(This syllabus is not part of the opinion of the Court. It has been prepared by the Office of the Clerk for the
convenience of the reader. It has been neither reviewed nor approved by the Supreme Court. Please note that, in
the interests of brevity, portions of any opinion may not have been summarized).
Argued September 14, 1999 -- Reargued November 29, 1999 -- Decided February 29, 2000
GARIBALDI, J., writing for a majority of the Court.
The primary issue in this appeal is whether plaintiff's cause of action is preempted by federal regulation.
In September 1996, plaintiff R.F. received a transfusion of blood for surgery that was infected with human
immunodeficiency virus (HIV), causing her to subsequently test positive for the virus. The blood had been screened
for HIV with the first commercially-available HIV blood screening test, which was manufactured by Abbott. R.F.
and her husband claim that Abbott's HIV blood test was defective because it failed to inform blood banks regarding
limitations inherent in the test and the need to retest where results were negative but “borderline.”
By 1983, scientists understood that AIDS was caused by a virus that could be transmitted through blood
and blood products. This discovery created a national health crisis with respect to the availability of safe blood.
The FDA took quick action by seeking help from both public and private sources in developing a screening test that
could detect the virus in blood samples.
Dr. Gallo of the National Cancer Institute published the first description of a screening test for the HIV
virus (the ELISA or EIA test) in May 1984. ELISA tests functioned by detecting the body's immune response (or
antibodies) to the virus or its components, rather than by detecting the virus itself. Shortly thereafter, the United
States government published a Notice in the Federal Register soliciting private manufacturers to further develop,
manufacture, and mass-distribute Dr. Gallo's prototype HIV screening test to the nation's blood banks. Abbott filed
a response to the Notice and was granted a license by the FDA to develop and manufacture the prototype.
The FDA considered the blood screening test as both a “device” under the Medical Device Amendments of
1976,
21 U.S.C. §360c to §360ee (“MDA”) to the federal Food, Drug and Cosmetic Act, and a “biologic” under the
Public Health Service Act,
42 U.S.C. §201 to §300aaa (“PHSA”). However, its development, manufacture and field
testing was overseen by the FDA's Office of Biologics and Research and Review (“OBRR”). Although Abbott's
test kit was largely regulated by the OBRR as a biologic, the OBRR required that the test be listed as a medical
device and its package insert drafted pursuant to the regulations for labeling medical devices.
It was undisputed at trial that the FDA was intimately involved in the development, clinical trials, and
license process of Abbott's proposed HIV blood screening test. This involvement continued after licensure with
respect to the monitoring of the test results and the development of a Second Generation Test.
As part of its license application, Abbott submitted a draft of the package insert. Abbott's draft suggested
retesting of certain borderline negative samples (those within a specified range of the cutoff value _ the value that
determines whether the blood sample is positive for the virus). The FDA, however, mandated that this provision be
deleted. The testimony at trial was that the FDA concluded there was no scientific basis to believe that samples
close to the borderline were more likely to be false-negative (actual positives that tested negative), and that this
would effectively redefine the cutoff to the lower value for which there would be a new set of borderline samples.
The warning and limitation language of the package insert was to a significant extent dictated by the FDA.
The FDA's letter accompanying the license specifically indicated that if Abbott sought to amend the
labeling or package insert, it would have to submit an amendment for review and approval before implementation.
Moreover, the test labeling was subject to a similar FDA regulation governing biologics which required a change in
labeling to be accepted by the FDA prior to the change becoming effective.
As evidenced by the package insert warnings, the FDA was aware of the limitations of Abbott's first
generation test and the ELISA tests in general. Specifically, the FDA understood that the tests were by design
subject to a window period during which an infected individual would not have detectable levels of antibodies,
causing the test to produce false-negative results. Accordingly, prior to the introduction of the Test on the market,
the FDA conducted a mass-mailing campaign to blood banks and physicians regarding the use and limitations of the
first HIV blood screening tests. The FDA's notices explicitly described the limitations of the tests, stating that a
negative antibody test result does not necessarily mean that one is free from virus because antibodies may not be
present or detectable if the infection was recent.
During the post-license period, the FDA continued to monitor the field performance of the First Generation
Test. Abbott was required to test a portion of every manufactured lot with control samples provided by the FDA,
and submit its data from those tests and lot samples. Abbott was prohibited from distributing any portion of a lot
before formal release by the FDA. The FDA also monitored the Test's performance by information collected from
blood banks, other government agencies, and scientific publications. Representatives of the FDA testified that
throughout the relevant 1985-86 period the Test was state-of-the-art.
The development of the Second Generation Test began as soon as the First Generation Test was marketed
in March 1985. Abbott submitted a license amendment for the Second Generation Test in July 1986, approximately
one month prior to R.F.'s transfusion. The amendment indicated that the p41 enriched test would be better able to
detect positive samples that were “borderline or negative” by the First Generation Test. Abbott requested
immediate permission to market the improved test, but the FDA first required that Abbott conduct clinical trials with
the proposed Second Generation Test. During those trials Abbott found a higher false-positive rate than expected
and reformed the test in the laboratory and began clinical trials again. The Second Generation Test was approved
for the market in January 1987. Abbott immediately withdrew the First Generation Test and notified customers
about the availability of an improved test.
Plaintiffs' main contention focused on whether Abbott provided adequate warnings within the package
insert. Specifically, plaintiffs assert that Abbott was aware that the Test was producing false-negative results in the
early part of 1986 for samples that produced results near the borderline or close to the cutoff value. Plaintiffs argue
that Abbott was required under New Jersey law to warn of the incidence and the inherent dangerousness of
borderline samples in a supplemental package insert and/or instruct blood banks to retest such borderline samples.
Abbott filed two motions for summary judgment arguing that the express preemption provision of the
MDA (
21 U.S.C. §360k(a) (“Section 360k(a)”) preempted plaintiffs' state law claims. The trial court denied
Abbott's motions. A five-week trial followed. The jury returned a verdict in favor of Abbott on all counts,
concluding that Abbott had provided sufficient and adequate warnings and that the Test was not defective.
