R.F. & R.F., VS ABBOTT LABORATORIES
Annotate this CaseThis case can also be found at 311 N.J. Super. 216.
NOT FOR PUBLICATION WITHOUT THE
APPROVAL OF THE APPELLATE DIVISION
SUPERIOR COURT OF NEW JERSEY
APPELLATE DIVISION
A-2050-96T2
R.F. AND R.F.,
Plaintiffs-Appellants,
v.
ABBOTT LABORATORIES,
Defendant-Respondent.
_________________________________________________________________
Argued March 17, 1998 - Decided May 7, 1998
Before Judges Long, Stern and Kleiner.
On appeal from the Superior Court of New
Jersey, Law Division, Bergen County.
George T. Baxter argued the cause for
appellants (Mr. Baxter, on the brief).
Anne M. Patterson argued the cause for
respondent (Riker, Danzig, Scherer, Hyland
& Perretti, attorneys; Kimball R. Anderson and
Alexis MacDowall, Winston & Strawn, pro
hac vice, of counsel; Ms. Patterson, on the
brief).
The opinion of the court was delivered by
STERN, J.A.D.
Plaintiffs appeal from a judgment based on a jury verdict in favor of defendant Abbott Laboratories ("Abbott"). We affirm the judgment.
In September 1986 plaintiff wife, R.F., received a blood transfusion incident to surgery and subsequently contracted human immunodeficiency virus ("HIV"). She and her husband brought this
action against various defendants, including Abbott which manufactured the HIV test used to screen the blood that was used in the transfusion. After plaintiffs settled with the other defendants, the case was tried against Abbott.
Plaintiffs' claims were based on Abbott's failure to give adequate warnings about its HIV test and that the test was defective. Plaintiffs specifically asserted that the blood screening test manufactured and distributed by Abbott was not reasonably fit, suitable or safe, because it failed to detect antibodies to HIV in the unit of blood transfused. In addition to this alleged design defect, plaintiffs contended that the test was not accompanied by adequate warnings or instructions to defendant Bergen Community Blood Center ("BCBC") which did the testing.See footnote 1 Abbott argued that the test was accompanied by proper product warnings and instructions approved by the Food and Drug Administration ("FDA") and that the alleged defect was an inherent scientific limitation in the screening test. The jury found in favor of Abbott.
On this appeal, plaintiffs urge various grounds for reversal. We need not address them, however, because we agree with Abbott that the judgment must be affirmed because plaintiffs' claims are preempted by the Medical Device Amendments of
1976, 21 U.S.C.A. 360c-360ee ("MDA"), to the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.A. 301-395.
In or around the spring of 1984 the virus later named HIV was identified as the cause of acquired immune deficiency syndrome, better known as AIDS. There can be no dispute that the development of blood tests to identify the HIV virus became a national health priority in light of the AIDS epidemic. Shortly thereafter, Dr. Robert Gallo developed the prototype enzyme-linked immunosorbent assay ("ELISA") test designed to detect HIV antibodies in the blood. Gallo's test detected the antibody to the virus in only about 85" of individuals infected with HIV. The FDA's Office of Biologics Research and Review ("OBRR"),See footnote 2 which oversees blood collection, processing, testing, and marketing, determined that Gallo's ELISA test represented the best available means to detect HIV in the blood supply. On May 3, 1984, by notice in the Federal Register, the FDA solicited private companies to develop an assay ELISA (or EIA) test, "for the detection of antibodies to the virus associated with AIDS." On May 9, 1984, Abbott applied "for authority to grow the HTLV III virus on a large scale, to develop an assay for detection of antibodies to HTLV III and for nationwide distribution of the assay kit." After months of work with Abbott and review of its
research, on March 1, 1985 the FDA issued a license which "authorized Abbott to manufacture and sell in interstate and foreign commerce HTLV III in an in vitro ELISA test. Pursuant to the licensing regulations, [however,] the OBRR required Abbott to submit ongoing stability studies for review and inclusion in the product license file."
