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Deferred prosecution agreement: Can it improve surgeon-patient communication?
Settlement can lead to discussions with patients on the surgeon’s role in developing new technologies improving care.
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The deferred prosecution by the U.S. Department of Justice against orthopedic manufacturers has received much publicity, suggesting to the general public that orthopedic surgeons are colluding with industry to promote their own financial gain. This impression is offensive to many if not all orthopedic surgeons who view their specialty as an ethical calling; one that is devoted to improving patient function and patient care quality. Between these two impressions exists a complex reality.
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Does the recent action by the Department of Justice (DOJ) present an opportunity to the orthopedic community that goes beyond the avoidance of criminal prosecution? To answer that question, we first must ask whether the acceptance of illicit consulting fees as alleged by the DOJ is a victimless crime. In other medical contexts, the answer seems clear.
Author Shannon Brownlee, in her book, Overtreated, writes extensively about the practices of drug companies, stating that they “… buy the loyalty of doctors with favors and gifts; inflate the benefits of drugs while deliberately obscuring their risks; and charge far too much for their products.”
As an example, she cites the drug Vioxx: “The only reason to use Vioxx was that it was supposed to be safer, yet doctors prescribed it to millions of patients who were at little to no risk of getting a gastrointestinal bleed from older, cheaper drugs. Merck sent doctors to all-expenses-paid seminars in exotic locales to learn about the drug. Internal memos from Merck obtained by Congress show that company scientists knew about the potential cardiac risk as early as 1997 …”
If Brownlee’s claims about Vioxx are true, then the practice of “buying the loyalty of doctors” produced clearly identifiable victims of a distasteful practice. This class of victims included those who lost their lives, family members who lost a loved one, as well as those who suffered serious injuries. It produced an equally clearly identifiable harm in inflating the cost of health care through the promotion of a substantially more expensive treatment for patients suffering from pain that was only marginally more effective.
Buying loyalty
Purchasing the loyalty of an orthopedic surgeon through a sham consulting agreement is undeniably offensive and cannot be endorsed, sanctioned, or ignored. Nonetheless, this practice does not easily lend itself to identifying patients as victims as suggested in Brownlee’s example of Vioxx. It is accepted that consulting agreements have produced no patient injuries. Further, in order for the offending consulting arrangements to have increased the financial burden of health care, the cost of these agreements would have to be passed on to the health care consumer through inflated prices. Or, the consulting arrangements would have to stimulate orthopedic surgeons to perform unnecessary or questionable procedures. There seems to be little evidence that these consulting agreements have increased costs through either of these mechanisms.
Still, despite the absence of patient harm from illicit consulting arrangements based on patient injury or increased costs, these industry-surgeon arrangements have produced victims, albeit of a different nature.
Right to know
Both American law and medicine recognize the importance of the patient’s right to know. As Justice Cardozo observed in the legal case Schloendorff v. Society of New York Hospitals, “Every human being of adult years and sound mind has a right to determine what shall be done with his own body.” While this has traditionally been viewed as a right to know the risks and benefits associated with a medical treatment, it can be extended to include the patient’s right to know of any undue influence that could impact a surgeon’s decision. This includes the decision to implant one manufacturer’s device over another based upon compensation by the manufacturer.
There is some evidence to suggest that there are differences between what physicians believe patients need to know and the information that the patient desires. As one observer noted in the Journal of Legal Medicine, “In general, physicians overestimate the extent to which people find information troublesome. In medical training, there is a bias toward nondisclosure which is evident in studies comparing patients’ desires for information with the physicians’ perceptions of that desire. For example, while only 13% of physicians say they would give “a straight statistical prognosis” to patients with advances lung cancer, 85% of the public wishes to have that sort of information.”
Albert Einstein once stated, “In the middle of difficulty lies opportunity.” Is it possible for the deferred prosecution agreement between implant manufacturers and the DOJ to serve as the basis for either enhancing or re-exploring the relationship between the orthopedic surgeon and his/her patient? Although the agreement itself is both aggressive and intimidating, nothing about it prevents orthopedic surgeons and device manufacturers from entering into legitimate agreements to advance the state of the art of implant surgery. It is important for every orthopedic surgeon to become familiar with the agreement so that he/she will continue to contribute to advancing orthopedic science through company-sponsored funding. Done properly, such conduct is entirely legal and laudable.
Disclosure
What remains uncertain is how to fulfill the requirement that financial arrangements be disclosed to patients to avoid conflicts of interest. It is in the disclosure process that Einstein’s maxim has the greatest potential to be realized. This disclosure can be viewed very narrowly almost as if the orthopedic surgeon was reading the “Miranda rights” afforded to criminal defendants. A sign could be placed on the office door or on the Website stating that the orthopedic surgeon received funds from a company; the consent forms could be amended to include a statement about any consulting fees or royalties thus received. While these might technically constitute disclosure, they are ineffective for conveying important information to a patient who is about to make a medical decision.
Another way to approach the issue of disclosure is as an opportunity to engage the patient in the process of understanding the orthopedic surgeon’s role in developing new medical technologies that could potentially improve outcomes and reduce complications. The orthopedic surgeon could consider informing the patient that he/she has an ongoing interest in medical research, and that their particular interest is focused in, for example, reducing the pain and recovery from total hip replacement.
He/she could ask if the patient has any questions about the surgeon’s role in the development of these new technologies. In the process, it could be explained to the patient that the research was funded by a particular orthopedic company, and that the surgeon was recommending the implantation of a device manufactured by that company. The patient could then ask questions about any potential differences between the products produced by different orthopedic manufacturers and also be advised that he/she should feel comfortable seeking a second opinion. The orthopedic surgeon should feel free to explain to the patient why he/she has selected a certain device even if the explanation consists of nothing more than stating that he/she routinely uses this manufacturer’s implant and has had good results.
Thomas G. Gutheil, MD, professor of psychiatry at Harvard University, has developed a model for communicating with patients that he has described as the “therapeutic alliance.” Orthopedic patients will undoubtedly be more curious about the practice of orthopedics because of the publicity created by the DOJ deferred prosecution. Orthopedic surgeons should view this publicity as an opportunity to re-discover their relationships with their patients through the process of more open communication about the critical role of the surgeon in advancing and improving orthopedic technology.
For more information:
- B. Sonny Bal, MD, MBA, is associate professor of hip and knee replacement at the Department of Orthopaedic Surgery, University of Missouri School of Medicine.
- Lawrence H. Brenner, JD, is on the faculties of orthopedics at Yale University and the University of Southern California and practices in Chapel Hill, N.C. Address all correspondence to Brenner at lb@lawrencebrennerlaw.com.