with the FDA requirements did not establish that the warnings on Phenergan's label were adequate: a
drug manufacturer is permitted under the FDA regulations to
change a drug label to add to or strengthen a warning without
prior FDA approval so long as it submits the revised warning for
192 Wyeth, 129 S. Ct. at 1191.
193 Id. at 1191-92.
194 Id. at 1192 (citation omitted).
195 Id. (citation omitted).
196 Id. at 1192.
197 Wyeth, 129 S. Ct. at 1192.
198 Id. (citation omitted).
199 Id. (citation omitted).
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142
[Vol. 13:117
FDA review and approval. 2 "° The jury ultimately found that Wyeth was negligent and that "Phenergan was a defective product
as a result of inadequate warnings and instructions"; the jury
awarded Levine $7.4 million in damages. 0 1
The Vermont Supreme Court affirmed.20 2 The Court recognized that the FDA's Physician Labeling Rule contained a preamble with preemptive language; however, the Court concluded
that the agency's assertion did not deserve deference. 20 3 The
Court determined that FDA labeling requirements "create a
floor, not a ceiling, for state regulation. "204 The Court found
that a manufacturer's duty to warn "does not create a conflict
with federal requirements because the FDA and the state share
the purpose of encouraging pharmaceutical companies to alter
their drug labels when they are inadequate. ' 20 5 The Court further determined that Levine's claims did not interfere with Congress' objectives because, in the Court's view, "Congress
intended that the FDCA would leave state law in place except
where it created a 'direct and positive conflict' between state and
federal law."
iii.
206
The United States Supreme Court Decision
Wyeth made two preemption arguments to the United
States Supreme Court: first, that it was impossible to comply with
state law without violating federal law and second, that "recognition of Levine's state tort action create[d] an unacceptable 'obstacle to the accomplishment and execution of the full purposes
and objectives of Congress,' because it substitutes a lay jury's decision about drug labeling for the expert judgment of the
20 7
FDA."
To guide its analysis, the Court identified two factual propositions decided during the trial court proceedings. First, "the
trial court proceedings established that Levine's injury would
not have occurred if Phenergan's label had included an ade200
201
202
203
204
205
206
207
Id. at 1192-93.
Id. at 1193.
Wyeth, 129 S. Ct. at 1193.
Levine, 944 A.2d at 193.
Id at 184.
Id. at 188.
Id. at 190.
Wyeth, 129 S. Ct. at 1193-94 (citation omitted).
2009]
OVERDOSED AND CONTAMINATED
quate warning about the risks of the IV-push method of administering the drug. ' 2°8 Second, the trial court proceedings
established that the "critical defect in Phenergan's label was the
lack of an adequate warning about the risks of IV-push
administration. 2 0
In order to determine whether Levine's claim - that
Phenergan's label was inadequate - was preempted by federal
law, the Court identified "two cornerstones of [its] pre-emption
jurisprudence":
First, "the purpose of Congress is the ultimate touchstone in
every pre-emption case." Second, "[i]n all pre-emption cases,
and particularly in those in which Congress has 'legislated...
in a field which the States have traditionally occupied,' . . . we
'start with the assumption that the historic police powers of
the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.' "210
To determine the "purpose of Congress," the Court examined
the history of federal regulation of drugs.2 m When the FDCA
was first enacted, it provided for pre-market approval of drugs,
whereby a drug could not be distributed until it was determined
by the FDA to be safe for use.21 2 Congress then enacted the
Drug Amendments of 1962; consequently, drug manufacturers
were required to prove not only that the drug was safe for use,
but that it was safe for use "under the conditions prescribed, recommended, or suggested in the proposed labeling. 21 3 Furthermore, the drug manufacturer had to "prove the drug's
effectiveness by introducing 'substantial evidence that the drug
will have the effect it purports or is represented to have under
the conditions of use prescribed, recommended, or suggested in
the proposed labeling."' 214 The Drug Amendments also "added
a saving clause, indicating that a provision of state law would
only be invalidated" if it created a "'direct and positive conflict'
Id. at 1194.
Id.
210 Id. at 1194-95 (citations omitted).
211 Id. at 1195.
212 Wyeth, 129 S. Ct. at 1195.
213 Id. (citing Drug Amendments of 1962, 21 U.S.C. §§ 102(d), 104(b)) (internal
citations omitted).
214 Id. (citations omitted).
208
209
144
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with the FDCA. 2 15
The Court noted that state tort law claims 'continued unabated despite . . .FDA regulation' and that Congress, despite
enacting an express preemption provision with regard to medical devices, never enacted a similar provision with respect to prescription drugs.2 6 When Congress again amended the FDCA in
2007, it did not enact a provision mandating FDA pre-approval
for all drug label changes; rather, it kept the ultimate responsibility for drug label changes with the drug manufacturer.2 1 7 The
Court believed it is "a central premise of federal drug regulation
that the manufacturer bears responsibility for the content of its
218
label at all times.
The Court then rejected Wyeth's claims. First, the Court
found it was not impossible for Wyeth to comply with both state
and federal law. 21 ' The Court recognized that generally, a manufacturer is only permitted to change a drug label after FDA approval of a supplemental drug application. 220 However, the
Court emphasized that an FDA regulation permits a manufacturer to change "a label to 'add or strengthen a contraindication, warning, precaution, or adverse reaction' or to 'add or
strengthen an instruction about dosage and administration that
is intended to increase the safe use of the drug"' without prior
FDA approval, so long as the drug manufacturer submits a supplemental drug application. 221 Thus, the Court rejected Wyeth's
claims that it would have been in violation of federal law if it
unilaterally changed Phenergan's label, especially given the absence of any evidence that the FDA would have rejected Wyeth's
proposed changes to the drug label.2 2 2 Wyeth failed to prove the
elements of its "impossibility pre-emption" defense.2 23
Second, the Court failed to find that recognition of Levine's
state tort action thwarted "the full purposes and objectives of
Congress" by substituting the expert judgment of the FDA for
215 Id. at 1196 (citation omitted).
216 Id. (citation omitted).
217 Wyeth, 129 S. Ct. at 1196.
218 Id. at 1197-98.
219 Id. at 1199.
220 ld. at 1196.
221 Id. at 1196; see also 21 C.F.R. §§ 314.70(c)(6)(iii)(A), (c) (6)(iii)(C).
222 Wyeth, 129 S. Ct. at 1197.
223 Id.
at 1199.
2009]
OVERDOSED AND CONTAMINATED
that of a lay jury. 224 The Court found Wyeth's argument relied
on an "overbroad view of an agency's power to pre-empt state
law," and contradicted all the evidence of Congress' purposes.2 2 5
The Court acknowledged that Congress decided not to provide a
federal remedy in light of the adequacy of "state rights of action,"22 6 but could only speculate whether or not Congress "recognized that state-law remedies [enhance] consumer protection
by motivating manufacturers to produce safe and effective drugs
and to give adequate warnings. '227 Ultimately, Congress' failure
to enact an express preemption provision and its awareness of
state tort litigation was "powerful evidence that Congress did not
intend FDA oversight to be the exclusive means of ensuring drug
228
safety and effectiveness."
Third, the Court determined that the FDA's preamble to
the Physician's Labeling Rule did not merit deference because it
was a mere assertion, not a regulation with the force of law, and
2 29
Congress had not authorized the FDA to preempt state law.
The Court stated, "[t] he weight we accord the agency's explanation of state law's impact on the federal scheme depends on its
thoroughness, consistency, and persuasiveness. ' 23 ° The Court
found the FDA's preamble did not meet this standard because it
was rendered inherently suspect due to the agency's procedural
failure to offer "[s] tates or other interested parties notice or opportunity for comment" on the preemption of state tort law. 23 '
Additionally, the Court found the agency's position in the preamble was a reversal of its longstanding policy to use its "limited
resources to monitor the 11,000 drugs on the market," and allow
224 Id. at 1193.
225 Id. at 1199.
226 Id. (citation omitted).
227 Wyeth, 129 S. Ct. at 1199-1200.
228 Id.
at 1200.
at 1201.
