What happens when a medical device company puts their profits ahead of patients? In the case of Synthes, it results in illegal clinical testing on patients.

Mina Kimes | CNN Money | September 18, 2012

Our medical malpractice cases often involve hospitals, HMOs and healthcare corporations that disregard basic patient safety rules.  But here’s a chilling account of medical corporate greed and disregarding patient safety we read about in CNN Money recently.

                As CNN Money reported, Synthes, a medical device company, disregarded a decision of the Food and Drug Administration and illegally tested a bone cement on people.

                In 2009 the US attorney in Philadelphia accused the company of running illegal clinical trials, essentially, experimenting on humans. Between 2002 and 2004, Synthes had tested a product called Norian XR, cement that is unique in its ability to turn into bone when injected into the human skeleton.  The FDA had approved two versions of Norian, the cement: Norian SRS, for use in the arm, and Norian CRS, for use in the skull. However, the FDA explicitly it would not authorize the marketing of Norian for use in filling spine fractures, instead instructing Synthes to obtain an Investigational Device Exemption (IDE) and complete clinical trials.

Instead of going through with clinical studies, Synthes marketed and promoted Norian for certain spine surgeries. In doing so they ignored scientists’ cautions that the cement could cause fatal blood clots. This decision resulted in the death of at least five patients, who had Norian injected into their spines, on the operating table.

                The Department of Justice targeted four high ranking executives, who accepted responsibility for the company’s crime of running unauthorized clinical trials and engaging in off-label marketing. Off-label marketing, the promotion of products for unauthorized uses, is very common in the health industry among drug and device makers. In fact, many companies have paid billions of dollars in fines. However this does not deter companies from engaging in off-label marketing, because potential profits often outweigh the fines.

                Ultimately, the four executives were sentenced to jail time, but Syntheses itself suffered little from their crime. The company sold the bone cement unit to another company for $1 million less than its fine. But the civil litigation over Norian is far from over. Four families of patients who were killed from operations involving Norian sued Synthes and the four executives.

                Good luck to the families.


To read the complete story, visit CNN Money.

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