Products liability implications of reprocessing and reuse of single-use medical devices

Food and Drug Law Journal

Volumn 53, Issue 3, 1998, Pages 385-402

  Hogan, Janice M ^a   Colonna, Thomas E ^a  

^a Hogan and Hartson   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DEVICE; DISPOSABLE EQUIPMENT; FOOD AND DRUG ADMINISTRATION; GOOD CLINICAL PRACTICE; HEALTH HAZARD; HUMAN; MEDICAL INSTRUMENTATION; MEDICAL LIABILITY; NEGLIGENCE; PRACTICE GUIDELINE; REVIEW; RISK ASSESSMENT;

CONSUMER PRODUCT SAFETY; DISPOSABLE EQUIPMENT; EQUIPMENT CONTAMINATION; EQUIPMENT REUSE; HUMANS; LIABILITY, LEGAL; RISK ASSESSMENT; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0031682610     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (129)

1. The terms "single use" and "disposable" are used synonymously.
2. While beyond the scope of this discussion, intellectual property rights claims have asserted that the reprocessing (cleaning and resterilization) of a single-use device violates the original manufacturer's trademark and patent rights. E.g., Mallinckrodt, Inc. v. Medipart, Inc., 976 F.2d 700 (Fed. Cir. 1992) (holding manufacturer may prohibit buyer from reusing device under patent law if manufacturer's restriction was reasonably within patent grant); Kendall Co. v. Progressive Med. Tech., Inc., 85 F.3d 1570 (Fed. Cir. 1996) (holding supplier not liable for contributory infringement without direct infringement by device purchasers).
3. Federal Food, Drug, and Cosmetic Act, Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. §§ 301 et seq. (1994)).
4. See infra discussion in section III.
5. See infra discussion in section IV.A.2.a.
6. For example, cardiac catheters, exclusive of sophisticated angioplasty devices, cost $15 to 580 each. See M.H. Radany et al., Is It Safe to Reuse Disposables?, 87 AM. J. NURSING 36 (1987).
7. Id. at 35-38; Cardiac Catheter Reuse Targeted by FDA, F-D-C REP. ("The Gray Sheet"), July, 7, 1997, at I&W2.
8. Reuse of Single-Use Equipment, 268 LANCET 1342 (1985) (Letter to Editor).
9. A survey of 501 consumers, conducted for Halsted Communications by Wilson & Associates, found that 19% percent of respondents stated that they would sue if they discovered that disposable medical devices had been reused in their medical treatment without their informed consent. Disposable Device Reuse Is Opposed by Most Consumers, F-D-C REP. ("The Gray Sheet"), Dec. 22, 1997, at I&W12.
10. See, e.g., COMMONWEALTH OF AUSTRALIA, DEP'T OF HUMAN SERVICES & HEALTH, DRAFT STATEMENT OF COMMONWEALTH POLICY ON THE REUSE OF SINGLE-USE THERAPEUTIC DEVICES (May 30, 1994). In addition, several European countries, including Italy and Spain, have prohibited reuse of single-use devices, and a number of other countries, including England and France, have issued statements disapproving reuse of disposable products. See CANADIAN HOSP. ASS'N, REPORT ON THE REUSE OF SINGLE-USE MEDICAL DEVICES tbl. 3 (1995) (discussing international perspectives) [hereinafter CHA REPORT].
11. See, e.g., COMMONWEALTH OF AUSTRALIA, DEP'T OF HUMAN SERVICES & HEALTH, DRAFT STATEMENT OF COMMONWEALTH POLICY ON THE REUSE OF SINGLE-USE THERAPEUTIC DEVICES (May 30, 1994). In addition, several European countries, including Italy and Spain, have prohibited reuse of single-use devices, and a number of other countries, including England and France, have issued statements disapproving reuse of disposable products. See CANADIAN HOSP. ASS'N, REPORT ON THE REUSE OF SINGLE-USE MEDICAL DEVICES tbl. 3 (1995) (discussing international perspectives) [hereinafter CHA REPORT].
12. ENT Endoscopic Sheath Barrier Claims Should be Based on 30 nm or Smaller Virus Size, FDA Says, F-D-C REP. ("The Gray Sheet"), Nov. 11, 1996, at I&W6.
13. See generally FOOD & DRUG ADMIN., DRAFT VERSION NEURO ENDOSCOPE GUIDANCE (July 7, 1994) [hereinafter NEURO ENDOSCOPE GUIDANCE], available at Food & Drug Admin., Draft Version Neuro Endoscope Guidance (last modified July 8, 1998) 〈http://www.fda.gov/cdrh/ode/214.html〉.
14. See generally FOOD & DRUG ADMIN., DRAFT VERSION NEURO ENDOSCOPE GUIDANCE (July 7, 1994) [hereinafter NEURO ENDOSCOPE GUIDANCE], available at Food & Drug Admin., Draft Version Neuro Endoscope Guidance (last modified July 8, 1998) 〈http://www.fda.gov/cdrh/ode/214.html〉.
