Essay: Case study – orthopaedic surgeon, ethics

This case study is about, in essence, an apparently successful orthopaedic surgeon who we find out is unethical. His primary job is as a consultant for companies that make medical devices used in hip replacements. He makes about $75,000 a year from this consulting work (in addition to the high income of an orthopedic surgeon). Dr. Rife owns shares of a company called StarDev. This company manufactures, among other things, “pedicle screws.” Pedicle screws are used to immobilize part of the spine. StarDev’s pedicle screw is supposed to be more durable than existing screws, but it reduces patient mobility a bit. there is a give and take there, and it is not certain whether the traditional model or StarDev’s model is better. As a result, StarDev is undergoing clinical trials of its screw.
Ms. Lee is an elementary-school PE teacher with back pain. Dr. Rife properly concluded that surgery was required. He recommended her for the trial, telling her that StarDev’s screw was more durable than the pedicle screws other surgeons used. She expressed interest, and he gave her the informed-consent form. The informed consent form was very long (25 pages) and the disclosure about Dr. Rife’s ownership of StarDev was buried somewhere in the middle. Ms. Lee did not read the form thoroughly, and she did not notice the disclosure. Her roommate did notice the disclosure, fortunately, and warned Ms. Lee about it. Ms. Lee was not concerned, went through with the trial, and was satisfied with the results.
Discussion
Dr. Rife’s actions were immoral for the reasons described in numbers 1 to 4 below.
1. In my view Dr. Rife’s involvement in the company should not have disqualified him from taking a leadership role in the trial. It seems to me that the reason it might is that he could have a conflict of interest, as he wants his company to perform well financially. But investigators will generally have some interest in the outcome of the trial: investigators who generally produce favorable results for medical-device trials will likely be retained by the device companies in the future. Dr. Rife’s  involvement with the company can also incentivize him to do a better job and be more careful as a result of his. His reputation is attached to the safety and long-term performance of the pedicle screws in a way that it would not be if he were an unaffiliated investigator.
2. Dr. Rife should not have recruited his own patients for the trial. By doing so, he the trust he has earned from his patients trust accumulated within the context of a relationship that is ordered towards their benefit, and not for his towards his own goals. Informed consent needs to be looked at as something nuanced and as something that isn’t as black or white as you know or don’t know. Obviously from this case its clear that there are levels to informed consent. it goes back to freedom of autonomy if someone knows all of the factor’s of an action thats one thing but it is in no way ethical if your tricking someone who is unknowingly risking more then what they would be comfortable with. There needs to be clearer distinctions  and a more thorough checklist for  informed consent in order to not have these types of complications. Even if the device truly is beneficial, his conflict of interest should prevent him from recommending trial participation.
3. I don’t see a problem. Society is very likely better-off when experts (who are very likely to be practicing doctors) consult on the creation of medical devices.
4. On utilitarianism, Dr. Rife’s actions were probably moral. We don’t know whether a traditional pedicle screw would have failed for Ms. Lee, so it is impossible to be certain. If the traditional pedicle screw would have failed, then Ms. Lee is probably better off. Her experimental screw did not fail, and the cost was only a slight decrease in mobility. But if it would not have failed, then Ms. Lee is definitely worse off. The cost of a slight decrease in mobility is not counterbalanced by any advantage over the traditional screw. On rule consequentialism, Dr. Rife’s actions were immoral for the reasons described above in 1–4.
On Kantian deontology, Dr. Rife’s actions were improper. He treated Ms. Lee as a means to an end (that end being the successful completion of the trial and the money that a successful trial would make him). The most sympathetic reading of Dr. Rife is that the end for which he treated Ms. Lee as a means is her own health and well-being. However, depriving a person of agency, even in order to do something that will make them better off, treats them as a means and not an end. It does not matter whether that end is one they would have chosen for themselves. The point is that they must have the opportunity to actually choose it. Dr. Rife could have accomplished this by being more careful about disclosing his conflicts of interest.
5. It would be helpful to know, hypothetically, what would have happened if Ms. Lee had used a traditional pedicle screw. If a traditional pedicle screw would have worked, then Ms. Lee would have been better off with one of those.
6. Yes. For the reasons I discussed above when applying Kantian deontology, a more thorough discussion of the conflict of interest, including encouraging Ms. Lee to seek a second opinion if she was unsure, would make his actions ethical, or at least less unethical. It would depend on exactly how Dr. Rife talked about the device and how he described his own conflicts of interest.
7. Probably not, I can think of relatively few people to whom that duty would be owed: the research subject himself or herself, the researchers, and any dependents of the research subject. With respect to the first candidate, one generally owes oneself only the duties which are necessary for human flourishing. Those are primarily moral duties; that is, they are duties that contribute to the development of a healthy personal character. So a person might have a moral responsibility to carefully read a consent form if, for instance, it is a psychoactive drug being tested.
In the case of the second candidate,  a subject might owe the researchers the obligation of checking the consent form to determine if there are any risks or dangers to which the subject is especially susceptible, so as to avoid derailing the study. However, that duty would serve only to mitigate the consequences of the researchers’ own failures in their own moral duties. The duty being to carefully explain all salient facts before providing a complex form, and also the duty to investigate the participants’ medical backgrounds independently. One generally does not owe others a duty to protect them from the consequences of their failures, absent some special relationship (for instance, the relationship of a parent to a child).
The third candidate is the most feasible out of all of them. A person who has dependents, for instance small children, who would be destitute without the support of that person has additional obligations. For instance, a person who has small children and who has no hope of finding a new job if he loses his current one has a moral obligation not to swear at his boss, even if his boss deserves it (and it would thus be okay for a person without dependents to do so). Not every person has such dependents, though, so the morality of proceeding with a trial without careful investigation will generally depend on whether one is supporting anyone else.