Medtronic to Lay Off Workers Amid Infuse Controversy

Filed May 24th, 2012 tmccoy



by: Michael Werner, Esq.

Following-Infuse-Controversy-Medtronic-lays-off-1000-workersMedtronic, Inc.—the creator of Medtronic Infuse bone growth protein—recently announced that it will lay-off 1,000 employees.   Medtronic’s announcement comes on the heels of continuing declines in earnings in its cardiac rhythm management and spinal products sector.

Although the U.S. Federal Drug Administration’s approval of the Medtronic infuse product was limited to lumbar anterior (front) surgery, for years surgeons have been using the graft for unapproved, “off-label” surgeries.   These “off-label” surgeries include spinal surgeries performed on the lumbar spine through the back, as well as both anterior and posterior (back) cervical surgeries.

As Parker Waichman’s website and blogs have discussed for some time, the Medtronic infuse product’s off-label use may cause serious injury, including:

  • abnormal and uncontrolled bone growth
  • cancer
  • retrograde ejaculation
  • male sterility

Additionally, patients may experience nerve injury, difficulty breathing and swallowing, and radiating pain throughout their body.

In light of the preceding, it is of no wonder that Medtronic’s spinal division has suffered a 26% decrease in sales of the infuse system last quarter alone.  In defense of the planned lay-offs, Medtronic’s Chief Financial Officer pronounced: “It’s kind of the normal, ongoing thing that goes forward was we shift resources from slower-growing markets to faster-growing markets.”  Interestingly, the company skirted the issue as to the cause of the slowly growing markets.

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