15. FOOD & DRUG ADMIN., GUIDANCE ON THE CONTENT AND FORMAT OF PREMARKET NOTIFICATION [510(K)] SUBMISSIONS FOR LIQUID CHEMICAL GERMICIDES 23 (Apr. 26, 1995) [hereinafter GERMICIDE GUIDANCE], available at Food & Drug Admin., Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Germicides (last modified May 23, 1997) 〈http://www.fda.gov/cdrh/ode/germic4.html〉. See also CHA REPORT, supra note 10; FOOD & DRUG ADMIN., GUIDANCE FOR THE CONTENT OF PREMARKET NOTIFICATIONS FOR BIOPSY DEVICES USED IN GASTROENTEROLOGY AND UROLOGY 7 (Feb. 10, 1993), available at Food & Drug Admin., Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology (visited July 22, 1998) 〈http://www.fda.gov/cdrh/ode/oderp482.html〉 (noting currency of guidance as of July 1997 with FDA review planned for July 1998).
16. FOOD & DRUG ADMIN., GUIDANCE ON THE CONTENT AND FORMAT OF PREMARKET NOTIFICATION [510(K)] SUBMISSIONS FOR LIQUID CHEMICAL GERMICIDES 23 (Apr. 26, 1995) [hereinafter GERMICIDE GUIDANCE], available at Food & Drug Admin., Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Germicides (last modified May 23, 1997) 〈http://www.fda.gov/cdrh/ode/germic4.html〉. See also CHA REPORT, supra note 10; FOOD & DRUG ADMIN., GUIDANCE FOR THE CONTENT OF PREMARKET NOTIFICATIONS FOR BIOPSY DEVICES USED IN GASTROENTEROLOGY AND UROLOGY 7 (Feb. 10, 1993), available at Food & Drug Admin., Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology (visited July 22, 1998) 〈http://www.fda.gov/cdrh/ode/oderp482.html〉 (noting currency of guidance as of July 1997 with FDA review planned for July 1998).
17. FOOD & DRUG ADMIN., GUIDANCE ON THE CONTENT AND FORMAT OF PREMARKET NOTIFICATION [510(K)] SUBMISSIONS FOR LIQUID CHEMICAL GERMICIDES 23 (Apr. 26, 1995) [hereinafter GERMICIDE GUIDANCE], available at Food & Drug Admin., Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Germicides (last modified May 23, 1997) 〈http://www.fda.gov/cdrh/ode/germic4.html〉. See also CHA REPORT, supra note 10; FOOD & DRUG ADMIN., GUIDANCE FOR THE CONTENT OF PREMARKET NOTIFICATIONS FOR BIOPSY DEVICES USED IN GASTROENTEROLOGY AND UROLOGY 7 (Feb. 10, 1993), available at Food & Drug Admin., Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology (visited July 22, 1998) 〈http://www.fda.gov/cdrh/ode/oderp482.html〉 (noting currency of guidance as of July 1997 with FDA review planned for July 1998).
18. FOOD & DRUG ADMIN., GUIDANCE ON THE CONTENT AND FORMAT OF PREMARKET NOTIFICATION [510(K)] SUBMISSIONS FOR LIQUID CHEMICAL GERMICIDES 23 (Apr. 26, 1995) [hereinafter GERMICIDE GUIDANCE], available at Food & Drug Admin., Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Germicides (last modified May 23, 1997) 〈http://www.fda.gov/cdrh/ode/germic4.html〉. See also CHA REPORT, supra note 10; FOOD & DRUG ADMIN., GUIDANCE FOR THE CONTENT OF PREMARKET NOTIFICATIONS FOR BIOPSY DEVICES USED IN GASTROENTEROLOGY AND UROLOGY 7 (Feb. 10, 1993), available at Food & Drug Admin., Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology (visited July 22, 1998) 〈http://www.fda.gov/cdrh/ode/oderp482.html〉 (noting currency of guidance as of July 1997 with FDA review planned for July 1998).
19. STAFF REPORT TO THE SENATE SPECIAL COMMITTEE ON AGING, HAZARDS IN REUSE OF DISPOSABLE DIALYSIS DEVICES, SEN. REP. 99-K, at 8 (Oct. 1986) [hereinafter SEN. REP. ON HEMODIALYZER REUSE]. An outbreak caused the deaths of fifteen patients treated at one dialysis center. Id. at 11. Insufficient disinfection of reprocessed hemodialysis equipment also has been linked to transmission of the HIV virus in several foreign countries. See, e.g., HIV Transmission in a Dialysis Center - Colombia (1991-1993), 274 JAMA 372 (1995); M. Velandia Scott et al., Transmission of HIV in Dialysis Centre, 345 LANCET 1417 (1995).
