Journal of the Academy of Hospital Administration

T.D. Dogra, S. Gupta

This is the concluding part of the series on “Medico Legal aspect of Health Care Delivery” and covers the important topic of product liability which is in the limelight due to technological advancements. It is hoped that this shall generate debate, discussion and thinking on this issue. Readers are invited to send their experience, opinion on this to the Editor.
Editors

PRODUCT LIABILITY IN MEDICAL CARE DELIVERY

A person who alleges an injury caused by a defective product may elect to base his legal cause of action on any of the three principle of products liability theories: negligence, warranty, or strict liability. These may be the criteria in criminal, civil, or consumer case proceeding for product liability in the court of law. However, the proceeding on a negligence theory in a products liability case requires an injured party to show that a specific defendant failed to exercise proper care in designing, testing, manufacturing, or marketing the allegedly defective medical product and that, as a reasonably foreseeable and proximate result of such negligence, the patient suffered the injury.

INTRODUCTION

The miraculous extension of life by high technology medical care, organ transplantation, mechanical substitutes, newer antibiotics, anesthetic agent and prosthetic products show the increase in powers of medical care delivery. Developing concurrently with the remarkable achievements of modern medical science and technology has been a similarly profound legal revolution in the body of law commonly known as products liability. Product liability describes the physical aent, which caused the injury in a situation in which a person is under a legal duty to the injured person. The injury or death of the patient may result unexpectedly by faulty, defective or negligently designed medical or surgical instruments or inadequate operating instructions. The manufacturer becomes responsible for injury or death in such case. The patient must prove that the defendant manufacturer departed from standards of due care, with respect to negligent design, manufacture, assembly, packaging, failure to test and inspect for defects or failure to warn or give adequate instructions. If the instrument functioned satisfactorily in previous operations or for several previous years in the hospital’s possession, it is a proof that it was not defective at the time of supplying. If subsequently the instrument develops a defect through ordinary and gradual wear and tear, or if the physician or the hospital misuses the manufacturer’s, medical products, the negligence liability would be imposed on the hospital or physician owner for the failure to inspect, test and repair such defects. The manufacturer becomes responsible if the patients can prove that the subsequent development of this defect was due to negligent design, structurally inferior component material, or improper assembly. An adequate warning cautions the user to follow directions and may also notify the risk of disregarding directions¹. This article reviews the theories available to an individual who alleges an injury cased by a defective product and sets forth the elements necessary to establish a cause of action on any of the principal products liability theories and the potential liability of the manufacturer of drug, blood products, medical equipments and various other product used in medical care delivery when some thing goes wrong due to the use of these product and comment future of product liability.

Theories of products liability

Whatever the danger and state of medical knoweldge, and however rare the susceptibility of the user, when the drug company positively and specifically represents its product to be free and safe from all dangers, and when the treating physician relies upon that representation, the drug company is liable when the representation proves to be false and harm results. The legal doctrine of negligence may be defined in terms of the duty of the person of “ordinary sense” grounds for products liability case requires an injured party to show that a specific defendant failed to exercise proper care in designing, testing, manufacturing, or marketing the allegedly defective product and that, as a reasonably foresceeable and proximate result of such negligence, the patient suffered injury.

Historically, a purchaser of goods has also been able to claim a breach of warranty against the immediate seller on the grounds that the goods were not as they were contracted to be. If a buyer could show that a seller made representations either expressly or impliedly about the quality of the goods that turned out to be inaccurate, the buyer would be allowed to recover appropriate damage without establishing any negligence by the seller. In early common law, the rule of cavent emptor, or “buyer beware”, prevailed. Changing social and economic considerations resulted in warranties, but only in situations where there had been an actual sale contract. “Given the contractual underpinnings of this cause of action, courts were reluctant to expand recovery for breach of warranty against anyone with whom the patient had not directly contracted. The term “privity” was given to the requirement that the parties have had actual dealings among themselves. “As the common law developed, however, certain aspects of tort law were grafted onto warranty law. As a result of this commingling of tort and contract law with breach of warranty actions, the privity requirement gradually eroded². Today, most countries including India allow a suit for breach of warranty against a seller by the ultimate consumer-under consumer protection act. An injured party proceeding on a warranty theory of liability need not prove negligence. Instead, it must be shown that the manufacturer or seller breached an expressed or implied promise that the product was both free from defects and fit for the ordinary purposes in which such products are customarily used.

