Another Medtronic Off-Label Lawsuit, Senator Charles E. Grassley

Jefferson City, MOAnother Medtronic Infuse lawsuit has been filed, claiming the off-label use of the Infuse bone graft left the plaintiff permanently disabled. A Missouri judge allowed the lawsuit to proceed after dismissing a motion by Medtronic Inc. to dismiss claims of fraud and intentional misrepresentation.

In September 2007, Laura Blankenship underwent cervical spine surgery involving fusion at C4-5, C5-6 and C6-7, with the Infuse bone graft placed at each level, which is an off-label procedure. (“Off-label” usage is defined as “use of a device for some other purpose than that for which it has been approved by the FDA.” Buckman Co. v. Plaintiffs’ LegalComm., 531 U.S. 341, 350 [2001].)

According to court documents, Blankenship claims that shortly after her surgery she experienced severe pain in her head, throat, neck, shoulders and arms, which resulted in her being permanently disabled and unable to maintain employment.

Medtronic off-label use

Blankenship blames her injuries on Medtronic’s improper promotion of the Infuse Bone graft for off-label purposes, and if she had known it was used off-label and aware of the risks involved, she would have never consented to the surgery. She further claims that Medtronic designed a marketing campaign specifically to encourage off-label use of its product by instructing its sales representatives to tell health care providers that the Infuse device was safe for all types of spinal surgeries, and not just those approved by the FDA.

The lawsuit points out that the FDA issued a letter to Medtronic on July 1, 2007 warning against the off-label use of the Infuse device in cervical spine placements and despite these warnings, Medtronic encouraged doctors to use the Infuse device off-label, i.e., non-approved procedures.

Blankenship’s lawsuit alleges failure to warn, design and manufacturing defect, fraud, strict liability, intentional misrepresentation and negligence. The lawsuit states that Medtronic created “a marketing plan that explicitly included the improper over-promotion of off-label uses, by artificially lowering the price of the surgery and instructing their sales forces to visit physicians and other health care providers and mislead them into the false belief that Infuse Bone Graft was safe for all spinal surgeries, and safe for use with non-FDA metal cage devices.”

One of six exhibits included in Blankenship’s claim is a “Staff Report on Medtronic’s Influence on Infuse Clinical Studies” prepared by the U.S. Senate Finance Committee. As well, letters written by Senator Charles E. Grassley were submitted regarding concerns about the safety and marketing of Medtronic’s Infuse bone graft.

Lastly, Blankenship claims that California’s unfair competition law was violated by Medtronic’s business dealings.

This recent decision by Judge Carol E. Jackson allowing Blankenship’s lawsuit to proceed (Case No. 4:13-CV-1087 (CEJ)) may have some bearing on a judge in California currently deciding whether to dismiss 21 products liability lawsuits, and many other Medtronic off-label lawsuits nationwide.