20. STAFF REPORT TO THE SENATE SPECIAL COMMITTEE ON AGING, HAZARDS IN REUSE OF DISPOSABLE DIALYSIS DEVICES, SEN. REP. 99-K, at 8 (Oct. 1986) [hereinafter SEN. REP. ON HEMODIALYZER REUSE]. An outbreak caused the deaths of fifteen patients treated at one dialysis center. Id. at 11. Insufficient disinfection of reprocessed hemodialysis equipment also has been linked to transmission of the HIV virus in several foreign countries. See, e.g., HIV Transmission in a Dialysis Center - Colombia (1991-1993), 274 JAMA 372 (1995); M. Velandia Scott et al., Transmission of HIV in Dialysis Centre, 345 LANCET 1417 (1995).
21. STAFF REPORT TO THE SENATE SPECIAL COMMITTEE ON AGING, HAZARDS IN REUSE OF DISPOSABLE DIALYSIS DEVICES, SEN. REP. 99-K, at 8 (Oct. 1986) [hereinafter SEN. REP. ON HEMODIALYZER REUSE]. An outbreak caused the deaths of fifteen patients treated at one dialysis center. Id. at 11. Insufficient disinfection of reprocessed hemodialysis equipment also has been linked to transmission of the HIV virus in several foreign countries. See, e.g., HIV Transmission in a Dialysis Center - Colombia (1991-1993), 274 JAMA 372 (1995); M. Velandia Scott et al., Transmission of HIV in Dialysis Centre, 345 LANCET 1417 (1995).
22. See GERMICIDE GUIDANCE, supra note 13, at 43; High Flux Dialysis Linked with Increased Pyrogenic Reactions, CDC Survey Shows, F-D-C REP. ("The Gray Sheet"), Nov. 28, 1994, at 10 [hereinafter Pyrogenic Reactions].
23. See CHA REPORT, supra note 10 (discussing safety of health care professionals).
24. See, e.g., NEURO ENDOSCOPE GUIDANCE, supra note 12, at 9; FOOD & DRUG ADMIN., CDRH, GUIDANCE FOR THE CONTENT OF PREMARKET NOTIFICATIONS FOR CONVENTIONAL AND ANTIMICROBIAL FOLEY CATHETERS (Sept. 12, 1994), available at Food & Drug Admin., CDRH, Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters (visited Aug. 29 1998) 〈http://www.fda.gov/cdrh/ode/ oderp097.html〉.
25. See, e.g., NEURO ENDOSCOPE GUIDANCE, supra note 12, at 9; FOOD & DRUG ADMIN., CDRH, GUIDANCE FOR THE CONTENT OF PREMARKET NOTIFICATIONS FOR CONVENTIONAL AND ANTIMICROBIAL FOLEY CATHETERS (Sept. 12, 1994), available at Food & Drug Admin., CDRH, Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters (visited Aug. 29 1998) 〈http://www.fda.gov/cdrh/ode/ oderp097.html〉.
26. See FOOD & DRUG ADMIN., LABELING REUSABLE MEDICAL DEVICES FOR REPROCESSING IN HEALTH CARE FACILITIES: DRAFT REVIEWER GUIDANCE (Apr. 1996) [herein after LABELING REUSABLE DEVICES].
27. FDA has noted the impact of device design on successful reuse and reprocessing. For example, the agency has stated that, "[a]s a rule, a reusable device should be designed so that it can be adequately cleaned. If a device cannot be adequately cleaned, any subsequent disinfection or sterilization process may not achieve the desired result." Id.
28. See 61 Fed. Reg. 52,602,52,610 (Oct. 7, 1996). See also FOOD & DRUG ADMIN., WORKING DRAFT OF THE CURRENT GOOD MANUFACTURING PRACTICE (CGMP) FINAL RULE 37 (July 1995) (21 C.F.R. pt. 820) [hereinafter GMP WORKING DRAFT].
29. Pub. L. No. 94-295, 90 Stat. 539 (1976) (codified at 15 U.S.C. § 55 and scattered sections of 21 U.S.C.).
30. Pub. L. No. 101-629, 104 Stat. 4511 (1990) (codified in scattered sections of 21 U.S.C.).
31. QSRs have replaced good manufacturing practices (GMPs) for devices. 21 C.F.R. pt. 820.
32. The agency had defined reprocessors of single-use devices for reuse as "remanufacturers." FOOD & DRUG ADMIN., CDRH, TRIAL BALLOON: DRAFT POLICY ON SERVICING REMANUFACTURING OF USED MEDICAL DEVICES (Sept. 20, 1995). The guidance suggested that remanufacturers "arc, in effect, marketing a new device, or contributing to the marketing of a new device," and that FDA would have required remanufacturers to obtain premarket approval or premarket clearance. Id. at 1.
33. FDA has stated that labeling changes to provide for reuse of a device that was previously labeled for "single use only" modify the device's intended use. FOOD & DRUG ADMIN., CDRH, DECIDING WHEN TO SUBMIT A 510(K) FOR A CHANGE TO AN EXISTING DEVICE at 11. (Jan. 10, 1997) available at Food & Drug Admin., CDRH, Deciding When to Submit a 510(k) for a Change to an Existing Device (visited Aug. 29, 1998) 〈http:// www.fda.gov/cdrh/ode/510kmod.html〉 [hereinafter 510(k) Guidance]. The 510(k) Guidance, however, does not apply to remanufacturers or refurbishers. 60 Fed. Reg. 53, 624 (1995).