Many countries have evolved basis for liability on the part of the manufacturer of a defective product. This is known as “strict liability in tort”. The theory behind strict liability is that is better social policy for manufacturers, rather than injured consumers, to bear the economic burdens, through products liability insurance or otherwise, for any injuries caused by defective products. Under the strict liability theory, an injured party need not prove negligence or any breach of warranty, but rather must establish only that the product causing the injury was defective whe it left the control of the manufacturer or the seller.

Generally, there are four fundamental types of product defects. The first may be considered the “manufacturing defect”. An improperly manufactured product is one that has been incorrectly manufactured or assembled and is thereby different from similar products manufactured. The second category of defective products is the defectively designed product. Such a products is identical to similar products manufactured by the defendant, all of which bear a common design flaw that renders the product unreasonably dangerous. The third category is a product that is defective because it has been inadequately tested. The fourth category is a product that is considered defective because the manufacturer has failked to provide the user with proper warnings or instructions regarding the product’s use. This type of claimed defect occurs frequently in cases involving pharmaceutical and medical products.

Under the strict liability theory, potential liability attaches not only to the product’s manufacturer, but also to its retailer and to any other person in the distribution chain who is “in the business of selling such a product”. Development in products liability theories, from negligence through strict liability, has made it easier for an injured party to establish a viable theory of recovery. Each new theory has expanded the law rather than merely replaced its predecessor. This broadening of recovery theories, however, has added new complexities to the products liability field. Depending on the facts of the case and upon the theories advanced, each products liability cause of action will have separate elements, varying burdens of proof, and different potential defenses. The central themse, however-which runs throughout all products liability causes of actionin the existence or nonexistence of a product defect at the time the product left the defendant’s control. This theme is essential to products liability and distinguishes it as a separate and unique field of law³.

The manufacturer’s liability

A manufacturer’s liability for its products may be established under the three theories discussed above negligence, warranty, and strict liability. For an injuredparty patient to establish a successful cause of action in negligence it must be proved that the defendantmanufacturer departed from reasonable standards of due care with respect to the design, testing, manufacture, assembly, inspection, packaging, or advertising of the product or failed to warn or give adequate instructions with respect to its use. The manufacturer owes this duty of due care to the ultimate user and not just to the immediate purchaser. A manufacturer’s liability on the theory of breach of warranty is often more closely linked with the contract of sale between the parties involved, specifically the manufacturer and the injured buyer. Privity of contract has been the principal hurdle in breach of warranty actions. Even if privity can be established, traditional warranty theory also requires the patient’s reliance, to his detriment, on an express or implied assertion by the defendant about the nature of the defective product. Without all of these elements, which are often difficult to establish, a warranty action will fail. Strict liability is a more attractive theory for a patient because it eliminates the key requirement of a negligence cause of action – the need for the patient to show that the defendant failed to exercise proper care in the manufacturing or marketing of the product. It also avoids the need for any contractual obligations between the manufacturer and the injured party as requirement for recovery. Under the strict liability theory, a patient needs only to establish that the product in question was so defective as to be unreasonably dangerous and that, as a result, injury was suffered⁴.