Plaintiff R.F. received a blood transfusion on September 5, 1986, during surgery at Valley Hospital in Ridgewood, New Jersey. The transfused blood had been collected and screened by defendant BCBC and tested using the Abbott HTLV-III ELISA test kit on August 26, 1986. This unit tested 0.121, slightly below the "cutoff value" for a positive reading of 0.128. Even though this unit was within .007 of the cutoff value, the instructions did not suggest or require retesting.
On November 4, 1986, the same blood donor again donated blood at BCBC. This donation, also tested with Abbott's ELISA test kit, was found to be above the 0.128 reading and, therefore, HIV positive. A review of BCBC records determined that blood from the earlier donation had been transfused into R.F.
Abbott's HIV screening test warned users that HIV-infected donors could escape detection. Its package insert advised that "[a] negative test result does not exclude the possibility of exposure to or infection with HTLV III." That warning, approved by the FDA, appeared in all commercially-licensed ELISA test kits. According to test instructions, only specimens with "absorbance values greater than or equal to the Cutoff Value ...
should be retested." However, the package insert did not direct laboratory technicians to retest blood if the unit recorded a reading anywhere below the cutoff value. To the contrary, it provided that "[s]pecimens with absorbance values less than the Cutoff Value are negative by the criteria of ABBOTT HTLV III EIA." The insert did not mention borderline readings or any margin of error.
Plaintiffs contend that R.F.'s blood sample should have been retested on August 26, 1986 in light of the reading that day. They argued before the trial judge that:
The Abbott instructions and warnings provided with the test kit do not recognize "weak reactive" test result or "borderline" test results. That is, if unit 0202 had tested .007 above the "cut off" it would have required retesting but since it was .007 below the "cut off" and numerically far greater than all other units tested but did not require retesting. The Abbott Laboratory instruction and warnings failed to advise the user of the test, for the Plaintiffs benefit, that under its criteria for interpreting the test results as strictly "reactive" or "non-reactive" that a certain number of "borderlines" would not be detected.
5. It is Plaintiffs allegation that Abbott Laboratories had knowledge at the time that it manufactured, marketed and distributed its HTLV-III test kit that under its criteria of interpreting test results as either "reactive" or "non-reactive" as opposed to recognizing occasional "borderline" or "weak reactive" test results.[] That in some cases "borderline" test results close to the cut off that were slightly below the cut off value would also be contaminated with the HIV virus. Plaintiff alleges that Abbott failed to
provide proper instructions and warnings as to the limitations of this test.See footnote 3
In her December 10, 1993 affidavit in support of a motion for reconsideration of the denial of Abbott's original motion to dismiss, Marijane Sidote Gregg, Manager of the Regulatory Affairs Department and subsequently Director of Regulatory Affairs for Abbott's Diagnostic Division, stated:
7. From January to April, 1985, Abbott submitted drafts of Abbott's ELISA test package insert to the FDA. These drafts addressed subjects required by the applicable federal regulation. In many instances, the FDA suggested specific language that Abbott was required to include in the package insert and Abbott engaged in an ongoing dialogue with the FDA concerning the ELISA test package insert. The insert submitted by Abbott to the FDA on March 1, 1985 reflects the FDA's revisions. The package insert dated April, 1985 ... is a true and accurate copy of the package insert that accompanied Abbott's ELISA test from July 1985 to January 1986. The contents of this package insert were approved by the Food and Drug Administration prior to dissemination. This package insert, and all subsequent package inserts, address the subject of false negative results in the manner required by the FDA. The license, dated March 1, 1985, reflects the FDA's approval of Abbott's ELISA test package insert for release to the public.
8. On February 28, 1985, at a meeting for the final review of Abbott's package insert, the FDA and I discussed the method for calculation of the test's cutoff value. The decision as to how to calculate the cutoff value, as reflected in Abbott's
package insert, was in accordance with the requirements of the FDA.
10. On July 28, 1986 Abbott sought FDA approval to modify its original EIA test. When Abbott sought FDA approval to modify its original EIA test, the FDA then reviewed Abbott's submission, evaluated its data, requested clarification, and approved Abbott's modified test in January, 1987. Prior to that time, Abbott was prevented by law from marketing the modified test or to change its then-current package insert. By federal regulation, any changes in the test or its accompanying literature first had to be approved by the FDA pursuant to 21 C.F.R. 601.12(a),(b).See footnote 4
Although plaintiffs advanced various legal and factual contentions, these critical facts were never contested. Nevertheless, Abbott's 1993 motion to dismiss on grounds of preemption was denied.