Plaintiffs appealed. In an unpublished decision, the Appellate Division affirmed the judgment in favor of
Abbott based on the conclusion that plaintiffs' claims were expressly preempted by the MDA. This Court granted
plaintiffs' petition for certification and subsequently ordered the Appellate Division to reconsider and also to
address plaintiffs' non-preemption arguments. In September 1998, in an unpublished opinion, the Appellate
Division again held that plaintiffs' failure to warn claims were preempted by the MDA. However, it also held that if
the claims were not preempted, plaintiffs were entitled to a new trial because the jury instructions were prejudicially
confusing.
This Court again granted plaintiffs' petition for certification. In September 1999, the case was presented to
the Court at oral argument. After argument, the Court requested the parties to file supplemental briefs to address the
extent to which Abbott and the FDA acquired evidence about the Test's safety after licensing, and whether Abbott
had a duty or was permitted to change the package insert after receiving any after-acquired evidence. In plaintiffs'
supplemental briefs they raised for the first time two new arguments: that the Test was not a medical device but
solely a biologic and therefore principles of implied rather than express preemption should apply; and that even if
Abbott was restricted from disseminating a new package insert, it should have issued additional warnings through
the use of physician letters or similar means.
HELD: Plaintiffs' State law claims are preempted by the FDA's regulation of the Test.
1. Preemption may be either expressed or implied. There are two types of implied preemption: field preemption,
where the federal regulation is so pervasive as to make reasonable the inference that Congress left no room for the
states to supplement it; and conflict preemption, where compliance with both federal and state regulations is
impossible or where state law stands as an obstacle to the accomplishment of the purposes and objectives of
Congress. Determining whether there is preemption is a fact-sensitive endeavor. State laws can be preempted by
federal regulations as well as federal statutes. (pp. 30-33)
2. Before the Appellate Division, the parties focused on whether the the MDA's express preemption provision was
applicable. The Court concludes, however, that based solely on principles of implied preemption, plaintiffs cannot
maintain their State failure to warn claim. The FDA's exercise of control and initiative over the Test's
development, packaging, and performance monitoring along with the unique circumstances under which the Test
arose (a national health crisis), give rise to implied preemption. Plaintiffs' contention that Abbott was permitted to
unilaterally change the package insert is without merit. (pp. 33-46)
3. The Court's ruling is not in conflict with its prior holdings, which are distinguishable. As stated above,
preemption determinations are extremely fact-sensitive, and based on the record and context of a particular case.
The FDA determined that it was unwise, and a threat to the nation's blood supply, to retest borderline negatives. It
weighed the harm and danger to unfortunate people, like R.F., against the public's greater need for a safer blood
supply. This was the FDA's decision, and this Court should not second guess it. (pp. 46-51)
4. Because of the court's preemption ruling, plaintiffs' other claims of trial error need not be addressed. The Court
observes, however, that a review of the record establishes that Abbott did not receive any after-acquired information
indicating that the Test's performance was inconsistent with the FDA's expectations. Therefore, the State law duty
to warn of after-acquired evidence is inapplicable. Plaintiffs' argument to the contrary was based on the testimony
of its expert, who was discredited at trial. (pp. 51-61)
As MODIFIED, the judgment of the Appellate Division is AFFIRMED.
JUSTICE STEIN, dissenting, is of the view that the majority's analysis exaggerates the legal significance
of the FDA's regulatory role, understates the materiality of the factual dispute concerning information about the
Test's deficiencies acquired by Abbott after licensing, and diminishes the precedential effect of this Court's federal
preemption jurisprudence.
CHIEF JUSTICE PORITZ and JUSTICES VERNIERO and JUDGE KING join in JUSTICE
GARIBALDI'S opinion. JUSTICE STEIN has filed a separate dissenting opinion, in which JUSTICES
O'HERN and COLEMAN join. JUSTICE LONG did not participate.
SUPREME COURT OF NEW JERSEY
A-66/
67 September Term 1998
R.F. AND R.F.,
Plaintiffs-Appellants
and Cross-Respondents,
v.
ABBOTT LABORATORIES,
Defendant-Respondent
and Cross-Appellant.
Argued September 14, 1999 -- Reargued
November 29, 1999 -- Decided February 29, 2000
On certification to the Superior Court,
Appellate Division.
Brian Wolfman, a member of the District of
Columbia and Arkansas bars, and George T.
Baxter argued the cause for appellants and
cross-respondents (Mr. Baxter, attorney).
Kimball R. Anderson, a member of the Illinois
bar, and Anne M. Patterson argued the cause
for respondent and cross-appellant (Riker,
Danzig, Scherer, Hyland & Perretti,
attorneys).
E. Drew Britcher submitted a brief on behalf
of amicus curiae, The Association of Trial
Lawyers of America_New Jersey (Leonard &
Butler, attorneys).
The opinion of the Court was delivered by
GARIBALDI, J.
In September 1986, plaintiff, R.F., received a transfusion
of blood incident to surgery, that was infected with the human
immunodeficiency virus (“HIV”), causing her to subsequently test
positive for the presence of that virus. The blood which was
transfused into R.F. had been previously screened for HIV
infection at the Bergen Community Blood Center (“BCBC”) with the
first commercially-available HIV blood screening test,
manufactured by defendant, Abbott Laboratories (“Abbott”),
available on the commercial market between March 1985 and January
1987.
R.F. and her husband (collectively, “plaintiffs”), claim
that the HIV blood test used by the BCBC was defective under
N.J.S.A. 2A:58C-2,See footnote 11 because its package insert failed to provide
adequate instructions or warnings regarding the sensitivity
limitations allegedly inherent in Abbott's test. Specifically,
plaintiffs contend that in light of its knowledge that the test
was not 100" sensitive, Abbott should have instructed blood banks
to retest samples that were negative yet “borderline,” meaning
samples that had yielded results close to the test's “cutoff
value.” The cutoff value was a value defined by the federal Food
and Drug Administration (“FDA”) in the test's instructional
pamphlet, to be used by blood bank technicians to measure whether
the HIV antibody was present in a donated blood sample.
After a five-week trial, a jury found that Abbott had
provided adequate warnings, and that the test was not defective.