In developing drug theories, the courts have expressly recognized and taken into account the fact that some products are “unavoidably unsafe” given current scientific knowledge. While there are very few decided cases, it would seem that this previously developed liability jurisprudence is directly applicable to artificial medical aid and given the embryonic nature of scientific understanding and experience in this field. To support the analogy of artificial organ liability concepts in terms of established drug liability theories, greater detail of a manufacturer’s duty deserves review. The manufacturer has the duty to warn of complications, side effects, and any potential hazards associated with its products. This duty requires a manufacturer to warn of known hazards as well as those hazards that it has a reasonable basis to suspect might occur. The courts have expressly recognized that prescription drugs are “unavoidably unsafe products” that can be dispensed only under a physician’s authorization. With extraordinary medical devices, there is no question that the manufacturer has the duty to furnish full and complete warnings to any physician considering implanting such a device. The question, which logically and necessarily follows, is whether the manufacturer’s duty to warn also extends to the patient-consumer. Although in the prescription drug context a manufacturer’s duty to warn generally extends only to the medical community, it is unclear at present whether, with respect to extraordinary medical devices, the manufacturer’s duty to warn should also extend to the patient-consumer⁵.

Liability of the physician

A patient’s suit against a physician for an injury resulting from the physician’s treatment is predicated on professional negligence or malpractice. Malpractice may be defined as “bad or unskillful practice on the part of a physician or a surgeon resulting in injury to a patient. : the “failutre of a physician to exercise the required degree of care, skill, and diligence,” or “the treatment by a surgeon or a physician in a manner contrary to accepted rules and with injuries resulting to the patient,” are all base upon which malpractice claims may be founded.

To present a cause of action for malpractice successfully against a professional practitioner, the patient must establish four essential elements. First, a cause of action must show that the physician in question owed the patient-patient a particular duty or obigation. This legal duty derives from the physicianpatient relationship, which requires the physician to act in accordance with specific standards of care established by the profession for the protection of the patient against unreasonable risks. Second, the patientpatient must establish that the physician failed to act in accordance with these standards⁶. An act or omission violating the standard of care owed to the patient is required. Third, the patient-patient must establish that a causal and reasonably foreseeable connection exists between the acts or omissions of the physician and the resulting injury. Fourth, the patientpatient must prove that the physician’s or omissions caused some actual loss or damage. The failure to establish any one of these four elements may defeat a malpractice claim.

Claims for breach of warranty provide an alternative approach for actions by patients against medical practitioners resulting from injuries suffered from medical instruments, drugs, or devices used in treatment. The determinative issue in this instance is whether a sale existed upon which a warranty action could be based⁷. A sale of goods, independent of the medical services provided, is generaly the touchstone for warranty recovery. Strict liability, has become a frequent theory upon which attempts to establish a physician’s liability are often premised by a patient injured through the use of any medical instrument or device. However, courts have been hesitant to apply strict liability against physician. Courts analyzing the physician-patient relationship have noted that the primary purpose of this relationship is the performance or rendition of professional medical service, distinguishing this from the sale of medical products. Accordintly, most courts in various country have rejected the application of the strict liability theory to the medical treatment provided by physicians.

Respondeal superior is a common law doctrine that imputes responsibility for an employee’s acts, carried out during the course of his employment, to the employer as the one who derives advantage from the act and, therefore, must answer for any resultant injury. The two requirements for application of this doctrine are specific. The person charged with liability must be an employer, or someone in direct control of the party who allegedly caused the injury. Further, the person charged with causing the injury must have been acting with the “scope of his employment” at the time the injury resulted. These two requirements have restricted application of this doctrine in the health care context. A doctor is a professional and traditionally was not classified as a hospital employee. Rather, the doctor was viewed as an independent contractor – retained at the expense and will of the patient, not the hospital. Although development in this area has been slow, some jurisdictions have changed the legal status accorded hospitals. Hospitals have an integral role in the patient’s overall treatment, and patients assume that if an error is committed, the hospital will take responsibility. This is based on the “apparent authority” of the hospital to supervise the treatment given, and has become another basis for attributing liability to hospitals⁸.

The law is accepted in a majority of jurisdictions. That hospital’s potential liability is to encompass most, if not all, of the hospital’s physicians, specialist, and staff. Another basis adopted by some jurisdictions for hospital liability for negligent treatment is termed corporate negligence. Under this doctrine, established by the USA Supreme Court in the leading case of Darling v. Charleton Community Memoral Hospital, a hospital has a duty to provide adequate medical care to its patients. This duty charged the hospital with responsibility for all treatment, which takes place within its boundaries, extending liability beyond activities traditionally considered under their direct control and governed by principles of respondents superior and, thus, include liability for acts or omissions of persons, such as physicians, who are not hospital employees. These broad principles of negigence liability on the part of the hospital would seem to be equallyapplicable in the specialized area of organ transplantation, although it must be recognized that proff of negligence in this evolving scientific area may often be difficult⁹.