After Abbott's 1993 motion for dismissal on preemption grounds was denied and reconsideration of that denial was also denied, Abbott moved for summary judgment in 1996. In support of one of the grounds advanced by the motion, Abbott presented Gregg's June 19, 1996 affidavit in which she stated that in October 1984 the FDA's Office of Biologics Research and Review "specifically referred Abbott to the appropriate labeling standards for container and package labels for licensed
biological products" in 21 C.F.R. 610.62 and 610.65, and packaging insert standards of 21 C.F.R. 809.10(b), and provided Abbott with a "Medical Device Listing" form necessary "for use in completing the application process." According to Gregg's 1996 affidavit, from December 1984 to April 1985, Abbott "submitted drafts of [its] ELISA test package insert to the OBRR," and "[i]n many instances, the FDA dictated the specific language that Abbott was required to include in the package insert." Abbott "engaged in an ongoing dialogue with the OBRR concerning the package insert" and "[t]he final insert submitted by Abbott to the OBRR on March 1, 1985, reflect[ed] the OBRR's revisions," and addressed "the subject of false negative results in the manner required and approved by the FDA."
Other affidavits in support of Abbott's 1996 motion also emphasized that the FDA reviewed and regulated the initial licensing and monitoring of ongoing performance of Abbott's blood test kit. Of particular significance is 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 ("CBER") (a successor name to the OBRR). According to Ms. Hoppe's affidavit:
5. I have personal knowledge of the regulatory approval process and monitoring application of Abbott's HTLV III ELISA test in blood banks and related donor deferral issues. As such I am aware that the FDA approved and regulated Abbott's HTLV III ELISA test as a biologic medical device. Although most medical devices are not required to be licensed, the FDA's licensing requirements provided the FDA with an
additional level of control for this test. For example, the licensing regulations require approval of every change in labeling and manufacturing. In addition, the FDA has the ability to suspend the license without going through other processes. The pre-approval process included review of all of the clinical trials (including plans and protocol), all of the data in the license application, as well as the development of the statements in the labeling. The FDA also was involved in the ongoing lot release testing and pre-licensing inspection which provided a level of assurance for product performance that was not available for other medical devices. In my twenty years of experience at the FDA I believe that this test was the one of most highly scrutinized with respect to initial licensing and monitoring of ongoing performance.
6. As referenced above, the HTLV III ELISA test is a medical device and licensed biological product. Abbott's HTLV III ELISA test was intensely reviewed and scrutinized not only in the time frame leading up to the March approval, but from thereon. Unlike drugs and devices, the FDA requires that biologic products be licensed as required by Section 351 of the Public Health Service Act so that the agency can maintain more control over the product. Throughout the life of a licensed product the FDA is more involved in every aspect of its manufacture. In addition, as a licensed product the FDA also has several remedial measure[s] available to it. For example, the FDA is able to immediately suspend the license and remove the product from the market if it feels that the product is unsafe.
7. 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. In particular, the FDA specifically dictated the language contained in the package insert sections entitled "PERFORMANCE
CHARACTERISTICS," "LIMITATIONS OF PROCEDURES," and "INTERPRETATION OF RESULTS." Also, the specific performance characteristics of the package insert are based directly upon the clinical data submitted in the license application. 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.
8. Once 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.
9. There also were no data that demonstrated that Abbott's HTLV III ELISA test did not meet the sensitivity limitations as set forth in the package insert. 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. For example, if the FDA had believed that the content of Abbott's package insert was no longer valid after the test was in use in the field, the FDA could have required Abbott to change the insert. Moreover, if the FDA later came to believe that it was necessary to add the term "borderline" to the insert it could have required Abbott to do so. However, the record reflects that Abbott already warned in its package insert that its test was not 100" sensitive. The FDA also could have recalled Abbott's test or independently warned customers had the FDA felt this was necessary. Again, the FDA did not feel that these types of actions were necessary and, as
such, was satisfied with the performance of Abbott's test.