In an unpublished decision, the Appellate Division affirmed on
other grounds holding plaintiffs' state law claims were preempted
by the “FDA's extensive scrutiny and monitoring of the
defendant's test and dictates regarding the warning inserts.”
The primary issue presented in this appeal is whether federal
regulation of Abbott's HIV blood screening test preempts
plaintiffs' cause of action for defective design and failure to
warn under N.J.S.A. 2A:58C-2.
In 1981, five cases of a rare pneumonia, were reported in healthy young men in Los Angeles. However, it was not until 1982 that the Centers for Disease Control (“CDC”) identified the infection as the autoimmune deficiency virus (“AIDS”). In the ensuing years, the number of newly-reported cases of AIDS grew exponentially:
1982: 593
1983: 3,000
1984: 6,900
1985: 8,000
1986: 14,000
By 1983, scientists understood that AIDS was caused by a virus
that could be transmitted through intra-venous drug use, blood
transfusions, or sexual contact, and had identified certain high
risk groups including: homosexual men, IV drug users, Haitian
immigrants, and hemophiliacs (persons suffering from a blood
clotting disorder requiring transfusions of large amounts of
blood proteins to prevent bleeding). The discovery that the HIV
virus could be transmitted through blood transfusions created a
national health crisis with respect to the availability of safe
blood, because donated blood was a high-risk source of infection,
and the pool of qualified blood donors was reduced by both
persons with AIDS, and members of the identified high-risk
groups. As a result, as early as 1983, the United States Public
Health Service recommended that physicians use transfusions
sparingly, and encourage autologous (or self) blood donation.
As the agency responsible for the safety of the blood
supply, the FDA took action quickly to contain the AIDS epidemic
by seeking help from both public and private sources. Initially,
the FDA turned to the National Cancer Institute (“NCI”), where in
May 1984, Dr. Robert Gallo had published the first description of
a screening test that could detect the HIV infection in blood
samples. Dr. Gallo's prototype screening test was an “ELISA” or
“EIA” test, a generic term that describes “Enzyme Linked
Immunoabsorbant Assays.” ELISA tests, which had been used for
the detection of other blood-borne viruses such as hepatitis,
function by detecting the body's immune response (or antibodies)
to a virus or its antigen components, rather than the virus
itself.See footnote 22 Dr. Gallo's prototype test used a bead coated with an
inactive form of the HIV virus, designed to detect the presence
of HIV antibodies in donated blood samples. If HIV antibodies
were detected, then it could be concluded that the patient's
immune system had been exposed to (and had responded to) the HIV
virus. The prototype was approximately 85" effective in
detecting infected samples. The government applied for, and
ultimately received, a patent for Dr. Gallo's HIV ELISA test.
On May 3, 1984, soon after Dr. Gallo's publication, the
United States government published a solicitation in the Federal
Register (“Notice”) seeking private manufacturers who could
further develop, manufacture, and mass-distribute Dr. Gallo's
prototype HIV screening test to the nation's blood banks. See
Request for Applications to Produce a Virus and an Assay System
for Detection of Antibodies to the Virus Associated with Acquired
Immune Deficiency Syndrome (AIDS),
49 Fed. Reg. 18899 (May 3,
1984). The Notice stated in part:
The Department of Health and Human Services solicits
applications to produce the HTLV-III[See footnote 33] virus and to develop
and distribute [Dr. Gallo's prototype] assay system for the
detection of antibodies to HTLV-III, the newly discovered
virus associated with the AIDS Syndrome, under
non-exclusive, royalty-bearing licenses from the Department
. . . .
[Id. at 18899.]
The Notice sought private manufacturers who could: (1) grow the
virus “on a large scale;” (2) develop an ELISA test kit for
distribution to blood banks, phasmapherisis centers, hematology
and disease laboratories, and medical research institutions; (3)
provide nationwide distribution of the HIV test kit; and (4)
monitor the field performance of the test in blood banks and
research laboratories. Id. at 18899-18900.
According to the terms of the Notice, a manufacturer was
required to obtain a license from the FDA prior to releasing its
test for commercial distribution. Id. at 18900. In “view of the
important public health considerations involved,” responses were
requested within 10 days from the date of the Notice. Ibid. Dr.
Harry Meyer, Director of the FDA's Center for Drugs and Biologics
from 1982 until September 1986, was involved in the selection of
manufacturers for the development of Dr. Gallo's test. Dr. Meyer
testified at trial that the “government wanted to see the most
efficient and rapid development not only [of] the initial test
but for the research for future generations of the test[;] . . .
[g]etting a good test out was about as high a priority as the
government had at the time.”
On May 9, 1984, Abbott filed a response to the Notice
demonstrating its capacity to develop and manufacture Dr. Gallo's
prototype. In July 1984, after reviewing the application and
meeting with a group of Abbott scientists and representatives to
discuss their proposal, the FDA informed Abbott that it would be
granted a license for the government's patent so that it could
develop and manufacture the prototype, and cultivate the virus.
According to Abbott's lead scientist in the development of the
HIV assay, Dr. John Heller, Abbott's primary purpose in the
test's development stage “was to further improve th[e] assay
regarding sensitivity,[See footnote 44] and also to scale up all of the
procedures so that we could manufacture on the order of millions
of tests a month.” Dr. Heller testified that there was “clearly
a sense of urgency” in Abbott's development of the test since the
company “knew that people were becoming infected through blood
transfusion, [and] . . . that people were dying of AIDS as a
result of blood transfusion.”
Four other manufacturers also were selected to develop Dr.
Gallo's prototype. Genetic Systems, Inc., headed by plaintiffs'
expert, Dr. Robert Nowinski, applied for, but did not receive, a
license to develop and manufacture the government's prototype.
However, Genetic Systems did ultimately manufacture an HIV blood
screening test which was licensed by the FDA in 1986 (one year
after Abbott's test was licensed), yet competed with Abbott's
version of the test somewhat unsuccessfully in the commercial
market.
