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

Id. at *4.Google Scholar

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

Id. at *4.Google Scholar

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

Benson, James et al., The FDA's Regulation of Medical Devices: A Decade of Change, 43 Food Drug Cosm.L.J. 495(1988).Google Scholar

Boguslaski, Mary J., Classification and Performance Standards under the 1976 Medical Device Amendments, 40 Food Drug Cosm. L. J. 421 (1985).Google Scholar

Id. at 428–429. The general controls provisions include registration, product listing, and premarket notification.Google Scholar

Id. at 425–426.Google Scholar

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

672 F. Supp. 907 (D. SC 1987).CrossRefGoogle Scholar

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

See, e.g., Moore v. Kimberly-Clark Corp., 867 F.2d 243 (5th Cir., 1989).Google Scholar

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

King, 1993 U.S. App. LEXIS 432 at *24.CrossRefGoogle Scholar

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

Brody, Garry S., Overview of Silicone Gel-Filled Breast Implants, in BREAST IMPLANT RESOURCE GUIDE, 1992, °8 at 1(American Society of Plastic and Reconstructive Surgeons 1992)[hereinafter ASPRS Overview].Google Scholar

Brody, Garry S., Safety Issues and the Silicone Breast Implant 3 (November 1992)(ASPRS public information)Google Scholar

21 U.S.C.A.°360(c) et seq. (1990)Google Scholar

Id.Google Scholar

General and Plastic Surgery Devices, 47 Fed. Reg. 2820 (1982). “[T]he panel believes that this device has demonstrated a reasonably satisfactory level of performance over a long period of time.”Google Scholar

General and Plastic Surgery Devices, 55 Fed. Reg. 20,570 (1990).Google Scholar

General and Plastic Surgery Devices, 53 Fed. Reg. 23, 862 (1988).Google Scholar

Staff of the House of Representatives Human Resources and Intergovernmental Relations Subcomm. of the Comm. on Government Operations, 102D CONG., 2D SESS., THE FDA'S REGULATION OF SILICONE BREAST IMPLANTS 5 (Comm.Print 1992) [hereinafter Staff Report]. This report was written and released by one nonelected Congressional staff member without consulting either the Committee or the FDA before its release. Therefore the conclusions of the report should be viewed as a staff opinion rather than the work of Congressional representatives. See Craig Thomas, Breast Implant Report Was Premature, N.Y. TIMES, January 23, 1993, at A1, A20.Google Scholar

General and Plastic Surgery Devices, 53 Fed. Reg. at 23, 873 (1988).Google Scholar

General and Plastic Surgery Devices, 56 Fed. Reg. 49,099,49,101 (1992).Google Scholar

ASPRS Overview, supra note 1 at 3.Google Scholar

Id.; Staff Report, supra note 8 at 26.Google Scholar

ASPRS Overview, supra note 1 at 3.Google Scholar

Id.Google Scholar

Fed. Reg. supra note 3 at 3436.Google Scholar

Fed. Reg. supra note 7 at 23,862.Google Scholar

Staff Report, supra note 8 at 10.Google Scholar

Id. at 37,41.Google Scholar

Id. at 4.Google Scholar

Id. at 17. The report cites internal memorandum made publicly available by Dow Corning on February 10, 1992 including Marchll, 1975 from Larson, W. and Brodhagen, T. to Rathgen, A. and May 13, 1975 from Talcott, T. to Larson, W.Google Scholar

Id. at 18. March 2, 1978, memorandum from Lewis, F. to Hirsch, M. made available by Dow Corning on February 10, 1992.Google Scholar

Id. at 19, 27. The report relies heavily on the letters from Dr.Vinnik, Charles who wrote to Dow on September 18 and 23, 1981 to voice his concerns about the 5% failure rate he experienced with Dow implants. The report indicates that other manufacturers like Surgitek were aware of leakage and rupture problems. The report points to specific deficiencies in the manufacturers' studies for the FDA including: (1) studies were for two years or less; (2) the majority of women were studied for only a few months; (3) patients were not asked about autoimmune disorders or cancer (information which would not be available through plastic surgeon's files); (4) the studies assumed the experiences of augmentation and reconstructive patients would be the same, even though very few reconstructive patients were used in the studies; (5) not all models of implants were tested.Google Scholar