10. All labeling changes for the HTLV III ELISA test must be approved by the FDA under 21 C.F.R. 601.12(b). Abbott could not have independently modified or otherwise changed its package insert without FDA approval since the HTLV III ELISA test was a licensed product. Once the cutoff is established, neither the manufacturer nor the blood banks are authorized to instruct technicians to deviate from the insert. Blood banks must run the test according to instructions authorized by the FDA. Under the applicable regulations, Abbott would have needed pre-approval from the FDA to change its labeling in any significant way. The FDA also considered advertising and promotion to be part of labeling as long as it related to the performance of the product. As such, Abbott could not have independently issued Dear Doctor or similar letters without FDA approval. In addition, recommended retesting of samples near the cutoff value effectively would constitute a change in the cutoff value and the FDA would consider this a major change in labeling. As such, the FDA would have required extensive additional data from clinical studies to demonstrate that such a change in the insert was supported. In the evaluation of how the test should be applied, the FDA considered and rejected the concept of retesting within +/-10" of the cutoff.
11. The FDA knew from the data in its possession that Abbott's test was not 100" sensitive and it very carefully considered the warnings that should be in the insert. The FDA was aware that there could be false negative results when setting the cutoff value and this was a known risk or limitation of the test. This limitation was described in the data in the insert under the section "PERFORMANCE CHARACTERISTICS." If sufficient antibodies were present in an individual, Abbott's test was very dependable in detecting those antibodies as expressed by the sensitivity and specificity data. The FDA considered the warnings in Abbott's package insert to be appropriate at all times leading up to the FDA's approval of Abbott's
subsequent test in January, 1987. The data in the insert gave users more precise information about the performance of the test and the FDA considered this information to be sufficient and appropriate for public safety.
12. The FDA was in continual communication with Abbott and the FDA had access to ongoing lot release information. All this time the FDA allowed the test to be on the market without any changes in labeling. If the FDA felt there were any problems that affected the safety of the test, or that legitimately invalidated the contents of the insert, or there were significant new developments requiring a change to the insert, the FDA had numerous opportunities available to it to take action. The fact that the FDA never took any such action demonstrates that the FDA felt the labeling for Abbott's test was appropriate and adequate.
[(Emphasis added).]
As already noted, Abbott argues that we should affirm the judgment because plaintiffs' claims are preempted by the Medical Device Amendments of 1976, 21 U.S.C.A. 360c-360ee, to the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.A. 301-395. Plaintiffs contend, however, that because Abbott did not file a cross-appeal, the preemption issue is not properly before us.See footnote 5
Because Abbott maintains that this is an additional reason for affirmance and not a reason for reversal, there is no need
for a cross-appeal. An order or judgment will be affirmed if the result is correct, even though the judge did not rule or decide the case on that basis. See Isko v. Planning Bd. of Township of Livingston, 51 N.J. 162, 175 (1968); Ellison v. Evergreen Cemetery, 266 N.J. Super. 74, 78 (App. Div. 1993). Thus, even though the trial judge rejected Abbott's preemption claim, its contention supports the ultimate judgment in its favor.
Section 360k of the MDA, entitled "State and local requirements respecting devices," provides:
(a) General rule
Except as provided in subsection (b) of this section [when a State or political subdivision applies for an exception], no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement__
(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.
[ 21 U.S.C.A. 360k.]
The regulation interpreting this section, 21 C.F.R. 808.1(b), provides:
Section 521(a) of the act [21 U.S.C.A.
360k(a)] contains special provisions governing the regulation of devices by States and localities. That section prescribes a general rule that after May 28, 1976, no State or political subdivision of a State may establish or continue in effect any requirement with respect to a medical device intended for human use having the force and effect of law (whether established by statute, ordinance, regulation, or court decision), which is different from, or in addition to, any requirement applicable to such device under any provision of the act and which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under the act.
In denying Abbott's 1993 motion, the trial judge focused on whether Abbott's package insert complied with the labeling requirements of 21 C.F.R. 809.10. That regulation provides in pertinent part:
(b) Labeling accompanying each product, e.g., a package insert, shall state in one place the following information in the format and order specified below, except where such information is not applicable, or as specified in a standard for a particular product class ....
