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Recent Developments in Health Law

Published online by Cambridge University Press:  01 January 2021

Gail Javitt ,
Ann Ashton ,
Christina Slawson ,
Elizabeth Graham ,
D.V.  and
K.M.F.
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Type
Recent Developments in Health Law
Information
Journal of Law, Medicine & Ethics , Volume 21 , Issue 1 , Spring 1993 , pp. 117 - 128
Copyright
Copyright © American Society of Law, Medicine and Ethics 1993

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References

References

Hutt, Peter, quoted in Felsenthal, Edward & Burton, Lee, FDA Approval Shields Firms in Injury Suits, WALL ST.J., Jan. 21, 1993, at B1.Google Scholar
No. 92-1278, 1993 U.S. App. LEXIS 432 (1st Cir., Jan. 15, 1993).Google Scholar
21 U.S.C.A § 360c et seq. (1990).Google Scholar
Congress passed the MDA as an amendment to the Food Drug Cosmetic Act, 21 U.S.C.A. § 301 et seq. (1990)Google Scholar
See Felsenthal, Edward & Burton, Lee, supra note 1 at B7; Stamps v. Collagen Corp., No. H-90-2242, 1991 U.S. Dist. LEXIS 20666, (S.D. Tex. Oct. 11, 1991) which addressed the same issue as King, is currently pending appeal before the Fifth Circuit. See Motion of Health Industry Manufacturers Association for Leave to File Brief as Amicus Curiae in King v. Collagen Corp., 1993 U.S. App. LEXIS 432 at *2.Google Scholar
King, , 1993 U.S. App. LEXIS 432 at *2–3.Google Scholar
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The opinion does not mention whether or not plaintiff had a personal history of autoimmune disease.Google Scholar
King, , 1993 U.S. App. LEXIS 432 at *3,4.Google Scholar
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The majority construed plaintiff's fraud claim to be based on a state anti-fraud statute, Mass.Gen.L.ch. 231 § 85J, and found that paintiff failed to meet the privity requirement of that statute. The occurrence, while recognizing that a Fifth Circuit court had held fraud claims not to be preempted, rejected that courts's interpretation. See Hurley v. Lederle Lab. Div. of American Cyanamid, 863 F.2d 1173 (5th Cir. 1988).Google Scholar
The implementing regulations define “any requirement” as “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 a device under any provision of the Act 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.” 21 C.F.R. § 801.1(b) (1992)Google Scholar
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Id. at 428–429. The general controls provisions include registration, product listing, and premarket notification.Google Scholar
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U.S. CONST. art. VI, cl. 2. The Supremacy Clause provides: “This Constitution, and the Laws of the United States which shall be made in pursuance thereof; and all Treaties made, under the Authority of the United States, shall be the supreme Law of the Land, and the Judges in every State shall be bound thereby, any Thing in the Constitution or Law of any State to the Contrary notwithstanding.”Google Scholar
Congress may effect preemption through either “express” or “implied” means. Express preemption requires that Congress state affirmatively its intention to preempt or supersede state law. In the absence of clear preemptive language in a statute, Congress' intent to preempt may be inferred by the courts. Factors that courts use in making such an inference include: (1) the comprehensiveness of the federal regualtions; (2) the dominance of the federal interest in the issue regulated; and (3) presence of direct conflict between state and federal law. In determining whether federal law preempts state law, the focus of judicial inquiry is on the intent of Congress. Westerfield, Marilyn P., Federal Preemption and the FDA: What Does Congress Want? 58 U. Cin. L. Rev. 263, 265–266 (1989).Google Scholar
For a comprehensive review of pharmaceutical cases addressing preemption under the MDA, see Jacklin, Beverly L., Annotation, Federal Pre-Emption of State Common-Law Products Liability Claims Pertaining to Drugs, Medical Devices, and Other Health Related Claims, 98 A.L.R. FED 124 (1992).Google Scholar
