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Getting the bad news about your artificial heart valve.

When the manufacturer of a medical device alone bears the responsibility for alerting recipients that the device may be defective, there is a certain temptation to gloss over the risk. The story of the Bjork-Shiley Convexo-Concave heart valve is a case in point.

If the steering mechanism on your car is found to have a manufacturing or design defect, the National Highway Transportation Safety Administration directs the manufactuer to send a letter to all owners of the model (a registry is kept for this purpose) with instructions concerning replacement or repair. Owners are thus warned about the problem and given information about what to do about it, and manufacturers are prepared to make the necessary adjustments. This arrangement assumes that owners have a right to know about relevant defects, manufacturers have an obligation to inform and repair, and the government has the responsibility to oversee this process. While this arrangement is not perfect, it acknowledges the vulnerability of consumers and the corresponding obligations of the manufacturer and the government to protect them.

What happens if a similar situation arises with your implanted artificial heart valve? Is there a similar system to warn recipients and provide information about what to do? The recent failure of hundreds of Bjork-Shiley Convexo-Concave (C/C) mechanical heart valves provides a case study on how information about the risk of failure was communicated to patients and the medical community. Unlike automobile recalls, the arrangements for dealing with defective heart valves were--until recently--indirect, ineffective, and marked by serious conflicts of interest. None of the three groups responsible for protecting patients with artificial heart valves--the Food and Drug Administration, the physicians and surgeons whose patients received the device, or the manufacturer (Shiley, Inc., of Irvine, California)--adequately responded to the discovery that the C/C valves were susceptible to strut fracture. The system placed commercial and professional interests over the rights of patients.

Mechanical Heart Valves

The development of mechanical heart valves is one of the success stories of contemporary medicine. Many persons with diseased heart valves become seriously disabled and soon die unless a prosthetic valve can be installed. The first mechanical heart valves were implanted in 1960, and since then their use has grown rapidly. Today about 40,000 American receive artificial heart valves each year.[1]

Shiley, Inc., has been a pioneer in the development of mechanical heart valves. In 1974 they developed their radial spherical (R/S) valve, consisting of a disk attached to two wire struts that allow it to swing open and shut in response to blood flow. The struts are welded to a metal ring that is covered with a teflon sewing ring for attachment to the heart. In 1979 Shiley introduced a similar valve, the 60[degrees] Convexo-Concave (C/C), which they believed would improve blood flow through the valve. A C/C valve that opened to 70[degrees] was also manufactured, but it was not approved for sale in the United States.

Blood clots (thromboses) caused by the presence of artificial implants are a serious problem and are responsible for the greatest percentage of complications that occur. Because the movement of blood is obstructed by the valve, there are areas of relatively stagnant flow where clots can form. They may form on the valve, preventing it from fully opening or closing, or they may break free and cause strokes, heart attacks, and other serious complications. Drugs to "thin" the patient's blood and reduce clotting are an essential part of the treatment after implantation, but there is a limit to their ability to reduce the incidence of thromboembolism--blood clots that break free and lodge in an artery, cutting off blood flow to tissues or organs. Shiley's 60[degrees] C/C valve, which appeared to allow better blood flow and promised a lower incidence of thromboembolism, was regarded as a significant improvement in heart valve technology.

A fracture of the outlet strut of the C/C valve occurred during clinical trials in 1978, and as more of the valves were implanted, other reports of similar fractures began to reach Shiley. While the number was not large in relation to the number of valves implanted, the fact that all the fractures were similar--occurring at the point where the outlet strut was welded to the ring--strongly suggested that a design or manufacturing problem was responsible for the failures. There had been a few fractures of the inlet strut of the similar radial-spherical (R/S) valve, but a welding change was made in 1975, and no further fractures occurred.

When the outlet strut of the C/C valve fractures, the disk falls out of its ring, resulting in unrestricted blood flow through the heart. Without a valve to close one end of the chamber, contractions cannot force blood out of the heart. This is a form of heart failure, and it requires immediate open heart surgery. Depending upon the location of the valve in the heart, the person has anywhere from a few minutes to one or two hours to live.[2] About two-thirds of the persons who experience valve failure die, and many survivors have serious complications[3]

Informing the Medical Community: I

Although the incidence of strut fracture was low, the results were catastrophic. Shiley began what turned out to be a series of voluntary recalls of the C/C valve. The recall letters were similar in format, reporting fractures, announcing a new test or manufacturing procedure that solved the problem, and asking that unimplanted valves be returned to be replaced with new, improved valves.

