Chicago Medical Malpractice Lawyer Blog

The New York Times (6/16) reports “a medical device maker, Synthes Inc., and four of its executives were indicted Tuesday on federal charges that they improperly promoted a bone filler for purposes not approved by the Food and Drug Administration including encouraging its use in what prosecutors called ‘unauthorized’ human trials.”

The Indictment was sought by the United States attorney in Philadelphia and is one of the strongest actions against medical drug and device makers in years. Michael L. Levy, the United States attorney said, “they put their profits ahead of responsible business practices and the truth.”

In 2002, the FDA approved the bone filler only for general bone repair but regulators “insisted that Synthes not promote its use for spinal procedures.” Charges in the indictment allege that Synthes company officials went behind the FDA’s back and approached selected operators to perform unapproved operations with the understandings that “the company would help them publish their clinical results.”

Cautionary findings, including possible severe blood clotting caused by the use of the bone filler were not taken seriously by executives. The company was further accused of running unauthorized human trials of the bone filler in spinal procedures, which may have lead to three deaths. These deaths were not reported to the FDA.

Improper business relationships between doctors and medical device makers are a cause for concern. If a doctor has the incentive to use one device over another, then patients cannot be certain that they are receiving the best quality care. Incentives drive human behaviors, and as a Chicago medical malpractice lawyer, I feel strongly that such incentives should not influence the doctor-patient relationship.