Lawsuits against Medtronic continue over its Infuse Bone Graft product. The medical device giant is being accused of marketing the product for off label uses not approved by the U.S. Food and Drug Administration (FDA).

Product liability lawsuits filed

According to news reports, product liability lawsuits have been filed against Medtronic for promoting off label uses of its Infuse Bone Graft, a liquid bone simulator. The product was approved for lumbar spine and dental procedures, but the company has allegedly been marketing the product for use in the cervical spine as well – something which the FDA has not approved. The latter has caused patients serious injuries and three lawsuits have already been filed against the company.

Details of the lawsuits

Three lawsuits, in California, Texas and New York, have been filed against Medtronic to date and legal analysts say that additional lawsuits are likely. Here are the details of those cases:

• California. The first reported wrongful death lawsuit was filed in December of 2008 by the family of Shirley Nesbit, a California woman who died after being given the product to treat neck pain. The product caused her throat to swell so severely that she suffocated before a breathing tube could be inserted. Interestingly, a Medtronic salesperson was present when her surgery took place, but her death was not timely reported to the FDA as required.
• Texas. The second reported lawsuit was filed in early January 2009 by Mary Selke who, like Nesbit, claims that the product made her unable to breathe or swallow during neck surgery. The side effect required her to undergo additional emergency surgery.
• New York. The third reported lawsuit was filed later in January 2009 by Paul Antonelli. Infuse was used during surgical spine surgery, and like the patients above, he too began to suffocate and was required to undergo additional emergency surgery. Antonelli’s lawsuit also claims that a Medtronic sales representative was present during his surgery.

Whistleblower lawsuit

In addition to the lawsuits described above, a whistleblower – or Qui Tam – lawsuit was also filed against Medtronic in January of 2009 alleging that the company entered into secret agreements with doctors to use its Infuse Bone Graft product.

If you’ve been injured due to a defective or dangerous product, contact an experienced products liability attorney to discuss your case and evaluate your options. Consultations with an attorney are free, without obligation and are strictly confidential.