Shiley sent these "Dear Doctor" letters to surgeons who had implanted the valve to inform them of the fractures. It was left to the discretion of the doctor to inform the recipients. Shiley's stated reason for not directly informing patients was the desire not to infringe upon the doctor-patient relationship: "A well-recognized medical principle is that only a physician can make the informed medical judgment whether, when and how the patient should be informed about the benefits of sophisticated medical devices and their potential complications."[4] A panel of medical experts created by Shiley agreed, saying that "physicians who are carring for patients who have had this prosthesis implanted should individualize the decision as to which patients should receive information regarding outlet strut fracture." This group was also concerned that "there may be substantial negative psychological effect on a patient who receives information about a potential problem of outlet strut fracture, particularly when the risk of failure is low and explantation may not be warranted."[5]

Federal regulations require that the FDA determine whether public notifications "may cause unnecessary and harmful anxiety in patients"; the FDA concluded that initial consultation between patients and their physicians is essential.[6] James Benson, acting commissioner of the FDA, testified that their general policy for dealing with warnings about any prescription device has been to notify the physician, who may then.

decide on the appropriateness of warning each individual patient, taking into account that person's specific situation and characteristics and the potential hazard presented by the device. In the case of the strut fracture problem, the physician can weigh the potential benefits of warning the patient about a fracture against the negative effects to the patient of the warning. For a given patient, for example, the physician would balance the extent to which a warning might enable the patient to get medical attention more quickly against the potential anxiety which the warning might induce and its negative effect on the quality of life.[7]

This argument is based on two considerations: the need for medical judgment to determine how hazardous the situation is in advising particular patients, and the desire not to cause unnecessary anxiety in patients. What is especially interesting about this argument is that its ethical approach focuses exclusively on providing benefits and avoiding harms to the patient, and is based on the physician's determination of the appropriate balance of benefits and harms. There is no suggestion that patients have a right to know about the dangers of their heart valve so that they can make decisions about how to evaluate and respond to the risk of failure. It was left entirely to the discretion of the surgeons to decide what information, if any, should be conveyed to the patient. The physician panel took the position that since explanation of the valve was more dangerous than the risk of valve failure, there were really no medical options for patients. Informing them of the risk of valve fracture would only create anxiety about their condition, for which there was no treatment.

This reasoning is invalid. First, the question of whether explantation is more dangerous than having a valve that might fracture is complex. Shiley underreported the mortality rates of valve fracture by including only known deaths, those officially reported to them. Since the symptoms of valve failure are very similar to heart failure, an autopsy is required to determine if a death is a result of valve fracture or heart failure. Autopsies are not routinely performed, so there are "hidden fractures" that are not distinguished from heart failures. The Health Research Group, a Ralph Nader organization, undertook a study of hidden fractures and concluded that the number of fractures is probably 50 percent higher than reported.[8]

Shiley has also overstated the danger of explantation by combining the mortality rates for both elective and emergency surgery. The risk for elective surgery is significantly lower, ranging from under 1 percent to 4 percent. Further, for some patients explanation is clearly the less dangerous option, as a recent Dutch study claims.[9] In this study, the cumulative failure rate of the 70[degrees] C/C valve over eight years was 17.4 percent, with a higher failure rate for younger patients. The larger valve was not approved for sale in the U.S.

Moreover, even if explantation poses more risk than valve failure, it is the patient's right to decide whether or not to take the greater risk. Shiley's argument assumes that no one would or should choose the greater risk posed by explantation. But that assumption is not true; a number of patients have chosen to have their C/C valves explanted.[10] Apart from medical decisions, knowing that one's heart valve is subject to fracture has important implications for one's personal life. Recipients must live with the awareness of the need to be taken to a medical facility which can perform immediate open heart surgery in an emergency (only about 700 of the over 6,000 hospitals in the U.S. can do this)[11] and to inform and instruct others how to assist them. This is not an insignificant issue. Carol Barbee was one of the recipients of a Bjork-Shiley C/C valve who was not told about the possibility of valve failure. When her husband, Fred, found Carol on the floor having difficulty breathing, he took her to the nearest emergency room rather than one farther away that was capable of emergency heart surgery. The Barbees were not warned of the valve's susceptibility to fracture and the need to choose an appropriate facility in an emergency. Carol Barbee died while being transferred to another hospital.[12]