230 Id. at 1201 (citation omitted).
229 Id.
231 Id. The decisions reads:
When the FDA issued its notice of proposed rulemaking in December 2000,
it explained that the rule would "not contain policies that have federalism
implications or that preempt State law." In 2006, the agency finalized the
rule and, without offering States or other interested parties notice or opportunity for comment, articulated a sweeping position on the FDCA's preemptive effect in the regulatory preamble. The agency's views on state law
are inherently suspect in light of this procedural failure.
Id. (citations omitted).
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[Vol. 13:117
state law to complement FDA regulations by offering a layer of
consumer protection.2 3 2 Generally, "manufacturers [that] have
superior access to information about their drugs, especially in
the postmarketing phase" can better benefit from increased involvement in state tort suits,23 3 which often "uncover unknown
drug hazards and provide incentives for drug manufacturers to
disclose safety risks promptly."2 3' 4 The FDA can better benefit by
allocating its resources to other areas. The FDA seemed to reject
this longstanding acceptance regarding the high value of state
tort suits.
Justice Breyer and Justice Thomas concurred; however, Justice Thomas disagreed with the majority's endorsement of implied preemption.2 3 5 He argued the supremacy clause will give
supreme status to only those laws which are made "in pursuance
of the Constitution. 2 3 6 In other words, a law is made in pursuance of the Constitution when it is within Congress's power to
enact and the law is enacted through the constitutionally required procedures. 2 7 Thus, Justice Thomas argued that the
Court strayed too far from traditional principles of preemption
by expanding federal statutes beyond their text through the doctrine of implied preemption.23 8 In particular, he criticized the
majority's discussion of the "purposes and objectives of Congress." 23 9 Instead, Justice Thomas argued " [p]re-emption must
turn on whether state law conflicts with the text of the relevant
federal statute or with the federal regulations authorized by that
text."24 0 He argued, under this standard, it was not impossible
for Wyeth to comply with both state and federal law because the
2 41
texts do not conflict.
Chief Justice Roberts and Justice Scalia joined Justice Alito
in the dissent. The dissent argued that the FDA's authority to
determine adequate labeling for a drug has been usurped by lay
232 Wyeth, 129 S. Ct. at 1201-02.
233 Id. at 1202 (citation omitted).
234 Id.
235 Id. at 1205 (Thomas, J., concurring).
236 Id. at 1206.
237 Wyeth, 129 S. Ct. at 1206.
238 Id.
239 Id.
240 Id.
241 Id.
at
at
at
at
1205.
1205-07.
1208.
1209.
OVERDOSED AND CONTAMINATED
20091
juries, and that the majority reached a conclusion that circumvented the FDA's expert policy judgments. 242 The dissent, like
the majority and in contrast to Justice Thomas, endorsed implied preemption, and suggested "it is irrelevant in conflict preemption cases whether Congress 'enacted an express pre-emption provision.' ,,243 The dissent analogized the case to Geier, and
would give deference to the FDA's intent to preempt state tort
law as expressed in the preamble to the Physician's Labeling
Rule because the preamble was published in the Federal Register like any other law.244 The dissent further commented that
'juries are ill-equipped to perform the FDA's cost-benefit-balancing function" because 'juries tend to focus on the risk of a particular product's design or warning label that arguably contributed
to a particular plaintiff's injury, not on the overall benefits of
that design or label. '245 Also, the dissent argued, "the FDA conveys its warnings with one voice, rather than whipsawing the
medical community with 50 (or more) potentially conflicting
246
ones."
Analysis of the Wyeth Decision and the Drug Labeling
Regime
D.
i.
Preserving a Necessary Cause of Action
Actor Dennis Quaid expressed the sentiment of many drug
consumers when he said, "[i]f all lawsuits were to be pre-empted
...
then 'it will basically make us uninformed and uncompensated lab rats.' ,247 Thus, the United States Supreme Court correctly decided Wyeth by holding that drug labeling regulations
promulgated by the FDA do not preempt state tort law claims
The Wyeth decision preserves the states historical role regarding domestic products. States have traditionally exercised
principal control over domestically produced and distributed
drugs, and although the FDCA allocated some authority to the
242 See generally Wyeth, 129 S. Ct. at 1229-30 (Alito, J., dissenting).
243 Wyeth, 129 S. Ct. at 1220.
244 Id. at 1228.
245 Id. at 1229-30.
246 Id. at 1230.
247 Dennis Quaid Tells Lawmakers How Drug Mix Up Nearly Killed His Newborn Twins,
MEDICAL NEWS TODAY, May 14, 2008, http://www.medicalnewstoday.com/articles/
107486.php.
QUINNIPIAC HEALTH LAW
[Vol. 13:117
federal government to regulate drugs, it also preserved state
law's ability to do the same, absent a direct and positive conflict
between state law and federal regulations. 248 The Wyeth Court
was persuaded by Congress' inaction or silence with respect to
whether the FDA's drug labeling regime preempts state tort law,
particularly in light of Congress' awareness of state tort litigation
and the enactment of a preemption provision with respect to
medical devices.24 9
Furthermore, the Wyeth decision fully exalts the importance
of state tort law claims. State tort law claims supplement federal
regulations and provide appropriate avenues, if not the only avenues, for injured parties, like the Quaids and the Hubleys, to
seek redress. Consequently, state tort suits provide an important
function for consumers, and the FDA, by exposing post-market
drug safety issues. In the Court's words, "State tort suits uncover
unknown drug hazards and provide incentives for drug manufacturers to [promptly] disclose safety risks."2 5 ° Although some
consumer advocates argue "that state tort law can sometimes
raise prices to the point where those who are sick are unable to
obtain the drugs they need, ' 25' a drug that is inadequately labeled can deprive a person of the benefit they seek, and may
cause more harm than good. State lawsuits "also serve a distinct
compensatory function that may motivate injured persons to
come forward with information. "252 The dissent correctly noted
that "state tort suits can peacefully coexist with the FDA's labeling regime, and they have done so for decades. '25 3 In addition,
the FDA is ill-equipped to exercise exclusive oversight of drug
labeling due primarily to a lack of resources.25 4
ii. The FDA's Troubling View of Preemption
Despite the positive results of the Wyeth decision, we are still
left with a disturbing belief that the FDA does not fully grasp the
inherent issues with the drug labeling regime. The FDA's posi248 See supra Part 11A; see also Brief for Appellee, supra note 62, at 6; see also Drug
Amendments of 1962, supra note 62, §202; see also EDA Origin, supra note 47.
249 Wyeth, 129 S. Ct. at 1200 (majority opinion).
250 Id. at 1202.
251 Id. at 1204 (Breyer,J., concurring).
252 Id. at 1202 (majority opinion).
253 Id. at 1231 (Alito,J., dissenting).
254 Wyeth, 129 S. Ct. at 1202-03 (majority opinion).
OVERDOSED AND CONTAMINATED
2009]
tion on preemption is troubling in several respects, and reveals
flaws in the Agency's attitude and understanding of the drug labeling regime. First, if Wyeth were decided differently, drug
manufacturers would be able to assert preemption as a defense
to liability if their drug was approved by the FDA; this would effectively immunize drug manufacturers from accountability for
their products. However, the Wyeth court emphasized that it is a
"central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label at all
times.
25 5
The FDA would portray its approval of a drug as a warranty
that the drug is safe and effective; yet, "FDA approval does not
represent a lifetime guarantee of safety and efficacy, and what is
newest is not always the best."2 56 The FDA has been under considerable pressure to get potentially life-saving drugs onto the
market, and as a result, safety has been compromised for speed
during the drug approval process.2 5 7 Wyeth argued that the
FDA "must be presumed to have performed a precise balancing
of risks and benefits" associated with a drug before it is approved
as safe and effective for its intended use.25 8 Indeed, the FDA has
stated that state failure-to-warn claims "threaten FDA's statutorily
prescribed role as the expert federal agency responsible for evaluating and regulating drugs."2 59
Yet, the FDA and drug manufacturers such as Wyeth ignore
the fact that the FDA did not always have to approve drugs
before they entered the market. 26 ° Prior to 1962, when many
drugs such as Heparin entered the market, a drug could be approved upon FDA inaction after a period of sixty days. 2 6 ' Furthermore, Congress has never authorized judicial review of a
new drug approval.2 6 2 Consequently, an interested party with
knowledge relevant to the safety or efficacy of a drug cannot
challenge the approval of the drug or bring to light the FDA's
255 Id. at 1197-98.
256 FUTURE OF DRUG SAFETY, supra note 77, at 2.
257 Id. at 154.
258 Wyeth, 129 S. Ct. at 1200.
259 Id. (citation omitted).
260 See FDCA of 1938, supra note 43, at § 355(h) (permitting an application for a
new drug to become effective after 60 days, despite FDA inaction).
