Feature Article

Lessons Learned from Stryker Biotech Case

Published: August 30, 2012
By: Robert L. Ullmann
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Although recently dropped, the DOJ case exposes risks in the physician-manufacturer relationship.

Earlier this year the U.S. Department of Justice announced that it was dropping all criminal charges against former Stryker Biotech employees shortly after the start of what was expected to be a fiercely fought six-week trial. Just days earlier, the government had settled with Stryker Biotech for a single misdemeanor plea and a $15 million fine—a paltry sum compared to fines of several hundred million dollars and even billions of dollars that the federal government has secured in other drug and medical device cases. When the Stryker trial abruptly ended, it seemed that much of the entire medical device industry breathed a collective sigh of relief.

The Stryker Biotech case exposed certain potential vulnerabilities inherent in the relationships between medical device companies and physicians that should receive the industry’s full attention. The decision of the Boston U.S. Attorney’s Office to wrap up its case so early in the proceedings temporarily precluded any public airing of these issues.
 
Given broad public concerns about potential doctor-industry conflicts of interest and the quality and cost of healthcare, aggressive law enforcement, legislative action, and civil litigation against medical device firms are not going away any time soon. While working with policy makers, the medical device industry would help itself greatly by addressing some of the difficult questions posed by the Stryker case and other legal proceedings. Fundamentally, our legal system must balance the need to insulate physicians from undue industry influence with the fundamental role that industry-physician collaboration plays in research, innovation, and the safe and effective use of medical devices.

Read the full article, "Stryker Biotech Case Exposes Risks in Physician-Manufacturer Relationship," on MD+DI's site.

Robert L. Ullmann
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