Many recipients have chosen to avoid any situation where they will not be close to a hospital capable of performing emergency open heart surgery. That means avoiding most air travel, particularly overseas, and vacations in remote areas. Some curtail physical activities in order to reduce stress on the heart. One woman reported that she was concerned about driving with her children in the car and was constantly aware of the need to stop the car safely if her heart valve fractured. All of these are significant life-style changes, made as a result of learning about the risk of valve fracture. There are many lawsuits making their way through the courts seeking compensation against Pfizer Inc., the parent company of Shiley, for emotional distress caused by the valve's potential for failure.[13]

The attitude of Shiley, its medical panel, and the FDA is contrary to the legal and ethical ideal of informed consent. While there are different legal and philosophical conceptions of informed consent, all of them begin with the idea that the competent patient has the right to decide what treatment to accept, if any, and the role of health care professionals is to provide relevant information associated with different health conditions and treatment options, and generally to support the patient's autonomous choice.[14] Informed consent makes the patient's right to choose a primary value and casts health care professionals in the role of advisors who draw upon their expertise to explain what the patient needs to know to make life decisions involving health. The paternalistic attitude that Shiley, the FDA, and the medical community took in this case is an ethical anachronism. Instead of allowing patients to decide what to do about the risk of valve fracture, Shiley and the FDA allowed surgeons to place themselves in the role of benevolent fathers and make that decision for their parents. This attitude, a throwback to an earlier "doctor knows best" approach to informing patients, has no place in contemporary medicine.[15]

The legal standard of disclosure for informed consent in most jurisdictions requires that the physician or surgeon inform patients of all material risks, those that a reasonable person would want to know. These would include significant risk of death and serious injury. Although the risk of death was low, the impact on the rhythm of life is significant. Ironically, the doctor who implanted Carol Barbee's valve was asked by New York Newsday whether he would want to know about the possibility of failure of the valve if he had one implanted in his heart. He said yes.

Another unpleasant irony of this case is that while there was much emphasis on letting doctors decide about informing patients in order best to attend to their needs and anxieties, a very large number of patients heard about the valve's potential for fracture on TV shows or through newspaper articles discussing allegations lodged by former Shiley employees about sloppy manufacturing. It is hard to imagine a better way to create anxiety than to learn about a serious problem with your heart valve in this way. It appears that very few patients learned about the risk from their doctors.

Negative Psychological Effects

The appeal to negative psychological effects is also a weak argument. Of course there will be negative psychological effects from learning that your heart valve may fail, but if the patient is to be treated as an autonomous adult, that information must be provided. It is possible that in some exceptional cases notification would be inappropriate--if, for example, a patient were to lose his or her capacity to make rational decisions as a result of being informed--but unless there is some clear disqualification, the patient's right to know should be respected. As Sissela Bok points out, a strong burden of proof is on those who wish to withhold significant information from competent patients.[16]

Had Shirley chosen to send letters directly to patients, suggesting that they consult their physicians or cardiologists about their heart valves, its action would not have been an interference in the practice of medicine. As long as no medical advice is given, such communications are legally and ethically acceptable. Patients have been directly informed by medical device manufacturers about problems with their products, particularly with experimental devices being used in clinical trials and usually with the cooperation of the clinical investigators. Notifying patients directly would have taken away the surgeon's option of not informing the patient at all.

Do manufacturers have an obligation to patients that allows or requires them to notify patients directly? One can argue that manufacturers have a duty to warn the persons who may be harmed by their products by looking at a similar situation in engineering ethics. The primary professional obligation of engineers is to "hold paramount the public safety, health, and welfare," which often means warning the public directly about danger when organizations refuse to act.[17] There is a substantial literature on the problems of whistle-blowing that has developed in response to this situation. The engineer's obligation is based on professional knowledge that may permit awareness of danger that would be hidden from ordinary persons. The people at Shiley who knew about their heart valve's tendency to fracture had a similar obligation to the recipients of the valves, who were ignorant of the hidden dangers lying within them.