261 Brief for Appellee, supra note 62, at 5.
262 Id.
150
QUINNIPIAC HEALTH LAW
[Vol. 13:117
possible failure to consider certain information; such drug safety
issues will only become apparent when a consumer is injured,
and the adverse event is reported. Thus, the FDA cannot be presumed to have performed a precise balance of the risks and benefits of a drug because of the external pressure on the agency to
get drugs onto the market, and the fact that many drugs, including Heparin, could be approved to enter the market by agency
inaction. Thus, if information regarding the safety or efficacy of
a drug slips through cracks during the approval process, state
tort lawsuits can, and do, serve the purpose of bringing this information to light.
iii.
The FDA's Capacity to Carry Out Its Responsibilities
Formally approved or not, however, the FDA is responsible
for a drug over its lifecycle, "from drug discovery to the end of its
useful life." 26 3 But, "[t] he FDA's ability to form judgments about
the safety and efficacy of drugs depends upon the submission of
data, usually from drug company sponsors, rather than on the
use of data developed independently or on its own initiative. '' 264
As the Wyeth Court noted, "[drug] manufacturers have superior
access to information about their drugs, especially in the
postmarketing phase." 26 5 Consequently, the FDA cannot, by itself, oversee post-market drug safety issues and at the same time,
remove incentives for drug manufacturers to notify the public of
drug safety risks.2 66
In fact, the FDA has "few tools... for addressing postmarketing safety issues. ' 2 6 7 After a drug is approved, the FDA's regulatory and enforcement options have been limited, often to doing
nothing or to participating in the voluntary withdrawal of the
drug from the market. 26 8 The FDA's primary tool is withdrawal
of the drug from the market, but where a drug has substantial
life-saving benefits, the threat of withdrawal often rings
hollow. 26 9 Another tool for the FDA in the promotion of post263 FUTURE OF DRUG SAFETY, supra note
264 Id. at 152.
265 Wyeth, 129 S. Ct. at 1202.
266
77, at 1.
See id.
267 FUTURE OF DRUG SAFETY, supra note
268 Id. at 155.
269 Id.; see also Drug Safety: FDA Needs to
77, at 153.
FurtherAddress Shortcomings in Its Postmarket
Decision-makingProcess Hearingbefore the Subcomm. On Oversight and Investigations of the H.
OVERDOSED AND CONTAMINATED
2009]
market drug safety is to require post-marketing studies, which,
until recently, was controversial.2 7 ° Under the FDAAA, the FDA
can now require sponsors to make certain drug labeling changes
and to conduct post-marketing studies instead of relying on voluntary compliance. 7 1
Nonetheless, the "FDA has limited resources to monitor the
11,000 drugs on the market. ' 27 2 The FDA has only nine thousand employees nationwide.2 7 3 The "FDA's Office of New Drugs,
which reviews new drug applications, employs over 1,000 physicians and scientists to review" new drug applications "and to supervise post-marketing studies."2 7 4 In contrast, the FDA's Office
of Drug Safety, which monitors adverse event reporting, has only
about one hundred employees.2 75
Additionally, a March 2006 report conducted by the Government Accountability Office (GAO) indicated that there is a
lack of communication between the two offices of the CDER,
which hinders the FDA's decision making process with regard to
post-market drug safety. 27 6 The GAO found that the "FDA
lacked a clear and effective process for making decisions about,
and providing management oversight of, postmarket drug safety
issues. 27 7 Furthermore, the GAO found that "there was a lack of
clarity about how decisions were made and about organizational
roles, insufficient oversight by management, and data constraints. '"278 The GAO also observed that "there was a lack of criComm. On Energy and Commerce, 110th Cong. 5 (2007) (statement of Marcia Crosse, Dir.,
Health Care, U.S. Gov't Accountability Off.), available at http://archives.energycom
merce.house.gov/cmtemtgs/110-he-hrg.050907.Crosse-testimony.pdf
[hereinafter
Statement of Marcia Crosse on Post-market Drug Safety].
270
See
FUTURE OF DRUG SAFETY,
supra note 77, at 155; see also Statement of Marcia
Crosse on Post-market Drug Safety, supra note 269, at 9 (stating that the "FDA does not
have broad authority to require that a drug sponsor conduct an observational study or
clinical trial for the purpose of investigating a specific postmarket safety concern.").
271 Statement of Paul Seligman, supra note 80.
272 Wyeth, 129 S. Ct. at 1202.
273 CHRISTINE HUMPHREY, AN ANALYSIS OF HEPARIN, ACCOUNTABILITY AND PRE-EMPTION: WHERE ARE WE Now? PART
pdf [hereinafter
274
Id.
II 3 (2008), http://fuerstlaw.com/files/heparinpt2.
HUMPHREY].
Id.
Statement of Marcia Crosse on Post-market Drug Safety, supra note 269, at 2; see
also FUTURE OF DRUG SAFETY, supra note 77, at 6 (stating that the Office Drug Safety is
now the Office of Surveillance and Epidemiology).
277 Statement of Marcia Crosse on Post-market Drug Safety, supra note 269, at 2.
278 Id.
275
276
QUINNIPIAC HEALTH LAW
[Vol. 13:117
teria for determining what safety actions to take and when to
take them, which likely contributed to disagreements over deci2 79
sions about postmarket drug safety."
Thus, the court in Wyeth correctly denied deference to the
FDA's position on preemption, expressed in the preamble to the
2006 Physician's Labeling Rule, finding it "inherently suspect."
The Court noted that the FDA's position was a "dramatic" reversal of its long-standing position that "state law offers an additional, and important, layer of consumer protection that
complements FDA regulation. ' 2 0 The Court also noted that the
"FDA traditionally regarded state law as a complementary form
of drug regulation. '28 1 Thus, the FDA's position on preemption
is without merit, and reveals a misunderstanding by the Agency
of its capacity to address post-market drug safety issues.
iv.
The FDA's Credibility: Too Little, Too Late
Besides its troubling, inconsistent view of state law causes of
action, "there is a perception of crisis that has compromised the
credibility of FDA." 282 In turn, the "FDA's credibility is intertwined with that of the [pharmaceutical] industry."2 3 In the
case of Heparin, Baxter was in a position to assist the FDA, and
the public, in post-market drug safety review, which arguably the
corporation failed to do. As previously mentioned, Baxter, as
the drug manufacturer, has primary responsibility for its drug
labels, 2 4 and under FDA regulations, Baxter was permitted to
change the content or color of its Heparin drug label without
prior FDA approval. 2 5 Baxter's failure to sufficiently diffuse the
labeling problem tainted the FDA's credibility.
For example, in May 2005, a report was sent to United States
Pharmacopeia's Medication Errors Reporting Program, regarding confusion with the label on one of Baxter's Heparin sodium
286
IV bags pictured below.
279 Id.
280 Wyeth, 129 S. Ct. at 1202.
281 Id.
282 FUTURE OF DRUG SAFETY, supra note 77, at 4 (citations omitted).
283 Id. at 5.
284 Wyeth, 129 S. Ct. at 1202.
285 See generally 21 C.F.R. § 314.70(c)(6) (2009); see also Wyeth, 129 S. Ct. at 1196.
2386 Practitioners'ReportingNews: Total Bag/Vial Content Confusion, US PHARMACOPEIA,
OVERDOSED AND CONTAMINATED
2009]
153
Generally, the label's coloring and layout emphasizes the red
box and "attention is drawn to the red box and not the total
volume contained in the bag. '28 7 As a result of this packaging,
patients were administered the wrong concentrated dose of Heparin. 28 8 The facility that used these bags "recommended to Baxter that they change their labeling to include the volume of the
bag in the same color and in the same location as the total num28
ber of heparin units."
