Doctor vs. device manufacturer: A case study in what not to do

by Lawrence H. Brenner, JD, and B. Sonny Bal, MD, JD, MBA

Although we usually would not highlight one article from the lay press so prominently in our column, a recent article in The New York Times addressing disagreements that arose between a large orthopedic implant manufacturer and one of its valued consultants is one which we feel needs perspective. This very public dispute is valuable in terms of the posture reportedly adopted by the feuding parties relative to one another, and the legal implications that could follow for years to come.

It is commonly known among trial lawyers that juries return damaging verdicts against some types of defendants more frequently than others. For instance, it is widely held that juries are reluctant to return verdicts against physicians and hospitals, but far more willing to rule against product manufacturers and nursing homes, even when the degree and extent of negligence may be the same. The New York Times article raises issues that may pose major problems for both device manufactures and surgeons facing the threat of patient lawsuits. Those problems relate to public perception, and how that can influence jury verdicts.

Lawrence H. Brenner

B. Sonny Bal

‘Public divorce’

The article, entitled “Surgeon vs. Knee Maker, Who’s Rejecting Whom,” described an “angry public divorce” between Dr. Richard A. Berger and Zimmer Holdings, Inc. While the article deals with a dispute between Berger and Zimmer over the safety of an artificial knee, the article casts the entire orthopedic industry in a decidedly unflattering light in several ways.

First, the article explicitly references the Department of Justice’s indictments over consulting contracts, asserting that consultant payments were poorly disguised kickbacks or bribes to orthopedic surgeons. Second, while the dispute between Berger and Zimmer is portrayed, ostensibly, as centering on patient safety issues, allusions to the “tens of millions of dollars” that Berger made for Zimmer, and references to the $8 million that was paid to Berger during the past decade, strongly suggest that the dispute is about money. These references may wrongly suggest to future jurors that financial self-interest permeates orthopedics.

Implant or technique?

This impression is reinforced by the article’s assertion that Zimmer refused to give Berger a new consulting contract following his complaints about an artificial knee model failing prematurely. Specifically, Berger had implanted an uncemented femoral component in total knee patients with the goal of less invasive and more efficient surgery. When a number of patients had to undergo repeat surgery to address loose femoral components that failed to achieve bony ingrowth, Berger raised the alarm. Zimmer blamed his technique instead, and cited competing data demonstrating the safety and efficacy of the femoral component in question.

The Times article cites a patient who wonders why this information relating to implant performance, which was being debated between the company and its consultant, was not disclosed to patients.

With this controversy played out in the public press, a potential juror may question whether Berger anticipated that Zimmer was going to terminate his contract and if his allegations were a form of public retaliation — or did Zimmer retaliate against Berger by terminating his contract? These are reasonable questions that will arise in the minds of lay readers, and future jurors who read the Times article.

Next, the article skeptically notes that the surgeon’s skill sets conveniently matched Zimmer’s marketing strategy, which was to distinguish itself from competitors by promoting minimally invasive procedures, such as the two-incision total hip replacement. It goes on to say that while Berger’s “virtuosity” as a surgeon was being widely promoted by Zimmer, his orthopedic colleagues alternatively raised issues about the safety of the technique.

Additional questions may be raised by readers of the article: Can there be minimally invasive total hip or knee replacement when all the surgeon is doing is making a smaller incision? Are there definable benefits to patients that have been well-documented and published in the literature to support the potential benefits versus the risks of the “minimally invasive approach”? Is the use of the phrase “minimally invasive” in an orthopedic context deceptive to patients, who at some preconscious level may associate it with laparoscopic procedures?

Jurors may wonder whether Berger is advancing the “art of orthopedic surgery,” as the Times article said he claims, or whether he was endangering patients by reducing surgical visibility, thereby increasing the risk of patient injury or implant failure. For his part, Berger, in his comments about the orthopedic industry, “… lambasted Zimmer executives as dissembling, out of touch bureaucrats.” Zimmer in turn defended its product, asserting that Berger’s surgical technique may be the underlying source of his poor patient outcomes.