CONCLUSION

The manufacturer of medications has a legal duty to use care in research and development of drugs and other medical products. The manufacturer of drug, medical equipment and other surgical product should recommend to the medical professionals prescribing conditions, precautionary measures to be taken and the side effects produced. Injury of a patient due to a drug reaction can result from the negligence or breach of warranty on the part of manufacturer, which is a valid cause of action against a manufacturer. The manufacturer is also liable due to the harm caused by the contamination of a drug. Once the physician has been warned about potential side effects, the manufacturer has no duty to ensure that the warning reaches the patient under normal circumstances. From the information’s received from the manufacturer and other medical sources, the doctor isrequired to inform the patient of those reasonably fore-seeable dangers inherent in the particular circumstances. If the doctor has or should have information, knowledge, or suspicion from any source that a certain medication is likely to produce serious side effects, he may become legally liable for prescribing it, if any substituted drug would have been adequate and satisfactory¹⁰. The foregoing overview of products liability theories in the rapidly developing field of high technology and computerized arena of medical care delivery in India discussed several aspects of legal doctrine that surrounds the future and may be standardize by passing health legislation concerned with medical equipment and product safety act in our country which exist in many western country.

REFERENCES

1. Indian Penal Code – Law Book Agency, Vol. 2, 1987.
2. Consumer Protection Act, 1987.
3. Bayless V Stutler, 642 S.W., 2d 586, 588 (1982).
4. Adams V Ison, 294 S.W. 2d 971, 973-974 (ky 1982).
5. Hofstedt. V. International Harvester Co. 98 N.W. 2d 808 (Minn. 1959).
6. McGuire V. Baird, 9 Cal. 2d 353, 70 P.2d.915 (1973).
7. Kirby V. Kuhns, 105 Oho App. 294, 152 N.E. 2d 341 (1997).
8. State V. Terry, 325 S.W. 2d 1 (Mo. 1959).
9. As a general rule only persons of scientific medical training are regarded as experts who may express opinions upon issues of sanity or insanity. Am. Jur. Evidence 851 (1988).
10. Cloud V. Market St. Ry. Co. 74 App. 2d 92, 169 P. 2d 191 (1989). See also Black v. (1922); Myers v. Wells, 272 S.W. 110 (Mo 1995); Clark v. Horowitz, 293 Pa. 441, 143 A. 131 (1928); City Nat’ 1. Bank v. Pigott, 270 S.W. 234 (Tex. Civ. App. 1996).
11. Scaglioni v. Oriti, 83 Ohio App. 351, 83 N.E. 2d. 657 (1948); King v. King, 150 Tex. 662, 244 S.W. 2d 660 (1996); Miller v. Miller, 237 Iowa 978, 23 N.W. 2d. 760 (1997).
12. McGulpin v. Bessmer, 241 Iowa 1119, 43 N.W. 2d 121 (1990). But in Meiselman v. Crown Heights Hospital, 285 N.Y. 389, 34 34 N.E. 2d. 367 (1996) it was said that residence alone neither bars a physician from testifying as an expert nor qualifies him to do so.
13. ASA, Basic guidelines for anesthesia care, in American Society of Anesthesiologists directory of members IV A1. C. at 427 (46th ed. 1981).
14. Gupta Sudhir Kumar, Sharma R.K. : Police Research & Development Journal : Vol : Qtr-IV, Oct-Dec. 1997, p-17-19.
15. Gupta Sudhir, Sharma RK : Medical Negligence – A review : Vol-33 No-4; Oct-Dec-1997,
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17. ASA, Suggestions for a record of anesthesia care to facilitate medical audit, in American Society of anesthesiologists directory of members 431 (46th ed. 1981).