9
A year later, "some patient safety advocates [] called on
Baxter Healthcare to change the labeling on heparin products
so that there is a greater distinction between adult and pediatric
doses. '29" However, the changes were not made or did not reach
all Heparin bags. An investigation found that
errors made by pharmacy and nursing staff caused the wrong
concentration of heparin to be used... [when] [a] pharmacy
technician... mistakenly retrieved a higher concentration of
May 31, 2005, http://www.usp.org/hqi/practitionerPrograms/newsletters/practitioner
ReportingNews/prn252005-05-31.html.
287 Id.
288 Id.
289
Id.
Anthony Vecchione, Heparin Overdoses Bring Changes, DRUG Topics, Oct. 26,
2006, http://drugtopics.modernmedicine.com/drugtopics/article/articleDetail.jsp?id=
379887 [hereinafter Vecchione].
290
154
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heparin (10,000 units per milliliter) instead of the lower-concentration heparin (10 units per milliliter) . . .[and] the
higher concentration heparin was delivered to the satellite
pharmacy that serves the pediatrics unit. A second pharmacy
technician, working in the satellite pharmacy, did not verify
the concentration of the delivery from the main
pharmacy ...291
In November 2007, the Quaid twins were given an overdose of
Heparin, primarily due to the similarity in the labels between the
adult vials and pediatric vials.2 9 2 In his testimony before Con-
gress, Quaid stated that the bottles of Heparin "were deadly similar in labeling and size. The 10,000-unit label is dark blue, and
the 10-unit bottle is light blue. '293 Furthermore, "if the bottles
are rotated slightly, as they often are when stored, they are virtu29 4
ally indistinguishable."
A month later, in December 2007, Baxter introduced a new
drug safety initiative to reduce medication errors by creating enhanced packaging of its drugs. Heparin was the first drug to receive the new enhanced label. 29 5 The label features a twenty
percent increase in font size, a unique color combination, and a
296
red tear-off label.
However, Baxter's actions may be too little too late. And
where was the FDA during this three-year period? More information is needed about the correspondence between Baxter and
the FDA regarding Heparin's drug labels to provide a better
evaluation of a claim against Baxter. If the FDA and Baxter had
entered into discussions regarding changes to Heparin's label,
and the FDA prohibited Baxter from making a certain change to
the label, such as changing the color, this fact may impact Baxter's liability under state law. 2 9 7 Nonetheless, plaintiffs lawyers
291 InvestigationReveals How Hospital Gave Dennis Quaid's Babies an Overdose, THE INSIDER, Dec. 5, 2007, http://www.theinsider.com/news/508304_Investigation Reveals_
How HospitalGaveDennis Quaids_Babies anOverdose.
292 Statement of Dennis Quaid, supra note 3, at 3.
293 Id.
294 Id.
Id.
296 Baxter Healthcare Corp., Baxter Introduces New Drug Safety Packagingfor High Alert
Medications: Enhanced Labels the First of Several Initiatives Aimed at Medication Error Reduction, http://araplus.com/aboutIbaxter/news_room/news-releases/2007/12-03-07drug-safety.html (last visited Jan. 13, 2009).
297 See Wyeth, 129 S.Ct. at 1198 (stating that "absent clear evidence that the FDA
295
OVERDOSED AND CONTAMINATED
2009]
would be remiss not to comprehend the significance of the decision in Wyeth v. Levine.
E.
Recommendations for the Improvement of Drug Labeling
Safety Issues
In the wake of the United States Supreme Court's decision
in Wyeth, consumers harmed by drug products with inadequate
labeling will be able to bring their claims in state court. As previously discussed, these lawsuits will serve the important function
of exposing drug safety issues caused, for example, by a drug's
inadequate label. However, in order to prevent the tragedies
that befell the Quaid family, and in order to assist the FDA in the
oversight of drug labeling, significant changes must be made to
the current drug labeling regime. Below, are a few recommendations to consider.
i.
Drug manufacturers must be vigilant in their duty to
update drug labels when new information, such as
adverse events or other safety risks, becomes available.
As previously discussed, Baxter was aware of potential issues
with its Heparin drug labels as early as 2005 but it failed to make
any labeling change until 2007. If Baxter had been vigilant in its
duty, Thomas Boone and Zoe Grace would likely not have been
overdosed.
ii. Hospitals should review their proceduresfor administering
medicine and implement changes as necessary.
When three premature infants died as a result of fatal doses
of Heparin at Methodist Hospital in Indianapolis, 298 the hospital
implemented a "series of drastic changes" to prevent the incident from happening again, including (1) initiating "a double
check for all drugs pulled from inventory"; (2) having one person "pull the drugs from inventory and another... read the drug
label and put the drug into the dispensing cabinet"; (3) eliminating all 10,000-unit Heparin from the hospital and no longer
keeping it in inventory; and (4) having "a minimum of two
would not have approved a change to Phenergan's label, we will not conclude that it
was impossible for Wyeth to comply with both federal and state requirements").
298 Vecchione, supra note 290.
QUINNIPIAC HEALTH LAW
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[Vol. 13:117
nurses validate all Heparin doses" administered in the "neonatal
and pediatric intensive care units."299
Likewise, Cedars-Sinai Hospital (Los Angeles, California),
where the Quaid twins were given an overdose of Heparin, instituted several changes. Cedars-Sinai discontinued use of Heparin
to flush catheters in the pediatric unit; instead, it uses saline solution. 3 0" The hospital also revised its "internal training [program] on the use of 'high alert' medications. 3 1 1 These kinds of
responses to adverse events need to be happening in all
hospitals.
iii. Implementing the use of bar-code technology in hospitals
should be a nationalpriority.
Some believe that "[t]he absence of bar-code technology
and a double-check system contributed to the fatal doses [of
Heparin]."3°2 Bar code technology involves affixing a bar code
to each dose of medication.30 3 The bar code on the medication
is scanned before the medication is given to the patient as an
additional step to make sure that the patient is receiving the correct medication.30 4 Patients have a bar-coded wrist band which a
doctor or nurse scans before administering the drug to the patient to make sure that the medication is approved for the particular patient.3 0 5 Some bar code scanners use a red light or green
light to indicate whether, upon scanning, the medication is ap36
proved for the particular patient.
Michael Cohen, M.S., President of the Institute for Safe
Medication Practices, said, "[I]f a hospital isn't looking into
adopting bar-code technology, it is making a terrible mistake....
299
Id.
300 Howard Breuer, HospitalAnnounces Changes in the Wake of Quaid Mishap, PEOPLE,
Dec. 5, 2007, http://www.people.com/people/article/O,,20164320,0O.html.
301 Id.
302 Vecchione, supra note 290.
303 Bar Code Technology in HospitalPharmacy Cuts Errors, HARVARDSCIENCE, Sept. 18,
2006, http://www.harvardscience.harvard.edu/medicine-health/articles/bar-code-tech
nology-hospital-pharmacy-cuts-errors.
304 See id.; Bar Code Label Requirement for Human Drug Products and Blood, 68
Fed. Reg. 12500, 12502 (Mar. 14, 2003) (codified at 21 C.F.R. pts. 201, 606, and 610)
[hereinafter FDA Bar Code Requirement].
305 FDA Bar Code Requirement, supra note 304, at 12502.
306 See Oprah, supra note 1.
2009]
OVERDOSED AND CONTAMINATED
It should become a requirement."3 °7 In fact, the FDA promulgated a rule in 2003 mandating drug manufacturers to include
bar codes on prescription medications. °8 However, in promulgating the rule the FDA realized that
[T]he bar codes' ability to prevent medication errors depends on many external factors... such as the availability of
bar code scanners, computer software that can process the
bar code information and compare it against patient information, training health care professionals to use scanning equipment, and the willingness
of hospitals to invest in bar code
30 9
scanning equipment.