. . . .
(3) Summary and explanation of the test. Include a short history of the methodology, with pertinent references and a balanced statement of the special merits and limitations of this method or product ....
. . . .
(5) Reagents:
. . . .
(ii) A statement of warnings or precautions for users as established in the regulations contained in 16 CFR Part 1500 [Hazardous Substances and Articles; Administration and Enforcement Regulations of the Federal Hazardous Substances Act] and any other warnings appropriate to the hazard presented by the product; . . . and any other limiting statements appropriate to the intended use of the product.
[21 C.F.R. 809.10.]
The judge quoted from the package insert that stated: "False positive test results can be expected with a test kit of this nature. The proportion of reactives that are falsely reactive will depend on the sensitivity and specificity of the test kit and on the prevalence of HTLV III antibody in the population to be screened." The judge noted the statistical analysis that followed that warning in the insert, and concluded: "This section of the insert, without question, has met the requirements of the labeling regulation" regarding false positive tests.
However, the judge found that the insert did not explain "false negative results." While the insert stated that "[a] negative test result does not exclude the possibility of exposure to or infection with HTLV III," the judge felt this was only "the hint of a false negative warning." He concluded that when read "in conjunction with the preceding paragraph" of the package insert, "one may arguably come to a different conclusion" about the need for additional testing, because the insert states that "`donors who are repeatably [sic] reactive for HTLV III antibody should be referred for a medical evaluation which may include additional testing ...'" The judge explained that this reference to "`negative test results' may arguably have been made in connection to the `additional testing' recommended in the insert and not the initial screening process."
The judge, in any event, concluded that Abbott did not comply with the federal labeling requirements because Abbott gave
no warnings about "the possibility of false negative reactives." The insert failed "to mention any relevant precautions that should be taken in the event a test result falls close to the `cutoff value.'" In contrast, the insert stated that "positive readings require retesting. In addition, the insert fails to provide an explanation of relevant factors that may cause false negative test results." Quoting King v. Collagen Corp., 983 F.2d 1130, 1136 (1st Cir.), cert. denied, 510 U.S. 824, 114 S. Ct. 84, 126 L. Ed. 2d 52 (1993), the judge stated that "[t]he goal of the MDA was to determine and regulate `the intended purpose of the device'... and [c]ontrol over such devices `ensures that the manufacturers will not be held liable for packaging and labeling imposed by the FDA.'" The judge concluded that Congress thus "intended to immunize manufacturers [only] when they comply with federal regulation, not if they go astray."
As a result of plaintiffs' argument that Abbott had knowledge that its screening test "produc[ed] false negative results" prior to R.F.'s September 5, 1986 surgery, and that by "not supplying a supplemental package insert, Abbott failed to adequately warn subsequent users of the test's deficient screening ability," the judge concluded that whether Abbott acquired sufficient knowledge to be held liable was "a question for the jury to decide," so that summary judgment was inappropriate. Quoting Feldman v. Lederle Lab., 125 N.J. 117, 155 (1991), (Feldman II), the judge concluded that Abbott could not "`reasonably sit idly by[,] immunized from responsibility for
those anticipated repercussions by legislation intended to promote [the] public health."See footnote 6
In Feldman II, the Supreme Court stated that the presence of the following factors reinforced the traditional presumption against federal preemption: (1) that there was no explicit provision for preemption of state tort claims; (2) that the subject matter infringed on a state's inherent powers to protect and promote the health and safety of its citizens; and (3) that preemption would effectively eliminate all means of recourse for the plaintiff. Id. at 156. The Court explained that if there had been a need to immunize prescription drug and antibiotic manufacturers from tort liability, the determination of that need should have been made by Congress in an unambiguous mandate. Ibid. Since to date Congress had not seen fit to express such a mandate, the Court refused to do so. Ibid.
Relying on Feldman, the trial judge's 1996 opinion again found that "it would be inconsistent with congressional intent to allow a defendant to escape from liability for its failure to warn of foreseeable dangers by hiding behind a congressional statute that was intended to protect the public's health and welfare," and after reviewing the then recent opinion of
Medtronic, Inc. v. Lohr, 518 U.S. 470, __, 116 S. Ct. 2240, 2254-59, 135 L. Ed. 2d 700, 720-26 (1996), adhered to his view that 21 U.S.C.A. 360k(a) did not preempt a plaintiff's state tort claims of design defect and failure to warn.