If manufacturers have a duty to warn of danger, how is that to be reconciled with the surgeon's or physician's duty to determine what to tell a particular patient, and even withhold information from them? One suggestion is for the manufacturer to send clear and strongly worded letters encouraging physicians and surgeons to inform their patients unless there is substantial reason not to do so. If this approach were reasonably effective, it would resolve the conflict between these obligations. When there is reasonable doubt that the usual procedure of indirect warnings through physicians would not be effective, a letter sent directly to patients could urge them to consult their physician for a discussion of their implant. This would not undercut the physician's responsibility to determine how much to reveal to particular patients. Such a communication would have to be sensitive to the physician-patient relationship, but it would be wrong to assume that letters of this kind are never acceptable. It is useful to bear in mind that other people besides physicians have ethical obligations here.

A more powerful obstacle to informing patients is that this would have spread the news about the problems with the heart valve. Bad publicity would likely follow, causing difficulty for Shiley's sales force. It is not unlikely that some patients would also seek legal advice and that lawsuits would result. While informing patients directly would have been ethically desirable, the disincentives for Shiley at this time were substantial, and it is not surprising that this step was not taken.

Informing the Medical Community: II

The issue of informing heart valve patients of the risk of fracture is complicated by whom Shiley chose to inform and the manner in which information was conveyed to them. When Shiley learned of the fracture problem they sent out "Dear Doctor" letters to the surgeons who had purchased the valves for implantation. Sales records were available for those individuals, but Shiley did not have records for the patients' cardiologists or family physicians. There was no complete record of patients who had received the heart valve, although some have suggested that such a list would not be difficult to compile.[18]

Of the three medical professionals the patient would have had contact with--the family physician, cardiologist, and surgeon--it is the surgeon who has the least contact with the patient. With the cardiologist and family physician there is an ongoing relationship, whereas the surgeon is seen only briefly, just before implantation. Most patients never see their surgeon after the operation. Thus notifying the surgeon minimizes the chances that the patient will be notified. The patients' cardiologists would be the persons most likely to have an ongoing contact with the patients and be able to advise them about their heart valve, but Shiley had no knowledge of them and made no effort to find them.

Under these circumstances, Shiley's claim that they did not notify patients directly because they did not want to interfere with the doctor-patient relationship has a distinctly hollow sound. It is hard to imagine that fear of damaging the rather casual contact between patient and surgeon had much to do with Shiley's actions.

Conflicts of Interest

The letters Shiley sent to the surgeons have been strongly criticized for the way they presented the information. For example, in its letter of April 1982 Shiley began by describing itself as "a responsible medical device manufacturer and the world's leading supplier of cardiac valve prostheses," who was informing physicians about clinical experience with their valves. The next paragraph describes the introduction of the C/C valves, their worldwide distribution, and their 50 percent reduction in thromboembolic episodes. After this fanfare, there is the information about the fractures:

Early in 1980, we asked that a selected group of Convexo-Concave valves be returned to Shiley for evaluation [the first recall] due to an incidence of strut fracture of .000103 (1.03 x [10.sup.-4]) per implant-month. Since May of 1980, we have distributed over 35,000 Convexo-Concave valves and 4 strut fractures have occurred in this group. The incidence of strut fracture in this group of valves has been reduced to .0000106 (1.06 x [10.sup.-5]) per implant month. This incidence can also be expressed as .0128 per 100 patient-years. This reduction in the incidence of mechanical failure is the result of continuing improvements in manufacturing methods and quality control inspection procedures.

The final paragraph is a comparison of the C/C valve with older Shiley valves for reduction of thromboembolic episodes and susceptibility of fracture. Although the C/C valve has a much higher rate of fracture, that is more than offset by "a 47% reduction in serious complications with the Convexo-Concave valve."[19]

This letter reads more like a promotional document than a warning about strut fracture. The relevant information about the fractures is carefully sandwiched between praises of the valve's virtues. The information itself is expressed in implant-months and the use of "[10.sup.-5]" emphasizes how small the problem is. Unfortunately, less than a month after this rosy communication, Shiley sent out another letter recalling all 29-33 mm C/C valves.

In contrast, a March 1990 communication from Shiley provides these linearized estimates of rates of fractures:

* All 21-27 mm valves 2.1 per 10,000 per year (0.021% per year)

* 29-33 mm valves manufactured prior to 2/1/81 5.4 per 10,000 per year (0.054% per year)

* 29-33 mm valves manufactured between 2/1/81 and 6/30/82 29.5 per 10,000 per year (0.295% per year)

* 29-33 mm valves manufactured after 6/30/82 8.7 per 10,000 per year (0.087% per year)[20]

Stating the failure rate in terms of the percentage of valves likely to fail each year provides a more understandable picture of the likelihood of valve failure, but these figures still suffer from the underreporting mentioned above.

