Medtronic Inc. a world leader in medical device technology recently announced that it plans to pay $22 million to settle claims with 950 persons over it’s INFUSE bone graft technology. Under the agreement Medtronic escaped admitting any liability over problems with INFUSE and indicated that it would vigorously contest future litigation.
This settlement may only be the tip of the iceberg however. An additional 1,200 filed claims and an estimated 2,600 unfiled claims remain pending. Medtronic anticipates incurring total settlement costs between $120 and $140 million dollars to resolve all of the claims.
In 2002 the FDA approved INFUSE for use in the lower back. Since it’s approval INFUSE has been used in over one million patients. In the suit Medtronic is accused of misleading doctors about the safety of INFUSE for ‘off label’ use in other parts of the body. U.S. lawmakers and spinal experts have also charged that Medtronic-sponsored studies overstated the product’s benefits and downplayed the risks.
Cases like this raise complicated questions of fault and causation when off-label use goes wrong. Doctors are not required to follow FDA approved uses and may prescribe drugs and devices for any use as they see fit. The side-effects from collateral uses may not be well understood or as safe as the uses approved by the FDA. Pharmaceutical companies are not supposed to actively market products off-label but it is nonetheless a lucrative practice that appears to continue as a way to increase revenues from existing drugs.
Manufacturers are often protected from suits due to U.S. Supreme Court decisions that exclude people injured by FDA approved medical devices from suing their makers. These decisions have been weakened recently as courts are becoming more and more willing to allow suits against manufacturers over injuries arising from off-label uses. When evaluating a potential medical malpractice case this raises an interesting new dimension of inquiry and avenue for recovery. An off-label use leading to injury may expose both the manufacturer and the physician to liability.
This is not the first trouble for Medtronic related to INFUSE. In 2012 disgruntled investors settle out-of-court for $85 million over claims of Medtronic illegally inflating it’s stock price by not disclosing the rampant off-label use of INFUSE.
Memphis Business Journal: “Medtronic Pays $22 Million to Settle Lawsuit“
MED Device Online: “Medtronic Agrees to Settle Certain INFUSE Bone Graft Product Liability Cases“