In Medtronic, the Court considered whether section 360k(a) preempted a state common-law action against the manufacturer of an allegedly defective pacemaker. 518 U.S. at ___, 116 S. Ct. at 2250-59, 135 L. Ed. 2d at 714-26. A divided Supreme Court held that Congress did not intend to bar a state common-law action (based on negligent design, negligent manufacturing, and inadequate labeling) for injuries resulting from the device. Medtronic, supra, 518 U.S. at ___, 116 S. Ct. at 2251-59, 135 L. Ed. 2d at 716-26.See footnote 7 In Part V of its opinion, the plurality joined by Justice Breyer to make a majority, see id., 518 U.S. at __, 116 S. Ct. at 2253-58, 135 L. Ed. 2d at 719-726, concluded that common-law duties have not been preempted by the MDA unless the FDA specifically preempts them by regulation, the state cause of action is based on a state law that is device specific and different from or additional to federal requirements, or the
state tort claim has the effect of establishing a substantive requirement for a specific device. 518 U.S. at ___, 116 S. Ct. at 2257-58, 135 L. Ed. 2d at 724-26. In Part V, the Court also noted that "[t]he presence of a damages remedy does not amount to the additional or different 'requirement' that is necessary under the statute" when the duties these remedies enforce parallel federal requirements. 518 U.S. at ___, 116 S. Ct. at 2255, 135 L. Ed. 2d at 722.
Abbott claims that this case is preempted because the FDA took an extensive role in the development of the ELISA test and the accompanying package inserts. The trial judge disagreed. As to plaintiffs' design defect claims, the trial judge cited and quoted Medtronic, 518 U.S. at ___, 116 S. Ct. at 2254, 135 L. Ed. 2d at 721, for the proposition that the Supreme Court "found the regulations in that case not substantive because the FDA `did not "require" Medtronics['] pacemaker to take any particular form for any particular reason.'" The judge believed that the FDA similarly "left the design of the HTLV-III test to Abbott Labs." He also determined that plaintiffs' labeling claims were not preempted by 21 U.S.C.A. 360k because plaintiffs, "similar to the plaintiff in Medtronic, alleged that [Abbott had] negligently failed to comply with federal regulations." He emphasized that the United States Supreme Court was "emphatically clear that a state common-law action will not be preempted if the duty imposed by the state is parallel to that of a federal law." The judge further noted that New Jersey imposed "the general duty o[n]
manufacturers to use due care to avoid foreseeable dangers in its products," and "the predicate for [plaintiffs'] failure to warn claim is the general duty to inform users and purchasers of potentially dangerous items of the risks involved in their use." The judge noted that "[t]hese were the same duties found to be of a general nature in Medtronic and which were not found to be preempted." He thus ruled here that "[t]hose same common-law duties are not preempted in this case."
Before us, Abbott contends that Medtronic, supra, 518 U.S. at ___, 116 S. Ct. at 2257, 135 L. Ed. 2d at 723-25 (1996), preempts plaintiffs' claims because (a) its test underwent a vigorous premarket approval process by the FDA; (b) the FDA imposed a specific mandate on Abbott after weighing competing considerations; and (c) plaintiffs' claims are inconsistent with, or in addition to, the mandate imposed on Abbott by the FDA. We conclude that the warning and defect claims are preempted and that the pretrial motions to dismiss should have been granted on preemption grounds because it was undisputed that the FDA specifically reviewed Abbott's package insert and approved it only after it incorporated changes the FDA had directed.See footnote 8 See Brill v. Guardian Life Ins. Co. of Am., 142 N.J. 520 (1995). With respect to plaintiffs' claim that Abbott became aware that its test failed to detect units of blood which were actually
positive, and that it had an obligation under New Jersey law to order additional testing or at least to change its warning, we note the uncontested fact that the FDA continued to monitor the result of Abbott's testing and had jurisdiction both to recall the test and order the introduction of an amended package insert. There was no genuine contest to the assertion of Marijane Gregg, Abbott's Director of Regulatory Affairs from 1985 to 1993, and the affidavit of the FDA's Deputy Director/Acting Director of the Division of Blood and Blood Products, Ann Hoppe, that Abbott was prohibited from modifying its test and changing its package insert warning until the FDA "reviewed" and "evaluated" Abbott's data which transcended the period from initial licensure in 1985 into early 1987. It was during this period that the relevant blood test was performed and plaintiff was transfused with the tainted blood. Given the uncontested material facts, we hold that the MDA requires dismissal of the State law claims even if the test was defective or the warning was inadequate.