Unfortunately, bar code scanners are expensive; they cost over
one thousand dollars.3 10 Whether or not cost is a deterrent, a
2006 study showed that only 9.4 percent of hospitals use bar
code technology for medication administration.3 '
Yet, bar-code technology is becoming prevalent in other areas of our lives; for example, local grocery stores are now
equipped with bar code scanners. The use of bar-code technology improves ones experience with buying, categorizing or using
products and should be implemented where we can benefit in
life-altering ways, not just for shopping convenience.
In light of the Quaids' overdose, Cedars-Sinai Hospital implemented bar-code technology. 31 2 Other hospitals should not
wait for a similar tragedy before following Cedars-Sinai's
example.
307 Vecchione, supra note 290 (internal citations omitted).
308 See FDA Bar Code Requirement, supra note 304, at 12502.
309
310
Id. at 12512.
Bar Coding Helps Hospitals Reduce MedicationErrors: TrackingErrorReduction Proves
Challenging, but Users are Pleased, http://findarticles.com/p/articles/mi-mONUZ/is_5_
12/ai_n13759942/?tag=content;colI (last visited Dec. 3, 2009).
311 Debbie Murphy, Barcode Basics: Why Printing,Symbology, and Media Choices Matter,
PATIENT SAFETY & QUALITY HEALTHCARE, Jul./Aug. 2007, http://www.psqh.com/julaug
07/barcode.html.
312 Elizabeth Fry, Dr. Oz and Dennis Quaid with Medical Mistakes - Show Recap,
ABOUT.COM, http://oprah.about.com/od/oprahshowrecaps/p/medicalmistakes.htm.
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zv.
[Vol. 13:117
The FDA should receive increasedfunding and resources
to enhance the effectiveness of its Adverse Event
Reporting System and health professionals should be
obligated to report adverse drug events to the
FDA.
Reports of adverse events submitted to the FDA are stored
in the agency's Adverse Event Reporting System (AERS). 3" 3
Quarter Watch, a pilot program developed by the Institute for
Safe Medication Practices "to improve patient safety through
regular monitoring of all adverse drug events reported to the
FDA. ' 314 This program found that "[a] record number of deaths
and serious injuries associated with drug therapy were reported
to the" FDA "in the first quarter of 2008. "315 Heparin ranked
16
second on the list of drugs with most reported serious injuries,
with 779 cases reported to the FDA in the first quarter of 2008,
3 17
including 102 deaths.
The chart below shows the number of deaths reported to
the FDA from January 1, 2007 to May 31, 2008; these are deaths
occurring after the patient was administered Heparin.3" 8 The
middle column shows the number of deaths regardless of cause.
The third column shows the number deaths where allergic reactions were reported. From January 1, 2007 to May 31, 2008,
Heparin was linked to 246 deaths.3 1 9
313 THE INSTITUTE FOR SAFE MEDICATION PRACTICES,
QUARTER WATCH:
2008 QuAR-
TER 1 6 (2008), http://www.ismp.org/QuarterAlVatch/20O8Q1.pdf [hereinafter QuARTER WATCH].
314
315
316
317
Id. at 1.
Id
Id.
Id. at 3.
318 PDA: Information on Adverse Events Reports and Heplarin, Nov. 18, 2008, http://
blog.heparin-law.com/2008/11/fda-information-on-adverse-event.html.
319 Id.
20091
159
OVERDOSED AND CONTAMINATED
Number of Deaths of Patients Receiving Heparin Reported to FDA,
January 1, 2007 through May 31, 2008
Month the Medical
Event(s) Occurred
Number of Reported
Deaths*
Reported Deaths with
One or More
Allergic/Hypotensive
Symptom(s)
Jan-07
6
3
Feb-07
2
1
Mar-07
5
2
Apr-07
7
4
May-07
3
1
Jun-07
5
2
Jul-07
6
3
Aug-07
4
4
Sep-07
3
2
Oct-07
10
5
Nov-07
12
11
Dec-07
34
23
Jan-08
50
32
Feb-08
49
29
Mar-08
14
10
Apr-08
7
4
May-08
5
3
Unknown date
24
10
Total
246
149
*The reports in this table concern heparin produced by any
320
manufacturer.
Studies indicate that no more than ten percent and possibly
as little as one to two percent of adverse events are reported to
the FDA. 32 1 For consumers and health professionals, submission
of reports is voluntary,3 22 and consequently, these numbers may
be understated. Drug manufacturers must investigate serious adverse drug reactions they become aware of, "[b]ut a company
320 Id.
321 QUARTER WATCH,
322
Id. at 1.
supra note 313, at 7.
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[Vol. 13:117
does not have to act unless informed of a potential adverse event
323
by an employee, consumer or health professional.
Additionally, the Institute for Safe Medication Practices "detected a significant technical error" in the way adverse event reports "were being coded by the FDA."3 24 Thus, the FDA needs
additional funding and resources to correct problems in its infrastructure to ensure accuracy of its data, and in turn, knowledge of the potential drug safety issues.
v.
A national method for determining the number of people
seriously injured or killed by prescriptiondrugs is
necessary in order to accurately quantify the problem
and to track progress in measures designed to
address the problem.
The true number of "individuals seriously injured or killed
by prescription drugs is unknown" because the data is "not calculated by a recognized statistical method."3 2' 5 Because of the
problems with collecting data in this field, many statisticians
have to estimate the numbers. One study, which aggregated information from "hospital admission studies collected over many
decades calculated that 100,000 persons die annually from the
complications of prescription drugs and 1 million or more may
be hospitalized." 2 6 To put this data in context, "44,572 persons
died in 2006 in motor vehicle accidents, 18,029 from homicide
and 560,102 from all forms of cancer.31 27 The Institute for Safe
Medication Practices concluded that the data from studies indicated "the need for additional progress to better manage the
3 28
risks [of prescription drugs] to patients.
IV. FDA Regulation of Foreign Drug Manufacturers
In addition to issues raised by the drug labeling dilemma
and federal preemption analysis, victims of contaminated Heparin, such as the Hubleys, face more hurdles in their attempt to
323 Id.
324 Id.
325
at 6.
at 3.
Id. at 6.
326 QUARTER WATCH, supra note
327
328
Id.
Id. at 4.
313, at 6.
OVERDOSED AND CONTAMINATED
2009]
find an adequate remedy against drug manufacturers in the
United States and abroad.
A.
29
The FDA's InternationalRole and the Globalization Act&
It is generally accepted that "most Active Pharmaceutical Ingredients (APIs) are made by foreign manufacturers. '330 Yet,
the FDA has limited ability to oversee foreign drug manufacturers.13 ' The FDCA requires foreign drug manufacturers exporting drugs to the United States to register with the FDA. 332 The
FDA also requires foreign drug manufacturers to comply with
the current Good Manufacturing Practice (cGMP) requirements. 33 The FDA educates regulatory counterparts in other
countries about United States public health standards, and on
how to comply with cGMP. 33 4 The FDA has also been an advocate for raising international health safety standards and for harmonizing the standards amongst different countries.3 3 5
The FDA is further responsible for monitoring products
3
within its jurisdiction that are imported to the United States. 1
The United States Customs and Border Protection notifies the
FDA when one of the products it regulates, such as a drug, is
offered for import. 33 7 The FDA screens drug products entering
the United States to determine whether the FDA has approved
the product, and "whether the manufacturing plant is registered
and the drug is listed. '33 ' The FDA can issue Import Alerts, to
See supra, Part II.A.iii.
FDA's Foreign Inspection Program: Hearing Before the Subcomm. On Oversight and Investigations of the H. Comm. On Energy and Commerce, I10th Cong. 3 (2007) (statement of
Carl Nielsen, Former Dir. of ORA's Div. of Imp. Operations and Policy, U.S. Food and
Drug Admin.), available at http://archives.energycommerce.house.gov/cmte mtgs/
110-oi-hrg.110107.Nielsen-Testimony.pdf [hereinafter Statement of Carl Nielsen].
