Product News and Recalls

J&J bought troubled Norian XR manufacturer to help own reputation

The Pennsylvania-based company Synthes produced a bone cement called Norian XR, which has been linked to the deaths of five patients who received it for spine surgery. Four high-ranking Synthes executives ended up doing jail time for their role in illegally marketing Norian, despite allegedly being aware of the health risks it presented.

Ironically, pharmaceutical giant Johnson & Johnson acquired Synthes specifically as a means of dealing with damage to J&J’s own reputation in the wake of what Fortune magazine describes as “a series of reputation-sullying recalls and lawsuits in recent years.”

A Fortune magazine article titled “Bad to the Bone: A Medical Horror Story” says J&J officials specifically cited Synthes’s “culture” and “values” as part of the company’s appeal in the nearly $20 billion acquisition. At the time, the Synthes officials awaited sentencing for their part in company practices that Fortune describes as tantamount to experimentation on unwitting human test subjects, with deadly consequences.

According to Fortune, Norian is a calcium-phosphate-based cement that gradually transforms into actual human bone when implanted in the skeleton. Although the U.S. Food and Drug Administration hadn’t approved Norian for spinal surgery, company officials illegally encouraged doctors to use it that way – despite being aware that it could cause fatal blood clots.

Johnson & Johnson is still dealing with the fallout from a series of high-profile recalls. Among those recalls is a type of all-metal artificial hip manufactured by company subsidiary DePuy Orthopaedics, which was pulled from the market in 2010 after a number of studies showed nearly half of them needed replacement within six years.

The DePuy hip implants were also prone to shedding toxic metal debris in patients’ soft tissues.

This year, Johnson & Johnson recalled four different types of transvaginal mesh implants, used to treat urinary incontinence and pelvic organ prolapse. The recall came in response to complaints that the devices caused severe pain and injuries for recipients.

See the Fortune story here:

http://features.blogs.fortune.cnn.com/2012/09/18/synthes-norian-criminal/