34. FDA has stated that labeling changes to provide for reuse of a device that was previously labeled for "single use only" modify the device's intended use. FOOD & DRUG ADMIN., CDRH, DECIDING WHEN TO SUBMIT A 510(K) FOR A CHANGE TO AN EXISTING DEVICE at 11. (Jan. 10, 1997) available at Food & Drug Admin., CDRH, Deciding When to Submit a 510(k) for a Change to an Existing Device (visited Aug. 29, 1998) 〈http:// www.fda.gov/cdrh/ode/510kmod.html〉 [hereinafter 510(k) Guidance]. The 510(k) Guidance, however, does not apply to remanufacturers or refurbishers. 60 Fed. Reg. 53, 624 (1995).
35. Reprocessed Single-Use Devices, F-D-C REP. ("The Gray Sheet"), Oct. 28, 1996, at 10.
36. GMP WORKING DRAFT, supra note 20, at 37. For example, regarding hemodialyzer reprocessing, FDA has stated that, "[a]s with dialyzer manufacturing, successful dialyzer reprocessing requires strict quality control and quality assurance, including reprocessing specifications, process control, and sample validation studies," FOOD & DRUG ADMIN., DRAFT - HEMODIALYZER TESTING: RATIONALE FOR GUIDANCE, REUSE LABELING 3 (Mar. 4, 1994) [hereinafter HEMODIALYZER TESTING]. Moreover, the agency has observed that different testing generally is necessary to ensure the quality of reprocessed devices than to ensure the quality of newly manufactured devices. Id. In addition, an FDA-commissioned California Department of Health Services survey of reprocessing practices in dialysis centers found that, "[dialysis] facilities are frequently not adhering to their protocols, and the general lack of quality control and assurance procedures indicates that at least some of the reuse programs are not operating in a state of control." SEN. REP. ON HEMODIALYZER REUSE, supra note 14, at 8.
37. See infra note 45.
38. See infra note 47.
39. 61 Fed. Reg. at 52,610. FDA previously issued Compliance Policy Guide (CPG) 300.200 (formerly CPG 7124.28), governing reconditioners and rebuilders of medical devices. This guide drew a distinction between reconditioners/rebuilders and entities that merely serviced or repaired devices, stating, in pertinent part, that: A reconditioner/rebuilder is a person or firm that acquires ownership of used medical devices and restores and/or refurbishes these to the device manufacturer's original or current specifications, or [to] new specifications, for purposes of resale or commercial distribution. (A person or firm that services, repairs, or reconditions a medical device and returns the device to its owner is not covered by this guide.) CPG 300.200. Under this policy, reconditioners/rebuilders are subject to FDA registration, labeling requirements, premarket notification, inspection, GMP (now QSRs), and medical device reporting requirements. Id.
40. Id. (emphasis added).
41. GMP WORKING DRAFT, supra note 20, at 189.
42. Id.
43. 61 Fed. Reg. at 52,610. See also supra note 24 and accompanying text. It is unclear whether a health care entity that reprocesses a disposable device in-house would be considered a manufacturer or a refurbisher under the QSRs. The entity arguably could be deemed a remanufacturer because reprocessing a single-use device may significantly change the device's performance, safety specifications, or intended use. The entity, however, also could be viewed as merely refurbishing the disposable device by returning it to the original manufacturer's specifications after it reaches the established end-of-life, i.e., a single use. In the former, QSR regulations could apply, but in the latter case, FDA's separate forthcoming rule for servicers and refurbishers presumably would govern the facility.
44. Pub. L. No. 105-115, 111 Stat. 2295 (1997).
45. See HEMODIALYZER TESTING, supra note 27.
46. LABELING REUSABLE DEVICES, supra note 18.
47. Id.
48. See PROCEEDINGS OF THE FIRST INTERNATIONAL CONFERENCE OF MEDICAL DEVICE REGULATORY AUTHORITIES (IMDRA) § III.A.5, sponsored by the World Health Organization, Pan American Health Organization, and FDA, Washington, D.C. (June 2-6, 1986).
49. Compliance Policy Guide 300.500 (formerly CPG 7124.16) (Sept. 24, 1987).
50. Id. (emphasis added).
51. Single-Use Device Reprocessing FDA Draft Policy Expected This Summer, F-D-C REP. ("The Gray Sheet"), Apr. 22, 1996, at I&W3 (citing Kimberly Trautman, Off. of Compliance, Center for Devices & Radiological Health, FDA, Remarks at the Ass'n for the Advancement of Med. Instrumentation (Apr. 9, 1996)).
52. Single-Use Device Reprocessing FDA Draft Policy Expected This Summer, F-D-C REP. ("The Gray Sheet"), Apr. 22, 1996, at I&W3 (citing Kimberly Trautman, Off. of Compliance, Center for Devices & Radiological Health, FDA, Remarks at the Ass'n for the Advancement of Med. Instrumentation (Apr. 9, 1996)).