Although the FDA considered the blood screening test as both
a “device” under the Medical Device Amendments of 1976,
21 U.S.C. §360c to § 360ee (“MDA”) to the federal Food, Drug and Cosmetic
Act,
21 U.S.C. §301 to § 395 (“FDCA”), and a “biologic” under
the Public Health Service Act,
42 U.S.C. §201 to § 300aaa (the
“PHSA”), the development, manufacturing, and field performance of
the HIV test, was overseen by the FDA's Office of Biologics
Research and Review (“OBRR”). That is consistent with the FDA's
1982 designation of the Bureau of Biologics as “the lead Bureau
for regulating certain medical devices used in the processing or
administration of biological products,” such as the test kit.
Working Relationship Agreement Among FDA's Bureaus of Medical
Devices, Radiological Health, and Biologics; Availability of
Document,
47 Fed. Reg. 15412, 15412 (April 9, 1982) (“Working
Relationship Agreement”). The FDA clarified in the Working
Relationship Agreement that “biological medical devices,” such as
Abbott's HIV blood screening test, are subject to the provisions
of both the FDCA and the PHSA. Ibid. Therefore, although the
test kit was largely regulated by the OBRR as a biologic (because
the virus was the main component of the test) the OBRR required
that the test be listed as a medical device, and its package
insert drafted pursuant to Labeling for In Vitro Diagnostic
Products, 21 C.F.R. § 809.10(b) (1985), a medical device
regulation.
It was undisputed at trial that the FDA was intimately and
proactively involved in the development, clinical trials, and
licensure process of Abbott's proposed HIV blood screening test.
Dr. Meyer described the relationship between the FDA and the
manufacturers as follows:
It was an intense relationship, I mean, it was a very
high pressured time. . . . There was a big stake in
getting that test out, so we all recognized it was
everybody's first priority. In all of the years I was
in FDA and talking about priorities on hot drug
development or hot biologic development, I can't think
of any time there was more priority than that intense
period of getting an effective AIDS test out.
Dr. Meyer testified that during the development and licensure of
the test, there was a “continual dialogue” between the FDA's
scientific staff and the manufacturers regarding their progress
and clinical results. Similarly after licensure, the FDA
continued this dialogue with respect to the monitoring of the
test, and the development of a Second Generation Test.
Throughout the fall of 1984, Abbott developed the HIV test
kit and submitted proposals to the FDA to conduct clinical
trials. Abbott's completed test had the same basic components
used by Dr. Gallo.See footnote 55 During December 1984, Abbott conducted
clinical trials of its proposed assay that included approximately
10,000 random donors, including a sample group of AIDS and ARC
patients (ARC patients are infected with the virus yet do not
exhibit the symptoms of full-blown AIDS). The results of the
trials using AIDS and ARC patients showed that the test was 98.3" effective in detecting the antibody in AIDS patients, and 65" effective in detecting the antibody in ARC patients. In
addition, the FDA collected 30,000 samples from across the United
States, distributing 6,000 samples to each of the five
manufacturers developing Dr. Gallo's prototype. Each
manufacturer tested the 6,000 samples with the proposed test,
returned the data to the FDA, and then the FDA published the
results.
On December 19, 1984, Abbott sent all of its clinical data
to Dr. Esber, Director of the OBRR Center for Drugs & Biologics,
with the product license application for the proposed test.
According to Marijane Sidote, Abbott's Director of Regulatory
Affairs throughout the relevant time period, the FDA “took the
unprecedented step of asking for raw data points [for the
clinical trials], and printouts from the machines, so they could
independently examine and analyze the data.” Moreover, Sidote
testified that:
[d]uring the next two-and-a-half months there was a
continual communication between me and the FDA groups
that were working on this product. They asked me for
additional information in some cases. One of the
things they asked us to do was to test samples that
they had in their laboratory, so they sent us several
thousand samples for us to test. The results of that
were also reported, so there was considerable paperwork
that I filed following the initial product license
application.
As part of the product license application, Abbott submitted
a draft of the test's package insert. In the December 19, 1984
draft, Abbott suggested that the package insert state: “Specimens
with absorbance values within a . 10" range of the Cutoff Value
should be retested to confirm the initial results.” (emphasis
added). However, in their January 29, 1985 response, according
to Sidote, the FDA “mandated that [this provision] be deleted.”
Dr. Heller testified that the FDA decided not to instruct blood
banks to retest “borderline” negative samples because: (1) there
was no scientific basis for the belief that samples close to the
borderline were more likely to be false-negative than negative
samples with results well-below the cutoff; and (2) such a
provision would effectively redefine the cutoff to the lower
value for which there would be associated a new set of
“borderline samples.”
Dr. Heller testified that in defining the test's cutoff
value, the FDA “specifically indicated [to Abbott] that they had
reentered all of the raw data and redid the statistical analysis
to determine that the cutoff was in the appropriate place.”
During this process, the FDA and Abbott balanced the goal of
maximized sensitivity with the problem of having an abundance of
false-positive results. The appearance of false-positive results
was a major concern throughout the development of the First and
Second Generation Tests, since false-positive results not only
caused a blood bank to destroy that particular sample, but also
disqualified the donor from future blood donations, thereby
further limiting the qualified source of donated blood.
The FDA's active role in setting the test's cutoff was
confirmed by Dr. Meyer who testified that, although Abbott
contributed to the discussion, the FDA ultimately determined the
appropriate cutoff value.See footnote 66 Dr. Meyer also testified more
generally that the “FDA virtually wrote parts of th[e] package
[insert], and one way you could see that, if you look at each of
the manufacturer's package [inserts] for that test at that time,
there are sections of them . . . that are virtually identical.”
In addition to rejecting the provision requiring negative
samples to be retested, according to Sidote the FDA “made very
extensive changes to [Abbott's package insert] draft[s], giving
[them] specific language that they wanted us to put in the
package insert.” Similarly, Dr. Heller testified that “the FDA
dictated . . . a lot of the language in the package insert, and
also dictated how the tables [reflecting the clinical trial data]
would be arranged and the order in which material would appear
within the package insert.” Dr. Meyer confirmed this testimony
stating the FDA was “intimately involved with Abbott in their
packag[e] labeling exactly indicating what the uses and
limitations of the test [we]re.”