Plaintiffs argue that our recent case, Baird v. American Medical Optics, 301 N.J. Super. 7 (App. Div.), certif. granted, 151 N.J. 467 (1997), requires rejection of Abbott's preemption claim. In Baird, we reviewed Medtronic and concluded that "under Medtronic all state common-law claims are not preempted." Baird, supra, 301 N.J. Super. at 15. We read five members of the Supreme Court in Medtronic "to find preemption only to the extent that the FDA has adopted a regulation inconsistent with or in
conflict with a requirement of state law." Ibid.See footnote 9 We further read Part V of the plurality opinion, joined by Justice Breyer, as controlling the issue of preemption of design defect and defective warning claims such as those involved in this case. Id. at 16-17. We now conclude that permitting a state suit based on an inadequate warning, or failure to change a warning, with language not only approved by, but also amended at the direction of, the FDA would be "inconsistent" with the federal "requirement" and, therefore, preempted by the MDA. In any event, Justice Breyer did not join Part VI of the plurality opinion (referred to in Part V), and we are satisfied that a majority of the Medtronic Court would find preemption in these circumstances. See Medtronic, supra, U.S. , 116 S. Ct. at 2259-62, 135 L. Ed. 2d at 726-30 (Breyer, J., concurring); id. at
, 116 S. Ct. at 2262-64, 135 L. Ed. 2d at 730-34 (O'Connor, J., concurring in part and dissenting in part). This is particularly true because Abbott's efforts to amend its warning was subject to FDA approval and delays necessary to obtain same. Also, Abbott maintained "ongoing communication between the FDA [and] the blood banking industry" relating to the test's performance. Similarly,
the FDA's role in developing, approving and monitoring Abbott's ELISA test, and its encouragement of the development of such tests to detect the AIDS virus, gives rise to the very immunity the MDA was designed to protect.
It is true that, unlike Medtronic, Baird did not involve a "grandfathered" device, and that like Baird, this case involves a "device" expressly preapproved for marketing by the FDA. However, unlike Baird, this case involves both the testing and approval of a high risk test for detecting a deadly virus and actual changes dictated by the FDA with respect to the package insert used pending its further study and decision. This case also deals with the FDA's exercise of its continuing jurisdiction to monitor the test results and its decision not to recall the test or to direct further changes to the insert. In the words of the FDA's Ann Hoppe, Abbott's ELISA test was "one of the most highly scrutinized" both before and after licensure. This case is therefore significantly different from Baird, and the record here - unlike the record there - requires a finding of preemption under the Medtronic rationale.
Accordingly the judgment for defendant Abbott Laboratories is affirmed.
Footnote: 8There can be no doubt that Abbott's ELISA test was a "medical device" because it was "intended for use in the diagnosis of disease or other conditions," 21 U.S.C.A. 321(h)(2). See United States v. Undetermined Number of Unlabeled Cases, 21 F.3d 1026, 1028 (10th Cir. 1994). Footnote: 9Use of the word "regulation" must be understood in its context, see Baird, supra, 301 N.J. Super. at 15-16. In the context of the issue now before us, reference only to "regulations" may be too narrow, although the MDA is implemented through regulations. Section 360k preempts inconsistent and additional "requirement[s]" of state law, and we read it to preempt state causes of action which are inconsistent with FDA "requirements" adopted pursuant to its authority under the MDA. We add that it does not appear to us that a state common-law suit is the appropriate vehicle by which to test whether the FDA had jurisdiction to order Abbott to take the action it did. - -
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