Berger publicly responded to surgeons who did not see the value of widespread dissemination of his technique, questioning whether they lack “the skill or patience to learn this technique.” He may of course be entirely correct; surgeons do not share the same set of skills or ability. Individual variations in depth perception, appreciation of three-dimensional anatomy, the intuitive feel for tissues, and the application of knowledge to the clinical setting are readily seen among orthopedic residents with similar backgrounds and qualifications. Common sense suggests, and the history of surgery shows that some surgeons are truly exceptional, and able to perform operations that cannot be readily disseminated to peers. It is possible that operations like the two-incision minimally invasive hip replacement were well ahead of their time, and simply too difficult and technically demanding to be performed by all surgeons.

Responsibility

How the contents of the Times article relate to law is that experienced litigators recognize it is often important for corporations and individual defendants to acknowledge responsibility for their acts in order to contain their liability exposure. Throughout the article neither Zimmer, nor Berger, made any effort to assume responsibility for poor patient outcomes, as each shifted blame to the other. This may be particularly salient given the recent public responses to the BP oil-spill failures and the Toyota recalls. In the case of BP, the early reaction of the company was to blame its partners who had done work on its oil well. Toyota executives’ first reaction was to shift blame to the floor mats, and even to the ability of some drivers. In both instances, the defendants, when faced with public anger, capitulated enough to accept responsibility and begin facing the respective problems, but the damage to corporate reputation, professionalism, and integrity had been done by that time.

In law, there is an informal doctrine embraced by at least one court called “palming off.” Palming off, in the litigation context, is where each defendant tries to blame the other defendant for the plaintiff’s injuries. Should any of Berger’s patients file suit, his attorney will likely seek to capitalize on the palming off impact between Zimmer and him, suggested in the Times article. This poses the real threat of inflaming a jury, which could potentially impact the size of the verdict. If the article’s content was transposed to a courtroom setting, there is little doubt that a sympathetic jury would return a “runaway verdict” for the innocent plaintiff trapped between two defendants unwilling or unable to accept responsibility for the patient’s outcome.

In any event, blaming another party is not a reliable method of immunizing oneself against liability. Legal tools have been developed to deal with scenarios in which a jury is so confused by multiple, highly skilled defendants blaming one another that jurors cannot decide who is at fault. In such cases, where it is certain that the offending conduct and resultant blame rest somewhere among the defendants in question, the jury can still return a large verdict against all defendants, leaving them to later sue each other and figure out how to apportion the damages. Shifting blame does not shift potential liability; in fact, it may simply increase the size of the verdict.

A related point is that in the Times article, there is no recognition by any of the quoted sources of the legitimacy of opposing views. This occurs on two levels: the dispute between Berger and Zimmer, and the dispute between Berger and other orthopedic surgeons.

The question arises whether Berger could have better served the orthopedic community had he made a comment such as, “All new medical technologies are controversial, and well-intentioned surgeons may disagree on the efficacy and inherent danger presented by such. While I respectfully disagree with some of my colleagues on the issue of minimally invasive procedures, I also recognize their concerns and respect their skill and devotion to the patients they serve.”

Similarly, there wasn’t any discussion concerning legitimate differences between Berger and Zimmer over whether the implant or the technique (or a combination of the two) may be producing undesirable outcomes.

Other legal actions

The timing of this Times article is relevant, in that it follows recent revelations that DePuy Orthopaedics may be “facing the first of what might be an avalanche of lawsuits over one of its hip implants …” This article, which appeared in the Massachusetts Medical Devices Journal, recites the allegations in one case, suggesting that DePuy failed to provide crucial information to the plaintiff’s orthopedic surgeon, relating to possible adverse patient reactions to its metal-on-metal bearing. While this case filing is still in the early stages, and the outcome is yet unknown, the withholding of critical patient safety information has traditionally inflamed jurors.

It is time for the orthopedic industry and surgeons to construct a positive public image, reinforcing the traditional notions of trust, empathy, safety, and credibility that our profession has worked hard to build. The failure to do so may lead to a cascade of lawsuits with unhappy results for both surgeons and manufacturers, and an accompanying erosion of public confidence and trust that will affect how we work. It may also impede efforts to reduce the poor and sometimes catastrophic outcomes that lead to such lawsuits in the first place.

This is an important topic; the Times article discussed herein is a segue into future columns that will continue to address related concerns as they develop.

Reference:

• Meir B. Surgeon vs. Knee Maker: Who’s Rejecting Whom? New York Times.June 20, 2010:BU1.

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.