The ethical responses of Shiley and the medical community are strongly influenced by their roles in the business of supplying medical devices. The clearest and most problematic is the relationship between manufacturer and surgeon. Producers of heart valves must sell them to implanting surgeons in a competitive market, a circumstance that does not provide much incentive to warn surgeons of defects. As one surgeon noted, "It is patently absurd and inherently fraught with conflict of interest to expect the manufacturer of a medical device to be the sole source of reporting problems with the device, in a fair and objective way, when the reports are being given to the doctors whom the manufacturers are simultaneously trying to convince to continue using the same product."[21] Hence it is not surprising that Shiley's "Dear Doctor" letters presented reassuring but convoluted statistics coupled with assurances that the problem had been solved with new tests or manufacturing techniques.

These arrangements for warning patients of potentially defective medical devices are grossly unethical. They are primarily designed to protect the interests of manufacturers and the prerogatives of the medical community, not the patient. The problems with the Bjork-Shiley 60[degrees] C/C heart valve produced needless deaths, created fears, and perhaps worst of all, contributed toward a growing distrust of the medical community, medical device manufacturers, and their government regulators. The rhetoric of preserving the doctor-patient relationship was used to protect commercial and professional interests, not people with possibly defective heart valves ticking in their chests.

Warning Recipients

The series of voluntary recalls of the C/C valve finally came to an end in 1986. Sales of the valve were down as the result of publicity about its failures, and Shiley preferred not to risk regulatory action. One month before the FDA was to reconvene a panel to consider withdrawing Shiley's premarket approval (their legal right to market the product), Shiley withdrew the valve from the market.

In December 1990, the FDA accepted a proposal by Shiley to locate about 23,000 people in the U.S. and Canada who have received the C/C valve implant and notify them of the danger of strut fracture. The program is being conducted by Medic Alert, a nonprofit foundation, and it asks heart specialists and hospital administrators to identify their patients with C/C valves. Recipients of the implants may enroll in an international implant registry to receive current information about their valve and will receive an identification card and a bracelet or necklace identifying them as having a C/C valve. Plans are being made to notify foreign governments about this program.[22]

Regulatory Changes

The history of regulatory reform is encapsulated in the Bjork-Shiley artificial heart valve case. Medical devices came under federal regulation relatively recently, with the passage of the Medical Device Amendments of 1976, in large part because of public outrage over deaths caused by the Dalkon Shield, an intrauterine contraceptive device. Shiley's premarket approval application for their C/C heart valve was one of the first received by the FDA, which was struggling to develop regulatory procedures for medical devices.[23] Before 1976 other reforms were established in the wake of scandals involving thalidomide (1962), sulfanilamide (1938), and all the way back to the original food and drug legislation of 1906, inspired by Upton Sinclair and the muckrakers. Every reform was initiated by public outcry over abuses, which the reforms eliminated or moderated. But social and technological change, economic pressure, and human ingenuity always seem to generate new ones.

Largely because of abuses revealed in the Bjork-Shiley C/C artificial heart valve case, Congress passed the Safe Medical Device Act of 1990. It contains a number of provisions that strengthen the system of notifying patients of problems with medical devices. Manufactorers of a device, "the failure of which would be reasonably likely to have serious adverse health consequences and which is (A) a permanently implantable device, or (B) a life-sustaining or life-supporting device used outside a device user facility ... shall adopt a system of device tracking."[24] This will allow manufacturers and the FDA to locate patients for warnings or product recalls, just like automobiles. Although the FDA has the legal authority to inform patients directly, that step will be taken only as a last resort. When there is a problem of this kind there are negotiations between the FDA and the manufacturer to make sure that patients receive the proper information, usually through their physicians. The physician's role in conveying information to patients is essentially intact but not absolute, as the FDA can bypass it. The new FDA commissioner, David Kessler, seems prepared to use that authority, stating recently that "when a critical device such as a heartvalve is found to have a problem that could result in death or serious injury, FDA has an obligation to see that doctors and patients are notified, so that they can consider the new information in deciding on a course of action."[25]

The Safe Medical Device Act also strengthens reporting requirements for defective devices, requiring user reports by hospitals, nursing homes, and physicians. The FDA can call for postmarketing surveillance of medical devices if it believes there is a problem and wants to find out how extensive it is. Although these provisions are an additional burden to manufacturers, it is considerably smaller than the burden imposed by previous arrangements on persons whose heart valve was found to be defective. It is a scandal that it took hundreds of deaths to provide these basic protections for implant patients.