53. Id. Physicians may prescribe or use approved devices for off-label indications in their practices, provided they do not promote the off-label use(s). FOOD & DRUG ADMIN., INVESTIGATIONAL DEVICE EXEMPTION MANUAL 4-61 (June 1996). Physicians, however, may not manufacture or market devices without appropriate approvals.
54. Refurbishers, Rebuilders, Reconditioners, Servicers, and "As Is" Remarketers of Medical Devices: Review and Revision of Compliance Policy Guides and Regulatory Requirements; Request for Comments and Information, 62 Fed. Reg. 67,011 (Dec. 23, 1997).
55. Refurbishers are: persons who, for the purpose of resale or redistribution, visually inspect, functionally test and service devices, as may be required, to demonstrate that the device is in good repair and performing all the functions for which it is designed. The device may or may not be cosmetically enhanced. Preventive maintenance procedures may or may not be performed. Refurbishers do not significantly change a finished device's performance or safety specifications, or intended use. Id. at 67,012.
56. 'As is' remarketers are: [persons who remarket devices of which] the operational condition . . . is unknown. The extent to which the device meets the operational requirements must be determined by the user prior to patient exposure. The device may or may not be cosmetically enhanced. "As is" remarketers do not change a finished device's performance or safety specifications, or intended use. Id.
57. Servicers are "persons who repair a device to return it to the manufacturer's fitness for use specifications, and perform the manufacturer's recommended scheduled preventive maintenance." Id.
58. The extent to which the FDCA preempts state product liability claims has long been disputed; however, the Supreme Court recently clarified the scope of federal preemption in Medtronic v. Lohr, 116 S. Ct. 2240, 135 L. Ed. 2d 700, 64 U.S.L.W. 4625 (1996). In Medtronic, the Court held that defective design claims are not preempted by an FDA determination of "substantial equivalence" through the 510(k) premarket notification process. Id. at 2254. The Court also concluded that the plaintiff's defective labeling claims were not preempted by 510(k) clearance. Id. at 2258. The Court did not reach the issue of whether premarket approval by FDA would preempt these types of state law claims.
59. FDA's analysis of manufacturer reports of adverse incidents with conventional and high permeability dialyzers showed that 46% were related to reuse of the devices. Pyrogenic Reactions, supra note 15, at 10.
60. See Catheter for Single Use Allegedly Reused: Broken Tip Leads to $970,000 Award, 11 BIOMEDICAL SAFETY STANDARDS 77 (July 15, 1981) (discussing unpublished case, case name not available).
61. Section 402A provides that: (1) One who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate 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. (2) the rule stated in subsection (1) applies although (a) the seller has exercised all possible care in the preparation and sale of his product, and (b) the user or consumer has not bought the product from or entered into any contractual relation with the seller. RESTATEMENT (SECOND) OF TORTS: PRODUCTS LIABILITY § 402A (1965). A new tentative draft of the Restatement has been issued, but is not yet final. RESTATEMENT (THIRD) OF TORTS: PRODUCTS LIABILITY, PROPOSED FINAL DRAFT (Apr. 1, 1997). The Proposed Final Draft would significantly modify section 402A. For example, the Restatement (Third) includes a section that specifically governs liability for prescription drugs and medical devices.
62. Section 402A provides that: (1) One who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate 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. (2) the rule stated in subsection (1) applies although (a) the seller has exercised all possible care in the preparation and sale of his product, and (b) the user or consumer has not bought the product from or entered into any contractual relation with the seller. RESTATEMENT (SECOND) OF TORTS: PRODUCTS LIABILITY § 402A (1965). A new tentative draft of the Restatement has been issued, but is not yet final. RESTATEMENT (THIRD) OF TORTS: PRODUCTS LIABILITY, PROPOSED FINAL DRAFT (Apr. 1, 1997). The Proposed Final Draft would significantly modify section 402A. For example, the Restatement (Third) includes a section that specifically governs liability for prescription drugs and medical devices.
63. RESTATEMENT (SECOND), supra note 51, § 402A.
64. See, e.g., Violette v. Smith & Nephew Dyonics, 62 F.3d 8 (1st Cir. 1995) (holding design of endoscope used for carpal tunnel syndrome procedure defective), cert. denied, 116 S. Ct. 1568 (1996).
65. See, e.g., Carlin v. Superior Ct., 920 P.2d 1347 (Cal. 1996) (holding failure to provide adequate warnings for prescription drug).
66. See, e.g., Fulton v. Pfizer Hosp. Prods. Group, 872 S.W.2d 908, 912 (Tenn. App. 1993) (holding doctrine of res ipsa loquiter has application only to law of negligence and does not apply in products liability action based on breach of warranty); Cather v. Catheter Tech. Corp., 753 F. Supp. 634 (S.D. Miss. 1991) (holding existence of product defect must be established before recovery granted in strict liability cases).