The affidavit of P. Ann Hoppe, who was at all relevant times
the Deputy Director/Acting Director of the FDA's Division of
Blood and Blood Products of the Center for Biologics Evaluation
and Research, confirmed that the warning and limitation language
of the package insert was “to a significant extent, dictated by
the FDA”:
Specifically, with respect to Abbott's
package insert, the warnings and statements
relating to the limitations of the test were
not only appropriate, but also were supported
by extensive clinical data that the FDA
reviewed. In addition, the language
contained in the insert was approved by the
FDA and, to a significant extent, dictated by
the FDA. . . . Not only did the FDA approve
the data in the insert, but the FDA also went
to great lengths to assure consistency among
manufacturers in the type of information that
was available to users in the package insert.
All of these licensed products have very
common elements in their package inserts, if
not identical language in some respects,
because the FDA participated in the drafting
of what should be contained therein.
[(emphasis added).]
In particular, the FDA essentially authored three critical
sections of the test's package insert entitled: “INTERPRETATION
OF RESULTS,” “LIMITATIONS OF PROCEDURE,” and “SENSITIVITY AND
SPECIFICITY.” Those sections appeared in identical form in each
of the five manufacturers' package inserts; none of them
mentioned “borderlines,” and none of them instructed users to
retest initially negative samples. The INTERPRETATION OF RESULTS
section of the completed package insert instructed blood bank
technicians:
1. Specimens with absorbance values less than that of
the Cutoff Value are negative by the criteria of
ABBOTT HTLV III EIA.
2. Specimens with absorbance values greater than or
equal to the Cutoff Value are considered reactive
by the criteria of the ABBOTT HTLV III EIA and
should also be retested before interpretation
using the original sample source.
3. Specimens which have been found to be repeatably
reactive [or repeatably above the Cutoff Value]
are interpreted to be positive for antibody to
HTLV III . . .
[(emphasis added).]
Both the LIMITATIONS OF PROCEDURE and the SENSITIVITY AND
SPECIFICITY sections indicated that the Test was not 100" sensitive in detecting the HIV antibody in truly infected blood
samples. Specifically, the LIMITATIONS OF PROCEDURE section
states in part: “A negative test result does not exclude the
possibility of exposure to or infection with HTLV III” (emphasis
supplied). Similarly, the SENSITIVITY AND SPECIFICITY section
sets forth a textual explanation of Abbott's clinical trials
which revealed:
1. Sensitivity based on an assumed 100" prevalence of
HTLV III antibody in AIDS patients is estimated to
be 98.3%.
2. SpecificitySee footnote 77 based on an assumed zero prevalence
of HTLV III antibody in random donors is estimated
to be 99.8%.
Moreover, Table III of the package insert, which summarized
Abbott's clinical trial data, concluded that Abbott's test was
positive in “57 (98.3") of
58 AIDS patients and 72 (67.3") of 107
ARC patients.”
On March 1, 1985, after the package insert was completed,
the OBRR issued a license that “authorized Abbott to manufacture
and sell in interstate and foreign commerce HTLV III in an in
vitro ELISA test,” hereinafter referred to as the “Test” or the
“First Generation Test.” In an accompanying letter to Abbott,
the FDA set forth several conditions of the license, including
that (1) Abbott submit “ongoing stability studies” of the Test
for review by the OBRR; (2) Abbott submit a sample of every lot
of the Test and await FDA approval before that lot is
commercially-distributed; and that (3) Abbott report all
significant product defects or product complaints concerning the
use of the Test.
In addition, the FDA's letter accompanying the license
specifically indicated that if Abbott sought to amend the
labeling or package insert of the Test, “it w[ould] be necessary
. . . to submit an amendment to either [the] product or
establishment license application for review and approval prior
to implementation.” Moreover, the Test's labeling was subject to
a similar, promulgated FDA regulation for biologics, 21 C.F.R. §
601.12, which stated:
(a) General Important proposed changes in location,
equipment, management and responsible personnel, or in
manufacturing methods and labeling, of any product for
which a license is in effect or for which an
application for license is pending shall be reported to
the Director, Office of Biologics Research and Review,
by the manufacturer, and unless in case of emergency,
not less that 30 days in advance of the time such
changes are intended to be made.
(b) Manufacturing methods and labeling Proposed
changes in the manufacturing methods and labeling may
not become effective until notification of acceptance
is received from the Director, Office of Biologics
Research and Review.
[Changes to be reported, 21 C.F.R. § 601.12 (1985)
(emphasis added).]See footnote 88
As indicated by its drafting of the package insert warnings,
the FDA was aware of the limitations of Abbott's First Generation
Test (and ELISA tests in general) at the time of its development.
Specifically, the FDA understood that since all ELISA tests
detected the presence of antibodies to virus, and not the
presence of viruses themselves, the tests were by design subject
to a “window period” during which an infected individual does not
have detectable levels of antibodies, causing the test to produce
false-negative results. That “window period” is the length of
time required for the body to produce enough antibodies to be
detected. In 1985-86, the scientific community could not predict
precisely how long the window period was for HIV. The FDA
understood that it was possible that there were individuals
infected with the HIV virus who had not yet produced HIV
antibodies and, therefore, could donate infected blood (fully
capable of spreading the disease) that could not be screened by
any of the manufacturers' ELISA tests.
Accordingly, prior to the introduction of the Test onto the
market, the FDA conducted a mass-mailing campaign to blood banks
and physicians regarding the use and limitations of the first HIV
blood screening tests. On February 19, 1985, the FDA sent a
memorandum to all registered blood banks in the United States,
including the BCBC, regarding the impending licensure of the
first HIV antibody blood screening tests. The FDA's memorandum,
summarizing an attached copy of the CDC's January 11, 1985
newsletter, explicitly described the limitations of the tests as
follows:
. . . [A] negative antibody test result does
not necessarily mean that one is free from
virus. Antibody may not have developed, or
be undetectable, if infection was recent.
There is at least one report that 4 of 96
individuals carried the virus for 6 months
without developing detectable antibodies.