Has Congress Solved the Problem?

Does this recent legislation eliminate the abuses of patients' rights that occurred in the Shiley heart valve case? There are three issues to consider. The first is getting reliable information about problems with medical devices; the second is the relationships among manufacturer, patient, and physician that prevented notification; and the third is the FDA's ability to act effectively.

Clearly the Safe Medical Device Act makes it much easier for the FDA to get information about the performance of medical devices. Before the act there was no requirement for hospitals to report failed valves, and those who voluntarily did so sent letters to Shiley, not to the FDA. Now user reports are required on all such failures, and they must go both to the manufacturer and to the FDA. In addition, the FDA can order postmarketing survellance--a study of a particular product already on the market--if problems seem to be developing.

The obstacles to informing patients arising from the relationships among manufacturer, physician, and patient have been diminished. The existence of a patient registry will make it possible to know who has a life-sustaining medical device and to get information directly to patients. The registry will include the patient's family physician as well as the surgeon, making it possible to contact the clinician who has an ongoing relationship with the patient. The FDA will continue to respect the physician-patient relationship but can intervene if necessary.

The act provides additional punitive powers to the FDA, which can now suspend a manufacturer's premarket approval, making it illegal to sell the product. This is similar to the Federal Aviation Administration's power to "ground" aircraft by suspending their airworthiness certificate, their legal right to fly.[26] The fDA can simply order a product off the market without having to prove to a court or anyone else that its action is justified. A hearing must be held within ten days, and the FDA can be challenged in court, but the agency has the advantage of being able to act and have the burden of proof on those who wish to challenge it, the reverse of the situation before the new legislation. The FDA is not likely to use its new powers very often, but the threat of suspending premarket approval will allow it to be more persuasive in dealing with medical device manufacturers.

Although all this is a significant improvement over the previous arrangements, it is worth noting that having the power to act is not sufficient: much depends upon the willingness of those who operate the regulatory machinery to use it. The threat of premarket approval suspension only works if the commissioner, who is appointed by the President, is viewed as likely to use it. The FDA seeks both to get medical devices on the market as quickly as possible and to make sure that they are safe and effective. These goals are often in conflict, for higher standards of safety entail longer periods of testing and delay introduction of new products.[27] In the last decade, the regulatory minimalism of the Reagan and Bush administrations emphasized getting new products out. Now the pendulum has swung in the other direction.

Congressman John Dingell, a strong proponent of the new legislation who chaired the Shiley hearings, clearly believes that the FDA could--and and should--have moved more forcefully against Shiley. Congress, and Dingell in particular, wanted to send a strong political message to the FDA concerning its enforcement of safety standards for medical devices. David Kessler, the new commissioner at the FDA, shows greater willingness to get tough with uncooperative producers. As important as the FDA's new powers is the new mood in the industry and at the FDA about the importance of safety.

The Patient as Consumer

The registry for informing car owners about problems with their cars is a consumer protection law. It is designed to ensure that consumers of expensive and potentially dangerous machinery will be notified of important information concerning the product they have purchased. Before the new act, consumers of expensive and potentially dangerous medical devices were treated only as patients. It was assumed that their interests would be protected by the FDA and the legal and ethical standards in the patient-physician relationship. The problems with the Bjork-Shiley C/C artificial heart valve showed that this arrangement was obviously defective, protecting mainly the manufacturer and the professional interests of physicians.

The Safe Medical Device Act recognizes medical devices as consumer items and provides protections for the patient as consumer. To protect patients it had to impose additional obligations on manufacturers, give additional power to the FDA, and limit the professional prerogatives of physicians. This is a significant step, surely not the last, in viewing the patient through the conceptual framework of a consumer of products rather than as a client. While the protections provided by the act are welcome and long overdue, the question of how this approach will affect the values and culture of medical practice is a troubling one.