Id. at 35.Google Scholar

Id. at 11. The Report fails to provide any information on precisely when these collaborations were occurring, or with what frequency these in-patient tests were performed.Google Scholar

Deadline Extended to Opt-out of Implant Case, MASSACHUSETTS LAWYERS’ WEEKLY, October 12, 1992 at 19.Google Scholar

Blum, Andrew, Breast Implants Hurt Children,NAT'L LAW JOURNAL FEB. 15, 1993 at 3,37.Google Scholar

In re Gel Breast Implants Products Liability Litigation, Docket No. 926, Judicial Panel on Multidistrict Litigation, 793 F. Supp. 1098; 1992 U.S. Dist.Google Scholar

Id.Google Scholar

“Deadline,” supra, p. 19, Sect. A.Google Scholar

Reed, Michael E., “Can Physicians be Held Liable as ‘Distributors' of Defective Products?” Breast Implant Resource Guide, ASPRS, 1992 Section Eight.Google Scholar

Many plaintiff's attorneys believe the state courts are more receptive to plaintiff's claims, See Connelly, Richard, From Flood to Deluge in Breast Implant Cases; Houston's Hot in Latest Mass Tort Craze, TEXAS LAWYER, Jan. 11, 1993 at 1.Google Scholar

See letter from Henderson, Jay and Allen, T. Scott Jr. Attorneys, Cruise, Scott, Henderson, & Allen, , L.L.P., to Gary [sic] Brody, M.D., (Sept. 18, 1992)(on file with the ASPRS), pp. 1–15.Google Scholar

See Strickland, N. Kathleen and Katerndahl, John P., Current Applications and Limitations of the Learned Intermediary Rule, Litigation and Administrative Practice Course Handbook Series, Litigation, Toxic Tort Case Essentials: Strategies, Experts, Motions, and ADR, Practising Law Institute, 1992, 446 PLI/Lit 259, citing Magee v. Wyeth Labs, 214 Cal. App. 2d 340, 350 (1963).Google Scholar

See Strickland and Katerndahl, supra, citing Love v. Wolf, 226 Cal.App.2d.378,395 (1964) and Hill v. Searle Laboratories, 884 F. 2d. 1064, 1070 (8th Cir. 1989).Google Scholar

See Strickland and Katerndahl, supra, citing Swayze v. McNeil Laboratories, Inc., 807F. 2d 464, 469–70 (5th Cir. 1987).Google Scholar

See Parke, Steven v., Davis & Co., 9 Cal. 3d 51, 65 (1973), Love, supra, 226 Cal.App.3d at 400.Google Scholar

McClintock, Toole v. Baxter, et al., MDAL, S.Div., Civ.No. 90-H-195-S.Google Scholar

McClintock, Toole v. Jr., et al., 778 F. Supp. 1543, 1546.Google Scholar

Toole, supra, 1547.Google Scholar

For example, Dow lost more than $1.7 million in Stern v. Dow Coming Corp. (unpublished), in the first case to suggest a relationship between silicone breast implants and auto immune disease. Dow amended its package insert to warn of an increased risk for auto immune disease in 1985.Google Scholar

Reed, supra, p.1.Google Scholar

Restatement (Second) of Torts, §402 A (1). The definition of strict liability from the Restatement (Second) of Torts provides: (1)One who sells any product in defective condition unreasonably dangerous to the user or consumer or to his property, if: (a) the seller is engaged in the business of selling such a product, and (b) it is expected to and does reach the user or consumer without substantial change in the condition in which it is sold.Google Scholar

Reed, supra, p.2.Google Scholar

See Providence Hospital v. Truly, 611 S.W.2d 127 (1980); Thomas v. St. Joseph Hospital, 618 S.W.2d 791 (1981).Google Scholar

Henderson, and Allen, , supra note 35.Google Scholar

Shons, A.R. Schubert, W., Silicone Breast Implants and Immune Disease, 28 Annals Plastic Surgery 491, 499–501 (1992).Google Scholar

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

See, O'Connor, Kevin, Patenting Animals and Other Living Things, 65 S. Cal. L. Rev. 597.Google Scholar

Supra. note 1 at D5.Google Scholar

Id.Google Scholar

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

American Dental Association v. Martin, — F.2d—, 1993 WL 17138 at *1 (7th Cir. 1993).Google Scholar