329
330
331
See id. at 2.
332
21 U.S.C § 360(h)(i) (2009); see also 21 C.F.R. § 207.40(c) (2009).
333 Statement of Andrew von Eschenbach, supra note 91.
334 Overview: Office of InternationalPrograms, supra note 92.
335 Id.
336 Drug Safety: PreliminaryFindings Suggest Weakness in FDA's Programfor Inspecting
Foreign Drug Manufacturers:Hearing Before the Subcomm. On Oversight and Investigations of
H. Comm. On Energy and Commerce, 109th Cong. 4 (2007) (testimony of Marci Crosse,
Dir., Health Care, U.S. Gov't Accountability Off.), available at http://www.gao.gov/
new.items/d08224t.pdf (FDA "is responsible for overseeing the safety and effectiveness
of human drugs that are marketed in the U.S., whether they are manufactured in foreign or domestic establishments.")
337 Statement of Andrew von Eschenbach, supra note 91.
338
Id.
QUINNIPIAC HEALTH LAW
[Vol. 13:117
get "field personnel to pay special attention to 3a39particular product, manufacturer, shipper and/or importer."
While the FDA is able to inspect foreign facilities,34 ° the process for doing so is challenging.3 4 ' In some countries, the FDA
must receive authorization from the government before entering and inspecting facilities. 4 2 In addition, foreign inspections
are costly.
34 3
If passed, the Globalization Act would increase FDA initiatives overseas by requiring the inspection of all drug manufacturing facilities that plan to trade interstate, 34 4 and authoring the
imposition of register fees on manufacturers to fund the inspections.34 5 The Globalization Act would also require all drug manufacturing facilities to be inspected before a drug manufactured
in the facility is introduced into interstate commerce. The Act
would further require country-of-origin labeling,3 4 6 and that facilities develop risk management plans.3 4 7 The FDA would have
to oversee and monitor these new initiatives.
B.
Chinese State Food and DrugAdministration
The Chinese State Food and Drug Administration (SFDA) is
the FDA's regulatory counterpart in China. In 2001, a revised
version of China's 1984 Drug Administration Law3 48 came into
effect and vested the SFDA with licensing authority. 34 9 The licensing scheme is complex; it consists of many different levels
but it is a necessary prerequisite that a pharmaceutical product
manufacturer obtain a manufacturer's license from the SFDA,
indicating that its facilities are appropriate for the manufacture
339 Id.
340
Statement of Andrew von Eschenbach, supra note 91.
341
Id.
Id.
Id.
344 Globalization Act, supra note 81, § 202(a) (2) (A).
345 Id. § 736C.
346 Id. § 206.
347 Id. § 204(b).
348 The Drug Administration Law of the People's Republic of China, enacted in
1984, was "the country's first comprehensive legislation regulating the research, production, and distribution of drugs ... " Qing Zhang, The Chinese Regulatoiy Licensing
Regime for PharmaceuticalProducts:A Law and Economics Analysis, 15 MICH. TELECOMM. &
TECH. L. Rv. 417, 420 (2009).
349 Qing Zhang, The Chinese Regulatory Licensing Regime for PharmaceuticalProducts: A
Law and Economics Analysis, 15 MICH. TELECOMM. & TECH. L. Rv. 417, 421 (2009).
342
343
2009]
OVERDOSED AND CONTAMINATED
of the product and that quality control arrangements are in
place.35 ° Manufacturers are also required to obtain a "Product
Permit Number from the SFDA" before "manufactur[ing] a new
351
drug or other drugs regulated by national standards.
Yet, the regulatory infrastructure in China is still in its infancy; the Chinese government has been working on revising its
cGMP for drugs, while drug manufacturers comply with cGMP's
inconsistently.3 52 The United States Commissioner of Food and
Drugs stated that the FDA has "limited knowledge of the quality
of ingredients and products manufactured in China as this fast
growing source is just beginning to put in place a national regulatory infrastructure."3 5' 3 In addition, he stated that from 2003 to
2007 "the number of FDA-registered drug manufacturers in
China has at least doubled."'3 54
Around seventy-five to eighty percent of all API's used by
United States drug manufacturers are imported from India and
China.3 5 5 China is the world's largest producer of the active ingredient in Heparin.35 6 Chinese manufacturers of APIs, who export to the United States, are required to register with Chinese
drug regulators. 5 7 However, "[m] ost of the shops that produce
the crude Heparin are not licensed or regulated by the [Chinese] Food and Drug Administration"; 358 many times the pig intestines for Heparin are collected and "dried in homes and small
factories." 5 9 Thus, "[t]he Chinese government considers [Heparin producers] chemical companies, not drug makers, and
therefore not subject to meeting the standards for making drugs
360
in China.
Id.
Id.
352 Statement of Andrew von Eschenbach, supra note 91.
353 Id.
354 Id.
355 Kristy Barnes, China's API Manufacturers Facing Further Crackdowns, INPHARMATECHNOLOGIST.COM, Dec. 13, 2007, http://www.in-pharmatechnologist.com/
Materials-Formulation/China-s-API-manufacturers-facing-further-crackdowns [hereinafter Barnes.]
356 China Gets Serious about Heparin Contamination, MEDHFADLINES.COM, Mar. 22,
2008, http://medheadlines.com/2008/03/22/china-gets-serious-about-Heparin-conta
mination/ [hereinafter China and Heparin Contamination].
357 Barnes, supra note 355.
358 China and Heparin Contamination, supra note 356.
359 Id.; see also Harris, supra note 39.
360 China and Heparin Contamination, supra note 356.
350
351
164
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[Vol. 13:117
Furthermore, in China, it is not mandatory to inspect plants
that manufacture drugs for export.3 6 Arguably, the SFDA is willing to work with foreign countries "to monitor drug-ingredient
production. ' 362 However, the SFDA believes "that based on international practice, 'safeguarding the legality, quality and safety
of active pharmaceutical ingredients' is the responsibility of the
importing countries. "363
C.
Contaminated Heparin
Baxter identified the Heparin contaminant as oversulfated
chondroitin sulfate, a Heparin-like product derived from animal
cartilage that is a derivative of a chemical compound normally
sold as a dietary supplement.3 6 4 The contaminant reacts like
Heparin, and consequently, it was not detected through traditional tests.3 "6 5 The FDA had to develop a new test, using state-of36 6
the-art technologies in order to isolate the contaminant.
When using this new test, Baxter located the site of the contamination - the SPL facility in Changzhou, China.36 7
Recent allegations suggest that contamination of Heparin
may have been deliberate. 8 First, the cost of the contaminant
used in the drug was markedly less than Heparin. The sulfate
cost only twenty dollars per kilogram compared to a cost of
$2,000 dollars per kilogram for Heparin.3 69 Second, the means
of acquiring the Heparin ingredients was completely unregulated and easy to infect with other ingredients. The Changzhou
SPL facility bought "its raw ingredients from a system of consolidators who [bought] the ingredients from thousands of
small, unregulated, producers. "370
361
362
Shows,
Chinese Supplier Never Checked, supra note 125.
Global Supply Chain: Monitoring Quality in China is Not Easy, as Heparin Problem
SUPPLY CHAIN DIGEST,
Mar. 18, 2008, http://www.scdigest.com/assets/On-
Target/08-03-1 8-4.php?cid= 1558&ctype=content.
363 Id.
364 Statement of Janet Woodcock, supra note 35, at 3.
365 Id.
366 Id.
367 Id.
368 Harris, supra note 39.
369 The Heparin Disaster: Chinese Counterfeits and American Failures- Hearing Before the
Subcomm. On Oversight and Investigations of the H. Comm. On Energy and Commerce, ll0th
Cong. 3 (2008) (staff testimony), available at http://archives.energycommerce.govcmte.mtgs/110-oi-hrg.042908.Nelson-Testimony.pdf [hereinafter Staff Testimony].
