The plaintiff in a product liability lawsuit asked the U.S. Supreme Court to take up the case, involving alleged off-label promotion of Medtronic‘s (NYSE:MDT) controversial Infuse bone-growth protein.
Patricia Caplinger wants the high court to review an April decision by the U.S Court of Appeals for the 10th Circuit that her state-law tort claims are preempted by federal law. Caplinger had argued that her claims survived preemption because the device was used in a manner not approved by the Food & Drug Administration.
In a Sept. 11 petition for certiorari, Caplinger asked the Supremes to decide “whether state-law claims based on injuries caused by a medical device are preempted where the device was not granted premarket approval for the particular use that caused the injuries and the manufacturer marketed the device for that unapproved use,” according to court documents.
Caplinger had lumbar spinal fusion surgery in August 2010, in which her surgeon used an unapproved posterior approach to implant the Infuse device, according to the documents. By the fall of that year her symptoms returned and worsened; Caplinger developed a foot-drop condition in her right leg “resulting from exuberant bone growth caused by the use of Infuse,” according to the petition. In December 2010 the foot-drop condition caused a tear in her anterior cruciate ligament, leading to knee surgery early the next year. Caplinger had revision spine surgery in September 2011 after MRI and CT scans revealed “exuberant” bone growth in her lumbar spine allegedly cause by Infuse, she claimed in the petition.
“Ms. Caplinger continues to suffer exuberant bone growth and the resulting pain, weakness, and foot drop. A June 2012 CT scan confirmed continuing exuberant bone growth that required additional surgery,” according to the petition.
The 10th Circuit appeals court said in May that it would not re-hear Caplinger’s suit en banc, a year after Medtronic agreed to settle approximately 950 product liability lawsuits for $22 million, but admitted no wrongdoing.
A month later, health insurer Humana (NYSE:HUM) leveled a racketeering lawsuit against Medtronic, accusing it of rigging the presentation of Infuse scientific data and of pushing its use in off-label procedures.