Pharmaceutical industry and physician relationships explored: Part 2

Editor’s Note: This article is the second in a two-part series dealing with the medical legal implications that arise from mass marketing efforts by the drug industry. Part 1 was published in the November issue of Orthopedics Today.

Author Paul Starr, in his classic book titled, “The social transformation of American medicine: The rise of a sovereign profession and the making of a vast industry,” provides a historical perspective on the medical community’s historical efforts to maintain its sovereignty and autonomy. This zeal for autonomy has been traditionally directed towards the federal government. The last several decades have also produced a strong response by organized medicine to the health care insurance industry invading the prerogative or autonomy of physicians in making choices about managing their patient’s health (an invasion of the medical profession’s sovereign right to decide what’s best for patient care).

In order to understand the legal issues that may flow from the vast marketing efforts by drug companies and manufacturers, physicians and surgeons need to understand that these efforts compromise medical sovereignty in a way that is subtle, yet potentially more powerful than either the federal government or the health care insurance industry.

This invasion of the sacred right of the physicians or surgeons to make independent health care decisions in collaboration with their patients poses legal exposure to individual physicians and surgeons in several ways. The relevant issues are explored further in this article, which follows our first, similar article on this subject that was published in the November issue of Orthopedics Today.

The clinical double-bind

B. Sonny Bal

Lawrence H. Brenner

In the early 1980s, a patient’s estate brought a lawsuit against a community hospital for the death of a much-loved wife and mother. The patient was morbidly obese and made an appointment with a general surgeon. She requested that the physician perform an ileojejeunal bypass surgery. The general surgeon advised her that there had been a consensus conference where bariatric surgeons concluded that the ileojejeunal surgery, which she had requested, was contraindicated in all patients because of the unacceptably high death rate.

The patient responded that she understood the high risk, but had failed to lose weight with a gastric stapling and told the surgeon, “I would rather be dead than obese. I know what I am doing, and I’m requesting that you perform the procedure.” When the procedure resulted in her death, her estate brought an action against the surgeon, whose defense was that he told the patient not to undergo the procedure, advised her of the high risk of death, that she accepted that risk, and that it would be unjust to hold him accountable for the consequences of a decision which she not only consented to, but insisted upon. In essence, the surgeon argued that he was in a “clinical double-bind” because if he failed to perform the surgery he would be denying the patient that which she desperately wanted, and if he did perform the surgery he was placing his patient at great risk of death.

The case resulted in a substantial settlement to the estate. What does this case have to do with massive drug marketing? Increasingly, drug manufacturers are marketing their products directly to patients since 2006. These advertisements are persuasive. They typically show a family in distress at the beginning of the ad, and the final images are of a cohesive, happy family, suggesting that the medication being advertised not only can address a medical problem, but will transform the patient’s life. Consequently, much like the patient who died in the ileojejeunal bypass procedure, the medical profession is reporting that patients now come to physician’s offices requesting drug products, which they have seen in advertisements. This has transformed the transaction between the physician and the patient. Classically, the patient would report signs and symptoms to the physician and surgeon, who would recommend a course of medical management.

Currently, one of the most widely marketed classes of drugs relates to antipsychotics, which have enormous profit margins for drug manufacturers, but also can produce devastating side effects such as tardive dyskinesia. The physician whose patients insist upon augmenting their antidepressant with an antipsychotic medication is in a liability/clinical double bind. If the physician refused augmentation and the patient commits suicide, then would there be liability for the patient’s death? If the physician capitulated and prescribed the antipsychotic, leading to tardive dyskinesia, then would be physician be liable for the complications?

It is clear that new protocols and methods of communicating with patients must be developed now that drug manufacturers have altered the decision-making process by appealing directly to patients to discuss, if not demand, highly advertised medications.

Conflict of interest

As the medical community continues to succeed in restricting the patient’s ability to collect damages through medical malpractice “reform,” attorneys who represent patients will find creative avenues to increase the chances of a substantial verdict. Those who have studied jury behavior have long known that plaintiffs who can introduce a financial element to a negligence claim stand a much better chance of obtaining a large verdict. They also stand a much better chance that the court would allow the jury to return a verdict that includes punitive damages. This has often occurred in product failure litigation. The Ford Pinto not only had a gas tank that could explode with lethal results, but the cost of making the car safer turned out to be rather minimal. In the ensuing litigation, this tradeoff of a large corporation saving a few dollars at the cost of consumer safety lead to massive verdicts, which included punitive damages.

What are the potential legal consequences if attorneys for patients discover that physicians or surgeons have received benefits in the form of cash, trips or even small items from drug or device manufacturers? Could a jury be inflamed if they believed that a physician or surgeon prescribed a new medication or performed a new procedure as a result of financial benefits they received? Would the court allow the jury to return a verdict that included punitive damages? Would these punitive damages serve to bypass any limitations on compensatory damages created by “reform?” As statutory caps on economic damages on medical malpractice claims get tested in a number of state supreme courts, these issues are increasingly worthy of closer examination.

Drug and device manufacturers typically promote new products and devices since they are more profitable and the patent protection creates a monopoly that can produce the desired free market effect — blockbuster sales greater than $1 billion. The typical cycle is that these new medications or devices are heavily marketed as better than existing drugs or devices. Unforeseen complications can then arise, leading to class action liability lawsuits. Physicians and surgeons can be named as defendants in these lawsuits for the failure to take appropriate steps to protect their patients.

From a liability standpoint, it is important to be skeptical with medical advances and new technologies and to exercise caution in thoroughly discussing with patients the uncertainties about any medication or product being heavily promoted as better than existing medications or technologies. Documentation of such forthright discussion in the record is helpful to later defense of a physician ensnared in litigation related to the new technology. Thus, the informed consent process becomes an important component of malpractice loss prevention in the face of new and heavily marketed drug advancements and new technologies. This is especially true if the prescribing physician has any financial or other beneficial interest in the underlying technology, vendor or manufacturer. There is no substitute for an honest and full disclosure of all information that may be deemed material to the patient decision-making process.

Further litigation

While the contours of the legal exposure created by drug and device marketing are still difficult to define, and will doubtless continue to evolve with further litigation, such as that related to failed metal-on-metal total hips, for example, there is little doubt that these marketing efforts create exposure to physicians and surgeons to liability lawsuits. More important, the subtle but powerful invasion of physician/surgeon sovereignty has to be resisted with the same organized zeal that medicine has demonstrated in opposing the loss of autonomy through federal intervention and the utilization restrictions imposed by the health care industry.

Much that is new will contribute to better results, shorter lengths of stay, and less pain for patients; but physicians and surgeons need to remain cautious and independent in their judgment. They also need to understand and adapt to the impact that mass marketing has on the demands that patients will make of them. Physician professional judgment is a time-honored strength and attribute of the medical profession that civilization holds in great esteem and deference; it should not yield to marketing pressures and financial inducements.

What do you think?

1. In the legal case mentioned above, do you feel that it was fair to hold the general surgeon liable to the patient’s estate in the ileojejeunal bypass case?
2. What is the best approach to discuss with patients your belief that their request that you prescribe a drug, which has been advertised, is not, in your opinion, in their best interest?
3. Is the receipt of gifts, speaker’s fees or other remuneration from the drug companies to promote their drug product a conflict of interest?
4. Can conflict of interest co-exist with the patient’s best interest, such that disclosure may not be necessary?

• B. Sonny Bal, MD, JD, MBA, is associate professor of hip and knee replacement in the department of orthopedic 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.