67. Porter v. Pfizer Hosp. Prods. Group, 783 F. Supp. 1466, 1474-75 (D. Me. 1992) (holding hip prosthesis manufacturer had no duty to warn surgeons as to product misuse that was not reasonably foreseeable at the time of sale).
68. Harwell v. American Med. Sys., 803 F. Supp. 1287, 1299 (M.D. Tenn. 1992) (noting that in rare instances, such as for oral contraceptives, patient warnings also may be required).
69. See Porter, 783 F. Supp. 1466, at 1474-75.
70. 493 A.2d 647 (N.J. Super. 1985).
71. Id. at 652.
72. Id.
73. See, e.g., Cruz v. Midland-Ross Corp., 813 F. Supp. 628, 630 (N.D. Ill. 1993) (memorandum opinion) (holding used equipment dealer that bought and soon resold used furnace was not in "original producing or marketing chain," and thus was not liable); Zavala-Pizano v. Industrial Handling Equip., 847 F. Supp. 621, 622-23 (C.D. Ill. 1994) (holding that seller of used equipment may not be held liable under theory of strict liability in as much as seller is outside of original producing and marketing chain).
74. Sellers of used products, for example, generally do not have the ability to pressure the original manufacturer to make product improvements. Unlike dealers who sell used products without reprocessing them, however, those who recondition or rebuild used products may be subject to strict liability. See Wynia v. Richard-Ewing Equip. Co., Inc., 17 F.3d 1084, 1087 (8th Cir. 1994). Distinguishing sellers of used products from those who recondition or rebuild products or both for sale, the U.S. District Court stated: [T]he policies behind the doctrine of strict liability, i.e., providing maximum protection for the injured party and discouraging the marketing of products having defects . . . . apply with similar force following remanufacture. Application of strict liability after original manufacture has been justified on other grounds as well: 1) the manufacturer distributor is better able to spread the risk than is the consumer; 2) reasonable consumer expectations; and 3) encouraging better products. We believe that these rationales can be applied following remanufacture as well . . . . [M]arkets [for used goods] generally speaking, operate on the apparent understanding that the seller, even though he is in the business of selling such goods, makes no particular representation about their quality simply by offering them for sale. [R]easonable consumer expectations, however, favor application of strict liability in circumstances where a rebuilt, used machine was sold as being in 'like new' condition. The purchaser of a 'like new' rebuilt machine is more justified in expecting performance and safety commensurate with that of a new machine than is a purchaser of an 'as is' used machine. Stillie v. AM Int'l, Inc., 850 F. Supp. 960, 961 (D. Kan. 1994) (internal punctuation omitted). Cf. Gonzalez v. Rutherford Corp., 881 F. Supp. 829, 841 (E.D.N.Y. 1995) (establishing exception to doctrine that strict liability does not apply to sale of used products by regular sellers of used products, even if they do not recondition or rebuild the products). Although courts have concluded that consumers have a lesser expectation of quality when seeking used products as opposed to new products, thus protecting used product dealers from strict liability, this "reduced consumer expectation" rationale may not apply to used medical devices. Cf. Cruz, 813 F. Supp. at 632 (holding that evaluation of strict tort or negligence liability for the seller of used products turns on whether the seller is the simple conduit for the transaction or has assumed a more intrusive and affirmative role by either warranting the condition of the product, or inspecting, reconditioning, or rebuilding the product).
75. Fugate v. AAA Mach., 593 F. Supp. 392, 393 (E.D. Tenn. 1984) (noting that the drafters of the Model Uniform Product Liability Act recommended that sellers of used products who rebuilt unmanufactured products should be subject to strict liability).
76. See Whitaker v. T.J. Snow Co., Inc., 953 F. Supp. 1034, 1044-45 (N.D. Ind. 1997).
77. Id.
78. See, e.g., Rollins v. Cherokee Warehouses, Inc., 635 F. Supp. 136, 137-38 (E.D. Tenn. 1986); Richardson v. Gallo Equip. Co., 990 F.2d 330 (7th Cir. 1993). In Richardson, Judge Posner explained: [A]ny reconstruction or reconditioning (as distinct from a mere repair . . .) which has the effect of lengthening the useful life of a product beyond what was contemplated when the product was first sold starts the statute of repose running anew . . . . Otherwise, the statute would create an inefficient incentive to reconstruct or recondition old products rather than build new ones, in order to reduce expected liability costs; for under such a regime[,] a product rebuilt after ten years would be immunized from liability. Id. at 331.
79. There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use . . . . Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous . . . . The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known[,] but apparently unreasonable risk. RESTATEMENT (SECOND), supra note 51, § 402A cmt k.
80. See Violette, 62 F.3d at 13-14 & n.3. Failure to inform physicians or patients or both of safer alternatives also may constitute a breach of duty to provide adequate warnings. Id.
81. Tansy v. Dacomed Corp., 890 P.2d 881, 885 (Okla. 1994) (products liability action against manufacturer of penile implant).
82. Id. at 886. In some jurisdiction, risk/utility balancing also may be a prerequisite to application of the Comment k defense. Id. at 887.
