Medtronic Inc., the Michigan based medical device giant, has seen its share of troubles in the past few years. From its
Sprint Fidelis recall to allegations of corruption, many say that the company's image has become tarnished. In fact, the New York Times recently reported that Medtronic may have paid a doctor to lie about the success of its controversial Infuse Bone Graft product at the Walter Reed Hospital in Iraq.
Infuse Bone Graft
Medtronic's Infuse Bone Graft product was approved for use in spinal surgeries and to treat broken bones. It was being used to treat soldiers' wounds at Walter Reed Hospital in Baghdad, Iraq and with great success – 92%. At least that's what was being reported by Dr. Timothy Kuklo who published an article about the product’s success in a British medical journal.
However, the U.S. Army investigated Kuklo's findings and found that they were not only untrue, but that he forged the signatures of four other doctors to publish those findings – claiming that they were co-authors – in order to add more credence to the report. So, why would he do that?
Medical device fraud
In addition to his medical duties, Kuklo – now a medical professor in Missouri – was also being paid by Medtronic as a consultant. The Times says that while Medtronic denied allegations of fraud, this is not the first time the medical device giant has been accused of questionable practices. In fact, Republican Iowa Senator Charles Grassley has been investigating Medtronic's practices for well over a year now, specifically that the company paid doctors a fee to recommend its products for unapproved uses – which has made the company big money. Medtronic reported that sales of its bioengineered products reached over $400 million over a six month period which ended in October of 2008. However, some of those profits may end up going to injured victims and whistleblowers…
Product liability & Qui Tam lawsuits filed
Product liability lawyers say that numerous lawsuits have been filed against Medtronic by injured patients or their surviving family members alleging that the Infuse Bone Graft product was used on their necks – which is not an FDA (U.S. Food & Drug Administration) approved use. A whistleblower (or Qui Tam) lawsuit has also been filed against the company by a former employee who alleges that Medtronic entered into secret agreements with doctors to use the product for unapproved uses.