Courts have differed over whether IUDs should be classified as drugs or medical devices. See, e.g., Tarallo v. Searle Pharmaceutical, Inc., 704 F. Supp. 653 (D.SC 1988) (holding that a genuine issue of material fact existed as to whether IUD was a drug or a device subject to the MDA).Google Scholar
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709 F. Supp. 662 (D.MD. 1989).Google Scholar
Plaintiffs also brought claims based on strict liability, fraudulent misrepresentation, and breach of warranty.Google Scholar
The court actually determined that the IUD should be classified as a drug and thus was not subject to the preemption provision of the MDA at all. Nevertheless, the court stated that even had the MDA applied, plaintiff's state law claims would not have been preempted.Google Scholar
See, e.g., Rinehart v. Int'l Playtex, Inc., 688 F. Supp. 475, (S.D. Ind. 1988).Google Scholar
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Hurley v. Lederle Lab. Div. of American Cyanamid, 863 F.2d 1173 (5th Cir. 1988) (holding, in case where FDA regulating under Food, Drug, and Cosmetic Act, that issue of material fact existed as to whether vaccine manufacturer provided FDA with all necessary and available information on which to base the prescribed warning).Google Scholar
King v. Collagen Corp., No. 92-1278, 1993 U.S. App. LEXIS 432 at *16.Google Scholar
112 S.Ct. 2608 (1992).Google Scholar
15 U.S.C.A. § 1331 et seq. (1982), as amended by the Public Health Ciigarette Smoking Act of 1969, 15 U.S.C.A. § 1334(b) (1982).Google Scholar
Section 1334(b), as amended by the Public Health Cigarette Smoking Act of 1969, stated: “No requirement or prohibition based on smoking and health shall be imposed under state law with respect to the advertising or promotion of any cigarettes, the packages of which are [lawfully] labeled.”Google Scholar
Cipollone, 112 S. Ct. at 2618.Google Scholar
King v. Collagen Corp., No. 92-1278, 1993 U.S. App. LEXIS 432 at *16.Google Scholar
See Jacklin, , supra note 21 at 129.Google Scholar
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Kipviscusi, W., Reforming Products Liability 45 (1991).Google Scholar
Recognizing this problem in a related context, the government has itself “underwritten” the liability risk for childhood vaccination by enacting the National Childhood Vaccine Injury Act (NCVIA). While the NCVIA does not preempt state tort law, it provides compensation for the unavoidable injuries that occur to a minority of children as a result of receiving vaccines such as DPT and polio. 42 U.S.C.S. § 300aa-1 et seq.Google Scholar
Boguslaski, , supra note 14 at 423Google Scholar
For an example of the criticism leveled against the FDA, see STAFF OF HOUSE COMM. ON ENERGY AND COMMERCE, SUBCOMM. ON OVERSIGHT AND INVESTIGATIONS, 98TH CONG., 1ST SESS., MEDICAL DEVICE REGULATION: THE FDA'S NEGLECTED CHILD (Comm. Print 1983).Google Scholar
See 21 C.F.R. 808.1(d) (1992).CrossRefGoogle Scholar
The court cites Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984), to support its contention that an agency's interpretation of its own statute is binding only if the interpretation is not contrary to Congress' intent. Collagen, King v, Corp., No. 92-1278, 1993 U.S. App. LEXIS 432 at *11.Google Scholar
Plaintiffs cannot sue the FDA for damages and the FDA does not have the authority to exact damages from manufacturers on their behalf.Google Scholar
Hurley v. Lederle Lab. Div. of Am. Cyanimid, 863 F.2d 1173 (5th Cir. 1988), 863 F.2d at 1173.Google Scholar
King, 1993 U.S. App. LEXIS 432 at *30.CrossRefGoogle Scholar
See, e.g. Chevron, 467 U.S. 837 at 843 (holding that if Congress has not addressed the precise question at issue, courts should accept reasonable administrative interpretations of law).Google Scholar

References

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References

Andrews, Edmund L., U.S. Resumes Granting Patents on Genetically Altered Animals, New York Times, Feb. 3, 1993, at A1.Google ScholarPubMed
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References

BC038105, reviewed in Technician Sues Patient with AIDS, Wins, NAT'L L.J., Feb. 22, 1993, at 6.Google Scholar
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