83. W. PAGE KEETON ET AL., PROSSER & KEETON ON THE LAW OF TORTS § 102 at 711-12 (5th ed. 1984 & Supp. 1988).
84. Id.
85. Fugate, 593 F. Supp. at 392; Rollins, 635 F. Supp. at 136.
86. It often is unclear whether the reprocessor is a "seller in the business of selling" the reconditioned product. One court explained that: This means that the seller, as a part of its commercial, profit-producing activity, is continuously involved in placing a particular product or line of products in the stream of commerce through selling the product to other persons or business entities. An entity is not a "seller" for purposes of the [Model Uniform Product Liability] Act where the product is sold only incidentally orin an isolated transaction in an attempt to dispose of it. Anderson v. Olmsted Utility Equip., 573 N.E.2d 626, 630-31 (Ohio 1991) (referring to Model Uniform Product Liability Act (U.P.L.A.) §§ 102[B] and 104). See also Rollins, 635 F. Supp. at 138 (stating that "in order for a reconditioner . . . to be held liable as a seller . . . it must be 'engaged in the business' of selling such products. This means that the seller, as a part of its commercial, profit-producing activity, is continuously involved in placing a particular product or line of products in the stream of commerce through selling the product to other persons or business entities.")
87. 464 N.W. 2d 667, 670 (Wis. 1991).
88. Rollins, 635 F. Supp. at 138; Anderson, 573 N.E.2d at 626 (holding that company that repaired truck with aerial lift, substantially rebuilding the lift and replacing truck, was subject to strict liability although it was not technically seller of the product).
89. 879 S.W.2d 618 (Mo. Ct. App. 1994).
90. Id. at 619.
91. Id. at 618.
92. E.g., Hector v. Cedars-Sinai Med. Ctr., 225 Cal. Rptr. 595 (Cal. Ct. App. 1986) (holding that rule of strict liability could not be applied to hospital providing allegedly defective pacemaker to patient because hospital, rather than being considered as seller of the product, was more properly viewed as provider of medical services). But see Harwell, 803 F. Supp. at 1287 (deeming implant of penile prosthesis a U.C.C. sale for breach of warranty claim against manufacturer); Porter, 783 F. Supp. at 1466 (deeming implant of acetabular cup prosthesis a U.C.C. sale for breach of warranty claim against manufacturer).
93. See, e.g., Detwiler v. Bristol-Myers Squibb Co., 884 F. Supp. 117 (S.D.N.Y. 1995) (holding that physician's modification of silicone for cosmetic injection subjected physician to potential strict liability claim); Phillips v. Orenteich, 1995 WL 351532 (S.D.N.Y. 1995) (unreported) (denying motion to dismiss strict liability claim against physician who reprocessed silicone for cosmetic injection because factual issue of whether physician was a "manufacturer" was unresolved).
94. Id.
95. See PROSSER & KEETON ON THE LAW OF TORTS, supra note 72, at 679-81.
96. See supra notes 17-18 and accompanying text.
97. See, e.g., ASS'N FOR THE ADVANCEMENT OF MED. INSTRUMENTS (AAMI), AAMI STANDARD FOR REPROCESSED HEMODIALYZERS.
98. Some courts have expanded respondeat superior doctrine to nonemployed physicians on the basis of apparent or ostensible agency theories. A physician is deemed an apparent or ostensible agent of a hospital when the patient relies on the hospital, rather than the individual physician, to provide care. Courts reason that this reliance is justified where: 1) the hospital holds itself out as providing particular services, i.e., emergency or radiology services); and 2) it is reasonable to view the physician providing these services as a hospital employee, Patients' inability to select the physician is an influential factor, and thus, these cases typically involve emergency physicians, radiologists, anesthesiologists, and pathologists. By extension, a hospital could be legally responsible for the decision to reuse a single-use device by a physician found to be the hospital's apparent or ostensible agent. See, e.g., Henderson v. Marx, 674 N.Y.S.2d 247 (holding hospital may be held vicariously liable for a physician's malpractice when the patient sought medical care from the hospital rather than from a particular physician, even where the allegedly negligent physician was an independent contractor).
99. See, e.g., Broussard v. United States, 989 F.2d 171 (5th Cir. 1993) (holding that hospital could not be held liable in tort because emergency room physician was "independent contractor").
100. Costa v. U.S. Dep't of Veterans' Affairs, 845 F. Supp. 64, 68-69 (D.R.I. 1994) (holding that residents could be considered hospital employees under "last servant" doctrine).
101. See, e.g., Thompson v. Nason Hosp., 591 A.2d 703, 706 (Pa. 1991) (noting that hospital could be subject to corporate liability if it failed to uphold proper standard of care, had actually or constructive knowledge of defect or procedures which created harm, and its negligence was a substantial factor in bringing about harm to patient); Pedroza v. Bryant, 677 P.2d 166 (Wash. 1984) (stating that standard of care to which hospitals will be held under the corporate-negligence doctrine is that of an average, competent practicioner acting in the same or similar circumstances).