See Provisional Public Health Service Inter-Agency
Recommendations for Screening Donated Blood and Plasma for
Antibody to the Virus Causing Acquired Immunodeficiency Syndrome,
Morbidity and Mortality Weekly Report, Vol. 34, No. 1 (Centers
for Disease Control) (Jan. 11, 1985). Soon thereafter, the FDA
sent out a similar “Dear Doctor” letter to all licensed
physicians in the United States, including R.F.'s physician,
expressly warning of the above limitations.See footnote 99 Dr. Meyer testified
that the FDA's circulation of these letters was an unusual and
“exceptional” measure, which demonstrated “the enormous effort
that was made not only by [the FDA] but also by industry and
others to fully inform users of [the new test of] what could be
expected of it.”
In view of the recognized limitations of the First
Generation Test, the development of a Second Generation Test
began as soon as the Test was licensed in March 1985. In
developing the Second Generation Test, Abbott focused on
isolating an antibody that could function as an “early marker” of
the infection, and therefore improve the Test's sensitivity in
the window period. During this post-licensure period, the FDA
continued to monitor both the field performance of the First
Generation Test and Abbott's development of a Second Generation
Test. Dr. Meyer testified that once the Test was marketed, there
was a “whole host of monitoring efforts” by the FDA, and that
there was “a lot of discussion on the monitoring of the test and
its performance in practice.” In fact, by FDA order, Abbott
tested a portion of every manufactured lot of the Test with a
control panel of samples provided by the FDA. Abbott then
submitted its data from those tests, and a sample of each lot, to
the FDA. After reviewing the data, and possibly testing the
sample lot themselves, the FDA would notify Abbott by letter or
fax whether the lot was approved for sale. Abbott was prohibited
from distributing any portion of a lot before a formal release
was received from the FDA.
According to Dr. Meyer, the FDA monitored the Test's
performance not only through information collected from Abbott
and the other manufacturers, but also from blood banks, other
government agencies, and scientific publications. Moreover,
throughout the relevant time period, Dr. Meyer represented the
FDA on the “AIDS Executive Task Force,” a group of
representatives from government agencies (such as the NIH and
CDC) who met to discuss AIDS-related issues. With respect to
the blood banks, Dr. Meyer explained that:
all of the users [of the Test] . . . are blood banks
that are under [FDA] regulation, so the major blood
bank organizations were doing a great deal of tracking
of performance, and those blood bank organizations
reported to us. You might even have major blood banks
that had the results and report directly to us. Then
in addition[,] . . . .[in] those early months after
[the Test] came out, we asked for and promptly got
reporting I think on an every two week interval from
essentially, I think it was well over 50 percent of the
blood and plasma phoresis facilities in the country
monitoring their experience repeat reactive rates.
Dr. Meyer testified that “[t]he other big avenue of
information . . . [was] the Centers for Disease Control.” Dr.
Meyer explained that the CDC was:
supporting all the testing activity by all the state
health networks throughout the country, and they were
all using this type of test, and they had an enormous
amount of experience in using tests of this sort . . .
I and people on my staff [we]re in more or less
continual dialogue with the CDC.
. . .
The CDC . . . was doing a lot of direct research on
the performance of the [T]est after the [T]est came
out. [At a meeting of the AIDS Executive Task Force,]
one of the critical articles that I heard the
preliminary report [of was] the big public workshop we
had at the NIH on performance of tests in July 1985, .
. . that was a report largely done by the CDC . . .
[T]hat gave us a great deal of information.
Similarly, in her affidavit P. Anne Hoppe stated that:
[o]nce Abbott's test was in wide use in the
field, there were ongoing communications
between Abbott and the FDA relating to the
test's performance. . . . As a result of the
ongoing communication between the FDA, the
blood banking industry and manufacturers such
as Abbott, the FDA was well-informed about
test performance in the field. . . . It is
significant to note that had the FDA felt
that Abbott's test was defective or that
Abbott's warnings were inadequate based upon
reliable and significant new information, the
FDA would have taken action to protect the
public's interest.
According to the trial testimony, the field performance
data, as well as independent scientific research, reinforced the
FDA and Abbott's initial belief that the incidence of false
negative results were not clustered around the cutoff, but rather
were distributed randomly below the cutoff value. In that
regard, both Dr. Thomas Zuck, the Director of the FDA's Division
of Blood and Blood Products, and Dr. Meyer testified that
throughout the relevant 1985-86 time period the Test was state
of-the-art. In fact, Dr. Meyer testified: “I can say without
qualification whatsoever that all those [F]irst [G]eneration
[T]ests were equivalent, there weren't any that were
significantly better than any others.” Similarly, Dr. Meyer
testified that “there [was] never any serious question that
Abbott's test or anyone else's test was not within the specs that
were described in the package circular.” That testimony was
confirmed by Dr. Zuck, who testified that the FDA had no concerns
about the sensitivity of the Test during the post-licensure
period.
On July 28, 1986, approximately one month prior to R.F.'s
transfusion, Abbott submitted a product license amendment for the
Second Generation Test, which indicated that the p41 enriched
test would be better able to detect positive samples that were
“borderline or negative” by the First Generation Test. (emphasis
added). In other words, the improved test was intended to be
better able to detect all positive samples that falsely
registered below the cutoff by the First Generation Test.
Although Abbott requested immediate permission to market the
improved test, the FDA first required that Abbott conduct
clinical trials with the proposed Second Generation Test. During
the clinical trials, Abbott found a higher false-positive rate
than expected and therefore, reformed the test in the laboratory
and began the clinical trials again. After submitting the second
round of clinical trials to the FDA, the Second Generation Test
was approved for the market in January 1987. Abbott immediately
withdrew the First Generation Test, and sent a Western Union
mailgram to customers stating that the test improved the
sensitivity and specificity of the First Generation Test.
On September 4, 1986, prior to the approval of the Second
Generation Test, R.F. received a unit of blood that was infected
with the HIV virus during orthopedic surgery in Valley Hospital
in Ridgewood, New Jersey. The unit of blood was previously
tested for HIV infection at the BCBC on August 26, 1986, with the
First Generation Test. When tested, the unit of blood was
“borderline negative” with a result of 0.121, slightly below the
cutoff value for a positive reading of 0.128.See footnote 1010 On November 4,
1986, the same blood donor again donated blood at BCBC. That
donation, also tested with the First Generation Test, was found
to be above the 0.128 reading and therefore, HIV positive. A
review of the BCBC's records determined that blood from the
earlier donation had been transfused into R.F.. On September 4,
1987, R.F. was notified that she was infected with HIV.