370 China and Heparin Contamination, supra note 356.
OVERDOSED AND CONTAMINATED
2009]
The FDA approved Baxter's application to change its Heparin manufacturing facility to the one in China, but did not inspect the facility. 371 However, Bob Parkinson, CEO of Baxter,
testified before Congress, "[W]e don't rely on FDA inspections
to ensure the quality of our product - that's our job. '3 72 Baxter
inspected the Chinese facility five months prior to the discovery
of the contamination and found that conditions were
adequate. 373
The results of Baxter's inspection of the China plant differed significantly from the FDA's when FDA officials eventually
toured the Changzhou factory. 374 FDA officials "described find-
ings that indicated flaws in record-keeping and a lack of evidence that appropriate steps were being taken to effectively rid
crude heparin of possible contaminants."3 7' 5 When the FDA released its inspection report, it stated, "Changzhou SPL's
processes for the 'repeated and efficient removal of impurities'
have 'not been evaluated' to determine their effectiveness. "376
Furthermore, the report stated, "'manufacturing instructions'
followed at the plant were 'incomplete.' 377
D.
Using the Heparin Case to Analyze the FDA's Competence
The contamination of Heparin shows weaknesses on the
part of drug manufacturers (Baxter in particular), Chinese drug
regulators, and the FDA to adequately address international
drug safety issues. After a series of Congressional hearings on
the FDA's ability to oversee foreign drug manufacturers and protect the public, Congressional staff found that "corporate due
diligence cannot be relied upon. '3 78 Yet, United States manufacturers have a responsibility to ensure the safety of foreign ingredients that are used to manufacture their finished drug
Families Tell U.S. Lawmakers, supra note 36; see also Harris, supra note 39.
Testimony of Baxter CEO, supra note 123.
373 Families Tell U.S. Lawmakers, supra note 36.
374 Staff Testimony, supra note 369, at 8.
375 Global Supply Chain: Monitoring Quality in China is Not Easy, as Heparin Problem
371
372
Shows,
SUPPLY CHAIN
DIGEST,
Mar. 18, 2008, http://www.scdigest.com/assets/On-
Target/08-03-18-4.php?cid=1558&ctype=content.
376 Id.
377 Id.
378
Staff Testimony, supra note 369, at 7.
166
QUINNIPIAC HEALTH LAW
[Vol. 13:117
products.3 79 Baxter performed an inspection of the Chinese facility in September of 2007 and found conditions adequate. Yet,
when the FDA performed an inspection soon after, the FDA
found quite the opposite. Congressional staff testified that either "Baxter's auditors were less then competent or the facility
fell radically out-of-compliance in the few months that elapsed
38 0
between the two inspections.
Chinese drug regulators did not certify the Chinese facility
that manufactured active ingredients for Baxter's Heparin to
make pharmaceutical products, and because the facility was not
certified, Chinese drug regulators did not inspect it.381 Furthermore, the FDA stated that "due to confusion over similar-sounding names," the Chinese facility that supplied Baxter's Heparin
was mistaken for a previously inspected facility;3 8 2 thus, the reason why the FDA did not inspect the facility before approving
Baxter's application to use it as its new Heparin facility.
Even if the FDA knew the right name of the facility, there is
no guarantee that the facility would have been inspected prior to
the importation of Heparin into the United States as the FDA
lacks the necessary resources to oversee and inspect all registered foreign manufacturers; the FDA is struggling just to fulfill
its domestic initiatives. Former Director of the Office of Regulatory Affair's Division of Import Operations and Policy, Carl Nielsen, stated before Congress, "[T]he current paradigm [for
regulation of the foreign drug industry] is grossly inadequate... and is incapable of determining or verifying the safety
and efficacy of most imported drug products." '8 3 Nielsen further stated, "Product liability is protecting us more than the
FDA's oversight of the international supply of pharmaceu3 84
ticals."
Nielsen argues that the current FDA organizational structure largely ignores the foreign industry.'
Nielsen estimates,
379 Statement of Andrew von Eschenbach, supra note 91.
380 Staff Testimony, supra note 369, at 9.
381 LegislatorsReview FDA Inspection Policy After Heparin Adverse Reactions, B-NET.COM,
Feb. 26, 2008, http://findarticles.com/p/articles/mi_6905/is_/ai_n28539377 [hereinafter Legislators Review FDA Inspection Policy].
382 Id.
383 Statement of Carl Nielsen, supra note 330, at 2.
384 Id. at 2.
385 Id. at 7.
2009]
OVERDOSED AND CONTAMINATED
" IT] he inventory of foreign manufacturers of [prescription] finished drugs and API's... range from approximately 3,000 to
6,000 firms. '3 86 With more drug manufacturing occurring offshore, Nielsen laments that the FDA, unfortunately, "has not redeployed, and will not re-deploy significant resources away from
the domestic industry to the international arena commensurate
with the industry trend," despite external pressure on the agency
to do so. 3 8 71 The FDA inspects almost all domestic facilities regu38 9 If
larly, 8 but only a few hundred foreign facilities each year.
the FDA continues to inspect the foreign drug prescription industry at the rate of two- to three-hundred firms per year, then
the manufacturers of [prescription API's] and finished drugs
would be competed on an inspection cycle up to 30 years....
Such a cycle would mean a 2-3 day inspection once every 30
years in the worst case to make sure drugs are made in a manner to ensure safety and efficacy. The best case scenario may
be approximately a 10 year inspection cycle....
The FDA needs "$250 million per year to inspect every foreign
drug manufacturer every other year; "s31 yet, in 2008, the FDA
allocated only about eleven million dollars to fund foreign drug
manufacturing facility inspections. 9 2 The Government Accountability Office (GAO) audit reported that "China, which has
the largest number of drug manufacturers eligible for FDA inspection (714), [was] earmarked for only 13 regulatory visits by
the FDA" in 2008, which translates to an examination of "less
than 2 per cent of the country's drug exporters.
If the Globalization Act is passed, the FDA will have more
resources and authority to conduct inspections abroad. Under
the Act, fees allocated to foreign drug manufacturers importing
386
387
388
389
Id. at 12.
Id. at 6-7.
Id. at 6. See generally 21 U.S.C § 374 (2009).
Statement of Andrew von Eschenbach, supra note 91.
390 Statement of Carl Nielsen, supra note 330, at 12.
391 HUMPHREY, supra note 273, at 1.
392 Drug Safety: PreliminaryFindingsSuggest Recent J'DA InitiativesHave Potential, but Do
Not Fully Address Weaknesses in Its Foreign Drug Inspection Program:Hearing Before the Subcomm. on Oversight and Investigationsof the H. Comm. on Energy and Commerce, 110th Cong.
(2008) (statement of Marcia Crosse, Dir., Health Care, U.S. Gov't Accountability Off.),
available at http://www.mindfully.org/Health/2008/FDA-Heparin-Chinese22apr8.
htm [hereinafter Statement of Marcia Crosse 2].
393 Barnes, supra note 355.
168
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drugs into the United States will fund the necessary inspections.3 9 4 Arguably, if foreign drug manufacturing establishments
are inspected more often, this in turn will lead to safer drugs
being imported to the United States. However, until the FDA
receives more funding to conduct inspections, it should come up
with a systematic plan to prioritize which facilities to inspect.
Currently, "there is no systematic rationale for choosing which
sites to inspect and which to ignore prior to approval by CDER
31' 9 5
of a foreign inspection application.
Some argue that the criteria "for prioritizing pre-approval
inspections would be geography, complexity of the manufacturing process, and sensitivity of the final drug product."39 6 For example, Congressional staff suggest that Baxter's request to
change the manufacturing site of its Heparin from Wisconsin to
China "should rank in the highest priority of risks. 39 7 Congressional staff point out that the manufacturing process for Heparin is very complex, in part because the drug's ingredients are
extracted from a biological source, and consequently, "manufacturing complexity should have triggered an inspection by FDA
before the product was approved for export." ' Also, the staff
explains that "heparin is a sterile drug administered to very sick
patients ... [b]ecause patients who receive heparin are particularly vulnerable physically, the margin for error in production is
virtually zero. 39 9 While following these criteria leads to logical
results, the FDA has not used such criteria when prioritizing its
site inspections.
