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William M. Sullivan, Jr., JD


Partner, Pillsbury Winthrop Shaw Pittman LLP; Co-leader, Corporate Investigations and White Collar Defense Team

What Evidence Is Needed to Prove an Unnecessary Stenting Procedure?

Proving unnecessary stenting in court is often a difficult task, as jurors are generally reluctant to find against a physician in instances where medical experts disagree with the physician’s reasonable medical judgment and decisions. Therefore, most cases that have proceeded to trial typically involve at least circumstantial evidence of wrongful conduct, such as diagnoses that are so gravely inaccurate as to be the result of fraud or systemic failures, including serious negligence.

 

Generally, establishing that a stenting procedure is unnecessary hinges upon the extent of the affected patient’s stenosis, or blockage, as previously determined by the treating physician.  Indeed, according to what has often been presented as the medical community’s consensus, apparently supported by the National Institute of Health’s National Institute of Neurological Disorders and Stroke, stent placement is considered to have limited efficacy, and thus is generally not necessary, until a patient has at least 70 percent stenosis and shows other symptoms of arterial narrowing and blockage.

 

Helpful standards to establish unnecessary stenting may also be drawn from several recent health care fraud prosecutions, which have focused on stenting procedures that, according to the government, failed to satisfy Medicare’s “medical necessity” requirement. In the Medicare context, even when a procedure is approved for Medicare billing, a cardiologist or medical facility may be engaging in misconduct if the treatment is not deemed to be a medical necessity for the patient. Thus, for instance, according to Medicare, carotid artery stenting is considered necessary only for patients who are at high risk and are candidates for carotid endarterectomy, a surgical procedure to remove plaque from the artery, and who also have symptomatic carotid artery stenosis at or above 70 percent. However, for patients that have symptomatic carotid stenosis at 50 percent, stenting is deemed to be a medical necessity only if the stenosis relates to the internal carotid artery, which supplies blood to most of the anterior portion of the cerebrum.

 

Nevertheless, proving unnecessary stenting becomes significantly more difficult when, after reviewing a patient’s angiogram, medical experts disagree as to the actual percentage of arterial blockage. Indeed, at least one court has found, quite recently, that interpreting angiograms is actually a difficult task and cardiologists frequently disagree with one another regarding the degree of stenosis. Moreover, it appears that inter-observer variability could very well account for significant differences between doctors’ reasonable interpretations, adding to potential discrepancies in the level of stenosis that is being diagnosed. Consequently, in this situation, proving that a stenting procedure was unnecessary will often rely on the availability of other circumstantial evidence reflecting related failures to comply with accepted best practices in identifying and diagnosing symptoms of blockage, as well as the percentage of stenosis.


 

Mr. Sullivan is a Partner at Pillsbury Winthrop Shaw Pittman LLP, practicing out of the Washington DC and New York offices. He concentrates on corporate internal investigations, trial practice and white-collar criminal defense, as well as complex civil litigation, securities enforcement, antitrust cartel investigations and litigation, export control and other regulatory actions.

 

He is the co-leader of the firm’s Corporate Investigations and White Collar Defense team, has substantial experience in the courtroom, the boardroom and in between, representing public and private companies as well as key executives and public officials in global corporate regulatory and internal investigations, parallel proceedings, trial and grand jury matters, congressional and independent counsel inquiries, public corruption matters and white collar criminal defense, with a particular emphasis on the Foreign Corrupt Practices Act (FCPA), antitrust and securities matters, international trade and export control, as well as the Foreign Tax Compliance Act (FATCA).

 

Previously, he was an Assistant United States Attorney for the District of Columbia. He has won over 70 federal criminal jury cases and has argued, and prevailed, in over 20 appeals in both New York and the District of Columbia. He won numerous Department of Justice awards and commendations.

 

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