B. Procedural History
On June 20, 1989, plaintiffs filed a complaint against
Abbott and others, including R.F.'s treating physician, BCBC, and
Valley Hospital. Prior to trial, plaintiffs settled their claims
against the all defendants other than Abbott for $1,500,000.
With respect to Abbott, plaintiffs alleged: (1) breach of implied
and express warranties; (2) inadequate warnings; (3) strict
products liability; (4) negligence; and (5) willful, intentional,
and wanton disregard for the rights and safety of others.
Plaintiffs' main contention focused on whether Abbott
provided adequate warnings within the package insert.
Specifically, plaintiffs assert that Abbott was aware that the
Test was producing false-negative results in the early part of
1986 for samples that produced results near the “borderline” (or
close to the cutoff value) of the Test. As a result, plaintiffs
argue Abbott was required under New Jersey law to warn of the
incidence and the inherent dangerousness of borderline samples in
a supplemental package insert, and/or instruct blood banks to
retest such “borderline” samples.See footnote 1111
On September 23, 1993 Abbott filed a motion for summary
judgment on the grounds that the express preemption provision of
the MDA, specifically
21 U.S.C. §360k(a) (“Section 360k(a)”),See footnote 1212
preempted plaintiffs' state law claims. Relying on Feldman v.
Lederle Laboratories,
97 N.J. 429 (1984) (“Feldman I”) and
Feldman v. Lederle Laboratories,
125 N.J. 117 (1991) (“Feldman
II”), the trial court denied Abbott's motion, holding that it
would be inconsistent with congressional intent to deny private
citizens a tort remedy based on the FDCA, since it is a statute
designed to protect the public's health and welfare; and
moreover, there were material issues of fact regarding whether
Abbott complied with federal warning requirements. Abbott's
motion for leave to seek an interlocutory appeal of that decision
was denied. In 1996, Abbott again filed a motion for summary
judgment alleging federal preemption of the state law claims. On
September 12, 1996, the trial court denied that motion largely
based on the United States Supreme Court decision in Medtronic v.
Lohr,
518 U.S. 470,
116 S. Ct. 2240,
135 L. Ed.2d 700 (1996).
Beginning in September 1996, the trial court conducted a
five-week jury trial to determine Abbott's liability. All the
evidence before this Court was before that jury. The jury
returned a verdict in favor of Abbott on all counts, concluding
that Abbott had provided sufficient and adequate warnings, and
that the Test was not defective. The trial court entered
judgment for Abbott on November 29, 1996.
The plaintiffs appealed. In an unpublished decision, the
Appellate Division affirmed the judgment in favor of Abbott
based on the conclusion that plaintiffs' claims were preempted by
the MDA. The panel reasoned that the FDA's inaction with respect
to the recall of the Test or modification of the Test's package
insert should be construed as approval in light of: (1) the
agency's extensive role in the development of the Test and the
inserts; (2) the agency's continued monitoring of the Test; and
(3) the agency's retention of jurisdiction to recall the Tests
and to direct the amendment of the package inserts. The panel
emphasized that Abbott was prohibited from altering the Test or
the package inserts prior to the FDA's completing its review of
Abbott's data, a task that was not accomplished until early 1987.
On July 15, 1998, this Court granted the plaintiffs'
petition for certification, and subsequently ordered the
Appellate Division to reconsider the plaintiffs' preemption
arguments in light of Baird v. Am. Med. Optics,
155 N.J. 54
(1998), and Medical Devices; Preemption of State Product
Liability Claims,
62 Fed. Reg. 65387 (Dec. 12, 1997) (to be
codified at 21 C.F.R. pt. 808);See footnote 1313 and to consider the plaintiffs'
non-preemption issues raised on appeal.
154 N.J. 606 (1998). In
September 1998, in an unpublished decision, the Appellate
Division again held that plaintiffs' failure to warn claims under
N.J.S.A. 2A:58C-2(b) were preempted by the MDA. However, that
court held that if the claims were not preempted, plaintiffs were
entitled to a new trial because the jury instructions were
prejudicially confusing.
We again granted plaintiffs' petition for certification.
158 N.J. 72 (1999). In September 1999, the case was presented to
the Court at oral argument. After the case was argued, we
informed the parties by letter that the case was to be set down
for further argument, and that they were to file supplemental
briefs to answer four questions: (a) What new evidence did
Abbott acquire after the licensing of the Test regarding its
safety? (b) Did Abbott have a duty, or was it permissible, to
change the Test's package insert or issue a warning after
receiving the alleged after-acquired evidence? (c) If the FDA
possessed the alleged after-acquired evidence, did this alter
Abbott's duties with respect to the Test's warnings? (d) Was
there a federal regulatory scheme in place during the summer of
1985 that was in conflict with the state product liability law
requiring manufacturers to inform users of after-acquired safety
evidence?
In response to that letter, the parties submitted
supplemental briefs and appendices. In plaintiffs' supplemental
briefs they raised for the first time two new arguments: (1)
that the Test was not a “medical device,” but solely a
“biologic,” and therefore principles of implied rather than
express preemption under Section 360k, should apply; and (2) that
even if Abbott was restricted from disseminating a new package
insert, it should have issued additional warnings through the use
of a “Dear Doctor” letter, telegram, or other similar means.
Pre-emption may be either expressed or implied, and “is compelled whether Congress' command is explicitly stated in the statute's language or implicitly contained in its structure and purpose.” Absent explicit pre emptive language, we have recognized at least two types of implied pre-emption: field pre emption, where 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,'” and conflict preemption, where “compliance with both federal and state regulations is a physical impossibility,” or where state law “stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress[.]”
[Gade v. Nat'l Solid Waste Management Assoc., 505 U.S. 88, 98, 112 S. Ct. 2374, 2383, 120 L. Ed.2d 73, 84 (1992) (citations omitted).]