In addition to a lack of resources and clear criteria for prioritizing which foreign facilities to inspect, the FDA faces diplomatic hurdles in its attempt to oversee foreign drug
manufacturing. Congressional investigators claim that Chinese
authorities were resistant to inspection of the facilities once contamination was suspected because "Chinese officials have disputed . . . that the contaminant caused death and injury," and
have asserted that "if the F.D.A. insists on inspecting Chinese"
395
396
See Globalization Act, supra note 81, § 736C.
Staff Testimony, supra note 369, at 6.
Id.
397
398
Id.
Id.
394
399 Id. at 6-7.
2009]
OVERDOSED AND CONTAMINATED
facilities, then the Chinese will insist "on the right to inspect
American drug plants."4 °
Nevertheless, the FDA was able to negotiate an agreement
with China to facilitate inspection of facilities.4"' In December
2007, the Secretary for the Department of Health and Human
Services, Michael Leavitt, 40 2 announced the signing of a Memorandum of Agreement (MOA) between the United States and
China to improve the safety of drugs and medical devices.40 3
The MOA, among other things, covers registration of facilities
with Chinese authorities, information sharing regarding inspectional failures, and under the agreement, "the Chinese will facilitate and expedite inspections by FDA investigators of Chinese
drug plants."40 4 However, the agreement only addresses "a fraction of the APIs being imported by China to the US."40 5
In the aftermath of the Heparin contamination, China's
SFDA "has implemented a new [regulatory plan] that requires
drug manufacturers to recall unsafe drugs voluntarily as soon as
they become aware of a problem, in order to minimise their exposure to the supply chain."40 6 More specifically,
Under the new recall system, [(1)] pharmaceuticals that are
classed as being harmful or potentially fatal which must be
recalled within 24 hours of the discovery of a safety issue;
[(2)] drugs that may cause temporary or reversible health
problems must be recalled within two days; and [(3)]
medicines that need to be recalled for non-safety related issues will be required to be removed from circulation within
three days.40 7
These rules will "apply to both domestic and foreign manufacturers importing drug products to China."408
In addition, China's SFDA "has issued a directive to the
makers of heparin ...to purchase supplies from only registered
400
401
402
403
Harris, supra note 39; see also Statement of Marcia Crosse 2, supra note 392.
Statement of Janet Woodcock, supra note 35, at 14.
Id.
Id.
405
Id.
Barnes, supra note 355.
406
407
408
Id.
Id.
Id.
404
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[Vol. 13:117
suppliers and to strengthen quality control standards."4 9 The
agency's directive "calls for the development of a system capable
of tracking the raw ingredients from the initial workshop all the
way up the supply line to the factory," and is supported by "a
similar announcement from the Chinese Ministry of
41
Commerce.""
In sum, the Institute for Safe Medication Practices found
that, in the case of Heparin, "[t] he scale of injury - hundreds of
deaths or serious injuries in a short period - underlines the importance of strengthening oversight of drug manufacture
abroad."4 1 ' Increasing the FDA's oversight will help ensure drug
safety and may prevent future drug contamination. In addition,
the FDA needs to increase the frequency of foreign inspections
to ensure safer drugs. To accomplish these goals Congress
should enact the Globalization Act of 2009, the FDA should reallocate resources to the foreign sector, and the FDA should continue to facilitate agreements with other countries to promote
drug safety.
E. Recommendations
In order to ensure the safety and effectiveness of drugs manufactured abroad, the following recommendations should be
implemented.
i.
Congress should enact the FDA GlobalizationAct.
The Globalization Act, would provide for mandatory inspections of drug facilities.4 1 2 Currently, it is only an agency policy to
inspect foreign facilities prior to the approval of a new drug.41 3
Furthermore, the Act would provide the FDA with more monetary resources to conduct the inspections. Thus, the Globalization Act will increase the safety and efficacy of drugs imported
into the United States by ensuring that facilities manufacturing
the drugs for import into the United States are inspected.
409 China and Heparin Contamination,supra note 356.
410
Id.
411 QUARTER WATCH,
supra note 313, at 4.
412 See GlobalizationAct, supra note 81, § 202.
413
Legislators Review FDA Inspection Policy, supra note 381.
OVERDOSED AND CONTAMINATED
2009]
In addition, the Globalization Act, as currently drafted, contains a provision for country of origin labeling. Such a requirement would increase transparency in the pharmaceutical supply
chain and lead to more informed decisions by consumers about
the drugs they take. For example, if doctors and patients were
aware that Baxter's Heparin API was manufactured in China,
and also that the FDA conducts very few inspections of facilities
in China, an informed consumer may choose to take a different
anticoagulant manufactured in the United States where inspections occur more frequently. In the case of Bonnie and Randy
Hubley, this information could have saved their lives.
ii.
Drug manufacturersshould implement a supply chain
threat evaluation system and the FDA should require
foreign drug manufacturers to keep detailed records
of drug ingredients as they move through the
supply chain.
The contamination of Heparin was accomplished with a
nearly undetectable drug. Drug manufacturers must be aware of
the potential supply chain threats and be prepared to address
them. In addition, the FDA should require foreign drug manufacturers to keep detailed records of drug ingredients as they
move through the supply chain in order to better evaluate and
isolate supply chain threats.
Ii.
If the FDA cannot fulfill its stated obligations with respect
to foreign drug manufacturing oversight, it should
adopt a policy to encourage drug manufacturers to
manufacture drugs domestically instead of
abroad.
The social and financial costs of foreign inspections are
high. Providing an incentive program for drug manufacturers to
increase domestic production of drugs would likely increase inspections of domestic facilities and be more cost efficient. It is
more costly for the FDA to conduct inspections of foreign facilities. Plus, it strains foreign relationship for the FDA to be dependent on foreign governments' permission to enter the
country for the purpose of conducting an inspection. This recommendation, however, would likely be met with resistance
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from drug manufacturers who continue to out-source production of drug ingredients because they are cheaper abroad than
in the United States. However, it still may be in the public interest to domestically manufacture drugs, as the FDA has clearjurisdiction to regulate domestic drug manufacturers and
consequently, it can more effectively monitor production and
ensure the protection of the nation's health.
V.
Conclusion
Although medical errors kill thousands of people each year,
they do not have to. The Heparin case study illustrates the tragic
costs of a preventable medical mistake. If the Heparin labels on
the vials of the adult doses were more distinguishable from the
pediatric doses, the Quaid twins may not have received lifethreatening overdoses of the drug. Drug manufacturers bear
the ultimate responsibility for the labels on their products and it
is a matter of public health to ensure drugs are adequately labeled for their proscribed use and distinguishable from different
concentrations of the same drug. The United States Supreme
Court affirmed this duty on the part of drug manufacturers and
correctly decided against preemption of state tort lawsuits,
thereby preserving the ability of consumers, such as the Quaids,
to seek redress for the harm done to them.
In addition, drug manufacturers retain ultimate responsibility for their finished drug product, even if the active ingredients
are manufactured abroad. Drug manufacturers must take care
to evaluate risks in the supply chain, and preserve its integrity to
prevent contamination of drugs like Heparin. If Baxter had exercised more diligence, it would have discovered that the facility
in China had not been inspected by Chinese drug regulators.
Baxter was already aware that the FDA had not inspected the
facility.4 14 These risk factors should have militated against Baxter's use of the particular supplier of Heparin's active ingredient. If Baxter had been more assiduous, Bonnie and Randy
Hubley may be alive today.
Finally, the Heparin case demonstrates the need for FDA
reform. The FDA is not adequately equipped to handle over414
Staff Testimony, supra note 369, at 8.
2009]
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173
sight of the drugs on the market and it needs increased resources to monitor post-market drug safety and exercise
oversight of foreign drug manufacturers. If we use the Heparin
case study as a platform for reform, we can start to make critical
changes to the FDA and the drug industry overall. In doing so,
the Heparin-related deaths will no longer be just unfortunate results of preventable medical mistakes. The Heparin tragedies
will be the first step of a necessary, long-awaited-for revolution
aimed at setting higher standards for drug manufacturing and
administration. We do an injustice to families like the Hubleys
and the Quaids if we ignore this call for change.