102. Thompson, 591 A.2d at 707; see also Johnson v. Misericordia Community Hosp., 301 N.W.2d 156 (Wis. 1981).
103. Thompson, 591 A.2d at 707.
104. Corrigan v. Methodist Hospital, 158 F.R.D. 70, 72-73 (E.D. Pa. 1994) (holding that hospital may be sued for negligently failing to oversee its doctors and failing to formulate, adopt, and enforce adequate rules and policies, which may include policies governing obtaining informed consent).
105. 42 C.F.R. § 405.
106. DHHS regulations are found at 45 C.F.R. § 46.116(a); FDA regulations are set Forth at 21 C.F.R. §§ 50.25(a)(5), 812.100; HCFA regulations regarding informed consent are found at 42 C.F.R. § 405.
107. See R. Lafferty & A, Giboffsky, Regulatory and Legal Issues in the Reprocessing and Reuse of Hemodialyzers, 9 J. LEG. MED. 279-311 (1988).
108. See supra note 86.
109. See supra note 96.
110. Cf. Mallinckrodt, 976 F.2d at 700 (holding use of patented product beyond scope of patent limitation could constitute infringement where device labeling for "single use only" is a viable condition of sale, and where restriction is within patent's scope or otherwise reasonable).
111. See, e.g., Reeves v. Acromed Corp., 44 F.3d 300 (5th Cir. 1995) (physician used metal bone implant for spine rather than labeled use in long bones of upper or lower extremities).
112. Cf. Craft v. Peebles, 893 P.2d 138 (Haw. 1995) (noting that manufacturer's package insert accompanying silicon breast implant stated that treatment of capsular contracture by manual compression could cause rupture and was not recommended.); Young v. Cerniak, 467 N.E.2d 1045 (Ill. App. Ct. 1984) (holding that physician deviated from recommended dosage in anticoagulant's package insert, but that insert's recommendations provided a formula, not explicit instructions, for dosage determination and did not include warnings).
113. The terms "original manufacturer" and "manufacturer" are used synonymously.
114. See Rolph, 464 N.W.2d at 667 (holding reconditioner has no duty under ordinary negligence to bring its reconditioned products into compliance with current safety standards where it does not hold itself out as so complying and where compliance is not requested by product's owner).
115. F. Chu et al., Reuse and Reprocessing of Disposable Medical Devices: Legal Liability Issues, 3 J. HEALTH CARE TECH. 5-11 (1986).
116. See Porter, 783 F. Supp. at 1466.
117. See 21 C.F.R. § 801.4.
118. See supra notes 14-16.
119. Pub. L. No. 91-596, 84 Stat. 1590 (1970) (codified at 29 U.S.C §§ 651 et seq.).
120. See PROSSER & KEETON ON THE LAW OF TORTS, supra note 72, at 679-81.
121. See supra notes 75 & 81 and accompanying text.
122. U.C.C. § 2-314 (1996).
123. Id. § 2-315.
124. Courts have reached different conclusions regarding whether a hospital's provision of medical products constitutes a U.C.C. sale. Compare M.C. Skelton v. Druid City Hosp. Bd., 459 So.2d 818, 822-23 (Ala. 1984) (holding patient injured when suture needle broke could bring claim for breach of implied warranties against hospital because, even if hospital was not a merchant, both sale of goods and service were involved), with Hector, 225 Cal. Rptr. at 595 (holding no breach of warranty claim possible against hospital because it was not a merchant).
125. See, e.g., Gentile v. MacGregor Mfg., 493 A.2d at 647 (denying claims for breach of warranty because helmet reconditioner was not a "seller"). A manufacturer may assert product misuse as a defense to a breach of warranty claim or as evidence that the alleged product defect did not proximately cause the plaintiff's injury. See, e.g., Fort Howard Paper Co. v. Standard Havens, Inc., 901 F.2d 1373, 1377 (7th Cir. 1990) (defense of misuse concerns whether breach of warranty in sale contract is proximate cause of damages); Herrick v. Monsanto Co., 874 F.2d 594, 598-99 (8th Cir. 1989) (while misuse normally arises in the context of strict liability it can arise in the context of breach of warranty where there is a lack of notice, disclaimer, and perhaps lack of privity); Southern III. Stone Co. v. Universal Eng'g Corp., 592 F.2d 446, 452 (8th Cir. 1979) (recovery for breach of warranty may be denied where the buyer's misuse of the goods has been the proximate cause of the alleged breach). For single-use medical devices, the original manufacturer may argue that reprocessing constitutes misuse.
126. U.C.C. § 2-313.
127. See, e.g., Tatum v. Cordis Corp., 758 F. Supp. 457 (M.D. Tenn. 1991) (holding general promotional statement (that pacemaker was manufactured to high quality standards) was insufficiently specific to constitute express warranty).
128. R. Priester & A. Caplan, Legal and Ethical Issues in the Practice of Reuse, 31 PERSP. HEALTHCARE RISK MGR. 7 (1991).
129. Id.