18. Hull Hospital v. Wheeler, 250 N.W. 637 (Iowa 1933); Noble v. First National Bank of Anniston, 1 So. 2d 289 (Ala. 1991).
19. Daly’s Astoria Sanatorium Inc. V Blair, 161 Misc. 716, 291 N.Y.S. 1006 (1993).
20. Findlay v. Board of supervisors of the country of Mohave, 72 Ariz, 58, 230 p. 2d 526 (1991), group health cooperative of Puget sound v. king country medical society, 39 wash. 2d 586, 237 p. 2d 737 (1991).
21. Stribling v. Jolley, supra ref. 7; Morgan v. state, 155 Neb. 247, 51 N.W. 2d 382 (1992).
22. Henderson v. city of Knoxville, 157 tenn, 477, 9 S.W. 2d 697 (1995); natale v. sisters of mercy of council bluffs, 243 iowa 582, 52 N.W. 2d 701 (1992), werens v. scotts bluff country medical society, 277 N.W. 378 (Neb. 1988) west coast hospital association v. hoare, 64 so. 2d 293 (Fla. 1993).
23. Henderson v. city of Knoxville, supra ref. 21.
24. Joseph C. Alan R. Moritz; Doctor and Patient and the law 4th ed pp. 451-459.
25. Manual for medical record librarian : Edna K. Huffman, RRL.
26. Medical law and Ethics in India : Homi Shapurji Mehta, M.S., F.C.P.S. (Bombay) J.P.
27. Legal aspects of medical records : Emmanuel Hayt, LL.B., and Jonathan Hayt, B.A., LLB.
28. Franklin CA. Modi’s text book of medical jurisprudence and toxicology, 528 Bombay, NM Tripathi Pvt. Ltd. 1st edition 1989.
29. Camps Robinson A. Gradwohl’s legal medicine 426 Bristol: John Wright and sons Ltd. 3rd Editions 1976.
30. Alfidi RJ. Informed consent, a study of patient reactions J.A.M.A. 1971; 216; 1325-9.
31. Set torth as a selected bibliography hereto is a list of references concerning the issues of product liability and organ transplantation, which the authors have relied upon in preparing this chapter. With respect to the topic at had, the authors direct interested readers to two leading articles in this field : Berg, Kosseff, The life and death of barney clark : A manufacturer’s liability for extraordinary medical device, for the defense 25(6):22 (June 1983): Noblett, An overview of litigation concerning products liability and medical devices, American Journal of trial, Advocacy 5 (2) : 309 (1981).
32. W. Prosser, W.P. Keeton, The law of toris (West Publishing Co., St. Paul, Minn.) 5th ed. 1984) at 677-79 (hereinafter cited as prosser).
33. Heaven v. Pender, 11 Q.B.D. 503, 509 (1883). For a good discussion of negligence standards, seet towards a jurisproudence of injury: The continuing creation of system of substantative justice in American tort law, report to the American Bar Association (1984) at 5-20 to 5-24.
34. Prosser, supra note 4, at 685-89. for a good discussion of products liability in the medical legal area. See also K. Fineberg, et. al., Obstetrics / Gyanecology and the law (Health Administration press, Ann Arbor, Mich). (1984) at 111 (hereinafter cited as Fineberg).
35. Prosser, supra note 4, at 679.
36. Fineberg, supra note 7 & 2.71 at 112.
37. Julien, supra note 15, at 2, col. 1 (this article considers and analyzes the four fundamental categores of product defects).
38. Restatement (second) of torts & 402A (1) (a) 1995).
39. 211 N.E. 2d 253 (111. 1965), cert. denied, 383 U.S. 946 (1966). See also McCafferty, Meyer, supra note 46 at & 13.02.
40. 42 U.S.C.A. & 273 (West Supp. 1985).

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T.D. Dogra – Professor & Head, Department of Forensic Medicine and Toxicology, AIIMS, New Delhi.
S. Gupta – Associate Professor, Department of Forensic Medicine and Toxicology, AIIMS, New Delhi.