I wish to thank Douglas Birsch and Diana Rosenberg of Villanova University and Benita Adler of the Public Citizen Health Research Group for reading earlier drafts of this essay and providing many useful suggestions.


[1.] "FDA and the Medical Device Industry," Hearing before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred First Congress, Second Session, 26 February 1990, Serial No. 101-27, p. 410.

[2.] "FDA and the Medical Device Industry," p. 175.

[3.] "The Bjork-Shiley Heart Valve: 'Earn as You Learn,' Shiley Inc.'s Breach of the Honor System and FDA's Failure in Medical Device Regulation," A Staff Report Prepared for the Use of the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, U.S. House of Representatives, February 1990, p. 2. This report is appended to "FDA and the Medical Device Industry."

[4.] "FDA and the Medical Device Industry," p. 593.

[5.] "FDA and the Medical Device Industry," p. 427. This conclusion was originally published by Hiratzka et al., "Outlet Strut Fracture of the Bjork-Shiley 60[degrees] Convexo-Concave Valve: Current Information and Recommendations for Patient Care," Journal of the American College of Cardiology 11, (May 1988): 1130.

[6.] 21 CFR 7.50 (1988); 43 Fed. Reg. 26,217 (16 June 1978); quoted in "FDA and the Medical Device Industry," p. 428.

[7.] "FDA and the Medical Device Industry," p. 225.

[8.] "The Bjork-Shiley Heart Valve," p. 48.

[9.] "FDA and the Medical Device Industry," pp. 180-81; Yolanda van der Graaf, Frits de Waard, Lex A. van Herwerden, and Jo Defauw, "Risk of Strut Fracture of Bjork-Shiley Valves," Lancet 339, no. 8788 (1992): 257-61.

[10.] "FDA and the Medical Device Industry," p. 180.

[11.] This information was supplied by the Health Research Group, Washington, D.C.

[12.] "FDA and the Medical Device Industry," pp. 154ff.

[13.] The Wall Street Journal, 21 June 1990.

[14.] Cf. Ruth Faden and Tom L. Beauchamp, A History and Theory of Informed Consent (New York: Oxford University Press, 1986).

[15.] See Paul Starr's Social Transformation of American Medicine (New York: Basic Books, 1982).

[16.] Tom L. Beauchamp and James F. Childress, Principles of Biomedical Ethics (New York: Oxford University Press, 1983), pp. 76ff.; Sissela Bok, Lying: Moral Choice in Public and Private Life (New York: Vintage Books, 1979), p. 252.

[17.] See Deborah Johnson, Ethical Issues in Engineering (Englewood Cliffs, N.J.: Prentice-Hall, 1991), p. 98. The literature on whistle-blowing is extensive. Some good places to enter it are: Frederick Elliston, John Keenan, Paula Lockhart, and Jane van Schaick, Whistleblowing Research: Methodological and Moral Issues (New York: Praeger, 1985); James C. Petersen and Dan Farrell, Whistleblowing: Ethical and Legal Issues in Expressing Dissent (Dubuque Iowa: Kendall/Hunt, 1986); Myron Peretz Glazer and Penina Migdal Glazer, The Whistleblowers: Exposing Corruption in Government and Industry (New York: Basic Books, 1989).

[18.] "FDA and the Medical Device Industry," p. 163.

[19.] "FDA and the Medical Device Industry," p. 16.

[20.] Product information letter from Shiley, 30 March 1990.

[21.] "FDA and the Medical Device Industry," p. 177.

[22.] IEEE Engineering in Biology and Medicine Magazine, June 1991, p. 70.

[23.] Cf. "The Bjork-Shiley Heart Valve," pp. 1, 5.

[24.] Safe Medical Devices Act of 1990, Public Law 101-629 [HR 3095]; 28 November 1990, Section 519 (21 U.S.C. 360i)(e)(1).

[25.] Quoted in the Wall Street Journal, 13 March 1992. Italics added.

[26.] See John Fielder and Douglas Birsch, The DC-10 Case: A Study in Applied Ethics, Technology and Society (Albany, N.Y.: SUNY Press, 1992), pp. 111ff.

[27.] For an account of fluctuations between these two poles, see Susan Foote, Managing the Medical Arms Race (Berkeley and Los Angeles: University of California Press, 1992).
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Date:Mar 1, 1993
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