Whether a state law stands as an obstacle to the accomplishment of a federal objective, requires a court to consider “the relationship between state and federal laws as they are interpreted and applied, not merely as they are written.” Jones v. Rath Packing Co., 430 U.S. 519, 526, 51 L. Ed.2d 604, 614, 97 S. Ct. 1305, 1310 (1977) (citations omitted).
The three categories of preemption are usually defined as express preemption, implied preemption, and conflict preemption. Laurence H. Tribe, American Constitutional Law, Vol.I, § 6-28 (3d ed. 2000). However, the Supreme Court and leading constitutional scholars agree that “preemption categories are not 'rigidly distinct.'” Gade, supra, 505 U.S. at 103 n.2, 112 S. Ct. at 2386 n.2, 120 L. Ed. 2d at 88 n.2 (citation omitted).
These three categories of preemption are anything but analytically air-tight. For example, even when Congress declares its preemptive intent in express language, deciding exactly what it meant to preempt often resembles an exercise in implied preemption analysis. So too, implied preemption analysis is inescapably tied to the presumption that Congress did not intend to allow state obstructions of federal policy, the existence of which is a central inquiry in conflict preemption analysis.
(emphasis in original).]
Determining whether federal law preempts state law is a fact
sensitive endeavor, based on a court's review of “fragments of
statutory language, random statements in the legislative history,
and the degree of detail of the federal regulation.” Erwin
Chemerinsky, Constitutional Law: Principles and Policies, § 5.2
(1997). However, preemption “'is not to be lightly presumed.'”
Turner v. First Union Nat'l Bank, ___ N.J. ___, 1
999 WL 1126238,
at *6 (Dec. 9, 1999) (quoting Franklin Tower One, L.L.C. v. N.M.,
157 N.J. 602, 615 (1999)).
When a federal regulation conflicts with state law, the same
preemption rules apply. Fidelity Fed. Sav. & Loan Ass'n v. de la
Cuesta,
458 U.S. 141, 153-54,
102 S. Ct. 3014, 3022-23,
73 L.
Ed.2d 664, 675 (1982). Despite the dissent's implication to the
contrary, see post at ___ (slip op. at 22-23), the United States
Supreme Court has held “repeatedly that state laws can be pre
empted by federal regulations as well as federal statutes.”
Hillsborough Cty. Fla. v. Automated Med. Laboratories, Inc.,
471 U.S. 707, 713,
105 S. Ct. 2371, 2375,
85 L. Ed.2d 714, 721 (1985)
(citations omitted). As long as the agency (1) intended to
preempt state law; and (2) acted within the scope of its
delegated authority, federal regulations will displace
conflicting state laws. Fidelity Fed., supra, 458 U.S. at 153-5,
102 S. Ct. at 3022-23, 73 L. Ed.
2d at 675.
Before the Appellate Division, the parties focused on whether Section 360k was applicable to this matter. We conclude, however, that based solely on principles of implied preemption, the plaintiffs cannot maintain their state failure to warn claim against Abbott.See footnote 1414
There are three types of implied preemption: (1) field preemption, “where the scheme of federal law and regulation is 'so pervasive as to make reasonable the inference that Congress left no room for the states to supplement it;'” (2) conflict preemption, where there is a conflict between federal and state law, rendering “'compliance with both federal and state regulations . . . a physical impossibility;'” and (3) preemption where “state law impedes the achievement of a federal objective;” in this case, even if federal and state law are “not mutually exclusive . . . preemption will be found if state law 'stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.'” Chemerinsky, supra § 5.2 (citations omitted). As with the three general types of preemption, these categories of implied preemption are not perfectly distinct, and in practice often overlap. Ibid.
A. Facts That Support Implied Preemption
In this case, both (1) the FDA's exercise of control and initiative over the Test's development, packaging, and field performance monitoring, and (2) the unique circumstances under which the Test arose (a national health crisis surrounding the emergence of the AIDS epidemic and the loss of a safe national blood supply), give rise to implied preemption of the plaintiffs' state law claims under each of the three categories of implied preemption.
As discussed in detail above, after scientists discovered the virus that caused the AIDS infection, the federal government turned to private industry to assist in expediently developing a blood screening test to curb the spread of the HIV virus. Once selected, Abbott and the other four manufacturers were directed to use the government's prototype in developing a test. It is undisputed that: (1) the FDA took an active role in, and then later scrutinized, the development and clinical trials of Abbott's proposed HIV blood test; (2) the FDA dictated the Test's warning labels, and explicitly rejected the additional warnings and instructions regarding borderline negative samples that the plaintiffs claim were required by state law; (3) the FDA continued to closely monitor the Test's field performance both through information received from Abbott, and information received directly from the nation's blood banks and scientific publications; (4) based on that information, the FDA believed throughout the relevant time period (1985-86) that the Test's field performance was consistent with the FDA's expectations and also with the warnings, limitations, and clinical results published in the Test's package insert; and (5) Abbott's product license, and 21 C.F.R. § 601.12, specifically prohibited it from unilaterally altering the Test's package insert or disseminating additional warnings through “Dear Doctor” letters or otherwise.See footnote 1515
Although the plaintiffs' contended at oral argument and in their briefs to this Court that Abbott was permitted to unilaterally change the package insert under 21 C.F.R. § 601.12(f)(2)See footnote 1616 and 21 C.F.R. § 814.39(d),See footnote 1717 that argument is without merit. 21 C.F.R. § 601.12(f)(2), proposed on January 29, 1996, see Changes to Approved Application, 61 Fed. Reg. 2739-01, 2740-44 (January 29, 1996), was not effective until October 7, 1997, see Changes to Approved Application, 62 Fed. Reg. 39890 01,39901 (July 24, 1997), and therefore is inapplicable to this case. Similarly, 21 C.F.R. § 814.39(d), proposed on December 12, 1980, see Medical Devices; Premarket Approval of Medical Devices; Proposed Establishment of Regulations, 45 Fed. Reg. 81769, 81776 (Dec. 12, 1980), was not effective until November 19, 1986, see Premarket Approval of Medical Devices, 51 Fed. Reg. 26342, 26352 53 (July 22, 1986), one month after R.F.'s transfusion, and therefore is also inapplicable to thi